chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Sleep deficit
Clinical narrative: covid test result=Positive; Covid test date=25Aug2021,covid test result=Positive; body aches.; fever, HA/fever last night; Coughing; Feels like " hit by truck"; Felt like she was super tired; Went into work because she thought she just didn't get enough sleep; This is a spontaneous report from a non-contactable nurse. A 62-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3248), dose 1 via an Intramuscular route of administration, on 28Jan2021 (age at vaccination: 61), in left arm as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 25Aug2021 the patient experienced covid test result as positive, body aches, fever, HA/fever last night, Coughing, feels like " hit by truck", felt like she was super tired, went into work because she thought she just didn't get enough sleep. Covid prior vaccination reported as unknown and post vaccination reported as yes. On 25Aug2021 the patient underwent lab test and procedure included SARS-CoV-2 test: positive. Treatment received reported as unknown. The patient had a physician office visit. The outcome of all events was recovering.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the event COVID_19, Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paralysis, Hypoaesthesia, Limb discomfort, Paraesthesia
Clinical narrative: the left side of my face felt numb like after i've been to a dentist but not severe enough I couldnt drink or had droopy features; the left side of my face felt numb like after i've been to a dentist but not severe enough I couldnt drink or had droopy features; minutes after shot my left foot fell asleep (Tingley); my left arm and hand fell asleep; This is a spontaneous report from a contactable other HCP (Patient). A 45-year-old male patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 01Aug2021 11:00 (Batch/Lot Number: FA7484) as DOSE 1, SINGLE (at the age of 45-year-old) for COVID-19 immunisation. The patient did not have any medical history. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included doxycycline (received within 2 weeks of vaccination) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient stated after minutes after shot his left foot fell asleep (Tingley), about 1 hour later my left arm and hand fell asleep. Also stated the left side of his face felt numb like after I've been to a dentist but not severe enough I couldn't drink or had droopy features on 01Aug2021 at 11:30. These symptoms lasted 3 days. Since the vaccination, the patient not tested for COVID-19. No treatment received for the events. The outcome of the events reported as recovered with sequelae on 04Aug2021.  No follow-up attempts needed. No further information expected.; Sender's Comments: A causal association between BNT162B2 and the reported event Facial paralysis cannot be excluded based on a compatible temporal relation. 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: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Joint stiffness
Clinical narrative: Joint stiffness and pain; Joint stiffness and pain; reactive inflammatory arthritis from the vaccine; This is a spontaneous report from a contactable consumer. An 80-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was unknown) via an unspecified route of administration on 12Feb2021 (at the age of 80-year-old) as single dose for COVID-19 immunization. Patient's medical history including any illness at time of vaccination was none. Family medical history relevant to AE was unknown. There were no concomitant medications. The patient had no prior vaccinations (within 4 weeks) and had no AE(s) following prior vaccinations. No additional vaccines administered on same date of the Pfizer suspect. In Feb2021, the patient experienced joint stiffness and pain and reactive inflammatory arthritis from the vaccine. Joint stiffness and pain started a little after her first vaccine and it got a lot worse after her second dose. Caller stated the patients first dose was in February and it started shortly after that and then it got worse after her second dose. The patient had no relevant tests. Outcome of the events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Computerised tomogram, Electrocardiogram, Heart rate
Clinical narrative: Fainted; high heart rate; low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0196), via an unspecified route of administration, in right arm on 06Aug2021 12:45 (at the age of 14-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 and allergy to amoxicillin. Concomitant medication included fish oil (OMEGA 3) and multivitamins. The patient experienced high heart rate, fainted and had low blood pressure on 07Aug2021 11:45. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures taken as a result of fainted, high heart rate and low blood pressure included fluids. The patient underwent lab tests and procedures which included x rays, blood work, EKG and CT scan in Aug2021. The outcome of the events was recovered in Aug2021.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Hypotension, Syncope, X-ray
Clinical narrative: Fainted; high heart rate; low blood pressure; This is a spontaneous report from a contactable consumer (patient). A 14-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EW0196), via an unspecified route of administration, in right arm on 06Aug2021 12:45 (at the age of 14-years-old) as dose 1, single for COVID-19 immunization. Medical history included COVID-19 and allergy to amoxicillin. Concomitant medication included fish oil (OMEGA 3) and multivitamins. The patient experienced high heart rate, fainted and had low blood pressure on 07Aug2021 11:45. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures taken as a result of fainted, high heart rate and low blood pressure included fluids. The patient underwent lab tests and procedures which included x rays, blood work, EKG and CT scan in Aug2021. The outcome of the events was recovered in Aug2021.
