chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Chills; Dizziness; Soreness at injection site; Fatigue; Muscle aches; Headache; TMJ aching (joint pain); Mild back pain on injection side; This is a spontaneous report from a contactable Nurse (the patient).  A 28-year-old female patient the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL3246, expiration date unknown) via an unspecified route of administration on 05Jan2021 at 08:45 (at the age of 28 years old) at an unspecified dose in the right arm for COVID-19 vaccination. Medical history included COVID-19 on an unspecified date, allergy to Penicillin and seasonal allergy from unknown dates.The patient was not pregnant at the time of vaccination. The patient was administered the vaccine in the hospital. Prior to the vaccination, the patient was diagnosed with COVID-19 (date not specified) The patient's historical vaccines include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number EK5730, expiration date unknown) on 15Dec2020 at 3:00 PM (at the age of 28 years old) at an unspecified dose in the left arm for COVID-19 vaccination. The patient was tested for COVID-19 after the first vaccination in the form of a nasal swab test on 24Dec2020 which was negative. Concomitant medication included cetirizine hydrochloride (ZYRTEC), biotin (BIOTIN), bifidobacterium infantis, lactobacillus acidophilus (PROBIOTIC). The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient reports having experienced a headache five (5) hours post the second vaccine, soreness at injection site, fatigue and muscle aches eight (8) hours post the second vaccine, chills and dizziness twelve (12) hours post the second vaccine, and TMJ aching and mild back pain on injection side twenty-four to forty-eight (24-48) hours post the second vaccine. Treatment was received for the events and included acetaminophen and ibuprofen.The clinical outcome of the events headache, vaccination site soreness, fatigue, muscle aches, chills, dizziness, joint aching and back pain was reported as recovered on an unspecified date in Jan2021.  It is unknown if the patient has been tested for COVID-19 since the second vaccination.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Arthralgia; Rigors; Severe headache; Severe myalgia; Nausea; Sore throat; Fever; first dose on 18Dec2020, second dose on 07Jan2021; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable Physician reported for himself.  A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 in left arm at single dose for COVID-19 immunization.  Medical history included carotid dissection. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included atorvastatin, acetylsalicylic acid (ASPIRIN). The patient experienced arthralgia, rigors, severe headache, severe myalgia, nausea, sore throat, fever all on 07Jan2021 20:00 with outcome of recovering. No treatment was received. Information about lot/batch number has been requested.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Off label use, Oropharyngeal pain, Pyrexia
Clinical narrative: Arthralgia; Rigors; Severe headache; Severe myalgia; Nausea; Sore throat; Fever; first dose on 18Dec2020, second dose on 07Jan2021; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable Physician reported for himself.  A 46-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 09:00 in left arm at single dose for COVID-19 immunization.  Medical history included carotid dissection. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 18Dec2020 17:00 for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID tested post vaccination and did not have COVID prior vaccination. The patient had no known allergies. Concomitant medication included atorvastatin, acetylsalicylic acid (ASPIRIN). The patient experienced arthralgia, rigors, severe headache, severe myalgia, nausea, sore throat, fever all on 07Jan2021 20:00 with outcome of recovering. No treatment was received. Information about lot/batch number has been requested.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Eye pain, Feeling cold
Clinical narrative: pain on eye movement; high fever; joint/muscle ache; joint/muscle ache; headache; nausea; unable to sleep; shivered most of the night unable to feel warm; shivered most of the night unable to feel warm; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; This is a spontaneous report from a contactable physician (patient himself). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899), via intramuscular on 04Jan2021 11:45 at single dose in left arm for covid-19 immunization.  Medical history included allergies: allergy to certain sunblock. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (lot number EH9899) for covid-19 immunization on 18Dec2020 10:00 AM in left arm via intramuscular. The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 12hrs after second vaccine (05Jan2021), patient had high fever, and accompanying symptoms such as joint/muscle ache, headache, nausea. Fever was severe enough, patient was unable to sleep and shivered most of the night unable to feel warm, patient was also unable to check temperature due to status of severe symptoms. Upon waking in the early morning, fever was better, symptoms of headache/nausea/joint/muscle ache persisted rest of day. Fever was around 101 rest of day time. By second day (05Jan2021 12:00 am), fever subsided, residual mild headache and pain on eye movement remained for another day. Eye pain on movement persisted for 4 days after fever. The patient took ibuprofen 200mg for high fever, joint/muscle ache, headache. Events were assessed as non-serious. Outcome of these events were recovering.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Insomnia, Myalgia, Nausea, Off label use
