chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Pain, Pain in extremity
Clinical narrative: backaches; extreme fatigue; leg and body aches; leg and body aches; recurring headaches; This is a spontaneous report from a contactable consumer reporting for granddaughter (patient) via medical information team. A 14-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown), via an unspecified route administered on 13Aug2021 (at the age of 14-year-old) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: unknown, expiration date: unknown) administered via unknown route on an unknown date as DOSE 1, SINGLE for COVID-19 immunization. The patient had no history of adverse events with any previous vaccines. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Reporter stated that patient received her second dose of the vaccine on 13Aug2021, after which she developed backaches on 26Aug2021, leg and body aches, recurring headaches, and extreme fatigue on 16Aug2021. The back ache was intermittent. Reporter stated that the extreme fatigue vary from tired to very tired and it is persistent with some extreme fatigue and that it goes up and down. It was reported that no medical treatment was given and patient just took Tylenol. No further details provided. The outcome of all the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Rectal haemorrhage
Clinical narrative: Rectal bleeding; This is a spontaneous report from a contactable Pharmacist. An adult female Pharmacist (patient) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection), via an unspecified route of administration on 23Aug2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. In Aug2021, the patient experiencing rectal bleeding (medically significant). The outcome of event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up; Sender's Comments: Based on the limited information in the case, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Rectal Bleeding. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Back injury, Extra dose administered, Off label use
Clinical narrative: injured his back; 3rd dose of the Pfizer covid vaccine booster; 3rd dose of the Pfizer covid vaccine booster; This is a spontaneous report from a contactable consumer (caregiver). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date in 2021, as dose 3, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Historical vaccine includes first and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1 and 2, single for COVID-19 immunization. The reporter stated that on an unspecified date in 2021, the patient received the 3rd dose of the Pfizer covid vaccine booster. The patient injured his back and was at the physical therapist along with the reporter. The patient was prescribed Prednisone and a Muscle relaxant during a telemedicine visit for the event injured his back and did not tell the doctor that he had received the vaccine. The outcome of the events were unknown.    The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Discomfort, Heart rate, Heart rate increased
Clinical narrative: Its 140, 138, beats per minute. It is persisting, her beats per minute has went up; Heart irregularities/ sky rocketing pulse rates and irregularity; Chest pain; Chest discomfort; Just uncomfortable/uneasy feeling; This is a spontaneous report from a contactable consumer. This contactable consumer (patients husband) reported for a 58-year-old female patient (reporters wife) that, A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 26Jul2021 (at the age of 58-years-old) as single dose for COVID-19 immunization. Medical history included as none. There were no concomitant medications. It was reported that the patient received second dose of COVID vaccine (Lot number- FD8448). In Aug2021 the patient experienced its 140, 138, beats per minute. it is persisting, her beats per minute has went up (medically significant), In 2021 heart irregularities/ sky rocketing pulse rates and irregularity (intermittent and random morning and night), chest pain, chest discomfort, just uncomfortable/uneasy feeling in 2021. Caller was calling because his wife received the covid vaccine. She received her first dose on 26Jul2021 and her second dose on 16Aug2021. After the first dose she experienced an adverse event. She had heart irregularities, chest pain and chest discomfort. She went to her primary care provider and had a physical. She followed up with her physical based on her pulse. She was having skyrocketing pulse rates and irregularity. They are referring her to a cardiologist to fit her for a heart monitor device. It's been really erratic she can pull up her information from her heart rate. The event heart irregularities was started the first of august week after the dose. In the middle of the night, she was not in pain just uncomfortable and she looked at her watch and its 140, 138, beats per minute. It was persisting, her beats per minute have went up and it's an uneasy feeling. For the treatment it was reported not yet she was waiting for the appointment to be fitted for a heart monitoring device. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. The AE require a visit to physician Office. No Prior Vaccinations within 4 weeks. AE did not occur following prior vaccinations. Patient underwent lab test and procedure which included Heart rate 140,138 her beats per minute has went up 2021.The outcome of the event its 140, 138, beats per minute. it was persisting, her beats per minute has went up, Heart irregularities/ sky rocketing pulse rates and irregularity was reported as not recovered and the outcome of the events Chest pain, Chest discomfort and Just uncomfortable/uneasy feeling was reported as unknown.  No follow-up attempts are possible, no further information expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular
Clinical narrative: Its 140, 138, beats per minute. It is persisting, her beats per minute has went up; Heart irregularities/ sky rocketing pulse rates and irregularity; Chest pain; Chest discomfort; Just uncomfortable/uneasy feeling; This is a spontaneous report from a contactable consumer. This contactable consumer (patients husband) reported for a 58-year-old female patient (reporters wife) that, A 58-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: FA7484) via an unspecified route of administration, administered in Arm Left on 26Jul2021 (at the age of 58-years-old) as single dose for COVID-19 immunization. Medical history included as none. There were no concomitant medications. It was reported that the patient received second dose of COVID vaccine (Lot number- FD8448). In Aug2021 the patient experienced its 140, 138, beats per minute. it is persisting, her beats per minute has went up (medically significant), In 2021 heart irregularities/ sky rocketing pulse rates and irregularity (intermittent and random morning and night), chest pain, chest discomfort, just uncomfortable/uneasy feeling in 2021. Caller was calling because his wife received the covid vaccine. She received her first dose on 26Jul2021 and her second dose on 16Aug2021. After the first dose she experienced an adverse event. She had heart irregularities, chest pain and chest discomfort. She went to her primary care provider and had a physical. She followed up with her physical based on her pulse. She was having skyrocketing pulse rates and irregularity. They are referring her to a cardiologist to fit her for a heart monitor device. It's been really erratic she can pull up her information from her heart rate. The event heart irregularities was started the first of august week after the dose. In the middle of the night, she was not in pain just uncomfortable and she looked at her watch and its 140, 138, beats per minute. It was persisting, her beats per minute have went up and it's an uneasy feeling. For the treatment it was reported not yet she was waiting for the appointment to be fitted for a heart monitoring device. Additional Vaccines Administered on Same Date of the Pfizer Suspect reported as None. The AE require a visit to physician Office. No Prior Vaccinations within 4 weeks. AE did not occur following prior vaccinations. Patient underwent lab test and procedure which included Heart rate 140,138 her beats per minute has went up 2021.The outcome of the event its 140, 138, beats per minute. it was persisting, her beats per minute has went up, Heart irregularities/ sky rocketing pulse rates and irregularity was reported as not recovered and the outcome of the events Chest pain, Chest discomfort and Just uncomfortable/uneasy feeling was reported as unknown.  No follow-up attempts are possible, no further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died after taking the vaccine; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were Not Provided. The reporter said his cousin died after taking the Covid vaccine and reported as serious due to death. The caller mentioned about that our website or recorded line doesn't say FDA approval and she told him that will be updated by the end of the day and they are aware of that. Reporter then started to say is the president lying and the agent ended the call at that time. Investigation Assessment was Not Provided. It was not reported if Autopsy Done. The outcome of the event was fatal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Reported Cause(s) of Death: died after taking the vaccine
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Vaccination Failure; Nasal Swab: Positive; This is a spontaneous report received from a contactable consumer(patient). A 35-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 (Lot Number: EL3247) at age of 34-year-old, dose 2 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (Lot Number: EP6955) at age of 34-year-old, both as single dose for covid-19 immunisation. Medical history included Penicillin hypersensitivity.  No covid prior vaccination. The patient's concomitant medications were not reported. No other vaccine in four weeks. The patient experienced vaccination failure on 26Aug2021.  No treatment received. The patient underwent lab tests and procedures which included sars-cov-2 test (Nasal Swab): positive on 26Aug2021.  The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Corneal disorder, Hypoaesthesia, Swelling face
