chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body mass index, Body temperature, Diarrhoea, Heart rate
Clinical narrative: Have had diarrhea everyday since the day after the vaccine,12Aug2021; Lost weight; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 28Sep2021, this case now contains serious adverse reaction(s). Information processed together.   This is a spontaneous report from a contactable consumer.  A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 11Aug2021 12:30 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included tobacco user.The patient previously took penicillin n and experienced anaphylaxis.  The patient had diarrhea everyday since the day after the vaccine on 12Aug2021, lost weight on Aug2021.  The patient underwent lab tests and procedures which included blood pressure measurement: 119/74   on 16Sep2021 Arm(L) , body mass index: 27.4   on 16Sep2021, body temperature: 98.2 fahrenheit on 16Sep2021, heart rate: 98   on 16Sep2021 98 BPM , oxygen saturation: 98 % on 16Sep2021, sars-cov-2 test: negative   on 27Aug2021, weight: 170 lbs on 16Sep2021. The patient presents with a chief complaint of diarrhea of the abdomen since approximately Mon, 16Aug2021. It has the following qualities: watery and loose stool. Context - Initial History: The patient reports that it had a sudden onset. The patient had no similar problems in the past. The patient reports no contact with a person with similar symptoms. The patient reports that the onset was: not associated with recent travel; not associated with camping, not associated with eating foods; not associated with drinking dirty water, not associated with heavy/fatty meals; not associated with exertion; not associated with taking antibiotics; Patient reports not testing positive for COVID-19 AND being asymptomatic for more than 24 days. Patient reports not receiving a COVID-19 vaccine.On 12Aug2021 Developed Diarrhea that has Lasted more Than A month. At first for About 3 weeks was Acute, Lost weight Imodium did not work. Benedryl helped slow it Down Went To doctor no one knows what to do. she gave me Azithromycin did not work. Continuing with Diarrhea, Better but not gone Almost six weeks After VAX.  Therapeutic measures were taken as a result of have had diarrhea everyday since the day after the vaccine,12Aug2021.Outcome of Diarrhea was recovering, of weight decreased was unknown.  No follow-up attempts are possible. No further information is expected
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen saturation, SARS-CoV-2 test, Weight, Weight decreased
Clinical narrative: Have had diarrhea everyday since the day after the vaccine,12Aug2021; Lost weight; The initial safety information received was reporting only non-serious adverse drug reaction(s), Upon receipt of follow-up information on 28Sep2021, this case now contains serious adverse reaction(s). Information processed together.   This is a spontaneous report from a contactable consumer.  A 64-years-old female patient received bnt162b2 (BNT162B2), dose 1 intramuscular, administered in Arm Left on 11Aug2021 12:30 (Batch/Lot Number: FC3181) as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included tobacco user.The patient previously took penicillin n and experienced anaphylaxis.  The patient had diarrhea everyday since the day after the vaccine on 12Aug2021, lost weight on Aug2021.  The patient underwent lab tests and procedures which included blood pressure measurement: 119/74   on 16Sep2021 Arm(L) , body mass index: 27.4   on 16Sep2021, body temperature: 98.2 fahrenheit on 16Sep2021, heart rate: 98   on 16Sep2021 98 BPM , oxygen saturation: 98 % on 16Sep2021, sars-cov-2 test: negative   on 27Aug2021, weight: 170 lbs on 16Sep2021. The patient presents with a chief complaint of diarrhea of the abdomen since approximately Mon, 16Aug2021. It has the following qualities: watery and loose stool. Context - Initial History: The patient reports that it had a sudden onset. The patient had no similar problems in the past. The patient reports no contact with a person with similar symptoms. The patient reports that the onset was: not associated with recent travel; not associated with camping, not associated with eating foods; not associated with drinking dirty water, not associated with heavy/fatty meals; not associated with exertion; not associated with taking antibiotics; Patient reports not testing positive for COVID-19 AND being asymptomatic for more than 24 days. Patient reports not receiving a COVID-19 vaccine.On 12Aug2021 Developed Diarrhea that has Lasted more Than A month. At first for About 3 weeks was Acute, Lost weight Imodium did not work. Benedryl helped slow it Down Went To doctor no one knows what to do. she gave me Azithromycin did not work. Continuing with Diarrhea, Better but not gone Almost six weeks After VAX.  Therapeutic measures were taken as a result of have had diarrhea everyday since the day after the vaccine,12Aug2021.Outcome of Diarrhea was recovering, of weight decreased was unknown.  No follow-up attempts are possible. No further information is expected
