chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Erythema, Extra dose administered, Nausea
Clinical narrative: After my third vaccine, I had an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. I am now at the 72 hour mar; After my third vaccine, I had an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. I am now at the 72 hour mar; acute stomach pain; nausea; diarrhea; vomiting; very itchy palms and feet.; The itchiness/redness on palms, fingers, and feet are acute when my stomach does not hurt; This is a spontaneous report from a contactable Consumer, reported for herself. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3180), dose 3 via an unspecified route of administration, administered in Arm Left on Mar2021 as a single dose for covid-19 immunization. Medical history included colitis ulcerative, hypothyroidism, anxiety, drug hypersensitivity. Concomitant medications received within 2 weeks of vaccination Entivyo infusion, Ozempic (75). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3180), dose 2 via an unspecified route of administration, administered in Arm Left on Mar2021 15:00 as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm right on 30Mar2021 09:00 as a single dose for covid-19 immunization. The patient had allergies with sulpha drugs. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After my third vaccine, the patient experienced an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. "I am now at the 72 hour mark and I am not able to keep any food down. Additionally, last night I woke up with very itchy palms and feet. There was no rash nor itchy feeling at the injection site. The itchiness/redness on palms, fingers, and feet are acute when my stomach does not hurt." The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. Narrative was added with case closure comment. No F/up activities required as per the AEM01 FAQ, no F/U is required for off label use without an associated AE Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Pruritus, Vomiting
Clinical narrative: After my third vaccine, I had an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. I am now at the 72 hour mar; After my third vaccine, I had an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. I am now at the 72 hour mar; acute stomach pain; nausea; diarrhea; vomiting; very itchy palms and feet.; The itchiness/redness on palms, fingers, and feet are acute when my stomach does not hurt; This is a spontaneous report from a contactable Consumer, reported for herself. A 46-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3180), dose 3 via an unspecified route of administration, administered in Arm Left on Mar2021 as a single dose for covid-19 immunization. Medical history included colitis ulcerative, hypothyroidism, anxiety, drug hypersensitivity. Concomitant medications received within 2 weeks of vaccination Entivyo infusion, Ozempic (75). Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: FC3180), dose 2 via an unspecified route of administration, administered in Arm Left on Mar2021 15:00 as a single dose for covid-19 immunization. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6203), dose 1 via an unspecified route of administration, administered in Arm right on 30Mar2021 09:00 as a single dose for covid-19 immunization. The patient had allergies with sulpha drugs. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. After my third vaccine, the patient experienced an onset of acute stomach pain at 7:30pm on August 24th (2 days after vaccine) followed by another 24 hours of nausea, diarrhea, and vomiting. "I am now at the 72 hour mark and I am not able to keep any food down. Additionally, last night I woke up with very itchy palms and feet. There was no rash nor itchy feeling at the injection site. The itchiness/redness on palms, fingers, and feet are acute when my stomach does not hurt." The patient did not receive any treatment. Outcome of the event was recovering, at the time of this report. Narrative was added with case closure comment. No F/up activities required as per the AEM01 FAQ, no F/U is required for off label use without an associated AE Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cold sweat, Extra dose administered, Headache