Sex: M
Vaccine: COVID19
Symptoms: Diabetes mellitus
Clinical narrative: The caller did not clarify if the caller was diagnosed with diabetes before or after receiving the vaccine; This is a spontaneous report. A contactable consumer (patient) reported for himself. A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Apr2021 as dose number unknown, single for COVID-19 immunization. The patient medical history included diabetes mellitus (The patient mentioned that he also has diabetes). Concomitant medication was not reported. Other Products, patient history and investigation assessment: not provided. The patient did not clarify if the patient was diagnosed with diabetes before or after receiving the vaccine in 2021. Reporter seriousness of the case was unspecified. The outcome of the event was unknown.  The lot number was not provided. Information on lot number has been requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chest pain, Echocardiogram, Electrocardiogram, Electrocardiogram ambulatory
Clinical narrative: About 2.5 weeks after my second vaccine, I started to have chest pains; returned with intense palpitations; The palpitations and pain decreased, I had a relatively normal set of data (2% of the time with PVCs)/recently the chest pains returned with intense palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 44-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number FA6780, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 10Jul2021 15:00 (at a age of 44-year-old) as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EW0181, Expiry: Unknown) via an unspecified route of administration, administered in Left arm on 19Jun2021 at 02:00 PM as dose 1 single, for COVID-19 immunisation. The patient medical history included bee sting allergy, Known allergies was with sulfa from an unknown date and unknown if ongoing. The patient was not positive for COVID-19 prior to vaccination and had been tested post vaccination. Patient did not receive any other vaccines within 4 weeks and other medications 2 weeks include women's daily multi vitamin prior to the COVID vaccine. It was reported that, about 2.5 weeks after her second vaccine, she started to have chest pains. After a week of intermittent chest pain, the pain was concentrated on her left side and she went to the ER where an EKG was done and blood work was done. She just moved when the chest pains were starting and since she didn't have her Holter data, they asked her to do another Holter monitor. In the meantime, the palpitations and pain decreased, she had a relatively normal set of data (2% of the time with PVCs) and felt back to normal for about 2 weeks. Then, recently the chest pains returned with intense palpitations. Patient just had an echo and an MRI done and awaiting results. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, electrocardiogram ambulatory: 15% of the time was with PVCs, after second dose she had a relatively normal set of data (2% of the time with PVCs), magnetic resonance imaging: unknown results on Aug2021, SARs-cov-2 test: negative on 01Aug2021 Nasal Swab, sars-cov-2 test: negative on 07Aug2021 Nasal Swab , sars-cov-2 test: negative on 28Jul2021 Other. No treatment was taken for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Palpitations, SARS-CoV-2 test
Clinical narrative: About 2.5 weeks after my second vaccine, I started to have chest pains; returned with intense palpitations; The palpitations and pain decreased, I had a relatively normal set of data (2% of the time with PVCs)/recently the chest pains returned with intense palpitations; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 44-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot number FA6780, Expiry date: Unknown) via an unspecified route of administration, administered in Arm Left on 10Jul2021 15:00 (at a age of 44-year-old) as dose 2, single for COVID-19 immunisation. The patient previously took bnt162b2 (BNT162B2, Lot number: EW0181, Expiry: Unknown) via an unspecified route of administration, administered in Left arm on 19Jun2021 at 02:00 PM as dose 1 single, for COVID-19 immunisation. The patient medical history included bee sting allergy, Known allergies was with sulfa from an unknown date and unknown if ongoing. The patient was not positive for COVID-19 prior to vaccination and had been tested post vaccination. Patient did not receive any other vaccines within 4 weeks and other medications 2 weeks include women's daily multi vitamin prior to the COVID vaccine. It was reported that, about 2.5 weeks after her second vaccine, she started to have chest pains. After a week of intermittent chest pain, the pain was concentrated on her left side and she went to the ER where an EKG was done and blood work was done. She just moved when the chest pains were starting and since she didn't have her Holter data, they asked her to do another Holter monitor. In the meantime, the palpitations and pain decreased, she had a relatively normal set of data (2% of the time with PVCs) and felt back to normal for about 2 weeks. Then, recently the chest pains returned with intense palpitations. Patient just had an echo and an MRI done and awaiting results. On an unspecified date in 2021 the patient underwent lab tests and procedures which included blood test: unknown results, echocardiogram: unknown results, electrocardiogram: unknown results, electrocardiogram ambulatory: 15% of the time was with PVCs, after second dose she had a relatively normal set of data (2% of the time with PVCs), magnetic resonance imaging: unknown results on Aug2021, SARs-cov-2 test: negative on 01Aug2021 Nasal Swab, sars-cov-2 test: negative on 07Aug2021 Nasal Swab , sars-cov-2 test: negative on 28Jul2021 Other. No treatment was taken for the events. The outcome of the events were not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Pyrexia
Clinical narrative: High fever; chest pain; back pain; This is a spontaneous report from a contactable consumer. A 35-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: FC3182 and expiration date was not reported), dose 2 via intramuscular route of administration in left arm on 25Aug2021 at 15:00 (age at vaccination 35-years-old) as single dose for COVID-19 immunization. The patient medical history included Anorexia. The patient's concomitant medications were not reported. The historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: FA7484 and expiration dates were not reported), dose 1 via an intramuscular route of administration in left arm on 04Aug2021 at 15:00 pm as single dose for COVID-19 immunization. No other vaccine in four weeks and no other medications in two weeks. On 26Aug2021 at 02:30 PM the patient experienced high fever, chest pain and back pain. The Adverse event resulted in Emergency room/department or urgent care. The patient treated with the Tylenol for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as withheld. The outcome of the events was recovering.  Follow-Up (07Sep2021): Follow-up attempts are completed. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Food allergy, Urticaria
Clinical narrative: I started to break out in the hives and I still do every single day; I have been getting the severe allergic reaction with the food that I have been okay with eating; When probed for the event is worsened, improved or persisting, Consumer stated, " Worse, but it's kind of goes up and down, like sometimes it's better and sometimes it's bad."; This is a spontaneous report from a contactable consumer. This contactable 18-year-old female consumer (patient) reported that: An 18-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0182), via an unspecified route of administration, administered in Arm Right on 11May2021 (at the age of 18-year-old) as single dose for covid-19 immunisation. Patient medical history reported as none. Medical condition related to adverse event reported as none. Family history related to adverse event It's kind of unknown because I am adopted. There were no concomitant medications. The patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0171), via an unspecified route of administration, administered in Left arm on 20Apr2021 (at the age of 18-year-old) as single dose for covid-19 immunisation. Patient was not received any other vaccine four weeks prior vaccination. Patient reported I was told to call if I had like lingering side effect of the vaccine (Covid-19 Vaccine). I got my first dose on 20Apr and second on 11May. Two weeks after on unspecified date in May2021, my second dose I started to break out in the hives and I still do every single day and I have been getting the severe allergic reaction with the food that I have been okay with eating. Patient reported when probed for the event is worsened, improved or persisting, patient stated, it was worse, but it's kind of goes up and down, like sometimes it's better and sometimes it's bad. Still experiencing the problem. Therapeutic measures were taken as a result of the events with Prednisone and Hydroxyzine. The outcome of the events was reported as not recovered.   Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Gingival bleeding, Gingival swelling, Rash pruritic, Skin discolouration
Clinical narrative: After 1st shot I had heart pain; After receiving my first Pfizer covid shot. I developed three very distinct mosquito like bites on my left arm. They were not going away, were very scratchy and developed a black dot within them; After receiving my first Pfizer covid shot. I developed three very distinct mosquito like bites on my left arm. They were not going away, were very scratchy and developed a black dot within them; Concurrently my gums swelled and were leaking blood/puss for unknown reasons; Concurrently my gums swelled and were leaking blood/puss for unknown reasons; This is a spontaneous report from a contactable consumer (patient). A 45-years-old female non-pregnant patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: FA6780), via an unspecified route of administration, administered in left arm on 19Jul2021 at 05:00 (at the age of 45-years-old) as single dose for COVID-19 immunisation. The patient's medical history included COVID-19 from an unknown date and unknown if ongoing. The patient had no known allergies. There were no concomitant medications. The patient after receiving first Pfizer COVID shot on an unspecified date developed heart pain, three very distinct mosquito like bites on left arm. They were not going away, were very scratchy and developed a black dot within them and concurrently the patient's gums swelled and were leaking blood/puss for unknown reasons. The patient had no other vaccine in four weeks; no other medications in two weeks. The patient received no treatment for the adverse events. The patient had COVID prior to vaccination and had not tested post vaccination. The clinical outcome for the events was unknown.  Follow-up (27Aug2021): This is a follow-up spontaneous report received in response to the mail trail sent regarding the confirmation below mentioned query. The response included:  Response: Dear Colleagues, please find translated form.  Follow-Up (03Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Decreased appetite, Illness, Influenza like illness
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional. A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On unspecified date 2021, The patient experienced, after the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and was due to get his second shot today but he had been "deathly ill", so bad that it was like flu like symptoms, she checked his temp every day, he had no energy/fatigue, kept a bucket next to him to throw up in, he was eating fine until 3 days ago, his breathing sounds was good. His temperature was 98. but yesterday it went to 100.1, she was not sure if he were dehydrated or not. She wanted to know what to do for him and if he should get the second shot or not today. These symptoms started one and a half weeks after getting the vaccine. My fiance had his shot. Three weeks ago and he started developing the flu like symptoms and that was a like symptoms because I was taking his temperature every hour and he was stayed at 98 all week so, I knew. It's side effect from the shot. I mean throwing up, fatigue but he also have no energy at all. It's hard for him to get up and go to bathroom. I am not finish. I know that, There are some side effects, That few people get but yesterday. He often loss his appetite and he losses appetite from three days and he haven't appetite. All week during all this because, I was eating three or four times a day and he was not eating and he was drinking lot of water and all sudden, Had already started again and now his temperature, It went from 98 to 100.1 and now he is due for his 2nd shot today and I am scared to taking with. I don't know, What to do about it. He doesn't have a doctor. He doesn't have a servant. I don't know, What to do." The patient underwent lab tests and procedures which included body temperature: 98 on 2021, body temperature: 100.1 on 2021. The outcome of events was unknown. Follow up attempt completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional. A 47-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on 2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On unspecified date 2021, The patient experienced, after the first dose of the Pfizer COVID-19 vaccine 3 weeks ago and was due to get his second shot today but he had been "deathly ill", so bad that it was like flu like symptoms, she checked his temp every day, he had no energy/fatigue, kept a bucket next to him to throw up in, he was eating fine until 3 days ago, his breathing sounds was good. His temperature was 98. but yesterday it went to 100.1, she was not sure if he were dehydrated or not. She wanted to know what to do for him and if he should get the second shot or not today. These symptoms started one and a half weeks after getting the vaccine. My fiance had his shot. Three weeks ago and he started developing the flu like symptoms and that was a like symptoms because I was taking his temperature every hour and he was stayed at 98 all week so, I knew. It's side effect from the shot. I mean throwing up, fatigue but he also have no energy at all. It's hard for him to get up and go to bathroom. I am not finish. I know that, There are some side effects, That few people get but yesterday. He often loss his appetite and he losses appetite from three days and he haven't appetite. All week during all this because, I was eating three or four times a day and he was not eating and he was drinking lot of water and all sudden, Had already started again and now his temperature, It went from 98 to 100.1 and now he is due for his 2nd shot today and I am scared to taking with. I don't know, What to do about it. He doesn't have a doctor. He doesn't have a servant. I don't know, What to do." The patient underwent lab tests and procedures which included body temperature: 98 on 2021, body temperature: 100.1 on 2021. The outcome of events was unknown. Follow up attempt completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Heavy menstrual bleeding, Menstrual disorder, Oligomenorrhoea
Clinical narrative: I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; I had a 15 day heavy menstrual cycle- which is very abnormal for me. Heavy bleeding and very painful.; This is a spontaneous report from a contactable other hcp. A 31-years-old non pregnancy female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EW0179) dose number unknown via an unspecified route of administration on Aug2021 (age at vaccination 31years old, Pregnant at Time of Vaccination: No) as single dose for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks and Other medications in 2 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Since the vaccination, the patient had not been tested positive for COVID-19. The patient experienced I had a 15-day heavy menstrual cycle- which is very abnormal for me. heavy bleeding and very painful on unspecified date in Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Cardiac stress test, Dizziness, Dyspnoea, Echocardiogram
Clinical narrative: blood pressure was 200/92 constant; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; short of breath; He also had abnormal EKG; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PFR; EM9810 via an unspecified route, administered in left arm on 09Feb2021 at 11:30 (31-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications within two weeks of vaccination. Vaccination facility type was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with Covid. On 09Feb2021 at 11:30, immediately following the 1st vaccine of Pfizer, he started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, his heartrate was in the constant 140s and his blood pressure was 200/92, constant. Every day he was very lightheaded, dizzy and short of breath. He also had abnormal EKG. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 200/92, stress test: unknown result, Echocardiogram: abnormal on an unknow date in 2021. Post vaccination the patient was not tested for Covid. Treatment medication such as Metoprolol was taken as result of events. The outcome of the events was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram abnormal, Heart rate, Heart rate increased, Hypertension, Palpitations
Clinical narrative: blood pressure was 200/92 constant; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; short of breath; He also had abnormal EKG; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PFR; EM9810 via an unspecified route, administered in left arm on 09Feb2021 at 11:30 (31-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications within two weeks of vaccination. Vaccination facility type was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with Covid. On 09Feb2021 at 11:30, immediately following the 1st vaccine of Pfizer, he started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, his heartrate was in the constant 140s and his blood pressure was 200/92, constant. Every day he was very lightheaded, dizzy and short of breath. He also had abnormal EKG. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 200/92, stress test: unknown result, Echocardiogram: abnormal on an unknow date in 2021. Post vaccination the patient was not tested for Covid. Treatment medication such as Metoprolol was taken as result of events. The outcome of the events was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Echocardiogram, Electrocardiogram, Heart rate increased, Hypertension
Clinical narrative: blood pressure was 200/92 constant; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; short of breath; He also had abnormal EKG; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PFR; EM9810 via an unspecified route, administered in left arm on 09Feb2021 at 11:30 (31-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications within two weeks of vaccination. Vaccination facility type was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with Covid. On 09Feb2021 at 11:30, immediately following the 1st vaccine of Pfizer, he started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, his heartrate was in the constant 140s and his blood pressure was 200/92, constant. Every day he was very lightheaded, dizzy and short of breath. He also had abnormal EKG. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 200/92, stress test: unknown result, Echocardiogram: abnormal on an unknow date in 2021. Post vaccination the patient was not tested for Covid. Treatment medication such as Metoprolol was taken as result of events. The outcome of the events was unknown.
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Immediate post-injection reaction, Palpitations
Clinical narrative: blood pressure was 200/92 constant; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; Immediately following the 1st vaccine of Pfizer, I started receiving heart palpitations and extreme dizziness/lightheadedness.  For 3 weeks following the vaccine, my heartrate was in the constant 140s; short of breath; He also had abnormal EKG; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: PFR; EM9810 via an unspecified route, administered in left arm on 09Feb2021 at 11:30 (31-year-old at vaccination) as a dose 1, single for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications within two weeks of vaccination. Vaccination facility type was reported as Hospital. The patient had not received any other vaccine in four weeks prior to vaccination. Prior to vaccination the patient was not diagnosed with Covid. On 09Feb2021 at 11:30, immediately following the 1st vaccine of Pfizer, he started receiving heart palpitations and extreme dizziness/lightheadedness. For 3 weeks following the vaccine, his heartrate was in the constant 140s and his blood pressure was 200/92, constant. Every day he was very lightheaded, dizzy and short of breath. He also had abnormal EKG. These adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood pressure measurement: 200/92, stress test: unknown result, Echocardiogram: abnormal on an unknow date in 2021. Post vaccination the patient was not tested for Covid. Treatment medication such as Metoprolol was taken as result of events. The outcome of the events was unknown.
Age: 39.0
Sex: F
Vaccine: PNC13
Symptoms: Incorrect route of product administration, Injection site pain
Clinical narrative: Administered subcutaneously; Pain in injection site; This is a spontaneous report from a contactable pharmacist from a Pfizer-sponsored program.   A 39-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), subcutaneously on 26Aug2021 (Morning with unknown time) at vaccination age 39 years old (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunization. Vaccination Facility Type Doctor's office. The patient's medical history included asplenic and concomitant medications was not reported. The patient experienced administered subcutaneously as opposed to IM (intramuscularly) (medically significant) on 26Aug2021 with outcome of unknown, pain in injection site (medically significant), having a lot of pain in the arm which patient believed was because of the placement being incorrect in Aug2021 with outcome of not recovered. The events were not requiring emergency room, physician office and hospitalization.  The lot number for pneumococcal 13-val conj vac (dipht crm197 protein) was not provided and will be requested during follow up.; Sender's Comments: A contributory role of PREVNAR 13 with incorrectly subcutaneous administration triggering the onset of vaccination site pain cannot be fully excluded.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: sore throat; stomach is bothering him; This is a spontaneous report from a Pfizer-sponsored program. A contactable Consumer reported for a male Patient (Reporter son)  A 13-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient experienced sore throat and stomach is bothering him on an unspecified date. The reporter considered the events as non-serious. The clinical course reported as follows Consumer said her 13-year-old son already received the 1st dose and was supposed to get the 2nd dose today. However, he was feeling a little bit under the weather. He has sore throat, and his stomach was bothering him. Consumer would like to know if he can push with getting the 2nd dose next week, which would be 4 weeks after his 1st dose, and if it would still work. Consumer said she is not sure if her son was exposed to someone who has Covid. For this, she will have him tested. She wants to know if she should postpone his 2nd dose until he is feeling well and has tested negative for Covid. The outcome of events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Patient tested positive for COVID-19 after completing full vaccination series.; Patient tested positive for COVID-19 after completing full vaccination series.; This is a spontaneous report from a non-contactable other hcp. A 53-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/lot number: EN5318) via an unspecified route of administration on 29Jan2021 (age at vaccination 53-years-old) as single dose, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN5318) via an unspecified route of administration on 19Feb2021 (age at vaccination 53years old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 26Aug2021, the patient experienced patient tested positive for covid-19 after completing full vaccination series. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 26Aug2021. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on information in the case, a possible causal association between the event Covid 19 and the suspect drug BNT162B2 cannot be excluded.
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 a non-contactable consumer. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported Expiry date: unknown), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. Covid prior vaccination was unknown. Covid was tested positive post vaccination. The patient reported that they both later tested positive for covid at around the same time, coughing, sneezing on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101120179 Same reporter/drug/event for different patients.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: she has an infection employee; This is a spontaneous report from a contactable other HCP (director of patient services) reported for a 58-year-old female patient. A 58-year-old female patient received first dose of bnt162b2 (COMIRNATY, Solution for injection, Batch/lot number: EW0196, Expiry date: unknown), via an intramuscular route unknown site on 29Jul2021 (age at vaccination: 58-year-old), 0.3 ml as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced infection. The patient was scheduled to receive second dose on 09Sep2021 (over 4 weeks after the first dose). The clinical outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received the first dose of the Pfizer covid vaccine on Aug 9 and she was diagnosed with covid on august 15; This is a spontaneous report from a contactable consumer (patient) reported for herself. A female patient of an unspecified age 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 on 09Aug2021 (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she received the first dose of the Pfizer COVID vaccine on 09Aug2021 and she was diagnosed with COVID on 15Aug2021. The patient underwent lab test which included COVID-19 test (Sars-cov-2 test): positive on 15Aug2021. The patient wanted to know when she will be eligible to get the second dose of the Pfizer COVID vaccine. Her doctor told her not to take the second dose and she did not need it. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: on 12Aug2021 she had first symptoms of the Covid19 virus, and on 17Aug2021 she was tested positive with the virus; on 12Aug2021 she had first symptoms of the Covid19 virus, and on 17Aug2021 she was tested positive with the virus; This is a spontaneous report from a contactable consumer(patient). A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration, in Right Arm on 30Jul2021 (at the age of 69-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 12Aug2021, the patient had experienced first symptoms of the covid19 virus, and on 17Aug2021 she was tested positive with the virus. She added that she was feeling better, and she wanted to know how to proceed with the 2nd dose. The events does not require a visit to emergency room and physician office. The patient underwent lab tests and procedures which included sars-cov-2 test positive: positive on 17Aug2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Formication, Swollen tongue
Clinical narrative: Start feeling like bugs crawling all over; About 4 hrs after shot tongue swelled up to fill inside her mouth; This is a spontaneous report from a non-contactable consumer (patient).   A 45-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, in the right arm, on 09Aug2021 at 02.15 PM, at single dose, for COVID-19 immunisation. The patient had not received any other vaccines within 4 weeks prior to the BNT162B2 vaccine. Relevant medical history included allergy from an unspecified date. The patient had not experienced Covid-19 prior vaccination. Concomitant medications were unknown. On 09Aug2021, at 04:00 PM, about 2 hrs after the vaccination, the patient experienced crawling sensation of skin described as "start feeling like bugs crawling all over". On 09Aug2021, about 4 hrs after the shot, tongue swelled up to fill inside her mouth. The patient was treated with Benadryl and 1hr or so later it started going down. The patient recovered from the adverse events on an unspecified date. Post the vaccination, the patient has not been tested for COVID-19.  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, SARS-CoV-2 test
Clinical narrative: Son received first dose 08Aug2021, tested positive 19Aug2021; This is a spontaneous report from a contactable consumer (Patient). An unspecified age male patient received received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: not provided), via an unspecified route of administration on 08Aug2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not provided. On 19Aug2021, the patient tested positive. Recovered no symptoms gone through isolation, even though antibodies don't make sense why.-  Declined to complete a report at this time. Unable to obtain further details. Provided caller with phone number (withheld), and the hours of operation prior to the transfer. Warm transfer from agent (withheld). The outcome of the event was recovered on an unknown date Aug2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.