Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Burning sensation, Decreased appetite, Feeling cold, Headache
Clinical narrative: I thought I was going to die; headache; burning up; continuously cold and shaking; continuously cold and shaking; pulse 90-100 "right on the nose" of 93; could not eat lunch or dinner yesterday; getting up thirsty drinking water all night long; kidney hurting; feeling pins and needles in entire body; The initial safety information received was reporting only non-serious adverse drug reaction. Upon follow-up on 08Sep2022, this case contains serious adverse reaction and all safety information processed together.  This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 at 10:00 as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: Apr2020 (unspecified if ongoing), notes: seven full weeks; "blood pressure" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "diaphragmatic hernia" (unspecified if ongoing), notes: from coughing; "glassing of lungs" (unspecified if ongoing). Concomitant medication(s) included: BABY ASPIRIN; EVISTA. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization; Bnt162b2 (DOSE 2), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER)), for COVID-19 Immunization; Bnt162b2 (DOSE 4 (BOOSTER)), for COVID-19 Immunization. The following information was reported: NEAR DEATH EXPERIENCE (medically significant) with onset 07Sep2022 at 22:30, outcome "unknown", described as "I thought I was going to die"; BURNING SENSATION (non-serious) with onset 07Sep2022 at 22:30, outcome "unknown", described as "burning up"; FEELING COLD (non-serious), TREMOR (non-serious) all with onset 07Sep2022 at 22:30, outcome "unknown" and all described as "continuously cold and shaking"; DECREASED APPETITE (non-serious) with onset 07Sep2022 at 22:30, outcome "unknown", described as "could not eat lunch or dinner yesterday"; PARAESTHESIA (non-serious) with onset 07Sep2022 at 22:30, outcome "unknown", described as "feeling pins and needles in entire body"; THIRST (non-serious) with onset 07Sep2022 at 22:30, outcome "unknown", described as "getting up thirsty drinking water all night long"; HEADACHE (non-serious) with onset 07Sep2022 at 22:30, outcome "unknown"; RENAL PAIN (non-serious) with onset 07Sep2022 at 22:30, outcome "unknown", described as "kidney hurting"; HEART RATE INCREASED (non-serious) with onset 07Sep2022 at 22:30, outcome "unknown", described as "pulse 90-100 "right on the nose" of 93". The patient underwent the following laboratory tests and procedures: Body temperature: (unspecified date) Unknown results, notes: Took her temperature and there was not any which was very odd; Heart rate: (Sep2022) 90-100. Clinical course: Patient went through the first four vaccines and had a reaction for four days with each one, but nothing like last night, where she thought she was going to die. On 07Sep2022, patient received COVID-19 Pfizer bivalent booster 12+ (0.3) and twelve hours later, she began to experience headache of her entire head all the way down into neck; she was burning up but also continuously cold and shaking, had covers and quilts but was still cold; her pulse was 90-100 "right on the nose" of 93; she could not eat lunch or dinner yesterday (07Sep2022); she was getting up thirsty drinking water all night long, if she drank a glass of water then she would pee a glass of water; kidney hurting on the right side; no temperature; feeling pins and needles in entire body. Today, she was able to eat breakfast but not hungry for lunch, continued to have headache and she did not have headache unless she hit her head on the pavement. She takes medication for blood pressure, cholesterol, and thyroid pill. She had COVID in Apr2020 for seven full weeks, causing a diaphragmatic hernia from coughing, has "glassing of lungs", liver and kidneys are "being watched" due to long-haul COVID. She wanted to know if her experience was normal and if her symptoms could be expected to return tonight. With the other shots it was not the same. Had four days but it was not intense. Yesterday was so intense that she thought that she might have go to the hospital. She slept for 8.5 hours and woke up not feeling as bad as last night. Pharmacist said that she may have a repeat performance. She had a headache and was not warm and not cold/shaking. Ate 1/2 bag of instant oatmeal with blueberries on it. She did not feel like that will come up. She was not hungry. It was so bad last night that she thought she was gonna die literally. It was nothing last night, was bad but not like she was going to die. This could be normal response to this version then okay. She wanted to know if she will have to take the shot take every six months. Other times that she took the shot and for four days, she was not herself. The reaction with the others as the first day was not so good as the fourth day, it started getting better. Pharmacist said it may well be that maybe in her body there was something going on and when that went in it started fighting really hard. She does not know.  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.