chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Palpitations, Pyrexia
Clinical narrative: Fever; Chills; Body Aches; Sweating; Fatigue; Insomnia; Sensation of pounding heart (could feel heart beat); Lethargy; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot Number: ER8727) via an unspecified route, administered in Left Arm on 23Mar2021 at 10:15 AM (34-year-old at vaccination) as single dose for covid-19 immunization. The patient's medical history included heart murmur and occasional anemia. Allergies to medications, food, or other products was reported as none. The patient's concomitant medications were reported as none within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 22:30, the patient experienced fever, chills, body aches, sweating, fatigue, insomnia, sensation of pounding heart (could feel heartbeat), lethargy. The events began 12hrs after 1st dose, and latest for 3 days, but still battling fatigue even after mild activity. Since the vaccination, has the patient was not been tested for COVID-19. No treatment received for resulted adverse events. The outcome of the event fatigue was not recovered, and the outcome of other events was resolving.  Follow-up activities closed. No Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report from a non-contactable consumer or other non hcp.     This is a spontaneous report from a non-contactable consumer (patient).  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 25Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced diarrhea (non-serious) on an unspecified date with outcome of unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Ear infection, Pain in extremity
Clinical narrative: ear infection; feeling off balanced where it was really bad this morning; sore arm; This is a spontaneous report from a contactable consumer reporting for herself via Pfizer sponsored program. A 64-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration on 23Mar2021 (at the age of 64-years-old) as 2ND DOSE, SINGLE for COVID-19 immunisation. Medical history included that she had ear disorder (ear problems) for a while now and had ear surgery in her left ear, immunodeficiency (immunocompromised), blood immunoglobulin g increased and blood iron increased from an unknown date and unknown if ongoing. Concomitant medication(s) included immunoglobulin g human (IGG) taken for immunodeficiency; ascorbic acid (VITAMINS C); colecalciferol (VITAMIN D [COLECALCIFEROL]); atorvastatin calcium (AVAMAX) taken for an unspecified indication from an unspecified start date and ongoing. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Mar2021 for COVID-19 immunisation. The patient experienced ear infection, feeling off balanced where it was really bad that morning, sore arm on unspecified date in Mar2021. Patient was asking when she could take steroids and antibiotic eardrops for an inner ear infection. This caused her concern because she had been feeling off balanced where it was really bad, the morning of this report. She mentioned that she experienced this right after the shot, and it lasted for a while and went away. She also mentioned that she had ear problems for a while now and had ear surgery in her left ear. She is not associating the symptoms she has been experiencing with the vaccine and is saying that it is most likely the ear infection. She mentioned that she just had a sore arm after getting vaccinated and denied any fever and chills afterwards. She mentioned that she is immunocompromised but claims that her immune system as well as she gets IgG infusions every night and takes vitamins C and D regularly. Her IgG and iron were up because of it. She was also taking Avamax. She mentioned that she has been in bed the whole day and that she was able to clean the house yesterday. She mentioned that she felt better and safer after getting vaccinated and felt that she had a better chance. It was reported that patient was associating her symptoms to the vaccine. Additional follow-up on 27Mar2021, reported that patient would like to ask if she can continue to take her prescribed medication such as steroids and antibiotic drop on her ear. Clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Localised infection
Clinical narrative: active infection/the spot was infected; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported for a male patient (Husband). A male patient of an unspecified age received first dose of 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 an unspecified date as dose 1, single for covid-19 immunization. Medical history included had a spot on his chest. The patient's concomitant medications were not reported. The patient experienced active infection/ spot was infected on 22Mar2021. Reporter and husband both had 1st dose of the Pfizer Covid 19 vaccine with 2nd dose due on 26Mar2021 (Friday). Prior to receiving 1st shot, husband had a spot on his chest which was removed after receiving 1st shot. After removal yesterday the spot was infected. Reporter would like to know if husband can receive the 2nd Covid vaccine on Friday with an active infection and while taking medication. Therapeutic measure was taken as result of event, unspecified medication. The outcome of event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 52-year-old male patient received First dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER2613), via an unspecified route of administration, administered in Arm Left on 27Mar2021 17:00 (at the age of 52-year-old) as dose 1, single for covid-19 immunisation. Medical history and known allergies were reported as no. Concomitant medications included atorvastatin (LIPITOR), amlodipine (NORVASK), omeprazole (PROTONIX). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included Lipitor, Norvask, Protonix. The patient experienced fever 101 on 28Mar2021 at 12:00. Seriousness of the event was reported as non-serious. The patient underwent lab tests and procedures which included body temperature: 101 on an unspecified date. The patient did not have covid prior to vaccination and has not been tested for Covid-19 post vaccination. The patient did not receive any treatment for the adverse event. The outcome of event was recovered on an unspecified date of 2021. No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anger, Asthenia, COVID-19, Chest pain, Chills
Clinical narrative: Crying; Positive for COVID; Headache; aches; Coughing; Feels weak and powerless; Chest pain between boobs that was very heavy; Angry; Chills/shivering; cold; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), intramuscular, administered in Arm Left on 16Mar2021 (at the age of 50-years-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 17Mar2021 the patient experienced headache, aches, coughing, feels weak and powerless, chest pain between boobs that was very heavy, angry, chills/shivering, cold. On 22Mar2021 the patient experienced positive for covid. On an unknown date the patient experienced crying. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Mar2021. The outcome of the events positive for covid, aches, cold and crying was unknown, for the event chest pain between boobs that was very heavy the outcome was resolved on 19Mar2021, for rest of the events the outcome was resolving.   Description of complaint: Patient received Pfizer COVID vaccine on 16Mar2021 and tested positive for COVID on 22Mar2021. Processing complaint for LOE as per verbatim not clear after first shot or second Covid positive. No correspondence as reporter information not provided. Reporter, his wife, son and daughter all received the Pfizer COVID vaccine. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6206 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations, and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EN6206, fill lot EN5339, and the bulk formulated drug product lot EN5327. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Crying, Headache, Nasopharyngitis, Pain
Clinical narrative: Crying; Positive for COVID; Headache; aches; Coughing; Feels weak and powerless; Chest pain between boobs that was very heavy; Angry; Chills/shivering; cold; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), intramuscular, administered in Arm Left on 16Mar2021 (at the age of 50-years-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 17Mar2021 the patient experienced headache, aches, coughing, feels weak and powerless, chest pain between boobs that was very heavy, angry, chills/shivering, cold. On 22Mar2021 the patient experienced positive for covid. On an unknown date the patient experienced crying. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Mar2021. The outcome of the events positive for covid, aches, cold and crying was unknown, for the event chest pain between boobs that was very heavy the outcome was resolved on 19Mar2021, for rest of the events the outcome was resolving.   Description of complaint: Patient received Pfizer COVID vaccine on 16Mar2021 and tested positive for COVID on 22Mar2021. Processing complaint for LOE as per verbatim not clear after first shot or second Covid positive. No correspondence as reporter information not provided. Reporter, his wife, son and daughter all received the Pfizer COVID vaccine. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6206 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations, and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EN6206, fill lot EN5339, and the bulk formulated drug product lot EN5327. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Crying; Positive for COVID; Headache; aches; Coughing; Feels weak and powerless; Chest pain between boobs that was very heavy; Angry; Chills/shivering; cold; This is a spontaneous report from a contactable consumer. A 50-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Batch/Lot Number: EN6206; Expiration Date: 30Jun2021), intramuscular, administered in Arm Left on 16Mar2021 (at the age of 50-years-old) as dose number unknown, 0.3ml single for covid-19 immunisation. The medical history and concomitant medications were not reported. On 17Mar2021 the patient experienced headache, aches, coughing, feels weak and powerless, chest pain between boobs that was very heavy, angry, chills/shivering, cold. On 22Mar2021 the patient experienced positive for covid. On an unknown date the patient experienced crying. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 22Mar2021. The outcome of the events positive for covid, aches, cold and crying was unknown, for the event chest pain between boobs that was very heavy the outcome was resolved on 19Mar2021, for rest of the events the outcome was resolving.   