Received Jul 4, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | Y019157 | OT / LA |
COUGH; HEADACHE; INJECTION SITE ERYTHEMA; INJECTION SITE PAIN; NAUSEA; OROPHARYNGEAL PAIN; PAIN; PAIN IN EXTREMITY; SWELLING; Information has been received from the Food Drug Administration (FDA) (agency # 2834478-1) on 16-JUN-2025 This spontaneous report refers to a 65-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions included head cold, Covid +, hypothyroidism, IBS,, asthma, reflux, and Allergy to Erythromycin. Concomitant medications included Wixela inhub (Fluticasone propionate;Salmeterol xinafoate), Levothyroxine (Levothyroxine sodium), Dicyclomine (Dicycloverine hydrochloride), Vitamin D3 Ol (Colecalciferol), Multivitamin (Ascorbic acid;Nicotinamide;Retinol;Riboflavin;Thiamine;Vitamin d nos), Calcium d (Ascorbic acid;Calcium gluconate;Calcium lactate;Calcium phosphate dibasic;Ergocalciferol), Vilazodone hcl (Vilazodone hydrochloride), Famotidine d (Famotidine), Alprazolams (Alprazolam), Clomipramine (Clomipramine hydrochloride). On 31-Mar-2025, at private, the patient was vaccinated in her left arm with the first dose of Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) intramuscular, lot #: Y019157, expiration date not provided but upon internal validation stablished as: 23-MAY-2026; dose and anatomical location were not provided) administered for prophylaxis. On 31-Mar-2025, the patient experienced cough, body aches, headache, sore throat and nausea, sore arm, redness, tenderness at injection site. (Baseball size) Self treated with Tylenol and OTC cold medicine. arm redness, swelling went down within 24 hours. Declined office visit to assess. On unspecified date in 2025, the patient recovered from all adverse events. The causal relationship between the adverse events and suspect vaccine was not reported.; Sender's Comments: Priority : 5 , Is case serious : No , Index user : , Index date : 2025-06-17 , MNSC number : , CLIC number : , ESTAR number : , IRMS number : 2834478-1 , Central date : 2025-06-17 , Classification : DMC, Attachment description : Post Marketing Basic , Safety case number :
Allergy to antibiotic; Asthma; COVID-19; Head cold; Hypothyroidism; Irritable bowel syndrome; Reflux oesophagitis
Wixela; Levothyroxine; Dicyclomine; Vitamin D3; multivitamin; Calcium+D; Vilazodone; Famotidine; Alprazolam; Clomipramine