Age: 64.0
Sex: F
Vaccine: COVID19, FLU4, VARZOS
Symptoms: Depressed level of consciousness, Tenderness, Urticaria
Clinical narrative: kind of knocked me out a little bit; she came down with a severe case of hives. The hives covered from her chest down to her ankles, and part of her back.; little soreness in her arm; Initial information received on 14-Oct-2022 regarding an unsolicited valid  serious case received from a consumer/non-hcp.  This case involves a 64 years old female patient who experienced kind of knocked me out a little bit, she came down with a severe case of hives. the hives covered from her chest down to her ankles, and part of her back. and little soreness in her arm while receiving vaccines moderna covid-19 vaccine, shingrix and influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included CORTISONE (CORTISONE).  On 09-Sep-2022, the patient received a  dose of suspect influenza quadrival a-b high dose hv lot UJ882AB via unknown route in the right arm. from prophylactic vaccination. On an unknown date, the patient received a  dose of suspect shingrix not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site from prophylactic vaccination. On an unknown date, the patient received a Booster dose of suspect moderna covid-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site from prophylactic vaccination.  On an unknown date the patient developed a serious kind of knocked me out a little bit (depressed level of consciousness) (unknown latency) following the administration of influenza quadrival a-b high dose hv, shingrix, moderna covid-19 vaccine. This event was assessed as medically significant.  On 13-Sep-2022 the patient developed a non-serious she came down with a severe case of hives. the hives covered from her chest down to her ankles, and part of her back. (urticaria) and little soreness in her arm (tenderness)  4 days following the administration of quadrival a-b high dose hv, shingrix, moderna covid-19 vaccine.  It was reported "She received Fluzone HD QIV for the first time on 09Sep2022. She has received flu shots for many years in the past without any problems other than a sore arm. This year, four days after the Fluzone HD QIV was administered in her right arm, she came down with a severe case of hives. The hives covered from her chest down to her ankles, and part of her back. They were so severe that she could not function. Her dermatologist gave her a shot of cortisone and she took antihistamines. Both her dermatologist and internist were not sure if the Fluzone HD QIV could be the cause, especially with the 4-day delay of onset, however the patient cannot think of anything else that she might have been exposed to that would have caused the hives. When the hives began, they started in the armpit of her right arm at that same level as the injection site. She discussed her previous experience with other vaccines as to how it is so unusual for her to have hives after Fluzone HD QIV. She received Moderna Covid vaccines. The bivalent Covid booster a week ago caused her to have a little soreness in her arm. When she received the second full dose of the initial series of Moderna Covid vaccine, that dose "knocked me off my feet and I could not get out of bed for 24 hours". All of the other Covid boosters did not cause problems for her. She has taken vaccines against typhoid, Td, and pneumonia without problems. The Shingrix vaccine "kind of knocked me out a little bit. I was told by other people that Shingrix really hurts." (see #01322462 for report for "other people"). Twenty-five or thirty years ago she had a TB test with ppd. After that test, her entire arm "blew up" instantly with a giant welt. She was told at first that she had TB. A follow-up chest x-ray was negative. It was realized that she did not have TB and that instead something was wrong with that test. She later had subsequent ppd tests without reactions. She says, "I suspect that test was contaminated with something".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events (she came down with a severe case of hives. The hives covered from her chest down to her ankles, and part of her back., little soreness in her arm, kind of knocked me out a little bit).  At time of reporting, the outcome was Recovering / Resolving for the event she came down with a severe case of hives. the hives covered from her chest down to her ankles, and part of her back., was Recovering / Resolving for the event little soreness in her arm and was Unknown for the event kind of knocked me out a little bit.; Sender's Comments: Sanofi company comment dated 24-Oct-2022: This case concerns 64 years old female patient who experienced kind of knocked me out a little bit, she came down with a severe case of hives. the hives covered from her chest down to her ankles, and part of her back. and little soreness in her arm while receiving vaccines moderna covid-19 vaccine, shingrix and influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent]. Based on information provided, the causal role of company suspect cannot excluded. Case will be re-evaluated post further update on information regarding underlying disease, risk precipitating factor, past medical history and patient lifestyle which will preclude a comprehensive assessment of this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.