chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Ear pruritus, Pruritus, Throat irritation
Clinical narrative: intense itching in left ear; throat and scalp began itching; throat and scalp began itching; cough; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in the right arm on 04Aug2021 09:15 (Batch/Lot number was not reported) as single dose (at the age of 59-years-old) for COVID-19 immunization. Medical history included multiple sclerosis (MS), asthma and known allergies: slight to shellfish, dust mites, roaches, feathers, box elder. Concomitant medications included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); levothyroxine sodium (SYNTHROID); spironolactone (SPIROLACTONE); and montelukast sodium (SINGULAIR); all taken for an unspecified indication, start and stop date were not reported. The patient also took an unspecified vitamin concomitantly. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Aug2021 09:30 (also reported as after 20 minutes), the patient experienced intense itching in left ear, throat and scalp began itching, and cough. The events were further described as: an intense itching in left ear began, itching intensified and throat and scalp began itching. The patient took liquid BENADRYL but itching in throat continued as well as an urge to cough. The patient took another dose of liquid BENADRYL and two puffs of albuterol inhaler. Itching continued until 10:45. The patient received treatments of 2 ZYRTEC, liquid BENADRYL and albuterol inhaler. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The patient was recovering from the events. The events were considered non-serious by the reporter.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I just got COVID after getting my first shot; I just got COVID after getting my first shot; This is a spontaneous report from a non-contactable consumer (patient) or other non hcp. This report received from program.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced just got covid after getting first shot. The patient underwent lab tests and procedures which included sars-cov-2 test, positive on an unspecified date. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Asthma, COVID-19, Drug ineffective, Illness
Clinical narrative: Asthma; Ended up getting Covid-19; Ended up getting Covid-19; Sick; very weak; This is a spontaneous report from a contactable Nurse. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. It was reported that patient had been very careful even after being vaccinated. She had been mask-wearing even after second vaccine but on an unknown date in 2021, she was ended up getting Covid-19 and it's been a month and she was still sick. She was hospitalized because she has asthma, she was still very weak which was horrifying because she was an active woman. In 2021, the patient underwent COVID-19 test which resulted positive. Outcome of the events sick and very weak was not resolved and whereas other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: The possibility of COVID-19, Drug Ineffective, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out. As there is limited information in the case provided, the causal association between the event "asthma" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Asthma; Ended up getting Covid-19; Ended up getting Covid-19; Sick; very weak; This is a spontaneous report from a contactable Nurse. A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunization. Medical history included ongoing asthma. The patient's concomitant medications were not reported. It was reported that patient had been very careful even after being vaccinated. She had been mask-wearing even after second vaccine but on an unknown date in 2021, she was ended up getting Covid-19 and it's been a month and she was still sick. She was hospitalized because she has asthma, she was still very weak which was horrifying because she was an active woman. In 2021, the patient underwent COVID-19 test which resulted positive. Outcome of the events sick and very weak was not resolved and whereas other events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. ; Sender's Comments: The possibility of COVID-19, Drug Ineffective, being an intercurrent condition cannot be ruled out. The response to the vaccine can vary from one person to another and hence the occurrence of the event post vaccination cannot be completely ruled out. As there is limited information in the case provided, the causal association between the event "asthma" and the suspect drug "BNT162B2" cannot be excluded. The case will be reassessed once new information is 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 regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: shortness of breath whenever I exercise/can't breathe very well; tightness in my chest; pain in chest whenever I exercise; This is a spontaneous report received from a contactable consumer (patient). A 26-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection), via an unspecified route of administration, administered in Arm Left on 09Apr2021 09:00 (at the age of 26-years-old) (Batch/Lot Number: EP7533; Expiration Date: Jul2021) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) taken for an unspecified indication, start and stop date were not reported. The patient had not received prior vaccination. The patient heard this, if she needs to report an adverse side effect. She states if she looking to report a side effect, can she do on website or you,she got shortness of breath and pain in chest whenever she exercises. It's Pfizer Covid 19 Vaccine. She wanted to report any time she exercises, she gets tightness in her chest and she can't breathe very well, and it started today when she got her first dose and that's in April and it still hasn't gone away on 09April2021. The patient had not tried anything as treatment in response to events. The patient underwent lab tests and procedures which included allergy test: unknown on unspecified date in Jul2021. The clinical outcome of all events was not recovered.