SACRAMENTO – California State Epidemiologist Dr. Erica S. Pan issued the following statement today recommending providers pause the administration of lot 41L20A of the Moderna COVID-19 vaccine due to possible allergic reactions that are under investigation.
“Our goal is to provide the COVID vaccine safely, swiftly and equitably,” said Dr. Pan. “A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic. Fewer than 10 individuals required medical attention over the span of 24 hours. Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna Lot 041L20A until the investigation by the CDC, FDA, Moderna and the state is complete. We will provide an update as we learn more.”
All appeared to be experiencing a possible severe allergic reaction during the standard observation period – a type of adverse event that the CDC reports some people have experienced when receiving a COVID-19 vaccine.
While no vaccine or medical procedure is without risk, the risk of a serious adverse reaction is very small. While less data exists on adverse reactions related to the Moderna vaccine, a similar vaccine shows that the expected rate of anaphylaxis is approximately 1 in 100,000.
More than 330,000 doses from this lot have been distributed to 287 providers across the state. The shipments arrived in California between Jan. 5 and 12. The state has not been notified of any other cluster or individual events related to this lot.
The manufacturer, Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are reviewing the lot and related medical information.
Below is the recommendation sent to providers today:
Recommendation that Providers Pause Administration of Moderna’s COVID-19 Vaccine Lot 041L20A
This week, a higher-than-usual number of adverse events were reported with a specific lot of Moderna vaccine (Moderna Lot 041L20A) administered at one community vaccination clinic. Fewer than ten individuals required medical attention over the span of 24 hours. Follow up investigation of outcomes of these individuals is underway, and more information will be forthcoming.
All appeared to be experiencing a possible severe allergic reaction during the standard observation period – a type of adverse event that the CDC reports some people have experienced when receiving a COVID-19 vaccine. The vaccine site switched to another lot of Moderna vaccine after closing for a few hours.
More than 330,000 doses from this lot have been distributed in the state, and we have not been notified of any other cluster or individual events related to this lot.
The manufacturer, CDC and FDA are promptly reviewing the lot and related medical information. No additional clusters have been reported. Their investigation continues, and we expect to learn more this week.
Out of an extreme abundance of caution and also recognizing the extremely limited supply of vaccine, we are recommending that providers use other available vaccine inventory and pause administration of vaccines from Moderna Lot 041L20A until the investigation is complete.
There are not immediate replacement doses during the pause in addition to pending orders scheduled for shipment in the next few days.
We expect to provide an update this week as we learn more.
Providers of COVID-19 vaccine should continue their routine precautions to recognize and manage allergic reactions and potential adverse events.
Trouble with Moderna vaccine in Californihttps://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html
These interim considerations provide information on preparing for the initial assessment and management of anaphylaxis following COVID-19 vaccination. Institutional practices and site-specific factors may also be considered. In all cases, appropriate medical treatment for severe allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of a COVID-19 vaccine.alert icon
Appropriate medical treatment for severe allergic reactions must be immediately available in the event that an acute anaphylactic reaction occurs following administration of an mRNA COVID-19 vaccine.
Observation period following COVID-19 vaccination
CDC currently recommends that persons without contraindications to vaccination who receive an mRNA COVID-19 vaccine be observed after vaccination for the following time periods:
30 minutes: Persons with a history of an immediate allergic reaction of any severity to a vaccine or injectable therapy and persons with a history of anaphylaxis due to any cause.
15 minutes: All other persons
Early recognition of anaphylaxis
Because anaphylaxis requires immediate treatment, diagnosis is primarily made based on recognition of clinical signs and symptoms, including:
Respiratory: sensation of throat closing, stridor (high-pitched sound while breathing), shortness of breath, wheeze, cough
Skin/mucosal: generalized hives, itching, or swelling of lips, face, throat
Symptoms of anaphylaxis might be more difficult to recognize in persons with communication difficulties, such as long-term care facility residents with cognitive impairment, those with neurologic disease, or those taking medications that can cause sedation. Persons with communication difficulties should therefore be monitored closely for the signs and symptoms of anaphylaxis listed above after receiving an mRNA COVID-19 vaccine, and should also be monitored for more non-specific signs of possible anaphylaxis including flushing, sudden increase in secretions (from eyes, nose, or mouth), coughing, trouble swallowing, agitation, or acute change in mental status.
