chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A lot of brain fog; I'm still feeling weak; stomach ache; very tired/I felt tired; Joint pain; body aches; headache; sore arm; dry cough/ dry hacking cough; dizziness; I kept waking up throughout the night with night sweats; This is a spontaneous report from a contactable consumer (patient). A 68-years-old non pregnant female patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number unknown), dose 1 via unspecified route into left arm at 02:30 PM on 11Feb2021 as DOSE 1, SINGLE for covid-19 immunization (at the age of 68 years). The patient medical history had included osteoarthritis (Beginning stage of Rheumatoid) and Allergy for wheat and milk products. The patient concomitant medications included Ergocalciferol (VIT D,5000iu). The patient took vaccine at School or Student Health Clinic. Patient did not take any vaccination prior to covid vaccination and also did not received other vaccine in four weeks. On 11Feb2021 at 4:00 PM the patient started to experience the adverse events. It was reported, on Day 1  patient experienced very sore arm, dry cough, and dizziness and I kept waking up throughout the night with night sweats and felt like something was moving through my body. On day 2 arm felt like somebody punched her with a brick, dizziness, dry hacking cough, very tired, joint pain and body aches, headache and took a Tylenol before went to bed. On Day 3 - she felt good and took the dog for a walk, worked on an art project, and went food shopping. On day 4 - Symptoms came back and felt tired, dizzy, and achy, and stomach-ache, couldn't do much of anything except eat and rest. she stayed home all day and took a Tylenol in the late afternoon. On day 5 - Just woke up. I am feeling better but I still feel like my body is out of balance. I'm still feeling weak and dizzy with body and stomach ache. On Day 6 - A lot of brain fog, dizzy, and body ache. difficulty performing basic tasks. The patient underwent lab tests and procedures, which included Covid 19 and was diagnosed as having negative by Nasal Swab test after taking covid-19 vaccine. Therapeutic measures were taken as a result of the events dizziness, dry cough/dry hacking cough, very tired/I felt tired, joint pain, body aches, headache, stomach ache and included treatment with Tylenol. The outcome of the events were not recovered.    Follow-up (14Jun2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeding disorder, Headache, Nausea
Clinical narrative: she cant hold down anything but a sip of water; severe dizziness; Headache; Nauseous; This is a spontaneous report received from a contactable consumer reported for a female patient (Sister). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on 13Feb2021 as unknown, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 16Feb2021, the patient cant hold down anything but a sip of water, had severe dizziness, headache and nauseous. It was reported that patient took the vaccine on Saturday and yesterday experienced severe headaches, nauseous, and severe dizziness; she cant hold down anything but a sip of water. The outcome of events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; body chills; body fatigue; arm soreness; joint pain; This is a spontaneous report from a contactable other health care professional (patient). A 22-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EN6201, patient was 22-year-oldand not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 01:15 PM as DOSE 2, SINGLE for covid-19 immunisation. Medical history reported as no. The patient's concomitant medications were not reported. Historical vaccine included first dos of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL8982, patient was 22-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 01:00 PM as DOSE 1, SINGLE for covid-19 immunisation. No other vaccine received in four weeks. No other medications received in two weeks. No covid prior vaccination and not tested covid post vaccination. No known allergies reported. On 13Feb2021 at 08:00 PM, the patient experienced headache, body chills, body fatigue, arm soreness, joint pain. No treatments were received for events. No Seriousness were reported. The outcomes of events were recovered on an unspecified date in 2021.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Fever 101.8 within 9 hours of vaccine; chills; fatigue; nausea; dry heaving; diarrhea; arm pain; loss of appetite; This is a spontaneous report from a non-contactable other hcp (health care professional). A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 17:15 pm (Batch/Lot Number: EN5318) as dose number unknown, single for covid-19 immunization (at the age of 30-years-old). Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included spironolactone (100 mg) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to augmentin and azithromycin. It was reported that after receiving the dose of vaccine 03Feb2021 at 17:15 pm and on 04Feb2021 at 02:00 am the patient experienced fever 101.8 within 9 hours of vaccination and also experienced chills, fatigue, nausea, dry heaving, diarrhea, arm pain-all lasting 48-72 hours. 6 days later-still have nausea, loss of appetite, diarrhea, fatigue. Therapeutic measures were taken with Tylenol as a result of adverse events. The patient underwent lab tests and procedures which included body temperature: 101.8 on 03Feb2021 and sars-cov-2 test (nasal swab): negative on 10Feb2021. The outcome of the event fever was reported as recovered with Sequel on an unspecified date in 2021 and patient was recovering from the events of chills, dry heaves and pain in arm and was not recovered from the events of fatigue, nausea, diarrhea and appetite lost.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Pyrexia, Retching, SARS-CoV-2 test
