chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular (at the age of 55-years-old), administered in Arm Right on 12Mar2021 21:00 (Lot Number: EN6207) as 1st dose, single for COVID-19 immunization. Medical history included rheumatoid arthritis from Apr2020 and ongoing, immune suppressed. The patient does take other unspecified concomitant medications. The patient experienced shingles on 21Mar2021. She received the first dose of the vaccine on 12Mar2021. The pain didn't get bad until the weekend. She is unsure if the shingles were brewing the prior week. The patient developed shingles one week after receiving the Pfizer Covid-19 vaccine. She didn't see her doctor. She showed him pictures from her phone. She went to the hospital because of the pain being so bad. The pain was really bad and she went to the emergency room on 21Mar2021. She was diagnosed with shingles while at the emergency room. They gave her medication and told her to follow up with her doctor. She had nerve pain from the left side of her back to the front. She had pain 3-4 days before she went the hospital. She was going out of her mind. Shingles are awful. She was not admitted to the hospital. Therapeutic measures were taken as a result of the event. The outcome of the event was recovering. No history of all previous immunization with the Pfizer vaccine considered as suspect, no additional vaccines administered on same date of the Pfizer suspect. No prior vaccinations (within 4 weeks). She received the second dose on 03Apr2021 (Lot: EP7533) in her right arm.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Tongue discomfort
Clinical narrative: my tongue has been burning since my second shot/ tongue also had a burning sensation; tingling a little later/ tongue started tingling; her tongue feeling a little funny; This is a spontaneous report from a contactable consumer (patient). A 73 years old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at same age, via an unspecified route of administration, administered in arm on 26Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), at age of 73 years old for covid-19 immunisation on 05Feb2021 and experienced sore arm. The patient experienced her tongue had been burning since her second shot on 27Feb2021 with outcome of not recovered, her tongue feeling a little funny on 26Feb2021 with outcome of unknown, tingling a little later on 27Feb2021 with outcome of unknown. Patient stated that with the second vaccine, when she was waiting to leave, she became, aware, of her tongue. By the next day, her tongue started tingling and her tongue also had a burning sensation. She did check with her doctor's office and called her doctor. The doctor recommended taking Benadryl for 3 days, and she stated that her reaction did not go away. She took one gel cap the first day, and then called her pharmacist, who told her to take 2 gel caps a day. She had a regularly scheduled appointment with her doctor. At the appointment, the doctor suggested she try steroids, reclarified as she followed the specific dose schedule. After taking the steroids, there was still a burning sensation. She did not know the name of the steroid. Her doctor thought her reactions would go away, and she stated they were livable, and not painful.   Follow up (15Apr2021): New information received from a contactable consumer includes: patient details and event details.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Breast pain
Clinical narrative: later she had pain under her left breast; This is a spontaneous report from a contactable consumer. A 78-year-old female patient received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose on 13Apr2021 via an unknown route in left deltoid for Covid-19 immunization. Medical history and concomitant drug were not provided. She received the vaccine in the left deltoid, later she had pain under her left breast similar to where an underwire bra would be.  The symptoms lasted for about 2 days but was only a little painful on 15Apr2021 morning. Outcome of the event was resolving.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain
Clinical narrative: Redness at injection site after first vaccine; Pain at injection site with first vaccine/ Soreness to arm after first vaccine; This is a spontaneous report from a contactable consumer (patient). This 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 09Mar2021 Arm Right single dose (Lot EN6206) for covid-19 immunisation. Medical history included ongoing Eczema for her whole life. Concomitant therapy was none. She states that with her first vaccine on 09Mar2021 she had Redness at injection site after first vaccine, pain and soreness at the injection site/ Soreness to arm after first vaccine that lasted for about 24-48 hours then it was gone. She denies any medical conditions, medications, labs, testing, or treatment relevant to these events.  Outcome of the events was recovered in Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Joint noise, Myalgia, Oral herpes, Vaccination site discharge, Vaccination site erythema
