Received Apr 23, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC20 | PNEUMO (PREVNAR20) | PFIZER\WYETH | 1 | — | LA |
Headache; Fatigue; Soreness of joints; Shortness of breath at a mild level; Usually had to get up every 90 to 120 minutes at night to urinate and that went to every 40 to 60 minutes; Resting pulse raised from 54 bpm to 84 bpm / pulse dropped to within 10 bpm of normal; Lack of sleep; This is a spontaneous report received from a Consumer or other non HCP. A 75-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN)), on 01Apr2026 as dose 1, single (Batch/Lot number: unknown) at the age of 75 years, in left arm for immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Aortic valve replacement" (unspecified if ongoing); "Bladder cancer" (unspecified if ongoing), notes: resolved; "kidney stones" (unspecified if ongoing); "A-Fib" (unspecified if ongoing); "skin cancer" (unspecified if ongoing), notes: resolved. Concomitant medication(s) included: BENAZEPRIL, start date: May2003; TAMSULOSIN, start date: Mar2011; TADALAFIL, start date: Mar2020; ELIQUIS, start date: Jul2025, stop date: Apr2026. The patient did not receive any vaccines on the same date as the vaccine(s). The patient did not receive any vaccines within 4 weeks PRIOR to the vaccine(s). The following information was reported: FATIGUE (non-serious) with onset 01Apr2026 at 20:00, outcome "recovering"; HEADACHE (non-serious) with onset 01Apr2026 at 20:00, outcome "recovering"; INSOMNIA (non-serious) with onset 01Apr2026 at 20:00, outcome "recovering", described as "Lack of sleep"; HEART RATE ABNORMAL (non-serious) with onset 01Apr2026 at 20:00, outcome "recovering", described as "Resting pulse raised from 54 bpm to 84 bpm / pulse dropped to within 10 bpm of normal"; DYSPNOEA (non-serious) with onset 01Apr2026 at 20:00, outcome "recovering", described as "Shortness of breath at a mild level"; ARTHRALGIA (non-serious) with onset 01Apr2026 at 20:00, outcome "recovering", described as "Soreness of joints"; NOCTURIA (non-serious) with onset 01Apr2026 at 20:00, outcome "recovering", described as "Usually had to get up every 90 to 120 minutes at night to urinate and that went to every 40 to 60 minutes". Therapeutic measures were not taken as a result of headache, fatigue, arthralgia, dyspnoea, nocturia, heart rate abnormal, insomnia. Additional information: The patient experienced headache, fatigue, soreness of joints, and shortness of breath at a mild level. The patient usually had to get up every 90 to 120 minutes at night to urinate and that went to every 40 to 60 minutes. Apparently as a result of lack of sleep, the symptoms worsened to moderate at 4, 5, and 6 days, and around 7th day, the resting pulse raised from 54 bpm to 84 bpm. Around the 9th day, pulse dropped to within 10 bpm of normal and to a level that is normal when the patient can't exercise, which he was not able to do. The symptoms all became mild again but persist through day 18. The patient has not had any fever during the entire episode. The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: AFib; Aortic valve replacement; Bladder cancer (resolved); Blood pressure high; Kidney stones; Skin cancer (resolved)
BENAZEPRIL; TAMSULOSIN; TADALAFIL; ELIQUIS