Received Jul 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| FLU3 | INFLUENZA (SEASONAL) (FLUCELVAX) | SEQIRUS, INC. | 1 | 946620 | IM / RA |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | M4B34 | IM / RA |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y007322 | IM / LA |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | Y013172 | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y019158 | IM / LA |
| FLU3 | INFLUENZA (SEASONAL) (FLUCELVAX) | SEQIRUS, INC. | UNK | 946620 | OT |
| HEPAB | HEP A + HEP B (TWINRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | M4B34 | OT |
| HPV9 | HPV (GARDASIL 9) | MERCK & CO. INC. | 1 | Y007322 | OT / LA |
| MMR | MEASLES + MUMPS + RUBELLA (MMR II) | MERCK & CO. INC. | 1 | Y013172 | OT / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y019158 | OT / LA |
ERYTHEMA; SKIN WARM; PERIPHERAL SWELLING; VOMITING; NAUSEA; TENDERNESS; Information has been received from the Food Drug Administration (FDA) (agency # 2834378-1) on 16-JUN-2025. This spontaneous report refers to a 43-years-old male patient. The patient's medical history and concomitant therapies were not reported. As concurrent conditions were reported diabetes, seizures and hyperlipidemia. On 27-Mar-2025, the patient was vaccinated with the first dose of Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE)) (lot #Y019158, expiration date: 20-May-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; the patient was also vaccinated with a dose of Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9) (lot #Y007322, expiration date: 18-Aug-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), (lot #Y013172, expiration date: 31-Jul-2026), dose number 1, (Dose 1), administered by Intramuscular route in Left Arm; with a dose of Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast)(TWINRIX) (lot #M4B34) administered by Intramuscular route (expiration date was not reported) and also with a dose of Influenza vaccine inact sAg 3v(45 µg FLUCELVAX) (lot #946620) administered by Intramuscular route (expiration date was not reported). All the five vaccines were administered as prophylaxis. On 28-Mar-2025, the patient experienced redness, swelling, warmth and tenderness in the left arm (for the first few days but this has subsided). He also has had nausea and vomiting for 9 day which was still going on. At the reporting time, the patient had not recovered from skin warm, peripheral swelling, erythema, vomiting, nausea and tenderness. The causal relationship between the events of skin warm, peripheral swelling, erythema, vomiting, nausea and tenderness with Pneumococcal 21-valent Conjugate Vaccine(CAPVAXIVE), Human Papillomavirus 9-valent Vaccine, Recombinant (GARDASIL 9), Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), Hepatitis a vaccine inact;Hepatitis b vaccine rHBsAg (yeast)(TWINRIX) and Influenza vaccine inact sAg 3v(45 µg FLUCELVAX) was not provided.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2834378-1 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Diabetes; Hyperlipidemia; Seizures