Received Mar 3, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| PNC13 | PNEUMO (PREVNAR13) | PFIZER\WYETH | 3 | — | — |
convulsions/terrible tremors, shakes/convulsions tremors and shaking; alternating hot sweats and chills/body sweats with fever; chills; body sweats with fever that would break; turned 50 gave 3rd pcv 13 shot; This is a spontaneous report received from a Consumer or other non HCP from medical information team, Program ID. A 50-year-old male patient received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), in 2009 as dose 3, single (Batch/Lot number: unknown) at the age of 50 years, in arm for immunisation. The patient's relevant medical history included: "emergency splenectomy", start date: 1984 (unspecified if ongoing); "respiratory issues" (not ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, in 2009 (same date) for immunisation. Vaccination history included: Prevnar 13 (DOSE 1), administration date: 1999, when the patient was 40 years old, for Immunization; Prevnar 13 (DOSE 2), administration date: 2004, when the patient was 45 years old, for Immunization; Influenza vaccine (flu shot every year), for Immunization. The following information was reported: HYPERHIDROSIS (non-serious) with onset 2009, outcome "recovered", described as "alternating hot sweats and chills/body sweats with fever"; PYREXIA (non-serious) with onset 2009, outcome "recovered", described as "body sweats with fever that would break"; CHILLS (non-serious) with onset 2009, outcome "recovered"; SEIZURE (medically significant) with onset 2009, outcome "recovered", described as "convulsions/terrible tremors, shakes/convulsions tremors and shaking"; INCORRECT DOSE ADMINISTERED (non-serious) with onset 2009, outcome "unknown", described as "turned 50 gave 3rd pcv 13 shot". Therapeutic measures were not taken as a result of seizure, hyperhidrosis, chills, pyrexia. Clinical course: In 1984, patient had an emergency splenectomy surgeon said would need to get flu and pneumonia shots, because patient did have respiratory issues, in his 30's he would get respiratory issues. When patient turned 40 and started going in for annual physicals and the doctor said we probably need to get a pcv 13 shot. Patient didn't have any respiratory issues beyond that and at his 45 y/o check up, they said the pneumonia shot can have every 5 years and gave patient another pcv 13 shot. Patient had no issues beyond that and when he turned 50 they said the pneumonia shot was up and gave another pcv 13 shot, that night patient had terrible tremors, shakes, convulsions, alternating hot sweats and chills, body sweats with fever that would break, it was a 5 or 6 hour occurrence. Fast forward to the next year, patient was at a health fair through his employment and they had the flu and pneumonia shots and he was visiting with a nurse taking this information, and they had a recap about the 3rd pcv 13 shot and she said, patient were only suppose to have [inaudible] pneumonia shot whole life. She said it could kill patient if I took the 4th, she said patient was only suppose to have two and then since he had side effects from the 3rd shot the 4th could kill patient. Patient asking if he's gonna be at risk or does it have a deadly reaction if he took Prevnar20 Vaccine. He has been 15 years nearly, his PVC would never give him that advise, he has a new PCP and it doesn't get him anywhere. As per caller (patient) he had an emergency where his spleen was removed that is why he needs to take a flu shot every year and pneumonia shots as per his doctor. When he was on his 30s he had some respiratory issues that attributed to his spleen and he took antibiotic about a year. As per caller during the third Prevnar 13 there was reaction that night that cause him to have convulsions tremors and shaking. No investigations. It was in 2009, and he was administered the shot during office hours and the reactions occurred after bedtime so maybe 5-10 hours afterwards 'this' close to duration". Immunizations on the same date with this Pfizer vaccine might be a flu shot. The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Medical History/Concurrent Conditions: Respiratory disorder; Splenectomy
INFLUENZA VACCINE