Symptoms often occur within 15-30 minutes of vaccination, though it can sometimes take several hours for symptoms to appear. Early signs of anaphylaxis can resemble a mild allergic reaction, and it is often difficult to predict whether initial, mild symptoms will progress to become an anaphylactic reaction. In addition, not all symptoms listed above are necessarily present during anaphylaxis, and not all patients have skin reactions. Symptoms are considered generalized if there are generalized hives or more than one body system (e.g., cardiovascular, gastrointestinal) is involved. If a patient develops itching and swelling confined to the injection site, the patient should be observed closely for the development of generalized symptoms (beyond the recommended observation periods noted above, if necessary). If symptoms are generalized, epinephrine should be administered as soon as possible, emergency medical services should be contacted, and patients should be transferred to a higher level of medical care. In addition, patients should be instructed to seek immediate medical care if they develop signs or symptoms of an allergic reaction after their observation period ends and they have left the vaccination site.
Medications and supplies for assessing and managing anaphylaxis
COVID-19 vaccines will likely be administered in a wide variety of clinical settings, including hospitals, long-term care facilities, outpatient medical offices, pharmacies, mass vaccination sites, and curbside or drive-through sites. These settings differ in terms of usual on-hand human and material resources to manage anaphylaxis. The following medications and supplies are important for evaluating and managing of anaphylaxis and are recommended for COVID-19 vaccination sites.
The following emergency equipment should be immediately available to the clinical team assessing and managing anaphylaxis.
Should be available at all sites
If feasible, include at sites (not required)
Epinephrine prefilled syringe or autoinjector*
Pulse oximeter
H1 antihistamine (e.g., diphenhydramine)†
Oxygen
Blood pressure cuff
Bronchodilator (e.g., albuterol)
Stethoscope
H2 antihistamine (e.g., famotidine, cimetidine)
Timing device to assess pulse
Intravenous fluids
Intubation kit
Adult-sized pocket mask with one-way valve (also known as cardiopulmonary resuscitation (CPR) mask)
*COVID-19 vaccination sites should have at least 3 doses of epinephrine on hand at any given time. †Antihistamines may be given as adjunctive treatment but should not be used as initial or sole treatment for anaphylaxis. Additionally, caution should be used if oral medications are administered to persons with impending airway obstruction.
Management of anaphylaxis at a COVID-19 vaccination site
If anaphylaxis is suspected, take the following steps:
Rapidly assess airway, breathing, circulation, and mentation (mental activity).
Call for emergency medical services.
Place the patient in a supine position (face up), with feet elevated, unless upper airway obstruction is present or the patient is vomiting.
Epinephrine (1 mg/ml aqueous solution [1:1000 dilution]) is the first-line treatment for anaphylaxis and should be administered immediately.
In adults, administer a 0.3 mg intramuscular dose using a premeasured or prefilled syringe, or an autoinjector in the mid-outer thigh.
The maximum adult dose is 0.5 mg per dose.
Epinephrine dose may be repeated every 5-15 minutes (or more often) as needed to control symptoms while waiting for emergency medical services.
Because of the acute, life-threatening nature of anaphylaxis, there are no contraindications to epinephrine administration.
Antihistamines (e.g., H1 or H2 antihistamines) and bronchodilators do not treat airway obstruction or hypotension, and thus are not first-line treatments for anaphylaxis. However, they can help provide relief for hives and itching (antihistamines) or symptoms of respiratory distress (bronchodilators) but should only be administered after epinephrine in a patient with anaphylaxis. Because anaphylaxis may recur after patients begin to recover, monitoring in a medical facility for at least several hours is advised, even after complete resolution of symptoms and signs.