Clinical narrative: At 17 days, I can see a red mark; I have a scab at the injection site 9 days after vaccination; Cold sore outbreak in the corner of my mouth 6 days after vaccination; couple days after vaccination I noticed my joints felt crunchy, like there was plastic wrap in them.; noticed a small scab there that was still kind of oozing a bit; If I push on the muscle there it's slightly sore; the other arm is not.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 at 13:45 (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunization.  Medical history included cold sore outbreak in the corner of mouth from an unknown date (had them before in the same spot, but less than once a year and usually a lot smaller). The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021, the patient had cold sore outbreak in the corner of his mouth 6 days after vaccination. On 15Apr2021, the patient had scab / small sore at the injection site 9 days after vaccination. On an unspecified date of Apr2021, about a week after vaccination, the patient noticed a small scab there that was still kind of oozing a bit. The patient also reported that, on an unspecified date in Apr2021, if he pushed on the muscle there it was noticed that the muscle was slightly sore; the other arm was not; couple days after vaccination he noticed his joints felt crunchy, like there was plastic wrap in them. 15 days after vaccination, he still had a scab. At 17 days, on 23Apr2021, he saw a red mark where the scab was formed. No corrective measures were taken by the patient. The outcome was reported as not recovered for the event cold sore mouth, vaccination site scab and recovered on an unspecified date in Apr2021 for a small scab there that was still kind of oozing a bit and unknown for rest of the events.  No follow-up attempts are needed. No further information is expected.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site scab
Clinical narrative: At 17 days, I can see a red mark; I have a scab at the injection site 9 days after vaccination; Cold sore outbreak in the corner of my mouth 6 days after vaccination; couple days after vaccination I noticed my joints felt crunchy, like there was plastic wrap in them.; noticed a small scab there that was still kind of oozing a bit; If I push on the muscle there it's slightly sore; the other arm is not.; This is a spontaneous report from a contactable consumer (patient). A 50-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 06Apr2021 at 13:45 (Lot Number: EW0151) as SINGLE DOSE for covid-19 immunization.  Medical history included cold sore outbreak in the corner of mouth from an unknown date (had them before in the same spot, but less than once a year and usually a lot smaller). The patient's concomitant medications were not reported.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Apr2021, the patient had cold sore outbreak in the corner of his mouth 6 days after vaccination. On 15Apr2021, the patient had scab / small sore at the injection site 9 days after vaccination. On an unspecified date of Apr2021, about a week after vaccination, the patient noticed a small scab there that was still kind of oozing a bit. The patient also reported that, on an unspecified date in Apr2021, if he pushed on the muscle there it was noticed that the muscle was slightly sore; the other arm was not; couple days after vaccination he noticed his joints felt crunchy, like there was plastic wrap in them. 15 days after vaccination, he still had a scab. At 17 days, on 23Apr2021, he saw a red mark where the scab was formed. No corrective measures were taken by the patient. The outcome was reported as not recovered for the event cold sore mouth, vaccination site scab and recovered on an unspecified date in Apr2021 for a small scab there that was still kind of oozing a bit and unknown for rest of the events.  No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Rash, Skin lesion, Vaccination site erythema, Vaccination site pain
Clinical narrative: swelling and redness to the injection site; Small bumps, like a rash on the swollen area; Small bumps, like a rash on the swollen area; swelling and redness to the injection site; this one burned when it was injected; this one burned when it was injected; This is a spontaneous report from a contactable consumer reported for herself. This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) via an unspecified route of administration in the left arm at 32 years old on 01Apr2021 between 14: 30 and 15: 00 at single dose  for COVID-19 immunization. Medical history included ongoing Eczema for her whole life. Concomitant medications were unknown. The patient had no prior vaccinations (within 4 weeks). The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) via an unspecified route of administration (injection) in the right arm at 32 years old on 09Mar2021 at single dose  for COVID-19 immunization, experiencing redness at injection site and pain and soreness at injection site. With her second vaccine on 01 Apr 2021 she stated it was different than the first one. This one burned when it was injected. She had swelling and redness to the injection site. The swelling got worse and the redness got darker and more purple. She then developed small bumps, like a rash, to the swollen area. She went to an urgent care on 07 Apr 2021 and they gave her Benadryl and Cortisone, which was helping. She had been taking these for about a week and a half per her report. The patient stated these symptoms were improving but were not all the way gone yet. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: swelling and redness to the injection site; Small bumps, like a rash on the swollen area; Small bumps, like a rash on the swollen area; swelling and redness to the injection site; this one burned when it was injected; this one burned when it was injected; This is a spontaneous report from a contactable consumer reported for herself. This 32-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EP7533) via an unspecified route of administration in the left arm at 32 years old on 01Apr2021 between 14: 30 and 15: 00 at single dose  for COVID-19 immunization. Medical history included ongoing Eczema for her whole life. Concomitant medications were unknown. The patient had no prior vaccinations (within 4 weeks). The patient previously received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN6206) via an unspecified route of administration (injection) in the right arm at 32 years old on 09Mar2021 at single dose  for COVID-19 immunization, experiencing redness at injection site and pain and soreness at injection site. With her second vaccine on 01 Apr 2021 she stated it was different than the first one. This one burned when it was injected. She had swelling and redness to the injection site. The swelling got worse and the redness got darker and more purple. She then developed small bumps, like a rash, to the swollen area. She went to an urgent care on 07 Apr 2021 and they gave her Benadryl and Cortisone, which was helping. She had been taking these for about a week and a half per her report. The patient stated these symptoms were improving but were not all the way gone yet. Outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sick after the vaccine; This is a spontaneous report from a contactable consumer. This consumer reported similar events for her friend and her friend's husband. This case was reported for her friend's husband.