chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Wheezing
Clinical narrative: could not breathe; Wheezing; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for covid-19 immunisation. The patient medical history and concomitant medication(s) not reported. Patient stated had a bad reaction to the vaccine (Unspecified vaccine) got. Patient had the real problems, sated had to go to the Emergency Room and they gave patient prednisone and Aleve as treatment and they did whatever they could because patient could not breathe and afraid to take the second shot that required. From that time patient had been wheezing and had to take inhaler. Patient doctor said actually taking the prednisone depresses the immune system, so patient did not get lot of effects of it because used prednisone every time to breather. The event outcome for events was unknown.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Rectal haemorrhage
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EW0151; Expiration date was not reported) on the left arm on 06Apr2021 (15:00) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included neuroendocrine lung cancer, asthma, and allergies to shellfish and IV contrast dye. The patient's concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EP7534; Expiration date was not reported) on 15Mar2021 (when the patient was 50 years old) for COVID-19 immunization. On 11Apr2021 (03:00), the patient had rectal bleeding, stomach cramps and diarrhea. The events were assessed as serious (medically significant), and had resulted into an emergency room/department or urgent care. The patient had received unspecified intravenous (IV) fluids as treatment for the reported events. The outcome of the events was recovering. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested post-vaccination.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Illness
Clinical narrative: she got pretty sick; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the first dose last 25Mar2021, and the second would be on 15Apr2021. She was asking if it was okay for her to take the second dose on an earlier date because she was having vacation. She said as well that she got pretty sick after the first dose, in Mar2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: she got pretty sick; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the first dose last 25Mar2021, and the second would be on 15Apr2021. She was asking if it was okay for her to take the second dose on an earlier date because she was having vacation. She said as well that she got pretty sick after the first dose, in Mar2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: she got pretty sick; This is a spontaneous report from a Pfizer sponsored program received from a contactable consumer (patient). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 25Mar2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got the first dose last 25Mar2021, and the second would be on 15Apr2021. She was asking if it was okay for her to take the second dose on an earlier date because she was having vacation. She said as well that she got pretty sick after the first dose, in Mar2021. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Headache, Pain, Pyrexia
Clinical narrative: delirium; chills; fever; headache; body aches; This is a spontaneous report from a non-contactable consumer (patient). A 60-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 13Apr2021 10:00 (at the age of 60-years-old) as single dose for COVID-19 immunisation. The patient took the first dose on 23Mar2021 at 10:00.  The patient's medical history and concomitant medications were not reported. On 13Apr2021 at 22:00, about 12 hours after receiving the 2nd dose, the patient experienced chills, fever, delirium, headache, and body aches. By 35 hours after the dose, symptoms were mostly past. The patient did not have COVID prior vaccination and patient was not tested post vaccination. The outcome of events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Headache, Nervousness, Thrombosis
Clinical narrative: Blood clots; headache; nervousness; anxiety; This is a spontaneous report from a non-contactable consumer (patient). A 34-year-old female patient not pregnant received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 03Apr2021 09:00 (Lot Number: ER8733) as single dose (at the age of 34-years-old) for covid-19 immunisation. Medical history included allergies (known allergies: yes). Concomitant medications in two weeks prior to the vaccination included vitamin B complex (B-COMPLEX), magnesium (MAGNESIUM), chlorophyll (CHLOROPHYLL), vitamin D NOS (VITAMIN D NOS). Patient did not receive other vaccine in four weeks prior to the COVID vaccine. It was unknown if patient had COVID prior vaccination. Patient was not tested for Covid post vaccination. On 03Apr2021 patient experienced blood clots, headache, nervousness and anxiety. Events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was required. Outcome of the events was unknown. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the available information, the known safety profile and the temporal association of BNT162B2 administration to the event of Thrombosis, a possible contribution of the drug to the event 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 appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Urinary retention, Viral infection