Considerations for anaphylaxis management in special populations
Older adults, including long-term care facility residents There are no contraindications to the administration of epinephrine for the treatment of anaphylaxis. Although adverse cardiac events, such as myocardial infarction or acute coronary syndrome, have been reported in some patients who received epinephrine for treatment of anaphylaxis (particularly among older adults with hypertension and/or atherosclerotic heart disease) epinephrine is the first-line treatment for anaphylaxis. It is important that sites providing vaccination to older adults, including long-term care facility residents, have healthcare personnel on hand who are able to recognize the signs and symptoms of anaphylaxis. This will help to not only ensure appropriate and prompt treatment in patients with anaphylaxis, but also to avoid unnecessary epinephrine administration in patients who do not have anaphylaxis.
Pregnant people Pregnant people with anaphylaxis should be managed the same as non-pregnant people. They should be closely monitored to ensure adequate perfusion, and their fetus should be closely monitored as well, as appropriate.
Patient counseling
Patients who experience anaphylaxis after the first dose of COVID-19 vaccination should be instructed not to receive additional doses. In addition, patients should be referred to an allergist-immunologist for appropriate work-up and additional counseling.
Reporting of anaphylaxis
Any adverse events that occur in a recipient following COVID-19 vaccination, including anaphylaxis, should be reported to the Vaccine Adverse Event Reporting System (VAERS). Vaccination providers administering a COVID-19 vaccine that is under Emergency Use Authorization are required by the Food and Drug Administration to report vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome, and cases of COVID-19 that result in hospitalization or death. Reporting is also encouraged for any other clinically significant adverse event, even if it is uncertain whether the vaccine caused the event. Information on how to submit a report to VAERS is available at https://vaers.hhs.govexternal icon or by calling 1-800-822-7967. In addition, CDC has developed a new, voluntary, smartphone-based tool, called v-safe, that uses text messaging and web surveys to provide patients with near real-time health check-ins after they receive a COVID-19 vaccination. CDC/v-safe call center representatives will follow up on reports of medically significant health impacts to collect additional information to complete a VAERS report. Information on v-safe is available here: /vsafe
Lieberman P, et al. “Anaphylaxis: A practice parameter update.” Annals of Allergy, Asthma & Immunology 2015; 115(5): 341-384. doi: 10.1016/j.anai.2015.07.019.
Shaker MS, et al. “Anaphylaxis-a 2020 practice parameter update, systematic review, and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) analysis.” Journal of Allergy and Clinical Immunology 2020;145(4):1082-1123. doi: 10.1016/j.jaci.2020.01.017.
Such a shame you may have tried to make Make America Great Again and you may have accomplished certain actions preventing America from going down the drain
But your arrogance and disdain plus your bullying and attempts at forced shame really called your self aggrandizement nothing but a cynical political game
Your attempted attempt at a coup made millions call you a political poop with no more intelligence than the characters on “F Troop”
Happy sailing you murderous and barbaric brute at the end of the day the fascists will say you were cute and I can only hope your Republican enablers will shut up an in embarrassment keep mute
Chapter 16 “Lessons learnt from the COVIDs; Fuck the Vulnerable Movement”
Initially COVID-19 witnessed a polite population when the only sacrifice was finding toilet paper then hiding out at home. Hospital beds just managed to cope with the seriously ill. Now the seriously ill and the fatalities were highly skewed towards the elderly in scandalously filthy and incompetently managed long term care residences housing the seriously ill elderly the medical system had worked blindly to keep alive despite the poor quality of life they had.
Yes as a cardiologist I had warned so many of these unfortunates their lifestyle was killing them but as many do (and often wisely) they ignored the warnings I gave them and many paid the price with strokes, heart attacks, diabetes and then once immobile obesity. So the fatalities were not the youngsters at an Alabama beach or at Trinity-Bellwood’s Park but the febrile and crippled elderly or the diabetics, obese, indigenous populations, or those affected by heart issues.
As the second wave of COVID-19 hit in 2021 the casualties were enormous and just about wiped out all those with comorbidities or ethnicity as described above. Yet the drain on the health system dealing with the comorbidities resulted in excluding millions from care if such a concept existed in their country.