Clinical narrative: fever (tmax 102.1F); chills; Cold sweat; headache; I developed swelling and a mild rash at the injection site; I developed swelling and a mild rash at the injection site; along with axillary lymphadenopathy; I received a third dose of the COVID vaccine on 23Aug/2021 as I am immune compromised and qualify for the booster dose.; I received a third dose of the COVID vaccine on 23/Aug/2021 as I am immune compromised and qualify for the booster dose.; This is a spontaneous report from a contactable Other HCP (patient). A 25-years-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FO8448), via an unspecified route on 23Aug2021 (at the age of 25-years) as dose 3, single in the left arm for covid-19 immunisation. The patient medical history included lupus nephritis, asthma and known allergies to sulfa antibiotics, amoxicillin, hyroxycholoroquine. The patient concomitant medications included Mycophenolic Acid, Tacrolimus (oral), Pantoprazole from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route on 28Jan2021 (at the age of 24-years) as dose 1, single in the left arm and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route on 18Feb2021 (at the age of 24-years) as dose 2, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Aug2021, the patient received a third dose of the COVID vaccine on 23Aug2021 as I am immune compromised and qualify for the booster dose, 12 hours post-injection, patient experienced fever (tmax 102.1F), chills, cold sweats, and headache. These symptoms resolved around 28 hours post-injection, 36 hours post injection, she developed swelling and a mild rash at the injection site, along with axillary lymphadenopathy. Patient did not received treatment for events. The outcome of the events was fever (tmax 102.1F), chills, cold sweats, and headache, swelling and a mild rash at the injection site, along with axillary lymphadenopathy was recovering and other events was unknown.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Off label use, Pyrexia, Vaccination site rash, Vaccination site swelling
Clinical narrative: fever (tmax 102.1F); chills; Cold sweat; headache; I developed swelling and a mild rash at the injection site; I developed swelling and a mild rash at the injection site; along with axillary lymphadenopathy; I received a third dose of the COVID vaccine on 23Aug/2021 as I am immune compromised and qualify for the booster dose.; I received a third dose of the COVID vaccine on 23/Aug/2021 as I am immune compromised and qualify for the booster dose.; This is a spontaneous report from a contactable Other HCP (patient). A 25-years-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FO8448), via an unspecified route on 23Aug2021 (at the age of 25-years) as dose 3, single in the left arm for covid-19 immunisation. The patient medical history included lupus nephritis, asthma and known allergies to sulfa antibiotics, amoxicillin, hyroxycholoroquine. The patient concomitant medications included Mycophenolic Acid, Tacrolimus (oral), Pantoprazole from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL8982), via an unspecified route on 28Jan2021 (at the age of 24-years) as dose 1, single in the left arm and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9267), via an unspecified route on 18Feb2021 (at the age of 24-years) as dose 2, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Aug2021, the patient received a third dose of the COVID vaccine on 23Aug2021 as I am immune compromised and qualify for the booster dose, 12 hours post-injection, patient experienced fever (tmax 102.1F), chills, cold sweats, and headache. These symptoms resolved around 28 hours post-injection, 36 hours post injection, she developed swelling and a mild rash at the injection site, along with axillary lymphadenopathy. Patient did not received treatment for events. The outcome of the events was fever (tmax 102.1F), chills, cold sweats, and headache, swelling and a mild rash at the injection site, along with axillary lymphadenopathy was recovering and other events was unknown.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Extra dose administered, Off label use, Pain in extremity
Clinical narrative: low grade fever, 99.6 degrees; Red spot on arm; Arm sore; Says she was fine after the booster vaccine; Says she was fine after the booster vaccine; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0187, expiry date: not reported, Age at vaccination: 60-year-old) via an unspecified route of administration on 20Aug2021 as DOSE 3, SINGLE for COVID-19 immunization. The patient medical history included immunocompromised. Concomitant medications were not reported. Historical vaccine included bnt162b2 (Lot number: EL3249) on 14Jan2021 as DOSE 1 and bnt162b2 (Lot number: EN9581) on 04Feb2021 as DOSE 2, SINGLE for covid-19 immunization. On 21Aug2021, patient experienced low grade fever, red spot on arm, arm sore, off label use and extra dose administered. She stated that she got the second dose of the Pfizer Covid Vaccine because she is a MS patient and was not able to walk after the second dose of the vaccine. She stated that she is in the immunocompromised risk category so she was eligible for the booster vaccine. States she got it and just had a low grade fever and a red spot on her arm and that's it. She called her neurologist after not being able to walk after the second dose of the vaccine; but she has not called him since she got the booster vaccine. She had to call emergency medical services after the second dose of the vaccine