Description of complaint: Patient received Pfizer COVID vaccine on 16Mar2021 and tested positive for COVID on 22Mar2021. Processing complaint for LOE as per verbatim not clear after first shot or second Covid positive. No correspondence as reporter information not provided. Reporter, his wife, son and daughter all received the Pfizer COVID vaccine. He did not get tested for COVID, but his wife, son and daughter did and they all tested positive after receiving the vaccine. He assumes he has COVID as well since he has the same symptoms and lives in the same household. Conclusion: The complaint for an adverse event requested by Safety with the use of the PFIZER-BIONTECH COVID-19 VACCINE lot EN6206 was investigated. The investigation included reviewing the manufacturing and packaging batch records, retained reference samples, deviation investigations, and an analysis of the complaint history for the reported lot and product type. The final scope was expanded to the reported finished goods lot EN6206, fill lot EN5339, and the bulk formulated drug product lot EN5327. A complaint sample or photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. The complaint was not confirmed.  Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chills, Dizziness, Feeling of body temperature change
Clinical narrative: it felt like a really bad flu; feeling icky and chilly and cold and hot; sweating; Feeling cold and then hot; high blood pressure/Blood pressure was crazy; nausea; dizziness; chills; she woke up so sick.; Headache; Aches; sore arm/Soreness of arm; This is a spontaneous report from a contactable consumer (patient herself).  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534, Expiry date: Unknown) via an unspecified route of administration in Left arm on 25Mar2021 at the age of 67-years-old as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. On 25Mar2021, the patient experienced soreness of her arm, on 28Mar2021, experienced blood pressure was crazy, nauseous, dizziness, headache, aches, feeling cold and then hot, she woke up so sick and chills, on an unspecified date experienced it felt like a really bad flu, feeling icky and chilly and cold and hot and sweating. Caller reported that yesterday, 28Mar2021, her blood pressure went way high.  Caller reported that yesterday, 28Mar2021, she tried to get up to go to the bathroom and was dizzy and nauseous. Caller reported that her blood pressure this morning, 29Mar2021 her blood pressure was still elevated. Caller reported that she got dizzy and nauseous again today, 29Mar2021, but that her blood pressure was ok when a second reading was taken. Caller reported that yesterday her headache was extreme and felt like her brain was going to blow off. Caller reported that one minute she would be feeling cold and the next minute she would be sweating. She reported that the day before on 28Mar2021, her blood pressure was crazy, she was nauseous, dizzy, and she thought her head was going to blow off. She reported that she stayed in bed and took aspirin the previous day on 28Mar2021. Caller reported that when she woke up this morning, 29Mar2021, she thought her headache was gone.  Caller reported that she got up to go to yoga and thought she couldn't even get in the car to drive. The patient underwent lab tests and procedures which included Blood pressure: 172/106 on 28Mar2021 and 154/92 on 29Mar2021. The outcome of event, Soreness of arm was recovered on 27Mar2021 and for high blood pressure/Blood pressure was crazy, chills, sick, feeling icky and chilly and cold and hot, sweating was unknown and for other events was recovering.  Batch/lot number was obtained. Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Illness, Influenza, Malaise
Clinical narrative: it felt like a really bad flu; feeling icky and chilly and cold and hot; sweating; Feeling cold and then hot; high blood pressure/Blood pressure was crazy; nausea; dizziness; chills; she woke up so sick.; Headache; Aches; sore arm/Soreness of arm; This is a spontaneous report from a contactable consumer (patient herself).  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534, Expiry date: Unknown) via an unspecified route of administration in Left arm on 25Mar2021 at the age of 67-years-old as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. On 25Mar2021, the patient experienced soreness of her arm, on 28Mar2021, experienced blood pressure was crazy, nauseous, dizziness, headache, aches, feeling cold and then hot, she woke up so sick and chills, on an unspecified date experienced it felt like a really bad flu, feeling icky and chilly and cold and hot and sweating. Caller reported that yesterday, 28Mar2021, her blood pressure went way high.  Caller reported that yesterday, 28Mar2021, she tried to get up to go to the bathroom and was dizzy and nauseous. Caller reported that her blood pressure this morning, 29Mar2021 her blood pressure was still elevated. Caller reported that she got dizzy and nauseous again today, 29Mar2021, but that her blood pressure was ok when a second reading was taken. Caller reported that yesterday her headache was extreme and felt like her brain was going to blow off. Caller reported that one minute she would be feeling cold and the next minute she would be sweating. She reported that the day before on 28Mar2021, her blood pressure was crazy, she was nauseous, dizzy, and she thought her head was going to blow off. She reported that she stayed in bed and took aspirin the previous day on 28Mar2021. Caller reported that when she woke up this morning, 29Mar2021, she thought her headache was gone.  Caller reported that she got up to go to yoga and thought she couldn't even get in the car to drive. The patient underwent lab tests and procedures which included Blood pressure: 172/106 on 28Mar2021 and 154/92 on 29Mar2021. The outcome of event, Soreness of arm was recovered on 27Mar2021 and for high blood pressure/Blood pressure was crazy, chills, sick, feeling icky and chilly and cold and hot, sweating was unknown and for other events was recovering.  Batch/lot number was obtained. Further information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pain in extremity
