chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever up to 106; headaches; muscle pains; chills; nausea; This is a spontaneous report from a contactable consumer or other non hcp. A 53-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Left on 21Mar2021 15:45 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included meloxicam (MELOXICAM) taken for an unspecified indication, start and stop date were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient did not receive other vaccine in four weeks of vaccination. Patient received Meloxicam as medications in two weeks of vaccination. Patient had no allergies to medications, food, or other products. Ethnicity information was available. On 21Mar2021 15:45 the patient experienced fever up to 106, headaches, muscle pains, chills, nausea. The patient underwent lab tests and procedures which included body temperature: 106 Fahrenheit on 21Mar2021 fever up to 106. The outcome of the events was recovering. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: pain in left arm and shoulder; pain in left arm and shoulder; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration in the left arm on 26Jan2021 at 16:00 (at the age of 74-year-old), dose 1, single for COVID-19 immunisation. Medical history included mild high blood pressure and pre-diabetes. Concomitant medications included lisinopril; metformin; ALPRAZOLAM (XANAX); ibuprofen. The patient had no allergies to medications, food or other products. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive other vaccines four weeks prior. The patient was not pregnant at the time of vaccination. The vaccine was administered at hospital. On 26Jan2021 at 17:00, the patient had pain in my left arm and shoulder after the first dose that never went away. The events resulted in doctor or other healthcare professional office/clinic visit. No treatment was received for the events. The patient had not been tested for COVID-19 since vaccination. The outcome of the events was not recovered.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021326535 Same reporter/product/patient, different dose and similar events
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in left shoulder on 18Mar2021 (at the age of 65-year-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing History and Investigations: Not taking any other medications than high blood pressure. Patient concomitant medications were not specified. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EN5318), via an unspecified route of administration, administered in left shoulder on 25Feb2021 (at the age of 65-year-old) as dose 1, single for covid-19 immunisation. Patient had a Flu shot and started feeling feverish. Last winter did not feel feverish. Did feel feverish after Flu shot in 2019. On 18Mar2021, the patient experienced chills. On an unspecified date in Mar2021, patient experienced. Had chills through the night of 18Mar2021. Probably was running a fever then. Patient Hadn't taken aspirin or Advil or anything like that. The patient underwent lab tests and procedures which included body temperature: 100.7 on Mar2021 fairly steady bouncing between 00 degrees and 101 degrees, body temperature: 101 on 19Mar2021 degree. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever; chills; headache; injection site pain; This is a spontaneous report from a contactable other health care professional. A 39-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in left arm on 22Mar2021 at 12:00 (at the age of 39-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) as dose 1, single for COVID-19 immunization (at the age of 39-years-old). Patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. No other medications in two weeks. No COVID prior vaccination. Facility where the most recent COVID-19 vaccine was administered at Workplace clinic. On 22Mar2021 at 21:30, the patient experienced fever, chills, headache and injection site pain. No treatment received for the adverse events. No COVID tested post vaccination. The outcome of the events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: I'm running a fever, 101F; I'm starting to feel like crap; This is a spontaneous report from a contactable consumer or other non hcp (female consumer).   A female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on 22Mar2021 as 2nd dose, single for covid-19 immunisation. Historical Vaccine was a female patient of an unspecified age received BNT162b2 (CONMINTARY, Solution for injection, Lot No was not reported), via an unspecified route of administration on unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications.  The patient experienced I'm running a fever, 101f, I'm starting to feel like crap on 22Mar2021.  The patient underwent lab tests and procedures which included body temperature: 101 Fahrenheit on 22Mar2021. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nausea, Pain, Pyrexia
Clinical narrative: fever; cough; body ache; nausea; This is a spontaneous report received from a contactable consumer or other non hcp. A 71-years-old female patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot number was not reported), via an unspecified route of administration on 18Mar2021,at the age of 71 years old,as Dose 2, SINGLE for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever, cough, body ache and nausea on Mar2021.The outcome of the event was unknown.Patient received no treatment for the adverse event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained..
