chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Nausea, Presyncope
Clinical narrative: Severe dizziness; almost blacked out; Nausea; Elevated heart rate.; This is a spontaneous report from a non-contactable health care professional (patient).  A 30-year-old female patient received the first dose of BNT162B2 (also reported as Pfizer-BioNTech COVID-19 mRNA vaccine, lot no: EK5730), via an unspecified route of administration on 08Jan2021 at 08:00 AM at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took penicillin and experienced allergies. The patient was vaccinated in a hospital. The patient was not administered any other vaccine in four weeks and had no other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. It was reported that the patient experienced severe dizziness, almost blacked out, nausea and elevated heart rate on 08Jan2021 at 4:00 PM. The patient did not receive any treatment for the events. The outcome of the events was not recovered. The events were reported to be non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Headache
Clinical narrative: she just just found out that 7 days ago she was exposed to covid; headache; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 18Dec202, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient is scheduled to receive the 2nd dose but she just found out that on 01Jan2021, 7 days ago, she was exposed to COVID, now she wanted to know if she could go along to get the vaccine or have her tested first.  She does not recall any symptoms aside from headache on an unspecified date. Outcome of the events was unknown.  Information about lot/batch has been requested
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: throat tightness; This is a spontaneous report from a non-contactable other healthcare professional (HCP). An 18-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK9231) via an unspecified route of administration on Jan2021 at a single dose in the left deltoid muscle for COVID 19 vaccination. Medical history and concomitant medications were not reported. The patient denied any history of previous adverse reactions to vaccines and denied reaction to her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID 19 vaccination on an unspecified date. The patient was seen at a COVID vaccine clinic today for her second dose of the COVID 19 vaccination. She was given the Pfizer vaccination in the left deltoid muscle. During her 15-minute waiting period after the injection, the patient began to experience throat tightness on Jan2021. Treatment included: Benadryl 25mg po (orally) and Solumedrol 125mg IM. The event did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. The outcome of the event was unknown.     No follow-up attempts are possible. Information about lot/batch has been obtained. No further information is expected.; Sender's Comments: A possible causal association between administration of BNT162B2 and the onset of throat tightness cannot be excluded, considering the plausible temporal relationship. Sever allergic reaction is the known risk for the product.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest pain, Chills, Feeling abnormal
Clinical narrative: feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect.  No further information was provided or obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Pyrexia, Vaccination site joint movement impairment
Clinical narrative: feeling badly; chills; fever/ 101.6 fever; terrible muscle aches; headache; arm was so sore; Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed; chest pain; chest pain, going into her back, on her left side; This is a spontaneous report from a contactable other healthcare professional (patient). A 44-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK9231, NDC number: 5926710001), intramuscular on 07Jan2021 (around 10ish in the morning) at single dose at right arm for covid-19 immunization. Medical history included vertigo from an unknown date and unknown if ongoing. At the beginning of the week, patient had some vertigo but when she went in for her second vaccine, the vertigo was gone already. There were no concomitant medications. There was no adverse event following prior vaccinations. There were no additional vaccines administered on same date of the Pfizer suspect. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, NDC: 59267100002 Lot: EH9899) intramuscular on 17Dec2020 at single dose at right arm for covid-19 immunization. Patient received the second dose of the vaccine in the morning, around 10 something on 07Jan2021 at the hospital she worked at. She started feeling badly around 7:00 at night 07Jan2021 with chills, 101.6 fever, terrible muscle aches, a headache. Her arm was so sore she couldn't even move it. She couldn't get herself dressed or undressed. She was having chest pain, going into her back, on her left side. When probed for the outcome of these symptoms, patient stated she had a fever, but not quite as high. She had been taking paracetamol (TYLENOL) and it was not helping. Patient provided the following product information for the paracetamol she was taking: TYLENOL, 500mg NDC: 6984270778 Lot: 9MR0454 Expiry date: Oct2021. The back pain/muscle pain was still there. She had chills but not as badly. The soreness in her arm had improved. Her arm was still sore, but not like it was yesterday. Outcome of events feeling badly, headache and chest pain was unknown, outcome of events chills, fever/ 101.6 fever, arm was so sore she couldn't even move it was recovering, outcome of events back pain/muscle pain was not recovered. The report is considered as non-serious. The adverse events resulted in neither doctor or other healthcare professional office/clinic visit, nor emergency room/department or urgent care. History of all previous immunization with the Pfizer vaccine considered as suspect.  No further information was provided or obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis
Clinical narrative: Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); Extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours); This is a spontaneous report from a contactable nurse (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1686) via an unspecified route of administration on 06Jan2021 11:00 AM at a single dose in the left arm for Covid vaccine. Medical history included GERD. Concomitant medication included omeprazole (received within 2 weeks of vaccination). The patient had known allergies to erythromycin and hydrocodone bitartrate/paracetamol (VICODIN). The patient was not pregnant at the time of vaccination. She was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). She did not receive other vaccines within four weeks prior to the COVID vaccine. On 06Jan2021 16:00 (04:00 PM), the patient experienced extremely warm/hot (whole body) with profuse sweating without fever measured (every 2 hours), it started 5 hours after injection and lasted 48 hours. Treatment was not received for the events. The events were non-serious in which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. She was not diagnosed with COVID-19 prior to vaccination. She had not been tested for COVID-19 since the vaccination (post vaccination). The outcome of the events was recovered on 08Jan2021 16:00.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching/redness at injection site; Itching/redness at injection site; Itching/redness up neck; Itching/redness up neck; This is spontaneous report from a contactable pharmacist. A 39-year-old female patient (unknown if pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscularly in the Left arm on 06Jan2021 at 08:15 PM (at the age of 39-years-old) as a single dose for COVID-19 immunization, lot number: EL0142. Patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Medical history included anxiety and depression, coronary artery spasm, hyperlipidemia. Known allergies included latex allergy (anaphylaxis). Concomitant medications in two weeks prior to the vaccination included atorvastatin 20mg, isosorbide mononitrate 60mg extended release (ER), multivitamin, omperazole 20mg, sertraline 50mg and tizanidine 2mg for muscle spasm. On 06Jan2021 h 08:15 PM patient experienced Itching/redness at injection site and up neck. Oral (PO) diphenhydramine hydrochloride (BENADRYL) 50mg was given to treat the events. Rapid Response called and observed for 30 min. Discharged to husband's care. It was unknown if, since the vaccination, patient has been tested for COVID-19. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Eye oedema, Eye swelling, Muscle spasms, Pain, Pain in extremity
Clinical narrative: sharp spams on the right side on the bottom/back of my head; some puffiness and swelling under my eye; some puffiness and swelling under my eye; swelling and pain in my arm; swelling and pain in my arm; sharp pain; This is a spontaneous report from a contactable Other Health Professional (patient) reported that a (44 unknown unit) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation.  The patient's medical history included had fillers or Botox under eyes as it was injected with that 5 months before Jan2021. The concomitant medications were not reported. Patient experienced normal side effects like swelling and pain in arm, but (about 2 days before 08Jan2021) on 06Jan2021 she experienced some puffiness and swelling under eye. This Saturday (09Jan2021) patient started experiencing sharp spams on the right side on the bottom/back of my head. Persistent for 3 days. The sharp pain lasts for a few seconds then goes away and then randomly comes again. Patient was experiencing symptoms and wanted to see if others have been reporting this as well. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: sharp spams on the right side on the bottom/back of my head; some puffiness and swelling under my eye; some puffiness and swelling under my eye; swelling and pain in my arm; swelling and pain in my arm; sharp pain; This is a spontaneous report from a contactable Other Health Professional (patient) reported that a (44 unknown unit) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot/Batch Number and Expiration Date unknown) via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunisation.  The patient's medical history included had fillers or Botox under eyes as it was injected with that 5 months before Jan2021. The concomitant medications were not reported. Patient experienced normal side effects like swelling and pain in arm, but (about 2 days before 08Jan2021) on 06Jan2021 she experienced some puffiness and swelling under eye. This Saturday (09Jan2021) patient started experiencing sharp spams on the right side on the bottom/back of my head. Persistent for 3 days. The sharp pain lasts for a few seconds then goes away and then randomly comes again. Patient was experiencing symptoms and wanted to see if others have been reporting this as well. The outcome of events was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blood pressure increased, Dizziness, Fatigue, Headache
