Received Sep 2, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Y013009 | OT |
she feels that the person who administered the CAPVAXIVE "shot so hard and so fast, which may have caused these side effects; Indication pneumonia; the rash is very warm to the touch; at the injection site, she experienced side effects of bleeding, as well as muscle and joint pain following the administration.; at the injection site, she experienced side effects of bleeding; at the injection site, she experienced side effects of bleeding, as well as muscle and joint pain following the administration.; muscle and joint pain; muscle and joint pain; chills throughout the entire day; very lethargic; fatigued; headaches; muscle on the side of the breast" was experiencing pain, and started to swell; pain and swelling has moved down further on her arm; pain and swelling has moved down further on her arm; red splotches all over".; This spontaneous report was received from a Patient and refers to herself, a 61-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant medications included Repatha (Evolocumab), Allegra (Bilastine), and Alvesco (Ciclesonide) (reported as Avesco). On 03-Aug-2025, the patient was vaccinated with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) Solution for injection (valid lot #Y013009, expiration date was not provide but established as: 17-Nov-2025) 0.5 mL administered by Intramuscular route for pneumonia (Product use in unapproved indication) (dose number and anatomical location were not provided). On an unspecified day in August 2025, she experienced side effects at the injection site of bleeding, as well as muscle and joint pain following the administration (vaccination site haemorrhage, vaccination site pain, vaccination site joint pain). The patient reported that on an unspecified day in August 2025 (over the course of the next few days), she experienced side effects of muscle and joint pain, chills throughout the entire day, very lethargic and fatigued, and headaches (myalgia, arthralgia, chills, lethargy, fatigue, headache). She reported that her "muscle on the side of the breast" was experiencing pain, and started to swell (muscle swelling). On an unspecified day in August 2025 (over the last few days), the patient reported that the pain and swelling had moved down further on her arm (pain in extremity, peripheral swelling), and she had developed (reported as had not developed- conflicting information) a rash that has "red splotches all over" (rash macular). Patient reported that the rash was "very warm to the touch" (skin warm). No other symptoms or side effects reported. No specific dates were reported for when patient experienced these symptoms, but patient stated that these have "all occurred over the last few days" (estimated as August 2025). Patient reported that she had "started to get her energy back the last few days, so she felt like she was recovering". The patient reported that she felt that the person who administered the Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) (on 03-AUG-2025) "shot so hard and so fast, which might have caused these side effects" (wrong technique in product usage process). She also reported that she asked her pharmacist about these side effects, but her pharmacist "tried telling me it was from a bug bite". The patient reported that she was "positive this was not from a bug bite." It was reported that bloodwork was done recently, but result was not provided. At the reporting time, the patient was recovering from the events. The action taken with Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) was assessed as not applicable. The causal relationship between the all events and Pneumococcal 21-valent Conjugate Vaccine (CAPVAXIVE) not provided.
REPATHA; ALLEGRA; AVESCO