chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain assessment, Pain in extremity, Paraesthesia
Clinical narrative: Tingling and Numbing as well as a Pins and Needles sensation feeling coming from my bicep, tricep, arm, hands and into my fingers in waves throughout the day; Tingling and Numbing as well as a Pins and Needles sensation feeling coming from my bicep, tricep, arm, hands and into my fingers in waves throughout the day; my right arm where I received BOTH Covid-19 Doses STILL gives me pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 12:00 (Lot number: FF884) at the age of 26 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Motrin, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Right, Vaccine Administration Time: 03:15 PM), administration date: 13Oct2021, when the patient was 26 years old, for COVID-19 Immunization. The following information was reported: PARAESTHESIA (medically significant), HYPOAESTHESIA (medically significant) all with onset 04Nov2021, outcome "not recovered" and all described as "Tingling and Numbing as well as a Pins and Needles sensation feeling coming from my bicep, tricep, arm, hands and into my fingers in waves throughout the day"; PAIN IN EXTREMITY (medically significant) with onset 04Nov2021, outcome "unknown", described as "my right arm where I received BOTH Covid-19 Doses STILL gives me pain". The patient underwent the following laboratory tests and procedures: pain assessment (0-10): (04Nov2021) 6-9, notes: lasts anywhere from 5-10 minutes to half an hour at times. Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia. Since his 2nd Covid-19 vaccine dose, that he had took on my right arm he had been experiencing tingling and numbing as well as a pins and needles sensation feeling coming from his bicep, tricep, arm, hands and into my fingers in waves throughout the day. The waves come and go throughout the day at least 8 times a day so far. The pain level, when it comes, ranges from a 6-9 out of 10 and lasts anywhere from 5-10 minutes to half an hour at times. He purposely slept on his left arm to reduce the pain, but his right arm where he received both Covid-19 doses STILL gives he pain. He woke up and go to sleep with the numbness and pins and needles sensation. It feels as if her arm was "asleep" but also aches and felt very sore. There was no Covid tested post vaccination.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Pain, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 16Sep2021 15:30 (Lot number: FC3180) at the age of 54 years as dose 2, single for covid-19 immunization in Workplace clinic. Relevant medical history included: "Known allergy; sulfa" (unspecified if ongoing). There were no concomitant medications. There is no other vaccine in four weeks. Other medications in two weeks were None. Past drug history included: Pinal, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0176, Location of injection: Arm Left, Vaccine Administration Time: 11:00 AM, Route of Administration: Intramuscular), administration date: 11Aug2021, when the patient was 53 years old, for Covid-19 Immunization.The following information was reported: PAIN IN EXTREMITY (non-serious), LYMPH NODE PAIN (non-serious), PAIN (non-serious) all with onset 17Sep2021, outcome "not recovered" and all described as "pain on opposite side of injection, in left axillary lymph nodes and below". The events was evaluated at the physician office visit (Events resulted in doctor or other healthcare professional office/clinic visit). Therapeutic measures were not taken as a result of the events.Clinical course: The next morning after second vaccine (17Sep2021), patient had woken with pain on opposite side of injection, in left axillary lymph nodes and below. It has been more than two months and it is still present and getting worse. It was reported event start date was 10Sep2021 04:30 AM (pending clarification). No Covid prior vaccination. No Covid tested post vaccination.; Sender's Comments: .
