chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid after receiving the shot/had the first dose of the Pfizer Covid-19 vaccine on (19Mar2021) but tested positive to Covid-19 on 25Mar2021; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/lot number and expiry date: not reported) via an unspecified route of administration on 19Mar2021 (at an age of 63 years-old) as dose 1, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Mar2021, the patient tested positive for covid. The patient stated that two days before the day of reporting, she took a shot of Damlanivimab at the hospital. Stated that she was supposed to have the second shot on 09Apr2021 and wanted to know since she had some other antibiotic could she take the second shot and clarified that it is for Pfizer Covid vaccine. The patient also wanted to know if its okay to take the second dose after being tested Positive to Covid-19. On 25Mar2021, the patient underwent lab tests and procedures which included sars-cov-2 test: positive. The clinical outcome of the covid-19 was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lethargy, Malaise, Pyrexia, Rash
Clinical narrative: Slight fever; Chills; Lethargy; Rash; Did not feel well; This is a spontaneous report from a non-contactable consumer via a Pfizer employee. A female patient in her 60s (7 decades) received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration as dose 2, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient did not feel well after her 2nd dose of the Pfizer Covid vaccine and experienced slight fever, chills, lethargy and a rash. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Neoplasm
Clinical narrative: my cancer has spread very quickly; This is a spontaneous report from Pfizer sponsored program   A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single and dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient's medical history included cancer from that diagnosed last year (2020). The patient's concomitant medications were not reported. It was reported that, the patient diagnosed with cancer last year (in 2020) and it was slowest growing kind by oncologist. The patient just got covid shots, both yours and as of Friday the patient's cancer has spread very quickly. The patient had to hear from you as soon as possible. The patient doesn't know where else to turn. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Rhinorrhoea, SARS-CoV-1 test
Clinical narrative: Little cough; Runny nose; Tested positive for covid; This is a spontaneous report from a contactable consumer. A 55-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 17Mar2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medication were not reported. The patient received his first COVID dose on 17Mar2021, afterwards the patient was not feeling well and on 29Mar2021, the tested positive for COVID-19. The patient reported that having mild symptoms, runny nose and a light cough. The patient reported that while the patient's isolation was completed. The patient was still had a little bit of a cough, but the patient was due for his second shot next day and asked if the patient should get it or wait. Call was not transferred to unit because the call was hanging up and Created Manual AE Form.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: diagnosed with covid-19; diagnosed with covid-19; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program COVAX US Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown, Expiration date: Unknown), via an unspecified route of administration on 19Mar2021 as dose 1, single for covid-19 immunisation. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient was diagnosed with covid-19. The patient wanted to know if he can still get the 2nd does, on 10Apr2021. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on an unspecified date in 2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: she tested herself for COVID-19 as a requirement for a procedure at the hospital; This is a spontaneous report from a contactable consumer or other non HCP (patient herself).     A 83-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 19Mar2021 (at the age of 83-years-old) as dose 1, 0.3 ML single for Covid-19 immunisation. The patient's medical history included diabetic; she has been diagnosed more than 20 years. The patient was allergic to sulfa. The patient had no history of previous immunization with the Pfizer vaccine. The concomitant medications included she takes many unspecified medications and does not want to list them on this report. The patient previously took penicillin and experienced allergy. No additional vaccines administered on same date of the Pfizer suspect. The patient had no other vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse event following prior vaccinations. The patient got the first shot of the Pfizer COVID-19 vaccine on 19Mar2021 at (Facility name). She had no adverse events, and everything was fine. She had no problems with it, she was doing very well with it. She wanted to make an appointment for COVID-19 testing. She was scheduled to get an epidural done and had some testing she needed to get done and part of that testing was a COVID-19 test. On 27Mar2021, nasal swab taken, and she tested herself for COVID-19 as a requirement for a procedure at the hospital. The test went through her nose. She received a call saying that she tested positive for COVID-19. The patient stated  that currently, her husband, her son, her daughter, even her dog was in quarantine. She was isolated for 12 days. The adverse event not required emergency room and physician office visit. She was scheduled to take the second dose of the vaccine on 09Apr2021. She wanted to know if she can take the second dose of the vaccine as scheduled. She stated it has been 12 days and she want to get retested and schedule her next appointment if she has to reschedule. She wanted to know would they still give her the second shot on 09Apr2021, should she still take it. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cold urticaria, Fatigue, Nasal congestion
