chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Acne, Facial pain, Fatigue, Feeling hot, Head injury
Clinical narrative: left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine).  The patient experienced face was numb on left side since 02Jan2021. The patient also experienced  pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday  and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved.  The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hyperhidrosis, Hypoaesthesia, Laboratory test, Lymphadenopathy
Clinical narrative: left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine).  The patient experienced face was numb on left side since 02Jan2021. The patient also experienced  pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday  and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved.  The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Swelling of eyelid
Clinical narrative: left eyelid swollen; she sweat a lot; rash on head around bump on her left; swollen lymph nodes on neck left side/right side/swollen lymph node on collar bone right side; pain in left side of her face; Fever; feel tired; felt like her body was hot; bump on head on left side; face was numb on left side; pimples to left eyebrows; possibly has shingles; This is a spontaneous report from a contactable consumer (patient). A 27 years old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0140) at her right arm at single dose for COVID-19 immunization on 29Dec2020. Relevant history included she had UTI, acne and dandruff which she had before the vaccine. Concomitant drug included clomifene citrate (CLOMID) since 30Dec2020 (5 days regimen). Past drug included she was taking Ampicillin 25mg prior to vaccine (last dose 2 days before vaccine).  The patient experienced face was numb on left side since 02Jan2021. The patient also experienced  pain in left side of her face, swollen lymph node on neck left side/neck right side, feel tired, felt like her body was hot, bump on head on left side, rash on head around bump on her left and fever since 03Jan2020. She took medication for fever. She felt good when take Motrin or Tylenol and then it came back again being tired. Then, the patient stated she sweat a lot since 04Jan2021, she had swollen lymph node on collar bone right side since 05Jan2021. The had left eyelid swollen since 06Jan2021. The patient also experienced pimples to left eyebrows that started Saturday or Sunday  and possibly had shingles since unknown date in Jan2021. The patient went to the doctor because the doctor suggested that she had shingles and she had the shingles test on 06Jan2021, while she had not gotten the results back yet. The outcome of event Fever was recovered with sequel on 06Jan2021. Outcome of event possibly had shingles was unknown. The outcome of event she sweat a lot was Resolving. The outcome of other events was not resolved.  The events pain in left side of her face, swollen lymph node on neck left side, rash on head around bump on her left, left eyelid swollen and pimples to left eyebrows was worsened.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: she received her first dose of COVID vaccine on 18Dec and a week later contracted COVID; she received her first dose of COVID vaccine on 18Dec and a week later contracted COVID; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs) from a contactable registered nurse (patient). This 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 18Dec2020 for COVID-19 immunization. Medical history and concomitant medication were not reported.  Patient stated she received her first dose of COVID vaccine on 18Dec and a week later contracted COVID (in Dec2020) after receiving COVID vaccine. She just wanted to find out the answer to some medical questions. She had questions about antibodies and whether or not she should take the second dose. She stated her second dose was scheduled in two days, on Friday. She said after being positive on 28Dec2020 for COVID-19 virus test, she received the medication Bamlanivumab 700 mg intravenous passive antibodies therapy to lessen the COVID symptoms and to keep her out of the hospital, which it did. The outcome of events was unknown.   Information about lot and batch number was requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling hot
Clinical narrative: chills; get occasionally warmer but temperature is normal/feeling warm in her body or feverish but never had a temperature/ 99 degrees Fahrenheit; This is a spontaneous report from a contactable consumer (patient). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140) via unspecified route in the left arm single dose for COVID-19 immunization on 28Dec2020, 16:45 at 39-year-old. No medical history. Concomitant medication was not reported. No additional vaccines administered on same date of the vaccination or within 4 weeks before the vaccination. The patient had a little bit of chills on 31Dec2020. The chills was on and off, it may have even been on 01Jan2021. The patient occasionally felt warmer, but her temperature was normal. She felt warm inside her body or feverish on 29Dec2020 but never had a temperature. She still felt the chills and feverish on and off. She had it all day yesterday 05Jan2021. The temperature was 99 degrees Fahrenheit on 05Jan2021, but she had been working in the house. After she sat down for a while the fever went away. The chills and feeling like she might have fever are persisting through today. She didn't treat the chills or feverish in any way. No physician office or emergency room visited. No relevant tests. Action taken for BNT162B2 was not applicable. Outcome of the events was not resolved. It was reported as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administered at inappropriate site, Vaccination site pain