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Depressed mood, Fatigue
Clinical narrative: feeling depressed; headache; fever to 100.4; low energy/had just had no energy for a day; not feel quite right; didn't sleep well; shoulder was aching; achiness; fatigued; He also got a bout of GERD that reactivated in the process; he got a third dose of the Pfizer BioNtech covid 19 vaccine Friday night.; he got a third dose of the Pfizer BioNtech covid 19 vaccine Friday night.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: FC3184; Expiration Date: 31Oct2021), via intramuscular route of administration, administered in Arm Left (Age at vaccination 77 years) on 27Aug2021, in the afternoon, as dose 3 (BOOSTER), 0.3 ML single (vaccination facility type was store), for covid-19 immunization. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EL3249), via an unspecified route (Age at vaccination 77 years) on 26jan2021 as dose 1, single and dose 2 of PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EN6201), via an unspecified route (Age at vaccination 77 years), on 16Feb2021, as dose 2, single for covid-19 immunization. On unspecified date after 2nd dose patient experienced minor reaction such as fatigue and loss of energy. Medical history included low RBC count and pancytopenia. There were no concomitant medications. Patient did not receive prior Vaccinations within 4 weeks. On 27Aug2021 patient got a third dose of the Pfizer BioNtech covid 19 vaccine on friday night. On 28Aug2021 the patient experienced feeling depressed, headache, fever to 100.4, low energy/had just had no energy for a day, not feel quite right, didn't sleep well, shoulder was aching, achiness, fatigue, He also got a bout of GERD that reactivated in the process. Timeframe between vaccination and starting of symptoms was 1 day. The patient underwent lab tests and procedures which included body temperature was 100.4 on 28Aug2021, red blood cell count was low on unspecified date. Outcome of events at the time of last observation was recovering/resolving.   Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Gastrooesophageal reflux disease, Headache, Immunisation, Off label use
Clinical narrative: feeling depressed; headache; fever to 100.4; low energy/had just had no energy for a day; not feel quite right; didn't sleep well; shoulder was aching; achiness; fatigued; He also got a bout of GERD that reactivated in the process; he got a third dose of the Pfizer BioNtech covid 19 vaccine Friday night.; he got a third dose of the Pfizer BioNtech covid 19 vaccine Friday night.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: FC3184; Expiration Date: 31Oct2021), via intramuscular route of administration, administered in Arm Left (Age at vaccination 77 years) on 27Aug2021, in the afternoon, as dose 3 (BOOSTER), 0.3 ML single (vaccination facility type was store), for covid-19 immunization. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EL3249), via an unspecified route (Age at vaccination 77 years) on 26jan2021 as dose 1, single and dose 2 of PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EN6201), via an unspecified route (Age at vaccination 77 years), on 16Feb2021, as dose 2, single for covid-19 immunization. On unspecified date after 2nd dose patient experienced minor reaction such as fatigue and loss of energy. Medical history included low RBC count and pancytopenia. There were no concomitant medications. Patient did not receive prior Vaccinations within 4 weeks. On 27Aug2021 patient got a third dose of the Pfizer BioNtech covid 19 vaccine on friday night. On 28Aug2021 the patient experienced feeling depressed, headache, fever to 100.4, low energy/had just had no energy for a day, not feel quite right, didn't sleep well, shoulder was aching, achiness, fatigue, He also got a bout of GERD that reactivated in the process. Timeframe between vaccination and starting of symptoms was 1 day. The patient underwent lab tests and procedures which included body temperature was 100.4 on 28Aug2021, red blood cell count was low on unspecified date. Outcome of events at the time of last observation was recovering/resolving.   Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Poor quality sleep, Pyrexia, Red blood cell count