Clinical narrative: blood pressure skyrocketed, it was 175/110/Very high blood pressure; almost falling down; Severe fatigue; Dizzy/dizziness; Bad headache/severe headache; Neck pain; This is a spontaneous report from a contactable nurse (reporting for herself).  An adult female patient (over the age for 60) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in an unspecified deltoid on 28Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced dizzy/dizziness, bad headache/severe headache, neck pain on 28Dec2020 and almost falling down, blood pressure skyrocketed (175/110)/very high blood pressure and severe fatigue on 29Dec2020 10:00.  Clinical details were reported as follows: After the vaccine the patient was there waiting for 20 minutes and when she got in her car, after about an hour after the patient was really dizzy and was driving and was going to get in the next lane and thank God did not get in an accident. The patient parked and called her family to come pick her up. She had a bad headache, neck pain and dizziness that lasted for an hour. Finally, they came in and took me home.  The patient slept for 7 hours. 9 hours after, the headache, neck pain, and dizziness were gone. The next day at 10:00 at work the patient almost fell down and one of the coworkers held her. The patients blood pressure skyrocketed, it was 175/110 and the patient was very dizzy again had severe fatigue.  Her blood pressure was high for about 2 hours and slowly came down, but the fatigue lasted for almost a week and it slowly got better. The patient underwent lab tests and procedures which included blood pressure measurement: 175/110   on 29Dec2020 skyrocketed/very high.  The outcome of the events was recovered on an unspecified date.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Impaired driving ability, Neck pain
Clinical narrative: blood pressure skyrocketed, it was 175/110/Very high blood pressure; almost falling down; Severe fatigue; Dizzy/dizziness; Bad headache/severe headache; Neck pain; This is a spontaneous report from a contactable nurse (reporting for herself).  An adult female patient (over the age for 60) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration in an unspecified deltoid on 28Dec2020 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced dizzy/dizziness, bad headache/severe headache, neck pain on 28Dec2020 and almost falling down, blood pressure skyrocketed (175/110)/very high blood pressure and severe fatigue on 29Dec2020 10:00.  Clinical details were reported as follows: After the vaccine the patient was there waiting for 20 minutes and when she got in her car, after about an hour after the patient was really dizzy and was driving and was going to get in the next lane and thank God did not get in an accident. The patient parked and called her family to come pick her up. She had a bad headache, neck pain and dizziness that lasted for an hour. Finally, they came in and took me home.  The patient slept for 7 hours. 9 hours after, the headache, neck pain, and dizziness were gone. The next day at 10:00 at work the patient almost fell down and one of the coworkers held her. The patients blood pressure skyrocketed, it was 175/110 and the patient was very dizzy again had severe fatigue.  Her blood pressure was high for about 2 hours and slowly came down, but the fatigue lasted for almost a week and it slowly got better. The patient underwent lab tests and procedures which included blood pressure measurement: 175/110   on 29Dec2020 skyrocketed/very high.  The outcome of the events was recovered on an unspecified date.    The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.; Sender's Comments: Based on the time association, the possible contribution of suspect BNT162B2 to the event blood pressure increased cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: exposed to my sister/she did not know she had Covid/I tested positive with Covid test; exposed to my sister/she did not know she had Covid/I tested positive with Covid test; This is a spontaneous report from a contactable other HCP (patient).  This female patient of unspecified age reported for herself that she received dose one of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiration date were not reported) on 21Dec2020 00:00 (at unspecified age) as single dose, unspecified route, for COVID-19 immunisation. Medical history and concomitant medications were not reported.  The Patient received the vaccine on 21Dec2020 and was exposed to her sister on 22Dec2020 she did not know she had Covid. Patient tested positive with Covid test on 26Dec2020. Patient is scheduled to get second dose 11Jan2021. Lab data included a positive Covid test on 26Dec2020. The outcome of exposed to my sister/she did not know she had Covid/I tested positive with Covid test was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.; Sender's Comments: The information currently provided is too limited to make a meaningful medical assessment hence, the events are conservatively assessed as related to the suspect drug BNT162B2 until further information becomes available. Efficacy of suspect drug however, is documented 7 days after second dose. Patient has received only the 1st dose.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Coronavirus test, Fatigue, Headache, Myalgia