Clinical narrative: sore left arm; inadvertent subcutaneous administration of the vaccine/patient was given the Covid vaccine subcutaneously and not intramuscularly; it was given way too low on the arm and not within the deltoid; This is a spontaneous report from a contactable other HCP. This other HCP reported for a female patient with unknown age that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, Expiry Date: 31Dec2059), via subcutaneous at left arm on 05Jan2021 at 0.3ml single for COVID-19 immunization. Medical history and concomitant medication were none. The inadvertent subcutaneous administration of the vaccine was reported. On 05Jan2021, patient was given the Covid vaccine subcutaneously and not intramuscularly. It was also reported that the sore left arm started immediately after immunization. The patient reported that it was given way too low on the arm and not within the deltoid. Outcome of event was unknown.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Heart rate, Heart rate increased, Hypersensitivity, Vaccination site pain
Clinical narrative: his arm being sore from the vaccination; experienced increased heart rate/Heart rate went up; Mouth dry; He was calling because he is wondering if this is (increased heart rate, mouth dry) considered a severe allergic reaction; This is a spontaneous report from a contactable physician who reported for himself. A 44-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899) 1st dose via an unspecified route of administration on 17Dec2020 in the evening time (around 6-7 or maybe a little later) at single dose on arm for COVID-19 immunization. Medical history was none.  The patient's concomitant medications were not reported. After getting the COVID Vaccine that same day, his heart rate went up and then it came down and he was fine. Later that night while sleeping he got up again because he could feel his heart rate going up. It was not way up, but he could tell it was up. He was trying to catch an actual reading on the monitor of his heart rate, but he was not able to before it came back down. He was calling because he is wondering if this was considered a severe allergic reaction. He got the vaccine and was able to walk to his car. His mouth got dry right after the vaccine within a minute or two and noticed his heart rate went up. Treatment: He took some deep breaths and drunk water and it got better. He drove home, but that at nighttime while sleeping he noticed his heart rate went up a couple of times, but then it came back down. He could not get a reading of heart rate right away. The highest he saw on the monitor that he was able to capture was 101 and then it came back down. He was not sure if this was because he was nervous. He just had a couple of episodes that night and then nothing again. He also experienced his arm being sore from the vaccination. However, he stated that is to be expected. He stated the arm sore started a few days after getting the COVID Vaccine and then it was gone. Stated he was calling because he was concerned because Pfizer said to report any issues. He started to feel better and added this may not even be an issue. He just got concerned. Mentioned he was not sure if real side effects or if he was over thinking things. Outcome of the events was resolved.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Lip swelling, Urticaria
Clinical narrative: swelling of lips; hives/Welts; This is a spontaneous report from a contactable consumer. A 66-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot no. and expiry date were unknown), via an unspecified route of administration in Left hip on 23Oct2015 at single dose for pneumonia shot. There were no medical history and concomitant medications. The patient experienced hives/welts on 24Oct2015 and swelling of lips on 21Nov2015. Further reported as follows: In Oct2015, received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) pneumonia shot. Next day in late afternoon of 24Oct2015, she broke out in hives and continued to have it, was sometimes quite severe but didn't itch. She had big welts mainly on the lower part of her body. Had a few welts on face and eyes. On 25Oct2015 called up to the hospital and was advised to use Calamine lotion and Benadryl. First time she saw a doctor was on 31Oct2015 and was prescribed Prednisone. On 04Mar2016 was the first time she didn't notice hives. One morning on 21Nov2015, Top lip was swollen and saw another PA. Was prescribed 1 Zantac daily, 1 Zyrtec daily, and 1-2 Benadryl at night. It looked like she had botox on her lips. She had that until the first week in March. On 28Nov2015 she was put back on Prednisone. On 30Dec2015 she went to Dermatologist and was prescribed some kind of tube of medicine. Was informed by dermatologist that pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) caused the reaction. It was confirmed that she has not yet received the COVID-19 Vaccine. Stated she is not in the group to receive it. The event hives/welts recovered on 04Mar2016 and the outcome of the remaining event was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nasal congestion, Nasopharyngitis, Pyrexia
