Received Sep 10, 2025
| Type | Name | Manufacturer | Dose | Lot | Route / Site |
|---|---|---|---|---|---|
| VARZOS | ZOSTER (SHINGRIX) | GLAXOSMITHKLINE BIOLOGICALS | 1 | UNK | IM / RA |
she had blisters and a circle around her left lower leg above the ankle; Pain in ears radiating down neck; Pain in ears radiating down neck; Pain in ears radiating down neck; sudden stabbing pain in her heart; This serious case was reported by a nurse via other manufacturer and described the occurrence of chest pain - cardiac in a female patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included COVID-19 vaccine for prophylaxis. Concurrent medical conditions included blood cholesterol increased, allergy to vaccine (She had experienced a reaction to tetanus toxoid and was advised not to receive any vaccines containing it due to her allergy) and food allergy (reaction she gets from food allergies). Concomitant products included rosuvastatin. In DEC-2019, the patient received the 1st dose of Shingrix (intramuscular, right arm) and the 1st dose of COVID-19 vaccine (intramuscular, right arm). In DEC-2019, an unknown time after receiving Shingrix and 20 min after receiving COVID-19 vaccine, the patient experienced chest pain - cardiac (Verbatim: sudden stabbing pain in her heart) (serious criteria GSK medically significant), ear pain (Verbatim: Pain in ears radiating down neck), radiating pain (Verbatim: Pain in ears radiating down neck) and neck pain (Verbatim: Pain in ears radiating down neck). On an unknown date, the patient experienced blister (Verbatim: she had blisters and a circle around her left lower leg above the ankle). The outcome of the chest pain - cardiac, blister, ear pain, radiating pain and neck pain were not reported. It was unknown if the reporter considered the chest pain - cardiac, ear pain, radiating pain and neck pain to be related to Shingrix and COVID-19 vaccine. The reporter considered the blister to be related to Shingrix. The company considered the chest pain - cardiac to be unrelated to Shingrix. The company considered the blister to be related to Shingrix. It was unknown if the company considered the ear pain, radiating pain and neck pain to be related to Shingrix and COVID-19 vaccine. It was unknown if the company considered the chest pain - cardiac to be related to COVID-19 vaccine. Linked case(s) involving the same patient: US2025AMR116309 Additional Information: GSK Receipt Date: 26-AUG-2025 The patient was the reporter. The reporter, a pediatric registered nurse, had given consent to be contacted. The COVID-19 vaccine was confirmed to be another company product, although the specific manufacturer was not identified. The consumer stated that she had spoken with company regarding a reaction she experienced from the Shingrix vaccine. During that conversation, she also mentioned her reaction to the COVID-19 vaccine. The pharmacist at company advised her to contact another company directly, explaining that the companies might not share information. The consumer had previously reported her reaction to VAERS, as her symptoms were not listed among the known side effects in the vaccine documentation. As a nurse, she had access to all relevant paperwork from the hospital where she worked and was among the first to receive the vaccine. She clarified that she had not received any company vaccine on the same day or within four weeks of the Shingrix vaccine. Her hospital had offered the COVID-19 vaccine, but she was initially hesitant due to her known allergy to Tetanus Toxoid. She feared an allergic reaction similar to one she had experienced after a previous vaccine. She explained that she had received the Shingrix vaccine in 2019, with blisters forming in a circular pattern around her ankle after the first dose, and around her right arm after the second dose. She had received two doses of the Shingrix vaccine from company. After the first dose, she developed blisters and a circular rash around her left lower leg above the ankle. After the second dose, she had a similar blister below the injection site on her right arm. She stated that she had received the Shingrix vaccine approximately 1.5 years before the COVID vaccine. As a healthcare worker, she was prioritized for early vaccination and received two doses of the COVID-19 vaccine. She experienced a reaction to the first dose, which was not listed in the side effect documentation. She reported it to VAERS but later learned she should have contacted company directly. She described the reaction as frightening. She did not experience any side effects from the second dose. Regarding her age at the time of the event, she was unsure but believed it was around December 2019 or 2020, when the first COVID vaccines were being administered. She described her ethnicity as mixed, with over ten nationalities in her family. She noted that many of her relatives had dark skin and that she herself had blue eyes, making it difficult to categorize her ethnicity. The vaccination took place in a hospital at around 5 pm. She believed the first dose was administered in December 2019, and the second dose in January 2020. She did not have her vaccination card available due to her house being flooded and was staying in a hotel at the time of the call. She