Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Dizziness, Feeling abnormal, Feeling cold
Clinical narrative: Thought she was going to faint; Took Tylenol felt "really bad"/Still a little bad; could not do anything that day; Headache; Body aches; Stomach ache; she was sick with a fever; Skin was warm/Fever; skin was warm; She felt chilly; Body weakness/ little weak; This case was reported by a nurse via call center representative and described the occurrence of sickness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included paracetamol (Tylenol) for product used for unknown indication.   The patient's past medical history included shingles (shingles outbreak in (around August 2021)- painful rash) and painful rash. Concurrent medical conditions included post herpetic neuralgia (post-herpetic neuralgia (PHN)- intermittent).   On 13th April 2022 15:00, the patient received the 1st dose of Shingrix. In April 2022, the patient started Tylenol at an unknown dose and frequency. On 14th April 2022, 1 days after receiving Shingrix, the patient experienced activities of daily living impaired and feeling bad. In April 2022, the patient experienced sickness, fever, skin warm, chilliness, weakness generalized, headache, general body pain and stomach pain. On 15th April 2022, the patient experienced felt faint. The action taken with Tylenol was unknown. On an unknown date, the outcome of the sickness, chilliness, weakness generalized, general body pain and stomach pain were recovered/resolved and the outcome of the fever, skin warm, activities of daily living impaired, headache, feeling bad and felt faint were unknown.   It was unknown if the reporter considered the sickness, headache and feeling bad to be related to Shingrix. The reporter considered the fever, skin warm, chilliness, weakness generalized, activities of daily living impaired, general body pain, stomach pain and felt faint to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-APR-2022 Reporter's Comment: The case was reported by the patient.  The patient did not have the lot number or expiration date of the injection but did provide the contact information for the pharmacy where she received the shot. The patient had the shot around 3:00 in the afternoon and felt fine until around midnight/early in the morning and then she thought that, something was wrong with her.  The patient did not take her temperature but felt like she was sick with a fever, her skin was warm and she felt chilly.  She had to use an electric blanket (to keep warm). She also experienced body weakness, headache, body aches and stomach ache. She took Tylenol.  She felt really bad on 14th April 2022 and could not do anything that day.  On 15th April 2022, she felt better but she was still a little weak, still a little bad. She felt like she thought that, she was going to faint.  After receiving Tylenol, the patient experienced activities of daily living impaired, feeling bad and felt faint. It was unknown if the reporter considered the activities of daily living impaired, feeling bad and felt faint to be related to Tylenol. The reporter consented to follow up.