chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Feeling hot, Peripheral swelling
Clinical narrative: Full arm became swollen, red, warm to the touch, mimicking a cellulitis-looking infection.  Redness was spreading to left lateral neck and across upper chest.  Took 50mg chewable Benadryl and 600mg motrin.  All symptoms subsided approximately an hour later.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, SARS-CoV-2 test positive, Tachycardia
Clinical narrative: Felt sore throat and tachycardia; Felt sore throat and tachycardia; COVID test came back positive; COVID test came back positive; This is a spontaneous report from a contactable physician, the patient.  A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 18Dec2020, as a single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On 28Dec2020, the patient felt sore throat and tachycardia. The patient also reported that on an unspecified date, in Dec2020, the COVID test came back positive (the Sepheid test, not the rapid test). The events were reported as non-serious. The patient underwent lab tests, which included COVID-19 test: positive on an unspecified date in Dec2020. It was unknown if the patient received treatment for the COVID test came back positive, felt sore throat and tachycardia. The clinical outcome of the events the COVID test came back positive, felt sore throat and tachycardia was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on available information, a possible contributory role of subject vaccine cannot be excluded for the reported events of LOE, COVID 19, Oropharyngeal pain and tachycardia, based on temporal relationship.  There is very limited information provided in this report.   This case will be reassessed upon receipt of follow-up information.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This caused immediate pain in the arm. The pain has continued for the past 20 hours.; This is a spontaneous report from contactable Nurse reporting for herself via Pfizer Sales Representative.  A 48-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot #EJ1685), intramuscular into the right arm on 29Dec2020 11:15 at 0.6 mL, single for COVID-19 immunization. Medical history was none. There were no concomitant medications. The administer cleaned the arm with alcohol but didn't wait for it to dry. On 29Dec2020 the patient experienced immediate pain in the arm. The pain has continued for the past 20 hours. The outcome was recovered.
Sex: U
Vaccine: COVID19
Symptoms: Oxygen saturation, Tachycardia
Clinical narrative: Temporary tachycardia; This is a spontaneous report from a contactable Physician. This physician reported similar events for 3 patients. This is the second of 3 reports.   A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Dec2020 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced temporary tachycardia on Dec2020 with outcome of recovered. The reporter monitored the patient using a pulse ox with a heart monitor. Let the patient drink water. She has monitored the patient for about 30 minutes and tachycardia has resolved in 30 to 40 minutes. The reporter was a bit concerned about what to expect and how to prepare for the patient's 2nd dose of the vaccine.   Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520685 Same reporter/drug/event, different patient;US-PFIZER INC-2020517983 Same reporter/drug/event, different patient
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Headache, Injection site pain
Clinical narrative: Estimated due date 06/24/2021. I just had arm pain at the injection site and severe headaches for about 2 days.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: a high fever; extreme fatigue; have allergies; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the second of eight reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patients
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the third of eight reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number can not be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter, drug, events, and different patients
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the fourth of eight reports.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter, drug, events, and different patients
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the fifth of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the sixth of eight reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 vaccination. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine on Dec2020. The patient had allergies, but it was unknown what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patient
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Flushing, Nasal pruritus, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Patient experienced a bit of flushing, itchiness in nose, eyes, tingling in mouth/scalp, and a little throat tightness after initial monitoring period of 15 minutes. Occurred 1-2 hours after dose admin. Resolved with no treatment, though Benadryl was recommended.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: high fever; extreme fatigue; patient had allergies, but it was unknown what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the seventh of eight reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown  what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020520682 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Hypersensitivity, Pyrexia