Clinical narrative: feeling depressed; headache; fever to 100.4; low energy/had just had no energy for a day; not feel quite right; didn't sleep well; shoulder was aching; achiness; fatigued; He also got a bout of GERD that reactivated in the process; he got a third dose of the Pfizer BioNtech covid 19 vaccine Friday night.; he got a third dose of the Pfizer BioNtech covid 19 vaccine Friday night.; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 77-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: FC3184; Expiration Date: 31Oct2021), via intramuscular route of administration, administered in Arm Left (Age at vaccination 77 years) on 27Aug2021, in the afternoon, as dose 3 (BOOSTER), 0.3 ML single (vaccination facility type was store), for covid-19 immunization. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EL3249), via an unspecified route (Age at vaccination 77 years) on 26jan2021 as dose 1, single and dose 2 of PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number: not reported/Lot Number: EN6201), via an unspecified route (Age at vaccination 77 years), on 16Feb2021, as dose 2, single for covid-19 immunization. On unspecified date after 2nd dose patient experienced minor reaction such as fatigue and loss of energy. Medical history included low RBC count and pancytopenia. There were no concomitant medications. Patient did not receive prior Vaccinations within 4 weeks. On 27Aug2021 patient got a third dose of the Pfizer BioNtech covid 19 vaccine on friday night. On 28Aug2021 the patient experienced feeling depressed, headache, fever to 100.4, low energy/had just had no energy for a day, not feel quite right, didn't sleep well, shoulder was aching, achiness, fatigue, He also got a bout of GERD that reactivated in the process. Timeframe between vaccination and starting of symptoms was 1 day. The patient underwent lab tests and procedures which included body temperature was 100.4 on 28Aug2021, red blood cell count was low on unspecified date. Outcome of events at the time of last observation was recovering/resolving.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood bilirubin, Blood bilirubin increased, Chills, Fatigue, Maternal exposure during pregnancy
Clinical narrative: high total bilirubin; fever; Chills; fatigue; maternal exposure during pregnancy, second trimester; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203), via intramuscular, administered in Arm (Deltoid) on 05Mar2021 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included risk factors for adverse pregnancy outcomes including environmental or occupational exposures such as seasonal asthma. Concomitant medications included Parental vitamins (capsules) for Pregnancy at QD (once a day) orally from Dec2020 and ongoing; acetylsalicylic acid (ASPIRIN) taken for pregnancy from Dec2020 to Jul2021. The patient had no prior vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in Deltoid on 12Feb2021 afternoon (at the age of 38-year-old) as single dose for COVID-19 immunization and experienced injection site pain. On 06Mar2021, the patient experienced fever/ chills in the morning and fatigue in the afternoon. The patient was pregnant at the time of vaccination. The first day of last menstrual period was in Oct2020 and estimated date of conception was in Nov2020. Gestation period at time of initial exposure was 3. The mother did not smoke, drink alcohol or did not use illicit drugs during this pregnancy. Obstetrical History included 3 previous pregnancies and 1 other child. She had 2 miscarriages/2 live births (one of the live births was preterm). Estimated delivery date was 21Jul2021 and the patient had scheduled c-section. It was full term live birth. Gestational age at birth was 39 weeks 4 days. The normal new born was female, weight at birth: 6 lbs 7 oz; length at birth: 19 in; head circumstance at birth: 34cm and Apgar score:1 min: 9; 5min: 9. The patient did not have any problem before delivery and during delivery (including delivery complications, fetal distress, amniotic fluid abnormal, abnormal placenta). After delivery she had high total bilirubin. Paternal information reported as follows: age of 45 years. Father did not have any exposure to products like any drugs (e.g., over-the-counter, medical prescription) during the mother's pregnancy. The father did not smoke during mother's pregnancy: he occasionally vaped. The father did not drink alcohol or did not use illicit drugs during mother's pregnancy. The patient did not receive any treatment for the events fever/ chills and fatigue. Outcome of the events fever, chills, fatigue was recovered in 2021; high total bilirubin was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high total bilirubin; fever; Chills; fatigue; maternal exposure during pregnancy, second trimester; This is a spontaneous report from a contactable pharmacist (patient). A 38-year-old pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6203), via intramuscular, administered in Arm (Deltoid) on 05Mar2021 (at the age of 38-year-old) as single dose for COVID-19 immunization. Medical history included risk factors for adverse pregnancy outcomes including environmental or occupational exposures such as seasonal asthma. Concomitant medications included Parental vitamins (capsules) for Pregnancy at QD (once a day) orally from Dec2020 and ongoing; acetylsalicylic acid (ASPIRIN) taken for pregnancy from Dec2020 to Jul2021. The patient had no prior vaccination. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN5318), via intramuscular, administered in Deltoid on 12Feb2021 afternoon (at the age of 38-year-old) as single dose for COVID-19 immunization and experienced injection site pain. On 06Mar2021, the patient experienced fever/ chills in the morning and fatigue in the afternoon. The patient was pregnant at the time of vaccination. The first day of last menstrual period was in Oct2020 and estimated date of conception was in Nov2020. Gestation period at time of initial exposure was 3. The mother did not smoke, drink alcohol or did not use illicit drugs during this pregnancy. Obstetrical History included 3 previous pregnancies and 1 other child. She had 2 miscarriages/2 live births (one of the live births was preterm). Estimated delivery date was 21Jul2021 and the patient had scheduled c-section. It was full term live birth. Gestational age at birth was 39 weeks 4 days. The normal new born was female, weight at birth: 6 lbs 7 oz; length at birth: 19 in; head circumstance at birth: 34cm and Apgar score:1 min: 9; 5min: 9. The patient did not have any problem before delivery and during delivery (including delivery complications, fetal distress, amniotic fluid abnormal, abnormal placenta). After delivery she had high total bilirubin. Paternal information reported as follows: age of 45 years. Father did not have any exposure to products like any drugs (e.g., over-the-counter, medical prescription) during the mother's pregnancy. The father did not smoke during mother's pregnancy: he occasionally vaped. The father did not drink alcohol or did not use illicit drugs during mother's pregnancy. The patient did not receive any treatment for the events fever/ chills and fatigue. Outcome of the events fever, chills, fatigue was recovered in 2021; high total bilirubin was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Cardiomegaly, Chest pain, Fatigue
Clinical narrative: chest pains; sick; enlarged heart; it hurt for the patient to take a breath; heart rate was 105; back pain; fatigue/tired; This is a spontaneous report from a contactable consumer (patient's mother). A 25-year-old female patient (consumer's daughter) received second 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 25Aug2021 at 15:00 (age at vaccination: 25 years), as dose 2, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Family history included cardiac history within the family. 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 28Jul2021 (age at vaccination: 25 years), as a single dose for COVID-19 immunization and stated that it feels like pressure and tight in her chest, left arm pit pain, stated that her left armpit is swollen, and stated that it hurts through to her back. The reporter reported that the patient got her second dose of the vaccine and on 26Aug2021 at 02:00 AM, she got really sick. She had chest pains back and pains. She had to be seen at the doctor. Her heart rate was at 105, her oxygen was still good and her blood pressure wasn't too bad. It went on for 2 or 3 days. She was a little freaked out about it. She was scared to death and she was mad at mother because she encouraged her to get it. She had concerns about her heart being enlarged. It terrified her because it hurt her to take a breathe in because of the pain in her chest and back. We will be following up with the doctor and possibly having an echo done. The patient was so tired, the fatigue was terrible. The fatigue wasn't gone and so the patient went to the doctor. The patient saw the nurse practitioner. The way the patient was de-scribing the pain in her back, it was the same way the caller felt when her heart was enlarged. The patient felt really really sick. The patient was supposed to get the second dose on a Wednesday and didn't get it until the following Wednesday because she couldn't get off work. The patient got the vaccine at 3:00 in the afternoon on 25Aug2021 and then 2:00 am on Thursday morning is when everything started. The chest pain got better but the patient has the back pain. Maybe the back pain was body aches, but the caller doesn't know. The patient went into work on Friday and they sent her right back home because she looked so bad. Everything seems to have improved. The patient underwent lab test and procedure included Blood pressure with her blood pressure wasn't too bad, heart rate 105 and oxygen saturation was good on an unspecified date. Outcome of the events was recovering.  The lot number for the vaccine (BNT162B2) was not provided. No follow-up at-tempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure measurement, Headache, Hypertension, Myalgia