Clinical narrative: Fever 101.8 within 9 hours of vaccine; chills; fatigue; nausea; dry heaving; diarrhea; arm pain; loss of appetite; This is a spontaneous report from a non-contactable other hcp (health care professional). A 30-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via intramuscular route of administration, administered in Arm Left on 03Feb2021 at 17:15 pm (Batch/Lot Number: EN5318) as dose number unknown, single for covid-19 immunization (at the age of 30-years-old). Medical history included asthma from an unknown date and unknown if ongoing. Concomitant medication(s) included spironolactone (100 mg) taken for an unspecified indication, start and stop date were not reported. The patient had known allergies to augmentin and azithromycin. It was reported that after receiving the dose of vaccine 03Feb2021 at 17:15 pm and on 04Feb2021 at 02:00 am the patient experienced fever 101.8 within 9 hours of vaccination and also experienced chills, fatigue, nausea, dry heaving, diarrhea, arm pain-all lasting 48-72 hours. 6 days later-still have nausea, loss of appetite, diarrhea, fatigue. Therapeutic measures were taken with Tylenol as a result of adverse events. The patient underwent lab tests and procedures which included body temperature: 101.8 on 03Feb2021 and sars-cov-2 test (nasal swab): negative on 10Feb2021. The outcome of the event fever was reported as recovered with Sequel on an unspecified date in 2021 and patient was recovering from the events of chills, dry heaves and pain in arm and was not recovered from the events of fatigue, nausea, diarrhea and appetite lost.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have rash on the left hand side of my body, on side of the stomach and on my back but on the side; 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, Batch/Lot number was not reported) via an unspecified route of administration in Arm Right on 16Feb2021 as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced "i have rash on the left hand side of my body, on side of the stomach and on my back but on the side" on 16Feb2021. Reported as, "I have a Pfizer shot this morning for the Covid 19 around 10'clock. I got the shot in my right arm. Now this evening I got it, I have rash on the left hand side of my body. On side of the stomach and on my back but on the side". Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: Fever; headache resulting in inability to attend work.; body aches; headache resulting in inability to attend work; This is a spontaneous report from a non-contactable consumer or other non-health care professional (patient). A 22-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration (at the age of 22-years), administered in arm right on 11Feb2021 at 13:15 as dose 2, single for COVID-19 immunization. Medical history included none from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration (at the age of 22-years), administered in arm right on 21Jan2021 at 13:15 as dose 1, single for COVID-19 immunization. The patient had no known allergies. The patient did not receive and any other vaccine in four weeks. The patient does not have covid prior vaccination and had not been tested for covid post vaccination. On 11Feb2021 at 18:00, the patient experienced fever, body aches, headache resulting in inability to attend work. The treatment was not received for the events. The facility type of vaccine was reported as workplace clinic. The clinical outcome for the events was reported as recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information expected
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Headache, Rash papular
Clinical narrative: there were a lot of little bumps all over my torso. Only some of them were reddish.; extreme fatigue; aching joints; headache; chills; skin feel really textured; This is a spontaneous report from a contactable consumer. This 26-year female consumer (patient) reported for herself that.  A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:15 as (At the age of 26-years) dose 1, single for covid-19 immunisation. Medical history included covid prior vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. Patient did not test covid post vaccination. No known allergies ware reported. Patient was not pregnant at the time of vaccination. The patient experienced there were a lot of little bumps all over my torso. only some of them were reddish, extreme fatigue, aching joints, headache, chills, and skin feel really textured on 13Feb2021 11:30. It was reported that the following day, for about 6 hours, patient experienced extreme fatigue, aching joints, headache, and chills. Patient then noticed 2 days later, there were a lot of little bumps all over his torso. Only some of them were reddish. Overall, it made his skin feel really textured. Patient did not receive any treatment for the events. The outcome of events was recovering.   Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Skin texture abnormal
