Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Pain in extremity, Poor quality product administered, Product storage error, Product temperature excursion issue
Clinical narrative: soreness at the injection site that permeated to his other arm; fatigue; They didn't realize over the weekend the temperature wasn't kept properly of the product; Then that product was administered to the patient; They didn't realize over the weekend the temperature wasn't kept properly of the product; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200150334 (Pfizer).  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Jan2022 (Lot number: FJ6369) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown, which he also experienced during his first and second shot (side effects he mentioned were: soreness at the injection site that permeated to his other arm, fatigue),), for COVID-19 immunization, reaction(s): "fatigue", "soreness at the injection site that permeated to his other arm"; Covid-19 vaccine (Dose 2, Manufacturer unknown, which he also experienced during his first and second shot (side effects he mentioned were: soreness at the injection site that permeated to his other arm, fatigue),), for COVID-19 immunization, reaction(s): "fatigue", "soreness at the injection site that permeated to his other arm". The following information was reported: PRODUCT STORAGE ERROR (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) all with onset 24Jan2022 and all described as "They didn't realize over the weekend the temperature wasn't kept properly of the product"; POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 24Jan2022, described as "Then that product was administered to the patient"; PAIN IN EXTREMITY (non-serious), described as "soreness at the injection site that permeated to his other arm"; FATIGUE (non-serious), described as "fatigue". No follow-up attempts are possible. No further information is expected.  Additional information: The vaccine was not studied in that manner and at this time we do not have information on that topic. Third dose of Covid-19 vaccine Pfizer was booster shot and manufacturer was unknown. The patient did not realize over the weekend the temperature was not kept properly of the product. Then that product was administered to the patient. They were advised that this may not be effective and to get another dose.Description of complaint: Caller following up on a previously filed report and mentioned that he received his Pfizer COVID vaccine booster dose on 24Jan2022, he was informed by the pharmacist that the vaccine was improperly handled over the weekend, the temperature in their storage got too low. The pharmacist called to notify him that it might not be effective because of the lower temperature and advised him to have a 4th shot. Probed for NDC, lot number and expiry date and caller does not see the NDC or expiry date on the COVID vaccination record card.   Follow-up (26Jan2021): This is a spontaneous follow-up report received from the same contactable Consumer.  Updated information included: Other relevant History (historical vaccine: reaction), New event (side effects he mentioned were: soreness at the injection site that permeated to his other arm, fatigue). Additional information updated.  No follow-up attempts are possible. No further information is expected.