Received Aug 11, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| TDAP | TDAP (BOOSTRIX) | GLAXOSMITHKLINE BIOLOGICALS | UNK | 95PUM | IM / RA |
facial paresthesia /facial numbness; Dizziness; Head pain /cephalgia; Fatigue; Migraine; Injection site pain /soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 39-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 95PUM) for prophylaxis. On 25-JUL-2025, the patient received Boostrix (intramuscular, right deltoid). On 25-JUL-2025, less than a day after receiving Boostrix, the patient experienced injection site pain (Verbatim: Injection site pain /soreness). On 26-JUL-2025, the patient experienced facial paresthesia (Verbatim: facial paresthesia /facial numbness), dizziness (Verbatim: Dizziness), headache (Verbatim: Head pain /cephalgia), fatigue (Verbatim: Fatigue) and migraine headache (Verbatim: Migraine). On 27-JUL-2025, the outcome of the headache was resolved (duration 1 day). On 28-JUL-2025, the outcome of the dizziness and fatigue were resolved (duration 2 days). The outcome of the injection site pain and migraine headache were unknown and the outcome of the facial paresthesia was not resolved. It was unknown if the reporter considered the injection site pain, facial paresthesia, dizziness, headache, fatigue and migraine headache to be related to Boostrix. It was unknown if the company considered the injection site pain, facial paresthesia, dizziness, headache, fatigue and migraine headache to be related to Boostrix. Additional Information: GSK Receipt Date: 28-JUL-2025 The patient reported that she received a Boostrix vaccination and in the evening, she had injection site soreness (pain). The patient mentioned 24 hours after the vaccination, she had dizziness, fatigue, headache, migraine headache and numbness to the left side of her face, upper and lower lips, tongue and under the sinus cavity on her left cheek. She visited the Emergency Department and was diagnosed with head pain, cephalgia, and facial paresthesia. A CT scan was performed with normal findings. She reported that her lips and the left side of her face are still numb. She denies any additional medications or vaccinations and any other health conditions.
Test Date: 20250726; Test Name: CT scan; Result Unstructured Data: (Test Result:normal,Unit:unknown,Normal Low:,Normal High:)