Clinical narrative: stuffed nose/stuffed up nose; fever (103F); headache; Cold like symptoms; This is a spontaneous report from a contactable consumer (consumer's daughter) via Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 15:00 in arm, (want to say left arm but not sure) at single dose for COVID-19 immunization. Medical history included overweight 200 lbs upwards from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had fever (103F), stuffed nose and a headache on 05Jan2021. The fever went down in the afternoon. The patient asked if it be caused by the vaccine, 1 week later? The patient works in the dietary department of a senior residency facility. The patient received her first dose of Pfizer COVID-19 Vaccine on 28Dec2020. In the morning of 05Jan2021, she woke up with a fever of 100.3 degrees fahrenheit and cold like symptoms. She knows that those symptoms are associated with the Pfizer COVID-19 vaccine from the product paperwork she has; but her question is is it could the symptoms still be from the vaccine when the symptoms did not start until 05Jan2021. The patient was supposed to receive second dose of vaccine around 18Jan2020. She was tested for COVID-19 05Jan2021 with unknown result as of this time. She was tested for COVID-19 31Dec2020 which was negative as far as caller knows. Patient has been tested for COVID-19 for weeks and so far as far as she knows the results have been negative. The results are supposed to be a 24 hour turn around to get results; and the patient explained to caller that if she does not hear anything back about the tests then she assumes they are negative. The patient underwent lab tests and procedures which included body temperature: 103 fahrenheit and 100.3 fahrenheit on 05Jan2021, COVID test: negative on 31Dec2020   , and unknown result on 05Jan2021. The outcome of the event cold like symptoms was recovering while unknown outcome for the remaining events.  Information about Lot/Batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: stuffed nose/stuffed up nose; fever (103F); headache; Cold like symptoms; This is a spontaneous report from a contactable consumer (consumer's daughter) via Medical information team. A 30-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 15:00 in arm, (want to say left arm but not sure) at single dose for COVID-19 immunization. Medical history included overweight 200 lbs upwards from an unknown date and unknown if ongoing. There were no concomitant medications. The patient had fever (103F), stuffed nose and a headache on 05Jan2021. The fever went down in the afternoon. The patient asked if it be caused by the vaccine, 1 week later? The patient works in the dietary department of a senior residency facility. The patient received her first dose of Pfizer COVID-19 Vaccine on 28Dec2020. In the morning of 05Jan2021, she woke up with a fever of 100.3 degrees fahrenheit and cold like symptoms. She knows that those symptoms are associated with the Pfizer COVID-19 vaccine from the product paperwork she has; but her question is is it could the symptoms still be from the vaccine when the symptoms did not start until 05Jan2021. The patient was supposed to receive second dose of vaccine around 18Jan2020. She was tested for COVID-19 05Jan2021 with unknown result as of this time. She was tested for COVID-19 31Dec2020 which was negative as far as caller knows. Patient has been tested for COVID-19 for weeks and so far as far as she knows the results have been negative. The results are supposed to be a 24 hour turn around to get results; and the patient explained to caller that if she does not hear anything back about the tests then she assumes they are negative. The patient underwent lab tests and procedures which included body temperature: 103 fahrenheit and 100.3 fahrenheit on 05Jan2021, COVID test: negative on 31Dec2020   , and unknown result on 05Jan2021. The outcome of the event cold like symptoms was recovering while unknown outcome for the remaining events.  Information about Lot/Batch number has been requested.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Pain