Clinical narrative: it felt like a really bad flu; feeling icky and chilly and cold and hot; sweating; Feeling cold and then hot; high blood pressure/Blood pressure was crazy; nausea; dizziness; chills; she woke up so sick.; Headache; Aches; sore arm/Soreness of arm; This is a spontaneous report from a contactable consumer (patient herself).  A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534, Expiry date: Unknown) via an unspecified route of administration in Left arm on 25Mar2021 at the age of 67-years-old as 1st dose, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior Vaccinations within 4 weeks were none. Adverse events following prior vaccinations were none. Family medical history relevant to adverse events were none. Relevant tests were none. On 25Mar2021, the patient experienced soreness of her arm, on 28Mar2021, experienced blood pressure was crazy, nauseous, dizziness, headache, aches, feeling cold and then hot, she woke up so sick and chills, on an unspecified date experienced it felt like a really bad flu, feeling icky and chilly and cold and hot and sweating. Caller reported that yesterday, 28Mar2021, her blood pressure went way high.  Caller reported that yesterday, 28Mar2021, she tried to get up to go to the bathroom and was dizzy and nauseous. Caller reported that her blood pressure this morning, 29Mar2021 her blood pressure was still elevated. Caller reported that she got dizzy and nauseous again today, 29Mar2021, but that her blood pressure was ok when a second reading was taken. Caller reported that yesterday her headache was extreme and felt like her brain was going to blow off. Caller reported that one minute she would be feeling cold and the next minute she would be sweating. She reported that the day before on 28Mar2021, her blood pressure was crazy, she was nauseous, dizzy, and she thought her head was going to blow off. She reported that she stayed in bed and took aspirin the previous day on 28Mar2021. Caller reported that when she woke up this morning, 29Mar2021, she thought her headache was gone.  Caller reported that she got up to go to yoga and thought she couldn't even get in the car to drive. The patient underwent lab tests and procedures which included Blood pressure: 172/106 on 28Mar2021 and 154/92 on 29Mar2021. The outcome of event, Soreness of arm was recovered on 27Mar2021 and for high blood pressure/Blood pressure was crazy, chills, sick, feeling icky and chilly and cold and hot, sweating was unknown and for other events was recovering.  Batch/lot number was obtained. Further information has been requested.
Sex: U
Vaccine: COVID19, UNK, UNK, UNK, UNK
Symptoms: Aphthous ulcer, Dizziness, Fatigue, Glossodynia
Clinical narrative: I felt a little tired; Dizzy; I got canker sores under my tongue and on my tongue and it hurt very much; I got canker sores under my tongue and on my tongue and it hurt very much; This is a spontaneous report from a non-contactable consumer (patient). A patient (unspecified age and gender) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6198), via an unspecified route of administration on 15Mar2021 as single dose for covid-19 immunisation; potassium chloride (POTASSIUM CHLORIDE, 750 mg for an unspecified indication); chromium picolinate (CHROMIUM PICOLINATE, 200 ug and still ongoing for an unspecified indication); phentermine (PHENTERMINE, 37.5 mg and still ongoing for an unspecified indication); hydrochlorothiazide (HYDROCHLOROTHIAZIDE, 25 mg for an unspecified indication). Reported that patient stopped taking the Hydrochlorothiazide and I stopped the Potassium Chloride after 2 days because it made me dizzy. So I still take the Phentermine and the Chromium picolinate. The patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201), on 15Mar2021 as single dose for covid-19 immunisation and experienced Little tired on the 2nd day. Reported that two weeks before that I had the 1st one and all I felt a little tired on the 2nd day but I don't know if this canker sores are from the Pfizer. Reported that patient took two medicines on Monday and I started it on Monday so there is a 50-50 chance that is the medicine or the Pfizer. On 18Mar2021, the patient experienced i got canker sores under my tongue and on my tongue and it hurt very much, on an unspecified date, the patient experienced i felt a little tired, dizzy. It was reported that reporter seriousness for I got canker sores under my tongue and on my tongue and it hurt very much, I felt a little tired, Dizzy was unspecified. Reported that 4 days after my 2nd shot I got canker sores under my tongue and on my tongue and it hurt very much because canker sore hurt. But it is a possible side effect because it was 4 days after the 2nd one. Thursday I got this canker sores though and in addition I started taking some extra pills different pills so I don't know if those pills caused me to have the canker sores. So that's why I say possible side effects. The outcomes of all events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Drug hypersensitivity, Erythema, Headache, Lymphadenopathy