Clinical narrative: she called her employee health and they set her up for a rapid test, which came back positive; she called her employee health and they set her up for a rapid test, which came back positive; Fighting cold; congested on left side of her nose; Mild chills; achy feeling on and off; Fatigue; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The Patient's 2 sons and husband (her husband had received his first Pfizer COVID vaccine dose on 13Mar) all tested positive for COVID week of 22Mar2021. Patient family member was taking care of all of them at home and was not wearing a mask or taking precautions because she assumed that the vaccination would prevent her from contracting it. But on 28Mar2021 she started to feel like she was fighting a cold or having allergies -somewhat congested on left side of her nose. She then started to have mild chills, achy feeling on and off, and fatigue. Symptoms were very mild by her definition but like the more severe version that the rest of her family was experiencing. She went to work on Monday through Wednesday of this week but on Wednesday 31Mar2021 she called her employee health and they set her up for a rapid test, which came back positive. She is quarantining at home now with the rest of her family. I have no further information regarding whether anyone else in her office who had the Pfizer vaccine contracted COVID. The outcome of all the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Vaccination failure
Clinical narrative: she called her employee health and they set her up for a rapid test, which came back positive; she called her employee health and they set her up for a rapid test, which came back positive; Fighting cold; congested on left side of her nose; Mild chills; achy feeling on and off; Fatigue; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection), dose 1 via an unspecified route of administration on 26Dec2020 (Batch/Lot number was not reported) as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 16Jan2021 (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The Patient's 2 sons and husband (her husband had received his first Pfizer COVID vaccine dose on 13Mar) all tested positive for COVID week of 22Mar2021. Patient family member was taking care of all of them at home and was not wearing a mask or taking precautions because she assumed that the vaccination would prevent her from contracting it. But on 28Mar2021 she started to feel like she was fighting a cold or having allergies -somewhat congested on left side of her nose. She then started to have mild chills, achy feeling on and off, and fatigue. Symptoms were very mild by her definition but like the more severe version that the rest of her family was experiencing. She went to work on Monday through Wednesday of this week but on Wednesday 31Mar2021 she called her employee health and they set her up for a rapid test, which came back positive. She is quarantining at home now with the rest of her family. I have no further information regarding whether anyone else in her office who had the Pfizer vaccine contracted COVID. The outcome of all the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: my daughter received her first shot of COVID and tested positive for COVID two days later; This is a spontaneous report from a contactable consumer (parent). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, 2 days after receiving the first dose of vaccine, the patient was tested positive for COVID. Reporter wanted to know if her child can receive the Pfizer vaccine or not. The patient underwent lab test and procedures which included SARS-COV-2 test: positive, on an unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Patient took pain medication in between doses; This is a spontaneous report received from a Pfizer sponsored program Covax Support from a contactable consumer (the patient, reported for herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry dates were not reported), via an unspecified route of administration on 13Mar2021 as single dose for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included tapentadol hydrochloride (NUCYNTA) for pain. Patient wanted to check if she could take the pain medication (tapentadol hydrochloride (NUCYNTA)). Patient was taking before having the 2nd dose. Patient took pain medication in between doses. Patient had the first dose on 13Mar2021, and the 2nd dose is scheduled on 05Apr2021. Outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: She has swelling of gland in her armpits; This is a spontaneous report received from a contactable consumer (patient's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration as dose 1, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter was calling for a friend who received a Pfizer first dose of COVID vaccine and she has swelling of glands in her armpits, and this has been going on for 25 days now. Patient did not receive the second dose they did not want to give it to her before they know what was happening. Reporter wanted to check was this was normal side effect because patient's medical doctors don't know what to say. Patient did not receive any treatment for the event. The patient was not recovered from the event.  No follow-up attempts are possible. Information about. Batch/lot number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site infection