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced sick after the vaccine on an unspecified date. Outcome of the events unknown.     No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417760 Same reporter/product, similar events, different patient
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac, Computerised tomogram, Dyspnoea, Fatigue
Clinical narrative: Labored breathing; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: OP7553) on 01Apr2021 at 17:00-18:00 in right arm at single dose for COVID-19 immunisation. Medical history included ongoing diabetic which diagnosed 19 years before. No family medical history relevent to events. Concomitant medications were none. No history of all previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). No event following prior vaccinations. Patient stated she had been having labored breathing since having the vaccine and fatigue in Mid Day on 04Apr2021. Patient clarified if she moves around too much, she gets tired and breathless and can't hardly breathe. Patient didn't think it was from the Pfizer vaccine at first, she had a cardiac catheterization done at first in Apr2021 and that was normal so they ordered a CT (Computerised tomogram) of her lungs and that was done on 14Apr2021 and it was normal. The only thing that she had done differently was she had the Pfizer vaccine. Events resulted a visit to Emergency Room and Physician Office on 07APR2021, she first went to the doctor's office, she ended up in the ER the next day and they wanted her to see a cardiologist and that was when she ordered the cardiac catheterization, since she was diabetic, the cardiologist was surprised she did not have any blockage, he said most have a little bit, but hers was normal, so he ordered a CT Scan of her Lungs to see if there was a blockage, blood clot or cancer and they were both fine.  No treatment received for the events. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Myself and my babysitter - both of us who are fully vaccinated since Feb with the Pfizer shot - tested positive this week as well; Myself and my babysitter - both of us who are fully vaccinated since Feb with the Pfizer shot - tested positive this week as well; This is a spontaneous report from a contactable consumer. This consumer reported similar event for 2 patients. This is the first of two reports. This patient reported for herself and for her babysitter. This case refers to the patient herself.  This is a spontaneous report from a contactable consumer. A 35-year-old female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) via an unspecified route of administration, administered in Arm Right on 24Feb2021 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took vercid [mebendazole], anectine and advil [ibuprofen] and experienced drug hypersensitivity. The patient received first dose of BNT162B2 on 04Feb2021 for covid-19 immunisation. It was reported that the Patient, fully vaccinated since February with the Pfizer shot, was tested positive. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 14Apr2021. Outcome of the events was recovering.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021423578 same reporter/drug/event, different patients
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for the Covid virus; This is a spontaneous report from a contactable consumer reporting for herself.  A 53-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 01Apr2021 16:50 (Batch/Lot Number: ER8737) as single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported.  The patient was  tested positive for the Covid-19 virus on 06Apr2021 with outcome of unknown.  The patient underwent lab tests and procedures which included sars-cov-2 test: positive   on 06Apr2021. Course of the event: The patient confirmed her First Dose was on 01APR2021 at 4:50 PM. The patient's son had mentioned that he didn't feel well and his friend tested positive the previous week and so because of that she thought to get tested. She took the Covid test on 06APR2021 and got the results the same day. She again confirms her scheduled Second dose date is on 22APR2021.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Inappropriate schedule of product administration
Clinical narrative: he missed the dose; he got sick; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient's mother) reported for a male patient that: A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number and Expiry date: Unknown), dose 1 via intramuscular route on 27Jan2021 at SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On unspecified date the patient got sick and missed the 2nd dose originally scheduled on 24FEB2021. He was given another schedule to get the 2nd dose which was last 28MAR2021and he missed again and asking will still need to get the 2nd dose of covid 19 vaccine. The outcome of the events were unknown.   No follow-up attempts are needed. Information about batch/lot number cannot be obtained.  Amendment (02MAY2021): This follow-up report is being submitted to amend previously reported information: Amended the event "Missed dose" recoded to Inappropriate schedule of vaccine administered.
