chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal faeces, Chills, Diarrhoea, Headache, Nausea
Clinical narrative: I was having diarrhea like yellowish liquid and it was really pungent smell; body aches; bumps in her right arm; nausea; fever; diarrhea; chills; headache; This is a spontaneous report received from a contactable consumer (Patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: FC3180), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Aug2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. On 20Aug2021, at noon. 1 hour after the vaccine the patient experienced nausea, fever, diarrhea, chills, headache, was having diarrhea like yellowish liquid and it was really pungent smell, body aches and bumps in her right arm. She received yesterday at noon the first shot and 1 hour after the vaccine she started to feel the side effects like nausea, diarrhea, fever, body ache, chills, headache and bumps in her right arm. She received the vaccine in her left arm. The outcome of event was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Skin mass
Clinical narrative: I was having diarrhea like yellowish liquid and it was really pungent smell; body aches; bumps in her right arm; nausea; fever; diarrhea; chills; headache; This is a spontaneous report received from a contactable consumer (Patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTEHC COVID-19 VACCINE, Batch/Lot Number: FC3180), Solution for injection, via an unspecified route of administration, administered in Arm Left on 20Aug2021 (at the age of 46-year-old) as single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. On 20Aug2021, at noon. 1 hour after the vaccine the patient experienced nausea, fever, diarrhea, chills, headache, was having diarrhea like yellowish liquid and it was really pungent smell, body aches and bumps in her right arm. She received yesterday at noon the first shot and 1 hour after the vaccine she started to feel the side effects like nausea, diarrhea, fever, body ache, chills, headache and bumps in her right arm. She received the vaccine in her left arm. The outcome of event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: 2 patients received a  0.6 ml was administered instead of 0.3ml of the Pfizer Covid vaccine; This is a spontaneous report from a contactable pharmacist. A 49-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: FC3181; Expiration Date: Oct2021), first dose via an unspecified route of administration on left side on an unspecified date in 2021, as a single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that caller stated 2 patients received a 0.6 ml was administered instead of 0.3ml of the Pfizer Covid vaccine. 2 patients were involved one 49 years old male and the other 16 years old male, both were given the Pfizer Covid vaccine inadvertently today. Caller was looking and wanting guidance on how to proceed. Lot number FC3181. The outcome of the event was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a temporal relation between the event Overdose and the administration of the vaccine cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test positive
Clinical narrative: I got covid 3 months after being fully vaccinated with the Pfizer Vaccine.; I got covid 3 months after being fully vaccinated with the Pfizer Vaccine.; This is a spontaneous report from a contactable consumer (patient). A 37-years-old male patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: er8731), via an unspecified route of administration in the left arm on 14Apr2021 at 15:00 (age at vaccination: 37-year-old) and second dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: Ew0173) via an unspecified route of administration in the left arm on an unspecified date, both as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. On 16Aug2021 at 17:00, patient got COVID 3 months after being fully vaccinated with the Pfizer Vaccine. Adverse event resulted in Doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The patient underwent lab test and procedure which included PCR covid test post vaccination, nasal Swab: positive on 18Aug2021 and 2 at home tests. The clinical outcome of COVID-19 was recovering.   Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fall, Head injury, SARS-CoV-2 test, Walking aid user
Clinical narrative: The second fall he hit his head and had to go to ER; causing my husband to fall twice in one week; dizziness causing my husband to fall twice in one week; walking with walker and assistance; This is a spontaneous report from a contactable consumer. A 72-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0168), dose 1 via an unspecified route of administration, administered in Arm Left on Aug2021 11:00 (at the age of 72-years-old) as a single dose for covid-19 immunization. Medical history included aneurysm from Apr2015 to an unknown date He was a survivor of a brain aneurysm with subarachnoid hemorrhage. The patient did not have any allergies. The patient had no other vaccine within four weeks and had other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 19Aug2021 13:00, 1 week after vaccine, the patient had onset of dizziness causing to fall twice in one week on an Aug2021. The second fall he hit his head and had to go to emergency room (ER). Hospitalized for 1 night. Still dizzy and walking with walker and assistance on Aug2021. The adverse event resulted in patient to visit emergency room/department or urgent care. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 19Aug2021 covid test post vaccination: Nasal Swab, in ER. The patient received treatment with neuro test and Antivert for dizziness. The seriousness of the event was considered as Hospitalization, Disability or permanent damage. Since the vaccination, the patient had been tested for COVID-19. Outcome of the event was not resolved.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: Lack of Efficacy. Symptomatic and Rapid COVID19 test result= positive.; Lack of Efficacy. Symptomatic and Rapid COVID19 test result= positive.; This is a spontaneous report from a contactable other healthcare professional. A 34-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an intramuscular, administered in left arm on 23Feb2021 (at the age of 34-year-old) as dose 2, single and BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration, administered in left arm on 01Feb2021 (at the age of 34-year-old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 20Aug2021, patient experienced lack of efficacy, symptomatic and rapid COVID19 test result was positive. It was unknown that, if patient received treatment for adverse event. The patient underwent lab tests and procedures which included COVID-19 test: positive on 20Aug2021. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Electrocardiogram, Investigation
Clinical narrative: Elevated  blood pressure 6 days after second vaccine/BP shot up to 185/117 in the am/very high again; felt woozy; This is a spontaneous report from a contactable physician (patient). A 66-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in the right arm on 14Aug2021 at 16:30 (at the age of 66-year-old) as dose 2, single for covid-19 immunisation. Facility type vaccine was pharmacy or drug store. Medical history was not reported (None). Known allergies were none. Concomitant medication included nebivolol hydrochloride (BYSTOLIC) taken for an unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration, in the left arm on 20Jul2021 at 12:00 (at the age of 66-year-old) as dose 1, single for covid-19 immunisation. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 20Aug2021 at 06:00, the patient experienced elevated blood pressure 6 days after second vaccine. BP was normal before second dose of vaccine. BP shot up to 185/117 in the am and he felt woozy, extra doses of bystolic during the day did not effect it. Went to ER at 4 pm, as he had not heard back frommy doctors office all day. they did an EKG and bloodwork. Prescribed Clonidine, it did bring it down, but the next day it was very high again. Adverse events resulted in emergency room/department or urgent care. Patient had received treatment for event was anti-hypertensive medication. The patient underwent lab tests and procedures which included blood pressure: 185/117 on 20Aug2021, blood pressure: down on 20Aug2021, blood pressure: very high on 21Aug2021, electrocardiogram: unknown results on 20Aug2021, blood work investigation: unknown results on 20Aug2021. Outcome of the events was not recovered.  The Lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 to the reported events cannot be excluded. Case will be reassessed upon receipt of additional information.  The impact of this report on the benefit/risk profile of the Pfizer drug 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: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got covid but took both pfizer vaccines in March; I got covid but took both pfizer vaccines in March; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on Mar2021 as dose 1, single for covid-19 immunisation and dose 2 via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On an unspecified date the patient experienced i got covid but took both pfizer vaccines in March. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I got terribly ill. It was to the point that 2 days later I was admitted to the hospital; This is a spontaneous report from Pfizer sponsored program from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (Formulation: Solution for injection; Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as Dose 1,Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Consumer stated that I recently had your first shot for covid. The next day, I got terribly ill. It was to the point that 2 days later I was admitted to the hospital. I have been told by my doctor to not get the second shot. It will be worst then the first one. This means I can no longer get protected. The outcome of the event was unknown.  Information about Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Headache, Nasal congestion, SARS-CoV-2 test, Vaccination failure