because she got to the bathroom but then could not get back off of the toilet and couldn't walk. She got her booster vaccine last Thursday, then states it was 20Aug2021. Caller verifies that she got the vaccine on 20Aug2021. Says she was fine after the booster vaccine. The next day she had a low grade fever that got to maybe 99.6 degrees. Red spot on her arm was also sore. Says it was about the size of a quarter or a fifty cent piece. Says it has gotten smaller and her arm is only sore if she touches that area. She stated she just wanted to report that after having not been able to walk after the second vaccine; she had not a bad reaction after the booster. The outcome of events extra dose administered, off label use was unknown and for event low grade fever, 99.6 degrees, was recovered, for event, red spot on arm, arm sore was recovering.  Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever, 99.6 degrees; Red spot on arm; Arm sore; Says she was fine after the booster vaccine; Says she was fine after the booster vaccine; This is a spontaneous report from a contactable pharmacist (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0187, expiry date: not reported, Age at vaccination: 60-year-old) via an unspecified route of administration on 20Aug2021 as DOSE 3, SINGLE for COVID-19 immunization. The patient medical history included immunocompromised. Concomitant medications were not reported. Historical vaccine included bnt162b2 (Lot number: EL3249) on 14Jan2021 as DOSE 1 and bnt162b2 (Lot number: EN9581) on 04Feb2021 as DOSE 2, SINGLE for covid-19 immunization. On 21Aug2021, patient experienced low grade fever, red spot on arm, arm sore, off label use and extra dose administered. She stated that she got the second dose of the Pfizer Covid Vaccine because she is a MS patient and was not able to walk after the second dose of the vaccine. She stated that she is in the immunocompromised risk category so she was eligible for the booster vaccine. States she got it and just had a low grade fever and a red spot on her arm and that's it. She called her neurologist after not being able to walk after the second dose of the vaccine; but she has not called him since she got the booster vaccine. She had to call emergency medical services after the second dose of the vaccine because she got to the bathroom but then could not get back off of the toilet and couldn't walk. She got her booster vaccine last Thursday, then states it was 20Aug2021. Caller verifies that she got the vaccine on 20Aug2021. Says she was fine after the booster vaccine. The next day she had a low grade fever that got to maybe 99.6 degrees. Red spot on her arm was also sore. Says it was about the size of a quarter or a fifty cent piece. Says it has gotten smaller and her arm is only sore if she touches that area. She stated she just wanted to report that after having not been able to walk after the second vaccine; she had not a bad reaction after the booster. The outcome of events extra dose administered, off label use was unknown and for event low grade fever, 99.6 degrees, was recovered, for event, red spot on arm, arm sore was recovering.  Follow-Up (30Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Immunisation, Lung disorder, Off label use, Polymerase chain reaction
Clinical narrative: I had my 3rd covid shot yesterday; I had my 3rd covid shot yesterday; I have a problem with my left lung; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Aug2021 at 14:30 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date in 2021 the patient experienced he had a problem with his left lung. The patient underwent lab tests and procedures on an unspecified date which included blood test: unknown results, polymerase chain reaction: unknown results, SARS-CoV-2 test: unknown results. It was reported that "the patient had his 3rd COVID shot yesterday. Question asked "if there is antibody testing available to check his immunity (regarding his 3rd dose). he had a blood test done previously an antigen and PCR test they were designed that he had powerful response to the virus. They said his immune system reacted and he had good protection; had enough protection as a result of the pfizer vaccine." "He asked if the 3rd shot the same dose." Caller stated, "he had a problem with his left lung. He had his 3rd COVID shot yesterday at 2:30 in the afternoon and today at 4pm he took 1 Celebrex pill. He took a pain killer 26 hours after his shot will that negate the covid shot he got. He asked if it would negate the antiviral in terms of protection. He also asked if he need to take another shot." Therapeutic measures were taken as a result of he had a problem with his left lung. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I had my 3rd covid shot yesterday; I had my 3rd covid shot yesterday; I have a problem with my left lung; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 25Aug2021 at 14:30 as dose 3 (booster), single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first and second dose of BNT162B2 administered on an unspecified date for COVID-19 immunization. On an unspecified date in 2021 the patient experienced he had a problem with his left lung. The patient underwent lab tests and procedures on an unspecified date which included blood test: unknown results, polymerase chain reaction: unknown results, SARS-CoV-2 test: unknown results. It was reported that "the patient had his 3rd COVID shot yesterday. Question asked "if there is antibody testing available to check his immunity (regarding his 3rd dose). he had a blood test done previously an antigen and PCR test they were designed that he had powerful response to the virus. They said his immune system reacted and he had good protection; had enough protection as a result of the pfizer vaccine." "He asked if the 3rd shot the same dose." Caller stated, "he had a problem with his left lung. He had his 3rd COVID shot yesterday at 2:30 in the afternoon and today at 4pm he took 1 Celebrex pill. He took a pain killer 26 hours after his shot will that negate the covid shot he got. He asked if it would negate the antiviral in terms of protection. He also asked if he need to take another shot." Therapeutic measures were taken as a result of he had a problem with his left lung. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Extra dose administered, Lymphadenopathy, Off label use
Clinical narrative: Lymph node swelling; pain in left armpit; 3rd dose of vaccine; 3rd dose of vaccine; This is a spontaneous report from a contactable other hcp (nurse) (patient). A 39-year-old (non-pregnant) female patient received third bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in arm left on 28Aug2021 13:00 (at the age of 39-year-old) at dose 3, (booster) single for covid-19 immunisation. Medical history included known allergies: Hazelnut, pollen. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]); ibuprofen (IBUPROFEN); paracetamol (TYLENOL); montelukast sodium (SINGULAIR) all taken for an unspecified indication, start and stop date were not reported, patient received these medications within 2 weeks of vaccination. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EH9899) via an unspecified route of administration, administered in arm left on an unspecified date (at the age of 39-year-old) at dose 1, single for covid-19 immunisation and received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in arm left on 01Jul2021 (at the age of 39-year-old) at dose 2, single for covid-19 immunisation. On 28Aug2021 13:00 the patient experienced 3rd dose of vaccine, on 28Aug2021 21:00 the patient experienced lymph node swelling, pain in left armpit. Reported Event: Lymph node swelling and pain in left armpit after receiving 3rd dose of vaccine. Began. First noticed approximately 8hrs after receiving vaccine, still present 21hr after receiving vaccine. Patient did not received treatment for the adverse events. Outcome of the events lymph node swelling, pain in left armpit was not resolved and remaining other events were unknown.  Follow-Up (08Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Burning sensation, Dyspnoea, Pain, Pain in extremity
Clinical narrative: pain in her arm; a burning sensation; she checked under her arm pit and she had two bumps that were really painful; bumps on her breasts that are really swollen.; bumps on her breasts that are really swollen.; she cannot breath; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, 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. The patient medical history and concomitant medications were not reported. Caller stated that yesterday she had the second dose of the Pfizer COVID-19 vaccine and she was starting to have symptoms. On an unspecified date she had a pain in her arm and a burning sensation as well. She stated that she checked under her arm pit and she had two bumps that were really painful and bumps on her breasts that were really swollen. She stated that her left arm was really aching as well. She stated that she had all these symptoms after the first dose from the first day. She stated that the symptoms just went away three days ago on 23Aug2021. She stated that the pain in her arm and in her breast was really bad. She stated that she felt like she cannot breath and if she took a breathe she had pain in her breast. She also stated she felt like she had tachycardia. Therapeutic measures were taken as a result of pain in her arm and she checked under her arm pit and she had two bumps that were really painful as she stated that someone told her to take 800 mg of Tylenol after getting the shot but the Tylenol didn't even take away 5 percent of the pain. The outcome of event she can not breathe was unknown while it was resolved for all other events on 23Aug2021.