Clinical narrative: Nervousness; High Anxiety; Headache; Muscle pain; High Blood Pressure; Tremors; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Aug2021 at 19:45 (at the age of 56-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included HIV, blood pressure, anxiety, depression from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medications included piroxicam (PAXIL), cobicistat, darunavir ethanolate (PREZCOBIX), raltegravir potassium (ISSENTRESS), bupropione, amlodipine 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: Unknown), via an unspecified route on Jul2021 at 19:30 (at the age of 56-years) as dose 1, 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 15Aug2021 at 12:00, the patient experienced nervousness, high anxiety, headache, high blood pressure, muscle pain, tremors. Patient received treatment for events with Amlopidine 10mcg, Xanax Half a pill of 1mcg as needed. Patient visited to Doctor or other healthcare professional office/clinic. The events was assessed as non-serious. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Tremor
Clinical narrative: Nervousness; High Anxiety; Headache; Muscle pain; High Blood Pressure; Tremors; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 05Aug2021 at 19:45 (at the age of 56-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included HIV, blood pressure, anxiety, depression from an unknown date and unknown if ongoing. The patient had no known allergies. The patient concomitant medications included piroxicam (PAXIL), cobicistat, darunavir ethanolate (PREZCOBIX), raltegravir potassium (ISSENTRESS), bupropione, amlodipine 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: Unknown), via an unspecified route on Jul2021 at 19:30 (at the age of 56-years) as dose 1, 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 15Aug2021 at 12:00, the patient experienced nervousness, high anxiety, headache, high blood pressure, muscle pain, tremors. Patient received treatment for events with Amlopidine 10mcg, Xanax Half a pill of 1mcg as needed. Patient visited to Doctor or other healthcare professional office/clinic. The events was assessed as non-serious. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (08Oct2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Oropharyngeal pain, Pyrexia, Rhinorrhoea
Clinical narrative: runny nose; sore throat; cough; fever; headache; This is a spontaneous report from a contactable consumer. A 69-years-old female patient received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for (at the age 69-year-old) COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient was diagnosed with COVID-19 prior to vaccination. Since the vaccination, it was unknown if the patient was tested for COVID-19 or not. It was unknown if the patient received any other vaccine within 4 weeks prior to the COVID-19 vaccine. It was unknown if the patient had any allergies. The patient's medical history and concomitant medications were not reported. On an unspecified date, after first dose, the patient experienced runny nose, sore throat, cough, fever and headache. Patient was following up with personal doctor for additional testing. The adverse event resulted in doctor or other health care professional office or clinic visit. It was unknown if the patient received any treatment for the events. The outcome of the events was unknown.  The lot number for the vaccine BNT162B2, was not provided and would be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Fatigue, Somnolence, Swelling, Vaccination site pain
Clinical narrative: Sleepy but she just slept that off; The swelling went down; Heaviness in the chest but it went away; Her left arm (injection site) was sore; She got tired; This is a spontaneous report from a contactable consumer or other non hcp.   A 76-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Aug2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient was healthy before vaccination. On unknown date the patient stated that she had no significant effect except that she was tired and sleepy but she just slept that off. Patient also stated that she experienced heaviness in the chest but it went away. The next day, her left arm (injection site) was sore but she massaged it like a regular vaccine and a couple of days later, the swelling went down. The outcome of event was unknown for sleepy, swelling and for left arm (injection site) sore and heaviness in the chest was recovered on unknown date 2021.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: Fever of 100.4; headache; chills; This is a spontaneous report from a contactable consumer or other Non Health Care Professional.   A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 01Sep2021 16:00 as DOSE NUMBER UNKNOWN, SINGLE (At the age of 23 Years) for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient experienced fever of 100.4 (pyrexia), chills and headache. The events had took place after the use of product. The patient underwent lab tests and procedures which included body temperature: 100.4 on unknown date. On an unspecified date in 2021, the event headache was recovered. At the time of reporting, the outcome of the events pyrexia and chills were unknown.          Query: Thanks for sending this information to safety. I hope that (Name withheld) is feeling better. Kindly confirm the awareness date of 01Sep since this is being received outside of the 24-hour reporting timelines. Please copy all on your reply.  Response: She got her shot at 4 pm on the 1st. I have been out of town with no access to the app. She is better this morning. No headaches.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature fluctuation, Erythema, Pain in extremity, Product administered at inappropriate site, Vaccination site mass