Clinical narrative: high fever; extreme fatigue; patient had allergies, but it was unknown  what the allergies are to; This is spontaneous report from a non-contactable consumer. This consumer reported similar events for eight patients. This is the eighth of eight reports.  A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer version of the vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on unknown date in Dec2020 at single dose, for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient got the vaccine at a facility then had a high fever and extreme fatigue after getting the vaccine in Dec2020. The patient had allergies, but it was unknown  what the allergies are to. The outcome of events was unknown.  No follow-up attempts are possible. Information on batch/Lot number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile; This is a spontaneous report from a contactable nurse, the patient.  A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; ; Lot number:  EH9899), via an unspecified route of administration, in the left arm, on 22Dec2020 at 12:15 PM (at the age of 30-year-old) as a single dose for COVID-19 immunization.  Medical history included irritable bowel syndrome, anxiety, depression, allergies to dust, cats and dogs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT), melatonin, and l-theanine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 9:00 AM, the patient experienced lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile.  The event was reported as non-serious. On 29Dec2020 the patient underwent lab tests, which included SARS-CoV-2 test (nasal swab) and SARS-CoV-2 test (PCR, covid test): both of which were negative. The patient did not receive any treatment for lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile.  The patient reported that its still present 8 days later remains about 2 finger widths wide and is firm/dense, mobile, now nontender.  The clinical outcome of the event lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile was not recovered.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased, Pyrexia
Clinical narrative: Light headed, felt feverish but body temperature was 97.4 F, felt like heart rate was elevated. Resolved after 20-30 minutes.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Hot flush, Myalgia, Pain
Clinical narrative: Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from a contactable Nurse (patient herself).  This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 20Dec2020 at 18:15 at single dose for COVID-19 immunisation. Vaccine location was Arm Right. The patient was not pregnant. Relevant medical history included elevated rheumatoid factor, restless leg syndrome and depression. Past drug history included allergy to ferrous gluconate. Relevant concomitant medications included pramipexole dihydrochloride (MIRAPEX). The patient was vaccinated at hospital, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination COVID test was not performed. Post-vaccination COVID tests were performed: nasal swab on 28Dec2020 was negative; PCR in Dec2020 was negative. On 21Dec2020 at 18:30, the patient had headaches, muscle pain, body aches, low-grade fever and frequent hot flashes throughout the day at random moments, along with headaches and bod. The patient was not treated for the events. The patient had not recovered from the events.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Headaches; Muscle pain; Low-grade fever; Body aches; Hot flashes; This is a spontaneous report from a contactable Nurse (patient herself).  This 48-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK5730), via intramuscular, on 20Dec2020 at 18:15 at single dose for COVID-19 immunisation. Vaccine location was Arm Right. The patient was not pregnant. Relevant medical history included elevated rheumatoid factor, restless leg syndrome and depression. Past drug history included allergy to ferrous gluconate. Relevant concomitant medications included pramipexole dihydrochloride (MIRAPEX). The patient was vaccinated at hospital, age at vaccination was 48-year-old. No other vaccine was received in four weeks. Pre-vaccination COVID test was not performed. Post-vaccination COVID tests were performed: nasal swab on 28Dec2020 was negative; PCR in Dec2020 was negative. On 21Dec2020 at 18:30, the patient had headaches, muscle pain, body aches, low-grade fever and frequent hot flashes throughout the day at random moments, along with headaches and bod. The patient was not treated for the events. The patient had not recovered from the events.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Headache, Injection site pain
Clinical narrative: Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nausea. Severe headache. Severe coughing with some sputum.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Productive cough
Clinical narrative: Extreme muscle soreness in whole body as well as injection site. Extreme shivering. Dizziness. Nausea. Severe headache. Severe coughing with some sputum.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Headache; Really really tired; Really really cold; Chills; Nausea; This is a spontaneous report from a contactable consumer (patient herself).  This 57-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1685, Expiration Date Mar2021), via intramuscular, on 28Dec2020 at 13:30 at single dose for COVID-19 immunisation. Vaccine location was left arm. Age at vaccination was 57-year-old. Relevant medical history included anxiety and fibromyalgia. The patient was receiving concomitantly a drug (unspecified) at dose of 60 mg daily from  Sep2020. This patient stated that she is not a healthcare professional but works in the diet area/kitchen of which is a hospital.  On 29Dec2020 she felt really really tired, got really really cold, had chills, nausea. On 30Dec2020, in the morning, she had onset of headache.  She still had a slight headache and a little nausea, but did not have the chills. She did not knowif this has anything to do with the vaccine but wanted to report the information. She did not plan to change her dose; she was scheduled to get the second dose on 15Jan2021 at 1:00pm which she still plans to get. The outcome of 'really really fatigue' and 'really really cold' was unknown; the event 'chills' recovered in Dec2020; the outcome of 'nausea' and 'headache' was recovering.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; Mild headache within first hour relieved some with Tylenol. 12 hours after injection, awoke to severe headache, and nausea; This is a spontaneous report from a contactable nurse (patient herself).  