Received Jul 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | — |
| TDAP | TDAP (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
She got urticaria, hives, all over her body come and go and she's had them on and off; This is a spontaneous report received from a Nurse. A 52-year-old female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 04Feb2025 as dose number unknown, 0.5ml single (Batch/Lot number: unknown) for immunisation; diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP), on 04Feb2025 as dose number unknown, single) for immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL. Vaccination history included: Tdap (Unknown dose number, unknown manufacturer), for immunization. The following information was reported: URTICARIA (non-serious) with onset 05Feb2025, outcome "not recovered", described as "She got urticaria, hives, all over her body come and go and she's had them on and off". The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received. Additional information: When probed about the side-effects, Pfizer Employee stated, patient got urticaria, hives, all over her body come and go and she's had them on and off since she got the vaccine on February 4th, 2025. Dose, route of administration, indication and anatomical location: Pfizer Employee stated, "The indication is for 50 and older. She received the dose that she should have got was 0.5 milliliters and she got it in her arm, but Pfizer employee do not know if it was her left arm or right arm. So, she got it in her deltoid muscle. Other medications and medical conditions: Pfizer Employee stated, "The only other medication she was taking was Lisinopril and the same day she got the Prevnar shot, she got it Tdap in the other arm. She was taking Lisinopril, the only medication she takes. The representative was trying to share that it was the same day she got Prevnar 20, she also received a Tdap (Hence suspect captured as Tdap), it is a vaccine for Tetanus diphtheria and pertussis. It is called Tdap, she received it on the same day in different arm. Product details for Tdap (LOT#, Expiration date, NDC# and UPC#): Pfizer Employee stated, patient did not give him any of that. She said she received a Tdap in the past by itself and never had a problem, that is what patient told Pfizer representative. Causality: Pfizer Employee stated, "Yes, she does and in end June, July and she still sees her, and hives come and go. She said she never got rid of them. She said they are all over the body, they come and go.Date of adverse event: Pfizer Employee stated, patient said with in 24 hours. So, patient would say February 5th, 2025. Still experiencing: Pfizer Employee stated, "Yes, she is, it comes and go." Treatment: Pfizer Employee stated, "I do not find out." Lab work: Pfizer Employee stated, "No, I do not know anything.
LISINOPRIL