So in many Western countries with hospital beds and possible life saving technology a movement began to form which took on the nomenclature of “Fuck the Vulnerable Movement”. It was somewhat reminiscent of the “We are the 99%” movement that flashed up and out in the 90’s.In this case it was not resentment but rather extreme fear of being left to die in street as “the fat, old and crippled” received all the medical attention. And many did die in the street but not before firebombing long term care facilities, committing murderous atrocities in aboriginal communities and bludgeoning to death the obese.
For a time they were contained by police and the military but they remained a bubbling lava core ready to re-emerge to meet Virus #26 with a virulent right wing movement. The core leadership was located in Michigan and Florida and apparently had links to the Klan. It made an easy transition to Europe in Hungary and Germany where it was nationalized by the neo-Nazi movement and exported to disaffected millennials throughout Europe.
The bottom line of these groups was why waste resources and vaccinations on the sickest and most frail. Why weren’t the healthy young population worth priority. As the vaccination supplies withered the Fuck the Vulnerable movement gained steam. At one point they managed to create a social media advertisement questioning the wisdom of vaccinating a 82 year old Alzheimer’s “vegetable” as opposed to a young family struggling to survive in the midst of job cuts. The politico-medico elites paid no attention to Darwinism.
Chapter 15 “Lessons learnt from the COVIDs: obedience and fear”
One of the best ways to control a population is through fear and it is even better when it involves their life. Stalin had executions and Siberia. Mao had re-education camps. Canada had the residential school system. In this case the cause of your death if you were not obedient was your life.
Hence on the advice of the medicos social distancing was the umbrella concept and that meant curtailment on freedom of association and a right to make a living but as I said medicos aren’t concerned with such esoteric concepts and neither did they have much compassion for the collateral damages caused by much of their advice although the politicos framed all decisions as political decisions on he advice of their “medical team”.
Of course at some point they miscalculated the vast overdoing of their propaganda made it close to meaningless hence the crowded beaches off the Alabama coast in the United States on Memorial Day in 2020 and the infamous Trinity-Bellwood’s Park in Toronto on the same week-end. Democracies are a bit flabby when it comes to effective propaganda. Unfortunately, both these incidents cased a huge surge in Alabama and in Toronto. When it comes to propaganda you can fool some of the people some of the time but you can’t fool them all the time so you have to freshen up the propaganda playbook to be most effective.
There was also fear of the COVID police who could fine you a substantial amount for violating social distancing rules. In some countries you could even be imprisoned and given the hotspots prisons were for COVID that just about amounted to a death sentence.
And the good honest citizens who cowered in fear in their homes could, along with some politicians, express their indignation at such irresponsibility leading to social ostracization of the irresponsible. Little did these good citizens realize they would be cannon fodder for the second COVID-19 in 2021.What is that expression, “There is no goodness in virtue”?
The propaganda campaigns were so effective that in Canada 64% of the population expressed anxiety in leaving the house. What a gift for the second wave COVID gods!
Thank goodness the medicos did not run the show during COVID times. You must remember they are there and their whole essence is to save lives. So they were best kept reigned in politically particularly as they were not elected officials. They are technocrats and many quite frankly are nerds with the personality of a cucumber. But they were valuable resources and a source of excuses in the struggle assisting (hopefully) the politicos in their decision making. And as for propaganda purposes they built the basis of the propaganda machine with their obsession with social distancing and mask wearing. Their daily press conferences were about as exciting as watching paint dry. They largely failed to see or ignored the medical collateral damage caused by the shut down of economies and true to physician form most lacked compassion. It was numbers, numbers, numbers then admonishments and threats to to public if you don’t do this and that you are transformed into a killing machine.
I have no beef against my fellow physicians as they are neither economists nor politicians. And serving politicians that appointed them was a shortcoming they had no part in. One has to remember they serve the elected politicians but their duty to the public’s health should not be forgotten and long as they made that clear to the politicos that was fine. In many cases, particularly on a federal level in the United States, they were ignored or in some cases mocked by ex-President Donald J. Trump.
There are many of you out there that express an opinion Ontario’s lockdown is ineffective or causing such high collateral damage it simply is not worth it. The bottom line is that medical systems can’t handle the load of the infected or soon will not be able to. Is it fair to say poor medical system management and cost saving measures in countries that have socialized medicine have lead to the dire situation we are approaching? Yet I have not heard a single story in the media discussing this.