Clinical narrative: pain on eye movement; high fever; joint/muscle ache; joint/muscle ache; headache; nausea; unable to sleep; shivered most of the night unable to feel warm; shivered most of the night unable to feel warm; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; This is a spontaneous report from a contactable physician (patient himself). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899), via intramuscular on 04Jan2021 11:45 at single dose in left arm for covid-19 immunization.  Medical history included allergies: allergy to certain sunblock. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (lot number EH9899) for covid-19 immunization on 18Dec2020 10:00 AM in left arm via intramuscular. The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 12hrs after second vaccine (05Jan2021), patient had high fever, and accompanying symptoms such as joint/muscle ache, headache, nausea. Fever was severe enough, patient was unable to sleep and shivered most of the night unable to feel warm, patient was also unable to check temperature due to status of severe symptoms. Upon waking in the early morning, fever was better, symptoms of headache/nausea/joint/muscle ache persisted rest of day. Fever was around 101 rest of day time. By second day (05Jan2021 12:00 am), fever subsided, residual mild headache and pain on eye movement remained for another day. Eye pain on movement persisted for 4 days after fever. The patient took ibuprofen 200mg for high fever, joint/muscle ache, headache. Events were assessed as non-serious. Outcome of these events were recovering.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue, Pyrexia
Clinical narrative: pain on eye movement; high fever; joint/muscle ache; joint/muscle ache; headache; nausea; unable to sleep; shivered most of the night unable to feel warm; shivered most of the night unable to feel warm; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; First dose: 18Dec2020 10:00 AM; second dose: 04Jan2021 11:45 AM; This is a spontaneous report from a contactable physician (patient himself). A 36-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EH9899), via intramuscular on 04Jan2021 11:45 at single dose in left arm for covid-19 immunization.  Medical history included allergies: allergy to certain sunblock. There were no concomitant medications. The patient previously took the first dose of BNT162B2 (lot number EH9899) for covid-19 immunization on 18Dec2020 10:00 AM in left arm via intramuscular. The most recent COVID-19 vaccine was administered was in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Roughly 12hrs after second vaccine (05Jan2021), patient had high fever, and accompanying symptoms such as joint/muscle ache, headache, nausea. Fever was severe enough, patient was unable to sleep and shivered most of the night unable to feel warm, patient was also unable to check temperature due to status of severe symptoms. Upon waking in the early morning, fever was better, symptoms of headache/nausea/joint/muscle ache persisted rest of day. Fever was around 101 rest of day time. By second day (05Jan2021 12:00 am), fever subsided, residual mild headache and pain on eye movement remained for another day. Eye pain on movement persisted for 4 days after fever. The patient took ibuprofen 200mg for high fever, joint/muscle ache, headache. Events were assessed as non-serious. Outcome of these events were recovering.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Fatigue, Pyrexia, Vomiting
Clinical narrative: Extreme fatigue; cold chills; fever; vomiting; abdominal pain; This is a spontaneous report from a contactable healthcare professional (patient) reported that a 24-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899, expiration date: not reported) on 17Dec2020 at 09:00 on the right arm then received the second dose on 07Jan2021 at 09:00 on the left arm both via an unspecified route of administration at a single dose for covid-19 immunisation. The patient medical history was reported as none. The patient was not pregnant. The patient has no allergies to medications, food, or other products. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications were not reported. On 07Jan2021 17:00, the patient experienced extreme fatigue, cold chills, fever, vomiting and abdominal pain. No treatment was received for the reported events. The outcome of the events was recovering. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible; information about lot number was already obtained.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia teeth, Influenza like illness, Therapeutic response unexpected
Clinical narrative: plantar fasciitis pain disappeared; hit hard as if flu; teeth are particularly sensitive to cold; This is a spontaneous report from a contactable nurse. A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose via intramuscular route on her left arm on 06Jan2021 (lot number: EL1823) at 15:45, and first dose via an unspecified route of administration on an unspecified date; both at a single dose for COVID-19 immunization. Medical history included hypothyroidism and tooth recession. Concomitant medication included levothyroxine. The patient previously took amoxicillin and experienced allergies. The patient's plantar fasciitis pain disappeared so she thought that her body was too busy responding to vaccine. She was hit hard as if flu. One notable side effect was that teeth were particularly sensitive to cold. She used Sensodyne for periodontal recession and they were really, really uncomfortable to cold. All occurred on 07Jan2021 at 15:00. Outcome of the events was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Headache; Left arm pain near injection site; Fatigue; This is a spontaneous report from a non-contactable consumer. A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140), via an unspecified route of administration on her left arm on 28Dec2020 at 12:45 at a single dose for COVID-19 immunization. Medical history included hypertension, migraine, polycystic ovaries (PCOS) and allergies to wasp venom and dust mites. The patient was not pregnant at the time of the vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. On 28Dec2020 at 15:45, the patient experienced mild left arm pain near injection site that lasted a few hours, severe fatigue which started 3 hours post injection and lasted for 4 hours; and moderate headache which started on 29Dec2020 (duration 3 days). The patient did not receive treatment for the adverse events. The patient recovered from the events.