Clinical narrative: mild headache; some nasal congestion; Unfortunately, I became infected last weekend, testing positive on 16Aug; I received both of my Pfizer vaccine shots in April. Unfortunately, I became infected last weekend; This is spontaneous report from a contactable consumer(patient). An unknown age and gender patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number were not reported) dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient past drug history included bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number were not reported) dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient received both of my Pfizer vaccine shots in April. Unfortunately, patient became infected last weekend, testing positive on 16Aug2021. patient symptoms, which were a mild headache and some nasal congestion, would have likely been severe if not for your vaccine. The patient underwent lab tests and procedures which included Covid-19 virus test was positive on 16Aug2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: having a stroke; had a seizure; increase of BP./My BP was 185/ 95; I felt dizzy at a meeting; felt fuzzy; a pressure behing my eyes; This is a spontaneous report from a contactable consumer (reported for herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 26Mar2021 (age at vaccination was 66-year-old) as dose 2, single for covid-19 immunisation in pharmacy or drug store. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. On 09Apr2021 16:00, the patient started to increase of blood pressure. The patient attends a clinic. BP was taken. Always 120/ 80 or slightly lower. The patient doctor appointments show the same. The patient was felt fuzzy and a pressure behind her eyes. The pharmacist took the patient BP and called for an ambulance. The patient BP was 185/95 and it gradually went done. The patient's doctor saw her the next week and the patient BP was fine. After a few weeks, the patient felt dizzy at a meeting. One lady thought patient was "having a stroke" and called 911 again. The patient had a seizure, and her BP was high again. For 4 months it was like this. The events resulted in doctor or other healthcare professional office and clinic visit, emergency room/department or urgent care. The patient lab tests blood pressure measurement was blood pressure increased 185/95, Cat (computerised tomogram) scan of the brain was unknown results, heart tests (various heart tests) unknown results on 09Apr2021. The patient sought treatment with a cardio specialist and various tests ordered. So far nothing had showed. The patient current on a third BP medication. They all had affected her blood levels and the mysterious fluctuations continue. The patient was supposed to have a hip replacement in 2 weeks. The outcome of the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Investigation, Ocular discomfort, Seizure
Clinical narrative: having a stroke; had a seizure; increase of BP./My BP was 185/ 95; I felt dizzy at a meeting; felt fuzzy; a pressure behing my eyes; This is a spontaneous report from a contactable consumer (reported for herself). A 66-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown), via an unspecified route of administration on 26Mar2021 (age at vaccination was 66-year-old) as dose 2, single for covid-19 immunisation in pharmacy or drug store. The patient medical history was not reported. The patient's concomitant medications were not reported. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 17Feb2021 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient had no known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. On 09Apr2021 16:00, the patient started to increase of blood pressure. The patient attends a clinic. BP was taken. Always 120/ 80 or slightly lower. The patient doctor appointments show the same. The patient was felt fuzzy and a pressure behind her eyes. The pharmacist took the patient BP and called for an ambulance. The patient BP was 185/95 and it gradually went done. The patient's doctor saw her the next week and the patient BP was fine. After a few weeks, the patient felt dizzy at a meeting. One lady thought patient was "having a stroke" and called 911 again. The patient had a seizure, and her BP was high again. For 4 months it was like this. The events resulted in doctor or other healthcare professional office and clinic visit, emergency room/department or urgent care. The patient lab tests blood pressure measurement was blood pressure increased 185/95, Cat (computerised tomogram) scan of the brain was unknown results, heart tests (various heart tests) unknown results on 09Apr2021. The patient sought treatment with a cardio specialist and various tests ordered. So far nothing had showed. The patient current on a third BP medication. They all had affected her blood levels and the mysterious fluctuations continue. The patient was supposed to have a hip replacement in 2 weeks. The outcome of the events was unknown.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 infection - positive test on 20Aug2021; COVID-19 infection - positive test on 20Aug2021; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 50-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. If other vaccine in four weeks was reported as unknown. The patient had been tested for COVID-19 since the vaccination. It was unknown if patient had covid prior vaccination. On 17Aug2021, after receiving the vaccine the patient experienced covid-19 infection - positive test on 20aug2021. The events were serious medically significant. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 20Aug2021. Treatment received for the events was reported was unknown. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Joint swelling, Pneumonia