Clinical narrative: infection at injection site; This is a spontaneous report from a contactable consumer or other non hcp. A adult female patient of unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation:Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date  as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. It was unknown that whether patient was pregnant (at the time of vaccination) and whether the patient diagnosed with COVID-19 prior to vaccination. It was unknown that since the vaccination whether the patient had been tested for COVID-19. The patient experienced infection at injection site on an unspecified date. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dizziness, Dyspnoea, Essential tremor, Gait disturbance
Clinical narrative: Sciatic nerve back pain; I have essential tremors.; Could not breathe, it caused pain; Could not move; Could not walk; Could not sit; Could not lay down; fever; Arm swollen up bigger than a baseball; Dizzy to the point where I almost fell four times; Entire body had tingling; numbness; Sweating; headache; rash on my face for three days and my arm; rash on my face for three days and my arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, solution), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 (Batch/Lot Number: EN6205) as dose 1, single for covid-19 immunisation. Medical history included neoplasm malignant, Low immune system, Respiratory and pulmonary issues, Neural issues, and Allergy. Concomitant medication included loratadine, montelukast, vitamin d3, primidone, salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported. Patient stated, I had been trying to get somebody to pick up through this the phone for two days here. I had a vision disability, so I can not go online to talk about the Pfizer vaccine side effects that were quite severe. Seemed to be signs and symptoms for the people I was close to who have the same chronic conditions, I didn't know if there's correlation. I was trying to get the data reported so the next vaccines that come out might possibly take this into account." Patient further stated, The side effects to the Pfizer's first dose. The first dose, I immediately had sciatic nerve back pain that lasted for the entire two days, so bad I could not move, I could not walk, I could not sit, I could not lay down, could not breathe it caused pain. I went to get a hold of the doctor who prescribed the medicines for that. Like I said, don't know if it's related because I also have a back inherent disabilities and I also have neural issues. I have essential tremors. I also had neural issues when I had disability with fractured hand. That was the worst from the first dose, there was a headache, there was rash on my face for three days and my arm, even though I was on the allergy medicine already that they prescribed was swollen up bigger than a baseball. I was also dizzy to the point where I almost fell four times. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Muscle rigidity, Paraesthesia
Clinical narrative: Sciatic nerve back pain; I have essential tremors.; Could not breathe, it caused pain; Could not move; Could not walk; Could not sit; Could not lay down; fever; Arm swollen up bigger than a baseball; Dizzy to the point where I almost fell four times; Entire body had tingling; numbness; Sweating; headache; rash on my face for three days and my arm; rash on my face for three days and my arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, solution), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 (Batch/Lot Number: EN6205) as dose 1, single for covid-19 immunisation. Medical history included neoplasm malignant, Low immune system, Respiratory and pulmonary issues, Neural issues, and Allergy. Concomitant medication included loratadine, montelukast, vitamin d3, primidone, salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported. Patient stated, I had been trying to get somebody to pick up through this the phone for two days here. I had a vision disability, so I can not go online to talk about the Pfizer vaccine side effects that were quite severe. Seemed to be signs and symptoms for the people I was close to who have the same chronic conditions, I didn't know if there's correlation. I was trying to get the data reported so the next vaccines that come out might possibly take this into account." Patient further stated, The side effects to the Pfizer's first dose. The first dose, I immediately had sciatic nerve back pain that lasted for the entire two days, so bad I could not move, I could not walk, I could not sit, I could not lay down, could not breathe it caused pain. I went to get a hold of the doctor who prescribed the medicines for that. Like I said, don't know if it's related because I also have a back inherent disabilities and I also have neural issues. I have essential tremors. I also had neural issues when I had disability with fractured hand. That was the worst from the first dose, there was a headache, there was rash on my face for three days and my arm, even though I was on the allergy medicine already that they prescribed was swollen up bigger than a baseball. I was also dizzy to the point where I almost fell four times. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Rash, Sciatica, Sitting disability