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Eye irritation, Fatigue, Muscle spasms
Clinical narrative: Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, the patient has not been tested for COVID-19.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Aches; Chills; menstrual like cramps (but post menopausal); Fatigue; Eye burning; low grade temp; This is a spontaneous report from a contactable nurse (patient). A 57-year-old female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on 06Jan2021 16:45 at a single dose on right arm for COVID-19 immunization. Medical history included, lactose intolerance. Concomitant medication included acetylsalicylic acid (ASPIRIN (E.C.), probiotics (PROBIOTICS), clarithromycin (MACROBID [CLARITHROMYCIN]), ibuprofen (MOTRIN [IBUPROFEN]), paracetamol (TYLENOL). The patient previously took Parafon Forte and experienced allergies. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: ek5730) on 17Dec2020 17:15 at a single dose on left arm for COVID-19 immunization. The patient experienced aches, chills, menstrual like cramps, fatigue, eye burning, and low grade temp on 07Jan2021 15:00. The outcome of the events was recovering. The events were assessed as non-serious. The facility where the most recent COVID-19 vaccine was administered was Hospital. 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. Since the vaccination, the patient has not been tested for COVID-19.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 07Jan2021 at 10:45 at single dose in left arm for covid-19 immunization. Medical history included allergies to penicillin. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), levothyroxine, desvenlafaxine succinate (PRISTIQ). The patient previously received the first dose bnt162b2 (Batch/lot number: EK5730) on 17Dec2020 at 15:00 in left arm for COVID-19 immunization at age of 33 years old. The patient experienced headache, dizziness, body aches, mild fever, chills, extreme fatigue, and soreness at injection site on 07Jan2021 at 23:00. All events were reported as non-serious by reporter. The patient didn't receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of all the events was resolved in Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Headache; dizziness; body aches; mild fever; chills; extreme fatigue; soreness at injection site; This is a spontaneous report from a contactable other HCP (patient). A 34-year-old non-pregnant female patient received the second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231), via an unspecified route of administration on 07Jan2021 at 10:45 at single dose in left arm for covid-19 immunization. Medical history included allergies to penicillin. Concomitant medication included ethinylestradiol, etonogestrel (NUVARING), levothyroxine, desvenlafaxine succinate (PRISTIQ). The patient previously received the first dose bnt162b2 (Batch/lot number: EK5730) on 17Dec2020 at 15:00 in left arm for COVID-19 immunization at age of 33 years old. The patient experienced headache, dizziness, body aches, mild fever, chills, extreme fatigue, and soreness at injection site on 07Jan2021 at 23:00. All events were reported as non-serious by reporter. The patient didn't receive treatment for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination, and has not been tested for COVID-19 since the vaccination. The outcome of all the events was resolved in Jan2021.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: Aching in arms & legs; After 2nd vaccine felt like I had the flu; This is a spontaneous report from a contactable consumer. A 66-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), first dose on 15Dec2020 15:00 (lot EH9899, expiry date not reported) in the left arm, then second dose on 05Jan2021 (lot EL0142, expiry date not reported); both via an unspecified route of administration at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had other medications (unspecified) in the two weeks prior to vaccination. The patient was not pregnant at the time of vaccination. On 06Jan2021 02:00, the patient experienced aching in arms and legs, and reported that after 2nd vaccine felt like patient had the flu. The patient did not receive any treatments for the events reported. The events were reported as not serious (did not result in death, not life-threatening, did not cause/prolonged hospitalization, not disabling/incapacitating and not a congenital anomaly/birth defect). The patient recovered from the events aching in arms and legs and felt like patient had the flu in Jan2021.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report from a contactable nurse reporting for herself. A 32-years-old female patient started to receive the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), on 07JAN2021 11:00 (at the age of 32-years-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient previously had BNT162B2 dose 1 for COVID-19 immunization. The patient had been experiencing chills and fever after she received the second dose of the Covid-19 vaccine on 07Jan2021 11:00AM. The symptoms started on 08Jan2021 around 3:00AM, she's still experiencing these symptoms and she took acetaminophen (TYLENOL) to lessen symptoms.  Outcome of the events was not recovered.  Information on batch/lot number requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Nasopharyngitis, Nausea, Pain in extremity