This 51-year-old female nurse received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EK9231), via an unknown route, on 28Dec2020 at 16:00 at single dose for COVID-19 immunisation. Vaccine location was left arm. The patient was not pregnant. Relevant medical history included type 2 diabetes. No known allergies. Relevant concomitant medications included metformin, pravastatin and paracetamol (TYLENOL). The patient was vaccinated at hospital, age at vaccination was 51-year-old. No other vaccine was received in four weeks. Post-vaccination COVID test was not performed On 28Dec2020 at 17:00, the patient had mild headache within first hour relieved some with paracetamol (TYLENOL). 12 hours after injection, awoke to severe headache, and nausea. Unrelieved with TYLENOL after one hour. She took ibuprofen, 'CLARITIN' and ondansetron hydrochloride (ZOFRAN).  Eventually relieved 1.5 hr after that. The patient recovered from both events in Dec2020.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: positive for covid; positive for covid; positive for covid; This is a spontaneous report from a contactable nurse (patient). A 43-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunization. completely excluded.  More information such as laboratory findings on nucleic acid /PCR test needed for meaningful medical assessment.The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID on 20Dec2020. Outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  More information such as virus genome /nucleic acid detection needed for meaningful medical assessment
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Painful arm; This is a spontaneous report from contactable nurse (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on 28Dec2020 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported to have received the Pfizer Covid vaccine yesterday (28Dec2020). The patient experienced painful arm even on the second day. The outcome of event was not recovered.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia oral, Lacrimation increased, Rhinorrhoea, Throat irritation
Clinical narrative: 5 minutes after receiving vaccine:  Itchy throat  Mouth numb Runny nose  30 minutes Eyes watering Headache
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable healthcare professional, the patient. A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection intramuscular in the right arm on 30Dec2020 at 08:00 (at the age of 43-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 30Dec2020 at 13:30, the patient experienced arm pain. No treatment was provided for the event arm pain. The outcome of the event arm pain was unknown. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Nervousness, Pruritus
Clinical narrative: Itching; Little bit nervous; This is a spontaneous report from a contactable consumer reporting for himself. A 59-year-old male patient received bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced itching and little bit nervous on an unspecified date with outcome of unknown.    The information on the Lot/Batch number has been requested.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Patient reports tingling in right forearm in top of right hand
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature abnormal, Chills, Feeling abnormal, Malaise
Clinical narrative: Don't feel good at all; Feel like chills and the temperature; Feel like chills and the temperature; Not feeling myself today; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 28Dec2020 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. In Dec2020 after vaccination, patient didn't feel good at all, the patient just feel like chills and the temperature and the patient was not feeling myself. The outcome of the events was unknown.   Information on lot number/Batch number was requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: sweating; Fatigue; Fever; Headache; chills; This is a spontaneous report from a contactable consumer.  A 38-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL1284, via an unspecified route of administration, in the left arm, on 29Dec2020 at around 17:15 (at the age of 38 years-old) as a single dose for COVID-19 immunization.  Medical history included ongoing high blood pressure, diagnosed about 15 years ago. There were no concomitant medications.  It was not known if the patient received any other vaccines within four weeks prior to the vaccination. On 30Dec2020, the patient experienced fatigue, fever, chills, headache and sweating. The clinical course was as follows: The patient reported that she started developing symptoms after having the COVID vaccine on 29Dec2020. On 30Dec2020, she was fatigued. The headache started earlier in the day. She did not have a thermometer on hand but she thought she had a fever and chills. She was wrapped up because she was so cold. She took 600mg of Ibuprofen around 13:30, which she thought broke her fever because she was sweating. She was still fatigued but not as bad as when she had a fever. The clinical outcome of the fever and chills was recovered, for the fatigue was recovering; the headache was not recovered; the outcome of the sweating was not reported. It was not known if she was tested for COVID-19 after the vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sweating; Fatigue; Fever; Headache; chills; This is a spontaneous report from a contactable consumer.  A 38-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), lot number: EL1284, via an unspecified route of administration, in the left arm, on 29Dec2020 at around 17:15 (at the age of 38 years-old) as a single dose for COVID-19 immunization.  Medical history included ongoing high blood pressure, diagnosed about 15 years ago. There were no concomitant medications.  