Clinical narrative: Sciatic nerve back pain; I have essential tremors.; Could not breathe, it caused pain; Could not move; Could not walk; Could not sit; Could not lay down; fever; Arm swollen up bigger than a baseball; Dizzy to the point where I almost fell four times; Entire body had tingling; numbness; Sweating; headache; rash on my face for three days and my arm; rash on my face for three days and my arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 55-years-old female patient received bnt162b2 (BNT162B2, solution), dose 1 via an unspecified route of administration, administered in Arm on 05Mar2021 (Batch/Lot Number: EN6205) as dose 1, single for covid-19 immunisation. Medical history included neoplasm malignant, Low immune system, Respiratory and pulmonary issues, Neural issues, and Allergy. Concomitant medication included loratadine, montelukast, vitamin d3, primidone, salbutamol (VENTOLIN [SALBUTAMOL]) taken for an unspecified indication, start and stop date were not reported. Patient stated, I had been trying to get somebody to pick up through this the phone for two days here. I had a vision disability, so I can not go online to talk about the Pfizer vaccine side effects that were quite severe. Seemed to be signs and symptoms for the people I was close to who have the same chronic conditions, I didn't know if there's correlation. I was trying to get the data reported so the next vaccines that come out might possibly take this into account." Patient further stated, The side effects to the Pfizer's first dose. The first dose, I immediately had sciatic nerve back pain that lasted for the entire two days, so bad I could not move, I could not walk, I could not sit, I could not lay down, could not breathe it caused pain. I went to get a hold of the doctor who prescribed the medicines for that. Like I said, don't know if it's related because I also have a back inherent disabilities and I also have neural issues. I have essential tremors. I also had neural issues when I had disability with fractured hand. That was the worst from the first dose, there was a headache, there was rash on my face for three days and my arm, even though I was on the allergy medicine already that they prescribed was swollen up bigger than a baseball. I was also dizzy to the point where I almost fell four times. The clinical outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back injury, Back pain, Dyspnoea, Fatigue, Hyperhidrosis
Clinical narrative: I had that 'jolting thing' (not clarified) take my breath away; I can't move, the pain was in my thoracic; I can't move, the pain was in my thoracic; back injury is in my thoracic; but there was increased swelling in my arm, bigger than a baseball.; my entire body had tingling; numbness; I had intense fatigue; flu like symptoms; had a fever; I was sweating; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: ER8730) via unknown route of administration on 27Mar2021 as dose 2 single for COVID-19 immunisation. Medical history included cancer (on the righthand side ovary with the appendix removed), low immune system, respiratory and pulmonary issues, neural issues, ongoing allergy, fractured hand, vision disability. Concomitant medications included loratadine for allergy, montelukast for allergy, colecalciferol (VITAMIN D3), primidone, salbutamol (VENTOLINE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) on 05Mar2021 for COVID-19 immunization and experienced sciatic nerve back pain (back inherent disabilities), could not move, could not walk, could not sit, could not lay down, could not breathe it caused pain, I have essential tremors, headache, rash (on my face for three days and my arm), swollen up, dizzy (to the point where I almost fell four times). It was reported that after the second dose, I had that 'jolting thing' (not clarified) take my breath away. I can't move, the pain was in my thoracic. My back injury was in my thoracic. Again, took the medicine that the doctor prescribed for me and that went away but there was increased swelling in my arm, bigger than a baseball. An allergy medicine took care of that. There was, the whole thing that I told you about was normal symptoms but they didn't really quite severe as just before the back pain came on, my entire body had tingling, numbness. And I didn't have headache this time but in addition to the back and the numbness and the swelling, I had intense fatigue, flu like symptoms. I had a fever that took two days to break even with Motrin and was so bad, I mean, I was sweating all on 27Mar2021. I am a cancer patient, happens to be the cancer that I had was on the right-hand side ovary with the appendix removed." The outcome of events was unknown.  No follow-up attempts are needed. No further information is required.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Influenza like illness, Movement disorder, Paraesthesia, Peripheral swelling