Yet the politico-medico elite seems to prefer the shaming approach that it is our fault we didn’t socially distance, wash our hands or wear masks yet some of this elite double dealt us by taking vacations this winter.
Despite your anger, frustration and fear perhaps take a moment for a chuckle when you hear that dog walking and doggie daycare is considered nonessential and prohibited. Wasn’t it Prime Minister Pierre Elliot Trudeau that said it was no business of the state in the bedrooms of the nation. The politicos have been messing with many of us causing job loss, destruction of businesses to name a few. Now they prohibit you from using the service of a dog walker and doggie daycare! So it makes sense to have twenty people walk their dogs and be out on the street instead of a single dogwalker or to force dog owners to walk their own dogs as they try to work from home and struggle with home schooling. And what are essential workers to do if they have no one to walk or care for their dogs?
If this pea brained strategy makes you angry blow off some steam. It might even mean your pooch is cooped up all day long without being able to relieve itself as you can’t leave work to take Fido on a walk. Or you might just see how inane the situation is and have a hearty laugh! I mean it is so intrusive the politicians might as well be in our bedrooms but that may be forthcoming in the next emergency order.
Dog walkers beware the COVID police are looking for you. Can the dogs be fined too! I am sure their owners can be.
Chapter 13:” lessons learnt from the COVIDs: the politicos”
The politicos at first glance seemed to be running the COVID outbreak. The inability of the medical system to handle the initial wave was a result of continual cuts made to the medical system by the politicos. That meant less PPE and less front-line medical workers and in effect non regulation of long-term care homes. Some politicians accepted the blame while others like former President Donald J. Trump who so tragically bumbled COVID management created a whole host of diversionary tactics to shift the blame or change the topic on American’s minds. But during the second wave of COVID-19 in 2021 he was no more as he met his deserved electoral fate in the 2020 Presidential election leading to the victory of “Sleepy Joe” Biden. He also met a nastier defeat which we will talk about shortly.
By the time COVID Plus petered out in 2025 just about any political leader in power at the outset of COVID-19 in 2019 was either defeated in election, removed by coup or subject to an assassination attempt.
So there you have it the blame game is easy to play in retrospect and I place it on the politicos for a variety of reasons the primary being lack of proper funding, the deregulation of long term care facilities, ignoring the severity of COVID calling it a nasty flu and in many countries the lack of socialized medicine making the lower groups in the socio-economic scale easy targets for the virus.
But I am not sure how apportioning the political blame will help deal with the next virus. I’d rather add up our collective lessons and learn from them.
Whether a democracy or authoritarian government most of them played it the same way with some willing to accept more risk than the others.
Márta (Natasa Stork) a brilliant 40 year old neurosurgeon who leaves her practice in New Jersey to meet Dr. János Drexler (Viktor Bódo) in Budapest returning to her home she never thought she would return to after some 20 years in the United States.
Did Márta actually meet Drexler at a medical convention in New Jersey or is this some obsessive fixation? Why did she quit her job as a leading neurosurgeon?
Márta was to meet Drexler at the Liberty Bridge in Budapest a month after their New Jersey medical convention but after flying to Budapest and going to the bridge at the appointed hour he is not at the bridge. Is the brilliant neurosurgeon suffering from some obsessive-compulsive disorder? There is no actual proof they met but Márta’s search of the convention shows Drexler was there. She confesses to an instantaneous connection to Drexler.
Márta is soon in a psychiatrist’s office relating her story instantly adding a psychological element to the story. Is she suffering from some metal illness that even highly educated neurosurgeons can fall prey to? Did she really have a conversation with Drexler at the convention or was it imaginary?
Well at least Drexler does exist but at their first meeting at the Budapest Medical Institute he claims no knowledge of her. Is Márta imagining the meeting and agreement to meet at the Liberty Bridge in Budapest?
As Márta rents an apartment in Budapest and settles into her new hospital job during a complicated neurosurgery Drexler shows up.