Clinical narrative: high fever; viral infection; neuro-urological disbalance causing acute urinary retention; This is a spontaneous report from a contactable consumer. An adult male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 22Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient had high fever on 01Apr2021 (the day he had presentation), he sought medical attention on 02Apr2021. He continued seeing doctors throughout last week. On 09Apr2021, as condition got worse, he was admitted to the ER again, and then moved to the hospital. He was having neuro-urological disblance causing acute urinary retention and some other issues. As it was rare and tests and imaging take time, doctors haven't been able to diagnose it yet, and may move him to a different hospital tomorrow. He think it will take more than 1-2 days to get better; definitely only a few days once treatment has been started. Earlier doctors were thinking it might be an autoimmune reaction to the vaccine (22Mar2021) affecting peripheral nerves, that doesn't seem to be the case anymore, however not sure yet. He haven't reported anything yet as nothing is confirmed. It could be more of a viral infection, he will know more in the next 1-2 days. The outcome of the events was unknown. It was unknown if the patient received any treatment for the events. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, and hospitalization.  Information on about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Cardiac disorder, Dyspnoea, Fatigue, Heart rate
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is the second of two reports of the same patient receiving the second dose of BNT162B2.  A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 17Mar2021 (Lot Number: EN6201) as single dose (at the age of 30) for covid-19 immunization. Medical history included ongoing asthma (diagnosed about 10 years ago), Basedow's disease from 01Mar2021 and ongoing, hypersensitivity, hyperthyroidism, anxiety. First dose of BNT162B2 was given on 22Feb2021 and she felt sick to her stomach, nausea, had no energy, 160 heart rate atrial fibrillation, hand tremors, shortness of breath, she felt exhausted, low grade fever, thyroid storm, felt tired, shaking, flu symptoms.  Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for allergy from 2020 to 24Feb2021, guaifenesin (MUCINEX) taken for hypersensitivity from Dec2020 to 20Feb2021.  When she got the second vaccine, her heart rate was high again. She did have a thyroid storm the day after the second dose (18Mar2021) and she was in the emergency room again since her heart rate was so high. It was reported that the vaccine did cause her thyroid storm. She knows vaccinations have to do with the immune systems, and if she has an autoimmune disease, she is thinking it may have come from it. States two doctors are certain that it triggered an immune response and wanted her to report this. She could barely stand up or talk, she was so short of breath and is guessing that was from her heart. She had normal flu like symptoms from the vaccine but does not think it was related to her thyroid. She has always had little cold symptoms after getting a vaccination. First night she felt very exhausted, tired. She had a low grade fever that Tylenol took care of and it went away within a day. She felt run down and it was vaccination related. The second day (19Mar2021) she had really bad hand tremors that moved into her body. She thought the shaking was from the vaccination and she took a video of it. She did not really have any other symptoms yet, then started to get really fatigued. She went to ER and her heart was really elevated. Each time she went to the doctor or the ER, her heart rate would be 20 beats faster then 20 beats faster again.  The outcome of her heart rate was high again / heart elevated/her heart rate would be 20 beats faster then 20 beats faster again, short of breath was recovering. The outcome of guessing that was from her heart, exhausted/tired/ felt run down/ really fatigued was not recovered. The outcome of the other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Influenza like illness, Loss of personal independence in daily activities, Nasopharyngitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is the second of two reports of the same patient receiving the second dose of BNT162B2.  A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 17Mar2021 (Lot Number: EN6201) as single dose (at the age of 30) for covid-19 immunization. Medical history included ongoing asthma (diagnosed about 10 years ago), Basedow's disease from 01Mar2021 and ongoing, hypersensitivity, hyperthyroidism, anxiety. First dose of BNT162B2 was given on 22Feb2021 and she felt sick to her stomach, nausea, had no energy, 160 heart rate atrial fibrillation, hand tremors, shortness of breath, she felt exhausted, low grade fever, thyroid storm, felt tired, shaking, flu symptoms.  Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for allergy from 2020 to 24Feb2021, guaifenesin (MUCINEX) taken for hypersensitivity from Dec2020 to 20Feb2021.  