Clinical narrative: I had that 'jolting thing' (not clarified) take my breath away; I can't move, the pain was in my thoracic; I can't move, the pain was in my thoracic; back injury is in my thoracic; but there was increased swelling in my arm, bigger than a baseball.; my entire body had tingling; numbness; I had intense fatigue; flu like symptoms; had a fever; I was sweating; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: ER8730) via unknown route of administration on 27Mar2021 as dose 2 single for COVID-19 immunisation. Medical history included cancer (on the righthand side ovary with the appendix removed), low immune system, respiratory and pulmonary issues, neural issues, ongoing allergy, fractured hand, vision disability. Concomitant medications included loratadine for allergy, montelukast for allergy, colecalciferol (VITAMIN D3), primidone, salbutamol (VENTOLINE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) on 05Mar2021 for COVID-19 immunization and experienced sciatic nerve back pain (back inherent disabilities), could not move, could not walk, could not sit, could not lay down, could not breathe it caused pain, I have essential tremors, headache, rash (on my face for three days and my arm), swollen up, dizzy (to the point where I almost fell four times). It was reported that after the second dose, I had that 'jolting thing' (not clarified) take my breath away. I can't move, the pain was in my thoracic. My back injury was in my thoracic. Again, took the medicine that the doctor prescribed for me and that went away but there was increased swelling in my arm, bigger than a baseball. An allergy medicine took care of that. There was, the whole thing that I told you about was normal symptoms but they didn't really quite severe as just before the back pain came on, my entire body had tingling, numbness. And I didn't have headache this time but in addition to the back and the numbness and the swelling, I had intense fatigue, flu like symptoms. I had a fever that took two days to break even with Motrin and was so bad, I mean, I was sweating all on 27Mar2021. I am a cancer patient, happens to be the cancer that I had was on the right-hand side ovary with the appendix removed." The outcome of events was unknown.  No follow-up attempts are needed. No further information is required.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I had that 'jolting thing' (not clarified) take my breath away; I can't move, the pain was in my thoracic; I can't move, the pain was in my thoracic; back injury is in my thoracic; but there was increased swelling in my arm, bigger than a baseball.; my entire body had tingling; numbness; I had intense fatigue; flu like symptoms; had a fever; I was sweating; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: ER8730) via unknown route of administration on 27Mar2021 as dose 2 single for COVID-19 immunisation. Medical history included cancer (on the righthand side ovary with the appendix removed), low immune system, respiratory and pulmonary issues, neural issues, ongoing allergy, fractured hand, vision disability. Concomitant medications included loratadine for allergy, montelukast for allergy, colecalciferol (VITAMIN D3), primidone, salbutamol (VENTOLINE). The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE) on 05Mar2021 for COVID-19 immunization and experienced sciatic nerve back pain (back inherent disabilities), could not move, could not walk, could not sit, could not lay down, could not breathe it caused pain, I have essential tremors, headache, rash (on my face for three days and my arm), swollen up, dizzy (to the point where I almost fell four times). It was reported that after the second dose, I had that 'jolting thing' (not clarified) take my breath away. I can't move, the pain was in my thoracic. My back injury was in my thoracic. Again, took the medicine that the doctor prescribed for me and that went away but there was increased swelling in my arm, bigger than a baseball. An allergy medicine took care of that. There was, the whole thing that I told you about was normal symptoms but they didn't really quite severe as just before the back pain came on, my entire body had tingling, numbness. And I didn't have headache this time but in addition to the back and the numbness and the swelling, I had intense fatigue, flu like symptoms. I had a fever that took two days to break even with Motrin and was so bad, I mean, I was sweating all on 27Mar2021. I am a cancer patient, happens to be the cancer that I had was on the right-hand side ovary with the appendix removed." The outcome of events was unknown.  No follow-up attempts are needed. No further information is required.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for Covid 19; tested positive for Covid 19; This is a spontaneous report from a Pfizer-sponsored program from 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 was not reported), first dose via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient tested positive for Covid 19 on unspecified date of 2021 (Friday) and is due for the second dose of the Pfizer Covid 19 vaccine 19Apr2021. Patient enquired whether she could take the second dose on the 19. The patient underwent lab tests and procedures which included Covid 19 found to be positive on unspecified date of 2021(Friday). The outcome of the events was unknown.  No follow up attempts are possible. Information about lot/batch number cannot be requested. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Bundle branch block right, Fatigue, Headache, Infection, Paranasal sinus discomfort