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Cognitive disorder, Dysarthria, Feeling abnormal, Immunisation
Clinical narrative: severe brain fog; trouble processing and articulating thoughts; Slurred speech; Trouble with physical balance; booster; arm hurt; body ached; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 09:45 (Lot number: FE3590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing); "reactivated EBV" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "SIBO" (unspecified if ongoing); "sensitive to gluten" (unspecified if ongoing), notes: sensitive to gluten; "allergies: dairy, foods with histamine" (unspecified if ongoing); "mold toxicity from mycotoxins" (unspecified if ongoing). The patient had no COVID-19 prior vaccination. Concomitant medication(s) included: FLU taken for influenza immunisation, administration date 13Oct2021; MELATONIN; BLISOVI FE 1/20; and numerous vits and supplement (unspecified). There was no other vaccine administered on same date with the suspect product. Past drug history included: Pantoprazole, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: Unknown, administered in left arm, Vaccine Administration Time: 01:30 PM), administration date: 04May2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot Number: Unknown, administered in left arm, Vaccine Administration Time: 02:00 PM), administration date: 13Apr2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (disability) with onset 10Nov2021 09:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (disability) with onset 10Nov2021, outcome "recovered", described as "arm hurt"; PAIN (disability) with onset 10Nov2021, outcome "recovered", described as "body ached"; FEELING ABNORMAL (disability) with onset 11Nov2021, outcome "recovered", described as "severe brain fog"; COGNITIVE DISORDER (disability) with onset 11Nov2021, outcome "recovered", described as "trouble processing and articulating thoughts"; DYSARTHRIA (disability) with onset 11Nov2021, outcome "recovered", described as "Slurred speech"; BALANCE DISORDER (disability) with onset 11Nov2021, outcome "recovered" (14Nov2021), described as "Trouble with physical balance". Therapeutic measures were not taken as a result of pain in extremity, pain, feeling abnormal, cognitive disorder, dysarthria, balance disorder. Clinical course: At night arm hurt and body ached. Next day (11Nov2021) severe brain fog, trouble processing and articulating thoughts. Slurred speech. Trouble with physical balance from Thursday (11Nov2021) to Sunday (14Nov2021). Adverse events start date/time was reported as 10Nov2021 03:00 AM (pending clarification). COVID-19 was not tested post vaccination.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: severe brain fog; trouble processing and articulating thoughts; Slurred speech; Trouble with physical balance; booster; arm hurt; body ached; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 09:45 (Lot number: FE3590) at the age of 50 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing); "reactivated EBV" (unspecified if ongoing); "endometriosis" (unspecified if ongoing); "GERD" (unspecified if ongoing); "SIBO" (unspecified if ongoing); "sensitive to gluten" (unspecified if ongoing), notes: sensitive to gluten; "allergies: dairy, foods with histamine" (unspecified if ongoing); "mold toxicity from mycotoxins" (unspecified if ongoing). The patient had no COVID-19 prior vaccination. Concomitant medication(s) included: FLU taken for influenza immunisation, administration date 13Oct2021; MELATONIN; BLISOVI FE 1/20; and numerous vits and supplement (unspecified). There was no other vaccine administered on same date with the suspect product. Past drug history included: Pantoprazole, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot Number: Unknown, administered in left arm, Vaccine Administration Time: 01:30 PM), administration date: 04May2021, when the patient was 49 years old, for Covid-19 Immunization; Bnt162b2 (Dose 1, Batch/Lot Number: Unknown, administered in left arm, Vaccine Administration Time: 02:00 PM), administration date: 13Apr2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (disability) with onset 10Nov2021 09:45, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (disability) with onset 10Nov2021, outcome "recovered", described as "arm hurt"; PAIN (disability) with onset 10Nov2021, outcome "recovered", described as "body ached"; FEELING ABNORMAL (disability) with onset 11Nov2021, outcome "recovered", described as "severe brain fog"; COGNITIVE DISORDER (disability) with onset 11Nov2021, outcome "recovered", described as "trouble processing and articulating thoughts"; DYSARTHRIA (disability) with onset 11Nov2021, outcome "recovered", described as "Slurred speech"; BALANCE DISORDER (disability) with onset 11Nov2021, outcome "recovered" (14Nov2021), described as "Trouble with physical balance". Therapeutic measures were not taken as a result of pain in extremity, pain, feeling abnormal, cognitive disorder, dysarthria, balance disorder. Clinical course: At night arm hurt and body ached. Next day (11Nov2021) severe brain fog, trouble processing and articulating thoughts. Slurred speech. Trouble with physical balance from Thursday (11Nov2021) to Sunday (14Nov2021). Adverse events start date/time was reported as 10Nov2021 03:00 AM (pending clarification). COVID-19 was not tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Paralysis