When she got the second vaccine, her heart rate was high again. She did have a thyroid storm the day after the second dose (18Mar2021) and she was in the emergency room again since her heart rate was so high. It was reported that the vaccine did cause her thyroid storm. She knows vaccinations have to do with the immune systems, and if she has an autoimmune disease, she is thinking it may have come from it. States two doctors are certain that it triggered an immune response and wanted her to report this. She could barely stand up or talk, she was so short of breath and is guessing that was from her heart. She had normal flu like symptoms from the vaccine but does not think it was related to her thyroid. She has always had little cold symptoms after getting a vaccination. First night she felt very exhausted, tired. She had a low grade fever that Tylenol took care of and it went away within a day. She felt run down and it was vaccination related. The second day (19Mar2021) she had really bad hand tremors that moved into her body. She thought the shaking was from the vaccination and she took a video of it. She did not really have any other symptoms yet, then started to get really fatigued. She went to ER and her heart was really elevated. Each time she went to the doctor or the ER, her heart rate would be 20 beats faster then 20 beats faster again.  The outcome of her heart rate was high again / heart elevated/her heart rate would be 20 beats faster then 20 beats faster again, short of breath was recovering. The outcome of guessing that was from her heart, exhausted/tired/ felt run down/ really fatigued was not recovered. The outcome of the other events was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Thyroid function test, Thyrotoxic crisis, Weight
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). This is the second of two reports of the same patient receiving the second dose of BNT162B2.  A 30-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in arm left on 17Mar2021 (Lot Number: EN6201) as single dose (at the age of 30) for covid-19 immunization. Medical history included ongoing asthma (diagnosed about 10 years ago), Basedow's disease from 01Mar2021 and ongoing, hypersensitivity, hyperthyroidism, anxiety. First dose of BNT162B2 was given on 22Feb2021 and she felt sick to her stomach, nausea, had no energy, 160 heart rate atrial fibrillation, hand tremors, shortness of breath, she felt exhausted, low grade fever, thyroid storm, felt tired, shaking, flu symptoms.  Concomitant medications included levocetirizine dihydrochloride (XYZAL) taken for allergy from 2020 to 24Feb2021, guaifenesin (MUCINEX) taken for hypersensitivity from Dec2020 to 20Feb2021.  When she got the second vaccine, her heart rate was high again. She did have a thyroid storm the day after the second dose (18Mar2021) and she was in the emergency room again since her heart rate was so high. It was reported that the vaccine did cause her thyroid storm. She knows vaccinations have to do with the immune systems, and if she has an autoimmune disease, she is thinking it may have come from it. States two doctors are certain that it triggered an immune response and wanted her to report this. She could barely stand up or talk, she was so short of breath and is guessing that was from her heart. She had normal flu like symptoms from the vaccine but does not think it was related to her thyroid. She has always had little cold symptoms after getting a vaccination. First night she felt very exhausted, tired. She had a low grade fever that Tylenol took care of and it went away within a day. She felt run down and it was vaccination related. The second day (19Mar2021) she had really bad hand tremors that moved into her body. She thought the shaking was from the vaccination and she took a video of it. She did not really have any other symptoms yet, then started to get really fatigued. She went to ER and her heart was really elevated. Each time she went to the doctor or the ER, her heart rate would be 20 beats faster then 20 beats faster again.  The outcome of her heart rate was high again / heart elevated/her heart rate would be 20 beats faster then 20 beats faster again, short of breath was recovering. The outcome of guessing that was from her heart, exhausted/tired/ felt run down/ really fatigued was not recovered. The outcome of the other events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heavy menstrual bleeding, Otitis media
Clinical narrative: Fluid in the ears causing dizziness and elevated blood pressure; Heavy blood flow during menstruation period with severe multi-day cramps; Fluid in the ears causing dizziness and elevated blood pressure; Fluid in the ears causing dizziness and elevated blood pressure; This is a spontaneous report from a contactable consumer (patient). This 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021 at 14:45 (at age 52-years-old) as a single dose for covid-19 immunisation. Medical history included facioscapulohumeral (FSH) muscular dystrophy from an unknown date and unknown if ongoing and drug hypersensitivity (sulfa drugs) from an unknown date and unknown if ongoing. Concomitant medications included olmesartan medoxomil (BENICAR) taken for an unspecified indication, start and stop date were not reported; and metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps. The adverse events resulted in an emergency room/department or urgent care visit. The patient underwent lab tests and procedures which included blood pressure measurement (30Mar2021): elevated. Therapeutic measures taken included unspecified medication. Clinical outcome of the events fluid in the ears causing dizziness and elevated blood pressure, and heavy blood flow during menstruation period with severe multi-day cramps was resolving. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lower limb fracture, Neoplasm malignant