Clinical narrative: exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: exhausted/Exhausted like she could just lay down and go to sleep; Exhausted like she could just lay down and go to sleep; freezing cold; slightly nauseous; not feel as zippy as she normally do; Arm hurting a little; This is a spontaneous report from a contactable consumer (patient herself, a dental hygienist) via Medical Information team. A 57-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection; lot number: EK5730, expiration date: Mar2021, NDC number was unknown), via an unspecified route of administration on the right arm (also reported as upper shoulder) on 07Jan2021 at 11:30 30 at a single dose for COVID-19 vaccination. The patient had no medical history. There were no concomitant medications. The patient reported she was feeling exhausted, freezing cold, slightly nauseous, and did "not feel as zippy as she normally do" on 08Jan2021. She wanted these effects recorded, and would like to know if they were normal, and would they happen to the same or higher intensity with the second dose. The patient further reported she had no adverse reaction on 07Jan2021 other than her arm hurting a little. Starting on 08Jan2021, she had felt exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous. She had been reading and was sure or was guessing this was normal, but wanted to verify that. She was not running a fever as of yet. Every time she tried to get up, she just laid back down. She felt fairly decent when she woke up, these events started later at the time of the report on 08Jan2021. She would not say these events were life threatening, but the CDC patient vaccine record card said to call to report any adverse events. She was scheduled for a second dose on 28Jan2021 and at this time did not plan to change dosing unless event worsening would occur. The patient had the vaccination, because she was always coming into contact with people with COVID at work. The patient had no investigation assessment. The reporter assessed the events as non-serious. The patient was recovering from the event "arm hurting a little," she was not recovered from the events "exhausted/exhausted like she could just lay down and go to sleep, freezing cold, and slightly nauseous," while the outcome of the event "not feel as zippy as she normally do" was unknown.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive COVID-19 test; positive COVID-19 test; positive COVID-19 test; This is a spontaneous report from a contactable pharmacist. A around 50-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration on 22Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician reported that he knew the patient got the vaccine on 22Dec2020. On 02Jan2021, he tested positive to COVID-19. The outcome of the events was unknown.  Information on the Lot/batch number has been requested.; Sender's Comments: The association between the event lack of effect (tested positive for COVID-19) with BNT162b2 can not be completely excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: I already have some muscle pain; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142, expiry date not reported), via an unspecified route of administration on 07Jan2021 09:30 at single dose on right arm for COVID-19 immunization. Medical history included none. There were no concomitant medications. The patient reported that she received the first dose of the vaccine yesterday (Thursday, 07Jan2021) and is scheduled to have the 2nd dose on 28Jan2021. She is asking if she should delay her Aerobics class the next day after the 28th because she knows that there are flu like symptoms that are associated with the 2nd dose of the vaccine. The patient stated, "What are the side effects after the 2nd dose? I already have some muscle pain." The patient also denied having any problems or symptoms after yesterday's shot (as reported, pending clarification). No other vaccine received that day and none in the 4 weeks prior. Not had any problems with the vaccines in past. When looking for name of vaccine states it was the one from Pfizer that was frozen, 170 degrees below zero. Mentions she is not a flu vaccine person and did not know if that matters. The adverse event did not require a visit to the Emergency Room or Physician Office. No relevant tests done. The outcome of the event was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain, Vaccination site pain
Clinical narrative: ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; ENTIRE body hurts. Joints, muscles; headache; Minimal pain at injection site; This is a spontaneous report from a contactable nurse (patient herself). A 56-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248; expiry date: unknown) intramuscular (left arm) on 07Jan2021 at 15:30, at a single dose, for COVID-19 immunization. Relevant medical history included hypertension (HTN), hypothyroid, and early pulmonary HTN. Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) intramuscular (left arm) on 17Dec2020 at 15:15 for COVID-19 immunization. The patient previously received bactroban ointment and experienced allergies. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered in the hospital. On 08Jan2021, at 5:00 a.m. the patient's entire body hurts, including joints and muscles and also had severe headache and minimal pain injection site (less sore than first shot). Patient confirmed that she did not have any of these symptoms with the first dose. Patient took ibuprofen but did not seem to help. Patient is a registered nurse working in a small, rural hospital. Outcome of the events headache and minimal pain at injection site was unknown, while for the remaining events was not recovered. The patient has not been tested for COVID-19 since vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vomiting