Clinical narrative: pneumonia; joint swelling; cardiac inflammation; This is a spontaneous report from a contactable consumer or other non HCP.   An adult male patient received bnt162b2 (BNT162B2, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. On an unspecified date, the patient experienced pneumonia, joint swelling and cardiac inflammation. The events resulted in hospitalization. Therapeutic measures were taken as a result of pneumonia (pneumonia), joint swelling (joint swelling), cardiac inflammation (myocarditis). The outcome of the events was recovering.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anaemia, Diplopia, Dizziness, Hypoaesthesia
Clinical narrative: Fainting; Lost of taste; Dizziness; Vision changes double vision; Tingling and numbness in my face hands arms and legs; Tingling and numbness in my face hands arms and legs; Having a period every 10 days; Anemia; Ring in my ears; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration in the right arm on 29Jan2021 (at the age of 37-year-old), dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265) administered via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 37-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 01Feb2021, the patient experienced fainting, lost of taste, dizziness, vision changes double vision, tingling and numbness in my face hands arms and legs, having a period every 10 days, anemia, ring in my ears. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on an unspecified. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Paraesthesia, SARS-CoV-2 test, Syncope, Tinnitus
Clinical narrative: Fainting; Lost of taste; Dizziness; Vision changes double vision; Tingling and numbness in my face hands arms and legs; Tingling and numbness in my face hands arms and legs; Having a period every 10 days; Anemia; Ring in my ears; This is a spontaneous report from a contactable consumer (patient). A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3246), via an unspecified route of administration in the right arm on 29Jan2021 (at the age of 37-year-old), dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL9265) administered via an unspecified route of administration in the left arm on 08Jan2021 (at the age of 37-year-old), dose 1, single for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. On 01Feb2021, the patient experienced fainting, lost of taste, dizziness, vision changes double vision, tingling and numbness in my face hands arms and legs, having a period every 10 days, anemia, ring in my ears. The patient underwent lab tests and procedures which included nasal swab COVID test: negative on an unspecified. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome, Herpes simplex, SARS-CoV-2 test
Clinical narrative: HSV2 Herpes; On set of Guillain-Barre Syndrome; This is spontaneous report from a contactable consumer.     A 67-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Feb2021 10:00 (Batch/Lot Number: EL 9263) as single dose for covid-19 immunisation  .  Medical history was not reported.  Concomitant medications included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported.  The patient experienced  HSV2 herpes  (hospitalization) on 13Jul2021 23:00 with outcome of recovering;  onset of Guillain-Barre syndrome  (hospitalization) on 26Jul2021 23:00 with outcome of recovering.  The patient was hospitalized for for Guillain-Barre syndrome  for 8 days. The patient was hospitalized for HSV-2 herpes for an unknown period of time.   The patient underwent lab tests and procedures which included : HSV-2 Positive on 13Jul2021; sars-cov-2 test: negative   on 09Aug2021 Nasal Swab.   Therapeutic measures were taken as a result of the reported events including : 4 treatments of IVIg.  Follow up information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Hypersensitivity, Pyrexia, SARS-CoV-2 test
Clinical narrative: Result:Positive; Result:Positive; Allergy like symptoms followed by a fever.; Allergy like symptoms followed by a fever.; This is a spontaneous report from a contactable consumer (patient herself). A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date (at age of 30-years-old) as dose number unknown, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. On 22Aug2021 the patient experienced result was positive (COVID-19 and drug ineffective). On an unspecified date in Aug2021, patient experienced allergy like symptoms followed by a fever. The AEs resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient had received any treatment for adverse events. The patient underwent lab tests and procedures which included SARS-COV-2 test (post vaccination) which was positive on 22Aug2021. The outcome of event COVID-19, allergy like symptoms followed by a fever was resolving.  No follow-up attempts are possible. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Hallucination, visual, Headache, Negative thoughts, Nervousness