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: little blurred vision after the first dose; This is a spontaneous report from a contactable patient. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced little blurred vision after the first dose.  The outcome was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report received from a contactable consumer who reported for a female (patient). The female patient of an unspecified age received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced rash appeared on both underarms to elbow and on both inner, upper thighs after covid-19 vaccination on 15Apr2021 with outcome of unknown. She is not pregnant at the time of vaccination. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Rash pruritic
Clinical narrative: Developed blister, itchy, burning rash under rt. breast and a smaller area under left breast about 30 hours after second dose; Developed blister, itchy, burning rash under rt. breast and a smaller area under left breast about 30 hours after second dose; Looked like shingles; This is a spontaneous report from a contactable consumer (patient). A 69-year-old non-pregnant female patient received bnt162b2 (Pfizer COVID 19), via an unspecified route of administration, administered in right arm on 01Apr2021 14:30 (Lot Number: EP7533) as 2nd dose, single for COVID-19 immunization. Medical history included allergy to xray contrast dyes from an unknown date and unknown if ongoing. Concomitant medications included rosuvastatin; HCTZ; duloxetine; letrozole; esomeprazole magnesium (NEXIUM); all taken for an unspecified indication, start and stop date were not reported. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received 1st dose of bnt162b2 (Pfizer COVID 19), administered in right arm on 09Mar2021 10:45 AM (Lot Number: EN6199) for COVID-19 immunization. The patient developed blister, itchy, burning rash under rt. breast and a smaller area under left breast about 30 hours after second dose; looked like shingles on 02Apr2021 17:30 with outcome of recovered in Apr2021. Lasted about 4-5 days. The events were assessed as non-serious. No treatment was received for the adverse events. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Palpitations
Clinical narrative: feeling like his heart was racing, Vitals stable. HR=74; This is a spontaneous report from a Pfizer Colleague's Immediate Family and Household Vaccination Program via a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient complained of feeling like his heart was racing, vitals stable and heart rate (HR) was 74 on an unspecified date. The patient sat for a bit and then said he was good. The patient was suggested to follow up with the primary care physician if the symptoms return. The outcome of the event was recovered at the reporting time.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired 2 days; This is a spontaneous report from a non-contactable consumer (patient) via Pfizer sponsored program. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tired for 2 days on an unspecified date. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tired for 1day; full body soreness 1 day; This is a spontaneous report received from Pfizer Program via a non-contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced tired for 1 day, and full body soreness 1 day. The outcomes of events were unknown.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This is a spontaneous report from a contactable consumer reported for herself. This female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 14Apr2021 at single dose for COVID-19 immunization. Medical history was not reported. Concomitant medications included tetanus vaccine toxoid (TETANUS TOXOID) on 06Apr2021 for dog bite. The patient previously received first dose of BNT162B2 on 24Mar2021 for COVID-19 immunization, and on 06Apr2021, she had tetanus shot at her doctor because she was bit by a dog. The patient experienced arm being sore on 14Apr2021 after second dose. The outcome of event was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: fever over 100 degrees F; fatigue; severe headache; diarrhea; muscle pain; chills; nausea; feeling unwell; This is a spontaneous report from a Pfizer-sponsored program, via  two contactable consumers, one of which was reporting for herself. A 65-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on 14Apr2021 at a single dose for covid-19 immunisation. Medical history included might have had a fever before getting the vaccine. The patient's concomitant medications were not reported. On 14Apr2021 in the evening, the patient experienced fever over 100 degrees Fahrenheit, fatigue, severe headache for two days, diarrhea, muscle pain, chills, nausea, and feeling unwell. The patient underwent lab tests and procedures which included body temperature: over 100 degrees Fahrenheit on 14Apr2021. The clinical outcome of the events, fever over 100 degrees Fahrenheit, severe headache for two days, diarrhea, muscle pain, chills, nausea, and feeling unwell, was recovered on an unknown date. The clinical outcome of the event, fatigue, was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Nausea, Pyrexia