Clinical narrative: there were a lot of little bumps all over my torso. Only some of them were reddish.; extreme fatigue; aching joints; headache; chills; skin feel really textured; This is a spontaneous report from a contactable consumer. This 26-year female consumer (patient) reported for herself that.  A 26-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL9262), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 14:15 as (At the age of 26-years) dose 1, single for covid-19 immunisation. Medical history included covid prior vaccination. Concomitant medication included venlafaxine hydrochloride (EFFEXOR) taken for an unspecified indication, start and stop date were not reported; bupropion hydrochloride (WELLBUTRIN) taken for an unspecified indication, start and stop date were not reported; ethinylestradiol, norgestimate (TRI-SPRINTEC) taken for an unspecified indication, start and stop date were not reported. Patient did not test covid post vaccination. No known allergies ware reported. Patient was not pregnant at the time of vaccination. The patient experienced there were a lot of little bumps all over my torso. only some of them were reddish, extreme fatigue, aching joints, headache, chills, and skin feel really textured on 13Feb2021 11:30. It was reported that the following day, for about 6 hours, patient experienced extreme fatigue, aching joints, headache, and chills. Patient then noticed 2 days later, there were a lot of little bumps all over his torso. Only some of them were reddish. Overall, it made his skin feel really textured. Patient did not receive any treatment for the events. The outcome of events was recovering.   Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Erythema, Limb discomfort, Lymphadenopathy, Pain
Clinical narrative: Chills; Fever; Arm still feels really heavy like hard to go; Big swelling underneath the arm where the lymph nodes are, had a lump; Body aches; Arm got really red and swollen; Arm got really red and swollen; Ringing in head really bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced chills, fever, arm got really red and swollen. It was reported that on 5th day patient's arm was not going down, arm still felt really heavy like hard to go, it was still really red. And then this morning (at the time of reporting) when the patient woke up, patient had a big swelling underneath patient's arm where the lymph nodes were, had a lump. It started in the middle of the night, that was ringing in patient's head. Patient's head was just ringing really bad and then had the body aches. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Tinnitus
Clinical narrative: Chills; Fever; Arm still feels really heavy like hard to go; Big swelling underneath the arm where the lymph nodes are, had a lump; Body aches; Arm got really red and swollen; Arm got really red and swollen; Ringing in head really bad; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of an unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 on an unspecified date for COVID-19 immunization. On an unspecified date, the patient experienced chills, fever, arm got really red and swollen. It was reported that on 5th day patient's arm was not going down, arm still felt really heavy like hard to go, it was still really red. And then this morning (at the time of reporting) when the patient woke up, patient had a big swelling underneath patient's arm where the lymph nodes were, had a lump. It started in the middle of the night, that was ringing in patient's head. Patient's head was just ringing really bad and then had the body aches. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: This is a spontaneous report received from a contactable other-healthcare professional (patient). A patient, of unspecified age and gender, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's  medical history and concomitant medications not reported. The patient experienced body aches, lymph node swelling, fever/chills, injection site pain/swelling, on an unspecified date. The outcome of the events: unknown. Follow-up (May 14, 2021): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasal congestion, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: After the second injection around 11pm, the same day, I got a fever of 101.4  which lasted into the next day at 100.8.; My body is aching, I have a bit of congestion, and my throat was a little sore when I got the fever.; My body is aching, I have a bit of congestion, and my throat was a little sore when I got the fever.; My body is aching, I have a bit of congestion, and my throat was a little sore when I got the fever.; This is a spontaneous report from a contactable consumer (patient reported for herself). A 26-year-old adult female patient (non-pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 23Feb2021 at 09:30 AM (at the age of 26-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination.Since the vaccination, the patient had not been tested for COVID-19. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL3247), via an unspecified route of administration, administered in Left arm on 04Feb2021 at 09:00 AM (at the age of 26-year-old), as single for covid-19 immunisation. On 23Feb2021 at 23:00, after the vaccination, the patient experienced fever of 101.4, body aching, a bit of congestion and her throat was a little sore. The clinical details of the events as follows: after the second injection around 11pm, the same day, she got a fever of 101.4 which lasted into the next day at 100.8. her body was aching, she had a bit of congestion, and her throat was a little sore when she got the fever. The patient underwent lab tests and procedures which included body temperature: 101.4 fahrenheit on 23Feb2021 which lasted into the next day (23Feb2021) at 100.8. No treatment was received for the adverse events. The events did not result in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. The report was non-Serious. The patient outcome of the events was Resolving at the time of this report.  No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Decreased appetite, Fatigue
