Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Scratch, Urticaria
Clinical narrative: scratch; hives / hives are just all over his abdominal area and trunk area and down his back but not on his gonads; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Lot number: GT19693) at the age of 72 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: BNT162b2 (Dose 1, Single, Lot: EN6208, expiry date 30Jun2021), administration date: 20Mar2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (Dose 2, Single, Lot: EN6206), administration date: 10Apr2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 03Feb2022, when the patient was 71-year-old, for COVID-19 immunization. The following information was reported: URTICARIA (medically significant) with onset 07Oct2022, outcome "not recovered", described as "hives / hives are just all over his abdominal area and trunk area and down his back but not on his gonads"; SCRATCH (medically significant), outcome "unknown". The events "hives / hives are just all over his abdominal area and trunk area and down his back but not on his gonads" and "scratch" required physician office visit. The patient underwent the following laboratory tests and procedures: bloodwork: Unknown result, notes: has no results to provide. Therapeutic measures were taken as a result of urticaria.  Additional information: He then got the Pfizer Omicron booster on 05Oct2022 at withheld; says "Pfizer GT19693, but the T might be a positive sign" on vaccination card. He developed hives since 07Oct2022, 2 days later and it is ongoing. He has been a mess ever since. We took a 4-day weekend shortly after that and had to go to an acute care center because it was that bad. He was put on prednisone which they kept upping and upping and now is on methotrexate, which is a cancer drug. This man is mean and miserable. He has gained weight because of prednisone. He has seen 5 different doctors; he has seen the same dermatologist for a long time and has been to an allergist. Male patient; DOB - he just turned 73-year-old. Consumer agreed and was warm transferred, Reported. Pfizer Medical Information has a caller reporting an adverse event for the Pfizer COVID19 vaccine for her husband who got the Pfizer omicron COVID vaccine on 05Oct2022 and had hives on 07Oct2023 which was two days later. He has seen five different doctors and is on prednisone and they kept upping the dose of the Prednisone and now he is on methotrexate. Caller verified the information provided and states he's gained weight because of the prednisone and the man is miserable and is making her miserable and he is still working as a public defender and it has been hard. Transferring agent states to call that she hopes he feels better regarding the patient and caller states it has been a long haul. She will complete the report and does not want anyone else and she had it regarding the vaccine two days before him and it is the easiest one she has had; no further details provided by the caller. They are their wits end and can't think about it and all he does is scratch. He got the Pfizer COVID vaccine for his first two doses of the original series with the first on 30Mar2021 and the 2nd dose 10Apr2021 and then the Pfizer booster she thinks was 03Feb2022 and he had no reactions on those until this Omicron booster. She is worried they are missing one regarding a dose of vaccine when they went and she is certain they've had five altogether. The patient's 1st dose was administered with lot that is handwritten and is EN6208 with expiry date 30Jun2021 and his patient card has no NDC numbers written on it; 2nd dose has lot and this gets confusing because the lot is EN6206 and no expiry date written; the 3rd dose has lot that starts with F and then J and it is hard to tell because it could be a 5 and then is 6369 at # with no expiry date written there and that is strange and it was at #. The dose on 05Oct2022 for the Omicron dose looks like G and a plus symbol or a D or a G and then 19693 for the lot number and it says # and then a date of 4465 and she does not know what that is. For the Omicron dose on 05Oct2022, it was an unknown dosage in his arm and she is not sure if it was left or right arm; the hives go up and down and when they had him on a heavy dose of prednisone then tried to take him off of it were and trying to wean him off and the hives are just all over his abdominal area and trunk area and down his back but not on his gonads. She has to get her old # up to get information and he does not carry his Prednisone or Methotrexate around with him; it just freaks her out that he is on these. He has been on Prednisone for forever it feels like. They had him on two different antihistamines a day. For the methotrexate 2.5mg, he takes it five tablets by mouth once weekly; the bottle is an orange pharmacy bottle and has no lot but has a rx number. They upped the Methotrexate dose. Prednisone is in an orange pharmacy bottle and he started out with Prednisone on cards and that went by the wayside and he takes 5mg four tablets by mouth every day; states she has to get a mirror to look at it and confirmed due to a pharmacy bottle, no lot, expiry date or NDC to provide. She is sure there is one missing in there regarding a vaccine listed on the patient card and thought they got Moderna until she looked at this card; for the 2nd round and omicron came out, their daughter suggested they get the Moderna one but they got the Pfizer at. Concomitant medications: No, nothing to provide but he takes his daily medications; no further details provided by the caller. Medical conditions: He has obesity now for sure and he is overweight now. He swims 4-5 times a week. Testing she does not know about it but he had bloodwork done a couple of times and they were trying to determine what it was and the doctor did some and another doctor with dermatology had some done and she has no results to provide. Patient details he just turned age 73. He has gained weight as he has been on prednisone for over 4 months now; guesses his weight as 235 pounds. Yes, there is a product complaint to report. Description of Product Complaint: Description of complaint: Suspect product prednisone; the hives go up and down and when they had him on a heavy dose of prednisone then tried to take him off of it; Prednisone is in an orange pharmacy bottle and he started out with Prednisone on cards and that went by the wayside and he takes 5mg four tablets by mouth every day; states she has to get a mirror to look at it and confirmed due to a pharmacy bottle, no lot, expiry date or NDC to provide. Product strength and count size dispensed: 5mg, Product Methotrexate: methotrexate 2.5mg, the bottle is an orange pharmacy bottle and has no lot; They upped the Methotrexate dose.