Clinical narrative: fever over 100 degrees F; fatigue; severe headache; diarrhea; muscle pain; chills; nausea; feeling unwell; This is a spontaneous report from a Pfizer-sponsored program, via  two contactable consumers, one of which was reporting for herself. A 65-year-old female patient received the second dose of the bnt162b2 (BNT162B2), via an unspecified route of administration on 14Apr2021 at a single dose for covid-19 immunisation. Medical history included might have had a fever before getting the vaccine. The patient's concomitant medications were not reported. On 14Apr2021 in the evening, the patient experienced fever over 100 degrees Fahrenheit, fatigue, severe headache for two days, diarrhea, muscle pain, chills, nausea, and feeling unwell. The patient underwent lab tests and procedures which included body temperature: over 100 degrees Fahrenheit on 14Apr2021. The clinical outcome of the events, fever over 100 degrees Fahrenheit, severe headache for two days, diarrhea, muscle pain, chills, nausea, and feeling unwell, was recovered on an unknown date. The clinical outcome of the event, fatigue, was not recovered.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Anger, Headache, Heart rate, Heart rate increased, Paranoia
Clinical narrative: Severe headache; psychosis; paranoia; resting heart rate 108; fever; extreme anger; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Er8729), via an unspecified route of administration in the right arm, on 17Apr2021 at 13:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), zinc (MANUFACTURER UNKNOWN), and other unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took oseltamivir phosphate (TAMIFLU) and experienced allergy. The patient experienced severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger on 17Apr2021 at 19:00.  The patient underwent lab tests and procedures which included resting heart rate: 108 on 17Apr2021. The patient did not receive any treatment as a result of the events. The clinical outcome of severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger was recovered with sequel (reported as: recovered with lasting effects) in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Psychotic disorder, Pyrexia
Clinical narrative: Severe headache; psychosis; paranoia; resting heart rate 108; fever; extreme anger; This is a spontaneous report from a contactable consumer (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: Er8729), via an unspecified route of administration in the right arm, on 17Apr2021 at 13:30 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), hydrochlorothiazide (MANUFACTURER UNKNOWN), acetylsalicylic acid (ASPIRIN), zinc (MANUFACTURER UNKNOWN), and other unspecified medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously took oseltamivir phosphate (TAMIFLU) and experienced allergy. The patient experienced severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger on 17Apr2021 at 19:00.  The patient underwent lab tests and procedures which included resting heart rate: 108 on 17Apr2021. The patient did not receive any treatment as a result of the events. The clinical outcome of severe headache, psychosis, paranoia, resting heart rate 108, fever, and extreme anger was recovered with sequel (reported as: recovered with lasting effects) in Apr2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: received her first dose of the vaccine on 02Apr2021 and tested positive for Covid on 07Apr2021; This is a spontaneous report from a Pfizer-sponsored program . A female consumer (patient herself) of an unspecified age received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown, Expiration date: Unknown) via an unspecified route of administration on 02Apr2021 as single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The consumer received her first dose of the vaccine on 02Apr2021 and tested positive for Covid-19 on last 07Apr2021. She was due for her second dose on Friday, 23Apr2021. She asked if she could take that second dose or if she has to completely start over. The caller asked how to reschedule her appointment. She stated the only phone number they gave her was this number. The patient underwent lab tests and procedures on 07Apr2021 which included Covid test: Positive. The outcome of the event was unknown.  Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a bad headache; This is a spontaneous report received from a contactable consumer (consumer).  A 45-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. On unknown date, the patient experienced bad headache. The outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea (3 or so very loose stools a day or more); This is a spontaneous report received from a contactable consumer (patient). A 62-year-old male consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) in Apr2021 (two weeks before the report) at single dose for COVID-19 immunisation at the age of 62-year-old. Medical history and concomitant medications were unknown. The patient received vaccine two weeks before the report (Apr2021), since then he has been experiencing what he described as severe diarrhea (3 or so very loose stools a day or more). The outcome of the event was unknown. No follow-up attempts are needed. Information on the lot/batch number has been requested. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Tremor