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Ocular hyperaemia, Oxygen saturation, Somnolence
Clinical narrative: her eyes looked off extra large and a kind of redness around the orbit; Groggy and eyes looked off; This is a spontaneous report received from a contactable other health care professional (parent) . A 17-years-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: not reported) via intramuscular route of administration in her left arm on 23Mar2021 at 14:00 (at the age of 17-years old) as dose 1, single for COVID-19 immunization.  Medical history included fainting and orthostatic hypotension.  Patient concomitant medication included The birth control medications). Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, did not receive any other vaccines within 4 weeks. Since the vaccination, has the patient has not been tested for COVID-19. On 23Mar2021 at 14:15, the patient experienced groggy and patient eyes looked off, extra-large and a kind of redness around the orbit -near the skin and the reporter reported as that she called an on-site employee emergency medical technician (EMT) facilitating the 15 minutes post shot. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the reported events. On an unspecified date, the patient underwent lab tests which include blood pressure(bp) and pulse oximeter (pulse ox) measurement with unknown result. The outcomes for the events redness of eyes and groggy was recovering at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Cough, Dysphonia, Oropharyngeal discomfort, Productive cough
Clinical narrative: Little ache in his upper back like by his kidneys; Voice has changed, a little hoarse; Throat started bothering him; Coughing every now and then, coughing up mucus; Coughing every now and then, coughing up mucus; This is a spontaneous report from a contactable consumer (patient) from a Pfizer-sponsored program. A 55-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 14Mar2021 10:30 (at the age of 55-year-old) (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. Medical history included none. The patient's concomitant medications were none. The patient did not receive any other vaccinations. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. On 15Mar2021, the patient had coughing every now and then. He would cough ups ome mucus, he calls it coal, he coughs up some coal. His throat started bothering him about night. On 17Mar2021, the reported that his voice has changed, a little hoarse and on 18Mar2021, he had little ache in his upper back like by his kidneys. The patient reported that he got up around 5:00 on 18Mar2021 and the back pain wasn't there. The back pain started around 7:00 on 18Mar2021. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Of my mouth to the chin started to..hello..hello..my chin started to swell; This is a spontaneous report from a contactable consumer or other non hcp.    A patient of unspecified age and gender received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was Reported that, A patient stated, got the first shot. A week later noticed the left side of my mouth to the chin started to swell. The outcome of the events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: sneezing; Itchy throat; runny nose; This is a spontaneous report from a Pfizer-sponsored program, via contactable consumer (patient).  A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration on 16Mar2021, as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Mar2021, the patient experienced sneezing, Itchy throat, and runny nose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: fever; pain at injection site; This is a spontaneous report from a Regulatory Authority. A non-contactable female consumer reported for herself that.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced fever, and pain at injection site on an unspecified date. It was reported that Caller received first vaccine and had fever and pain at injection site. Wanted to know should she return to work with fever. The outcome of events was unknown.  No follow-up attempts are Possible. Information on lot/batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: fever; chills; sore arm; This is a spontaneous report from a contactable consumer a Pfizer sponsored program with Regulatory Authority Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation.  Medical history included covid-19. On 18Mar2021 at 04:30, the patient experienced fever, chills and sore arm.  Therapeutic measures were taken as a result of fever. The patient stated the symptoms started at 430 this morning and she experienced Fever, chills, sore arm and now is starting to feel better. She stated she had Covid prior to the 1st dose and the nurse told her that she would be probably feel like this. She took tylenol to help with her fever. There were no unaddressed medical questions referred or forwarded to Medical Information. Outcome of the events were recovering.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: Blisters on the rash on leg; Skin rash on legs and arms; This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration, in right arm, on 09Mar2021 at 10:15 (at the age of 60-year-old), at dose number unknown single for COVID-19 immunization. It was reported that, the patient had no relevant past medical history. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. The patient did not have any allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. On 10Mar2021 at 17:00, the patient had skin rash on legs and arms, more dominant on right arm and leg. The patient also had blisters on the rash on leg. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. Therapeutic measures were taken included treatment with steroid cream (unspecified). The clinical outcome of the events was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: fever; chills; body aches; fatigue; 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 17Mar2021 (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported. On 18Mar2021, the patient experienced fever, chills, body aches and fatigue. The outcome was unknown for the reported events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Chills; Fever; This is a spontaneous report from a contactable consumer or other non-health care professional (patient himself). This report was received via Pfizer sales representative. An adult male patient of age 5 decades (reported as Late 40s/early 50s) received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. The patient experienced chills and fever on an unspecified date. Events took place after use of product. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Breast pain, Influenza like illness, Joint stiffness
