Received Oct 16, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| COVID19 | COVID19 (COVID19 (MODERNA)) | MODERNA | UNK | — | — |
| FLU3 | INFLUENZA (SEASONAL) (AFLURIA) | SEQIRUS, INC. | UNK | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | UNK | — | — |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | — |
| COVID19 | COVID19 (COVID19 (UNKNOWN)) | UNKNOWN MANUFACTURER | UNK | — | — |
| HEP | HEP B (ENGERIX-B) | GLAXOSMITHKLINE BIOLOGICALS | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | UNK | — | — |
ARTHRALGIA; VACCINATION SITE PAIN; PRODUCT ADMINISTERED AT INAPPROPRIATE SITE; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES; This spontaneous report was received from Food and Drug administration (FDA) (agency number was not provided) and refers to 50-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included diabetes, rheumatoid arthritis and clindamycin allergy. Historical drugs included Clindamycin. Concomitant medications included insulin, methylphenidate hydrochloride (RITALIN), metformin, meloxicam, motrin (IBUPROFEN), prenatal vitamins, magnesium, vitamin e, vitamin C, Vitamin d and calcium. On 03-DEC-2024, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot # and expiration date were not reported) reconstituted with sterile diluent (MERCK STERILE DILUENT), (lot # and expiration date were not reported); with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (lot # and expiration date were not reported); with Moderna COVID-19 vaccine (lot # and expiration date were not reported); with Hepatitis b vaccine rHBsAg (yeast) (ENERIX B) (lot # and expiration date were not reported); with Influenza vaccine inact split 3v (AFLURIA) (lot # and expiration date were not reported) for prophylaxis. On 05-Dec-2024, the patient experienced arthralgia, product administered at inappropriate site and loss of personal independence in daily activities. The pharmacist gave the patient two shots on each shoulder, and one in my left forearm, on my right shoulder he did one too high and sge still have pain in that shoulder, he did two in my left shoulder and the pain is unbearable. The patient had to go to the er a couple days after because they pain was too much. The patient have been to the er three times since December and 05-FEB. This has completely affected every area of my life. The pain has not gotten better and the patient did not know where to go from here. At the reporting time, the patient had not recovered from the events. The action taken with the study vaccines regarding the events was not applicable. The causal relationship between the suspect vaccines regarding the events was not reported. Follow up information has been received from Food and Drug Administration FDA (Agency #2842690-1) via Vaccine Adverse Experience Report (VAERS) on 17-JUL-2025 and refers to a 50-year-old female patient. On 03-DEC-2024, the patient received 1 dosage form of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (exact dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis. On the same date, she also received 1 dosage of influenza vaccine inact split 3v (AFLURIA), route of administration reported as "OT", 1 dosage form of hepatitis B vaccine (ENGERIX-B), both for prophylaxis and 1 dosage form of mRNA-1273.712/elasomeran/ coronavirus (COVID) 19 vaccine (SPIKEVAX), route of administration reported as "OT" for prophylaxis of COVID 19, and 1 dosage form of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), route of administration was reported as "OT" (the vaccine was reconstituted with sterile diluent (MERCK STERILE DILUENT))(exact dose, anatomical location, lot # and expiry date were not provided) for prophylaxis. On 03-DEC-2024 (previously reported as on 05-Dec-2024), the patient experienced product administered at inappropriate site (the pharmacist gave her two shots on each shoulder, and one in her left forearm, no details provided). On 03-DEC-2024 (also reported as on 05-DEC-2024 after receiving mRNA-1273.712/elasomeran/ COVID 19 vaccine (SPIKEVAX), conflicting information), the patient experienced arthralgia, loss of personal independence in daily activities, vaccination site pain. On her right shoulder the pharmacist did one shot too high, and she still had pain in that shoulder. Pharmacist gave two in her left shoulder and the pain was unbearable. She had to go to the emergency room a couple days after because the pain was too much. She was in the emergency room three times since an unknown date in December 2024 and 05-FEB-2025. This had completely affected every area of her life. The pain did not get better, and she did not know where to go from there. She underwent laboratory test and X-ray, but no results were reported. Treatment information was not reported. The outcome of all events was reported as not recovered. The causal relationship between the suspect vaccines regarding the events was not reported. It has been determined that case safety report UID NUMBER US-009507513-2310423 is a duplicate of case safety report UID NUMBER US-009507513-2278357. Therefore, case safety report UID NUMBER US-009507513-2310423 is being deleted from our files and the cases are consolidated into case safety report UID NUMBER US-009507513-2278357.
Diabetes; Drug hypersensitivity; Rheumatoid arthritis
insulin; Ritalin; metformin; meloxicam; Motrin; prenatal vitamins; magnesium; vitamin e; vitamin c; vitamin d; calcium; sterile diluent