Received May 23, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | EB499 | LA |
sore arm (area were vaccine was administered); Dizziness; Headache; Blurry vision; Sweating; Fatigue extreme; Tinnitus; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 12-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number EB499, expiry date 26-AUG-2027) for prophylaxis. On 18-MAY-2025, the patient received Boostrix (left arm). In MAY-2025, an unknown time after receiving Boostrix, the patient experienced injection site pain (Verbatim: sore arm (area were vaccine was administered)). On 18-MAY-2025, the patient experienced dizziness (Verbatim: Dizziness), headache (Verbatim: Headache), blurred vision (Verbatim: Blurry vision), sweating (Verbatim: Sweating), fatigue (Verbatim: Fatigue extreme) and tinnitus (Verbatim: Tinnitus). In MAY-2025, the outcome of the injection site pain was resolved. On 18-MAY-2025, the outcome of the dizziness, headache, blurred vision, sweating, fatigue and tinnitus were resolved. It was unknown if the reporter considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix. It was unknown if the company considered the dizziness, headache, blurred vision, sweating, fatigue, tinnitus and injection site pain to be related to Boostrix. Additional Information: GSK receipt date: 19-MAY-2025 Patient's mother stated that bout 10 seconds after the patient was administered the vaccine, patient began to feel following symptoms (dizziness, bad headache, blurry vision, profuse sweating, extreme tinnitus, extreme fatigue). Patient was given some water to drink, and in about 5 to 10 minutes later, symptoms stopped. Patient had a sore arm (area were vaccine was administered) later that night. Symptoms did not recur and patient had fully recovered.