Clinical narrative: vomiting, migraine
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Eye pain, Fatigue, Headache, Herpes zoster
Clinical narrative: severe fatigue day of vaccine, next day 1/7 also headache and general feeling unwell and arm pain at site of injection. Fatigue and headache-stabbing pain R side of head continue. Head pain increased overnight 1/12.  Rash on forehead started 1/10 or 1/11, eye pain.  1/13 went to urgent care and diagnosed with  shingles.  Today rash continues,eye worse, severe pain on R side of head mostly in front of and around R ear into jaw and neck. Started on Valtrex
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Malaise, Neck pain, Pain in jaw, Rash
Clinical narrative: severe fatigue day of vaccine, next day 1/7 also headache and general feeling unwell and arm pain at site of injection. Fatigue and headache-stabbing pain R side of head continue. Head pain increased overnight 1/12.  Rash on forehead started 1/10 or 1/11, eye pain.  1/13 went to urgent care and diagnosed with  shingles.  Today rash continues,eye worse, severe pain on R side of head mostly in front of and around R ear into jaw and neck. Started on Valtrex
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: severe fatigue day of vaccine, next day 1/7 also headache and general feeling unwell and arm pain at site of injection. Fatigue and headache-stabbing pain R side of head continue. Head pain increased overnight 1/12.  Rash on forehead started 1/10 or 1/11, eye pain.  1/13 went to urgent care and diagnosed with  shingles.  Today rash continues,eye worse, severe pain on R side of head mostly in front of and around R ear into jaw and neck. Started on Valtrex
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dizziness, Dyspnoea, Headache
Clinical narrative: Headache,dizziness, sob, chest pain, nausea, vomiting, fever, muscle and joint pain.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Vomiting
Clinical narrative: Headache,dizziness, sob, chest pain, nausea, vomiting, fever, muscle and joint pain.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Chills, Headache, Pain, Pyrexia
Clinical narrative: Starting at 2200 on 1/12/21, I began experiencing fever (101.9F), chills, body aches, and headache. The fever broke at around 0600 on 1/13/21, but the headache and body aches persisted until about 1200 on 1/13/21 when I took Ibuprofen.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Starting at 2200 on 1/12/21, I began experiencing fever (101.9F), chills, body aches, and headache. The fever broke at around 0600 on 1/13/21, but the headache and body aches persisted until about 1200 on 1/13/21 when I took Ibuprofen.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Hyperhidrosis, Syncope
Clinical narrative: Rapid heart rate, severe sweating, inability to breathe, narrowing vision, fainting, anxiety
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tunnel vision
Clinical narrative: Rapid heart rate, severe sweating, inability to breathe, narrowing vision, fainting, anxiety
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Rapid heart rate, severe sweating, inability to breathe, narrowing vision, fainting, anxiety
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis, Presyncope
Clinical narrative: Rapid heart rate, severe sweating, inability to breathe, narrowing vision, fainting, anxiety
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Rapid heart rate, severe sweating, inability to breathe, narrowing vision, fainting, anxiety
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Dyspnoea, Heart rate increased, Hyperhidrosis, Syncope
Clinical narrative: Severe sweating, rapid heart rate, blurring vision, dizziness, shortness of breath,  near syncopy
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Tunnel vision
Clinical narrative: Severe sweating, rapid heart rate, blurring vision, dizziness, shortness of breath,  near syncopy
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Syncope
Clinical narrative: Severe sweating, rapid heart rate, blurring vision, dizziness, shortness of breath,  near syncopy
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hyperhidrosis, Presyncope
Clinical narrative: Severe sweating, rapid heart rate, blurring vision, dizziness, shortness of breath,  near syncopy
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Severe sweating, rapid heart rate, blurring vision, dizziness, shortness of breath,  near syncopy
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Somnolence, Visual impairment
Clinical narrative: First episode ocular migraine- flashing zig zag shapes in right eye lasting about 30 minutes. Still groggy next morning.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: red, itchy spot at injection site 9 days after vaccine given
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness
Age: 32.0
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Patient states: Eight days after injection patient seen that she had a red hive like circle around injection site. Patient states NO fever, pain, irritation, cough, or discomfort.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Flushing, Throat tightness