Clinical narrative: a fever of 103 degrees; second dose on 05Jan2021; Strong headache on the left side/Strong headache but stronger on the forehead area; chills; overall body aches; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 17Dec2020 at a single dose, and then second dose (lot number: EL3246, expiry date not reported), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medications were not reported. The patient had not been tested for COVID-19 since the vaccination. On 18Dec2020, the patient had a strong headache on the left side, chills and overall body aches. On 05Jan2021, the patient had a strong headache but stronger on the forehead area, body aches, chills and on 05Jan2021, a fever of 103 degrees. This time the patient could not go to work due to these symptoms. No therapeutic measure was taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 103  on 05Jan2021, sars-cov-2 test: positive on 2020 prior to vaccination. Clinical outcome of chills and pain was recovered on an unspecified date while for the other events was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: a fever of 103 degrees; second dose on 05Jan2021; Strong headache on the left side/Strong headache but stronger on the forehead area; chills; overall body aches; This is a spontaneous report from a contactable consumer. A 42-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685, expiry date not reported), via an unspecified route of administration in the left arm on 17Dec2020 at a single dose, and then second dose (lot number: EL3246, expiry date not reported), via an unspecified route of administration in the left arm on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19. Concomitant medications were not reported. The patient had not been tested for COVID-19 since the vaccination. On 18Dec2020, the patient had a strong headache on the left side, chills and overall body aches. On 05Jan2021, the patient had a strong headache but stronger on the forehead area, body aches, chills and on 05Jan2021, a fever of 103 degrees. This time the patient could not go to work due to these symptoms. No therapeutic measure was taken as a result of the events. The patient underwent lab tests and procedures which included body temperature: 103  on 05Jan2021, sars-cov-2 test: positive on 2020 prior to vaccination. Clinical outcome of chills and pain was recovered on an unspecified date while for the other events was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Occupational exposure to SARS-CoV-2, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: COVID Rapid Test and COVID-19 PCR test positive/ symptomatic/ fever/ not feeling well; COVID Rapid Test and COVID-19 PCR test positive/ symptomatic/ fever/ not feeling well; This is a spontaneous report from a Pfizer-sponsored Program Pfizer First Connect. A contactable nurse reported for a male patient (husband) with unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730) via IM injection left deltoid on 19Dec2020 at single dose for COVID Prevention. Medical history and concomitant medications were none. The patient did not receive any other vaccines on the same day as the COVID vaccine. The patient was a healthcare professional. The vaccine was not specifically prescribed to the patient, but rather was given to him via his workplace policy, although it was not mandatory. The patient received 1st dose on 19Dec2020, and he had exposure to the virus at work, and on 01Jan2021 he woke up with a fever and was not feeling well and tested positive for COVID-19. Currently he is still symptomatic. The reporter is inquiring about how to follow up with the second dose for the patient, as the patient is due for his second dose on 09Jan2021. It was reported that it had mostly been a low grade fever. The patient had both COVID Rapid Test and COVID-19 PCR test performed on 01Jan2021, and both were positive. The outcome of event was unknown.  The reporter was unsure of seriousness for the patient's positive COVID tests, so far it had not been terrible, but he was still symptomatic, so it was hard to say seriousness at this time. Relatedness of vaccine to event fever and positive COVID test both rapid and PCR from the reporter was unrelated.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 cannot be completely excluded. However, it is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Flushing, Headache
Clinical narrative: Flu like symptoms/ I'm feeling flu-like; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over/Was fevered; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over; A mild headache; Being dizzy; Nausea; Overwhelming feeling of being sick.; Feeling poorly.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3246, expiration date: 30Apr2021, route of administration unknown injection to left arm at 8:45 am on 02Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. It was reported that patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine 02Jan2021. She began to have flu like symptoms within like an hour of being administered that first dose. She asked how long she could expect these symptoms to last; because everything she has read said they usually last like 2-3 days. Flu like symptoms: Event started as a mild headache that she took paracetamol (TYLENOL) for to ward off. By the next day: 03Jan2021 she could not get out of bed, was fevered taking ibuprofen (MOTRIN) or paracetamol (TYLENOL) around the clock to treat symptoms described as negative effects. She had onset of headaches, being dizzy, nausea, overwhelming feeling of being sick. It is almost like time release; she will feel like she is getting better and almost ok and then will be getting sick again. She is still feeling poorly. She probably