Clinical narrative: back started hurting; Left leg started shaking/When stands up, left leg keeps shaking; This is a spontaneous report from a contactable consumer or other non hcp(patient's Mother).  A 17-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) , via an unspecified route of administration, administered in arm left on 15Apr2021 09:30 (Batch/Lot number was not reported) as single dose for covid-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient experienced about 25 minutes after the vaccine, back started hurting and her left leg started shaking. When she stand up her left legs kept shaking, both on 15Apr2021 09:55 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash
Clinical narrative: she had another headache 'on a scale of 1-10 its like a 12'; she has a rash.; This is a spontaneous report from a Pfizer sponsored program support via a contactable consumer (patient). A 56-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE, for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 23Mar2021 for covid-19 immunisation and experienced headache and migraine-like.  After the 2nd dose the patient had another headache 'on a scale of 1-10 its like a 12'. And now, on her upper torso, she had a rash. She had taken Benadryl. The outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Rash vesicular, Vaccination site discharge, Varicella
Clinical narrative: a bump with fluid, like a chicken pox bump at the site of the shot; a bump with fluid, like a chicken pox bump at the site of the shot; bump broke and fluid came out of it; This is a spontaneous report from a contactable consumer. This contactable consumer (patient) reported that a 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8729) at the age of 62-years, via an unspecified route of administration in right shoulder on 12Apr2021 09:30 at single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient historically received first single dose of BNT162B2 for COVID-19 immunization and had no problems. Patient stated that there was a bump with fluid, like a chicken pox bump at the site of the shot, no other redness. Stated later that night bump broke and fluid came out of it, he put a band-aid on it, it may have a scar later. The events occurred 13Apr2021, no emergency room, no physician office. Outcome of the events was not recovered/not resolved.   No follow-up attempts are needed. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body aches; a little headache; This is a spontaneous report from a Pfizer Sponsored Program. A contactable consumer (patient's mother) reported for a 22-year-old female patient that who received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 22-years, via an unspecified route of administration at single dose for COVID-19 immunisation. Medical history included in 2020, she got COVID last year, was positive last year in this time but the date was confused, had the blood test that was negative but her PCR was positive, so they said that she never got COVID and then in Sep2020 she had the antibodies and her daughter said "she got COVID one time", consumer was so confused because the testing wasn't clear. Concomitant medications were not reported. The patient historically received first single dose of BNT162B2 for COVID-19 immunization. During call consumer mentioned that her daughter got the second vaccine and everything was good with her. She could feel side effects but she was good. Consumer said that the only side effects were body aches and a little headache. That is it. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle contusion, Vaccination site pain
Clinical narrative: bruising  pain in the muscle on the left arm; bruising  pain in the muscle on the left arm; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that the 87-year-old male patient received first dose of bnt162b2 (BNT162B2, Pfizer COVID 19 Vaccine), by injection via an unspecified route of administration, administered in Arm Left on 01Apr2021 noon (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. The patient medical history was none. Family History was none. The patient's concomitant medications were not reported. The patient experienced bruising  pain in the muscle on the left arm  started at noon or short time after on 01Apr2021 with outcome of recovered in Apr2021.   