Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Tremor
Clinical narrative: Severely ill/could not get out of bed; Bed-ridden; Felt like she had a bad case of the flu; Muscles were extremely weak; Fell out of bed; Huge headache; Nausea; Stomach cramping; Could not get out of bed; Needed help to walk to the bathroom / Symptoms were so awful/debilitating; Dehydrated; Hard to drink; Hard to breathe / Trouble breathing; Symptoms were so awful/debilitating; Horrible diarrhea/went to the bathroom a lot; Shaking uncontrollably; Shivering uncontrollably; This case was reported by a consumer via call center representative and described the occurrence of unwell in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included bilateral pneumonia. Previously administered products included Flu shot (patient had received flu shot in the past). Concurrent medical conditions included retinopathy, diabetes, hard of hearing, sinus disorder, immunocompromised, disorder equilibrium, allergy to antibiotic and penicillin allergy.   On 8th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 8th September 2020, less than a day after receiving Shingrix, the patient experienced unwell. In September 2020, the patient experienced bedridden, influenza like illness, muscle weakness, tremor, shivering, fall, headache, diarrhea, nausea, stomach cramps, mobility decreased, weakness, dehydration, swallowing difficult, difficulty breathing and feels awful. Shingrix was discontinued. On an unknown date, the outcome of the unwell, bedridden, influenza like illness, muscle weakness, tremor, shivering, fall, headache, diarrhea, nausea, stomach cramps, mobility decreased, weakness, dehydration, swallowing difficult, difficulty breathing and feels awful were recovered/resolved.   It was unknown if the reporter considered the unwell, bedridden, influenza like illness, fall, mobility decreased, weakness, swallowing difficult, difficulty breathing and feels awful to be related to Shingrix. The reporter considered the muscle weakness, tremor, shivering, headache, diarrhea, nausea, stomach cramps and dehydration to be related to Shingrix.  Additional details were provided as follows: The reporter was patient herself. The patient was hard of hearing thus it was a bit difficult for communication with her. The lot number details were not asked to the patient as she was elderly. The patient received the vaccine in her upper arm and within 7 hours she became severely ill. The patient mentioned that she was bed-ridden and felt like she had a bad case of the flu and that her muscles were extremely weak and a;so that she was shaking/shivering uncontrollably for at least 12, possibly 24 hours; such that she fell out of bed. The patient also had a huge headache and had horrible diarrhea for 24 hours. She had nausea and stomach cramping and mentioned that her symptoms were so severe that she could not get out of bed. She further said that she went to the bathroom a lot and needed help to walk to the bathroom. She had become dehydrated because it was hard to drink due to the nausea. It was also hard to breathe for her but she did convey that as she had pre-existing sinus problems, so she indicated that she often had trouble breathing. The symptoms lasted for 3 to 4 days. She stated that she almost went to the hospital because her symptoms were so awful/debilitating. She started to feel "human" again by the weekend, on Saturday and had not seen her physician but she did call him and he had advised her not to get the second shot of the Shingrix series. She said that she felt fine then.  She also conveyed that she has had other immunizations before but never had an issue like that and also said that flu shot did not phase her out and further said she did not have fever or vomitting. The reporter consented to follow-up. The reporter provided her personal email address but did not have a personal fax number. This case has been linked to US2020187916 ( husband's case), reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020187916:Husband's case