Clinical narrative: developed chills early evening; today got a Fever of 98.3; Dragging tired; feeling joints hurt; no appetite; feels like the flu; This is a spontaneous report from a Pfizer sponsored program support. A contactable female consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. Medical history included felt tired before receiving vaccine. The patient's concomitant medications were not reported. She received vaccine Yesterday and felt tired before receiving vaccine. After receiving the vaccine, she experienced developed chills early evening. Today she got a fever of 98.3, dragging tired, feeling joints hurt, no appetite, feels like the flu. She concerned what if she had started to develop covid yesterday before vaccine. The patient underwent lab tests and procedures which included body temperature: 98.3 fahrenheit. The outcome of events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: developed chills early evening; today got a Fever of 98.3; Dragging tired; feeling joints hurt; no appetite; feels like the flu; This is a spontaneous report from a Pfizer sponsored program support. A contactable female consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single for covid-19 immunisation. Medical history included felt tired before receiving vaccine. The patient's concomitant medications were not reported. She received vaccine Yesterday and felt tired before receiving vaccine. After receiving the vaccine, she experienced developed chills early evening. Today she got a fever of 98.3, dragging tired, feeling joints hurt, no appetite, feels like the flu. She concerned what if she had started to develop covid yesterday before vaccine. The patient underwent lab tests and procedures which included body temperature: 98.3 fahrenheit. The outcome of events was unknown.  Information about lot/batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Limb discomfort, Muscle disorder, Oral pain
Clinical narrative: He was walking funny: His legs were going all the way up and coming back down.; Exhausted; Not get his muscles to respond; Stomach and thighs had a full rash; Fever; So sick; Gold tooth which he got 6 months ago, started to hurt; Mouth sores; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Medical information team. A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose of COVID vaccine (BNT162B2, solution for injection) on unspecified date for COVID-19 immunization and experienced arm soreness (These side effects were only after the 2nd dose. Following the 1st dose, he had arm soreness but nothing like this). The patient experienced that he was walking funny his legs were going all the way up and coming back down, patient was wondering if it may have been neurologic, exhausted, not get his muscles to respond, stomach and thighs had a full rash, fever, so sick, gold tooth which he got 6 months ago, started to hurt, and mouth sores on an unspecified date in 2021. The patient underwent lab tests and procedures which included pyrexia with unknown results. The outcome of the events was unknown.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Toothache
Clinical narrative: He was walking funny: His legs were going all the way up and coming back down.; Exhausted; Not get his muscles to respond; Stomach and thighs had a full rash; Fever; So sick; Gold tooth which he got 6 months ago, started to hurt; Mouth sores; This is a spontaneous report from a contactable consumer or other non hcp (patient) via Medical information team. A male patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection, Lot number was not reported), via an unspecified route of administration on 13Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient historical vaccine includes first dose of COVID vaccine (BNT162B2, solution for injection) on unspecified date for COVID-19 immunization and experienced arm soreness (These side effects were only after the 2nd dose. Following the 1st dose, he had arm soreness but nothing like this). The patient experienced that he was walking funny his legs were going all the way up and coming back down, patient was wondering if it may have been neurologic, exhausted, not get his muscles to respond, stomach and thighs had a full rash, fever, so sick, gold tooth which he got 6 months ago, started to hurt, and mouth sores on an unspecified date in 2021. The patient underwent lab tests and procedures which included pyrexia with unknown results. The outcome of the events was unknown.  Information on the lot/batch number has been requested.   Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: General feeling of body aches; low grade fever; headache; This is a spontaneous report from a contactable consumer (patient). A 52-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL3247) via an unspecified route of administration on 22Feb2021 (at the age of 52-years-old) in right arm as a single dose for covid-19 immunization. The patient's medical history, known allergies to medications, food, or other products were reported as none and concomitant medications were not reported. The patient did not receive any other vaccine within four weeks or any other medications within two weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Since the vaccination, the patient had not been tested for covid-19. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; lot number: EL3247) on 03Feb2021 in left arm for covid-19 immunization. The patient experienced general feeling of body aches, low grade fever and headache on 22Feb2021. The symptoms occurred within 12 hours of second covid-19 vaccine dose. The patient did not receive any treatment. 48 hours after dose, the symptoms significantly lessened and were almost gone. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea
Clinical narrative: I became light-headed; breathing was off.; This is a spontaneous report from a contactable consumer (Patient). A 53-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration on 12Feb2021 14:00 (at the age of 53-years-old) in Arm Right, as dose 1, single for COVID-19 immunization. The patient Medical history included breast cancer from an unknown date and unknown if ongoing Breast cancer 19 years ago, sepsis from 2020 to an unknown date Sepsis from surgery in 2020, surgery from 2020 to an unknown date Sepsis from surgery in 2020. Concomitant medications included, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]), vitamin d3 (VITAMIN D3), probiotics (PROBIOTICS), multi-vitamin and Fish all taken for an unspecified indication, start and stop date was not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccinations within four weeks. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination patient was not tested for COVID-19 and patient had no known allergies. On 12Feb2021 14:15, within seconds of receiving the vaccine the patient experienced she became light-headed, breathing was off. These symptoms dissipated within 2-3 minutes. Patient concerned about taking the 2nd vaccine. The patient did not received treatment for the adverse events. The outcome for the events was recovered in Feb2021.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Skin irritation, Vaccination site swelling
Clinical narrative: Rash; irritation; swelling at injection site; headache; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6201), dose 1 via an unspecified route of administration, administered in right arm on 16Feb2021 14:45 (at the age of 61-year-old) as single for covid-19 immunisation. Medical history included high blood pressure, asthma, seasonal allergies and Penicillin allergy (z pack) from an unknown date and unknown if ongoing. Patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient neither diagnosed with COVID-19 prior to vaccination nor tested since the vaccination. Concomitant medications included amlodipine besilate (AD [AMLODIPINE BESILATE]) 5 mg, montelukast 10 mg and fexofenadine hydrochloride (ALLEGRA) - all taken for an unspecified indication, start and stop date were not reported. On 17Feb2021 18:30 the patient experienced rash, irritation, swelling at injection site and headache. No treatment was received for the events. Outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Three days after receiving the vaccine, my left cheek felt numb. It lasted over an hour and then went away.Two days later,once again, my left cheek felt numb (like Novocaine was wearing off); This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9264), via an unspecified route of administration on arm left on 15Feb2021 11:00 AM (Age at Vaccination: 70 years) as dose 1, single for COVID-19 immunisation. Facility type vaccine  was reported as Public Health Clinic/Veterans Administration facility. The patient medical history was reported as none and had no known allergies. Covid prior vaccination and covid tested post vaccination was reported as no. If other vaccine in two or four weeks was reported as no. The patient Concomitant medications were not reported. On 18Feb2021 12:00 PM, Three days after receiving the vaccine, my left cheek felt numb and tingly. It lasted over an hour and then went away. Two days later, once again, my left cheek felt numb (like Novocaine was wearing off). Again it lasted about an hour and a half. I have never ever experienced this before receiving the vaccine. This morning it feels like it is starting again. My concern.do I receive the second vaccine??? The patient did not receive any treatment for the events. The outcome of the event was not resolved.  No Follow-up attempts are needed. No further information is expected.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Achiness; Muscle soreness; Joint soreness; This is a spontaneous report from a contactable consumer. This 75-year-old male patient started to receive Pfizer Covid 19 (BNT162B2) (Batch/Lot number: EL1283, Expiration date: Unknown), via an unspecified route at left shoulder, on 16Feb2021 around 11:00 as DOSE 2 SINGLE for Covid 19 immunization (age at vaccination: 75-Year-old). Medical history was reported as none. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (Batch/Lot number: EL1283) on 24Jan2021. On 17Feb2021 patient experienced Achiness, Muscle soreness and Joint soreness. Patient asked if he could take some Tylenol for these events. No therapeutic treatments were received. On an unspecified date the outcome of the events was reported as recovering/resolving.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, SARS-CoV-2 test