Clinical narrative: Flu like symptoms; body itch; skin pain; muscle pain; bone pain; joint pain/stiffness; joint pain/stiffness; low grade fever; breast pain on left side (same side as injection); tinnitus; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Patient historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 11 hours after the second COVID injection, the patient experienced flu like symptoms, Symptoms included total body itch, skin pain, muscle pain, bone pain, joint pain/stiffness, low grade fever. Also had significant breast pain on left side (same side as injection) and tinnitus on an unspecified date. Symptoms lasted 18 hours. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain of skin, Pruritus, Pyrexia, Tinnitus
Clinical narrative: Flu like symptoms; body itch; skin pain; muscle pain; bone pain; joint pain/stiffness; joint pain/stiffness; low grade fever; breast pain on left side (same side as injection); tinnitus; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Patient historical vaccine included 1st dose of BNT162B2 (Lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. 11 hours after the second COVID injection, the patient experienced flu like symptoms, Symptoms included total body itch, skin pain, muscle pain, bone pain, joint pain/stiffness, low grade fever. Also had significant breast pain on left side (same side as injection) and tinnitus on an unspecified date. Symptoms lasted 18 hours. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Pyrexia
Clinical narrative: Fatigue; Fever; Dizziness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fatigue, Dizziness, Fatigue. The clinical outcome of the events was unknown at the time of report. No follow up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea; Nausea; Fever; Headahce; Body pain; Abdomen pain for 72 hours; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 41-year-old), as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included lupus, fibromyalgia, high blood pressure, asthma, long covid , seizure disorder and factor v deficiency. Concomitant medication included 24 Rxs since an unknown date for an unknown indication. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EN6198 and expiry date not reported), via an unspecified route of administration, administered on arm left, on 26Feb2021 15:45 (at the age of 41-year-old), as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 (as reported). Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 18:45, the patient experienced diarrhea, nausea, fever, headache, body pain, abdomen pain for 72 hours, non-stop and was waiting for the events to go away. Happened with 2nd shot only. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: fever on 20Mar2021. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Diarrhea; Nausea; Fever; Headahce; Body pain; Abdomen pain for 72 hours; This is a spontaneous report from a contactable consumer (patient). A 41-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number and expiry date not reported), via an unspecified route of administration, on an unspecified date (at the age of 41-year-old), as dose 2, single for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included lupus, fibromyalgia, high blood pressure, asthma, long covid , seizure disorder and factor v deficiency. Concomitant medication included 24 Rxs since an unknown date for an unknown indication. Historical vaccine included BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot number EN6198 and expiry date not reported), via an unspecified route of administration, administered on arm left, on 26Feb2021 15:45 (at the age of 41-year-old), as dose 2, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 (as reported). Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 18:45, the patient experienced diarrhea, nausea, fever, headache, body pain, abdomen pain for 72 hours, non-stop and was waiting for the events to go away. Happened with 2nd shot only. The patient did not receive any treatment for the reported events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient underwent lab tests and procedures which included body temperature: fever on 20Mar2021. The clinical outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Headache; fever; chills; nausea; dizziness; injection site pain; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient). A 42-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 2, single. The patient medical history and concomitant medications were not reported. No history of reactions, no underlying medical conditions. Historical vaccine included patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient experienced headache, fever, chills, nausea, dizziness, injection site pain post dose 2 of BNT162b2. Patient reported that events took place after use of product. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Headache; fever; chills; nausea; dizziness; injection site pain; This is a spontaneous report from a contactable Consumer or other non-health care professional (Patient). A 42-years-old female patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 2, single. The patient medical history and concomitant medications were not reported. No history of reactions, no underlying medical conditions. Historical vaccine included patient received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, batch no/Lot number: Not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date, patient experienced headache, fever, chills, nausea, dizziness, injection site pain post dose 2 of BNT162b2. Patient reported that events took place after use of product. Outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: headache; fever; body aches; This is a spontaneous report from a contactable consumer or other non hcp. A 60-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  Historical Vaccine BNT162B2 1st dose covid-19 vaccine for Covid-19 immunisation. on an unspecified date the patient experienced headache fever body aches. Outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: Severe headache; Fever up to 103 degrees F.; Body aches; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration in left arm on 18Mar2021 at 09:30 am (at the age of 45 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021 at 22:00 patient experienced severe headache, fever up to 103 degrees F., body aches. The patient underwent lab tests and procedures which included body temperature: 103 degrees Fahrenheit. Therapeutic measures were taken as a result of severe headache, fever up to 103 degrees f., body aches with 400 mg Advil on 19Mar2021 at 10.30 am. All symptoms resolved and did not return. The outcome of events was recovered on 19Mar2021 at 11:30.