Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: had a reaction to the first booster dose of the Pfizer Covid-19 vaccine and reports that he had complaints of hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 79-year-old male patient received BNT162b2 (BNT162B2), on 25Sep2021 as dose 3 (booster), single (Lot number: FF8839) at the age of 79 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (1st dose 05Feb2021, Lot: EL3302, Expiry: Unknown , Injection in the right arm), administration date: 05Feb2021, when the patient was 79-year-old, for covid 19 immunization; BNT162b2 (2nd dose 26Feb2021, Lot: EL3302, Expiry Unknown , Injection in the right arm), administration date: 26Feb2021, when the patient was 79-year-old, for covid 19 immunization. The following information was reported: URTICARIA (non-serious) with onset 25Sep2021 at 20:00, outcome "recovered" (26Sep2021), described as "had a reaction to the first booster dose of the Pfizer Covid-19 vaccine and reports that he had complaints of hives". Therapeutic measures were taken as a result of urticaria.  Additional information: Caller was an 80-year-old female who is calling about the Pfizer Covid-19 vaccine.  Caller reports that her HCP contacted her and informed her that she was given a second booster dose of the Pfizer Covid-19 vaccine (unable to specify color cap) that was stored 5 days past the 10 week of the BUD in the refrigerator temperature range. HCP told the Caller that it was up to her if she should get vaccinated again or not. Caller also reports that her 80-year-old husband had a reaction to the first booster dose of the Pfizer Covid-19 vaccine and reports that he had complaints of hives. Caller reports that her husband saw his HCP yesterday 04May2022 and that two HCP's told him to take Benadryl beforehand but that the CDC says not to take Benadryl before getting the Pfizer Covid-19 vaccine. Caller also reports that the HCP was going to prescribe an EpiPen before her husband received another Pfizer Covid-19 vaccine but the HCP changed his mind and will not prescribe the EpiPen. Caller was asking what should she do about getting revaccinated with the second dose of the Pfizer Covid-19 vaccine. Reporter stated, had a call this morning where I had my second booster shot on the 27th of last month and they said that they discovered that the vaccine is they gave me was actually supposed to be used up by the 22nd. It was you know, the best date to be used by was 22Apr but I had it on the 27th. So, I said you know if I am not comfortable at that, that they could re do it and I think well you know is it still effective and they said probably but they do not know. In response to Pfizer drug safety: Reporter stated, I want to know if they said I could have a re-done but I don't know what's the best thing is to do to you know it just would it still be effective five days after the used by date for them. Reporter stated, also my husband had a reaction to the first booster (Further not clarified hence suspect captured as Unspecified Booster) he broke out in hives and so we do not know if he should get the booster to next one. Was on 27Apr and the LOT number is FK9895. The one that were my husband had a reaction was LOT number FF8839. Expiration date, Reporter stated, he has that on 25Sep2021 (25Sep2021). Reporter was informed about Pfizer Drug Safety and Pfizer Medical Information Department. Reporter further stated, okay, do you want to give me other number and then I can just call or you can connect me. Reporter was provided with the contact# for Pfizer medical information as option 3; 8 AM to 9 PM; Monday to Friday. Reporter further stated, Okay but you can tell me then is it's okay about the getting this vaccine, that was like should of then used up. Reporter was informed that Pfizer Medical Information department is the concerned department for her query. In response to further probing: Reporter stated, well it would be good to have it document it because you know we don't know if my husband should continue to get them or not. Reporter was again informed that Pfizer Medical Information department is the concerned department for her query. Reporter further stated, okay, but as a pharmacist would you be able to answer this my husband (Incomplete sentence). You cannot. Okay, it is not about information, it's a question about taking Benadryl before the vaccine.  The caller reported that she received the 2nd Covid-19 booster dose and the pharmacy and her HCP got in touch with her, and told her that the product was stored in the refrigerator 5 days past the 10 weeks use by date. She also reported that her 80-year-old husband had a reaction to the first booster dose of the Covid-19 vaccine. He had hives. The caller verified the information provided by the transferring agent. Caller's husband, the patient in this report, was also on the line during the call. Hives: He received the vaccine 25Sep2021 and stated that he developed the hives that evening. He no longer has the hives, they got better by the next morning. He took Benadryl and used calamine lotion and they were gone by the next day. Her husband did not receive a 4th dose due to his reaction of hives. 2nd dose Lot number: She said that she suspects he would have had the same lot number she had for his second dose, but they had the same lot number as the first dose as he did listed for his second dose. Time of onset: (24-hour clock): About 8:00pm. No prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine.