chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Weight, X-ray
Clinical narrative: tightness on the chest; chest was hurting and felt like it has been compressed; congested; body aches/ his body is still aching/ body was aching/ achy; headaches; fever/ he has a temperature at 100; tired; felt weak; feeling kind of hot and achy; This is a spontaneous report from a contactable consumer (patient). A 46-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL9261, expiry date unknown) via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient had no medical history and no known allergies. There were no concomitant medications. The patient did not receive medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient had not been tested for COVID-19. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 29Dec2020, 11:00AM at a single dose on the left arm for COVID-19 immunization. The patient reported he is probably 160 pounds, 5ft 6 inches; he received the second dose of the COVID-19 vaccine on 20Jan2021, while being due for it on 19Jan2021. He explained having body aches, headaches, fever, tired, and felt weak the following morning (21Jan2021, 04:30 AM) and therefore went to the ER. He had blood works and an X-ray done on 21Jan2021 (results unknown) and they said he had no COVID. Today, 22Jan2021, he has a temperature at 100, his body is still aching, the headaches are there along with a tightness on the chest that concerns him. He also described it as his chest was hurting and felt like it has been compressed. Patient asked what to do. He then mentioned that the nearby urgent care had refused to take him because the vaccine is still 'under investigation' and the ER is far away. Patient also reported that he was feeling kind of hot and achy, body was aching on 21Jan2021.Today, 22Jan2021, he was still the same. He got a fever, was congested, and his body is aching. Patient did not received treatment for the events. Outcome of the events 'body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, felt weak, 'feeling kind of hot and achy,' and congested was not recovered. Outcome of the other events was unknown. The events body aches/ his body is still aching/ body was aching/ achy,' headaches, 'fever/ he has a temperature at 100,' tired, and felt weak required Emergency room visit and were reported as medically significant.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Appendicectomy, Appendicitis, Laparoscopic surgery, SARS-CoV-2 test negative
Clinical narrative: Acute appendicitis; This is a spontaneous report from a contactable physician reporting for herself. A 31-year-old female patient received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EK4176), intramuscular in the left arm, on 16Jan2021 at 18:30, at single dose, for COVID-19 immunisation. Medical history included iron deficiency anaemia, migraine and drug allergy to amoxicillin. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medications included multivitamin and ferrous sulfate (unknown manufacturer). Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech, lot# EH9899), on 26Dec2020 at 04:15 PM, intramuscular in left arm for COVID-19 immunisation. The patient experienced acute appendicitis on 20Jan2021 at 09:00 with outcome of recovering. The patient went to the emergency room and was hospitalized due to the event in Jan2021 for 1 day. Therapeutic measures were taken as a result of the event and included laparoscopic appendectomy. The patient underwent lab tests and procedures which included COVID-19 PCR test (nasal swab): negative on 20Jan2021.; Sender's Comments: Given the nature of the medical condition and the overall clinical picture, the event appendicitis is most likely an intercurrent medical condition and is assessed as unrelated to bnt162b2. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: high fever of 101.8; body aches; headache; rigors/chills; shaking; increased pain at injection site; one instance of vomiting; This is a spontaneous report from a contactable other health professional (patient).  A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: El3302, via an unspecified route of administration on 20Jan2021 02:00 at a SINGLE DOSE for covid-19 immunization.  Medical history included allergies to penicillin and cephalosporin. Patient received her first dose of BNT162B2 on 30Dec2020 at (12:00) (lot number: ELO140), (in the right arm) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported.  The patient developed a high fever of 101.8 (unit not provided), chills, body aches, headache, rigors, shaking, increased pain at injection site, and one instance of vomiting starting approximately 6 hours after her second dose (for clarification) of the vaccine (20Jan2021, 20:00). the outcome of event was reported as 'recovering'. the patient did not receive any treatment due to the events. The events were considered as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vomiting
Clinical narrative: high fever of 101.8; body aches; headache; rigors/chills; shaking; increased pain at injection site; one instance of vomiting; This is a spontaneous report from a contactable other health professional (patient).  A 30-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: El3302, via an unspecified route of administration on 20Jan2021 02:00 at a SINGLE DOSE for covid-19 immunization.  Medical history included allergies to penicillin and cephalosporin. Patient received her first dose of BNT162B2 on 30Dec2020 at (12:00) (lot number: ELO140), (in the right arm) for COVID-19 immunization. Patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. The patient's concomitant medications were not reported.  The patient developed a high fever of 101.8 (unit not provided), chills, body aches, headache, rigors, shaking, increased pain at injection site, and one instance of vomiting starting approximately 6 hours after her second dose (for clarification) of the vaccine (20Jan2021, 20:00). the outcome of event was reported as 'recovering'. the patient did not receive any treatment due to the events. The events were considered as non-serious by the reporter.  No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Back disorder
Clinical narrative: Back problems; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 20Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient's wife and the patient both had their shot two days ago (20Jan2021) and patient had back problems and the doctor wanted him to get a cortisone shot. The reporter was asking if it can interfere with the COVID shot. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Fatigue, Headache, Myalgia
Clinical narrative: Weak; Fatigued; Fever; Muscle Aches; Couldn't Taste; Pounding Headache; This is a spontaneous report from a non-contactable consumer (reporting for a friend). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes 1st dose of bnt162b2 on an unspecified date for COVID-19 immunization. The reporter's friend (who is a doctor) could not leave bed for one whole day after the 2nd shot and felt weak, fatigued, fever, muscle aches, could not taste and pounding headache on 14Jan2021. The patient did not receive treatment for the events. Prior to vaccination the patient has no COVID. The outcome of the events was recovered on Jan2021.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Weak; Fatigued; Fever; Muscle Aches; Couldn't Taste; Pounding Headache; This is a spontaneous report from a non-contactable consumer (reporting for a friend). A 42-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine includes 1st dose of bnt162b2 on an unspecified date for COVID-19 immunization. The reporter's friend (who is a doctor) could not leave bed for one whole day after the 2nd shot and felt weak, fatigued, fever, muscle aches, could not taste and pounding headache on 14Jan2021. The patient did not receive treatment for the events. Prior to vaccination the patient has no COVID. The outcome of the events was recovered on Jan2021.  No follow-up attempts are possible. Information about batch/ lot number cannot be obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Diarrhoea, Fatigue, Headache
Clinical narrative: Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity.  On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Off label use, Pain in extremity, Product use issue
Clinical narrative: Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity.  On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Medical history included systemic lupus; Medical history included systemic lupus; Fever; Vomiting; Diarrhea; Abdominal pain; Joint/muscle pain; Joint/muscle pain; Nausea; Fatigue; Severe headache; Sore arm; This is a spontaneous report from a contactable consumer (patient).  A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3249, via an unspecified route of administration in the right arm on 15Jan2021 13:00 at SINGLE DOSE (first dose) for COVID-19 immunization. Medical history included systemic lupus, "hypothyroid", Leiden Factor V. Patient's known allergies: penicillin, erythromycin and tetracycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medications included hydroxychloroquine, clopidogrel bisulfate (PLAVIX), acetylsalicylic acid (ASPIRIN), fluoxetine hydrochloride (PROZAC), bupropion hydrochloride (WELLBUTRIN). The patient previously took erythromycin and experienced drug hypersensitivity, tetracycline and experienced drug hypersensitivity.  On 15Jan2021 16:00, the patient experienced fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm. Outcome of events was fever, vomiting, diarrhea, abdominal pain, joint/muscle pain, nausea, fatigue, severe headache and sore arm not recovered. Outcome of the other events was unknown. Patient did not receive any treatment for the events.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Nausea
Clinical narrative: Headache; Nausea; extreme Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 43-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL3249), via an unspecified route of administration at the left arm on 21Jan2021 14:30 at a single dose for covid-19 immunization. The patient medical history includes chronic kidney disease. The patient was not pregnant from the time of administration. The patient was taking numerous unspecified medications. The patient previously took amoxicillin sodium;clavulanate potassium (AUGMENTIN) and experienced allergy. On 21Jan2021 at 04:30 PM the patient experienced headache, nausea and extreme diarrhea. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in doctor's office/urgent care. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Apathy, Dizziness, Feeling abnormal, Nausea
Clinical narrative: haven't felt like herself; dizziness/lightheadedness; stomach started to turn/nausea; no ambition; stomach pain; This is a spontaneous report from a contactable consumer (patient). An 87-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on an unspecified date in Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that she haven't felt like herself. She woke up in the morning and felt good but by 2pm, she experienced dizziness/lightheadedness, stomach started to turn/nausea, no ambition and stomach pain. She took a pain pill and sat down for a couple of hours and then the stomach pain resolved. She wanted to know if these were all normal and if she should get the second dose given the side effects that she experienced. The outcome of the event stomach pain was recovered on an unspecified date while unknown for the other events.  Information on the batch/lot number has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: terrible case of diarrhea; arm is sore; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3749), intramuscular on 20Jan2021 15:30 at a single dose on left arm for COVID-19 immunization. Medical history included ongoing COPD, diagnosed probably 7 years ago. There were no concomitant medications. The patient's arm began to get sore the day after receiving the vaccine, 21Jan2021. She had a CAT scan earlier last week, but this was prior to the vaccine. She had the terrible case of diarrhea this morning, 22Jan2021, but she hasn't had diarrhea since then. She got up this morning. She was feeling fine, she drank 2 cups of coffee. She was pouring herself a cup of orange juice, and she had a terrible case of diarrhea. The outcome of the event diarrhea was unknown, arm is sore was recovering. Vaccination Facility Type was Physician's office. Adverse events did not require a visit to Emergency Room nor Physician Office. No prior vaccinations (within 4 weeks). No adverse events following prior vaccinations.
Sex: F
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity
Clinical narrative: sweating while sleeping overnight; pain/soreness in arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL9261) in the hospital, via an unspecified route of administration on 20Jan2021 at a single dose on the left arm for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. It was reported that the patient experienced pain/soreness in arm that has remained for 2 days and experienced sweating while sleeping overnight which is not typical for her sleep patterns. The events were reported to have occurred on 20Jan2021. The outcome of the events was recovering. The patient did not receive any treatment for the events. The events were reported as non-serious.  Since the vaccination, the patient has not been tested for COVID-19.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: injection site left arm turned "kinda pinky/red and a little puffy; her arm turned "kinda pinky/red and puffy."; injection site left arm/tender to the touch; injection site left arm/little heat/warm; This is a spontaneous report from a contactable consumer (patient). An 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration in the left arm on 19Jan2021 14:20 at a single dose for covid-19 immunisation. Medical history included ongoing obesity from 2018 (onset was around time her husband died in 2018. She thinks she started getting more sedentary and picking up weight about then). The patient's concomitant medications were not reported. The patient had no history of previous immunization with the Pfizer vaccine and no additional vaccines administered on same date of the bnt162b2. The patient previously had smallpox vaccine for immunization when she was a child and that of which really worked, but it was not just a neat little thing and she still has the scar on her upper arm; and varicella zoster vaccine rge (cho) (SHINGRIX) on unspecified date in 2019 for immunization. She had quite a reaction to this first dose of SHINGRIX vaccine but cannot remember what the symptoms she had were; she was down for a few days with that. She told her family doctor about the reaction, and that she received the vaccine at (pharmacy name); the family doctor said she should not get the second dose of the SHINGRIX. On 20Jan2021, the patient experienced her injection site left arm turned "kinda pinky/red and a little puffy, with a little heat/warm and tender to the touch." Outcome of the all the events was unknown.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site pain
Clinical narrative: this shot was much too high, barely in the deltoid.; immediate pain; This is a spontaneous report from a contactable physician (patient). A 72-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3247), via an unspecified route of administration at left arm on 21Jan2021 at 19:00 (reported as 07:00 PM) at SINGLE DOSE for COVID-19 immunisation. The patient was administered COVID-19 vaccine at the hospital. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior to vaccination. Medical history included Allergies: Penicillin. The patient's concomitant medications were not reported. The patient reported "Received first covid vaccine 21Jan. Nurse's technique was poor and I had immediate pain. I'm a physician, I know where the deltoid is and this shot was much too high, barely in the deltoid. I'm concerned about vaccine failure. Should we check antibody levels?" The event started on 21Jan2021 at 19:00 (reported as 07:00 PM). The reporter considered the events as non-serious. The patient did not receive treatment for the events. It was also reported that since the vaccination, the patient has not been tested for COVID-19. The patient had not yet recovered from the event immediate pain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol increased, COVID-19, Cough, Dizziness, Feeling abnormal
Clinical narrative: due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but she tested positive for COVID yesterday; Dizzy; starting to get foggy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899 or EH9897), via an unspecified route of administration at the left arm on 04Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing diabetic, blood pressure high, high cholesterol and sore arms from previous vaccines (unspecified).She had energy for a whole week after getting the vaccine, that she has not had for a long time, she even cleaned out her whole garage; has been waiting to do that for 3 years; had to make herself stop to rest. There were no concomitant medications. The patient got her first dose on 04Jan2021 and was due to get the 2nd dose this coming 25Jan2021, but she tested positive for COVID on 21Jan2021. She has been sick for a week which started with an irritating cough on 14Jan2021. She went to the ER because she was dizzy as could be on Jan2021. She does not remember which day; she was starting to get foggy on Jan2021. She was not admitted. She did a drive through rapid test on 21Jan2021 and it was positive. Lot numbers: Handwriting on her card was bad and she cannot tell if the last digit of the Lot number is a 9 or 7. The vaccine was administered in an open tent clinic outside  in a parking lot outside a hospital and not in a military facility. The outcome of the event was unknown.   Information on Lot/Batch has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Malaise, SARS-CoV-2 test positive
Clinical narrative: due to get the 2nd dose, but she tested positive for COVID yesterday; due to get the 2nd dose, but she tested positive for COVID yesterday; Dizzy; starting to get foggy; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899 or EH9897), via an unspecified route of administration at the left arm on 04Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing diabetic, blood pressure high, high cholesterol and sore arms from previous vaccines (unspecified).She had energy for a whole week after getting the vaccine, that she has not had for a long time, she even cleaned out her whole garage; has been waiting to do that for 3 years; had to make herself stop to rest. There were no concomitant medications. The patient got her first dose on 04Jan2021 and was due to get the 2nd dose this coming 25Jan2021, but she tested positive for COVID on 21Jan2021. She has been sick for a week which started with an irritating cough on 14Jan2021. She went to the ER because she was dizzy as could be on Jan2021. She does not remember which day; she was starting to get foggy on Jan2021. She was not admitted. She did a drive through rapid test on 21Jan2021 and it was positive. Lot numbers: Handwriting on her card was bad and she cannot tell if the last digit of the Lot number is a 9 or 7. The vaccine was administered in an open tent clinic outside  in a parking lot outside a hospital and not in a military facility. The outcome of the event was unknown.   Information on Lot/Batch has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Headache, Nasal congestion, Polymerase chain reaction
Clinical narrative: Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; lack of strength; This is a spontaneous report from a contactable other hcp (patient himself).  A 57-year-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL1284, expiry date not reported), via an unspecified route of administration on 08Jan2021 12:00 at a single dose on right arm for covid-19 immunization.  Medical history included hay fever. Prior to vaccination patient was not diagnosed with Covid-19.  Concomitant medication included melatonin taken within 2 weeks of vaccination on unspecified date for unspecified indication. On 15Jan2021 (also reported as 17Jan2021-pending clarification), it was reported that patient had stuffed nose, developed after 7 days of vaccination. Nose became painful to touch. Light chills, light headache and lack of strength. Patient received treatment of TYLENOL and decongestant. Since the vaccination the patient has been tested for Covid-19. On 11Jan2021, patient had PCR and nasal swab, and both were negative. The facility where the most recent Covid-19 vaccine administered was in a hospital.  The outcome of events was recovering.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinalgia, SARS-CoV-2 test
Clinical narrative: Stuffed nose, developed after 7 days; Nose became painful to touch; Light chills; light headache; lack of strength; This is a spontaneous report from a contactable other hcp (patient himself).  A 57-year-old male patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Solution for injection, lot no. EL1284, expiry date not reported), via an unspecified route of administration on 08Jan2021 12:00 at a single dose on right arm for covid-19 immunization.  Medical history included hay fever. Prior to vaccination patient was not diagnosed with Covid-19.  Concomitant medication included melatonin taken within 2 weeks of vaccination on unspecified date for unspecified indication. On 15Jan2021 (also reported as 17Jan2021-pending clarification), it was reported that patient had stuffed nose, developed after 7 days of vaccination. Nose became painful to touch. Light chills, light headache and lack of strength. Patient received treatment of TYLENOL and decongestant. Since the vaccination the patient has been tested for Covid-19. On 11Jan2021, patient had PCR and nasal swab, and both were negative. The facility where the most recent Covid-19 vaccine administered was in a hospital.  The outcome of events was recovering.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Chills; Fever of 101; Swollen glands or lymph nodes at the base of her skull; lymph node venapathy; Aches; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right deltoid, on 16Jan2021 (also reported as 15Jan2021), at a single dose, for COVID-19 immunization. The patient's medical history included therapy for her back. There were no concomitant medications. After the patient got her first vaccine on 16Jan2021 (also reported as 15Jan2021) which was almost a week now, she was experiencing side effects. In Jan2021, the patient had chills, fever of 101, swollen lymph nodes, and aches. The patient had swollen glands or lymph nodes at the base of her skull, the lymph node venapathy (unspecified; as reported). The patient underwent a COVID-19 test yesterday (21Jan2021) to be sure (unknown results). The patient asked that if this is from the vaccine, how long could she expect to have these side effects. The patient was scheduled for it for the second dose in February. As treatment for the events, the patient was taking ibuprofen (MOTRIN), had taken paracetamol (TYLENOL EXTRA STRENGTH) at 1000 mg every 6 hours, and ibuprofen (ADVIL) at 400 mg. The patient had not recovered from the events. The patient considered that the events had a causality with the suspect product.