Clinical narrative: Personality change; Panic attacks; Horrible headaches; overcome by scary thoughts and images, felt like bugs are everywhere; scary thoughts and images, felt like bugs are everywhere; Anxious; Scared of everything; This is a spontaneous report received from a contactable consumer (parent).   A 13-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 14:00 (at the age of 13-year-old) (Batch/Lot Number: EW0178) as single dose for COVID-19 immunisation, administered at Pharmacy or Drug Store.  The patient medical history was none. No known allergies. The concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25May2021 the patient experienced personality change (disability) with outcome of not recovered, panic attacks (disability) with outcome of not recovered, horrible headaches (disability) on 25May2021 with outcome of not recovered, overcome by scary thoughts and images, felt like bugs are everywhere (disability) with outcome of not recovered, anxious (disability) with outcome of not recovered, scared of everything (disability) with outcome of not recovered. The course of events was as follows: Within days of receiving the vaccine the patient experienced a complete personality change. She began having panic attacks, couldn't leave the house, wouldn't go outside. She has horrible headaches every day. She was overcome by scary thoughts and images. Felt like bugs are everywhere even though there are none around. She was anxious and scared of everything that used to be so easy for her. The adverse events resulted in any of the following Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of events with Naproxen. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Personality change
Clinical narrative: Personality change; Panic attacks; Horrible headaches; overcome by scary thoughts and images, felt like bugs are everywhere; scary thoughts and images, felt like bugs are everywhere; Anxious; Scared of everything; This is a spontaneous report received from a contactable consumer (parent).   A 13-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in arm left on 22May2021 14:00 (at the age of 13-year-old) (Batch/Lot Number: EW0178) as single dose for COVID-19 immunisation, administered at Pharmacy or Drug Store.  The patient medical history was none. No known allergies. The concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25May2021 the patient experienced personality change (disability) with outcome of not recovered, panic attacks (disability) with outcome of not recovered, horrible headaches (disability) on 25May2021 with outcome of not recovered, overcome by scary thoughts and images, felt like bugs are everywhere (disability) with outcome of not recovered, anxious (disability) with outcome of not recovered, scared of everything (disability) with outcome of not recovered. The course of events was as follows: Within days of receiving the vaccine the patient experienced a complete personality change. She began having panic attacks, couldn't leave the house, wouldn't go outside. She has horrible headaches every day. She was overcome by scary thoughts and images. Felt like bugs are everywhere even though there are none around. She was anxious and scared of everything that used to be so easy for her. The adverse events resulted in any of the following Doctor or other healthcare professional office/clinic visit, Disability or permanent damage. Therapeutic measures were taken as a result of events with Naproxen. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicitis, Arthralgia, Computerised tomogram, SARS-CoV-2 antibody test
Clinical narrative: appendix irritation; pain on right side under hip; This is a spontaneous report from Contactable other HCP (patient) reported for herself. A 37-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: FA 7484), dose 1 via an unspecified route of administration, administered in Arm Left on 30Jul2021 at 12:30 (at the age of 37-year-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications received within 2 weeks of vaccination included ethinylestradiol, ferrous fumarate, norethisterone acetate (AUROVELA 24 FE), fluoxetine hydrochloride (FLUOXETINE) fluoxetine 40mg, doxycycline (DOXYCYCLINE) doxycycline 100mg all were taken for an unspecified indication, start and stop date were not reported. The patient previously took sulfonamides and experienced hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient other medical history was none. Patient did not have covid prior vaccination and was tested for covid post vaccination. Structured information (Patient episode name) reported as none. The patient experienced appendix irritation on 19Aug2021 and pain on right side under hip on 12Aug2021. The patient was hospitalized for appendix irritation for 1 days. It was reported that, thursday 12Aug patient had pain on right side under hip which faded after 24 hours, on 16Aug pain resumed had urinalysis from MD and on 19Aug went to ER where CT revealed appendix irritation and enlargement emergency appendectomy performed. Event treatment included appendectomy. The patient underwent lab tests and procedures which included computerised tomogram that included appendix irritation on 19Aug2021, it was reported that on 19Aug went to ER where CT revealed appendix irritation and enlargement emergency appendectomy performed. Patient also had sars-cov-2 antibody test that was negative on 19Aug2021. The case was assessed as serious. Event resulted in the Doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Outcome of the events were recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event appendicitis and 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Dyspnoea, Feeling abnormal, Heart rate increased
