Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Paraesthesia, Paraesthesia oral, Pruritus generalised, Rash generalised
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp (patient). This case involves Adult female patient who experienced several violent reactions like anaphylactic shock, it started all over again, tingling of her lips, noted tingling of her lips and extremities and it scared her, had a terrific allergy attack, itchy all over/ they were itchy as were the bumps at the top of her bra-line/ a few days later the itching once again became overwhelming and she was covered in itchy bumps, that started on her stomach, a couple of little welts on her jaw-line, under her ear and her face and body turned red, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Rheumatoid arthritis and Herpes zoster. Concomitant medications included PREDNISONE for Rheumatoid arthritis. On 11-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ004AB, exp date: 30-Mar-2019, via unknown route in the left deltoid. On an unknown date, the patient developed a serious several violent reactions like anaphylactic shock, it started all over again (anaphylactic shock) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. This event was assessed as medically significant. On the same day, within 10 minutes of administration, the patient developed a non-serious had a terrific allergy attack (hypersensitivity), her face and body turned red (generalised erythema), and she was itchy all over (pruritus) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious tingling of her lips (paresthesia oral) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 28-Sep-2018, the patient developed a non-serious a couple of little welts on her jaw-line, under her ear (urticaria) 17 days following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious noted tingling of her lips and extremities and it scared her. (Paresthesia) (Unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Case description: Caller stated that she received FLUZONE HD and Within 10 minutes of administration, she had a terrific allergy attack, her face and body turned red, and she was itchy all over. She stated that she noted tingling of her lips and extremities and it scared her. She was in the process of driving to her daughters and when she got there, her daughter gave her three 30 ml dosage cups of BENADRYL. She states that after the third one, the itching began to subside, but then she was drunk from the BENADRYL. A few weeks later (28-Sep-2018) she flew to visit family. At the time of flight, she noted a couple of little welts on her jaw-line, under her ear. They were itchy as were the bumps at the top of her bra-line. Caller states that a few days later (on 01-Oct-2018), while flying back, the itching once again became overwhelming and she was covered in itchy bumps, that started on her stomach. She had been using topical hydrocortisone and BENADRYL for relief of itching and the condition seemed to be abating, but when the exacerbation occurred, she went to her HCP and was prescribed additional steroids. She had another exacerbation on 04-Oct-2018. After steroid course, caller states that she was better, but still slightly itchy. She states that on 31-Oct-2018, she sat down to a bowl of homemade chicken soup and it started all over again. Caller stated that she is on chronic prednisone treatment for RA. When she went to her primary care physician he told her that since the initial reaction occurred immediately after vaccination, that means that it was the vaccine that caused the reaction. Caller states that HCP told her it couldn't be an egg allergy because she eats eggs, so it must be impurities in the vaccine. (Other relevant tests included No Lab data was reported.) The patient was treated with DIPHENHYDRAMINE, PARACETAMOL, BENADRYL for Pruritus and HYDROCORTISONE for Pruritus. The patient outcome was reported as Unknown for several violent reactions like anaphylactic shock, it started all over again, had a terrific allergy attack, tingling of her lips, as Unknown for noted tingling of her lips and extremities and it scared her, for  a couple of little welts on her jaw-line, under her ear and as Unknown for her face and body turned red and as Not Recovered / Not Resolved on an unknown date for itchy all over/ they were itchy as were the bumps at the top of her bra-line/ a few days later the itching once again became overwhelming and she was covered in itchy bumps, that started on her stomach; Sender's Comments: This case concerns an adult female who presented with anaphylactic reaction after vaccination with FLUZONE HD. The time to onset is not known. Moreover, allergic history and tolerance to previous vaccinations are important points to consider in this case, which is missing at present. Based upon the reported information, the role of the vaccine cannot be assessed.