Reporte zur Charge UH922AB

Symptomtext

food panel it showed that she had a sensitivity to an egg; chest felt strained like when you are holding your breath swimming under water; trouble seeing; face was swollen like an egg; eyes had a sticky substance in them like Elmer's glue and they were oozing; funny feeling in her chest; cough; Initial information received on 09-Apr-2021 regarding an unsolicited valid serious case from a consumer/non-health care professional via Global Media Information (GMI reference number 00555398). This case involves a 56 years old female patient who experienced chest felt strained like when you are holding your breath swimming under water (chest discomfort); funny feeling in her chest (feeling abnormal) , trouble seeing (visual impairment), face was swollen like an egg (swelling face), eyes had a sticky substance in them like Elmer's glue and they were oozing (eye discharge), cough, after receiving INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE [FLUZONE]. Past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. At the time of the event, the patient was found sensitive to egg (food allergy). In January 2014, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE (0.5 prefilled syringe, lot UH922AB and expiry date not reported) via unknown route in an unknown administration site for prophylactic vaccination. In January 2014, Patient stated that the reaction she had was not within the first 15 minutes and she said she took her daughter as well and it was in the late afternoon 3:30-4 pm and then probably 2-3 hours later she noticed her chest felt strained like when you are holding your breath swimming under water (chest discomfort). She stated that it started with cough and then she had the funny feeling in her chest (feeling abnormal) and was laying on couch watching tv and had trouble seeing (visual impairment). She also reported that, she was watching a show and then went to the bathroom and saw that her face was swollen like an egg (swelling face) and her eyes had a sticky substance in them like Elmer's glue and they were oozing (eye discharge), so she drove to the ER (emergency room) and she was informed that it was an allergic reaction to the vaccine. She stated that she eats eggs and did not have a problem but when she did a food panel it showed that she had a sensitivity to an egg (contraindication to vaccination, same day latency). All the reported events were assessed as serious, as the patient was hospitalized for these events. She reported that her reaction was not a sore arm. Hence, reported that caller would like to know the ingredients in the Fluzone vaccine from January 2014 contained eggs, that was Preservative free because she had an above adverse reactions that landed her on the hospital. Also stated that she wanted to do her due diligence now to know the ingredients before she got a Covid (coronavirus disease) vaccine and a flu vaccine because she does not want the same thing to happen again. The caller wanted her son who has cerebral palsy and autism to receive the COVID 19 vaccine and she was not sure if what she experienced was genetic. The caller also stated that she had paperwork and it was a clinic summary they gave her. She states that she was not sure if it was reported as an adverse reaction because her paperwork said it was not submitted so it looked like she had trouble submitting the information. Other relevant laboratory test were not reported. It was not reported if the patient received a corrective treatment. At time of reporting, the outcome was unknown for all the reported events. It was also reported that the patient was looking for information in the DailyMed website that only went back to 03-Aug-2015 in terms of their prescribing information, on what was in the vaccine she received and she would like a call back in regards to this.; Sender's Comments: This case involves a 56 years old female patient who had chest discomfort, feeling abnormal, visual impairment, swelling face, eye discharge and cough, after vaccination with INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. The time to onset is compatible. It was also a case of contraindication to vaccination as the patient was allergic to egg. However, further information on patient's medical condition at the time of vaccination and lab tests were not reported. Based upon the reported information, the role of a vaccine cannot be assessed.