Clinical narrative: had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; temperature of 99.9°F; throat tickled 2 out of 10 and had a sore throat; throat tickled 2 out of 10 and had a sore throat; "mild" body aches; pain on her biceps as if "after doing some curls"; "mild intermittent" headache; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that She received the first dose of the Pfizer vaccine on 19Dec2020 and she did good with that, and only had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER. This week, her boyfriend tested positive for COVID on Monday, he had all symptoms from Sunday, including temperature 104.5°F, his body ached, could not lift his head off the bed, his throat was "red and scratchy", loss of taste and smell, and nasal congestion. She had mild symptoms on Monday and Tuesday, her main symptom was temperature of 99.9°F, her throat tickled 2 out of 10 and had a sore throat, she did not lose taste or smell, no nasal congestion, she did have "mild" body aches, pain on her biceps as if "after doing some curls", "mild intermittent" headache, she tested negative for COVID on Monday and Wednesday 06Jan2021. She thought the first dose of the vaccine may have protected her, she was supposed to get the second dose of the vaccine yesterday, but her job quarantined her till the end of the month and she could not get the second dose, they think these symptoms could be side effects of the vaccine. At her other job, they presumed her positive, quarantined for 10 days from that Monday, they think the vaccine protected her and thus she tested negative. The outcome of the events was unknown.   Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Throat irritation, Vaccination site erythema
Clinical narrative: had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; temperature of 99.9°F; throat tickled 2 out of 10 and had a sore throat; throat tickled 2 out of 10 and had a sore throat; "mild" body aches; pain on her biceps as if "after doing some curls"; "mild intermittent" headache; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that She received the first dose of the Pfizer vaccine on 19Dec2020 and she did good with that, and only had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER. This week, her boyfriend tested positive for COVID on Monday, he had all symptoms from Sunday, including temperature 104.5°F, his body ached, could not lift his head off the bed, his throat was "red and scratchy", loss of taste and smell, and nasal congestion. She had mild symptoms on Monday and Tuesday, her main symptom was temperature of 99.9°F, her throat tickled 2 out of 10 and had a sore throat, she did not lose taste or smell, no nasal congestion, she did have "mild" body aches, pain on her biceps as if "after doing some curls", "mild intermittent" headache, she tested negative for COVID on Monday and Wednesday 06Jan2021. She thought the first dose of the vaccine may have protected her, she was supposed to get the second dose of the vaccine yesterday, but her job quarantined her till the end of the month and she could not get the second dose, they think these symptoms could be side effects of the vaccine. At her other job, they presumed her positive, quarantined for 10 days from that Monday, they think the vaccine protected her and thus she tested negative. The outcome of the events was unknown.   Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER; temperature of 99.9°F; throat tickled 2 out of 10 and had a sore throat; throat tickled 2 out of 10 and had a sore throat; "mild" body aches; pain on her biceps as if "after doing some curls"; "mild intermittent" headache; This is a spontaneous report from a contactable Nurse (patient). A female patient of an unspecified age received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that She received the first dose of the Pfizer vaccine on 19Dec2020 and she did good with that, and only had "mild" injection site pain and redness, fatigue after 12-hr shifts at the ER. This week, her boyfriend tested positive for COVID on Monday, he had all symptoms from Sunday, including temperature 104.5°F, his body ached, could not lift his head off the bed, his throat was "red and scratchy", loss of taste and smell, and nasal congestion. She had mild symptoms on Monday and Tuesday, her main symptom was temperature of 99.9°F, her throat tickled 2 out of 10 and had a sore throat, she did not lose taste or smell, no nasal congestion, she did have "mild" body aches, pain on her biceps as if "after doing some curls", "mild intermittent" headache, she tested negative for COVID on Monday and Wednesday 06Jan2021. She thought the first dose of the vaccine may have protected her, she was supposed to get the second dose of the vaccine yesterday, but her job quarantined her till the end of the month and she could not get the second dose, they think these symptoms could be side effects of the vaccine. At her other job, they presumed her positive, quarantined for 10 days from that Monday, they think the vaccine protected her and thus she tested negative. The outcome of the events was unknown.   Information on the Lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Numbness on the face; Numbness along the left side of her mouth; This is a spontaneous report from a contactable consumer (patient). This 33-year-old female consumer received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL0142 and Expiration date was Mar2021) on 08Jan2021 12:30 (at the age of 33-years) as single dose, unspecified route in left arm for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to BNT162B2. On 08Jan2021 16:10 she started to experience numbness on the face and numbness along left side of mouth.  The outcome of event numbness on the face was unknown, and numbness along left side of mouth was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Erythema, Lethargy, Pain