Clinical narrative: right bundle branch block; sinus pressure; fatigue; headaches; infection to toes; This report is received from Pfizer Sponsored Program. This is a spontaneous report from a contactable other HCP. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on Mar2021 as unknown, single for covid-19 immunisation; tofacitinib citrate (XELJANZ, Strength: 5 mg), oral from 02Mar2021 (Batch/Lot number was not reported) to Mar2021, at 5 mg, 2x/day and oral from Mar2021 (Batch/Lot number was not reported) and ongoing, at 5 mg, daily for rheumatoid arthritis. The patient's medical history and concomitant medications were not reported. The patient stated one week after starting XELJANZ infection reported to toes (on Mar2021) and ordered "foot soaks" patient states since then there has been improvements with the infection md aware, no further information provided. 14Mar2021 patient reports going to emergency room after COVID vaccine, states she was diagnosed with a right bundle branch block (on Mar2021) and Doctor of Medicine (MD) was aware. No further information provided. The patient reported sinus pressure, fatigue, and headaches (on Mar2021) since start of therapy and on-going. The MD was aware. No further information provided. She was sensitive to medication, her doctor said to take one 5mg tablet daily then she will re-evaluate how she was doing before she takes two 5mg tablets per day. The MD was aware. Outcome Attributed to Adverse Event: Other serious (Important Medical Events). The action taken in response to the events for tofacitinib citrate was dose reduced. The outcome of the event right bundle branch block was unknown. The outcome of the events sinus pressure, fatigue, headaches was not recovered and outcome of the event infection to toes was recovering.   No follow up attempts are possible. Information about lot/batch number cannot been obtained.; Sender's Comments: The events were considered intercurrent conditions and unrelated to suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) and Tofacitinib citrate.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for the COVID-19 virus; Tested positive for the COVID-19 virus; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable male consumer (patient) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, NDC#, UPC#, LOT# and expiration date: unknown) via an unspecified route of administration on 21Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 03Apr2021, the patient tested positive for the covid-19 virus. The patient underwent lab tests and procedures which included covid-19 virus: positive on 03Apr2021. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: patient tested positive for COVID-19; patient tested positive for COVID-19; she is also pregnant; This is a spontaneous report from a contactable pharmacist via Pfizer sponsored program. This pharmacist reported information for both mother and fetus/baby. This is mother case. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date: was not reported), via an unspecified route of administration on 18Mar2021 as Dose 1,single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient was tested positive for COVID-19 and she is also pregnant. The mother reported she became pregnant while taking BNT162B2(Pfizer covid 19 vaccine). The patient underwent lab tests and procedures which included sars-cov-2 test positive on unknown date. The patient reports the caller about the vaccine as product complaint issue. The patient was in quarantine before the 2nd Dose was due. The outcome of event was unknown.  Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.; Sender's Comments: Based on the current available limited information in the case provided, the causal association between the event Covid 19 and Drug ineffective and the use of suspect product BNT162B2 cannot be fully assessed as full immunity is known to acquire only after full dosage of Covid19 vaccination. The case will be reassessed if additional information becomes available.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient herself) reported that a 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8730, Expiry date: unknown, at the age of 45-year-old), dose 1 via an unspecified route of administration, administered in arm left on 26Mar2021 15:00 as single for covid-19 immunisation. The vaccination facility was in the stadium. Medical history included support immune system. Concomitant medications included vitamin d NOS, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) for support immune system and ongoing. The patient started taking vitamins since Covid started, for a year ago. No additional vaccines administered on same date of the suspect. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient experienced positive covid-19 test with symptoms on 05Apr2021. The patient asked was it needs to test negative before getting the second dose of Pfizer Covid-19 vaccine on 16Apr2021. The patient was infected with virus after the first dose was given on 26Mar2021. The patient was positive on 05Apr2021, that was when they had the test. Post vaccination, on an unknown date the patient was tired. The patient went to the urgent care where they had the COVID test. The patient was not hospitalised. The patient lab test included COVID-19 test (sars-cov-2 test) was positive on 05Apr2021. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, SARS-CoV-2 test
Clinical narrative: tired; tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 49-year-old male patient (husband) received BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8730, Expiration Date: unknown, Age at Time of Vaccination: 49-year-old), via left upper arm, on 26Mar2021 15:00 as dose 1, single for covid-19 immunisation. Medical history was not reported. The concomitant medications included vitamin D as 50 mcg every day and vitamin C as 282 mg every day, both ongoing from an unspecified date for immunity and to support immune system (Patient started taking vitamins since Covid started, for a year now). It was reported to ask if the patient needed to test negative before getting the second dose of the Pfizer Covid-19 vaccine on 16Apr2021. Reporter was a woman calling on behalf of husband to inform that her husband had his first dose of the Pfizer COVID-19 vaccine on 26Mar2021, and was tested positive for covid-19 on 03Apr2021. Patient has not yet received the second dose of the product. He went to an Urgent Care where they did the test. Patient was not hospitalized. Patient took no prior vaccinations (within 4 weeks). Patient experienced no adverse events prior vaccinations, he was tired after the covid-19 vaccine. Lab test included COVID-19 Test positive on 03Apr2021. The outcome of events were unknown.     