Clinical narrative: I had Cornea transplant in my eye in my left and right eye and it affected my left cornea transplant. So, now I have 70% vision in my left eye. I do not have full vision in my left eye; I had Cornea transplant in my eye in my left and right eye and it affected my left cornea transplant. So, now I have 70% vision in my left eye. I do not have full vision in my left eye; I received the swelling of the face, left side, tremendously and it is numb; I received the swelling of the face, left side, tremendously and it is numb; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received the first dose of BNT162B2 (PFIZER BIONTECH COVID 19 VACCINE ) via an unspecified route of administration on the left arm on 16Aug2021 at 01:00 (Lot Number: RA1987; Expiration Date: Unknown) at the age of 54-year-old as single dose for COVID-19 immunization. Medical history included depression, arthritis and gout. Investigation assessment was none. Prior vaccination, the patient haven't had the vaccination in 25 years. Concomitant medications included naproxen taken for arthritis and ongoing and mirtazapine. On 18Aug2021 at 01:00, 48 hours after the shot, the patient experienced swelling of the face, left side, tremendously and it is numb. On 20Aug2021, the patient had cornea transplant in eye in left and right eye and it affected left cornea transplant. So, now, the patient had 70% vision in left eye. The patient didn't had full vision in left eye. So, the patient was seeing an eye specialist regarding this matter and trying to get vision back. The patient couldn't wear eye glasses any longer because he gone to get new prescription and everything to correct he cornea. The patient stated "all this because of this Pfizer injection". The patient also stated the anatomical site was left arm and that's why he was affected on the left side of face and he didn't think of that and it's possible. The patient stated the due date of the second dose of BNT162B2 was 01Sep2021. NO treatment was received for vision loss, numbness in face and facial swelling and the patient stated he was going to see the doctor on Monday. The patient have had read the Pfizer paper work. He wanted to known how he get the compensation for his  illness. And he stated that he have seen the program, the Pfizer has compensation for his injury. The outcome of vision loss and corneal disorder was unknown. The outcome of other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: She was barely four months vaccinated when we got Covid; She was barely four months vaccinated when we got Covid; This is a spontaneous report from a contactable consumer. A 39 years old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular on 07Apr2021 as DOSE 2, SINGLE, dose 1 via an unspecified route of administration on 17Mar2021 (Lot Number: EP7534) at age of 38 years old as DOSE 1, SINGLE for covid-19 immunisation  .  The patient medical history was not reported.     The patient's concomitant medications were not reported.  The patient was barely four months vaccinated when got covid on 24Aug2021. The outcome of events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Polymerase chain reaction, Vaccination failure
Clinical narrative: On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test; On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test; This is a spontaneous report from a contactable consumer (patient). A 55 year old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, solution for injection), dose 2 intramuscular, administered in Arm Left on 16Feb2021 08:00 (at the age of 54 years old) (Lot number was not reported) as dose 2, single; the first dose intramuscular, administered in Arm Left on 26Jan2021 08:00 (Lot number was not reported) as dose 1, single for COVID-19 immunisation. Medical history included known allergies to amoxicillin. There were no concomitant medications. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not pregnant at the time of vaccination. No other vaccines received within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. On 12Aug2021, symptoms started in the evening. On 14Aug2021: PCR (nasal swab) COVID test was taken. On 17Aug2021: notification of positive test. The event resulted in a Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. Since the vaccination, the patient has been tested for COVID-19. The outcome of the event was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive following full COVID-19 vaccination.; Patient tested positive following full COVID-19 vaccination.; This is a spontaneous report from a non-contactable other health care professional. A 43-year-old male patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN5318) dose 2 via an unspecified route of administration 24Feb2021 (at the age of 42-years-old) as dose 2, single and bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN5318) dose 1 via an unspecified route of administration 05Feb2021 (at the age of 42-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive following full COVID-19 vaccination on 20Aug2021. 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 and since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests and procedures which included Covid Test was positive on 20Aug2021. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events drug ineffective and covid-19 and BNT162B2.