Clinical narrative: allergic reaction to the Pfizer shot; paralyzed; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). This consumer reported for a male patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as single dose for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (medically significant) with onset Nov2021, outcome "unknown", described as "allergic reaction to the Pfizer shot"; PARALYSIS (medically significant) with onset Nov2021, outcome "unknown", described as "paralyzed". Clinical course: The caller was calling regarding a report she had previously filed regarding her reaction to the Pfizer Covid shot. During the call, she stated that she went for a test one day and she told the nurse that she had an allergic reaction to the Pfizer shot and the nurse told her that so did her husband and now he was paralyzed.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea, Tinnitus, Vision blurred
Clinical narrative: blurred vision; ringing in hears; nausea; sweating; dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non- HCP). The reporter is the patient. A 9-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 16Nov2021 13:57 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Patient did not receive other vaccine in four weeks. Patient did not have COVID prior vaccination. The following information was reported: VISION BLURRED (non-serious) with onset 16Nov2021 14:00, outcome "recovering", described as "blurred vision"; TINNITUS (non-serious) with onset 16Nov2021 14:00, outcome "recovering", described as "ringing in hears"; NAUSEA (non-serious) with onset 16Nov2021 14:00, outcome "recovering", described as "nausea"; HYPERHIDROSIS (non-serious) with onset 16Nov2021 14:00, outcome "recovering", described as "sweating"; DIZZINESS (non-serious) with onset 16Nov2021 14:00, outcome "unknown", described as "dizzy". Therapeutic measures were not taken as a result of vision blurred, tinnitus, nausea, hyperhidrosis, dizziness. Clinical course: Within 3 mins of vaccine- ringing in hears, nausea, sweating, dizzy, blurred vision.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: positive covid antigen saliva rapid test; positive covid antigen saliva rapid test; This is a spontaneous report received from a non-contactable reporter (nurse). An adult female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 25Mar2021 (Lot number: EL3247) as dose 2, single and administration date 04Mar2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "exposure to unvaccinated children 10Nov2021 who likely got it at school", start date: 10Nov2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 11Nov2021, outcome "unknown" and all described as "positive covid antigen saliva rapid test". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (11Nov2021) positive. Clinical course: positive covid antigen saliva rapid test on 11Nov2021 after exposure to unvaccinated children 10Nov2021 who likely got it at school.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information currently available, a lack of efficacy with bnt162b2 in this patient cannot be completely excluded.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Hypersensitivity, Immunisation
Clinical narrative: Allergic reaction; Hives at injection site; difficulty breathing; pain & swelling at injection site; pain & swelling at injection site; fever; nausea; fatigue; headache; Dose received: 3; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Nov2021 10:00 (lot number: EW0185) at the age of 23-years-old as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing); "Bipolar type 2" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing); "Known allergies: Berries" (unspecified if ongoing); "Known allergies: Beef" (unspecified if ongoing); and "Known allergies: adhesive" (unspecified if ongoing). Concomitant medications included: LAMICTAL; CYMBALTA; TYLENOL; and BEN. Vaccination history included: BNT162B2 (lot number: EW0153, in left arm at dose 1, single), administration date: 10Apr2021, when the patient was 23-years-old, for COVID-19 immunization and BNT162B2 (lot number: EW0172, in left arm at dose 2, single), administration date: 01May2021, when the patient was 23-years-old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 10:00, outcome "unknown", described as "Dose received: 3"; HYPERSENSITIVITY (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "Allergic reaction"; VACCINATION SITE URTICARIA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "Hives at injection site"; DYSPNOEA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "difficulty breathing"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 16Nov2021 10:15, outcome "recovered" (Nov2021) and all described as "pain & swelling at injection site"; PYREXIA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "fever"; NAUSEA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "nausea"; FATIGUE (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "fatigue"; and HEADACHE (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "headache". Therapeutic measures were taken as a result of hypersensitivity, vaccination site urticaria, and dyspnea. Additional information: The patient has no COVID prior to vaccination. There were no other vaccines in four weeks. She was not tested for COVID post vaccination. Vaccine facility type was reported as public health clinic/veterans administration facility. She took BENADRYL for hypersensitivity, vaccination site urticaria, and dyspnea.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Vaccination site pain, Vaccination site swelling, Vaccination site urticaria
