Sex: F
Vaccine: COVID19
Symptoms: Anxiety, COVID-19, Chills, Dysstasia, Feeling abnormal
Clinical narrative: She got the vaccine yesterday and tested positive; stated that she vomit looks like a dark blood; fever; chills; feels like crap; she felt like she could not stand up; worried; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  A 69-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, SINGLE, Caller states she can't remember the last time she got one, which was over a year ago (did not specify)), administration date: 2022, for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19Sep2023, outcome "unknown"; FEELING ABNORMAL (non-serious) with onset 19Sep2023, outcome "unknown", described as "feels like crap"; PYREXIA (non-serious) with onset 19Sep2023, outcome "unknown", described as "fever"; DYSSTASIA (non-serious) with onset 19Sep2023, outcome "unknown", described as "she felt like she could not stand up"; HAEMATEMESIS (medically significant) with onset 19Sep2023, outcome "unknown", described as "stated that she vomit looks like a dark blood"; ANXIETY (non-serious) with onset 19Sep2023, outcome "unknown", described as "worried"; COVID-19 (non-serious), 1 day after the suspect product(s) administration, outcome "unknown", described as "She got the vaccine yesterday and tested positive". Clinical course: Reporter said that she got the new vaccine yesterday and she experienced severe adverse event. She would like to know what happened. She also stated that she vomits, looks like a dark blood. She said that she got the new vaccine yesterday and she experienced severe adverse event. She would like to know what happened. She also stated that she vomits looks like a dark blood. Caller got disconnected prior to warm transfer. She confirmed she is calling regarding the Comirnaty Covid-19 vaccine that just came out. She stated she is 69 years old. Last night she thought she was gonna die, she has fever that was really high, had chills all night. Today, she feels like crap. Before vomiting she felt like she could not stand up which worried and when she did stand up, that is when she vomited. Caller states if she vomits like that again she will go to the ER (emergency room). After drinking a lot of water and (food company name withheld), states she is feeling better. She can't remember the last time she got one, which was over a year ago (did not specify). She got the vaccine yesterday and tested positive. She vomited like coffee grinds that looked like dark blood. She also stated that she got a high fever and chills. She said that it was more severe this time. She was wondering if that happened with the vaccine. Created a manual AE form because the caller had a severe adverse event after taking the vaccine.    The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.