Received Apr 24, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | MD3414 | IM / RA |
| COVID19 | COVID19 (COVID19 (PFIZER-BIONTECH)) | PFIZER\BIONTECH | 1 | — | OT / RA |
4 big losses appeared like 3 in a row and then around the other one like in the form of a J; arm just start to itch; This is a spontaneous report received from a Consumer or other non HCP. A 76-year-old male patient received BNT162b2 omicron (kp.2) (COMIRNATY (2024-2025 FORMULA)), on 18Apr2025 as dose 1, single (Batch/Lot number: unknown) at the age of 76 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (DOSE 1, SINGLE), administration date: 2020, for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 2, SINGLE), for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization, reaction(s): "No adverse event"; Comirnaty (DOSE 1, SINGLE, Right arm), administration date: Oct2024, for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: SKIN DISORDER (non-serious) with onset Apr2025, 450 min after the suspect product(s) administration, outcome "recovering", described as "4 big losses appeared like 3 in a row and then around the other one like in the form of a J"; PRURITUS (non-serious) with onset Apr2025, 450 min after the suspect product(s) administration, outcome "recovering", described as "arm just start to itch". Therapeutic measures were taken as a result of skin disorder, pruritus. Additional information: Patient stated, He called because any of these Pfizer COVID Vaccine since 2020, every booster every 6 months and this was the first one he had a little bit of adverse side effect. Patient stated, About 7 and half hours after he had this shot (Comirnaty), all of a sudden his arm just start to itch and 4 big losses appeared like 3 in a row and then around the other one like in the form of a J. So, there are about 4 of them about the size of the quarter. It was like crazy and everything, but it really expands. He was sitting there and it was like he felt it coming. He could feel them actually burst out. So, he had been putting on this anti-itch cream and everything for the last 2 and half days and they had gone down slightly inside. He stated, he requested the booster after 6 months. He had one last October. Patient did not take any other vaccine on the same date with Pfizer vaccine.