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer. A 18-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via intramuscular, administered in arm right on 17Apr2021 at 11:15 (age at vaccination 18-years-old, non-pregnant) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE and dose 1 intramuscular, administered in arm left on 29Mar2021 at 10:45 (Batch/Lot Number: EP6955) as DOSE 1, SINGLE for covid-19 immunization. Medical history included migraine from an unknown date and unknown if ongoing. There were no concomitant medications. Facility where the recent COVID-19 vaccine was administered was clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. On 25Jul2021, patient experienced COVID-19. It was reported patient tested positive for Covid-19, results received 04Aug21. Patient did not receive any treatment for the events. The events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included PCR/ nasal swab on 03Aug2021 which was positive (results received on 04Aug21). The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Choking, Cough, Dysphonia, Fatigue, Feeling abnormal
Clinical narrative: Choking; Tired/worn out all a week; sluggish; coughing; in a fog/starts laughing and it feels like something went down the wrong pipe; throat feels strange/feels like its closing but she knows its not; hoarse; can't think; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Jul2021 (Lot Number: EW0181; Expiration Date: 30Aug2021) as dose 1, single for COVID-19 immunization.  Medical history included heart murmur which was diagnosed at birth on 07Apr1962 and laryngitis from an unknown date. The patient also had unspecified reactions to medicines. There were no concomitant medications.  The patient had nothing with the first dose, she was just tired and sluggish and worn out all week in Jul2021. The patient had to go see the throat doctor. The doctor ordered the tube to go down her throat because she has been choking since she had the first dose but its not as bad. The patient choked on chicken noodle soup. The patient stated that she starts coughing really bad and starts laughing and it feels like something went down the wrong pipe in Jul2021. The patient's throat feels strange. It feels like its closing but she knows its not. The patient added that by 17:00 (unknown date in 2021) she will be totally hoarse. The patient was in a fog and can't think on an unknown date in Jul2021. The outcome of the event choking was not recovered. The outcome of the events tired/worn out all a week and sluggish was recovering while the outcome of the other events was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Thinking abnormal, Throat tightness
Clinical narrative: Choking; Tired/worn out all a week; sluggish; coughing; in a fog/starts laughing and it feels like something went down the wrong pipe; throat feels strange/feels like its closing but she knows its not; hoarse; can't think; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Jul2021 (Lot Number: EW0181; Expiration Date: 30Aug2021) as dose 1, single for COVID-19 immunization.  Medical history included heart murmur which was diagnosed at birth on 07Apr1962 and laryngitis from an unknown date. The patient also had unspecified reactions to medicines. There were no concomitant medications.  The patient had nothing with the first dose, she was just tired and sluggish and worn out all week in Jul2021. The patient had to go see the throat doctor. The doctor ordered the tube to go down her throat because she has been choking since she had the first dose but its not as bad. The patient choked on chicken noodle soup. The patient stated that she starts coughing really bad and starts laughing and it feels like something went down the wrong pipe in Jul2021. The patient's throat feels strange. It feels like its closing but she knows its not. The patient added that by 17:00 (unknown date in 2021) she will be totally hoarse. The patient was in a fog and can't think on an unknown date in Jul2021. The outcome of the event choking was not recovered. The outcome of the events tired/worn out all a week and sluggish was recovering while the outcome of the other events was unknown.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Sluggishness
Clinical narrative: just tired/worn out all week; sluggish; This is a spontaneous report from a contactable consumer.  An 83-year-old female patient (reporter's mother) received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration on 12Jul2021 (Lot Number: EW0181; Expiration Date: 30Aug2021) as dose 1, 0.3 ml single for COVID-19 immunization.  Medical history included pacemaker on an unknown date, fall on 13Feb2021 and a concussion in her head on an unknown date. There were no concomitant medications. The patient was just tired and sluggish and worn out all week which started the day of the first dose of the vaccine, 12Jul2021 and lasted a week or so. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On unknown date, it was reported that patient experienced: Pfizer covid vaccine effectiveness is lowered by 36 fold. Outcome of the event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Autoimmune disorder, Gait disturbance, Musculoskeletal stiffness, Rheumatoid arthritis