Clinical narrative: Allergic reaction; Hives at injection site; difficulty breathing; pain & swelling at injection site; pain & swelling at injection site; fever; nausea; fatigue; headache; Dose received: 3; This is a spontaneous report received from a non-contactable reporter (consumer). The reporter is the patient.  A 23-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 16Nov2021 10:00 (lot number: EW0185) at the age of 23-years-old as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Gastroparesis" (unspecified if ongoing); "Bipolar type 2" (unspecified if ongoing); "Chronic pain" (unspecified if ongoing); "Known allergies: Berries" (unspecified if ongoing); "Known allergies: Beef" (unspecified if ongoing); and "Known allergies: adhesive" (unspecified if ongoing). Concomitant medications included: LAMICTAL; CYMBALTA; TYLENOL; and BEN. Vaccination history included: BNT162B2 (lot number: EW0153, in left arm at dose 1, single), administration date: 10Apr2021, when the patient was 23-years-old, for COVID-19 immunization and BNT162B2 (lot number: EW0172, in left arm at dose 2, single), administration date: 01May2021, when the patient was 23-years-old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 16Nov2021 10:00, outcome "unknown", described as "Dose received: 3"; HYPERSENSITIVITY (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "Allergic reaction"; VACCINATION SITE URTICARIA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "Hives at injection site"; DYSPNOEA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "difficulty breathing"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious) all with onset 16Nov2021 10:15, outcome "recovered" (Nov2021) and all described as "pain & swelling at injection site"; PYREXIA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "fever"; NAUSEA (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "nausea"; FATIGUE (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "fatigue"; and HEADACHE (non-serious) with onset 16Nov2021 10:15, outcome "recovered" (Nov2021), described as "headache". Therapeutic measures were taken as a result of hypersensitivity, vaccination site urticaria, and dyspnea. Additional information: The patient has no COVID prior to vaccination. There were no other vaccines in four weeks. She was not tested for COVID post vaccination. Vaccine facility type was reported as public health clinic/veterans administration facility. She took BENADRYL for hypersensitivity, vaccination site urticaria, and dyspnea.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Illness, Loss of consciousness
Clinical narrative: passed out on the toilet; horrible sweats; sickest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF CONSCIOUSNESS with onset Dec2020, outcome "unknown", described as "passed out on the toilet"; HYPERHIDROSIS (non-serious) with onset Dec2020, outcome "unknown", described as "horrible sweats"; ILLNESS (non-serious) with onset Dec2020, outcome "unknown", described as "sickest". Clinical courses: It was the sickest the caller has seen her since she was a little kid. Caller thought it was the Pfizer COVID vaccine that was administered.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Biopsy, Immunisation, Mouth ulceration
Clinical narrative: an auto immune disease; mouth ulcers; little ulcer in my mouth; never had any mouth ulcer like this; My doctor, the booster on September 4th; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 (Lot number: FC3182) at the age of 35 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization; Bnt162b2 (Dose 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 04Sep2021, outcome "unknown", described as "My doctor, the booster on September 4th"; MOUTH ULCERATION (medically significant) with onset 06Sep2021, outcome "unknown", described as "mouth ulcers; little ulcer in my mouth; never had any mouth ulcer like this"; AUTOIMMUNE DISORDER (medically significant), outcome "unknown", described as "an auto immune disease". The event "mouth ulcers; little ulcer in my mouth; never had any mouth ulcer like this" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: biopsy: the sores and it came back inconclusive. Therapeutic measures were taken as a result of mouth ulceration, autoimmune disorder.  Additional information: Method of assessment for Mouth ulcer was Introspection and Drug result was Related. I have been the multiple doctors for Mouth ulcer and they have never seen them like this and nobody really knows what to do. They said it could be related to the vaccine but they don't know what to do as you know as an adverse to call and reported, that's why I am calling to do. I was fine before ever got the booster. I have tried antibiotic and then they tried some steroids and none of it seems to you know, it help a little bit (Further clarification unknown)) but never went away. The steroid was Prednisone and then the antibiotic they had me was Levaquin and the other medication was Amoxicillin (Intent: Treatment). I take immunosuppressant therapy for auto immune disease. Vaccination facility was Pharmacy, drug store. No other vaccines.; Sender's Comments: Based on the current available information and a possible contributory role of suspect product BNT162B2 to the development of events mouth ulceration, autoimmune disorder cannot be totally excluded. The case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Cardio-respiratory arrest