Clinical narrative: my heart is fluttering; I had horrible air hunger; a rapid heart rate; I awoke from a nap because it was causing my body to freak out; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 30-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration (age at vaccination 30-year) in Left Arm on 17Aug2021 at 01:15 PM as dose 1, single for COVID-19 immunization. Medical history included Lyme disease, diverticulum, Possible PCOS, all from an unknown date and unknown if ongoing. Concomitant medications included vitamin d3/k/a, app+, bart+, dtc+, tbb+, o.n.e, taken for an unspecified indication, start and stop date were not reported. No known allergies were reported. No COVID prior vaccination was reported. The patient was not tested COVID post vaccination. On 18Aug2021 the patient experienced her heart was fluttering, she had horrible air hunger, a rapid heart rate, she awoke from a nap because it was causing my body to freak out. It was reported by the patient that "she received her shot Tuesday. Wednesday night she had horrible air hunger and a rapid heart rate. That was Friday and after working, during sleep, her heart was fluttering so much so that she awoke from a nap because it was causing her body to freak out. Have had air hunger episodes since Wednesday". No treatment was received for the adverse events. The clinical outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Lip pruritus, Lip swelling
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Immediately got chest pain; Itchy tongue; Severe dizziness and lightheadedness; Turned whiter than white; Lip started to swell and got really itchy; Lip started to swell and got really itchy; Feels tired; Almost died;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 16Aug2021 11:00 as dose 1, single for covid-19 immunisation (age at vaccination: 53 years). Medical history included ongoing rheumatoid arthritis diagnosed with about 6 years ago, overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bactrim and experienced allergy, cipro [ciprofloxacin] and experienced drug allergy. The patient experienced almost died, feels tired on an unspecified date in Aug2021, immediately got chest pain, itchy tongue, severe dizziness and lightheadedness with, turned whiter than white, lip started to swell and got really itchy on 16Aug2021. The reporter stated that, she received her first dose Pfizer Covid Vaccine on Monday, 16Aug2021. She immediately got chest pain, itchy tongue, severe dizziness and light headedness. The caller s daughter stated, the patient got whiter than white after receiving the first dose Pfizer Covid Vaccine. The caller stated she had the chest pains. Her lip started to swell and got really itchy. She received the first dose Pfizer Covid Vaccine at the Pharmacy and they Pharmacy did not do anything, it was awful. The caller stated she almost died and the pharmacy did nothing. The caller stated she was allergic to Cipro and Bactrim and was overweight. The caller shared this information with the Pharmacy and they said it would be fine. It was reported that, chest pain was still ongoing back and forth. The caller still felt tired and bouts of dizziness. The caller stated the chest pain had improved but still getting bouts and was super tired. Itchy tongue went away maybe about 2.5 hours after, was still having severe dizziness and lightheadedness off and on throughout the day, turned whiter than white, lip swelling and got really itchy went away like a few hours after the first dose. The caller stated, she knew she had to go to the hospital and was covered in hives and had trouble breathing (Caller clarified this occurred after taking Cipro). The caller could not drive and the Pharmacist was a moron and did not do anything, she could have died right there in the pharmacy. The outcome of almost died was unknown, immediately got chest pain was recovering. The outcome of severe dizziness and lightheadedness and feels tired was not recovered, other events: recovered on16Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Near death experience, Pallor, Tongue pruritus