Clinical narrative: developed an autoimmune condition; probably has sjogren's syndrome; few symptoms of rheumatoid arthritis; couldn't walk; morning stiffness; joint pain; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of two reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient developed an autoimmune condition, probably has Sjogren's syndrome, had a few symptoms of rheumatoid arthritis, couldn't walk with the morning stiffness and joint pain  after the vaccine. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events 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.,Linked Report(s) : US-PFIZER INC-202100998397 same reporter/product/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Sjogren's syndrome
Clinical narrative: developed an autoimmune condition; probably has sjogren's syndrome; few symptoms of rheumatoid arthritis; couldn't walk; morning stiffness; joint pain; This is a spontaneous report from a contactable nurse. This nurse reported similar events for two patients. This is the second of two reports.   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), 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's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient developed an autoimmune condition, probably has Sjogren's syndrome, had a few symptoms of rheumatoid arthritis, couldn't walk with the morning stiffness and joint pain  after the vaccine. The outcome of the events was unknown.   The lot number for BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the temporal association, a possible contributory role of BNT162B2 to the development of reported events 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.,Linked Report(s) : US-PFIZER INC-202100998397 same reporter/product/event, different patient
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypertension, Pain in extremity, Peripheral swelling
Clinical narrative: blood pressure was high; at 188/122; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work.; her left hand, the fingers were swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (left shoulder) on 30Jul2021 (about 12:15 or 12:30) (Lot Number: FA7485) as DOSE 2, SINGLE for covid-19 immunization. Medical history and family history included high blood pressure. Concomitant medication included losartan taken for high blood pressure from May2021 and from Jun2021. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jul2021 (lot number EW0198) for covid-19 immunization. The patient was calling regarding the Pfizer Covid vaccine. She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work. In her left hand, the fingers were swollen. She could not lay on her left arm. It was the fingers on the left side and it was on Monday and Tuesday. Today (04Aug2021), one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny. It kind of throbs but was kind of the same. The patient did not receive treatment for these events, she just took her blood pressure medicine. The events did not require visit to emergency room but she was going to go today (04Aug2021), this morning when she got up to take her blood pressure pill, her blood pressure was high. It was basically 188/122. Her hand was still swollen. The patient was advised to contact her primary care provider for any medical advice. Outcome of the event "blood pressure was high; at 188/122" was unknown, while not recovered for other events.  Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: blood pressure was high; at 188/122; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny; She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work.; her left hand, the fingers were swollen; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left (left shoulder) on 30Jul2021 (about 12:15 or 12:30) (Lot Number: FA7485) as DOSE 2, SINGLE for covid-19 immunization. Medical history and family history included high blood pressure. Concomitant medication included losartan taken for high blood pressure from May2021 and from Jun2021. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Jul2021 (lot number EW0198) for covid-19 immunization. The patient was calling regarding the Pfizer Covid vaccine. She took the shot Friday (30Jul2021) and they had taken it in the left shoulder. It was swollen that Friday and Saturday, Sunday, Monday and Tuesday and until today and she was at work. In her left hand, the fingers were swollen. She could not lay on her left arm. It was the fingers on the left side and it was on Monday and Tuesday. Today (04Aug2021), one finger on the left side was swollen and was hard to make a fist, it hurts and it feels funny. It kind of throbs but was kind of the same. The patient did not receive treatment for these events, she just took her blood pressure medicine. The events did not require visit to emergency room but she was going to go today (04Aug2021), this morning when she got up to take her blood pressure pill, her blood pressure was high. It was basically 188/122. Her hand was still swollen. The patient was advised to contact her primary care provider for any medical advice. Outcome of the event "blood pressure was high; at 188/122" was unknown, while not recovered for other events.