Clinical narrative: the injection was on the side of her arm and not in the center of the deltoid; hard lump that extends to the inner portion of her arm/developed a lump; Arm was sore, bright red; arm was sore, bright red; she had a temperature and woke up cold and she is usually hot; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration in Arm on 09Jan2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received past drug BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: Not reported, Expiry date: Unknown), via an unspecified route of administration in Arm on an unspecified date as dose 1, single for COVID-19 immunisation. On 09Jan2021, the patient stated the injection was on the side of her arm and not in the center of the deltoid. On an unspecified date in 2021, she developed a hard lump that extends to the inner portion of her arm that continued till that day (8 months later), her arm was sore, bright red and had a temperature and woke up cold and she is usually hot. After receiving the second dose her arm was sore, bright red, and states it looks like she's "been working out." She states was very visible when she was wearing sleeveless shirts. Caller states she developed a lump and showered her doctor who wasn't sure. States that you can see it, it looks like she has been working out with that arm from the shoulder down you can see it and feel it. States it's like a fatty muscle and her other arm was flat. Caller states she doesn't think she should get the booster in that arm, she doesn't know if it will penetrate that lump. States she didn't have a bad experience. States she was a nurse and has a license. States she never took the flu shot so she thought it was her body reacting kind of in shock. States she got the vaccine on Saturday and on Sunday she took Tylenol and her arm was really sore. Caller states she doesn't know if it was going to go away. States it was weird. Caller states it doesn't hurt now, only when pushing on it and it doesn't bother her and it looks weird. Therapeutic measures were taken for the events lump, arm was sore, bright red and temperature and woke up cold and she is usually hot with Tylenol. The outcome of the events 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: Dizziness, Dyspnoea, Fatigue, Palpitations, Vomiting
Clinical narrative: dizzy; her heart was racing; a little SOB; throwing up; exhausted; This is a spontaneous report from a contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), via an unspecified route of administration on 20Apr2021 (at the age of 39-year-old) as dose 1, single for COVID-19 immunization. Medical history included severe anxiety. The concomitant medications were not reported. The patient experienced dizzy, her heart was racing, which made her a little short of breath, an episode of dizziness and throwing up on 20Apr2021. That evening she had an episode of dizziness and throwing up. She was exhausted for a week. She went up to the health department to get her second dose 21 days later and the health department wouldn't let her get the second vaccine and they said it was a severe reaction, and she was not allowed to get the second dose. She did start a masters program in nursing. So she had to get vaccines for it. This upcoming Tuesday would be 2 weeks. She got the MMR and Varicella vaccine on 24Aug2021. She enquired if she need to wait a solid two weeks before getting the second dose of the Pfizer Covid 19 vaccine. After the vaccine she had a reaction and she was unsure if it was anxiety or a true reaction. With the new Delta Variant, she wanted the second dose. She asked if Pfizer thought that was a severe reaction and asked if it was still okay to get the second dose because of the time lapse since the first dose. She was not immune to varicella chicken pox. The outcome of the events was unknown.   The lot number for the vaccine, BNT162B2 was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This is a spontaneous report received from a contactable consumer (mother).  A female patient (reporter's youngest daughter) of an unspecified age received a dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced rash on an unspecified date with outcome of unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fear of injection, Osteoarthritis, Pruritus, Rash, Tremor