will not get the scheduled second dose of vaccine because she is absolutely terrified of getting it; they say the second dose is supposed to be worse than the first dose; and if it is she will probably be bedbound if she gets the second dose. She has never had any reactions to any vaccinations including flu vaccine that she has gotten every year. Patient further stated that she had the COVID vaccine and felt sick. She was feeling flu-like, feverish, fatigue, feeling flushed, achy all over and had been in bed for a couple days. Patient wanted to know if a booster dose will be necessary in the future. Patient had not recovered from flu like symptoms, while outcome of the other mentioned events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Flu like symptoms/ I'm feeling flu-like; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over/Was fevered; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over; I'm feeling flu-like, feverish, fatigue, feeling flushed, achy all over; A mild headache; Being dizzy; Nausea; Overwhelming feeling of being sick.; Feeling poorly.; This is a spontaneous report from a contactable consumer (patient). A 51-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EL3246, expiration date: 30Apr2021, route of administration unknown injection to left arm at 8:45 am on 02Jan2021 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. It was reported that patient was administered her first dose of Pfizer BioNTech COVID-19 Vaccine 02Jan2021. She began to have flu like symptoms within like an hour of being administered that first dose. She asked how long she could expect these symptoms to last; because everything she has read said they usually last like 2-3 days. Flu like symptoms: Event started as a mild headache that she took paracetamol (TYLENOL) for to ward off. By the next day: 03Jan2021 she could not get out of bed, was fevered taking ibuprofen (MOTRIN) or paracetamol (TYLENOL) around the clock to treat symptoms described as negative effects. She had onset of headaches, being dizzy, nausea, overwhelming feeling of being sick. It is almost like time release; she will feel like she is getting better and almost ok and then will be getting sick again. She is still feeling poorly. She probably will not get the scheduled second dose of vaccine because she is absolutely terrified of getting it; they say the second dose is supposed to be worse than the first dose; and if it is she will probably be bedbound if she gets the second dose. She has never had any reactions to any vaccinations including flu vaccine that she has gotten every year. Patient further stated that she had the COVID vaccine and felt sick. She was feeling flu-like, feverish, fatigue, feeling flushed, achy all over and had been in bed for a couple days. Patient wanted to know if a booster dose will be necessary in the future. Patient had not recovered from flu like symptoms, while outcome of the other mentioned events was unknown.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache
Clinical narrative: dizziness; flushing; HA (Headache); This is a spontaneous report from a non-contactable healthcare professional. A 51-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date, then the second dose (lot number: EK9231, expiry date not reported) via intramuscular route of administration the left deltoid muscle on 06Jan202, both at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience dizziness, flushing and HA (headache). She denied rash, hives, welts, difficulty breathing, difficulty swallowing, wheezing, throat tightness, hoarseness, stridor, itching, and lightheadedness. No therapy/ treatment was given. Events were non-serious. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Pain in extremity, Tachycardia
Clinical narrative: tachycardia (HR110-120); left arm soreness; This is a spontaneous report from a contactable physician (patient). A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at the left arm on 16Dec2020 14:00 (lot number: EH9899) at a single dose, then intramuscular at the left arm on 05Jan2021 16:00 (lot number: EK9231) at a single dose for COVID-19 immunization in the hospital. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient medical history was not reported. The patient has no allergies to medications, food, or other products. Concomitant medications included allopurinol and atorvastatin. The patient experienced left arm soreness and tachycardia with hr of 110-120 on 06Jan2021 16:30. No treatment was given in response to the events. The patient assessed the events as non-serious. The outcome of the events was not recovered. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since vaccination.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021; got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as "Age-48, Unit-Unknown") received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated she got the covid 19 vaccine on 29Dec2020 and tested positive for covid on 05Jan2021. She wanted to know what to do about the second dose of the vaccine.   Information about Lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: I ended up testing positive on Monday 04Jan2021; I ended up testing positive on Monday 04Jan2021; This is a spontaneous report from a contactable Other Health Professional (patient). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number was not reported, via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Family history included patient was "99.9% sure that his daughter at day care had direct contact (COVID-19)". It was reported that the patient received first dose on 30Dec2020, and that same Wednesday morning 99.9% sure that his daughter at day care had direct contact (COVID-19). He ended up testing positive on Monday 04Jan2021 with outcome of unknown, and was scheduled for second dose on 04Jan2021. He asked for specific recommendation for his weird situation.   Information on Lot/Batch has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported events of suspected LOE and SARS-CoV-2 test positive due to temporal relationship.  There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.   This case will be reassessed once additional information is available.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Nervousness
Clinical narrative: nervous; very cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not provided), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history included seizure. The patient's concomitant medications were not reported. The caller reported having seizures once in awhile and asked if this vaccine was meant for everyone or if there is a different one that people with seizures are supposed to get. The caller stated the seizures are a pre-existing condition and she has not had a seizure since receiving the vaccine. The caller stated that she did speak with her doctor and he said it was fine for her to receive the vaccine and she received the first dose on an unspecified date on Saturday but she got nervous and very cold. The reporter wondered if she should get the second dose as normal then. The reporter wanted to know the answer soon because of the nerves. She has calmed down a bit and wanted to hear what someone has to say right away. The outcome of the events was unknown. This case reported as non-serious.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dizziness, Dizziness postural, Fatigue, Pain in extremity
Clinical narrative: anaphylactic reaction; arm was really sore; tiredness; dizzy; This is a spontaneous report from a contactable other health professional (patient). A 53-year-old female patient received bnt162b2 (Pfizer-biontech covid-19 vaccine), via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunization. Medical history included shellfish allergy. The patient's concomitant medications were not reported. The patient experienced anaphylactic reaction on an unspecified date, dizzy on 31Dec2020, arm was really sore on an unspecified date, tiredness on an unspecified date. Event details: She was dizzy that day especially with changing positions, she didn't need to go to the doctor or anything. It wasn't severe. She was just a little dizzy. It's probably just the vaccine and it did go away. Her arm was really sore and went away after a few days. the tiredness, it wasn't a big deal. She did feel better about. it wasn't a serious anaphylactic reaction. It didn't happen right away. She had arm soreness. it wasn't immediate. She usually didn't have. It was really weird. She thought she was well hydrated. The outcome of event was really sore was resolved, outcome of other events was unknown.   Information on the Lot/Batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the anaphylactic reaction and other reported events due to temporal relationship.  There is very limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Generalized Lymphadenopathy; This is a spontaneous report from a contactable physician (patient). A 34-years-old female patient (not pregnant) received first dose bnt162b2 (lot number: EH9899) (Pfizer BioNTech COVID-19 Vaccine), intramuscular on 21Dec2020 08:00 on left arm at single dose for COVID-19 immunization. Medical history included penicillin. No other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. The patient experienced generalized lymphadenopathy on 21Dec2020. No treatment received for the event. Outcome of event was not recovered. Since the vaccination the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: exposed to Covid positive patient; This is a spontaneous report from a contactable nurse (patient). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of Covid19 vaccine on Dec2020 and was due for his second dose  on 07Jan2021 (reported as today, day 21).  However, his wife contracted Covid19 tested positive on 01Jan2021. He wanted to know when he should get his 2nd dose, having been exposed to Covid positive patient on Jan2021 and >21 days. His wife tested positive for Covid last Friday and he was on isolation/ negative on PCR. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Facial paresis, Paraesthesia