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for a patient. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number, NDC number, UPC number and Expiry Date was unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced had covid break through after taking pfizer covid vaccine. Reporter stated, had Covid break through after taking Pfizer Covid vaccine. Reporter did not have the information on Patient details. The patient underwent lab tests and procedures which included (Covid) sars-cov-2 test. Had covid on an unspecified date. Reporter seriousness for Had Covid break through after taking Pfizer Covid vaccine was unspecified. The outcome of events suspected covid-19 was unknown. The lot number for the vaccine, [Vaccine, BNT162B2], was not provided and will be requested during follow up.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fall, Feeling abnormal, Near death experience
Clinical narrative: Just in case I die because of the vaccine; I feel real bad, I feel like everything around me is moving; Light-headed; I feel like, I am gonna fall down whenever I am walking or whenever I am sitting down; I got a burning sensation in my chest, I feel like its burning; It just uncomfortable that it burns; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old female consumer received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Aug2021 in left arm at single dose, dose unknown for COVID-19 immunisation at the age of 36-year-old. Lot number was FA7485. There was no medical history. The concomitant medications were unknown. In Aug2021, the patient reported just in case the she die because of the vaccine, she experienced she felt real bad, she felt like everything around me was moving, Light-headed, she felt like she was going to fall down whenever she was walking or whenever she was sitting down, she got a burning sensation in her chest, she felt like it was burning; it was just uncomfortable that burned. The patient was treated with ADVIL. The outcome of the events was unknown. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer metastatic
Clinical narrative: metastatic breast cancer; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 2, SINGLE and the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A potential AE has been reported to the Pfizer Clinical Trials Contact Center. The caller (patient) stated that she has received both doses of the Pfizer vaccine. Caller has metastatic breast cancer and she is getting ready to start stage 4 of her treatment. She will be taking an immunosuppressant drug. No other additional information was provided. Outcome of the event was unknown.  No follow-up attempts are possible; information about the batch/lor number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Spinal pain, Thirst
Clinical narrative: Very thirsty no matter how much I drink; I'm on fire; Feels like spine is being ripped outof patient's body; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7484) via an unspecified route of administration in the right arm on 04Aug2021 at 11:45 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously took brexpiprazole (REXULTI) for unknown indication on an unknown date and experienced drug allergy. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 04Aug2021 at 01:30, the patient felt like her spine was being ripped out of the body. She was on fire, very thirsty no matter how much she drunk. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. It was unknown whether any therapeutic measures were taken as a result of the events. The clinical outcome of events felt like her spine was being ripped out of the body, patient was on fire, very thirsty was recovered with sequelae on an unknown in Aug2021.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Drug ineffective, Feeling abnormal, Loss of personal independence in daily activities
Clinical narrative: Received Pfizer Covid shots already. I had Covid in Feb2021; Received Pfizer Covid shots already. I had Covid in Feb2021; pneumonia; Went home on oxygen for 3 months; Feel terrible every day/ so miserable; have to take naps everyday; No energy; Not get back to normal every day things; This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as a single dose, dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, the patient experienced pneumonia and stated that received Pfizer COVID shots already and had COVID in Feb2021. Hospitalized for a week. On an unknown date, the patient went home on oxygen for 3 months and experienced feel terrible every day/ so miserable, have to take naps everyday, no energy, not get back to normal every day things. On an unspecified date in Feb2021, the patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation decreased, Pneumonia, SARS-CoV-2 antibody test, Somnolence
Clinical narrative: Received Pfizer Covid shots already. I had Covid in Feb2021; Received Pfizer Covid shots already. I had Covid in Feb2021; pneumonia; Went home on oxygen for 3 months; Feel terrible every day/ so miserable; have to take naps everyday; No energy; Not get back to normal every day things; This is a spontaneous report from a contactable consumer (the patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as a single dose, dose 1 via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On unspecified date in Feb2021, the patient experienced pneumonia and stated that received Pfizer COVID shots already and had COVID in Feb2021. Hospitalized for a week. On an unknown date, the patient went home on oxygen for 3 months and experienced feel terrible every day/ so miserable, have to take naps everyday, no energy, not get back to normal every day things. On an unspecified date in Feb2021, the patient underwent lab tests and procedures which included SARS-COV-2 antibody test: positive. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Food allergy