Clinical narrative: Itching of my skin/skin and entire body is so itchy; slight burning sensation across my entire body surfaces; This is a spontaneous report from a contactable other health professional (patient). A 29-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: Ens318), via an unspecified route of administration, administered in left arm on 22Feb2021 12:15 (at the age of 29-year-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had received first dose BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection, Batch/Lot Number: Ej1g86), via an unspecified route of administration, administered in left arm on 11Jan2021 02:45 (at the age of 29-year-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Feb2021 16:00, it was reported that, on early evening of the day after receiving the second vaccine the patient experienced itching of my skin. It has become worse and the patient missed work because skin and entire body was so itchy. Patient reported no rash, just an itchy, slight burning sensation across entire body surfaces. The patient underwent lab tests and procedures which included nasal swab: unknown results on 23Feb2021. Patient did not received treatment for an events. Seriousness reported as non-serious. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events was not recovered.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: experienced Fatigue,no energy; sore throat; joint pain; This is a spontaneous report from a contactable consumer or other non hcp (Patient) from a Pfizer A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. No medical history and no concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1, on an unspecified date for covid-19 immunization. It was reported that Patient received second dose of Covid vaccine over a month ago but in the last 5 days she has experienced Fatigue, sore throat, joint pain, and no energy. She took Covid test Monday, and it was negative. She is calling to see if this could be side effects this long after taking the vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative. The outcome for the events was reported as unknown at the time of this report.   Information about lot/batch has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Felt chills; feverish; tired; had body aches for 24 hrs after 2nd dose of vaccine.; This is a spontaneous report from a non-contactable physician. A 54-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Jan2021 (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received bnt162b2 on an unspecified date as dose 1, single for covid-19 immunisation. The patient experienced felt chills, feverish, tired, and had body aches for 24 hrs after 2nd dose of vaccine on an unspecified date of 2021. Patient did not receive treatment for events. Patient did not have covid prior vaccination and covid was not tested post vaccination. The outcome of all events was recovered on an unspecified date of 2021.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is 1st of 2 reports. This consumer reported for a male patient. A male patient, of unspecified age, received unknown dose number of of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot#unknown, expiration date: unknown), via unspecified route, administered on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. On an unspecified date, after the vaccination, patient experienced chills, aches, pain, a little fever and etc. The events assessed non-serious, with outcome of unknown. No follow-up attempts possible. No further information expected. Follow-up (Apr 2, 2021): 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 have been completed and no further information is expected. Sender's comments: Linked report(s): INC-2021204977; same product and events, diferent patient
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Mild general body aches; Mild fever, 101F; Mild/moderate headache; Tiredness; This is a spontaneous report from a Non contactable consumer (Patient). A 29-Years old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL3247) via unspecified route of administration, administered in left arm on 16Feb2021 03:45 PM (age at vaccination was 29) as DOSE 2, SINGLE for COVID 19 immunisation at workplace clinic. The patient had covid prior vaccination. The patient's concomitant medications were not reported. Patient had no known allergies. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3247), via an unspecified route of administration on 26Jan2021 03:30 PM as DOSE 1, SINGLE for COVID-19 Immunization. Patient had not been tested post vaccination. The patient experienced Mild fever, 101F, Mild/moderate headache, Tiredness, Mild general body aches on 17Feb2021 03:00 AM. The patient also underwent the lab test and procedures included body temperature and resulted into 101F. The outcome of events was recovering.  No follow up attempts were possible. No further information was expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Malaise, Pyrexia
