Received Jun 30, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC21 | PNEUMO (CAPVAXIVE) | MERCK & CO. INC. | UNK | Z016259 | OT |
The patient reported itching at the injection site as well; she has felt "hyper"; had dust in her throat; pain during the injection/injection site was sore; large red circle on her arm that was "red as a tomato" at the injection site/the redness had started to go away and turned pink; lot of blood on the gauze that was placed over the injection site; she had to spit out a bunch of clear fluid or phlegm.; heart feels like it is racing; injection site hot to the touch; "as hard as a rock".; This Spontaneous report was received from Consumer or other non health professional and referred to a/an 76-year-old ( Race Unknown ) ( Ethnicity Unknown) Female Elderly patient. The patient's concurrent condition included Heart murmur The patient's historical drugs included Pneumococcal vaccine (Pneumococcal vaccine). The patient's concomitant medications were not reported. On 16-Jun-2026, the patient started therapy with Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 (1.00 dosage form) (total) (Batch/Lot Number: Z016259) (Expiration date: 12-Aug-2027) via Unknown. The patient started therapy with Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 for the treatment of prophylaxis, On 16-Jun-2026, the patient experienced pain during the injection/injection site was sore (Vaccination site pain). On 16-Jun-2026, the patient experienced large red circle on her arm that was "red as a tomato" at the injection site/the redness had started to go away and turned pink (Vaccination site erythema). On 16-Jun-2026, the patient experienced injection site hot to the touch (Vaccination site warmth). On 16-Jun-2026, the patient experienced "as hard as a rock". (Vaccination site induration). On 16-Jun-2026, the patient experienced she has felt "hyper" (Psychomotor hyperactivity). On 16-Jun-2026, the patient experienced heart feels like it is racing (Palpitations). On 16-Jun-2026, the patient experienced had dust in her throat (Throat irritation). On 16-Jun-2026, the patient experienced lot of blood on the gauze that was placed over the injection site (Vaccination site haemorrhage). On 16-Jun-2026, the patient experienced she had to spit out a bunch of clear fluid or phlegm. (Productive cough). On 19-Jun-2026, the patient experienced The patient reported itching at the injection site as well (Injection site pruritus). At the time of reporting, the patient was recovering from Vaccination site erythema . At the time of reporting, the patient was recovering from Vaccination site warmth . The Outcome of Palpitations was not provided. The Outcome of Vaccination site pain was not provided. The Outcome of Vaccination site induration was not provided. The Outcome of Injection site pruritus was not provided. The Outcome of Psychomotor hyperactivity was not provided. The Outcome of Throat irritation was not provided. The Outcome of Vaccination site haemorrhage was not provided. The Outcome of Productive cough was not provided. The action taken with Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Palpitations was Not applicable with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Vaccination site pain with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Vaccination site erythema with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Vaccination site warmth with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Vaccination site induration with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Injection site pruritus with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Psychomotor hyperactivity with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Throat irritation with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Vaccination site haemorrhage with Not Applicable dechallenge and rechallenge results. Case Assessments: Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 regarding Productive cough with Not Applicable dechallenge and rechallenge results. The Consumer or other non health professional considered the causality for the event Vaccination site pain to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Vaccination site erythema to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Vaccination site warmth to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Vaccination site induration to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Injection site pruritus to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Psychomotor hyperactivity to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Palpitations to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Throat irritation to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, the causality for the event Vaccination site haemorrhage to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported,, and the causality for the event Productive cough to Pneumococcal 21-valent Conjugate Vaccine Solution for injection 114412038:4347 was not reported, The Consumer or other non health professional considered the event Vaccination site pain to be non-serious, the event Vaccination site erythema to be non-serious, the event Vaccination site warmth to be non-serious, the event Vaccination site induration to be non-serious, the event Injection site pruritus to be non-serious, the event Psychomotor hyperactivity to be non-serious, the event Palpitations to be non-serious, the event Throat irritation to be non-serious, the event Vaccination site haemorrhage to be non-serious, and the event Productive cough to be non-serious
Heart murmur