explained that her passport and vaccine documentation were at her flooded home, and she expected to return in several weeks. She had been displaced for nine weeks. At the time of vaccination, she was not taking any medications. She later began taking Rosuvastatin for elevated cholesterol, which had since improved. A CT scan of her heart conducted about 1.5 years ago revealed calcium buildup in two arteries, including the widowmaker. Her daughter and husband had similar findings and were also prescribed statins. She had undergone lab work about a month prior but had not had any tests in the past two weeks. She had completed bloodwork the previous month and saw her physician for physical exams twice a year. She reported that she did not receive any treatment for the reaction to the Shingrix vaccine. The pharmacy did not advise any action, but she later reported the incident to company. She attributed the blisters to the Shingrix vaccine. Regarding the COVID-19 vaccine, she experienced symptoms within 20 minutes of receiving the first dose, including stabbing pain in her heart and ears, radiating down her neck. She did not receive treatment and reported the reaction to VAERS, noting that her symptoms were not listed in their database. She stated that the vaccine was administered in her right arm, as she always preferred that side. Although she was unsure of the exact route of administration due to her fear of needles, she believed it was likely intramuscular (IM), based on how the injection was given. She confirmed that the reaction did not result in hospitalization. She had asked what to do in case of a reaction due to her tetanus allergy, especially since she was working with premature infants at the time. She was advised to call for help if needed. When asked if she wanted to know what to do for future reactions, she agreed. The nurse reported that she had experienced an adverse reaction to the company COVID-19 vaccine in December 2019, during its initial release when it was only available to hospital staff. She recalled receiving the vaccine around 5 pm at the hospital where she worked. Within 20 minutes, while using the stairs, she had to sit down due to a sudden stabbing pain in her heart. She described the sensation as similar to a knife stabbing her heart and ears, with pain radiating down her neck, comparable to reactions she had experienced from food allergies. She likened it to the sting of a jellyfish. She also shared her history with other vaccines. She had experienced a reaction to tetanus toxoid and was advised not to receive any vaccines containing it due to her allergy. She clarified that these reactions were unrelated to the COVID-19 vaccine and were mentioned only for context. The caller expressed that she had been terrified to receive the COVID-19 vaccine and had asked her coworkers why she should get it. They told her it could help prevent hospitalization or the need for a respirator, so she agreed to take it. After experiencing the reaction, she reported it to VAERS, as her symptoms were not listed in the vaccine's documentation. She was later advised to contact another company, which she had not known was necessary until speaking with a pharmacist at company. She stated that she only had a reaction to the first dose of the COVID-19 vaccine. For the second dose, which she received around January, she was given Tylenol and did not experience any side effects. She had asked what she should have done during her initial reaction and was told to call the rapid response team, but she did not do so. Instead, she continued working and cared for the infants in her unit. Her healthcare provider had not mentioned any further vaccinations, but she wanted to ensure her provider could evaluate her before making any decisions. She was informed about company medical information and provided with the contact number. She was informed about the risks associated with Comirnaty, including myocarditis and pericarditis, and was advised to seek medical attention if symptoms such as chest pain, shortness of breath, or a fast-beating heart occurred within two weeks of vaccination. The caller had not known that another company might not receive information from VAERS and appreciated the guidance provided.; Sender's Comments: A case of Angina pectoris, an unknown time after receiving Shingrix, in a female patient. Report is inconsistent with causal relation to the vaccine product, considering absence of biological plausibility and alternative risk factor (high blood cholesterol) and Co-suspect products included COVID-19 vaccine.
Allergy to vaccine (She had experienced a reaction to tetanus toxoid and was advised not to receive any vaccines containing it due to her allergy); Blood cholesterol increased; Food allergy (reaction she gets from food allergies)
ROSUVASTATIN
Test Name: Blood test; Result Unstructured Data: (Test Result:not reported,Unit:unknown,Normal Low:,Normal High:); Test Name: CT scan heart; Result Unstructured Data: (Test Result:see text,Unit:unknown,Normal Low:,Normal High:); Comments: CT scan heart showed showed elevated calcium in two heart arteries, including the widowmaker, Similar condition found in daughter and possibly husband, Statin prescribed based on scan results