Clinical narrative: cardiopulmonary arrest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 91 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number 1), for covid-19 immunization; Bnt162b2 (Dose number 2), for covid-19 immunization. The following information was reported: CARDIO-RESPIRATORY ARREST (death), outcome "fatal", described as "cardiopulmonary arrest". The reporter believed booster killed patient. The patient date of death was unknown. The reported cause of death was cardio-respiratory arrest. She died of cardiopulmonary arrest within 48 hours of getting booster, she had nothing acute going on. It was not reported if an autopsy was performed.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Reported Cause(s) of Death: died of cardiopulmonary arrest
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath; 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 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "allergic to sulfa" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DYSPNOEA (hospitalization), outcome "unknown", described as "shortness of breath".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Computerised tomogram, Headache, Hypertension, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 13:15 (Lot number: EN 6202) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EM 9810, administration time=11:45 AM, vaccine location Left arm), administration date: 10Feb2021, when the patient was 46 years old, for COVID-19 immunization.The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "I've been having serve headache / severe headache that makes me cry"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE VESICLES (non-serious), SKIN EXFOLIATION (non-serious), WOUND (non-serious) all with onset 04Mar2021, outcome "not recovered" and all described as "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound"; HYPERTENSION (non-serious) with onset 04Mar2021, outcome "not recovered", described as "high blood pressure". The events "i've been having serve headache / severe headache that makes me cry", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound" and "high blood pressure" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vaccination site reaction, vaccination site vesicles, skin exfoliation, wound, hypertension.Additional information: Patient applied elimination series by cutting off coffee and soda to try and figure what was going on as he had never in his 47 years of existence experienced such severe headache that makes him cry. Treatment was received for events and were CT scan, medication.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Skin exfoliation, Vaccination site reaction, Vaccination site vesicles, Wound
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 13:15 (Lot number: EN 6202) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (lot number=EM 9810, administration time=11:45 AM, vaccine location Left arm), administration date: 10Feb2021, when the patient was 46 years old, for COVID-19 immunization.The following information was reported: HEADACHE (non-serious) with onset 04Mar2021, outcome "not recovered", described as "I've been having serve headache / severe headache that makes me cry"; VACCINATION SITE REACTION (non-serious), VACCINATION SITE VESICLES (non-serious), SKIN EXFOLIATION (non-serious), WOUND (non-serious) all with onset 04Mar2021, outcome "not recovered" and all described as "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound"; HYPERTENSION (non-serious) with onset 04Mar2021, outcome "not recovered", described as "high blood pressure". The events "i've been having serve headache / severe headache that makes me cry", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound", "reaction on my left arm at the spot of injection the following day in form of a blister and it later pealed off and turned to a wound" and "high blood pressure" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, vaccination site reaction, vaccination site vesicles, skin exfoliation, wound, hypertension.Additional information: Patient applied elimination series by cutting off coffee and soda to try and figure what was going on as he had never in his 47 years of existence experienced such severe headache that makes him cry. Treatment was received for events and were CT scan, medication.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Ear discomfort, Fatigue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in left shoulder (deltoid), administration date 04Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On 04Sep2021, the patient was given the 1st dose of the Pfizer COVID -19 Vaccine. The following day the patient had the following side effects: Unable to walk for 24 hours, Dizziness, Light-headedness, Vomiting, and Could not respond to other people. At 4:30 a.m. on 05Sep2021 the patient woke up because the left foot was on fire. Then fire went to left ear and then to left nostril. The patient stated mind was not clear. On Monday, 06Sep2021, the patient had extreme fatigue, no energy.  