Clinical narrative: can't handle antibiotics or seafood/allergic to them; can't handle antibiotics or seafood/allergic to them; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored Program COVAX Support (report's cousin). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as dose 2, single, first dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced can't handle antibiotics or seafood/allergic to them. The outcome of the events were unknown.   Information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer (patient) or other non-healthcare professional received from a Pfizer colleague.   A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the patient got Covid after receiving first Pfizer vaccine shot and experienced symptoms of sinus, headache, sore throat, and muscle ache on an unspecified date. Seemed like bad sinus infection. The events took place after use of product. On an unspecified date, the patient underwent lab tests and procedures which included Covid (SARS-CoV-2 test), resulted as got Covid after receiving first Pfizer vaccine shot. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness, Polymerase chain reaction, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6203), via an unspecified route of administration, administered on arm left on 17Mar2021 (age at vaccination was 46-year-old) as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EL3247), via an unspecified route of administration, administered in arm left on 24Feb2021 as dose 1, single for covid-19 immunization at clinic. Medical history was reported as none. The patient concomitant medications were reported as none. Device Date was 05Aug2021.The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient has not received any other medications the patient received within 2 weeks of vaccination. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient tested for COVID-19. The patient stated tested positive for covid on 28Jul2021 and sick on an unknown date 2021. The patient was tested for COVID on the 27Jul2021 and received result. On an unknown date 2021 (following day) the patient was sick so was not able to log in and report. Since the vaccination, the patient was tested for COVID-19. The patient lab tests included polymerase chain reaction PCR (nasal swab) was positive on 27Jul2021 and negative on 03Aug2021. No treatment medications were received for the event tested positive for covid. The outcome of the event COVID-19 was resolving and the outcome for the event sick was unknown.   No follow-up attempts are needed. No further information is expected
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: This is a spontaneous report from a contactable consumer (Patient). A 61-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 04Feb2021 (at the age of 60-years-old) as a dose 1, single and again received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 25Feb2021 (at the age of 60-years-old) as a dose 2, single for COVID-19 immunisation at clinic. No medical history and concomitant medications were reported. The patient has no known allergies. The patient received unspecified medications within two weeks prior to vaccination. The patient did not receive any other vaccine in four weeks prior to vaccination. The patient was not diagnosed with COVID prior to vaccination. The patient was tested for COVID post vaccination. On 21Jul2021, the patient experienced Positive PCR COVID test. The patient underwent lab tests which included SARS-COV-2 test: Positive PCR COVID test on 21Jul2021, and SARS-COV-2 test: Positive Nasal Swab on 03Aug2021. The patient did not receive any treatment for adverse event. The outcome of event Positive PCR COVID test was recovering.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Thrombosis
Clinical narrative: Patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli; Patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli; This is a spontaneous report from a contactable physician.   A 59-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on 01Apr2021 (at the age of 59-Years-old) as dose 2, single for COVID-19 immunisation. Medical history included none from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot Number: Not reported), via an unspecified route of administration on Mar2021 (at the age of 59-Years-old) as dose 1, single for COVID-19 immunisation with no reaction were reported. Prior vaccination was reported as none. The patient was not tested for COVID after vaccination. There were no known allergies. The patient experienced patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli on 07Jun2021. The patient was hospitalized for patient experienced a blood clot in her right leg, followed by bilateral pulmonary emboli for 2 days. Patient received treatment for the reported event included Eliquis. The outcome of the events reported as recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of serious events Thrombosis  and Pulmonary embolism cannot be totally 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: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer (the patient). This adult non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an intramuscular route of administration on 02Mar2021 (Lot Number: UNKNOWN) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an intramuscular route of administration on 23Mar2021 (Lot Number: UNKNOWN), both as single dose for COVID-19 immunization. Medical history included hypercholesterolemia, arthritis and premature ventricular contractions. The patient has no known allergies. The patient did receive other unspecified medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. After the second vaccination received on 23Mar2021, the patient tested positive for COVID-19 on 17Jul2021 which resulted in a visit to the doctor or other healthcare professional office/clinic. No treatment was received for the adverse event(s). The clinical outcome of the event(s) "tested positive for COVID-19" was reported as resolved on an unspecified date in 2021.  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: she tested positive for COVID19; she tested positive for COVID19; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  It was reported that, around four weeks after administration of covid-19 vaccine, around 23Apr2021 she was tested positive for covid19. Patient said that it has been 5 months and she has not received her 2nd dose. Patient thought she was protected after the first dose but tested positive for covid19. Treatment details for the event was not reported. The outcome of the event was unknown.  The lot number for BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Caller continues to say that the vaccine is giving him Covid-19; Caller continues to say that the vaccine is giving him Covid-19; This is a spontaneous report from a non-contactable consumer (patient).   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number and Expiration Date: unknown), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an un-specified date, the patient continued to say that the vaccine was giving him covid-19. The case was assessed as non-serious. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. Outcome of events was unknown.   No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Oral herpes, Staphylococcal infection
Clinical narrative: multiple cold sored on my mouth; staph infection; Shingles; This is a spontaneous report from a contactable nurse (patient).  A 55-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 10Feb2021 17:00 (Batch/Lot Number: EM9810) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included HTN, Bilat PE's(9y ago), chronic sinusitis/bronchitis and allergies to Contrast Dye. Concomitant medication included colecalciferol (RX D) taken for an unspecified indication, start and stop date were not reported. Patient previously took BNT162B2 (lot number: em3247) in Jan2021 as dose 1 administered in the right arm for Covid-19 immunization. On 22Mar2021 at 13:00, 6 weeks after the second Covid vaccine, patient developed shingles, and required Rx medication. On 11Jul2021, 21 weeks after the second Covid vaccine, she developed a staph infection in several places of her body requiring Rx medication. On 31Jul2021, 24 weeks after the second Covid vaccine, she developed multiple cold sores on my mouth, requiring prescription Zovirax and Valtrex. The outcome of events was reported as not recovered.  Follow-up attempts are completed. The following information on the batch number has been obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tested positive for Covid; Tested positive for Covid; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 51-year-old male patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number- UNKNOWN) via an unspecified route of administration in right arm on 26Jan2021 06:45 as dose 1, single (at the age of 51-years-old) for COVID-19 immunization at Workplace clinic. Patient medical history was reported as none. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Patient had no allergies. Since the vaccination, the patient has not been tested for COVID-19. On 10Jul2021 at 18:00, the patient had tested positive for COVID-19. The adverse events did not result in prolongation of hospitalization. No treatment was given for the adverse event. The patient underwent lab tests and procedures which included Sars-cov-2 (nasal swab) test with result as positive on 10Jul2021. The outcome of the event COVID-19 was resolved with sequel on an unspecified date in 2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anger, Arthritis, Depressed mood, Emotional distress, Fatigue
Clinical narrative: Annoyances appeared; ringing in the ear 24 hours; Headaches; Hand arthritis; fatigue; they appeared is a continuous malaise that is changing my way of life and everything; I don't feel good emotionally; I am depressed; This is a spontaneous report from a non-contactable consumer (Patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), dose 1 via an unspecified route of administration on Jan2021 as dose 1, single, dose 2 via an unspecified route of administration on Feb2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced annoyances appeared, ringing in the ear 24 hours, headaches, hand arthritis, fatigue, patient never had they appeared is a continuous malaise that is changing my way of life and everything, patient don't feel good emotionally, patient depressed. The outcome of event was unknown.  Information on the lot/batch number has been requested.