Clinical narrative: Patient had slight throat tightness, dry cough and flushed.  Benadryl 25 mg given by mouth. Observed for 30 min and all symptoms resolved.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Body temperature increased, Chills, Computerised tomogram, Computerised tomogram neck, Fatigue
Clinical narrative: Initial symptoms were normal symptoms: 100.3 temp/fagitue/chills/body aches - this occurred 11 hours after the shot and lasted for about a day.  then 3-4 days after vaccine noticed tender and swollen subclavicular lymph node.  Appointment made with PCP 1/5/2021- followed by bloodwork, ultrasound, andCT scan to rule out cancer and other concerns.  Reactive lymph nodes was the ultimate diagnosis.  At this time was educated to see an ENT if the nodes do not decrease in size.  As of today note resolving of size of lymph nodes - will continue to monitor.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Laboratory test, Lymphadenopathy, Pain, Ultrasound scan
Clinical narrative: Initial symptoms were normal symptoms: 100.3 temp/fagitue/chills/body aches - this occurred 11 hours after the shot and lasted for about a day.  then 3-4 days after vaccine noticed tender and swollen subclavicular lymph node.  Appointment made with PCP 1/5/2021- followed by bloodwork, ultrasound, andCT scan to rule out cancer and other concerns.  Reactive lymph nodes was the ultimate diagnosis.  At this time was educated to see an ENT if the nodes do not decrease in size.  As of today note resolving of size of lymph nodes - will continue to monitor.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia oral, Tremor
Clinical narrative: Received COVID vaccine and within 15 mins had numbness of lips, shaking and flushed cheeks
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Oropharyngeal pain, Palpitations
Clinical narrative: feeling flushed, palpitations and sore throat 5 minutes after administration
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Rash erythematous
Clinical narrative: Woke up 1/14 in am  and L deltoid area itchy. Noted localized pinkish/red rash measuring about 40 mm x 95 mm in circumference. No noticeable swelling present. Applying hydrocortisone area to site and will monitor.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Decreased appetite, Dry mouth, Fatigue
Clinical narrative: Had headache, fatigue , muscle aches arm and body. muscle aches upper chest and legs, chills, nausea,dry mouth,loss of appetite. I was tested on 1/6/21 result positive for covid. was prescribed azithtromycin 500mg , 1 tablet per day for 7 days. I took tylenol for pain and quarantined since then.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, SARS-CoV-2 test positive
Clinical narrative: Had headache, fatigue , muscle aches arm and body. muscle aches upper chest and legs, chills, nausea,dry mouth,loss of appetite. I was tested on 1/6/21 result positive for covid. was prescribed azithtromycin 500mg , 1 tablet per day for 7 days. I took tylenol for pain and quarantined since then.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Fatigue, Headache, Night sweats
Clinical narrative: One week after injection; Left arm swollen, rash, extreme arm pain and arm felt as if it was burning.  Entire body was itching, developed sore throat, headache, fatigue, night sweats and chills for approximately 48 hours.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: One week after injection; Left arm swollen, rash, extreme arm pain and arm felt as if it was burning.  Entire body was itching, developed sore throat, headache, fatigue, night sweats and chills for approximately 48 hours.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: C/O  itching "all over".  No rash  or respiratory symptoms reported or observed. Pepcid 20mg po and Benedryl 50mg IM X 1 dose. Symptoms resolved within 15 minutes. Pt. discharged home with driver.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: One week to the day of receiving vaccine(1/13/21) I woke up with a large red hive-type spot near injection site.  The spot was hot to the touch and slightly swollen.  My arm ached and felt heavy.   The next day (1/14/21) the red hive-type spot had doubled in size.  The spot is still hot to the touch and my arm is still achy.  I spoke with a nurse at the health department and she recommended I report the symptoms here and follow up with my doctor.  I left a message for my doctor but have not heard back.  The day of my injection (1/6/21) the only side effect I had was a sore arm.  No other symptoms until 1/13/21.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Limb discomfort
Clinical narrative: One week to the day of receiving vaccine(1/13/21) I woke up with a large red hive-type spot near injection site.  The spot was hot to the touch and slightly swollen.  My arm ached and felt heavy.   The next day (1/14/21) the red hive-type spot had doubled in size.  The spot is still hot to the touch and my arm is still achy.  I spoke with a nurse at the health department and she recommended I report the symptoms here and follow up with my doctor.  I left a message for my doctor but have not heard back.  The day of my injection (1/6/21) the only side effect I had was a sore arm.  No other symptoms until 1/13/21.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Resident had immediate elevation of heart rate with discharge heart rate after 15 min monitoring of 135 bpm.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling, Sleep disorder
Clinical narrative: Awoke at 3 am on 1/14/2021 with eye pain and swelling , at 6:30 am eye swelling in right eye was more prominent, rinsed eyes with cold water  multiple times. Swelling still exists 1/14/2021 at 1315, (time of typing this information).  Seeing slight improvement.
