Received Jun 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT / LA |
Fever blister; a suspected allergic reaction; vaccination site redness; vaccination site swelling; fever; This spontaneous report was received from a nurse referring to a 64-year-old female patient. The patient's concurrent conditions included type 2 diabetes mellitus (T2DM), and Asthma. Concomitant medications included Valtrex (Valaciclovir hydrochloride), Aspirin (Acetylsalicylic acid; Ascorbic acid), Advair (Fluticasone propionate; Salmeterol xinafoate), and Albuterol (Salbutamol sulfate). Drug Reactions/Allergies included Opioids (Opioids), Dilantin (Phenytoin), and Meperidine (Pethidine). On 30-May-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) 0.5 mL administered by Intramuscular route in Left Deltoid for prevention of pneumococcal infection (lot # and expiration date were not reported) On 30-May-2025, the patient experienced vaccination site redness and vaccination site swelling. Vaccine was given in the left deltoid and redness and swelling was noted immediately after administration but wasn't warm or painful. The patient reported a subjective fever but never took her temperature (pyrexia). On 03-Jun-2025, the patient experienced a suspected allergic reaction (Hypersensitivity). On that day, the patient presented to the clinic with a suspected allergic reaction. The patient's temperature was taken at the appointment, and it was reported that the patient to be afebrile. It was also reported that the patient had fever blisters around her mouth and was given Valtrex as treatment (Oral herpes). At the reporting time, the patient was recovering the reported events. The causal relationship between the events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was unknown. Lot # is being requested and will be submitted if received.
Asthma; Type 2 diabetes mellitus
Medical History/Concurrent Conditions: Drug allergy
Valtrex; aspirin; ADVAIR; Albuterol