Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation, Influenza like illness, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Flu like symptoms; Booster; Vaccine was stored at 48 rather than 46; Vaccine that was not stored at the correct temperature; 48 is too warm; Vaccine was stored at 48 rather than 46; Vaccine that was not stored at the correct temperature; 48 is too warm; Vaccine was stored at 48 rather than 46; Vaccine that was not stored at the correct temperature; 48 is too warm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101689842 (Pfizer).  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 19Oct2021 (Lot number: FH8020) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Malignant VasoVagal" (unspecified if ongoing), notes: 29 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (She confirmed that all three doses were Pfizer products. None of them have an expiration date on the card. 1st dose on 27Feb2021, Lot EN6202, Injected in left upper arm in the muscle), administration date: 27Feb2021, when the patient was 61 years old, for COVID-19 immunization; Bnt162b2 (2nd dose on 20Mar2021, Lot EN6206, Injected in left upper arm in the muscle. The 1st 2 doses has the time on them.), administration date: 20Mar2021, when the patient was 61 years old, for Covid-19 Immunization.The following information was reported: IMMUNISATION (non-serious) with onset 19Oct2021, outcome "unknown", described as "Booster"; PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), PRODUCT STORAGE ERROR (non-serious) all with onset Oct2021, outcome "unknown" and all described as "Vaccine was stored at 48 rather than 46; Vaccine that was not stored at the correct temperature; 48 is too warm"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 19Oct2021, outcome "unknown", INFLUENZA LIKE ILLNESS (non-serious) with onset 20Oct2021, outcome "recovering" and all described as "Flu like symptoms".  Additional information: Consumer stated that she took Pfizer booster shot on 19Oct (not clarified) at a pharmacy, withheld. She was contacted by them and told that the vaccine was stored at 48 rather than 46 and that was the information. So, she could get another booster and not wait in line, she could get an antibiotic test but they were out antibody tests when she went to get one. Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number and provided with the website as withheld. Consumer thought the website was not going to speak about the vaccine that was not stored at the correct temperature. The site says, she went on the site and 48 is too warm and it says, too warm, take precautions or something like that. Consumer was again informed that Pfizer medical information is the concerned department for all queries. Further probing could not be done as consumer hung up abruptly. Hence, product details (expiration date, NDC#, UPC#), purchase details and other details were unknown and limited information was available over the call. The consumer stated that the website says to store this between 40-46F and above 46F there is a red thermometer. She wanted to know if the product was still effective and whether she is fully protected to see if she needed another booster dose. Her HCP (not the vaccination provider) told her to call Pfizer. She stated she has the lot number so Pfizer should be able to trace how it was stored. Consumer did not know the specifics of how her vaccine was stored improperly. She stated that she was told by (Facility name) it reached 48F but she did not know the duration of time. She also do not know if this excursion occurred before or after dilution. The consumer stated she was frustrated. She stated that Pfizer should know the efficacy of the vaccine the best when it is stored at this temperature (outside what is in the PI). She was angry at the bureaucracy of the treatment. She stated that this was ridiculous and not acceptable. She asked if it would be safe for her to "just get a second booster dose" of the Pfizer COVID-19 vaccine since she was not sure if the booster dose she received on 19Oct2021 was effective due to the temperature excursion. Other products, patient history and Investigation Assessment were reported as No. The third dose was given between 12:00-14:00. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as None. Experienced Flu like symptoms in morning. Any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s) and Family Medical History Relevant to AE(s) were reported as none. No relevant testes were performed. Phone Out 09:12 AM EST, 1St attempt by phone to HCP to obtain mailing information. Phone answered by the receptionist who provided the physicians fax number and mailing address. Receptionist did not provide her name.  Follow-up attempts completed. No further information expected.