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Immediately got chest pain; Itchy tongue; Severe dizziness and lightheadedness; Turned whiter than white; Lip started to swell and got really itchy; Lip started to swell and got really itchy; Feels tired; Almost died;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 16Aug2021 11:00 as dose 1, single for covid-19 immunisation (age at vaccination: 53 years). Medical history included ongoing rheumatoid arthritis diagnosed with about 6 years ago, overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bactrim and experienced allergy, cipro [ciprofloxacin] and experienced drug allergy. The patient experienced almost died, feels tired on an unspecified date in Aug2021, immediately got chest pain, itchy tongue, severe dizziness and lightheadedness with, turned whiter than white, lip started to swell and got really itchy on 16Aug2021. The reporter stated that, she received her first dose Pfizer Covid Vaccine on Monday, 16Aug2021. She immediately got chest pain, itchy tongue, severe dizziness and light headedness. The caller s daughter stated, the patient got whiter than white after receiving the first dose Pfizer Covid Vaccine. The caller stated she had the chest pains. Her lip started to swell and got really itchy. She received the first dose Pfizer Covid Vaccine at the Pharmacy and they Pharmacy did not do anything, it was awful. The caller stated she almost died and the pharmacy did nothing. The caller stated she was allergic to Cipro and Bactrim and was overweight. The caller shared this information with the Pharmacy and they said it would be fine. It was reported that, chest pain was still ongoing back and forth. The caller still felt tired and bouts of dizziness. The caller stated the chest pain had improved but still getting bouts and was super tired. Itchy tongue went away maybe about 2.5 hours after, was still having severe dizziness and lightheadedness off and on throughout the day, turned whiter than white, lip swelling and got really itchy went away like a few hours after the first dose. The caller stated, she knew she had to go to the hospital and was covered in hives and had trouble breathing (Caller clarified this occurred after taking Cipro). The caller could not drive and the Pharmacist was a moron and did not do anything, she could have died right there in the pharmacy. The outcome of almost died was unknown, immediately got chest pain was recovering. The outcome of severe dizziness and lightheadedness and feels tired was not recovered, other events: recovered on16Aug2021.  Follow-up attempts are completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Lip swelling, Near death experience
Clinical narrative: Describe the adverse event(s), treatment, and outcome(s), if any: (symptoms, signs, time course, etc.) Immediately got chest pain; Itchy tongue; Severe dizziness and lightheadedness; Turned whiter than white; Lip started to swell and got really itchy; Lip started to swell and got really itchy; Feels tired; Almost died;  This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 53-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 16Aug2021 11:00 as dose 1, single for covid-19 immunisation (age at vaccination: 53 years). Medical history included ongoing rheumatoid arthritis diagnosed with about 6 years ago, overweight from an unknown date and unknown if ongoing. There were no concomitant medications. The patient previously took bactrim and experienced allergy, cipro [ciprofloxacin] and experienced drug allergy. The patient experienced almost died, feels tired on an unspecified date in Aug2021, immediately got chest pain, itchy tongue, severe dizziness and lightheadedness with, turned whiter than white, lip started to swell and got really itchy on 16Aug2021. The reporter stated that, she received her first dose Pfizer Covid Vaccine on Monday, 16Aug2021. She immediately got chest pain, itchy tongue, severe dizziness and light headedness. The caller s daughter stated, the patient got whiter than white after receiving the first dose Pfizer Covid Vaccine. The caller stated she had the chest pains. Her lip started to swell and got really itchy. She received the first dose Pfizer Covid Vaccine at the Pharmacy and they Pharmacy did not do anything, it was awful. The caller stated she almost died and the pharmacy did nothing. The caller stated she was allergic to Cipro and Bactrim and was overweight. The caller shared this information with the Pharmacy and they said it would be fine. It was reported that, chest pain was still ongoing back and forth. The caller still felt tired and bouts of dizziness. The caller stated the chest pain had improved but still getting bouts and was super tired. Itchy tongue went away maybe about 2.5 hours after, was still having severe dizziness and lightheadedness off and on throughout the day, turned whiter than white, lip swelling and got really itchy went away like a few hours after the first dose. The caller stated, she knew she had to go to the hospital and was covered in hives and had trouble breathing (Caller clarified this occurred after taking Cipro). The caller could not drive and the Pharmacist was a moron and did not do anything, she could have died right there in the pharmacy. The outcome of almost died was unknown, immediately got chest pain was recovering. The outcome of severe dizziness and lightheadedness and feels tired was not recovered, other events: recovered on16Aug2021.  Follow-up attempts are completed. No further information is expected.