Clinical narrative: This is a spontaneous report from contactable consumer (patient). This is based on the information received by Pfizer (Mfr. Control No: 21K-163-4051214-00).   A 72-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: Not reported) via intramuscular route of administration on Mar2021 (at the age of 72 year) as a Dose 2, Single and via intramuscular route of administration on 03Mar2021 (at the age of 72 year) as a Dose 1, Single, both doses for COVID-19 immunization.The patient also received Adalimumab (HUMIRA, Formulation: Solution for injection in pre-filled pen, Batch/Lot number: Not reported) via Subcutaneous route of administration on an unspecified date as Dose number unknown, Single for Moderate to Severe Rheumatoid Arthritis. The patient's medical include allergies. The patient's concomitant medication were not reported. On an unknown date in 2021, osteoarthrosis, rash on the arms all the way up to the shoulders and big knots on the arms a lot of itching for 3 to 4 month after covid injection, shaking when administered Humira/ get nervous when giving the injection. It was unknown if patient was enrolled in a Covid-19 vaccine trial. Outcome of the event Osteoarthrosis was unknown while for all other events it was recovered on an unknown date in 2021.  The reporter assessment the causality relationship between BNT162B2 and events Rash over arms, Itchy upper limbs was assessed as possible while causality of the event osteoarthritis, Fear of injection, Shaking was not reported.   The causality relationship between Humira and events Rash over arms, Fear of injection, Itchy upper limbs, Shaking was assessed as no reasonable possibly while causality of the event osteoarthritis was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Breast mass, Chills, Pain, Pyrexia, Swelling
Clinical narrative: Fever; Chills; Body ache from the joints; my whole body and that side of my body swelled; I develop a mass; under my armpit towards my breast; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. Medical history included DVTs (deep vein thrombosis), Pulmonary emboly for which she currently being treated (not appropriately clarified). Concomitant medication included atorvastatin calcium (XARATOR) taken for an unspecified indication, valproate semi sodium (DEPAKOTE), zonisamide (MANUFACTURER UNKNOWN) taken for cluster headache, gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy on the left side, start and stop date were not reported. The patient was on Xarelto (further clarification about xarelto was unknown). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Aug2021 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient had not received any other vaccine within 4 weeks. On an unspecified date in Sep2021, probably about 6 hours after vaccination, the patient started experiencing fever, body ache from the joints, chills, whole body and that side of her body swelled, develop a mass; under her armpit towards her breast. The patient reported that she had second injection on Wednesday and she had like the fever the chills the body ache from the joints but then on she thought it was Friday or Thursday night, she develop a mass and she would say it was definitely a mass underneath her more under armpit towards breast and the same side of where she got the injection. It seemed like her whole body and that side of her body swelled. The mass was like probably the size of her fist. The treatment taken in response to adverse events the nurse stated, right now she is trying to just take self- treatment. Everybody thinks they should go to the emergency room but she was just trying to take self-treatment as a nurse you know how we are. Just Tylenol around the clock.The patient do have a history of DVT and TEs and she was on Xarelto (further clarification about xarelto was unknown, hence not captured as suspect) and so that's why patient choose the Pfizer so that was one of the big concerns specially when she developed this mass. The patient knew it's very common with the mass and for lymph nodes but she didn't know of it's in relationship to any other the vascular system. The patient not undergone any lab test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Axillary mass, Chills, Fatigue, Lymph node pain
Clinical narrative: Fever; Chills; Body ache from the joints; my whole body and that side of my body swelled; I develop a mass; under my armpit towards my breast; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. Medical history included DVTs (deep vein thrombosis), Pulmonary emboly for which she currently being treated (not appropriately clarified). Concomitant medication included atorvastatin calcium (XARATOR) taken for an unspecified indication, valproate semi sodium (DEPAKOTE), zonisamide (MANUFACTURER UNKNOWN) taken for cluster headache, gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy on the left side, start and stop date were not reported. The patient was on Xarelto (further clarification about xarelto was unknown). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Aug2021 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient had not received any other vaccine within 4 weeks. On an unspecified date in Sep2021, probably about 6 hours after vaccination, the patient started experiencing fever, body ache from the joints, chills, whole body and that side of her body swelled, develop a mass; under her armpit towards her breast. The patient reported that she had second injection on Wednesday and she had like the fever the chills the body ache from the joints but then on she thought it was Friday or Thursday night, she develop a mass and she would say it was definitely a mass underneath her more under armpit towards breast and the same side of where she got the injection. It seemed like her whole body and that side of her body swelled. The mass was like probably the size of her fist. The treatment taken in response to adverse events the nurse stated, right now she is trying to just take self- treatment. Everybody thinks they should go to the emergency room but she was just trying to take self-treatment as a nurse you know how we are. Just Tylenol around the clock.The patient do have a history of DVT and TEs and she was on Xarelto (further clarification about xarelto was unknown, hence not captured as suspect) and so that's why patient choose the Pfizer so that was one of the big concerns specially when she developed this mass. The patient knew it's very common with the mass and for lymph nodes but she didn't know of it's in relationship to any other the vascular system. The patient not undergone any lab test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia
Clinical narrative: Fever; Chills; Body ache from the joints; my whole body and that side of my body swelled; I develop a mass; under my armpit towards my breast; This is a spontaneous report from a contactable Nurse (patient). A 57-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Sep2021 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. Medical history included DVTs (deep vein thrombosis), Pulmonary emboly for which she currently being treated (not appropriately clarified). Concomitant medication included atorvastatin calcium (XARATOR) taken for an unspecified indication, valproate semi sodium (DEPAKOTE), zonisamide (MANUFACTURER UNKNOWN) taken for cluster headache, gabapentin (MANUFACTURER UNKNOWN) taken for neuropathy on the left side, start and stop date were not reported. The patient was on Xarelto (further clarification about xarelto was unknown). The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Aug2021 (at the age of 57-years-old) as dose 1, single for COVID-19 immunisation. The patient had not received any other vaccine within 4 weeks. On an unspecified date in Sep2021, probably about 6 hours after vaccination, the patient started experiencing fever, body ache from the joints, chills, whole body and that side of her body swelled, develop a mass; under her armpit towards her breast. The patient reported that she had second injection on Wednesday and she had like the fever the chills the body ache from the joints but then on she thought it was Friday or Thursday night, she develop a mass and she would say it was definitely a mass underneath her more under armpit towards breast and the same side of where she got the injection. It seemed like her whole body and that side of her body swelled. The mass was like probably the size of her fist. The treatment taken in response to adverse events the nurse stated, right now she is trying to just take self- treatment. Everybody thinks they should go to the emergency room but she was just trying to take self-treatment as a nurse you know how we are. Just Tylenol around the clock.The patient do have a history of DVT and TEs and she was on Xarelto (further clarification about xarelto was unknown, hence not captured as suspect) and so that's why patient choose the Pfizer so that was one of the big concerns specially when she developed this mass. The patient knew it's very common with the mass and for lymph nodes but she didn't know of it's in relationship to any other the vascular system. The patient not undergone any lab test. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood glucose, Blood iron, Chest discomfort, Dyspnoea
Clinical narrative: My chest is feeling like it's tightened itself; I am having a lot of trouble breathing; Headache; I am feeling little bit off; I don't feel well; This is a spontaneous report from a contactable consumer, the patient. A 31-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 02Sep2021 (age at the time of vaccination 31-years-old), as a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date (age at the time of vaccination 31-years-old), as a single dose for COVID-19 immunization. On 02Sep2021, the patient experienced My chest is feeling like it's tightened itself, I am having a lot of trouble breathing, Headache, I am feeling little bit off, and I don't feel well. The patient took Excedrin for headache while patient did not receive any treatment for other events. The patient did not receive any other vaccine prior to 4 weeks of COVID Vaccine. The patient underwent lab tests and procedures which included blood cholesterol, blood glucose, blood iron and lipids which was great on an unspecified date in 2021. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and would be requested during follow up.