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: pain in her arm; a burning sensation; she checked under her arm pit and she had two bumps that were really painful; bumps on her breasts that are really swollen.; bumps on her breasts that are really swollen.; she cannot breath; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, 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. The patient medical history and concomitant medications were not reported. Caller stated that yesterday she had the second dose of the Pfizer COVID-19 vaccine and she was starting to have symptoms. On an unspecified date she had a pain in her arm and a burning sensation as well. She stated that she checked under her arm pit and she had two bumps that were really painful and bumps on her breasts that were really swollen. She stated that her left arm was really aching as well. She stated that she had all these symptoms after the first dose from the first day. She stated that the symptoms just went away three days ago on 23Aug2021. She stated that the pain in her arm and in her breast was really bad. She stated that she felt like she cannot breath and if she took a breathe she had pain in her breast. She also stated she felt like she had tachycardia. Therapeutic measures were taken as a result of pain in her arm and she checked under her arm pit and she had two bumps that were really painful as she stated that someone told her to take 800 mg of Tylenol after getting the shot but the Tylenol didn't even take away 5 percent of the pain. The outcome of event she can not breathe was unknown while it was resolved for all other events on 23Aug2021.  No follow-up attempts are needed; information about lot/batch number can not be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: fever. Overnight fever went up around 102; chills; I had a large red/hot injection site from 2nd-5th day.; joint aches; body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for covid-19 immunisation.  Medical history included rubber sensitivity from an unknown date and unknown if ongoing known allergies: latex, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jul2021 21:00, the patient experienced fever, overnight fever went up around 102, chills, i had a large red/hot injection site from 2nd-5th day, joint aches, body aches. The patient underwent lab tests and procedures which included body temperature: 102 on an 18Jul2021; Verbatim: Overnight fever went up around 102. No treatment was taken as a result of events. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: fever. Overnight fever went up around 102; chills; I had a large red/hot injection site from 2nd-5th day.; joint aches; body aches; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 49-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on an unspecified date as dose 1, single for covid-19 immunisation.  Medical history included rubber sensitivity from an unknown date and unknown if ongoing known allergies: latex, drug hypersensitivity from an unknown date and unknown if ongoing known allergies: Penicillin. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, it was unknown that the patient diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 18Jul2021 21:00, the patient experienced fever, overnight fever went up around 102, chills, i had a large red/hot injection site from 2nd-5th day, joint aches, body aches. The patient underwent lab tests and procedures which included body temperature: 102 on an 18Jul2021; Verbatim: Overnight fever went up around 102. No treatment was taken as a result of events. The outcome of the events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: I spent almost 4 days in bed with fever headache and severe joint/muscle pain.; I spent almost 4 days in bed with fever headache and severe joint/muscle pain.; I spent almost 4 days in bed with fever headache and severe joint/muscle pain.; I had no injection site pain the second time but I was not well until day 6-7 and still weirdly tired until almost 2 weeks after 2nd dose.; I had no injection site pain the second time but I was not well until day 6-7 and still weirdly tired until almost 2 weeks after 2nd dose.; second dose I had a fever much quicker, by about 5pm.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Ew0196 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 18Jul2021 at 12:00 PM (age at vaccination: 49 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies: latex and Penicillin. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization at Pharmacy or Drug Store and had fever, chills, vaccination site warmth, and joint ache. The patient did not receive any other vaccine in four weeks. It was unknown if the patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that with her second dose she had a fever much quicker, by about 5 pm on 18Jul2021. All her symptoms were much much worse. She spent almost 4 days in bed with fever, headache and severe joint/muscle pain. She had no injection site pain the second time but she was not well until day 6-7 and still weirdly tired until almost 2 weeks after 2nd dose. The patient did not receive any treatment for the events. Outcome of the events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I spent almost 4 days in bed with fever headache and severe joint/muscle pain.; I spent almost 4 days in bed with fever headache and severe joint/muscle pain.; I spent almost 4 days in bed with fever headache and severe joint/muscle pain.; I had no injection site pain the second time but I was not well until day 6-7 and still weirdly tired until almost 2 weeks after 2nd dose.; I had no injection site pain the second time but I was not well until day 6-7 and still weirdly tired until almost 2 weeks after 2nd dose.; second dose I had a fever much quicker, by about 5pm.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: Ew0196 and expiry date was not reported), via an unspecified route of administration, in Arm Left, on 18Jul2021 at 12:00 PM (age at vaccination: 49 years), as a single dose for COVID-19 immunization at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. The patient's medical history included known allergies: latex and Penicillin. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as a single dose for COVID-19 immunization at Pharmacy or Drug Store and had fever, chills, vaccination site warmth, and joint ache. The patient did not receive any other vaccine in four weeks. It was unknown if the patient was diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient reported that with her second dose she had a fever much quicker, by about 5 pm on 18Jul2021. All her symptoms were much much worse. She spent almost 4 days in bed with fever, headache and severe joint/muscle pain. She had no injection site pain the second time but she was not well until day 6-7 and still weirdly tired until almost 2 weeks after 2nd dose. The patient did not receive any treatment for the events. Outcome of the events was recovering.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Headache, Influenza, Myalgia, Off label use
Clinical narrative: got the third vaccine; got the third vaccine; Aching; Headache; Muscle ache; Slightly fever; I thought, I got the flu; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number: FC3181), dose 3 via an unspecified route of administration, administered in Arm Right on 16Aug2021 as DOSE 3, SINGLE for covid-19 immunisation. Medical history included Common variable immunodeficiency (It's called CVID- common variable immunodeficiency syndrome), Diabetic Type-I, Coronary artery disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Consumer stated, I take medicine for my heart, I will have all day if I tell you my medication, I have a list that long. (further clarification unknown). The patient previously received first dose of bnt162b2 (Lot number: EN6204) on 09Mar2021 as dose 1, single, second dose of bnt162b2 (Lot number: ER8734) on 24Mar2021 as dose 2, single for COVID-19 immunisation and experienced aching and all that for couple of days. Consumer stated, I just want to know if you guys have some information, I got my 3rd vaccine it's maximum this Monday coming up will be the second two weeks all and because I have an immune deficiency(history) and I have had some of the side effects with the last two shot cause I have just achy and stuff for couple of days, but this one is two weeks out and I am still feeling that way, I don't know but I should still be feeling the effects this far out. Consumer stated, Right, I got the third vaccine because they suggested that you have an immune deficiency you get the third booster, so that's what I did because of the advice the FDA and all has put that information out so when I did, I didn't had no problem, when I got it, first got it, but last couple of times that I have gotten the shot, I am achy and suffered a few days, this is two weeks out and I am still feeling those side effects, I thought I got the flu. The outcome of the events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: got the third vaccine; got the third vaccine; Aching; Headache; Muscle ache; Slightly fever; I thought, I got the flu; This is a spontaneous report from a contactable consumer. A 44-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot number: FC3181), dose 3 via an unspecified route of administration, administered in Arm Right on 16Aug2021 as DOSE 3, SINGLE for covid-19 immunisation. Medical history included Common variable immunodeficiency (It's called CVID- common variable immunodeficiency syndrome), Diabetic Type-I, Coronary artery disease from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Consumer stated, I take medicine for my heart, I will have all day if I tell you my medication, I have a list