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: So my friends husband that received the Pfizer vaccination in April has developed Covid/he has developed Covid over a week ago. He is pretty sick; So my friends husband that received the Pfizer vaccination in April has developed Covid/he has developed Covid over a week ago. He is pretty sick; This is a spontaneous report from a contactable consumer (patient's wife) via Pfizer sales representative. A male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number, expiration date was not reported), via an unspecified route of administration, on Apr2021, at dose number unknown, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the full vaccination (as reported) at the end of Apr2021 and developed Covid over a week ago from the time of report (19Aug2021). Also reported that he was very sick. The outcome of the event was unknown.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: dizziness/lightheaded; brain fog; kind of head pressure not being there; This is a spontaneous report from a non-contactable consumer (Patient). A 57-years-old male patient 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 27Jul2021 (age at vaccination 57 years) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 2021 the patient experienced dizziness/lightheaded, brain fog, kind of head pressure not being there. Patient reported that symptoms have improved some not completely and asking if the second Pfizer Covid 19 Vaccine will cause "worst vertigo?" also asking if the vaccine will cause Central Nervous System issues, if any have been reported? The outcome of event was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 PCR test positive; COVID-19 PCR test positive; This is a spontaneous report from a Pfizer Sponsored Program Covax US Support. A contactable consumer (patient) reported that a 68-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection) (age at the time of vaccination was 68-year-old), on 08Jan2021 15:00 (Lot Number: EL3248) as dose 2, single and on 18Dec2020 15:00 (Lot Number: EK5730) as dose 1, single, both via an unspecified route of administration, administered in Arm for covid-19 immunization. Medical history included and concomitant medications were reported as none. Other vaccinations within four weeks prior to the first administration date of the suspect vaccine: None. It was reported that the patient COVID-19 PCR test was positive on 14Aug2021 and was treated with Regeneron antibody treatment via Subcutaneous injections. One injection in back of each arm, two injections in abdomen. All injections administered at one time. She was told that if she needs to get a 3rd/booster dose she would need to wait 90 days after the Regeneron treatment before doing so. She asked do we have information on this. It was unknown whether culture performed. There were predisposing factors (eg. immunosuppression, contact with other infected persons). Then patient went to an urgent care (Physician Office) for follow-up to see if she was progressing as expected). The outcome of event COVID-19 was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Joint range of motion decreased, Limb injury, Pain in extremity
Clinical narrative: Certain joints on Right hands/right middle finger got stuck in straight position, point finger had the most damage; Certain joints on Right hands/right middle finger got stuck in straight position, point finger had the most damage; Second toe on right foot started hurting; Took first Covid-19 vaccine and had Anaphylactic reaction; This is a Solicited report based on the information received by Pfizer (Manufacturer Control No: 21K-163-4051900-00) received from a contactable consumer (patient).   Solicited report by a consumer of a 50 year old female with events of took first covid-19 vaccine/had anaphylaxis and non-serious certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting with Humira (Adalimumab). There was no reported medical history. On unknown dates, the patient experienced certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting. On 30Jun2021, the patient experienced took first covid-19 vaccine/had anaphylaxis. Pfizer covid-19 vaccine (tozinameran) was also considered suspect. On the morning she had certain joints on right hand, right middle finger got stuck in a straight position and point finger had the most damage, second toe on right foot was starts hurting. Took first covid -19 vaccine had anaphylaxis within 5 minutes after take first shot. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. On 30Jun2021, patient received 1st dose COVID-19 Vaccine manufactured by Pfizer.  Causality for Humira (Adalimumab) The reporter's causality for the event(s) of took first covid-19 vaccine/had anaphylaxis, certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting was not provided. opinion is that there is no reasonable possibility that the events of took first covid-19 vaccine/had anaphylaxis, certain joints on right hands/right meddle finger got stuck in straight position, point finger had the most damage and second toe on right foot started hurting are related to Humira(adalimumab).  Check all appropriate to Adverse reaction: Other Medically important condition.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment  The lot number for bnt162b2 was not provided and will be requested during follow up; Sender's Comments: For events Joint range motion decreased, Limb injury, Pain in extremity the company causality was assessed as Unrelated as there was no strong relation to make it Related. But where as for event Anaphylactic reaction which has a strong temporal association with suspect BNT162B2 company causality was assessed as Related.