Received Nov 7, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z010457 | OT |
insomnia; rash had developed where the injection was completed; sweating; nausea; injection site symptoms: pain; injection site symptoms: redness; injection site symptoms: itching; This spontaneous report was received from a Physician Assistant and refers to a 64-year-old female patient. The patient's medical history was not reported. Her concurrent conditions included hypothyroidism, Sjogren Syndrome, palpitations, amoxicillin, cephalosporin, sulfa, penicillin allergy, and latex allergy. Historical drugs included amoxicillin, cephalosporin, sulfa (sulfanilamide), and penicillin. Concomitant medications included alendronate sodium (FOSAMAX), alprazolam, colecalciferol (reported as Vit D3), calcium, magnesium, vitamins NOS (reported as multivitamin) and levothyroxine sodium (TIROSINT) . On 29-Oct-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot #Z010457, expiration date: 26-Nov-2026) 0.5 mL total, administered by intramuscular route for pneumonia prevention (anatomical site, dose number in series were not reported). On this same night of 29-Oct-2025, after the dose was administered, she began experiencing symptoms such as insomnia, sweating, nausea, as well as injection site symptoms: pain, redness, itching, and that a rash had developed where the injection was completed (vaccination site erythema, vaccination site pain, vaccination site pruritus, vaccination site rash). The patient had been in contact with their physician to report the symptoms and seek medical advice, in which the physician directed the patient to apply hydrocortisone cream and take acetylsalicylic acid (ASPIRIN) or cetirizine (ZYRTEC) as needed for symptoms. It was unknown if the patient went to the hospital or if any other treatments were provided. At the reporting time, the outcome of insomnia, sweating, nausea, vaccination site erythema, vaccination site pain, vaccination site pruritus was unknown (however, it was stated that it took about 5 days for most of the symptoms (unspecified which ones) to go away). At the reporting time, the patient had not recovered from vaccination site rash (reported as the rash was still present as of 03-Nov-2025). The causal relationship between the above mentioned events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was not provided.
Allergy to antibiotic; Hypothyroidism; Latex allergy; Palpitations; Sjogren's syndrome
FOSAMAX; ALPRAZOLAM; VIT D3; CALCIUM; MAGNESIUM; MULTIVITAMIN; TIROSINT