Received Feb 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | UNK | — | LA |
it may have been a seizure; biting my tongue; feeling confused; arm soreness around the injection site; hive; itching; being tired; This is a spontaneous report received from an Other HCP. A 50-year-old female patient (not pregnant) received pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), on 29Jan2025 at 09:45 as dose number unknown, single (Batch/Lot number: unknown) at the age of 50 years, in left arm for immunisation; varicella zoster vaccine rge (cho) (SHINGRIX), on 04Jan2025 as dose 1, single, in left arm for immunisation. The patient's relevant medical history included: "Hashimoto's thyroiditis" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "GERD" (unspecified if ongoing); "tubular adenoma" (unspecified if ongoing); "osteoarthritis" (unspecified if ongoing); "chronic diarrhea" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "fibroids" (unspecified if ongoing); "myopia" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "known allergies: PCN" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing); "known allergies: Adhesives" (unspecified if ongoing); "known allergies: IV contrast" (unspecified if ongoing); "known allergies: cocoa butter" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; VALACYCLOVIR [VALACICLOVIR]; LOSARTAN; AMLODIPINE; FAMOTIDINE. Past drug history included: Celebrex, reaction(s): "known allergies"; Itraconazole, reaction(s): "known allergies"; Nitrofurantoin, reaction(s): "known allergies"; Tolfaftate, reaction(s): "known allergy"; Glucagon, reaction(s): "known allergies". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "arm soreness around the injection site"; FATIGUE (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "being tired"; TONGUE BITING (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "biting my tongue"; CONFUSIONAL STATE (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "feeling confused"; URTICARIA (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "hive"; SEIZURE (medically significant) with onset 29Jan2025 at 21:15, outcome "recovering", described as "it may have been a seizure"; PRURITUS (non-serious) with onset 29Jan2025 at 21:15, outcome "recovering", described as "itching". The clinical course was reported as follows: The patient got the shot (as reported) on 29Jan2025 morning, she developed a little arm soreness around the injection site. Additionally, she was lying in her bed in the evening and about 12 hours after the shot, fell asleep and then woke up a few minutes later biting her tongue and feeling confused; it may have been a seizure. Within minutes of this possible seizure, she got a very itchy hive in her butt crack (gluteal cleft). The itching was so severe it kept her awake much of the night. It was a lump that she couldn't see because of the location, but she could feel with her fingertips. Treated it with topical hydrocortisone and topical diphenhydramine that only helped partially. It was less itchy on 30Jan2025 morning but still lumpy. She did not have any other hives or rashes, and other than being tired. Was fine on 30Jan2025 morning, no more potential seizure activity, she reported she did not have epilepsy. Therapeutic measures were not taken as a result of seizure, vaccination site pain, tongue biting, confusional state, fatigue. Therapeutic measures were taken as a result of urticaria, pruritus. 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.; Sender's Comments: There is not a reasonable possibility that the reported event seizure was related to the suspect product event most likely due to patient underlying contributory factors. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators as appropriate.
Medical History/Concurrent Conditions: Adenoma; Adhesive tape allergy; Chronic diarrhea; Contrast media allergy; Dyslipidemia; Endometriosis; Fibroids; Food allergy; GERD; Hashimoto's thyroiditis; Hypertension; Latex allergy; Myopia; Osteoarthritis; Penicillin allergy
SYNTHROID; VALACYCLOVIR [VALACICLOVIR]; LOSARTAN; AMLODIPINE; FAMOTIDINE