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer or other non hcp. A 20-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration on 26Apr2021 (age at vaccination: 20-year-old, Batch/Lot Number: EW0170) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscular route of administration on 05Apr2021 (age at vaccination: 20-year-old, Batch/Lot Number: ER8729) as single dose for COVID-19 immunisation. On 27Aug2021, the patient experienced tested positive for COVID. The patient underwent lab tests and procedures which included sars-cov-2 test (nasal swab): positive on 27Aug2021. No treatment was reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Doctor or other healthcare professional office/clinic visit required for events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Type 2 diabetes mellitus
Clinical narrative: Developed Diabetes type II; Dose 1 on 20May2021 09:00 AM/dose 2 on 20May2021; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration at the age of 59-year-old administered in arm left on 20May2021 (Batch/Lot number was not reported) at single dose, dose 1 via an unspecified route of administration at age of 59-year-old administered in arm left on 20May2021 09:00 AM (Batch/Lot number was not reported) at single dose for covid-19 immunisation. Medical history was reported as none. There was no covid prior vaccination and no covid tested post vaccination. No known allergies. Concomitant medications were reported as none. There was no other vaccine in four weeks and no other medications in two weeks. The patient developed diabetes type II on 05Jul2021. The patient was hospitalized for 5 days. Adverse event resulted in Emergency room/department or urgent care, hospitalization and life-threatening illness. The patient received treatment included insulin and oral meds. The outcome of event was not recovered.  The lot number for the [BNT162B2], was not provided and will be requested during follow up.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea, Pyrexia, SARS-CoV-2 test, Throat tightness
Clinical narrative: shot throat started closing up; couldn't breathe; Fever day one day two 1.5 days into shot throat started closing up couldn't breathe. Went to er everything checked out except I was in anaphylaxis from a allergy.; Fever; This is a spontaneous report from a contactable nurse (patient). This non-pregnancy 35-year-old female patient received bnt162b2 (Brand=Pfizer), dose 1 via an unspecified route of administration, administered in arm left on 25Aug2021 10:00 (Batch/Lot Number: Fa7485) as dose 1, single for covid-19 immunisation. Medical history included chronic pain depression. Concomitant medication included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination: paracetamol. Known allergies: No true allergies just adverse side effects like clarithromycin (MACROBID) vomiting trazadone weird dreams varenicline tartrate (CHANTIX) we. The patient experienced anaphylaxis and fever on 25Aug2021 13:00, shot throat started closing up couldn't breathe on 26Aug2021.  Fever day one day two 1.5 days into shot throat started closing up couldn't breathe. Went to ER everything checked out except she was in anaphylaxis from an allergy. No new meds or foods eaten. No new allergens introduced except vaccine. Never had a true allergic reaction in my life only side effects from certain meds like vomiting with clarithromycin for instance. Her throat still felt like it was trying to close up about once a day and she had to take more benedryl. The adverse event result in Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event). Treatment received for the adverse event included Iv steroids famotidine and benedryl. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19: Covid rapid at work on 19Aug2021: Negative (Nasal Swab). The outcome of event shot throat started closing up was not recovered. The outcome of other event was unknown.; Sender's Comments: The events was considered related to suspect drug based on strong temporal association and known safety profile of the drug.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Thrombosis
Clinical narrative: blood clog on left leg; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received the first dose of BNT162B2 (PFIZER COVID-19 VACCINE, lot number: Ep8732, also reported as Em9809), at the age of 66 years old, in right arm on 24Mar2021 at 09:30 at single dose for COVID-19 immunisation. The patient's medical history was not reported. Known allergies was N/A. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications were received in two weeks was N/A. On 12Aug2021 at 20:15, the patient had a blood clog on left leg. Clog removed on 16Aug2021. Event resulted in emergency room/department or urgent care, hospitalization, life threatening illness (immediate risk of death from the event). The patient was hospitalized for one day. Since the vaccination, the patient had been tested for COVID-19. The patient underwent lab tests and procedures which included COVID test (nasal swab): unknown results on 06Aug2021. Therapeutic measures were taken as a result of event and included treatment with surgery. The outcome of event was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, solution for injection), via an unspecified route of administration on 26Aug2021 (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Medical history included ongoing anticoagulant therapy from an unknown date. Concomitant medication included ongoing apixaban (ELIQUIS) and Metoprolol; both taken for blood thinner start and stop date was not provided. On 26Aug2021 after receiving the first dose of Pfizer Covid 19 Vaccine, the patient had chills, felt tired and had a little arm pain. On 26Aug2021, the patient took Ibuprofen, as a treatment. Patient scheduled for the second dose of Pfizer Covid 19 Vaccine on 16Sep2021 but was unable to make it since she was scheduled for a surgery on that day. The outcome of events was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Pain at the injection site.; sore arm; arm felt feverish; This is a spontaneous report from a Pfizer sponsored program via a consumer reported for a patient (reporter's daughter in law). A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date in 2021 (age at vaccination was unknown) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location an unspecified date in 2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization and experienced flu symptoms for a week after the first vaccine, her arm felt feverish and sore arm on the injection arm. She felt like she had the flu for 5-7 days. Her doses were either in Apr2021 and May2021 or May2021 and Jun2021. It was the end of Apr2021 or the middle of May2021 and the second one was probably in Jun2021. On an unspecified date in 2021, the patient experienced pain at the injection site, sore arm and her arm felt feverish. She didn't want to report it because she felt like it was normal. The reporter and her daughter in law had the same side effects. The outcome of the events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101119253 same reporter/SD/AE,different patient
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebral thrombosis, Thrombosis, X-ray
Clinical narrative: life threatening blood clots/blood clots to brain and clots in neck; life threatening blood clots/blood clots to brain and clots in neck; This is a spontaneous report from a contactable consumer. A 38-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on Feb2021 (Lot number was not reported) at the age of 38-year-old as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Medical history and concomitant medications were not reported.  It is reported the caller reports he has a couple of family members who had the Covid vaccine back in Feb2021. They suspect they are experiencing a side effect of the life-threatening blood clots on Feb2021. They have never had issues until they had the vaccine. He found out that the day after the vaccine, his sister-in-law, blood clots, life threatening blood clots to brain and clots in neck started, but it hasn't been confirmed but the doctors say there is a high suspicion and likelihood there is blood clotting. She just got the x-ray from emergency room 2 days ago and went back yesterday and they are still waiting for the results. Caller unsure if patient had both shots. Know she got a Pfizer Covid shot and the day after the blood clots started. Event caused patient visit physician office and emergency room. The patient underwent lab tests and procedures which included x-ray: still awaiting results on Feb2021.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: I tested positive for a breakthrough infection of COVID-19; I tested positive for a breakthrough infection of COVID-19; This is a spontaneous report from a non-contactable consumer (patient). A 28-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0185), via an unspecified route of administration on arm right on 16May2021(age at vaccination: 28 Years) as dose 2, single and received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0171), via an unspecified route of administration on arm right on 25Apr2021 as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications were not reported. On 16Aug2021, the patient tested positive for a breakthrough infection of COVID-19. The event resulted in Doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has tested for COVID-19. Treatment received was reported as no. The lab test included SARS-CoV-2 test(Nasal Swab): positive on 17Aug2021.The outcome of event was resolving.  No follow up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough COVID-19 case; Breakthrough COVID-19 case; This is a spontaneous report received from a non-contactable consumer (patient). This 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 11Mar2021 at the age of 73-year-old (lot unknown) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Other medical history and allergies was Unknown. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient received any other medications within 2 weeks of vaccination. The patient experienced Breakthrough COVID-19 on 21Jul2021 and reported as Non-serious. It was unknown if treatment received for AE. Since the vaccination, the patient has been tested for COVID-19 which included Nasal Swab covid test on 21Jul2021 with Positive result. The outcome of the event was Recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Confirmed breakthrough COVID-19 infection; Confirmed breakthrough COVID-19 infection; This is a spontaneous report from a contactable consumer. This consumer reported that a Non-pregnant 43-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 05Mar2021 at the age of 43-year-old (Lot unknown) as single dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. Medical history and concomitant medications were not repoted. It was unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was Confirmed breakthrough COVID-19 infection on 27Aug2021. No Hospitalization Prolonged associated. Event reported as non-Serious. It was unknown if Treatment received. Since the vaccination, the patient has been tested Positive for COVID-19 Nasal Swab on 27Aug2021. The outcome of the event was Recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: They both later tested positive for COVID at around the same time; They both later tested positive for COVID at around the same time; This is a spontaneous report from same non-contactable consumer for 2 patient about same events. This is 2 of 2. This consumer reported that a male patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date (Lot unknown) as a single dose for COVID-19 immunization. It was unknown If Covid prior vaccination. Medical history and concomitant medications were not reported. This report is about two patients, both of whom received the vaccine. They both later tested positive for COVID at around the same time. Their illness was not severe and was mostly coughing, sneezing, etc. Event was reported as serious. There is Covid tested post vaccination with the result of Positive. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101116677 Same reporter/drug/event for different patients.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Gait inability
Clinical narrative: Stroke; Can't walk; This is a spontaneous report from a contactable consumer. A 4-decade-old 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 was not reported. The patient's concomitant medications were not reported. On unspecified date, the patient experienced Stroke and was unable to walk. The reporter stated she was told, from the group of employees, that they know a woman, who was in her 30's and healthy, that had a stroke, and can't walk after the Pfizer vaccine. Reporter stated she was at a pharmacy and was told by the pharmacist that the BioNTech vaccine was the one that was not FDA approved, and the vaccine that was approved, was not in stock. Reporter stated she was told that some employees are sick with Covid right now, after having the Pfizer vaccine. Reporter stated that her personal surgeon, told her, not to get the Pfizer vaccine, and to wait for other vaccines, such as Novovax. Reporter stated her surgeon is not recommending the Pfizer vaccine to his employees. Reporter stated telling their employees that Pfizer is only 35% effective, not 95% effective. Reporter stated the employees were told that only the vaccinated employees got Covid, not the unvaccinated employees. Reporter does not provide any specific details. Reporter stated her surgeon was not recommending the Pfizer vaccine to his employees. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She has swollen not swollen, Painful arm first; This is a spontaneous report from a contactable consumer (patient's mother). A 13-years-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, on an unspecified date (age at the time of vaccination 13-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced She has swollen not swollen, Painful arm first. No treatment was received. No prior vaccine within four weeks. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Pain in extremity
Clinical narrative: really painful and hemorrhagic menstrual cycles; really painful and hemorrhagic menstrual cycles/hemorrhagic cycle and cramps and pain. excruciating painful, hemorrhagic cramps and pain; Painful arm first and second dose; This is a spontaneous report from a contactable consumer (mother) reported for patient(daughter). A 13-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The medical history of the patient was reported as no. The concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2(solution for injection) on an unspecified date as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the covid vaccine. The reporter stated her daughter got vaccinated with the Pfizer vaccine and had adverse event. She had swollen not swollen, Painful arm first and second dose and she got a really, really painful and hemorrhagic menstrual cycles, she usually doesn't have menstrual cramps for anything like that but she was up in the middle overnight one hour in excruciating pain. Cramps and pain which was not the usual course, so reporter thought for the safety report it was really important hemorrhagic cycle and cramps and pain. On a scale of 0 to 10 on the 'EVA' she had 9, so it was excruciating painful which was again it was very, it was not at all that usual mode of operating. Therapeutic measures were not taken as a result of events. The outcome of the events was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.