Received May 13, 2026
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | 4A4BM | LA |
felt like her lungs were inflamed; injection site ache and soreness; warm injection site; pink injection site; injection site was the size of a baseball; Ringing in ears; Flu-like symptoms; in bed with migraine; left arm also became itchy from the shoulder to the mid-bicep/ itching; face and cheeks became red/ flushing; face and cheeks became sensitive; face and cheeks became hot; Lung irritation; severe fatigue/ felt rundown/ exhausted; Perspiration excessive/ armpit sweat that was excessive; Low grade fever; ache; felt like her immune system was working at a high level; This serious case was reported by a consumer via call center representative and described the occurrence of lung inflammation in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 4A4BM, expiry date 18-MAR-2027) for prophylaxis. On 21-FEB-2026 17:30, the patient received the 1st dose of Shingrix (left arm) .5 ml. On 21-FEB-2026, less than a day after receiving Shingrix, the patient experienced lung inflammation (Verbatim: felt like her lungs were inflamed) (serious criteria GSK medically significant) and ringing in ears (Verbatim: Ringing in ears). On 22-FEB-2026, the patient experienced injection site pain (Verbatim: injection site ache and soreness), influenza-like symptoms (Verbatim: Flu-like symptoms), fatigue (Verbatim: severe fatigue/ felt rundown/ exhausted), sweating increased armpits (Verbatim: Perspiration excessive/ armpit sweat that was excessive) and low grade fever (Verbatim: Low grade fever). On 23-FEB-2026, the patient experienced injection site warmth (Verbatim: warm injection site), injection site erythema (Verbatim: pink injection site), injection site swelling (Verbatim: injection site was the size of a baseball), migraine (Verbatim: in bed with migraine), itchy upper limbs (Verbatim: left arm also became itchy from the shoulder to the mid-bicep/ itching), facial flushing (Verbatim: face and cheeks became red/ flushing), hyperesthesia (Verbatim: face and cheeks became sensitive), feeling of warmth facial (Verbatim: face and cheeks became hot), lung irritation (Verbatim: Lung irritation) and pain (Verbatim: ache). On an unknown date, the patient experienced immune system disorder (Verbatim: felt like her immune system was working at a high level). The patient was treated with zolmitriptan (Zomig). The outcome of the lung inflammation, injection site pain, injection site warmth, injection site erythema, injection site swelling, ringing in ears, influenza-like symptoms, migraine, itchy upper limbs, facial flushing, hyperesthesia, feeling of warmth facial, lung irritation, fatigue, sweating increased armpits, low grade fever, pain and immune system disorder were resolved (duration 2 weeks). It was unknown if the reporter considered the lung inflammation, injection site pain, injection site warmth, injection site erythema, injection site swelling, ringing in ears, influenza-like symptoms, migraine, itchy upper limbs, facial flushing, hyperesthesia, feeling of warmth facial, lung irritation, fatigue, sweating increased armpits, low grade fever, pain and immune system disorder to be related to Shingrix and Shingrix Pre-Filled Syringe Device. The company considered the lung inflammation to be unrelated to Shingrix and Shingrix Pre-Filled Syringe Device. It was unknown if the company considered the injection site pain, injection site warmth, injection site erythema, injection site swelling, ringing in ears, influenza-like symptoms, migraine, itchy upper limbs, facial flushing, hyperesthesia, feeling of warmth facial, lung irritation, fatigue, sweating increased armpits, low grade fever, pain and immune system disorder to be related to Shingrix and Shingrix 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: 06-MAY-2026 The reporter was a patient who received her first dose of Shingrix in the left arm on 21-FEB-2026 at approximately 17:30 pm She reported that about one hour after vaccination, she experienced ringing in her ears and developed a wheezing cough. One day following the vaccination, she felt generally rundown and experienced soreness and aching at the injection site. She also reported flu like symptoms, marked exhaustion, and the onset of a low grade fever accompanied by increased perspiration. Two days after vaccination, the reporter stated that she continued to feel rundown and remained in bed due to a migraine, which was treated with Zomig. At that time, she continued to experience a wheezing cough and described a sensation that her lungs felt inflamed. She further reported that her left arm became warm, sore, and pink at the injection site, with swelling approximately the size of a baseball. The left arm was also described as itchy from the shoulder to the mid bicep. The reporter stated that it felt as though her immune system was working at a high level. She additionally experienced facial flushing, with her face and cheeks becoming hot, red, and sensitive. She reported excessive perspiration in the armpit region that persisted for approximately two weeks. All reported symptoms are resolved within two weeks. The patient subsequently questioned whether she should receive the second dose of the Shingrix series. It was noted that she was still within the recommended dosing interval and had not missed the second dose.; Sender's Comments: A case of Pneumonitis, less than a days after receiving 1st dose of Shingrix in a 58-year-old female patient. Case lacks further information on medical history, concurrent conditions and laboratory data. Based on the available information a possible causality that the event was caused by the GSK product cannot be ascertained. Consent for further follow-up has not been received.
Test Name: Body Temperature; Result Unstructured Data: (Test Result:low grade fever,Unit:unknown,Normal Low:,Normal High:)