Clinical narrative: felt like she had Covid; felt like she had Covid; stomach cramps; chills; aches; not feeling good; temp was around 101- 101.6/fever 102; Icy hot sensation; lethargy; arm was red and swollen; arm was red and swollen; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from Jul2020. The patient's concomitant medications were not reported. The patient got her injection on Tuesday (specified date unknown) at 3pm. Felt good but then woke up with stomach cramps. She went to work and at around 1pm she started having chills, aches and not feeling good at 4:30 pm her temp was around 101- 101.6 so she took Tylenol went to bed. She woke up with fever 102 and felt like she had Covid all over again reporting that she had covid in Jul. Having what she has heard described as "Icy hot sensation" and lethargy and not feeling good with chills aches. Then on Thursday her arm was red and swollen with the redness expanding swelling and her fever was going back up. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, the local reactions and flu like symptoms following vaccination with BNT162B2 are more likely attributed to the vaccine use.  Further information like diagnostic detection of virus genetic material or virus protein antigen needed for meaningful medical assessment on protective effects with the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia, Sensory disturbance
Clinical narrative: felt like she had Covid; felt like she had Covid; stomach cramps; chills; aches; not feeling good; temp was around 101- 101.6/fever 102; Icy hot sensation; lethargy; arm was red and swollen; arm was red and swollen; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. Medical history included covid-19 from Jul2020. The patient's concomitant medications were not reported. The patient got her injection on Tuesday (specified date unknown) at 3pm. Felt good but then woke up with stomach cramps. She went to work and at around 1pm she started having chills, aches and not feeling good at 4:30 pm her temp was around 101- 101.6 so she took Tylenol went to bed. She woke up with fever 102 and felt like she had Covid all over again reporting that she had covid in Jul. Having what she has heard described as "Icy hot sensation" and lethargy and not feeling good with chills aches. Then on Thursday her arm was red and swollen with the redness expanding swelling and her fever was going back up. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the information currently available, the local reactions and flu like symptoms following vaccination with BNT162B2 are more likely attributed to the vaccine use.  Further information like diagnostic detection of virus genetic material or virus protein antigen needed for meaningful medical assessment on protective effects with the vaccine.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Headache, Nausea, Oxygen saturation
Clinical narrative: feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and  headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: feeling "not quite right"; nausea; headache; arm was sore/ it felt like someone shot him in the arm; This is a spontaneous report from a contactable consumer. A 46-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL0140), via an unspecified route of administration on 24Dec2020 10:00 at SINGLE DOSE at left arm for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. On 31Dec2020, the patient experienced headache, "lungs felt uber clean and clear," and nausea. The patient stated about a week afterward he started feeling "not quite right" He stated his arm was sore for about 12 hours after the shot, but this has resolved. He has already seen his PCP, lungs are clear, and Covid test was negative. He said that a week ago, he started to feel not quite right. He said that his lungs felt uber clean, but stated that he had a headache and nausea every now and then. He was wondering if it is related to the vaccination. He said that he went to the doctor and his O2 sat was 99% and she did not even think he needed a Covid test, but the rapid test was Covid negative. He stated that on the website that it says that up to 7 days after vaccination 77% of people reported fever, chills, headache and other symptoms. He said that he did not know that you could experience side effects a week after getting a vaccine. He said that his eases his mind a little bit. He wanted to know if it could be because of the vaccine? He stated that sometimes he feels fine and other times he feels strange. He stated that sometime he just feels different. He said that he received the vaccine on 24Dec2020. Caller said that sometimes he is perfectly fine and then he will get the headache or nausea for a few moments and then it would go away. Caller said that at the doctor's office his blood pressure was 118/78 and his O2 sat was 99% He stated that he does work around Covid patients and takes all precautions when he is around them. He said that exactly 12 hours later after receiving the vaccine at 2200 24Dec2020, he said that it felt like someone shot him in the arm. 2-3 hours after he got up on 25Dec2020 it was gone. Caller said that he rarely gets sick and has not had the flu vaccine. The outcome of the events nausea, and  headache was not recovered, and arm was sore was recovered on 25Dec2020, while unknown for the event feeling abnormal.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Lethargy, Pain
Clinical narrative: Fever (101-102 F); chills; body ache; lethargic; a weird tingling sensation on her butt, leg, and back; redness, hardness, and swelling at the injection site; redness, hardness, and swelling at the injection site; redness, hardness, and swelling at the injection site; stomach cramps at night; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685 and expiry date: 21Mar2021), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 in Jul2020. The patient's concomitant medications were not reported. The patient mentioned she had the 1st shot on Tuesday (05Jan2021) and woke up during the night with stomach cramps but didn't put it together that the cramps may be from the vaccine. She went to work on Wednesday and around 1pm in the afternoon (06Jan2021), she started to feel feverish with chills and aches; just was not feeling good. She experienced fever (101-102 F), chills, and body ache. When she got home around 4:30pm, her temperature was 101, so