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Body aches; chills; headache; fever; This is a spontaneous report from a contactable consumer (patient) via Pfizer sales representative. A 66-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced body aches, chills, headache, fever on an unspecified date. Events took place after use of product. The outcome of events body aches, chills, headache, fever was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a contactable consumer (patient) based on information received by Pfizer from , Inc. (Reference no.: NVSC2021US056465_NS).  A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 on an unspecified date for COVID-19 immunisation. Patient said she got a rash after getting her second COVID-19 vaccine (unspecified date). The outcome of the event was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal behaviour, Agitation, Euphoric mood, Feeling abnormal, Flushing
Clinical narrative: This dose did not make me feel sick, just high; Severe brain fog; Body high; Dilated pupils; Flushed skin; Acting "silly"; This is a spontaneous report received from a contactable consumer (patient). This is the first of three reports. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 19Mar2021 at 09:00 (at the age of 27-year-old) as a dose 2, single for COVID-19 immunization. Medical history included allergic to kiwi fruits and severe allergic reaction to an unknown dye found in LO LOESTRIN Fe. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20) and naproxen (ALEVE), for unknown indications from unknown dates. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation and felt sick. The patient frequently had adverse reactions to medicines and had previously received diazepam (VALIUM) which made her extremely hyper. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021 at 15:00, the patient felt like she ate a strong dose of marijuana a few hours after vaccination and no one she talked to had an effect like this. This is around the time that she had felt sick when she received the first dose. This dose did not make her feel sick but she was just high. Her father said he had the same reaction, though. Symptoms included severe brain fog, body high, dilatedpupils/flushed skin, acting silly for lack of a better word. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events feeling high, severe brain fog, body high, dilated pupils, flushed skin, acting silly. The clinical outcome of the events feeling high, severe brain fog, body high, dilated pupils, flushed skin, acting silly was recovered with lasting effects on an unknown date on Mar2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Mydriasis
Clinical narrative: This dose did not make me feel sick, just high; Severe brain fog; Body high; Dilated pupils; Flushed skin; Acting "silly"; This is a spontaneous report received from a contactable consumer (patient). This is the first of three reports. A 27-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 19Mar2021 at 09:00 (at the age of 27-year-old) as a dose 2, single for COVID-19 immunization. Medical history included allergic to kiwi fruits and severe allergic reaction to an unknown dye found in LO LOESTRIN Fe. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL FE 1/20) and naproxen (ALEVE), for unknown indications from unknown dates. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation and felt sick. The patient frequently had adverse reactions to medicines and had previously received diazepam (VALIUM) which made her extremely hyper. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Mar2021 at 15:00, the patient felt like she ate a strong dose of marijuana a few hours after vaccination and no one she talked to had an effect like this. This is around the time that she had felt sick when she received the first dose. This dose did not make her feel sick but she was just high. Her father said he had the same reaction, though. Symptoms included severe brain fog, body high, dilatedpupils/flushed skin, acting silly for lack of a better word. The adverse event did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events feeling high, severe brain fog, body high, dilated pupils, flushed skin, acting silly. The clinical outcome of the events feeling high, severe brain fog, body high, dilated pupils, flushed skin, acting silly was recovered with lasting effects on an unknown date on Mar2021.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Moderate Pain at injection site; low grade fever; headache; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, formulation: solution for injection, lot number: not reported, expiry date: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced moderate pain at injection site, low grade fever, headache post vaccination. Clinical outcome of the events was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Injection site pain, Pyrexia
Clinical narrative: injection site pain; Chills; Mild fever (99.5F); Feeling more tired than normal; This is a spontaneous report from a contactable consumer or other non hcp (patient).   A 51-years-old male patient received BNT162b2 (Solution for injection, Lot No: EN6203; Expiration Date: Jun2021), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation.  Medical history included benign prostatic hyperplasia from an unknown date and unknown if ongoing. Concomitant medication(s) included alfuzosin (ALFUZOSIN) taken for an unspecified indication, start and stop date were not reported; vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) taken for an unspecified indication, start and stop date were not reported.The patient experienced injection site pain, chills, mild fever, feeling more tired than normal on an unspecified date.  The patient underwent lab tests and procedures which included body temperature: 99.5 fahrenheit on. Event took place after use of product. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever/ a fever right around a 100 Degrees; Chills; Headache; Body aches; This is a spontaneous report received from a contactable consumer or other non hcp.A 54-years-old female patient received 1st dose of bnt162b2 (Pfizer Covid-19 Vaccine,Batch/Lot Number: EN6204),via an unspecified route of administration on 17Mar2021,at the age of 54 years old, as Dose 1,single for covid-19 immunization.The patient medical history and concomitant medications were not reported.The patient experienced fever, chills,headache, body aches on 17Mar2021.The patient underwent lab tests and procedures which included pyrexia: 100 degrees on Mar2021.Therapeutic measures were taken as a result of fever/ a fever right around a 100 degrees.The patient received tyenol as treatment for fever.The outcome of the event fever was not recovered while other events outcome was recovered.  Follow-up (21Mar2021): This is a spontaneous report received from Pfizer sponsored program Support. A contactable female consumer (patient) reported for herself  that Cold transferred to hospital. Manual  form created.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Migraine, Pyrexia, Somnolence
Clinical narrative: 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; Within 5 hours woke up with awful migraine; fever of 100; feeling sleepy immediately; Swollen lymph node only under left arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613), via an unspecified route of administration in left arm on 19Mar2021 13:45 (at the age of 61-years-old) as dose 2, single for COVID-19 immunization. Medical history included Latex allergy (use latex free), and Avascular necrosis (AVN). Concomitant medications included acetylsalicylic acid (ASPRIN); phenobarbital (PHENOBARB); clopidogrel bisulfate (PLAVIX); topiramate (TOPAMAX) and simvastatin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration in right arm on 26Feb2021 15:15 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization and experienced Pain in arm, sleepy, Stabbing pain at injection and nauseous. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced feeling sleepy immediately on 19Mar2021, fever of 100 and within 5 hours woke up with awful migraine on 19Mar2021 20:00, 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad on 21Mar2021 01:45 and swollen lymph node only under left arm on an unspecified date in Mar2021. Patient said not even 2 days had passed and getting worse each day. It was unknown if patient received treatment for events. Since the vaccination, patient has not been tested for COVID-19. Outcome of events within 5 hours woke up with awful migraine was resolved on 21Mar2021 04:00, feeling sleepy immediately was resolved after 5 hours on 19Mar2021, fever of 100 was resolved after 4 hours on 20Mar2021.Outcome of 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad was unknown. Event Swollen lymph node only under left arm was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad; Within 5 hours woke up with awful migraine; fever of 100; feeling sleepy immediately; Swollen lymph node only under left arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER2613), via an unspecified route of administration in left arm on 19Mar2021 13:45 (at the age of 61-years-old) as dose 2, single for COVID-19 immunization. Medical history included Latex allergy (use latex free), and Avascular necrosis (AVN). Concomitant medications included acetylsalicylic acid (ASPRIN); phenobarbital (PHENOBARB); clopidogrel bisulfate (PLAVIX); topiramate (TOPAMAX) and simvastatin. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN6200), via an unspecified route of administration in right arm on 26Feb2021 15:15 (at the age of 61-years-old) as dose 1, single for COVID-19 immunization and experienced Pain in arm, sleepy, Stabbing pain at injection and nauseous. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced feeling sleepy immediately on 19Mar2021, fever of 100 and within 5 hours woke up with awful migraine on 19Mar2021 20:00, 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad on 21Mar2021 01:45 and swollen lymph node only under left arm on an unspecified date in Mar2021. Patient said not even 2 days had passed and getting worse each day. It was unknown if patient received treatment for events. Since the vaccination, patient has not been tested for COVID-19. Outcome of events within 5 hours woke up with awful migraine was resolved on 21Mar2021 04:00, feeling sleepy immediately was resolved after 5 hours on 19Mar2021, fever of 100 was resolved after 4 hours on 20Mar2021.Outcome of 36 hours after the shot the patient experienced vaccination site swelling, vaccination site rash which hurts and itch bad was unknown. Event Swollen lymph node only under left arm was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Headache, Myalgia, SARS-CoV-2 test, Sinus congestion
Clinical narrative: sinus congestion; muscle aches; headaches; cough; This is a spontaneous report from a contactable consumer (patient). This is the first of two reports. A42-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6200), via an unspecified route of administration in the left arm on 22Feb2021 at 09:00 at the age of 42-year-old as a dose 1, single for COVID-19 immunisation. The patient medical history included hypertension. Concomitant medications included benazepril hydrochlorothiazide, Pantoprazole (PROTONIX), loratadine (CLARITIN) all for unknown indication from unknown date. The Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The Patient had not tested positive for COVID-19 since the vaccination. The patient experienced cough on 14Mar2021 at 22:00 and sinus congestion, muscle aches and headaches on 15Mar2021. The patient underwent lab tests and procedures, which included COVID-19 Virus test on 15Mar2021 and resulted negative. The outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blister, Pruritus
Clinical narrative: After the 1st shot, I started getting a couple of blisters on my leg, near my collar bone and on my back. Only 3 of them. They were small little blisters, but they itched terribly; After the 1st shot, I started getting a couple of blisters on my leg, near my collar bone and on my back. Only 3 of them. They were small little blisters, but they itched terribly.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation.  The patient's medical history and concomitant medications were not reported.  After the first shot, patient started to getting a couple of blisters on leg, near collar bone and on back. Among them, 3 small little blisters, itched terribly. 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.