that long. (further clarification unknown). The patient previously received first dose of bnt162b2 (Lot number: EN6204) on 09Mar2021 as dose 1, single, second dose of bnt162b2 (Lot number: ER8734) on 24Mar2021 as dose 2, single for COVID-19 immunisation and experienced aching and all that for couple of days. Consumer stated, I just want to know if you guys have some information, I got my 3rd vaccine it's maximum this Monday coming up will be the second two weeks all and because I have an immune deficiency(history) and I have had some of the side effects with the last two shot cause I have just achy and stuff for couple of days, but this one is two weeks out and I am still feeling that way, I don't know but I should still be feeling the effects this far out. Consumer stated, Right, I got the third vaccine because they suggested that you have an immune deficiency you get the third booster, so that's what I did because of the advice the FDA and all has put that information out so when I did, I didn't had no problem, when I got it, first got it, but last couple of times that I have gotten the shot, I am achy and suffered a few days, this is two weeks out and I am still feeling those side effects, I thought I got the flu. The outcome of the events was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Illness, Immunisation, Nasopharyngitis, Off label use
Clinical narrative: had a cold ever since the booster dose/didn't know she was suppose to wait 8 months to even get the booster shot, she just went and they gave it to her; She has been sick with a cold; cold/had a cold for a week; had a cold ever since the booster dose/didn't know she was suppose to wait 8 months to even get the booster shot, she just went and they gave it to her; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0183), via an unspecified route of administration, administered in Arm Left on 23Aug2021 11:00 (at the age of 52-year-old) as dose 3 (booster), single for covid-19 immunisation. Medical history included ongoing High blood pressure (Diagnosed about 15 years ago). The patient's concomitant medications were not reported. The patient previously received first dose of bnt162b2 (Batch/Lot Number: EW0182) administered in Arm Left on 21May2021 (at the age of 51-year-old) as dose 1, single and the second dose of bnt162b2 (Batch/Lot Number: EW0183) administered in Arm Left on 14Jun2021 (at the age of 51-year-old) as dose 2, single for covid-19 immunisation and after second dose she slept all day, and her arm was hurting. Additional vaccines administered on same date of the Pfizer suspect was reported as none. On 24Aug2021 at 09:00, the caller experienced cold ever since the booster dose was administered and she asked if that was a normal side effect. Caller reported she had the booster shot and has had a cold for a week. The caller remarked that she did not know she was supposed to wait 8 months to even get the booster shot, she just went, and they gave it to her. She wanted to know if this was normal. She stated she had been sick with a cold since she had the dose. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. The outcome of event cold was not recovered, and sickness was unknown.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Extra dose administered, Feeling hot, Flushing, Off label use, Pain in extremity
Clinical narrative: arm was sore; patient received booster dose of Pfizer; patient received booster dose of Pfizer; flushing; warmth sensation; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: FC3180, Expiry date: Unknown) via an unspecified route of administration on 08Aug2021 as dose 3, single for COVID-19 immunisation. The patient previously received first dose of BNT162B2 for COVID-19 immunization dose 1 (Pfizer Lot: EL0142) on 12Jan2021 and experienced arm pain the next day, fatigue, malaise x 7 days, periodic migraine headaches. The patient received second dose of BNT162B2 for COVID-19 immunization as dose 2 (Pfizer lot: EL3247) on 02Feb2021 and experienced sore arm the next day. Medical history included hiv infection, meniere's disease, autoimmune disorder, polypharmacy, Ménière's disease symptoms have worsened with increased hearing loss verified by ENT all from unspecified date and unknown if ongoing. The patient's concomitant medications were not reported. On 08Aug2021, the patient experienced flushing, warmth sensation, patient received booster dose of Pfizer. On 09Aug2021, the patient experienced arm was sore. The outcome for flushing and warmth sensation was recovered on 08Aug2021, patient received booster dose of Pfizer and arm was sore was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: low grade fever; headaches; I was very tired, Tiredness; Injection site pain; site is red; slight swelling in the arm; muscle pain kind of all over; didn't feel well; whole arm was pain; had kind of few side effects for third