she took acetaminophen (TYLENOL) for it. During the night, her temperature went up to 102. She stated that she felt like she did when she had COVID in Jul2020, including being lethargic. She also had a weird tingling sensation on her butt, leg, and back. The weird sensation down her back, butt, and legs felt like "tingles that runs through you." She has heard others describe it as being like icy hot. She also noticed redness, hardness, and swelling at the injection site. Yesterday, she tried applying ice to her arm, and last night she had trouble sleeping because she still had the aches and chills. Today, her arm was larger and the red area has spread and it's hard. She clarified that it had been hard the whole time she's had the redness and swelling. She reported that the swelling on her arm was larger and harder, and the red area has spread. She also had a fever (101.6 F), chills and body ache, so she's getting ready to take some more acetaminophen (TYLENOL). She was starting to get concerned because it's been 3 days (72 hours) since she got the vaccine and she thought that the side effects would be over with by now. She was asking if these are common side effects and how long should they last. She stated "I am a bit concerned with taking the 2nd dose after this. Are there any recommendations on this?" The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: Fever (101-102 F); chills; body ache; lethargic; a weird tingling sensation on her butt, leg, and back; redness, hardness, and swelling at the injection site; redness, hardness, and swelling at the injection site; redness, hardness, and swelling at the injection site; stomach cramps at night; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685 and expiry date: 21Mar2021), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included COVID-19 in Jul2020. The patient's concomitant medications were not reported. The patient mentioned she had the 1st shot on Tuesday (05Jan2021) and woke up during the night with stomach cramps but didn't put it together that the cramps may be from the vaccine. She went to work on Wednesday and around 1pm in the afternoon (06Jan2021), she started to feel feverish with chills and aches; just was not feeling good. She experienced fever (101-102 F), chills, and body ache. When she got home around 4:30pm, her temperature was 101, so she took acetaminophen (TYLENOL) for it. During the night, her temperature went up to 102. She stated that she felt like she did when she had COVID in Jul2020, including being lethargic. She also had a weird tingling sensation on her butt, leg, and back. The weird sensation down her back, butt, and legs felt like "tingles that runs through you." She has heard others describe it as being like icy hot. She also noticed redness, hardness, and swelling at the injection site. Yesterday, she tried applying ice to her arm, and last night she had trouble sleeping because she still had the aches and chills. Today, her arm was larger and the red area has spread and it's hard. She clarified that it had been hard the whole time she's had the redness and swelling. She reported that the swelling on her arm was larger and harder, and the red area has spread. She also had a fever (101.6 F), chills and body ache, so she's getting ready to take some more acetaminophen (TYLENOL). She was starting to get concerned because it's been 3 days (72 hours) since she got the vaccine and she thought that the side effects would be over with by now. She was asking if these are common side effects and how long should they last. She stated "I am a bit concerned with taking the 2nd dose after this. Are there any recommendations on this?" The outcome of the events was unknown.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Bradykinesia, Chills, Fatigue, Gait disturbance
Clinical narrative: convulsive chills, fever- (high); convulsive chills; fever- (high); all of my muscles and joints were flaring in extreme pain; all of my muscles and joints were flaring in extreme pain; I could NOT move my vaccine  arm more than 3 inches and my whole body hurt; my vision was extremely blurry; When I tried to walk, it was slow; achy/whole body hurt; tired, and took a nap; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient (no pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on the left arm on 05Jan2021 11:00 AM at single dose for COVID-19 immunisation.  Medical history included having Covid the 3rd week in Mar2020, Positive for Antibodies in early May2020. Fairly sick but not emergency situation "Long haulers" covid symptoms that continued through Nov2020. Patient still had skin pain. Other medical history included hashimoto's. Past drug event included known allergy to codeine. The patient's concomitant medications included 25 mg of Levothyroxine in two weeks. No other vaccine in four weeks. On 05Jan2021 at 12:30, patient felt achy, tired, and took a nap. By 2:00ish. The patient's vision was extremely blurry and continued for 2 days. At 05Jan2021 8 pm- 6 hours later of convulsive chills, fever- (high) and all of her muscles and joints were flaring in extreme pain. Patient could not move vaccine arm more than 3 inches and whole body hurt as if she had been hit by a train. When patient tried to walk, it was slow. Patient groped walls for support. Patient had a televisit with a doctor friend who said this was not a normal side effect and go to emergency room (ER). Doctor or other healthcare professional office/clinic visit. Covid test post vaccination included nasal swab, Covid -19 diagnostic on 08Jan2021 with pending result. No treatment received for events. The outcome of convulsive chills fever was unknown. The outcome of other events was recovered in Jan2021.