Age: 45.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: I received the Moderna Covid 19 Vaccination four days ago.  This morning I began to sweat, then I  suddenly had intense nausea, followed by  stomach pains.  This was followed by a bout  of diarrhea for a a couple of hours.  I didn't eat anything out of the ordinary.   The diarrhea has subsided, but my stomach is still bothering me.  I'm also very tired, achy and out of it.  My doctor said to report this as a potential side effect.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Injection site erythema, Injection site rash, Pain in extremity, Pyrexia
Clinical narrative: Rash and redness around injection site Arm soreness Chills Fever
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Oedema peripheral
Clinical narrative: Injection site reaction of 6 cm on the right deltoid. Developed 7-8 days after immunization. Subjective swelling in the right axilla, but not noted on exam. No other systemic symptoms.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Systemic: Rash (other than injection site)-Mild
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Pain in extremity, Paraesthesia, Peripheral coldness
Clinical narrative: SYMPTOMS BEGAN THE DAY AFTER VACCINATION.  STARTED WITH NUMBNESS AND TINGLING IN RIGHT FOOT.  PAIN IN SAME AREA THAT DAY.  WEAKNESS OF ARCH IN FOOT.  SAME SYMPTOMS CONTINUED UNTIL 01/14/21.  ON 01/14, BOTH RIGHT AND LEFT FEET, ANKLES, LEGS (ABOVE THE KNEE DOWN).  THESE SYMPTOMS SPECIFICALLY INCLUDE TINGLING, PRICKLY, SLIGHT NUMBNESS.  CONDITION GETS BETTER AND WORSE FOR NO REASON.  ESSENTIALLY FEELS LIKE LEGS ARE WAKING UP AFTER THEY HAVE FALLEN ASLEEP.  ALSO HAS THE SAME SYMPTOMS IN BOTH ARMS (ELBOW DOWN) AND HANDS.  HANDS FEEL VERY COLD.  SAME SYMPTOMS IN RIGHT SIDE OF FACE INCLUDING EAR.  NO SEVERE PAIN PRESENT.  NOT TAKEN ANY ACTION TO RESOLVE AS OF YET.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Injection site erythema, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: One week after injection   Hives , swelling , warm to touch at injection site   Next date increased redness increased size    Virtual appointment with Heath care provider   Dx allergic reaction   Recommend hydrocortisone cream to site.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Pt states while waiting the 15 min post vaccine, he felt that he was getting sleepy/drowzy
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Paraesthesia oral
Clinical narrative: within 15 minutes developed dysphagia, tongue tingling. : transferred to ED  : Observed for 4 hrs and d'cd to home
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pain
Clinical narrative: Chills, headache,  general ache for 1 day. Lymphadenopathy for 3 days.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus
Clinical narrative: She self-reports having "SVT" (patient is a nurse) and feeling flushed and itchy. She resolved this and then almost two weeks later she a large area of erythema, swelling and itching over the vaccine site with axillary pain and itching.  She had been taking some OTC antihistamine with some relief. She was advised not to take the second shot. This was at her appointment on 1/12/2021.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular tachycardia
Clinical narrative: She self-reports having "SVT" (patient is a nurse) and feeling flushed and itchy. She resolved this and then almost two weeks later she a large area of erythema, swelling and itching over the vaccine site with axillary pain and itching.  She had been taking some OTC antihistamine with some relief. She was advised not to take the second shot. This was at her appointment on 1/12/2021.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: 4 cm of redness at injection site 14 days after vaccine