Despite Márta’s reflections to her Hungarian psychiatrist she ma be imagining everything Drexler shows up and eventually there is a torrid love scene. A result of a real Hungarian encounter or a mythical New Jersey meeting? I think the New Jersey meeting was real as Drexler admits to it but says he never took seriously the meeting on Liberty Bridge. But what is reality and fiction is becoming difficult to determine.
It so difficult to make a decision with this Hitchcockian inspired film. I watched it twice and the ending four times!
The film ends with Drexler looking for Márta at Liberty Bridge and she fails to show then switches to a scene with Drexler delivering an enormous speaker to Marta’s flat or is this imaginary?
A confusing film as it what is reality and imagination.
My take is that Márta is on track with reality and there was a meeting with Drexler and an agreement to meet at Liberty Bridge despite her meeting with a psychiatrist. Whether this was there any mutual intent to meet I will leave to your answer
However in a psycho-thriller I may be way out of bounds and that makes your interpretation of the movie precious.
Madness? Obsessive compulsive disorder? Reality with Drexler protecting his upstanding identity. Perhaps it is one over the other or a complicated selection of bits and pieces of what I have suggested.
As a viewer I feel this is in the Hitchcock tradition and like Jimmy Stewart in “Rear View Window” I am watching a thriller I can’t quite pin a finger on!
The film has been selected as the Hungarian entry for the Best International Feature Film at the 93rd Academy Awards,
You can see the trailer herehttp://www.filmswelike.com/films/preparations-to-be-together-for-an-unknown-period-of-time
The film is in Hungarian with English subtitles and stats with digital TIFF Bell Lightbox on January 22 and after that virtually throughout Canadian theatres including the Vancity theatre in Vancouver, the Subury Indie Cinema and the City Cinema in Charlottetown all on January 29th..
This Lili Horvát film is 92 minutes long and is in Hungarian with English or French subtitles.
Chapter 12 “lessons learnt from the COVIDs: the cult of the front-line worker”
There are the medical professionals and politicians who form the top of the pyramid in the COVID narrative but there are also grocers, gas station attendants, bus and taxi drivers and a whole host of people in “essential businesses” that remained open throughout the COVIDs.
Hey I was one of those front-line workers as a cardiologist at a major Toronto hospital so I am the last one to express an uncaring thought or word about front-line workers. Indeed I’ll even go along with the politico propaganda campaign that called them heroes because given the poor planning and hospital cuts of the politicos for most countries in the world that had a decent healthcare system there simply were not enough front-line workers and a lack pf personal protective equipment (PPE) to fight the battle. Budget cuts or “rationalizations” if you prefer
However these medical front-line workers were manufactured into a cult by the media and the propaganda. Again back to my travels in the 1970s in the Iron Curtain countries where socialist realism art played a predominant role in the “education” of the proletariat. Brave factory workers with the hammer and sickle flag in one hand and a hammer in the other striving to meet the objectives of the Central Committee’s 10-year plan.
The media had a field day showcasing the brave front-line medical workers with sappy music and dialogue and special 3-minute specials like “Our Heroes”. I can tell you we were all simply doing our job under difficult conditions and for the non-physicians for substandard pay, no life insurance of short- or long-term disability plans. Although many jurisdictions did come through with some increases for medical staff battling the COVIDs. What good is a few extra dollars for your family when you die when you have no life insurance or are disabled without disability plans?
My thoughts on this was that the front-line workers were used as a propaganda tool for morale purposes for the politicos and for touching and emotional stories by the media. And as people are amoebas, they lapped it up.
What was disturbing was the militarism developing in terms of the vocabulary used for COVID such as “battle”, “war”, “skirmish” “front-line” and like the Americans in Vietnam we had daily kill and wounded counts. And then the inane flights of the American Blue Angels and Canadian snowbirds to “boost the morale” of the population or should we say troops. Speaking of war were the budget cutting politicos traitors? Some countries might call the politicos who had whistle-blowers and critics of government management of COVID disappear or fall out of windows murderers. Don’t get me wrong front-line workers are heroes as anyone with a brain realizes that. What bothered many of us these heroes were an agent of political control and shamefully used as propaganda.
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