shot; had kind of few side effects for third shot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received third dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/lot number: EW0168, Expiry date: unknown), via an unspecified route on 16Aug2021, as a single dose for covid-19 immunization. Medical history included Crohn's disease for which patient takes chemo drug to keep Crohn's under control, asthma and patient was immuno-compromised. Concomitant medications included mother drugs: pantoprazole, mild Calcium, alendronate sodium (FOSAMAX), mercaptopurine (PURINETHOL, 6-MP) and immuno-compromise drug, a chemodrug (further clarification unknown if patient was suffering from side effects hence captured as suspect of unspecified medication). Historical vaccine included first dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN5318) on 05Feb2021 and second dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN6201) on 26Feb2021 both as a single dose for covid-19 immunization and experienced no side effects. Patient did not receive any other vaccines prior to the COVID vaccine. On an unknown date (age at the time of onset of reaction/event: 65-year-old), patient experienced few side effects for third shot: injection site pain hurt for over a week/almost a week and half. Just was started feeling better. Patient was very tired/tiredness, had headaches and muscle pain kind of all over. Also, had a low-grade fever, slight swelling in the arm, site is red, didn't feel well and whole arm was pain. Patient guess would be that the first shot to the second shot was so bad that his body did not have the chance to build up antibodies and response. So, when the third shot came around, it was really worked. Patient did not receive any treatment for the events. He was just happy that he had response. The patient underwent lab test and procedure which included weight measurement of 295 Ibs on an unknown date and 290 lbs on 29Aug2021 (actually, she was 290, measured himself today 290, not confirmed). No blood work was done. The clinical outcome of the events following third dose was patient feeling fine now, it's just, patient was trying to report what he had.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Pain in extremity, Peripheral swelling, Pyrexia, Vaccination site erythema
Clinical narrative: low grade fever; headaches; I was very tired, Tiredness; Injection site pain; site is red; slight swelling in the arm; muscle pain kind of all over; didn't feel well; whole arm was pain; had kind of few side effects for third shot; had kind of few side effects for third shot; This is a spontaneous report from a contactable consumer (patient). A 66-year-old male patient received third dose of bnt162b2 (Pfizer Covid-19 Vaccine, Solution for injection, Batch/lot number: EW0168, Expiry date: unknown), via an unspecified route on 16Aug2021, as a single dose for covid-19 immunization. Medical history included Crohn's disease for which patient takes chemo drug to keep Crohn's under control, asthma and patient was immuno-compromised. Concomitant medications included mother drugs: pantoprazole, mild Calcium, alendronate sodium (FOSAMAX), mercaptopurine (PURINETHOL, 6-MP) and immuno-compromise drug, a chemodrug (further clarification unknown if patient was suffering from side effects hence captured as suspect of unspecified medication). Historical vaccine included first dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN5318) on 05Feb2021 and second dose of bnt162b2 (Pfizer Covid Vaccine, Solution for injection, Lot number: EN6201) on 26Feb2021 both as a single dose for covid-19 immunization and experienced no side effects. Patient did not receive any other vaccines prior to the COVID vaccine. On an unknown date (age at the time of onset of reaction/event: 65-year-old), patient experienced few side effects for third shot: injection site pain hurt for over a week/almost a week and half. Just was started feeling better. Patient was very tired/tiredness, had headaches and muscle pain kind of all over. Also, had a low-grade fever, slight swelling in the arm, site is red, didn't feel well and whole arm was pain. Patient guess would be that the first shot to the second shot was so bad that his body did not have the chance to build up antibodies and response. So, when the third shot came around, it was really worked. Patient did not receive any treatment for the events. He was just happy that he had response. The patient underwent lab test and procedure which included weight measurement of 295 Ibs on an unknown date and 290 lbs on 29Aug2021 (actually, she was 290, measured himself today 290, not confirmed). No blood work was done. The clinical outcome of the events following third dose was patient feeling fine now, it's just, patient was trying to report what he had.   Follow-up attempts are completed. No further information is expected.