Received Oct 15, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| UNK | VACCINE NOT SPECIFIED (NO BRAND NAME) | UNKNOWN MANUFACTURER | 1 | 37KF3 | IM / LA |
Anaphylaxis; patient did not sleep well that night; patient's entire face was a complete circle (her entire face was swollen); Her upper and lower eye lids were swollen; She was also swollen under her chin and neck; patient felt super tired and felt super dizzy, and was having achiness; Her face started to tingle; felt shaky; patient was also experiencing a choking sensation; had weakness in the left arm and left leg; felt super dizzy; was having achiness; arm began to feel sore; began to turn red; headache; fatigue/patient felt super tired; terrible back pain; flu-like symptoms; Patient took her temperature at 11 pm and it was 100.1 degrees F; This serious case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 32-year-old female patient who received Flu Seasonal TIV Dresden (Fluarix 2025-2026 season) (batch number 37KF3, expiry date 20-JUN-2026) for prophylaxis. The patient's past medical history included asthma (Asthma), postural orthostatic tachycardia syndrome (Postural orthostatic tachycardia syndrome), hydronephrosis (Hydronephrosis of kidney), celiac disease (Celiac disease), hypermobility syndrome and endometriosis. Concurrent medical conditions included anxiety (Anxiety), depression (Depression), sleep disorder, latex allergy (Latex allergy), allergy to animal (Animal allergies), drug allergy (Chlorhexidine Allergy) and drug allergy (Allergy to Naproxen, In past, experienced swelling of face and chin with Naproxen). Concomitant products included fexofenadine hydrochloride (Allegra), desvenlafaxine succinate monohydrate (Pristiq) and trazodone. On 30-SEP-2025 11:30, the patient received the 1st dose of Fluarix 2025-2026 season (intramuscular, left arm) .5 ml. On 30-SEP-2025, an unknown time after receiving Fluarix 2025-2026 season, the patient experienced fever (Verbatim: Patient took her temperature at 11 pm and it was 100.1 degrees F). On 30-SEP-2025 18:00, the patient experienced pain in arm (Verbatim: arm began to feel sore), erythema of extremities (Verbatim: began to turn red), headache (Verbatim: headache), fatigue (Verbatim: fatigue/patient felt super tired), back pain (Verbatim: terrible back pain) and influenza-like symptoms (Verbatim: flu-like symptoms). On 01-OCT-2025, the patient experienced dizziness (Verbatim: felt super dizzy), pain (Verbatim: was having achiness), choking sensation (Verbatim: patient was also experiencing a choking sensation) and weakness of limbs (Verbatim: had weakness in the left arm and left leg). On 01-OCT-2025 09:00, the patient experienced facial swelling (Verbatim: patient's entire face was a complete circle (her entire face was swollen)), swelling of eyelid (Verbatim: Her upper and lower eye lids were swollen), local swelling (Verbatim: She was also swollen under her chin and neck), tiredness (Verbatim: patient felt super tired and felt super dizzy, and was having achiness), tingling (Verbatim: Her face started to tingle) and tremor (Verbatim: felt shaky). On an unknown date, the patient experienced anaphylaxis (Verbatim: Anaphylaxis) (serious criteria GSK medically significant) and sleeplessness (Verbatim: patient did not sleep well that night). The patient was treated with ibuprofen, Steroids, diphenhydramine hydrochloride (Benadryl) and prednisone. The outcome of the anaphylaxis, pain in arm, erythema of extremities, headache, fatigue, back pain, influenza-like symptoms, fever, sleeplessness, facial swelling, swelling of eyelid, local swelling, tiredness, dizziness, pain, tingling, choking sensation and tremor were resolving and the outcome of the weakness of limbs was not resolved. It was unknown if the reporter considered the anaphylaxis, pain in arm, erythema of extremities, headache, fatigue, back pain, influenza-like symptoms, fever, sleeplessness, facial swelling, swelling of eyelid, local swelling, tiredness, dizziness, pain, tingling, choking sensation, weakness of limbs and tremor to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. The company considered the anaphylaxis to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. It was unknown if the company considered the pain in arm, erythema of extremities, headache, fatigue, back pain, influenza-like symptoms, fever, sleeplessness, facial swelling, swelling of eyelid, local swelling, tiredness, dizziness, pain, tingling, choking sensation, weakness of limbs and tremor to be related to Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional Information: GSK receipt date: 02-OCT-2025 The reporter reported that around 6 pm that day on the day of vaccination the patient arm began to feel sore, and began to turn red. She felt hot and cold, and shaky. At 9 am the next day, the patient entire face was a complete circle, her entire face was swollen. Her upper and lower eye lids were swollen, the patient could only see half-way out of her eyes. The patient was also swollen under her chin and neck. The patient took Ibuprofen for the swelling. The patient felt super tired and felt super dizzy, and was having achiness. The patient tried to sleep it off, after she woke up, the patient realized her swollen face was not going down, it was getting worse. The patient began to have weakness in her left arm and left leg. Her face started to tingle. The patient was also experiencing a choking sensation. Around 4:30 pm, the patient went to an urgent care center where she was told she was exhibiting signs of anaphylaxis. The patient was given injectable steroids, injectable Benadryl, and a nebulizer treatment to treat her symptoms. The patient was subsequently prescribed Prednisone for 5 days, and Benadryl after every 8 hours. On 02nd October 2025, the patient face was a little less swollen and had weakness in the left arm. The patient felt her symptoms were getting better, but were still worrisome. The patient did not take the placebo tablets in the birth control pills, so no periods.; Sender's Comments: A case of Anaphylactic reaction, less than a week after receiving Fluarix 2025-2026 season and Fluarix Pre-Filled Syringe Device. Report is consistent with causal relation to the vaccine product, considering plausible time to onset and biological plausibility.
Allergy to animal (Animal allergies); Anxiety (Anxiety); Depression (Depression); Drug allergy (Chlorhexidine Allergy); Drug allergy (Allergy to Naproxen, In past, experienced swelling of face and chin with Naproxen); Latex allergy (Latex allergy); Sleep disorder
Medical History/Concurrent Conditions: Asthma; Celiac disease; Endometriosis; Hydronephrosis (Hydronephrosis of kidney); Hypermobility syndrome; Postural orthostatic tachycardia syndrome
Allegra; PRISTIQ; TRAZODONE
Test Date: 20250930; Test Name: Body temperature; Result Unstructured Data: (Test Result:100.1,Unit:degree F,Normal Low:,Normal High:)