Clinical narrative: Fractured knee; Cancer; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and expiration date were not reported) on 11Mar2021 as a single dose, with route of administration unspecified, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient had fractured knee and cancer. The patient was hospitalized on an unspecified date in 2021 due to the fractured knee. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pulmonary thrombosis, Ultrasound scan
Clinical narrative: blood clot in my lung; This is a spontaneous report received from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), on unspecified date at single dose for COVID-19 immunization. The patient's medical history included he/she was not a smoker. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2, on unspecified date at single dose for COVID-19 immunization. It was reported that patient had been diagnosed with a blood clot in his/her lung shortly after receiving his/her second dose of the COVID vaccine. He/she was not sure if they would be interested in what was going on in his/her case, but patient's doctor said it would be helpful to notify them and that they may be interested in this diagnosis. He/she had his/her legs and many other areas checked out (Ulta sounds etc), but there was no sign of clotting anywhere except for his/her lung so far. He/she was not a smoker and he/she had never had surgery or any major procedures. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Pain, Tinnitus
Clinical narrative: tinnitus; Head numbness /facial/head numbness; pain; lymphnode hardening / swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Mar2021 at 11:00 (first dose , lot ER9810 ) and  on 06Apr2021 at 11:15 (second dose, lot ER8732), both intramuscular in left shoulder at single doses for covid-19 immunisation .  Patient medical history and concomitant medications were none. Family medical history included ascending crucial aneurysm- congenital , intermittent high blood pressure  especially when doctors, lawyers  or cops and COPD from smoking but quit 3 years ago (relatives were not specified).The patient experienced tinnitus and head numbness on 16Mar2021 at 15:00, both serious per disability; on an unknown date in 2021 pain and lymphnode hardening occurred. The events were described as follows: first dose side effects were awful. Tinnitus, facial/head numbness and swollen lymph nodes-painful. The outcome of the events was not reported. Patient will want to see Anti-Histamines might help  and didn't want to take them with shots  they may get side agitated (as) reported.No treatment given.Similar events were reported after second dose, however condition was less awful compare to first dose. Tinnitus was less acute in tone and volume, numbness only on right top back of head (on an unknown date in 2021). Lymph gland on left side tender on 06Apr2021 at 13:00  and painful. Outcome of the events was recovering. It was reported that doctor looked in but couldn't see inner ear. It was suggested to go to ENT; patient lost insurance  took the chance on 2nd dose because doctor  would and could not say if the 2nd would be a repeat of 1st (as rpeorted). Patient figured he/she'd just lose the mind to the sound and numbness since so much doctor could not say 2nd would be repeat of first (as reported).No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness
Clinical narrative: tinnitus; Head numbness /facial/head numbness; pain; lymphnode hardening / swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 16Mar2021 at 11:00 (first dose , lot ER9810 ) and  on 06Apr2021 at 11:15 (second dose, lot ER8732), both intramuscular in left shoulder at single doses for covid-19 immunisation .  Patient medical history and concomitant medications were none. Family medical history included ascending crucial aneurysm- congenital , intermittent high blood pressure  especially when doctors, lawyers  or cops and COPD from smoking but quit 3 years ago (relatives were not specified).The patient experienced tinnitus and head numbness on 16Mar2021 at 15:00, both serious per disability; on an unknown date in 2021 pain and lymphnode hardening occurred. The events were described as follows: first dose side effects were awful. Tinnitus, facial/head numbness and swollen lymph nodes-painful. The outcome of the events was not reported. Patient will want to see Anti-Histamines might help  and didn't want to take them with shots  they may get side agitated (as) reported.No treatment given.Similar events were reported after second dose, however condition was less awful compare to first dose. Tinnitus was less acute in tone and volume, numbness only on right top back of head (on an unknown date in 2021). Lymph gland on left side tender on 06Apr2021 at 13:00  and painful. Outcome of the events was recovering. It was reported that doctor looked in but couldn't see inner ear. It was suggested to go to ENT; patient lost insurance  took the chance on 2nd dose because doctor  would and could not say if the 2nd would be a repeat of 1st (as rpeorted). Patient figured he/she'd just lose the mind to the sound and numbness since so much doctor could not say 2nd would be repeat of first (as reported).No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Neoplasm malignant
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable pharmacist reported for a male patient an unspecified age received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had his first dose of COVID-19 vaccine on 08Feb2021. Since then, he had a medical diagnosis of cancer and he needed chemo treatment and now it's been over the 6-week window from his first dose. The pharmacist was inquiring if the patient can have the second dose of the vaccine. Outcome of the event was unknown.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Based on the information provided, the event "medical diagnosis of cancer" is likely to be an intercurrent event unrelated to the use of suspect product BNT162B2. This case will be reassessed should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood insulin, Cerebrovascular accident, Fall, Speech disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient's wife). A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6203), dose 2 via an unspecified route of administration on 19Feb2021 (at the age of 74years) as single dose for COVID-19 immunization. The patient received the first dose of BNT162B2 (lot number: EL9262) on 28Jan2021 (at the age of 74years) for Covid-19 immunization and stated no reactions. Medical history included high blood pressure and diabetes but are all currently under control and feeling some leg pain before the vaccine was administered. It was reported that in the past the doctors thought he experienced TIA (transient ischemic attack) but wasn't sure if that was accurate. Concomitant medications included lisinopril (LISINOPRIL), trazodone (TRAZODONE), insulin (INSULIN), bupropion hydrochloride (WELLBUTRIN), and prednisone (PREDNISONE); all taken for an unspecified indication, start and stop date were not reported. It was reported that on 19Feb2021 the patient received the 2nd dose of Pfizer Covid vaccine and stated he remember feeling some leg pain before the vaccine was administered earlier. On Sunday 21Feb2021, the reporter (patient's wife) began noticing that the patient was showing symptoms of a stroke. The patient's one leg was rapidly kicking, and his speech began to slur. The patient was then rushed to ER (emergency room) and hospitalized. At the hospital it was confirmed that the patient was having a stroke. The patient recovered and was doing rehab for his leg. Few weeks later, the patient had an accident in his home while getting up to go to the bathroom and fell. The patient was rushed to the Trauma center. The patient's wife was upset as she carried their vaccine cards to the trauma center to confirm to staff that the patient did not need another Covid vaccine shot and later found out that the patient was given a 3rd (Moderna Covid vaccine) at the trauma center. The patient stated that he does not think the vaccine was related but was upset that the trauma center did not listen to her to take the info with the complete vaccine card present to avoid 3rd shot from another brand. The patient's insulin levels are under control, but the reporter was concerned when the patient does not eat within a certain timeframe. The outcome of events stroke and speech disorder was recovered on an unspecified date; outcome of event fall was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection
Clinical narrative: taking antibiotics for a UTI; This is a spontaneous report from a contactable consumer (patient) via the . A female patient of an unspecified age received the first dose of bnt162b2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient was scheduled to get the second dose of the vaccine on 15Apr2021. However, the patient is taking antibiotics for a UTI. She's taking this medicine for 5 days. Patient wants to know if she can take the vaccine while taking the antibiotics. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Neutropenia
Clinical narrative: Neutropenia; This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received first dose of COVID vaccine she had neutropenia. She wanted to know if Pfizer was conducting a study on immunocompromised people. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Lymphadenopathy, Pain, Peripheral swelling, Thrombosis
Clinical narrative: Subsequently - a doctor discovered numerous blood clots in that leg; then a blood clot in one of her lungs; her left leg (she was inoculated on the left side) swelled up; it was painful; She is being treated but the lymphadenopathy has not subsided in her leg; she is now unable to walk without a cane; This is a spontaneous report from a contactable consumer.  A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number not reported) on an unspecified date in 2021 at single dose (inoculated on the left side) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received the vaccine few weeks ago, in 2021, and within 3 hours, she recounted her left leg (she was inoculated on the left side) swelled up dramatically it was painful. Subsequently a doctor discovered numerous blood clots in that leg, then a blood clot in one of her lungs. She is being treated but the lymphadenopathy has not subsided in her leg and she was now unable to walk without a cane. The outcome of lymphadenopathy and unable to walk without a cane events was not recovered; outcome of the other events was unknown.Reporter asked if there were reports of blood clots that have been validated as a result of the Pfizer shot. Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: big heart blood clot; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 21Mar2021 12:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation (Age at vaccination: 66 years). Medical history was reported as none. There were no concomitant medications. The patient experienced big heart blood clot on 23Mar2021 14:00. Therapeutic measures were taken as a result of big heart blood clot. Outcome of the event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Haemolytic anaemia, Headache, Jaundice, Nausea
Clinical narrative: Chills; headache; nausea; jaundice; Hemolysis/hemolytic anemia; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7583), administered in left arm, on 06Apr2021 at 13:00 (at the age of 33-years-old) at single dose for COVID-19 immunisation. Medical history included hereditary spherocytosis, allergies to sulfa drugs. Patient was not pregnant. No covid prior vaccination. Concomitant medications were not reported. No other vaccines were received in four weeks. The patient previously received the first dose of BNT162b2 (lot number: EN6208) on 14Mar2021 at 04:00 PM (at the age of 33-years-old) administered in left arm for COVID-19 immunization. The patient experienced chills, headache, nausea starting 14 hours after the 2nd dose, on 07Apr2021 at 03:00, and persistent on and off for 5 days. Hemolysis and jaundice started 2-3 days after the shot, in Apr2021, (patient had hemolytic anemia) and had continued to deteriorate 7 days post-vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included covid test post vaccination, on 11Apr2021, nasal swab (Abbot Rapid Molecular): negative. The patient was recovering from the events.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history of hereditary spherocytosis cannot be completely ruled out.  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: 33.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills; headache; nausea; jaundice; Hemolysis/hemolytic anemia; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7583), administered in left arm, on 06Apr2021 at 13:00 (at the age of 33-years-old) at single dose for COVID-19 immunisation. Medical history included hereditary spherocytosis, allergies to sulfa drugs. Patient was not pregnant. No covid prior vaccination. Concomitant medications were not reported. No other vaccines were received in four weeks. The patient previously received the first dose of BNT162b2 (lot number: EN6208) on 14Mar2021 at 04:00 PM (at the age of 33-years-old) administered in left arm for COVID-19 immunization. The patient experienced chills, headache, nausea starting 14 hours after the 2nd dose, on 07Apr2021 at 03:00, and persistent on and off for 5 days. Hemolysis and jaundice started 2-3 days after the shot, in Apr2021, (patient had hemolytic anemia) and had continued to deteriorate 7 days post-vaccine. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures, which included covid test post vaccination, on 11Apr2021, nasal swab (Abbot Rapid Molecular): negative. The patient was recovering from the events.; Sender's Comments: The reported events are assessed as possibly related to the suspect drug BNT162B2 based on strong temporal association, but possible contributory effects from patient's medical history of hereditary spherocytosis cannot be completely ruled out.  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: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Syncope, Throat tightness
Clinical narrative: nearly faint; Feeling of throat closure; rapid heartbeat; This is a spontaneous report from a non-contactable consumer (patient). A 32-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm right on an unspecified date (at the age of 32-years-old) as a single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history was reported as none. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced feeling of throat closure, rapid heartbeat and nearly faint. The patient did not received any treatment for the events. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Chest discomfort, Dyspnoea
Clinical narrative: Angioedema; chest tightness; SOB; This is a spontaneous report from a contactable nurse (patient). This nurse reported similar events for different doses. This is the second of two reports. A 56-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: ER8734) administered in right arm on 07Apr2021 at 18:00 (at the age of 56-years-old) at single dose for COVID-19 immunisation. Medical history included prior history of idiopathic angioedema, several other antibiotics allergies - rash, hornet and wasp sting allergies; no chronic health conditions. Patient was not pregnant. No COVID prior vaccination; no COVID tested post vaccination. Concomitant medication included diphenhydramine hydrochloride (BENADRYL) taken at 50 mg for 3 for 12 hours pre-dose; no other vaccine received in four weeks. The patient previously took ZITHROMAX and experienced allergies - anaphylactic; the patient received the first dose of BNT162b2 (lot number: EP7534) on 17Mar2021 at 06:00 pm (at the age of 56-years-old) administered in the right arm for COVID-19 immunisation and experienced angioedema. The patient experienced angioedema, chest tightness, shortness of breath (SOB); initial reactions started around 12:00 noon on 08Apr2021, slowly continued to get worse throughout the day. Had to go to emergency room (ER) that evening. Angioedema reoccurred the following night and again on 10Apr2021. Another trip to ER on 10Apr2021 due to angioedema, chest tightness and SOB. The events were treatment with BENADRYL, SOLUMEDROL IV, PEPCID IV, nebulizer. The patient had recovered from the events in Apr2021.; Sender's Comments: Based on a positive temporal association, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported Angioedema, Chest Tightness and shortness of Breath. Consider also possible contributory effects from patient's medical history 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-2021330573 same patient, vaccine different dose