Clinical narrative: sore,achy; allergic reaction; swollen glands; sore throat; fever up to 101F; face, ears, neck and chest turned bright red, very hot; face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish; nausea; Headache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 17Mar2021, as dose 2, 0.3 ml single, in left arm, for COVID-19 immunisation. The patient's medical history included unspecified allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 24Feb2021, as single dose in left arm for COVID-19 immunization. The patient's historical vaccine also included flu shot in Oct2020 and was bruised, the whole musculature from the shoulder to almost elbow, was very sore. The patient's past medication included Tetracycline take for unknown indication and experienced allergy. On 18Mar2021, 1 day after the second dose of vaccine, the patient experienced headache and nausea. On 19Mar2021, the patient experienced fever up to 101, her face, ears, neck and chest turned bright red, very hot to touch. Patient's ace, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and had allergic reactions. On an unspecified date after the second dose, the patient also experienced swollen glands, a little achy, sore and had sore throat. The patient underwent lab test and procedure which included body temperature: 101. The clinical outcome of event fever up to 101 was resolved on an unspecified date and event nausea was resolved on 20Mar2021. The clinical outcome of events headache, face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and event face, ears, neck and chest turned bright red, very hot was resolving. The clinical outcome of all other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia, Swelling
Clinical narrative: sore,achy; allergic reaction; swollen glands; sore throat; fever up to 101F; face, ears, neck and chest turned bright red, very hot; face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish; nausea; Headache; This is a spontaneous report from a contactable consumer. A 69-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6207), via an unspecified route of administration on 17Mar2021, as dose 2, 0.3 ml single, in left arm, for COVID-19 immunisation. The patient's medical history included unspecified allergies. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6198), via an unspecified route of administration on 24Feb2021, as single dose in left arm for COVID-19 immunization. The patient's historical vaccine also included flu shot in Oct2020 and was bruised, the whole musculature from the shoulder to almost elbow, was very sore. The patient's past medication included Tetracycline take for unknown indication and experienced allergy. On 18Mar2021, 1 day after the second dose of vaccine, the patient experienced headache and nausea. On 19Mar2021, the patient experienced fever up to 101, her face, ears, neck and chest turned bright red, very hot to touch. Patient's ace, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and had allergic reactions. On an unspecified date after the second dose, the patient also experienced swollen glands, a little achy, sore and had sore throat. The patient underwent lab test and procedure which included body temperature: 101. The clinical outcome of event fever up to 101 was resolved on an unspecified date and event nausea was resolved on 20Mar2021. The clinical outcome of events headache, face, ears, throat, neck, and chest were bright red and bumpy and swollen, looked like a red puffer fish and event face, ears, neck and chest turned bright red, very hot was resolving. The clinical outcome of all other events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: now I feel like I have a cold with an off and on low grade fever; now I feel like I have a cold with an off and on low grade fever; This is a spontaneous report from a contactable consumer.  A female consumer of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot Number: EP6955) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient reported now she felt like she had a cold with an off and on low grade fever on 26Mar2021 with outcome of unknown. She stated that if she calls her doctor all they are going to tell her to take some Mucinex.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Feeling hot, Heart rate increased
Clinical narrative: felt anxious; hot; had a fast heart beat for a minute; This is a spontaneous report from a contactable consumer.  A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 29Mar2021 (Batch/Lot number was not reported) (at the age of 61- year-old) as single dose for covid-19 immunisation.  The patient had received first dose of vaccine on an unknown date. The patient medical history was not reported.  The patient's concomitant medications were not reported.  History included she has an allergy to Penicillin.  After a few minutes of vaccine administration, the patient felt anxious, then really hot, she was fanning herself, had a fast heart beat for a minute, after a minute it went away and she didn't tell anyone. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: closing of the throat; This is a spontaneous report from a contactable consumer. A 91-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown), dose 2 via an unspecified route of administration on an unspecified date (at the age of 91-year-old) as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, it was unknown whether the patient has been tested for COVID-19. On an unspecified date after second dose, the patient experienced a sensation of the closing of the throat. The patient called 911 and EMTs came to assist. She declined going to the hospital and stayed with her daughter that night for observation. The symptoms subsided by the next day. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The outcome of the event was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 58-years-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in left arm on 16Mar2021 at 09:30 as dose 1, single (at the age of 58-years-old) for COVID-19 immunization. Medical history included salfa allergy. There were no concomitant medications. Prior to the vaccination, within four weeks patient did not receive any other vaccines and not diagnosed with COVID-19. And not received any other medications within 2 weeks of vaccination. On 19Mar2021 at 16:00, The patient experienced fever 102, headache, chills and nausea. The patient underwent lab tests and procedures which included body temperature: 102 (unknown units) on 19Mar2021. Since the vaccination, the patient had not been tested for COVID-19. The reporter classified the events as non-serious and stated the events result doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The outcome of the events was resolving. No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Headache, Pain
Clinical narrative: Headache; Flare ups of pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable other HCP and a contactable consumer (patient) reported that:  A 65-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 (at the age of 65-years-old), as dose 1, single for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), oral route, daily, from 17Dec2020 (Batch/Lot number was not reported) to an unspecified date, at 11 mg (Tablet (30's), as reported), daily for rheumatoid arthritis. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced headache and flare ups of pain. Patient states received 1st dose of COVID vaccine 03Mar2021 and has had headaches on and off and flare ups of pain for the past 2-3 weeks and it has been better the past 2-3 days no headaches or pain. MD was aware. No description of severity (i.e. If hospitalized for event). Not any medications patient was using at or around the time of the adverse event and dates of therapy. (Exclude medications used to treat event.) No any relevant tests/laboratory data including dates. Outcome of the events was recovered on an unspecified date.  No follow-up attempts are needed. Information on Batch number, Lot number cannot be obtained.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood test, COVID-19, Chills, Headache
Clinical narrative: fever of 101.6; headache; chills; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265), dose 2 intramuscular, administered in Arm Left on 16Feb2021 at 13:00 (65-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no other vaccine within 4 weeks prior to the current vaccination. The patient had received the first dose of the bnt162b2 on 01Feb2021 and had experienced Itching rash/ hives.  Concomitant medication included prednisone. On 16Feb2021 22:00, the patient experienced fever of 101.6, headache, chills and body ache. It was reported that the patient was advised to get 2nd vaccine. The patient had lowered prednisone on 26feb 2021 by dermatologist visit. Being weaned off prednisone slowly. At the date of report rash itching 99% gone, some residual marks on arms prednisone dose 2.5 mg every other until 26Mar2021 then wean off antihistamine. It was reported that the second dose of vaccine had typical adverse reaction. As bad as all of this was she felt blessed to have received and complete covid 19 vaccine and thanked Pfizer. The patient gave consent to contact her if additional information was required. The patient underwent lab tests and procedures which included blood glucose: high on 12Feb2021, blood test: high   on 12Feb2021 Out of range , covid-19: negative on 08Feb2021, neutrophil count: high on 12Feb2021, white blood cell count: high on 12Feb2021. Treatment was given with Motrin for the events. Outcome of the events were recovered on 17Feb2021 at 22:00 hours.   No Follow-up attempts are needed. No further information is expected
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Neutrophil count, Pain, Pyrexia, White blood cell count
Clinical narrative: fever of 101.6; headache; chills; body ache; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265), dose 2 intramuscular, administered in Arm Left on 16Feb2021 at 13:00 (65-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. The patient had no other vaccine within 4 weeks prior to the current vaccination. The patient had received the first dose of the bnt162b2 on 01Feb2021 and had experienced Itching rash/ hives.  Concomitant medication included prednisone. On 16Feb2021 22:00, the patient experienced fever of 101.6, headache, chills and body ache. It was reported that the patient was advised to get 2nd vaccine. The patient had lowered prednisone on 26feb 2021 by dermatologist visit. Being weaned off prednisone slowly. At the date of report rash itching 99% gone, some residual marks on arms prednisone dose 2.5 mg every other until 26Mar2021 then wean off antihistamine. It was reported that the second dose of vaccine had typical adverse reaction. As bad as all of this was she felt blessed to have received and complete covid 19 vaccine and thanked Pfizer. The patient gave consent to contact her if additional information was required. The patient underwent lab tests and procedures which included blood glucose: high on 12Feb2021, blood test: high   on 12Feb2021 Out of range , covid-19: negative on 08Feb2021, neutrophil count: high on 12Feb2021, white blood cell count: high on 12Feb2021. Treatment was given with Motrin for the events. Outcome of the events were recovered on 17Feb2021 at 22:00 hours.   No Follow-up attempts are needed. No further information is expected