It was not known if the patient received any other vaccines within four weeks prior to the vaccination. On 30Dec2020, the patient experienced fatigue, fever, chills, headache and sweating. The clinical course was as follows: The patient reported that she started developing symptoms after having the COVID vaccine on 29Dec2020. On 30Dec2020, she was fatigued. The headache started earlier in the day. She did not have a thermometer on hand but she thought she had a fever and chills. She was wrapped up because she was so cold. She took 600mg of Ibuprofen around 13:30, which she thought broke her fever because she was sweating. She was still fatigued but not as bad as when she had a fever. The clinical outcome of the fever and chills was recovered, for the fatigue was recovering; the headache was not recovered; the outcome of the sweating was not reported. It was not known if she was tested for COVID-19 after the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: Extreme exhaustion; Headache; My arm was sore; This is a spontaneous report from a Pfizer Sponsored Program. A contactable healthcare professional (HCP, patient) reported that a female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 26Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 29Dec2020, the patient experienced extreme exhaustion, headache, her arm was sore. No symptoms at all till 72 hours after the vaccine. The outcome of events was unknown.   Information on Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Influenza like illness, Pain
Clinical narrative: Flu like symptoms, chills and body aches with A 100.2 temp.. last 12/31-1/1
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: she started to feel "pick, pick, pick" starting in the ears; This is a spontaneous report from a contactable other healthcare professional (patient).  A female patient of an unspecified age (Age: 67; Units: Unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 30Dec2020 16:20 to 30Dec2020 16:20 as single dose for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  The patient reported she received the vaccine on 30Dec2020 16:20 and four hours post administration she started to feel 'pick, pick, pick' starting in the ears. The outcome of the event was unknown.  Information about Lot/batch no has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chills, Diarrhoea, Malaise, Nausea
Clinical narrative: Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; This is a spontaneous report from a contactable nurse (patient).  A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm, Had same feeling the next day but better compared to the day before. In addition, the nurse reported she woke up to breastfeed. Outcome of the events feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm were recovering.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Throat tightness
Clinical narrative: Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; Feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm; This is a spontaneous report from a contactable nurse (patient).  A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 28Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. In Dec2020, the patient experienced feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm, Had same feeling the next day but better compared to the day before. In addition, the nurse reported she woke up to breastfeed. Outcome of the events feeling sick, throat a little bit tight but it was fine, severe abdominal cramping, had the feeling of throwing up but did not happen, diarrhea, chills, had a rash in forearm were recovering.  Information on lot/batch number has been requested.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Local site reaction- raised red, itchy area approximately 2 inches high by 4 inches wide at site of injection.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: fever, chills, headache, etc.; fever, chills, headache, etc.; fever, chills, headache, etc.; This is a spontaneous report from a contactable other healthcare professional (patient).  A female patient of unspecified age started to the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), unspecified route of administration on 30Dec2020 as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  In Dec2020, the patient experienced fever, chills, headache, etc. The reporter inquired is it ok to take ibuprofen (MOTRIN) Motrin or  acetaminophen (TYLENOL). Outcome of the events fever, chills and headache were unknown. Information on lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself.  A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension.  The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: Persistent headache/ felt very sick with headache on and off; I had body ache; Nausea; Dizzy; I was feeling very weird/ felt awful; my arm hurt; This is a spontaneous report from a contactable nurse reporting for herself.  A 70-years-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EH9899 (as reported: "don't know if it E or and F, looks like EH9899") & Expiry Mar2021, via an unspecified route of administration on 22Dec2020 as a single dose (age at vaccination 70 years old), for COVID-19 immunization. Medical history included pulmonary hypertension.  The patient's concomitant medications were not reported. The patient had a persistent headache that doesn't go away, and had body ache (onset 23Dec2020). She reported feeling "like I had COVID." She went and got tested because she was a healthcare worker; her first test was negative (Dec2020) and her second test today (29Dec2020) was negative. She thought because it all started the day after vaccine (23Dec2020), that day she felt very sick with headache on and off, nausea, and was dizzy. She was feeling very weird and her arm hurt and she knew that she was going to have some side effect, so she went to work and took some ibuprofen (MOTRIN) for the pain and that was it. She took the vaccine on Tuesday, Wednesday she felt awful, Thursday, the only thing she had was pain in arm that's it but Friday started again with headache and all these symptoms that haven't gone away. The clinical outcome of the event persistent headache, body ache, nausea, dizzy, feeling very weird/ awful was not recovered.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Headache after shot was administered. At 0400 began having chills, body aches, redness and itching around injection site, nausea, sore throat, ear ache. Took Excedrin migraine. Symptoms have resolved.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oropharyngeal pain, Pain