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Loss of consciousness, Presyncope, Seizure
Clinical narrative: lost consciousness for a brief period; doing something that looked like a small seizure; got tunnel vision; vasovagal response; feel faint, dizzy, and lightheaded; feel very weak; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EP7524. Medical history included periodontal surgery. Concomitant medications included spironolactone, adapalene, benzoyl peroxide (Epiduo Forte), azelaic acid (FINACEA), aciclovir, hydrocortisone (Xerese). The patient believed she experienced some kind of vasovagal response. On 13Apr2021 at 08:00, the patient got up from sleeping and went to the restroom, where she started to feel faint, dizzy, and lightheaded. The patient sat down and got tunnel vision and she started to feel very weak but regained her vision after sitting. The patient was helped back to bedroom but had to stop and sit in the floor where patient lost consciousness for a brief period, less than 10 seconds. Her partner said patient was doing something that looked like a small seizure. The patient had had this response before many times when giving blood and even after her periodontal surgery. The patient was recovering from the events.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Tunnel vision
Clinical narrative: lost consciousness for a brief period; doing something that looked like a small seizure; got tunnel vision; vasovagal response; feel faint, dizzy, and lightheaded; feel very weak; This is a spontaneous report from a contactable consumer (patient).  A 30-year-old female consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 12Apr2021 at 14:30 at single dose in left arm for COVID-19 immunisation at the age of 30-year-old. Lot number was EP7524. Medical history included periodontal surgery. Concomitant medications included spironolactone, adapalene, benzoyl peroxide (Epiduo Forte), azelaic acid (FINACEA), aciclovir, hydrocortisone (Xerese). The patient believed she experienced some kind of vasovagal response. On 13Apr2021 at 08:00, the patient got up from sleeping and went to the restroom, where she started to feel faint, dizzy, and lightheaded. The patient sat down and got tunnel vision and she started to feel very weak but regained her vision after sitting. The patient was helped back to bedroom but had to stop and sit in the floor where patient lost consciousness for a brief period, less than 10 seconds. Her partner said patient was doing something that looked like a small seizure. The patient had had this response before many times when giving blood and even after her periodontal surgery. The patient was recovering from the events.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Superficial vein prominence, Thrombosis, Ultrasound scan
Clinical narrative: 15cm Blood clot in left leg - lower calf.; Superficial vein prominence; This is a spontaneous report from a contactable consumer (patient herself).  This 50-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ER8732), via an unknown route in the left arm, on 27Mar2021 at 14:45 (at the age of 50-year-old) at single dose for COVID-19 immunisation, administered at hospital. Relevant medical history included Factor V Leiden and varicose veins. The patient did not have allergies. The patient did not have COVID-19 before vaccination. Relevant concomitant medications included acetylsalicylic acid (ASPIRIN), levothyroxine sodium and Women's multivitamin (unspecified). On 07Apr2021, the patient presented 15 cm blood clot in the left leg-lower calf and superficial vein prominence. The events required a physician office visit. An ultrasound was done but results were not provided. Therapeutic measures taken as result of the events included enoxaparin sodium (LOVENOX) injections for 14 days. Post-vaccination COVID test was not performed. The patient was recovering from the events.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Cheilitis, Condition aggravated, Fatigue, Headache
Clinical narrative: Flared- Autoimmune Disorder; Flared- Autoimmune Disorder; Extreme Fatigue; Fever; Headache; Body Aches; Muscle Tremors; Rash on Tongue and Lips; Rash on Tongue and Lips; This is a spontaneous report from a contactable consumer. This 49-year-old male consumer (patient) reported for himself that he received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number was not reported) via an unspecified route of administration in right arm on 01Apr2021 12:00PM (at the age of 49-year-old) at single dose for COVID-19 immunisation. Relevant medical history included known allergies to mushrooms, latex and adhesive; mystenias Gravis (preliminary diagnosis) and autoimmune disorder (still in research). The patient had not COVID prior to vaccination. Concomitant medications were not reported. On 01Apr2021 12:00PM the patient experienced extreme fatigue, fever, headache, body aches, muscle tremors, rash on tongue and lips flared- autoimmune disorder (diagnosis still pending research - as reported) symptoms lasted for more than 4 days. The patient was tested for COVID post vaccination - no results reported. The events were resolving at the time of report.  Information on the lot/batch number has been requested.