Received Jun 3, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | 1 | — | IM / LA |
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | — | OT / LA |
I experienced severe, entire-body aches; decreased ability to focus; I currently have a marked decrease in range of motion and functional use of my left arm due to the severity of the localized pain; with the most intense systemic discomfort localized to my thoracic spine; injection site has developed a red, pruritic rash, and my left deltoid became firm and indurated; I currently have a marked decrease in range of motion and functional use of my left arm due to the severity of the localized pain; injection site has developed a red, pruritic rash, and my left deltoid became firm and indurated; injection site has developed a red, pruritic rash, and my left deltoid became firm and indurated; Information has been received from Food and Drug Administration (FDA) (2888040-1). This Spontaneous report refers to a 43-years-old male patient. The patient's medical history included Dental pain. The patient's concurrent conditions included Type 2 diabetes and GERD. The patient's past medications were not reported. The patient's concomitant medication included tirzepatide (MOUNJARO) and Pantoprazole sodium (PANTOPRAZOLE). On 04-Mar-2026, the patient was vaccinated at pharmacy with Pneumococcal 21-valent Conjugate Vaccine Solution for injection (CAPEXIVE), 1 dosage form, via Intramuscular on left deltoid (strength, specific dosage, lot number and expiration date were not provided) with an aggressive, high-velocity technique; the vaccinator pinched the deltoid firmly with significant skin pull and delivered the medication rapidly over approximately 1/4 of a second. Additionally, the vaccinator failed to observe the standard 15-minute post-vaccination monitoring period, explicitly instructing her that could leave the pharmacy immediately after the injection and stating that observation was no longer provided at their location. On 05-Mar-2026 (also reported as day 1 post-vaccination), patient experienced severe, entire-body aches (pain) and a decreased ability to focus (Disturbance in attention), which nearly prevented him from completing clinical shift as a physician on Thursday. Upon awakening on Day 2, he considered calling in sick to work but did not want to cancel appointments for his patients. Patient had significant difficulty seeing patients due to pain. In addition, the injection site developed a red, pruritic rash, and my left deltoid became firm and indurated (Injection site rash, Injection site erythema and Injection site induration). He currently had a marked decrease in range of motion and functional use of my left arm due to the severity of the localized pain (Injected limb mobility decreased and injection site pain), with the most intense systemic discomfort localized to my thoracic spine (Spinal pain). Prior to the injection patient was fully functional. The outcome of the events were not provided. It was not reported the causality assessment between the events and suspect vaccines.
GERD; Type 2 diabetes mellitus
Medical History/Concurrent Conditions: Tooth pain
Mounjaro; pantoprazole