Clinical narrative: Headache after shot was administered. At 0400 began having chills, body aches, redness and itching around injection site, nausea, sore throat, ear ache. Took Excedrin migraine. Symptoms have resolved.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: Covid like symptoms; fever; muscle aches; This is a spontaneous report from a contactable Nurse. A 58-year-old male patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: unknown), via an unspecified route of administration on 29Dec2020 at single dose for COVID-19 immunization. The patient medical history included positive for COVID in Sep2020. He was positive 98 days before receiving the vaccine. Concomitant medications were not reported.  The patient experienced covid like symptoms which include fever and muscle aches on Dec2020. Patient would like to know if receiving the vaccine after having COVID in September was causing his symptoms; if his symptoms are expected or common after the first dose; and if he should receive the second dose. Event outcome was unknown.  Information about lot/batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: injection site pain, swelling, and redness; injection site pain, swelling, and redness; injection site pain, swelling, and redness; This is a spontaneous report from a contactable consumer (patient). A 57 year old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot Number/Expiration date: not provided), via an unspecified route of administration, on 28Dec2020 (at the age of 57 years old), at the hospital she works out of, as a single dose in the left arm for COVID-19 immunization. Relevant medical history included penicillin allergy. Concomitant medication was not provided. The consumer reported that she has taken no new medications, and did not receive any other vaccines when she got this one. On the same day, on 28Dec2020, the consumer experienced injection site pain, swelling, and redness. The consumer described the injection site swelling, and redness as a big bullseye, it is a raised knot, and the whole area is red. The consumer reported that she used a tape measure to measure it, and it was only 2 inches by 2.5 inches. The consumer reported that the redness, swelling, and pain she has does not interfere with her day other than she is sore and it is big. Treatment received for the events included icing it off and on. The outcome of the events injection site pain, swelling, and redness was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Euphoric mood, Headache, Pain in extremity
Clinical narrative: sore arm; a bit of a headache; an uncontrollable urge to happy dance; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable consumer (patient).  A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in Dec2020 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. Twenty-four hours later in Dec2020, the patient got a sore arm, a bit of a headache, and an uncontrollable urge to happy dance, but otherwise feeling pretty unchanged. Outcome was unknown. Information about lot/batch number cannot be obtained.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, COVID-19, Cough, Headache
Clinical narrative: Temp 102.0, muscle and joint pain, coughing, headache Tested positive for COVID on 1/2/2021
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test positive
Clinical narrative: Temp 102.0, muscle and joint pain, coughing, headache Tested positive for COVID on 1/2/2021
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Body ache and headache; Body ache and headache; This is a spontaneous report from a contactable Nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 29Dec2020 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced body ache and headache (non-serious) on 31Dec2020. She has no fever. The patient asked, "I'm concerned about my side effects. Should I get tested for COVID-19?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Nasopharyngitis, Pyrexia
Clinical narrative: I have 99 fever; My arm is sore; Cold; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Batch/lot number, NDC and UPC number and expiry Date: unknown), via an unspecified route of administration in Dec2020 (at the age of 67-year-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient's concomitant medications were not reported. In Dec2020, the patient woke up with a 99 fever that went to 98.4, arm was sore and didn't know if it was a cold. The patient was treated with ibuprofen for sore arm. The clinical outcome of 99 fever, arm was sore and cold was unknown.    No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: no
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; Vommiting, Body aches, Fever of 102; This is a spontaneous report from a contactable other healthcare professional, the patient. A 36 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number unknown), via intramuscular route of administration in the left arm on 28Dec2020 at 08:00 AM (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient had no relevant medical history. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not have any allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 28Dec2020, the patient experienced vomiting, body aches and fever of 102. The report was reported as non-serious. The patient was not treated for vomiting, body aches and fever of 102. The clinical outcome of vomiting, body aches and fever of 102 was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 (rapid test nasal swab) on 31Dec2020 and was negative.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: little bit of soreness in my arm; This is a spontaneous report from a contactable consumer, the patient.  A 73-year-old patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 29Dec2020 (at the age of 73-years-old) as a single dose for COVID-19 vaccination. The patient medical history was not reported.  The patient's concomitant medications were not reported.  The patient stated "I just got my shot yesterday and I'm 73 and I was sure that I was gonna have something but I got absolutely nothing. A little bit of soreness in my arm but I can live with that."  The clinical outcome of soreness in arm, was unknown.    Information on the lot/batch number has been requested.