Wow a lot packed into Number 4 ... and so specific too! Glad it was tested on 8 mice!
And more on storage, transportation, dosage, and aspirating
PFIZER-BIONTECH COVID-19 VACCINE, BIVALENT
The vaccination provider is responsible for mandatory reporting of the following to the Vaccine Adverse Event Reporting System (VAERS):
vaccine administration errors whether or not associated with an adverse event,
serious adverse events* (irrespective of attribution to vaccination),
cases of myocarditis,
cases of pericarditis,
cases of Multisystem Inflammatory Syndrome (MIS) in adults and children, and
cases of COVID-19 that result in hospitalization or death.
Complete and submit reports to VAERS online at https://vaers.hhs.gov/reportevent.html. For further assistance with reporting to VAERS call 1-800-822-7967. The reports should include the words "Pfizer-BioNTech COVID-19 Vaccine, Bivalent EUA" in the description section of the report
Source: https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/f6da3019-5c22-42a7-9e55-dc2e6d3ccc2d/spl-doc
Also, take a look at these dosage, storage, and transportation requirements while you’re at it.
Simple as 1, 2, 3?
If unable to meet these requirements, what happens then?
DOSAGE AND ADMINISTRATION
The storage, preparation, and administration information in this Fact Sheet apply to the Pfizer-BioNTech COVID-19 Vaccine, Bivalent supplied in:
single dose vials with gray caps and labels with gray borders, and
multiple dose vials with gray caps and labels with gray borders.
DO NOT DILUTE PRIOR TO USE.
Storage and Handling
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
Do not refreeze thawed vials.
Vial Storage Prior to Use
Cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may arrive frozen at ultra-cold conditions in thermal containers with dry ice.
Once received, frozen vials may be immediately transferred to the refrigerator [2°C to 8°C (35°F to 46°F)], thawed and stored for up to 10 weeks. The 10-week refrigerated expiry date should be recorded on the carton at the time of transfer. A carton of 10 single dose vials may take up to 2 hours to thaw at this temperature. A carton of 10 multiple dose vials may take up to 6 hours to thaw at this temperature.
Alternatively, frozen vials may be stored in an ultra-low temperature freezer at -90°C to -60°C (-130°F to -76°F) for up to 12 months from the date of manufacture. Do not store vials at -25°C to -15°C (-13°F to 5°F). Once vials are thawed, they should not be refrozen.
If cartons of Pfizer-BioNTech COVID-19 Vaccine, Bivalent are received at 2°C to 8°C (35°F to 46°F), they should be stored at 2°C to 8°C (35°F to 46°F). Check that the carton has been updated to reflect the 10-week refrigerated expiry date.
Regardless of storage condition, the vaccine should not be used after 12 months from the date of manufacture printed on the vial and cartons.
Vial Storage During Use
If not previously thawed at 2°C to 8°C (35°F to 46°F), allow vials to thaw at room temperature [up to 25°C (77°F)] for 30 minutes.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be stored at room temperature [8°C to 25°C (46°F to 77°F)] for a total of 12 hours prior to the first puncture. After first puncture, the multiple dose vial should be held between 2°C to 25°C (35°F to 77°F). Multiple dose vials should be discarded 12 hours after first puncture.
Transportation of Vials
If local redistribution is needed, vials may be transported at -90°C to -60°C (-130°F to -76°F) or at 2°C to 8°C (35°F to 46°F).
Dosing and Schedule
A single booster dose (0.3 mL) of Pfizer-BioNTech COVID-19 Vaccine, Bivalent may be administered at least 2 months after completion of primary vaccination or receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine.
Not seeing any recommendations to aspirate either.
Yet here is Dr. John Campbell (with over 1 million views) explaining why it is best to aspirate:
Several other substackers have written about aspirating:
Aspiration was taught to me as an army medic. We used to vaccinate all the incoming recruits and officer cadets and I did that role for a number of years giving at least a thousand vaccines all up. I recall at least three times aspirating blood. So it isn't common, 0.3% chance as a guess. But it does happen that you can and do end up in a vein sometimes. Because nobodies blood vessels are exactly the same and in the same place.
As an old RN (USA) I am very confused by all this controversy around aspiration...we were taught to aspirate every single time we gave an intramuscular injection; it was not optional. Has this changed?