The clinical course was reported as follows: Caller states he was down there a week and a half ago to the health center SSM to get his shot. He is hearing all kinds of things on TV. Mentions he is 83 years old, later corrects to 87 years old and in good shape. Adds he only had bruising pain in the muscle on the left arm that happened almost right away and went away in a day or two. Adds his daughter and son-in-law were upset with their physical being by themselves in they are in their late 50s and 60s. He is asking should he get the second shot? Adds he is He is due to come back on the 15Apr2021, later corrects to 19Apr2021. States he received the first dose of the Pfizer COVID 19 vaccine on 01Apr2021 at noon in his left shoulder muscle. He is supposed to go back next Monday on 19Apr2021 for the second dose. Mentions his wife died a year ago and he is a Christian and he knows he is going to be with his wife in heaven. Adds she had the thing where they put the thing in her arm and you go three days a week. She has a cleaning out of the thing and he never saw her again. He didn't get to say goodbye. Adds she died on Easter Sunday. Mentions he is going to see his doctor very soon. Adds he has had no signs of COVID. Asking is it okay for him to not get the second dose. History of all previous immunization with the Pfizer vaccine considered as suspect was none. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none.No AE(s) require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. Relevant test was none  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Nausea, Vision blurred
Clinical narrative: Not focusing very well; Totally dizzy and unable to walk very well because of the dizziness; Totally dizzy and unable to walk very well because of the dizziness; Nauseous; This is a spontaneous report from a contactable consumer (patient) for herself. A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 Vaccine, Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in Arm Right on 12Apr2021 13:30 as a single dose for COVID-19 immunization. Medical history included ongoing diabetes mellitus: Diabetic. Concomitant medications included metformin; acetylsalicylic acid (ASPIRIN); calcium carbonate, colecalciferol (VITAMIN D 2000), and Cholesterol Pill, Blood Pressure Pill (unspecified); all taken for an unspecified indication, from an unknown date and ongoing. The patient experienced totally dizzy and unable to walk very well because of the dizziness on 13Apr2021 with outcome of recovered on 14Apr2021, nauseous on 13Apr2021 with outcome of recovered on 14Apr2021, not focusing very well on 15Apr2021 with outcome of not recovered. Treatment included drinks a lot of fluids. The report is not related to a study or programme. She received the vaccine on Monday 12Apr2021 at 13:00. She drank a lot of fluids and ate and went to bed and slept a full 8 hours straight. When she woke up, she was totally dizzy and unable to walk very well because of the dizziness and she had a nauseous feeling, but never vomited. Stated that was on Tuesday and lasted most of the day, sort of subsiding towards evening. When she woke up, she was still dizzy. She was not focusing very well. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. No AE require a visit to Emergency Room or Physician Office. There was AEs following prior vaccinations. No Prior Vaccinations (within 4 weeks). No vaccines were administered on same date of the Pfizer Suspect.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pain, Swelling
Clinical narrative: got the Covid shot, within 4 hours, his bee sting was swollen about 4-5 inches in diameter with a red mark around it; got the Covid shot, within 4 hours, his bee sting was swollen about 4-5 inches in diameter with a red mark around it; got the Covid shot, within 4 hours, his bee sting was swollen about 4-5 inches in diameter with a red mark around it; This is a spontaneous report from a contactable consumer (patient). A 57-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 14Apr2021 at 13:00 (Batch/Lot Number reported as E0138, looked like a EU0138. Caller stated it looks like an E, or maybe a V. Caller verified it was handwritten.) as single dose for covid-19 immunisation. The patient did not get COVID. Medical history included he got stung by a bee. History of all previous immunizations with the Pfizer vaccine considered as suspect was none.  Caller verified it was his first Pfizer Covid vaccine. No Additional Vaccines administered on same date of the Pfizer suspect. The patient did not receive Prior Vaccinations within 4 weeks, no other medical history, family relevant history or tests. The patient had no other concomitant products. Caller stated two days ago he got stung by a bee and about 24 hours later after that, there was nothing wrong where he got stung, he couldn't even see a mark. Caller stated about 24 hours later, he got the Pfizer shot, Covid shot, within 4 hours after that, the bee sting had swollen about 4-5 inches in diameter with a red mark around it and its a little painful, not bad.  Caller stated he got the shot at 13:00 and about 17:00 or 18:00, it started swelling. Caller stated it wasn't any emergency or anything. Caller stated he was stung on the stomach. Caller stated the swelling started about 4 to 5 hours after the shot. Caller stated there's swelling with redness. Caller states it's still swollen, it's about the same. The events onset date was 14Apr2021. The reported events did not require a visit to Emergency Room or Physician Office. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.