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: he received his first dose of the vaccine on 14Mar2021 and tested positive for Covid  a couple weeks after the first dose on 24Mar2021; This is a spontaneous report from a contactable consumer (patient, self-reporting) via Medical Information Team. A 62-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown and expiration date was not reported), via an unspecified route of administration on 14Mar2021 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. He received his first dose of the vaccine on 14Mar2021 and tested positive for COVID a couple weeks after the first dose on 24Mar2021. He did not have any symptoms or anything. He was tested because he had an exposure. He asked if he can still get his second dose on Saturday. He stated he was going to go up there on Saturday and talk to them. He stated that he got an invitation for Saturday to receive his second dose but he was having an issue with the thing using the link that they sent him. He wanted assistance. He stated he cannot use computers and declined the website from the attached document. He stated he will just go up there and talk to them. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 24Mar2021. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Hypersensitivity, Palpitations, Rash
Clinical narrative: Maybe vaccine immune response made me extra sensitive; broke out in a rash on face and chest; racy heart rate after vaccination; This is a spontaneous report received from a contactable consumer (patient). A 50-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- ER26B) via an unspecified route of administration in left arm on 25Mar2021 at 11:00 (at the age of 50-years-old) as dose 2, single for COVID-19 immunization. Medical history included Colitis ulcerative (from May 2000-ongoing). Patient was allergic to clindamycin, fennel, cinnamon, adhesive. The patient previously took clindamycin and experienced allergy to clindamycin. Concomitant medication received within 2 weeks of vaccination included adalimumab (HUMIRA). Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6198) via an unspecified route of administration in arm on 04Mar2021 at 15.00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization and no reaction on previous exposure to vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant at the time of vaccination. On 31Mar2021, 6 days later patient broke out in a rash on face and chest. Patient went through her week to see if any new products, topical ETC, food, touched anything etc but no other unusual culprit. Patient had a friend trouble shoot this with her as well. The only X factor was the vaccine. On 31Mar2021 at 13:00 hours, patient stated maybe vaccine immune response made her extra sensitive. The rash was still there. If it does not go away, She will check with in with her allergy doctor. Patient stated living in covid, She was able 2 isolate the one change -vaccine. On unspecified date in 2021, she also had racy heart rate after vaccination. Cleared up by June. Patient took lots of Benadryl plus oatmeal baths for broke out in a rash on face and chest. Since the vaccination, the patient had not been tested for COVID-19. Reporter assessed the seriousness as important medical event. The outcome of the event racing heart rate increased was recovered on an unspecified date in Jun 2021 and outcome of the other events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: experienced fever overnight; This is a spontaneous report received from a Pfizer sponsored program. A contactable consumer reported for a female patient (mother) of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number and expiration date: Not reported), via an unspecified route of administration on 26Mar2021, as a DOSE 1 SINGLE FOR COVID-19 IMMUNIZATION. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced experienced fever overnight'. Caller was asking if this is a normal side effect of the vaccine and if his mother can take a medicine for the fever. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: has an infection; This is a spontaneous report from Pfizer-sponsored program female patient reported for(herself). A Non-contactable female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date was not reported) via unspecified route of administration on unspecified date as dose number unknow, single for COVID-19 Immunization. The patient medical history and concomitant medications were not reported. It was unknown patient was pregnant. On unspecified date, patient taken the vaccine and has an infection and was wondering if she could take a medication called macrobid. Patient was explaining her problem caller stop responding and few minutes later hanged up. The outcome of the event was unknown.  No follow up needed. No further information is excepted.