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Chills; Fever of 101; Swollen glands or lymph nodes at the base of her skull; lymph node venapathy; Aches; This is a spontaneous report from a contactable nurse (patient). An 81-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration in right deltoid, on 16Jan2021 (also reported as 15Jan2021), at a single dose, for COVID-19 immunization. The patient's medical history included therapy for her back. There were no concomitant medications. After the patient got her first vaccine on 16Jan2021 (also reported as 15Jan2021) which was almost a week now, she was experiencing side effects. In Jan2021, the patient had chills, fever of 101, swollen lymph nodes, and aches. The patient had swollen glands or lymph nodes at the base of her skull, the lymph node venapathy (unspecified; as reported). The patient underwent a COVID-19 test yesterday (21Jan2021) to be sure (unknown results). The patient asked that if this is from the vaccine, how long could she expect to have these side effects. The patient was scheduled for it for the second dose in February. As treatment for the events, the patient was taking ibuprofen (MOTRIN), had taken paracetamol (TYLENOL EXTRA STRENGTH) at 1000 mg every 6 hours, and ibuprofen (ADVIL) at 400 mg. The patient had not recovered from the events. The patient considered that the events had a causality with the suspect product.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Pregnancy test positive
Clinical narrative: unfortunately she had a miscarriage about 5-6 days before her second dose; positive pregnancy test a few days after the first dose.; positive pregnancy test a few days after the first dose.; This is a spontaneous report from a contactable consumer. A 32-year-old female patient (3 weeks pregnant at time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on left arm on 31Dec2020 at single dose for covid-19 immunisation. The patient medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included iron and minerals nos, vitamins nos (PRENATAL VITAMINS). The patient had a negative pregnancy test in 2020 before getting the first vaccine dose, but then had a positive pregnancy test in Jan2021 a few days after the first dose, but unfortunately she had a miscarriage in Jan2021, about 5-6 days before her second dose. She has an appointment scheduled with OBGYN for the miscarriage. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the miscarriage was recovering.; Sender's Comments: Based on the temporal relationship, the association between the event miscarriage with BNT162b2 can not be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dissociation, Dizziness, Fatigue, Malaise
Clinical narrative: I can't get feeling myself; feeling sick; having dizziness, lightheadedness; pain in the stomach; tired; head is going around; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age  (Age: 87; Unit: Unspecified) received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she had the covid vaccine first dose on a Monday and after the shot she had been feeling sick (onset date not reported). She further stated "I can't get feeling myself, having dizziness, lightheadedness, pain in the stomach, feeling sick, tired, head is going around." She wanted to know if that was due to the vaccine. The events were considered as non-serious by the reporter. Patient wanted to know if she should take the second dose. The outcome of the events was unknown.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: I can't get feeling myself; feeling sick; having dizziness, lightheadedness; pain in the stomach; tired; head is going around; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age  (Age: 87; Unit: Unspecified) received first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/lot number and exp date not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient stated that she had the covid vaccine first dose on a Monday and after the shot she had been feeling sick (onset date not reported). She further stated "I can't get feeling myself, having dizziness, lightheadedness, pain in the stomach, feeling sick, tired, head is going around." She wanted to know if that was due to the vaccine. The events were considered as non-serious by the reporter. Patient wanted to know if she should take the second dose. The outcome of the events was unknown.  Information about lot number and expiry date for the suspect product will be requested in follow-up attempts.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat; headache; severe pain at injection site; body aches; congestion/runny nose; congestion/runny nose; fever; This is a spontaneous report from a contactable consumer (patient).  A 29-year-old female patient receive the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the hospital, via an unspecified route of administration on 19Jan2021 at 15:15 on the left arm at a single dose for COVID-19 immunization.  Medical history included migraine with aura from an unknown date and unknown if ongoing. Concomitant medication included unspecified prenatal vitamins. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sore throat, headache, severe pain at injection site, body aches, congestion/runny nose and fever all on 19Jan2021 at 17:30. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious. The patient underwent a post vaccination COVID test via nasal swab on 21Jan2021 with a negative result.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Sore throat; headache; severe pain at injection site; body aches; congestion/runny nose; congestion/runny nose; fever; This is a spontaneous report from a contactable consumer (patient).  A 29-year-old female patient receive the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248) in the hospital, via an unspecified route of administration on 19Jan2021 at 15:15 on the left arm at a single dose for COVID-19 immunization.  Medical history included migraine with aura from an unknown date and unknown if ongoing. Concomitant medication included unspecified prenatal vitamins. The patient had no known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient experienced sore throat, headache, severe pain at injection site, body aches, congestion/runny nose and fever all on 19Jan2021 at 17:30. The patient did not receive treatment for the events. The outcome of the events was recovering. The events were reported as non-serious. The patient underwent a post vaccination COVID test via nasal swab on 21Jan2021 with a negative result.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizzy; This is a spontaneous report from a contactable consumer. A 70-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 21Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient woke up on 22Jan2021 and was feeling dizzy. She was asking if that was normal. Outcome of the event was unknown.  Information on lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Got the first dose of the vaccine yesterday. About an hour after is when her arm starting getting sore; This is a spontaneous report from a contactable consumer (patient).  A 70-year-old female patient received bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from 21Jan2021 to 21Jan2021 as SINGLE DOSE (first dose) for COVID-19 immunisation.  Medical history included none.  There were no concomitant medications. The patient is a 70/yo female who is very concerned that she 'took half of a Tylenol Migraine' yesterday morning before receiving her first dose of Pfizer-Biontech Covid19 vaccine.  She stated she came home, started reading on the internet, and is worried now that the dose won't be efficacious.  She also reports a sore arm and wants to know 'if that's a good sign' of immune response. She also stated that her doctors 'don't know, and told me to call you'.  Got the first dose of the vaccine yesterday. About an hour after is when her arm starting getting sore. It got progressively more sore throughout the day. This morning it has improved but is still sore when she raises her arm. Treatment: Took Tylenol. This was before she read this article. The nurse was the one who told her to take Tylenol. She goes for her second dose on 11Feb2021. The patient got the first dose of the COVID Vaccine yesterday. Before she went to get her shot she was getting a migraine so she took half of a Tylenol Migraine. She read that if you take Tylenol before getting the vaccine that it can effect the efficacy, the patient was asking if this was true.  The outcome of the event was recovering.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Axillary pain, Chills, Lymphadenopathy, Pain
Clinical narrative: getting intermittent sharp zapping pains on my left side of my external Obliques; woke up with my left armpit hurting and lymph nodes swollen on my left breast; woke up with my left armpit hurting and lymph nodes swollen on my left breast; feel achy; had chills; This is a spontaneous report from a contactable nurse (patient). A 37-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EJ1686) via an unspecified route of administration on the left arm on 19Jan2021 18:00 at a single dose for COVID-19 immunization. Medical history included celiac, anxiety depression, ADHD, cold sores sometimes, secondary infertility, seasonal allergies, sulfa allergy. Concomitant medication included lisdexamfetamine mesilate (VYVANSE), sertraline hydrochloride (ZOLOFT), metformin, ibuprofen, pyridoxine hydrochloride (B6) and folic acid. Previously the patient experienced allergies: hydrocodone, naproxen. The patient received first dose of BNT162B2 on 28Dec2020 for COVID-19 immunization (lot number: EL1284, left arm). After her 2nd vaccine (20Jan2021) she felt achy and had chills, no fever that was expected. Then the second day after her vaccine on 21Jan2021 12:00 AM, she woke up with her left armpit hurting and lymph nodes swollen on her left breast. Then on my third day (22Jan2021) she woke up and still had the left armpit pain and swelling and now she was getting intermittent sharp zapping pains on her left side of her external Obliques. She could not find anything online about the armpit pain and swelling and the Obliques pain. She was a nurse also and just wanted reassurance her that this was normal she was gonna get better. No treatment was received for the events. The events resulted to a doctor or other healthcare professional office/clinic visit. The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Events were reported as non-serious. Patient was not pregnant. Outcome of the events was not recovered.