The patient also had headache for 12 days.  The patient decided not to get the second dose as the patient could not put the body through this again. The patient had an extreme violent allergic reaction according to the CDC, whom called, and the doctor, who the patient visited.  The following information was reported: HYPERSENSITIVITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "extreme violent allergic reaction "; INTELLECTUAL DISABILITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "Mind not clear"; GAIT INABILITY (non-serious) with onset 05Sep2021, outcome "recovered" (Sep2021), described as "unable to walk for 24 hours"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "unknown", described as "Dizziness / light-headedness"; VOMITING (non-serious) with onset 05Sep2021, outcome "unknown", described as "vomiting"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 05Sep2021, outcome "unknown", described as "could not respond to other people"; BURNING SENSATION (non-serious) with onset 05Sep2021 04:30, outcome "unknown", EAR DISCOMFORT (non-serious), NASAL DISCOMFORT (non-serious) all with onset 05Sep2021, outcome "unknown" and all described as "left foot on fire, then fire went to left ear and then to left nostril"; FATIGUE (non-serious) with onset 06Sep2021, outcome "unknown", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 06Sep2021, outcome "unknown", described as "no energy"; HEADACHE (non-serious) with onset 05Sep2021, outcome "recovered" (16Sep2021), described as "headache for 12 days".   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Gait inability, Headache, Hypersensitivity, Intellectual disability, Loss of personal independence in daily activities
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in left shoulder (deltoid), administration date 04Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On 04Sep2021, the patient was given the 1st dose of the Pfizer COVID -19 Vaccine. The following day the patient had the following side effects: Unable to walk for 24 hours, Dizziness, Light-headedness, Vomiting, and Could not respond to other people. At 4:30 a.m. on 05Sep2021 the patient woke up because the left foot was on fire. Then fire went to left ear and then to left nostril. The patient stated mind was not clear. On Monday, 06Sep2021, the patient had extreme fatigue, no energy.  The patient also had headache for 12 days.  The patient decided not to get the second dose as the patient could not put the body through this again. The patient had an extreme violent allergic reaction according to the CDC, whom called, and the doctor, who the patient visited.  The following information was reported: HYPERSENSITIVITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "extreme violent allergic reaction "; INTELLECTUAL DISABILITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "Mind not clear"; GAIT INABILITY (non-serious) with onset 05Sep2021, outcome "recovered" (Sep2021), described as "unable to walk for 24 hours"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "unknown", described as "Dizziness / light-headedness"; VOMITING (non-serious) with onset 05Sep2021, outcome "unknown", described as "vomiting"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 05Sep2021, outcome "unknown", described as "could not respond to other people"; BURNING SENSATION (non-serious) with onset 05Sep2021 04:30, outcome "unknown", EAR DISCOMFORT (non-serious), NASAL DISCOMFORT (non-serious) all with onset 05Sep2021, outcome "unknown" and all described as "left foot on fire, then fire went to left ear and then to left nostril"; FATIGUE (non-serious) with onset 06Sep2021, outcome "unknown", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 06Sep2021, outcome "unknown", described as "no energy"; HEADACHE (non-serious) with onset 05Sep2021, outcome "recovered" (16Sep2021), described as "headache for 12 days".   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Nasal discomfort, Vomiting
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administered in left shoulder (deltoid), administration date 04Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. On 04Sep2021, the patient was given the 1st dose of the Pfizer COVID -19 Vaccine. The following day the patient had the following side effects: Unable to walk for 24 hours, Dizziness, Light-headedness, Vomiting, and Could not respond to other people. At 4:30 a.m. on 05Sep2021 the patient woke up because the left foot was on fire. Then fire went to left ear and then to left nostril. The patient stated mind was not clear. On Monday, 06Sep2021, the patient had extreme fatigue, no energy.  The patient also had headache for 12 days.  The patient decided not to get the second dose as the patient could not put the body through this again. The patient had an extreme violent allergic reaction according to the CDC, whom called, and the doctor, who the patient visited.  