Clinical narrative: muscle weakness on one side of her face; On 06Jan2021 I suddenly have tingling and muscle weakness on one side of my face.; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number=eh9899), intramuscularly on left arm at 07:15 AM on 21Dec2020 at single dose for COVID-19 immunization. Medical history included high blood pressure and asthma, no allergies to medications, food, or other products. Concomitant medication included lisinopril and non-hormone birth control. The patient suddenly had tingling and muscle weakness on one side of her face at 07:30 AM on 06Jan2021. All events were reported as non-serious. The patient did not receive any treatment from events. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient had not been tested for COVID-19. The outcome of events was not recovered.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vaccination site pain
Clinical narrative: once by injection in the left shoulder/Shoulder pain; Whole body was hurting; Nausea; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of bnt162b2 (PFIZER COVID 19 VACCINE, Batch/lot number: EL3246, expiry: unknown), via an unspecified route of administration on 30Dec2020 at single dose (once by injection in the left shoulder) for COVID-19 immunization (Healthcare worker). Medical history was reported as none. There were no concomitant medications. On 01Jan2021, it was reported that the patient experienced shoulder pain, whole body was hurting, and nausea.  Patient asked, after getting the vaccine, if one was able to get COVID, she clarified that she meant after the first dose of the vaccine. She got the typical symptoms and side effects after she got the first dose, like shoulder pain. She is curious if you can still get COVID after the first dose. She is sure you are better off after the second one, but was curious about after the first one. The patient was taking COVID Vaccine because she is a Healthcare worker. Patient is a medical assistant. It was also reported that her shoulder pain was more prominent than her body. She works in the field and people are getting COVID after the first dose of the vaccine. She is concerned on if she could still get it or not. She gets the second dose on 20Jan2021. The outcome of the event once by injection in the left shoulder/Shoulder pain was recovered on 04Jan2021, whole body was hurting was recovered on 02Jan2021, and nausea was recovered on 01Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia
Clinical narrative: rapid heart rate; trouble sleeping; This is a spontaneous report from a contactable healthcare professional. A 34-year-old male 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 the left deltoid on Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had the first vaccine approximately 2 weeks ago (Dec2020) and since then, patient have been having a rapid heart rate, especially at night time. He had trouble sleeping because it was beating fast. It was more pronounced the first week after vaccination on Dec2020. Patient will have a doctor's appointment on 08Jan2021. Outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Blood pressure decreased, Blood pressure measurement, Feeling hot
Clinical narrative: feeling that I was going to pass out. faint; warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart; Fast heartbeat; headache; blood pressure went down drastically; tachycardia; weak; looked pale; Anxiety; This is a spontaneous report from a contactable Other HCP (patient). A 47-year-old female (not pregnant) patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 18Dec2020 10:00 at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history included patient was alergic to environmental or insect allergens. No food no medication''. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included loratadine. The patient receive other vaccines within 4 weeks prior to the COVID vaccine was immunotherapy vaccine against mold, insect, mites on 02Dec2020 on both arms. It was reported ''3mins post injection: warm feeling starting on my right arm going down to my left leg. feeling that I was going to pass out. faint. goes and come. I was feeling that I was going to pass out like 3 times , but I was in a wheelchair.. Thanks God and warm feeling from my right leg up to my heart. Fast heartbeat, and weak and sudden headache. Symptoms goes and come. it last 15 mins. Once I was brought to ER.. they estabilize my tachycardia and gave me benadryl. I did get better, but still weak. Stay 2 hours for observation. By the time I got to ER, I was a little better. Physician diagnoses as Anxiety event. because I got estabilize and never got a rash, difficulty breathing. I am 100%, my body for whatever reason it could be, did not welcome the vaccine. and blood pressure went down drastically...i looked pale as they told me.''. Adverse events start date was reported on 18Dec2020 10:03 AM. Case was non-serious. Treatment received for the adverse events included medicine for tachychardia and Benadryl. AE warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart and feeling that I was going to pass out. faint resulted in: [Emergency room/department or urgent care]. The outcome of the events ''warm feeling starting on my right arm going down to my left leg/warm feeling from my right leg up to my heart'' and ''feeling that I was going to pass out. faint'' was reported as recovered. The outcome of other events was unknown.  Information about Lot/batch number has been requested.