Reporte zur Charge UI191AA

Symptomtext

internally bleeding; extraordinarily thirsty; lightheaded; heart rate was high; lots of irregular beats; shaky; heavy case of the flu; Initial information received on 09-Apr-2021 regarding an unsolicited valid serious case received from a consumer. This case involves a 55 year old female patient who experienced internally bleeding (internal haemorrhage), extraordinarily thirsty (thirst), lightheaded (dizziness), heart rate was high (heart rate increased), lots of irregular beats (heart rate irregular), shaky (tremor) and heavy case of the flu (influenza), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Medical history, medical treatment, concomitant medication, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UI191AA and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient developed a serious internally bleeding (internal haemorrhage), extraordinarily thirsty (thirst), lightheaded (dizziness), heart rate was high (heart rate increased), lots of irregular beats (heart rate irregular), shaky (tremor), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were assessed as medically significant. On an unknown date, the patient developed a non-serious heavy case of the flu (influenza) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported that Caller stated that she had a bad reaction 10/10/2014. Caller is requesting the ingredients in product, so she can get Covid (coronavirus disease) 19 vaccine. The caller states that her reaction was very severe and she ended up in the (ER) emergency room for six hours. She was drinking large amounts of water but her thirst could not be quenched. She said that by the time they tried to do an ultrasound it had stopped and run its course. She states that this happened instantaneously after getting the shot and it was like she was getting the flu but she is used to that and it happened very rapidly. She felt like she had a heavy case of the flu and she woke up at 2 am and she was passing blood and thought her heart was going to explode. She said at the ER they just told her she had an allergic reaction to the shot and then her whole body went back to normal. She states that now have COVID and she is not eligible for the vaccine because she had this reaction and she needs to be able to get the ingredient list so they can cross check the ingredient list so she can get it and see her grandkids again. This is all the information she provided at the time of her call. Other relevant laboratories details not reported. It was not reported if the patient received a corrective treatment. On an unknown date, the patient recovered from the all events.; Sender's Comments: This case involves a 55 year old female patient who experienced internally bleeding (internal haemorrhage), extraordinarily thirsty (thirst), lightheaded (dizziness), heart rate was high (heart rate increased), lots of irregular beats (heart rate irregular), shaky (tremor) and heavy case of the flu (influenza), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Time to onset is unknown. Concomitant medication and laboratory data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon the reported information, role the vaccine cannot be assessed.