Clinical narrative: fever/she had a fever of 104/ Monday morning her temp was 101 yet; chills; swelling; she was tired; she didn't feel good; she couldn't stop shaking; This is a spontaneous report from a contactable consumer.  An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6200; Expiration Date: 21Feb2021), via an unspecified route of administration on 20Feb2021 (at the age of 83-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included weight decreased (patient was going to say her weight is 135 but she has lost some weight so it may be less than that) from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 21Feb2021 patient had a fever, chills and some swelling after the first dose of the pfizer COVID-19 vaccine. Sunday patient had a fever of 104 and patient was tired. Fever was 104 and patient did not feel good and chills, they were so very bad patient could not stop shaking. Trying to see if patient continue go ahead and have the second one plan mark down 13Mar2021. Patient wanted to know if this was a reason not to get the second dose. Possible duplicate AE. Patient stated the efficacy of the vaccine was after two doses and it was a good thing we have this vaccine. Patient was worried that reaction might be worse after the second dose and was wondering if patient should get the second dose. Her children said they thought patient should go to the ER but anyway, it all worked out at home. Patient said the fever was resolved, Monday morning temp was 101 yet, so it probably went away Monday afternoon or evening, the chills went away Monday as well. Patient has an appointment coming up. The patient underwent lab tests and procedures which included body temperature: 104 on 21Feb2021 and body temperature: 101 on 22Feb2021. The outcome of the events pyrexia and chills were recovered on 21Feb2021 while other events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Tremor
Clinical narrative: fever/she had a fever of 104/ Monday morning her temp was 101 yet; chills; swelling; she was tired; she didn't feel good; she couldn't stop shaking; This is a spontaneous report from a contactable consumer.  An 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EN6200; Expiration Date: 21Feb2021), via an unspecified route of administration on 20Feb2021 (at the age of 83-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included weight decreased (patient was going to say her weight is 135 but she has lost some weight so it may be less than that) from an unknown date and unknown if ongoing. Concomitant medication was not reported. On 21Feb2021 patient had a fever, chills and some swelling after the first dose of the pfizer COVID-19 vaccine. Sunday patient had a fever of 104 and patient was tired. Fever was 104 and patient did not feel good and chills, they were so very bad patient could not stop shaking. Trying to see if patient continue go ahead and have the second one plan mark down 13Mar2021. Patient wanted to know if this was a reason not to get the second dose. Possible duplicate AE. Patient stated the efficacy of the vaccine was after two doses and it was a good thing we have this vaccine. Patient was worried that reaction might be worse after the second dose and was wondering if patient should get the second dose. Her children said they thought patient should go to the ER but anyway, it all worked out at home. Patient said the fever was resolved, Monday morning temp was 101 yet, so it probably went away Monday afternoon or evening, the chills went away Monday as well. Patient has an appointment coming up. The patient underwent lab tests and procedures which included body temperature: 104 on 21Feb2021 and body temperature: 101 on 22Feb2021. The outcome of the events pyrexia and chills were recovered on 21Feb2021 while other events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Pain, Paraesthesia, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP. A 49-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# not reported), via an unspecified route of administration, on Feb 16, 2021, single dose, for COVID-19 immunisation. Medical history included Hashimoto's syndrome. Concomitant medications included thyroid replacement medication. After receiving the first dose of vaccine, patient experienced tiredness, body aches, next day 102ºF. Thursday all subsided but felt a little groggy from what she experienced. Since Saturday, she has had pins and needles in extremities. Last night it got bad and then today it's equally bad. Also has heartburn all over her stomach and chest. Concerned about the pins and needles. She asked if this could be Guillain Barré syndrome. The outcome of the heartburn, pins and needles in extremities: unknown; other events tiredness, body aches, fever recovered on an unspecified date 2021. No follow-up attempts needed. Follow-up attempts are completed. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; headache; nausea; chills; low-grade fever; This is a spontaneous report from a non-contactable consumer (patient). A 24-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318) dose 2 via an unspecified route of administration in left arm, on 16Feb2021 at 11:00 AM (at the age of 24-year-old) as single dose for COVID-19 immunisation at Workplace clinic. Medical history was none. No known allergies. Concomitant medication included nitrofurantoin (MACROBID) received in two weeks. Historical Vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318) dose 1 via an unspecified route of administration in left arm, on 26Jan2021at 03:00 PM (at the age of 24-year-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient was not tested for COVID-19. On 16Feb2021 at 10:00 PM, the patient experienced Injection site pain, headache, nausea, chills, low-grade fever. No treatment was received for events. The outcome of events was recovering.  No follow-up attempts are possible. No further information is expected.