The following information was reported: HYPERSENSITIVITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "extreme violent allergic reaction "; INTELLECTUAL DISABILITY (medically significant) with onset 05Sep2021, outcome "unknown", described as "Mind not clear"; GAIT INABILITY (non-serious) with onset 05Sep2021, outcome "recovered" (Sep2021), described as "unable to walk for 24 hours"; DIZZINESS (non-serious) with onset 05Sep2021, outcome "unknown", described as "Dizziness / light-headedness"; VOMITING (non-serious) with onset 05Sep2021, outcome "unknown", described as "vomiting"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 05Sep2021, outcome "unknown", described as "could not respond to other people"; BURNING SENSATION (non-serious) with onset 05Sep2021 04:30, outcome "unknown", EAR DISCOMFORT (non-serious), NASAL DISCOMFORT (non-serious) all with onset 05Sep2021, outcome "unknown" and all described as "left foot on fire, then fire went to left ear and then to left nostril"; FATIGUE (non-serious) with onset 06Sep2021, outcome "unknown", described as "extreme fatigue"; ASTHENIA (non-serious) with onset 06Sep2021, outcome "unknown", described as "no energy"; HEADACHE (non-serious) with onset 05Sep2021, outcome "recovered" (16Sep2021), described as "headache for 12 days".   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Dizziness, Fatigue, Headache, Hypoaesthesia
Clinical narrative: the entire left side of her body was numb; Daily headaches; bodyaches; fatigue; posterior cervical lymphadenopathy; dizziness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Dec2020 10:30 (Lot number: EL8982) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing); "covid prior vaccination" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPOAESTHESIA (disability) with onset 29Dec2020, outcome "not recovered", described as "the entire left side of her body was numb"; HEADACHE (disability) with onset 29Dec2020, outcome "not recovered", described as "Daily headaches"; PAIN (disability) with onset 29Dec2020, outcome "not recovered", described as "bodyaches"; FATIGUE (disability) with onset 29Dec2020, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (disability) with onset 29Dec2020, outcome "not recovered", described as "posterior cervical lymphadenopathy"; DIZZINESS (disability) with onset 29Dec2020, outcome "not recovered", described as "dizziness". The events "the entire left side of her body was numb", "daily headaches", "bodyaches", "fatigue", "posterior cervical lymphadenopathy" and "dizziness" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: covid-19: unknown results. Therapeutic measures were taken as a result of hypoaesthesia, headache, pain, fatigue, lymphadenopathy, dizziness.  AE treatment: MRI, muscle relaxers, still continuing to seek treatment. AE resulted in: Doctor or other healthcare professional office/clinic visit Disability or permanent damage. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient received the second dose of BNT162B2 (lot number: EL1284) intramuscular in the arm left on 20Jan2021 at 04:45PM for COVID-19 Immunization. The patient had no covid tested post vaccination.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: the entire left side of her body was numb; Daily headaches; bodyaches; fatigue; posterior cervical lymphadenopathy; dizziness; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 29Dec2020 10:30 (Lot number: EL8982) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pre-diabetic" (unspecified if ongoing); "covid prior vaccination" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HYPOAESTHESIA (disability) with onset 29Dec2020, outcome "not recovered", described as "the entire left side of her body was numb"; HEADACHE (disability) with onset 29Dec2020, outcome "not recovered", described as "Daily headaches"; PAIN (disability) with onset 29Dec2020, outcome "not recovered", described as "bodyaches"; FATIGUE (disability) with onset 29Dec2020, outcome "not recovered", described as "fatigue"; LYMPHADENOPATHY (disability) with onset 29Dec2020, outcome "not recovered", described as "posterior cervical lymphadenopathy"; DIZZINESS (disability) with onset 29Dec2020, outcome "not recovered", described as "dizziness". The events "the entire left side of her body was numb", "daily headaches", "bodyaches", "fatigue", "posterior cervical lymphadenopathy" and "dizziness" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: covid-19: unknown results. Therapeutic measures were taken as a result of hypoaesthesia, headache, pain, fatigue, lymphadenopathy, dizziness.  AE treatment: MRI, muscle relaxers, still continuing to seek treatment. AE resulted in: Doctor or other healthcare professional office/clinic visit Disability or permanent damage. The patient had no other vaccine in four weeks, no other medications in two weeks. The patient received the second dose of BNT162B2 (lot number: EL1284) intramuscular in the arm left on 20Jan2021 at 04:45PM for COVID-19 Immunization. The patient had no covid tested post vaccination.; Sender's Comments: Based on strong temporal relationship, a possible causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug; first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug; 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 54 year-old male patient received bnt162b2 (COMIRNATY), administration date 01Apr2021 (Lot number: EP7534) as dose 2, single and administration date 11Mar2021 (Lot number: EN6204) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 18Aug2021, outcome "unknown" and all described as "first dose was on 11Mar. His second dose was 01Apr. COVID positive 18Aug". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (18Aug2021) positive. It was reported that he received his first and second vaccine doses and 3 months later on August 18th, he tested positive for Covid.