No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine; This is a spontaneous report from a Pfizer-sponsored program  A contactable consumer reported for a 17-year-old female patient (daughter). A 17-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8730), via an unspecified route of administration on left upper arm on 26-MAR-2021 15:00 (Age at Vaccination: 17 years) at single dose for protection, the patient is in volleyball and working. There was no Prior Vaccinations and Adverse events following prior vaccinations. The patient medical history was not reported. Patient's Medical History (including any illness at time of vaccination) was reported as none. Family Medical History Relevant to adverse events was reported as none. The patient Concomitant medications included VITAMIN C ASC ACID and VITAMIN D [COLECALCIFEROL], both taken for immunity and to support immune system since Covid started, for a year now. On 05Apr2021, the patient tested positive for covid-19 after receiving the first dose of the Pfizer covid-19 vaccine. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none.The reporter called on behalf of her daughter to ask if she needs to test negative before getting the second dose of the Pfizer Covid-19 vaccine on 16Apr2021. CEP agent states the patient had covid-19 on 3Apr2021. Is there a Product Complaint: Yes. The relevant lab test included test: COVID-19 Test, result: positive on 05Apr2021. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Fatigue, Liver injury
Clinical narrative: feel very tired; Since the second vaccine I've experienced, on a daily basis, a temperature rise of one degree when I awaken to 98.6 which rises to 99.7 in the late afternoon and reverts back to 98.6 at bed time.; Tylenol is going to wreck my Liver; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient) reported that a 65-years-old non-pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 17:45 as 2ND DOSE, SINGLE for covid-19 immunisation; paracetamol (TYLENOL), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. Medical history included asthma; high blood pressure and high cholesterol. Patient had allergies to medications, food, or other products includes Penicillin. Concomitant medication(s) included hydrochlorothiazide (HYDROCHLOROTHIAZIDE); montelukast sodium (MONTELUKAST SODIUM) and atorvastatin (ATORVASTATIN). On an unknown date in Apr2021, the patient experienced tylenol is going to wreck my liver; On 06Apr2021 16:00, since the second vaccine i've experienced, on a daily basis, a temperature rise of one degree when i awaken to 98.6 which rises to 99.7 in the late afternoon and reverts back to 98.6 at bed time; On an unknown date, feel very tired. The patient underwent lab tests and procedures which included body temperature:100.8 on 06Apr2021 went up to 100.8 then the next day it went down to 100.1, then the day after went down to 100 , body temperature: 100.1 on 07Apr2021 the next day it went down to 100.1 , body temperature: 100 on 07Apr2021 then the day after went down to 100 , body temperature: 99.7 on 08Apr2021 then on the 4th day, it went down to 99.7. It was reported that consumer stated since patient second shot of Pfizer COVID 19 vaccine I had on April 5th, I feel very tired and my temperature, I woke up with my temperature of 99.7 and on 11 O' clock at night it goes down to 98.6 and my normal is 97.6. So I feel like it was going on for so long. So was that normal. Consumer stated she want to report this because her doctor said to take Tylenol and Tylenol is going to wreck my Liver, I can't take it every day. She don't go outside the house because she don't know what was going on. Consumer stated she took something for high cholesterol, high blood pressure and asthma. The clinical outcome of event Tylenol is going to wreck my Liver; feel very tired was unknown; while other was not recovered.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain
Clinical narrative: I felt a sharp pain under my left lower rib; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm Left on 06Mar2021 at 08:45 (at the age of 56-year-old) as single dose for covid-19 immunization. Medical history included Crohns disease with ileostomy and Levaquin allergy from an unknown date and unknown if ongoing. Concomitant medications included ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. On 12Mar2021 at 12:00 patient felt a sharp pain under left lower rib and initially thought it was a pulled muscle. It continued to bother the patient. Patient received second doe of vaccine BNT162b2 on an unspecified date and the pain traveled from beneath his rib, up his left side to armpit. After several days patient saw doctor and described to him that the pain was similar to shingles pain that patient had 24 years ago. The doctor put patient on Acyclovir and a muscle relaxant. After 1 month, doctor sent patient for a CT scan, it came back inconclusive. Patient still had the pain under rib. Patient received muscle relaxants as therapeutic measure for the event. Patient required doctor or other healthcare professional office/clinic visit due to the event. The case was reported as non-serious. Outcome of the event was not recovered.  No follow-up attempts are needed. No further information is expected.