Received Apr 25, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 4DS4N | OT |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y011819 | OT / LA |
The left arm injection site demonstrated continuous bleeding; sickness feeling; the entire upper portion with pain and a little itching; the entire upper portion with pain and a little itching; Lethargy; The patient said that the swelling, redness, and warmth; The left arm showed redness and swelling; The left arm showed redness and swelling; This spontaneous report was received from other health professional regarding to a 64-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported. On 21-FEB-2025, the patient started therapy with the first dose of pneumococcal 21-valent conjugate vaccine (CAPVAXIVE), lot number Y011819 (lot number Y011819 had been verified to be valid lot number for, expiration date was not provided, but upon an internal validation, established as 01-OCT-2025), and with hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX), lot number 4DS4N, both administered by intramuscular route in left arm, for prophylaxis. Since 22-FEB-2025, the patient's left arm injection site demonstrated continuous bleeding in comparison to the right arm injection sites per patient. The left arm showed redness and swelling down the entire upper portion with pain and a little itching. The patient said that the swelling, redness, and warmth improved a little after the second night. Lethargy and sickness feeling reported for two days, ibuprofen (MOTRIN) and paracetamol (TYLENOL) was taken by the patient to alleviate the symptoms. The patient stated that she has never experienced any adverse reactions to her previous vaccinations and was contemplating going to the ER the prior day but did not. The reporter visually inspected the sites and redness was present but was much better as per patient. The reporter instructed the patient to take diphenhydramine if the redness or itching continued and to let us know if the areas did not continue to improve. The patient was satisfied with consult about this reaction. On an unspecified date in 2025, the patient recovered from the events. The causal relationship between the events and pneumococcal 21-valent conjugate vaccine (CAPVAXIVE) and hepatitis a vaccine inact;hepatitis b vaccine rHBsAg (yeast) (TWINRIX) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-04-22 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2827677 , Central date : 2025-04-22 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :