chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Myalgia, Neck pain
Clinical narrative: left side neck and shoulder pain; left side neck and shoulder pain; back and inner left arm muscle pain; back and inner left arm muscle pain; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3302), via an unspecified route of administration in right arm on 28Feb2021 16:30 (at the age of 75-years-old) as dose 1, single for COVID-19 immunization. Medical history included Penicillin allergy and Graves' disease. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any vaccines within four weeks. The patient's concomitant medications were not reported. The patient experienced left side neck and shoulder pain, back and inner left arm muscle pain on an unspecified date. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Chromaturia, Faeces discoloured, Fatigue, Night sweats
Clinical narrative: Night sweat; Discoloration stool; fever; fatigue; Chills; Discoloration urine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in arm left on 13Mar2021 at 12:06 PM (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Patient did not receive any other vaccine prior vaccinations within 4 weeks. On 16Mar2021, the patient experienced fever, fatigue, chills, discoloration urine. On 17Mar2021, the patient experienced discoloration stool. On 18Mar2021, the patient experienced night sweat. Patient reporting he had some really adverse reactions to the vaccine. Adds he had fever; night sweats; chills; fatigue and his stool was discolored and his urine has been discolored. Clarifies he received the first dose of the Pfizer COVID 19 vaccine on 13Mar2021 at 12:06PM in the left arm. His side effects didn't really start until Tuesday night, then continued Wednesday and Thursday. By Saturday he thought he was better and then last night was horrible again. Adds his urine is dark and his stool looks light colored. He is scheduled for the second dose on 03Apr2021. He is asking what to do; he can't take much more of this; wants to know if this in normal. Product: Pfizer COVID 19 vaccine; treatment first dose 13Mar2021; provides lot number from vaccination card but does not see NDC or expiration date. Outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Night sweat; Discoloration stool; fever; fatigue; Chills; Discoloration urine; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EN6202), via an unspecified route of administration, administered in arm left on 13Mar2021 at 12:06 PM (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were reported as none. Patient did not receive any other vaccine prior vaccinations within 4 weeks. On 16Mar2021, the patient experienced fever, fatigue, chills, discoloration urine. On 17Mar2021, the patient experienced discoloration stool. On 18Mar2021, the patient experienced night sweat. Patient reporting he had some really adverse reactions to the vaccine. Adds he had fever; night sweats; chills; fatigue and his stool was discolored and his urine has been discolored. Clarifies he received the first dose of the Pfizer COVID 19 vaccine on 13Mar2021 at 12:06PM in the left arm. His side effects didn't really start until Tuesday night, then continued Wednesday and Thursday. By Saturday he thought he was better and then last night was horrible again. Adds his urine is dark and his stool looks light colored. He is scheduled for the second dose on 03Apr2021. He is asking what to do; he can't take much more of this; wants to know if this in normal. Product: Pfizer COVID 19 vaccine; treatment first dose 13Mar2021; provides lot number from vaccination card but does not see NDC or expiration date. Outcome of all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: low grade fever; This is a spontaneous report from a non-contactable consumer (patient). This consumer reported for three patients. This is the first of three reports. An adult male patient of an unspecified age (27-28 years old) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number was not reported), via an unspecified route of administration on 17Mar2021 as dose 2, single for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced low grade fever on an 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Body temperature, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: fever 100.6-100.8 for 24 hours; tired; heavy eyes; no appetite; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 61-year-old female patient received second 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 19Mar2021 (at the age of 61-year-old) at dose 2, single for covid-19 immunisation. Medical history and concomitant medications were not reported. Patient previously received first dose of bnt162b2 for covid-19 immunisation. On an unspecified date in 2021 the patient experienced fever 100.6-100.8 for 24 hours, tired, heavy eyes, no appetite. Date patient learned of incident: Sunday, 21Mar. The patient underwent lab tests and procedures which included fever: 100.6-100.8 on an unspecified date. Outcome of the events was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: fever; light headedness; This is a spontaneous report from a contactable consumer (patient). An adult 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 number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever and light headedness. 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 obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Got fever or got infected somewhere; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (husband) of unknown age that who received the dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 15Mar2021 as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Mar2021 the patient started running fever, it has been a week patient got the vaccine and the concern was if the fever was related to the vaccine or maybe he got infected somewhere in between. The event outcome was unknown.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Nausea; fever; Pain and swelling in left arm; Pain and swelling in left arm; headache; muscle pain; Body pain; This is a spontaneous report from a contactable consumer (reported for herself). A 48-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 at 14:45 (at the age of 48-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). Concomitant medication(s) included sumatriptan succinate (IMITREX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient experienced nausea on 22Mar2021 at 17:00, fever, pain and swelling in left arm, headache, muscle pain and body pain on an unspecified date in 2021. No treatment was given for the events. The clinical course was as follows: muscle pain a Injection site that spreads to shoulders and left jaw. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: Nausea; fever; Pain and swelling in left arm; Pain and swelling in left arm; headache; muscle pain; Body pain; This is a spontaneous report from a contactable consumer (reported for herself). A 48-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EP7534/Batch number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 22Mar2021 at 14:45 (at the age of 48-years-old) as dose 1, single for covid-19 immunisation at Pharmacy. Medical history included covid-19 from an unknown date and unknown if ongoing (If covid prior vaccination: Yes). Concomitant medication(s) included sumatriptan succinate (IMITREX) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient experienced nausea on 22Mar2021 at 17:00, fever, pain and swelling in left arm, headache, muscle pain and body pain on an unspecified date in 2021. No treatment was given for the events. The clinical course was as follows: muscle pain a Injection site that spreads to shoulders and left jaw. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Headache, Pyrexia
Clinical narrative: fever; headache; loss of taste; This is a spontaneous report from a contactable consumer (patient). A 27-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, headache, loss of taste. Patient wanted to know are there any medications he can take. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Asking if his wife can take Tylenol; High fever; This is a spontaneous report from a contactable consumer (patient's husband) from a Pfizer Sponsored Program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Mar2021 (Lot number and expiration date was not reported) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had high fever on an unspecified date. The patient's husband was asking if his wife can take paracetamol (TYLENOL). The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Lacrimation increased, Pruritus, Urticaria
Clinical narrative: Itchy hands; Small hives; Itchy, watery eyes; Itchy, watery eyes; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 19Mar2021 15:30 (at the age of 57-year-old) (Lot Number: EP7534) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Medical history included seasonal allergies, mild asthma. Concomitant medications included allergy medicines. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 26Feb2021 (at the age of 57-year-old) (Lot Number: EN6203) as dose 1, single for COVID-19 immunization. The patient previously took bactrim and experienced allergy. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient experienced itchy hands, small hives, itchy, watery eyes on 21Mar2021. The patient did not receive treatment for the events. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Illness, Pyrexia
Clinical narrative: has been sick; she had a fever and the fever lasted for 4 days; This is a spontaneous report received from a contactable consumer or other non hcp. A 24-years-old female patient received 1st dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Batch/Lot Number: EN6207; Expiration Date: 31Jul2021),via an unspecified route of administration, administered in Arm Left on 19Mar2021 11:00,at the age of 24 years old,as Dose 1,single for covid-19 immunization.Medical history included hormone level abnormal and blood prolactin increased from an unknown date and unknown if ongoing. Concomitant medication(s) included cabergoline taken for hormone level abnormal,blood prolactin increased from an unspecified start date and ongoing.The patient experienced she had a fever and the fever lasted for 4 days on 21Mar2021,has been sick on an unspecified date.The patient underwent lab tests and procedures which included body temperature:100 fahrenheit on, body temperature: 102 fahrenheit on 21Mar2021.Therapeutic measures were taken as a result of she had a fever and the fever lasted for 4 days.Tylenol NDC 50580-608-02, LOT PHA151, EXP May2021. Dose 500mg acetaminophen, diphenhydramine-HCI 25 mg, on tablet once daily by mouth. she took one a day the past 2 days.The patient body temp was 102F on 21Mar2021,it has come down to 100F now, which she says is not a lot. Confirmed temperature units with caller as Fahrenheit.The adverse events didn't result on emergency room visit or physician visit.The patient had not received any vaccination within 4 weeks.The outcome of the event was recovering. Follow-up (25Mar2021): This is a follow up spontaneous report from a contactable consumer.patient was calling about the COVID 19 Vaccine.Physician details was updated. Follow-up (30Mar2021): This is a follow-up spontaneous report in response to the mail trail sent regarding the confirmation of the reporter (also the patient's) name. This report included that:reporter details was updated.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: fever of 99.1 F; feeling tired/tiredness; headache; This is a spontaneous report from a consumer (patient) via a regulatory uthority. A female patient of an unspecified age received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Mar2021, 1 day after vaccination the patient experienced headache, tiredness, fever. She was wondering if she can take a pain reliever. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia, Pyrexia, Vaccination site erythema
Clinical narrative: till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; started swollen and red at injection site/Left (injection arm) swelling; started swollen and red at injection site/Left (injection arm) swelling, really red; fever; till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; This is a spontaneous report from a non-contactable consumer (patient). A female patient of age 51 (units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 22Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she had a side effect, don't know if it was normal. Patient received the Pfizer covid vaccine on Monday (22Mar2021). On Tuesday (23Mar2021), the patient experienced fever. On Wednesday (24Mar2021), the patient experienced left (injection arm) swelling, really red. started swollen and red at injection site, but slowly throughout till today (25Mar2021) burning, and tingling sensation, down arm underneath arm pit and starting today (25Mar2021) like a numbing tingling feeling up the left side of her neck, spreading at the site out through the arm. It did it two days after. Patient stated that it seemed like it was getting, not worse as far as tingling or redness, it was just spreading, still red, tinging burning sensation, like when stood next to a fireplace or heater, warm on that side, it was like a warmness tingling. The patient wanted to know if there is anything that she can take to help it, or it would go away. The outcome of the events pyrexia, vaccination site swelling and hypoaesthesia was unknown and rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; started swollen and red at injection site/Left (injection arm) swelling; started swollen and red at injection site/Left (injection arm) swelling, really red; fever; till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; till today burning, and tingling sensation, down arm underneath arm pit and starting today like a numbing tingling feeling up the left side of my neck, spreading at the site out through the arm; This is a spontaneous report from a non-contactable consumer (patient). A female patient of age 51 (units: unknown) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown) via an unspecified route of administration, in left arm on 22Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that she had a side effect, don't know if it was normal. Patient received the Pfizer covid vaccine on Monday (22Mar2021). On Tuesday (23Mar2021), the patient experienced fever. On Wednesday (24Mar2021), the patient experienced left (injection arm) swelling, really red. started swollen and red at injection site, but slowly throughout till today (25Mar2021) burning, and tingling sensation, down arm underneath arm pit and starting today (25Mar2021) like a numbing tingling feeling up the left side of her neck, spreading at the site out through the arm. It did it two days after. Patient stated that it seemed like it was getting, not worse as far as tingling or redness, it was just spreading, still red, tinging burning sensation, like when stood next to a fireplace or heater, warm on that side, it was like a warmness tingling. The patient wanted to know if there is anything that she can take to help it, or it would go away. The outcome of the events pyrexia, vaccination site swelling and hypoaesthesia was unknown and rest of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Somnolence, Vaccination site nodule, Vaccination site pain
Clinical narrative: fever; headache; a red knot that was hot and sore to the touch; a red knot that was hot and sore to the touch; a red knot that was hot and sore to the touch; slept for 36 hours; This is a spontaneous report from a contactable Nurse (Patient) via Pfizer Sales Representative. A 66 (unit: unknown) female patient received second 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 19Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient had previously 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 26Feb2021 as a single dose for COVID-19 immunisation. On an unspecified date, it was reported that Female 66 had a local reaction. It was a red knot that was hot and sore to the touch. She also developed a fever and headache. She slept for 36 hours. the reporter of the adverse events and she was the patient. She is a retired nurse. Her first COVID vaccine was on 26Feb2021, and her second vaccine was on 19Mar2021. If you need any additional information, please let me know. 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: Vaccination site warmth
Clinical narrative: fever; headache; a red knot that was hot and sore to the touch; a red knot that was hot and sore to the touch; a red knot that was hot and sore to the touch; slept for 36 hours; This is a spontaneous report from a contactable Nurse (Patient) via Pfizer Sales Representative. A 66 (unit: unknown) female patient received second 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 19Mar2021 as a single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The Patient had previously 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 26Feb2021 as a single dose for COVID-19 immunisation. On an unspecified date, it was reported that Female 66 had a local reaction. It was a red knot that was hot and sore to the touch. She also developed a fever and headache. She slept for 36 hours. the reporter of the adverse events and she was the patient. She is a retired nurse. Her first COVID vaccine was on 26Feb2021, and her second vaccine was on 19Mar2021. If you need any additional information, please let me know. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be requested.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia, Rash, Skin exfoliation
Clinical narrative: rash after the second dose it got a lot worse; peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse; Low grade fever with second vaccine; Fatigue with second vaccine/Really tired with second vaccine; headache; This is a spontaneous report from a contactable consumer or other non hcp. A 24-years-old female patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EN6205), dose 2 via an unspecified route of administration, administered in Arm Right on 09Mar2021 12:00 as DOSE 2, as an unspecified dose SINGLE for covid-19 immunisation. The historical vaccine was bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: E19269), dose 1 via an unspecified route of administration, administered in Right Upper Arm on 16Feb2021 13:00 as DOSE 1, SINGLE as an unspecified dose for covid-19 immunisation. Medical history included, from an unknown date and unknown if ongoing Patient History: No. There were no concomitant medications. Patient mentioned she had time off from work because she had regular side effects. Patient stated that when it appeared after her first vaccine, she thought maybe she had gotten into something that caused it. On 10Mar2021 the patient experienced low grade fever with second vaccine, fatigue with second vaccine/ really tired with second vaccine, headache, rash after the second dose it got a lot worse on an unspecified date, peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse on an unspecified date. Therapeutic measures were taken as a result of rash after the second dose it got a lot worse, peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse. The outcome of the events low grade fever with second vaccine, fatigue, headache was recovered, rash after the second dose it got a lot worse was unknown, peeling of skin on the palms of hands and around fingers, after the second dose it got a lot worse was not recovered. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Influenza like illness, Pyrexia
Clinical narrative: Fever; Flu-like symptoms; Chills; Dizzy; This is a spontaneous report received from a contactable consumer or other non-healthcare professional (patient). A 38-years-old female patient received unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), 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 fever, flu-like symptoms, chills, dizzy on an unspecified date. Event took place after use of product. The outcome of the events was reported as unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Got Fever; Body ache; This is a spontaneous report from a contactable consumer (patient). A 42-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 25Mar2021 13:45 (at the age of 42 years old) as dose 2, single for COVID-19 immunisation. Medical history reported as none. No allergies to medications, food, or other products. There were no concomitant medications patient received within 2 weeks of vaccination. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 04Mar2021 (at the age of 42 years old) as single for COVID-19 immunisation. Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced got fever, body ache on 25Mar2021 22:00. No treatment received for the adverse event. Since the vaccination, the patient did not tested for COVID-19. The case was reported as non serious. Outcome of all the events were recovering.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Heart rate, Heart rate increased, Nausea, Pyrexia
Clinical narrative: fever; chills; nausea; increased heart rate; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (Pfizer-BioNtech Covid-19 Vaccine, Solution for injection), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient experienced fever, chills, nausea and increased heart rate. Patient wanted to know if it was safe to take the second dose. The patient underwent lab test and procedure which included increased heart rate. The clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Body aches; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EP6955), via an unspecified route of administration in left arm on 24Mar2021 at 12:15 PM (at the age of 26 years old) as single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3248), via an unspecified route of administration in left arm on 03Mar2021 at 02:15 PM (at the age of 26 years old) for covid-19 immunisation. The patient did not receive any other medications within 2 weeks of vaccination. 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 hasn't been tested for COVID-19. On 25Mar2021 at 08:30 patient experienced fever, body aches, chills and headache. The patient did not received treatment due to the events. The outcome of events was recovered with sequel on an unspecified date in 2021.  Information on Lot/Batch number was available. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Low grade fever (100.6 degrees); Body aches; Headache; Fatigue; This is a spontaneous report from a contactable consumer (Patient). A 44-year-old non pregnant female patient received second dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EN6203), via an unspecified route of administration on 24Mar2021 at 09:45 AM (at the age of 44-year-old) administered in Arm Left as a single dose for COVID-19 immunisation at Workplace clinic. The patient had received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: EN6203), via an unspecified route of administration on 01Mar2021 at 09:45 am administered in Arm Left as a single dose for COVID-19 immunisation at Workplace clinic. The patient medical history was reported as none. The patient had allergies to penicillin. 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 has not been tested for COVID-19. On 25Mar2021 at 01:00 AM, the patient experienced Low grade fever (100.6 degrees), body aches, headache, fatigue. Query included that the Drug safety unit recently received the attached report submitted by you via website. Please help to confirm the date that you became aware of the adverse events in this report as these effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any colleague learned of the adverse event. If you learned of these events from another colleague, please provide the date that the first colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a colleague became aware of the adverse events. The clinical outcome of the events was recovered.  Follow up attempts are completed. No further information is expected
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever, "almost as bad as when I had COVID infection"; This is a spontaneous report from a contactable consumer. An unspecified age of non-pregnant female patient 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 an unspecified date as a single dose for COVID-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Fever, almost as bad as when she had COVID infection. It was unknown whether the patient had received any treatment for the event. It was unknown whether If COVID tested post vaccination. The outcome of the event was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Pyrexia, Vaccination site mass
Clinical narrative: A knot at injections site; Increased temperature/fever of 100.5; Dizziness/is dizzy; Nauseated; Throw up; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that:  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on 25Mar2021 (on Thursday) as dose 2, single for covid-19 immunization. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 26Mar2021 (morning), patient experienced increased temperature/fever 100.5, dizziness, dizzy, nauseated, feels like she was going to throw up and a knot at injections site. She was wondering if that was normal. The patient underwent lab tests and procedures which included body temperature increased to 100.5. The outcome of the events was reported as unknown.  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: low fever; chills; body ache; light head aches; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer (patient) reported. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on Mar2021 as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient had received first dose of the vaccine Saturday afternoon and on Mar2021 was experiencing side effects such as low fever, chills, body ache, and light head aches and wanted to know if it was normal. There were no unaddressed medical questions referred or forwarded to Medical Information. Outcome of the event was unknown, at the time of this report. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Exposure via breast milk, Pyrexia
Clinical narrative: Baby had a fever; nursing; This is a spontaneous report received from a contactable consumer. This consumer reported for a 11-month-old patient (baby) of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via trans mammary route of administration on 07Mar2021 at 08:00 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 08Mar2021, baby had a fever starting the day after, went up to 105 and doctor could not find any cause, despite running many tests. Wanted you to know to keep track. The patient underwent lab tests and procedures which included fever was went up to 105 (unknown units) on 08Mar2021. The action taken in response to the event(s) for bnt162b2 was not applicable. Motrin and fluids for baby given as treatment for fever. The outcome of the fever was reported as resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021330473 Mother/Baby case
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Pyrexia
Clinical narrative: Swollen gland; Low grade fevers; Chills; This is a spontaneous report from a contactable consumer (patient) received via a Pfizer Sponsored Program. A 65-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6199), via an unspecified route of administration in the left arm on 08Mar2021 at 13:00 (at the age of 65-years-old) as e dose 1, single for COVID-19 immunization. The most recent COVID-19 vaccine was administered in the health clinic/administration facility. Medical history included ongoing anaphylactic allergy to hornet venom/carry Epi pen, will go into anaphylactic shock without epi pen, from an unknown date and unknown if ongoing. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. It was unknown if, prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated that since the first shot on 8Mar21, she had experience low grade fevers and chills (no dates, but several days after the first shot, more so like a week after the first shot), off and on since the first shot. She had a low-grade fever last night (25Mar2021), but had not checked her temperature that day (26Mar2021). From 23Mar to present (26Mar), she had a swollen gland on the left side of her throat. Her second shot was scheduled for 29Mar21 and she was wondering if her symptom will interfere with the vaccine response, or if the vaccine will interfere with whatever her immune system was currently responding to (if it was not the first shot that was causing the swollen gland). She was wondering whether, under the current circumstances, she will receive an adverse response to the second shot - or a dangerous response, which makes her concerned whether she should postpone the second shot until after she felt better. She was due for a doctor visit that day (26Mar) to determine cause and treatment. Patient further stated that, the swollen gland has gotten a little better and she was not sure if she needs to actually go in to see the doctor. Patient wanted to ask, how long do side effects last after the first shot. The events resulted in physician office visit. The clinical outcome for the event low grade fevers and chills was not recovered and recovering for swollen gland.  No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: slight fever; aches; chills; nauseated; This is a spontaneous report from a contactable consumer (patient herself). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included covid-19 in December in case it might be a factor. The patient's concomitant medications were not reported. On an unknown date, reported as next day, the patient experienced slight fever, aches, chills and was nauseated. It lasted for that day and was over. The reporter would like to know if the side effects from the covid vaccine would be worse after the 2nd dose or could she get the dose without having any symptoms. The outcome of the events was unknown. There was no product quality complaint (PQC) present.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aspartate aminotransferase, Aspartate aminotransferase increased, Malaise
Clinical narrative: elevated liver tests (AST); felt ill; This is a spontaneous report from a Pfizer sponsored program. A contactable Nurse and consumer (patient) reported that a 62-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 01Mar2021 (at the age of 62-year-old) as dose 2, single for COVID-19 immunisation; axitinib (INLYTA, Film-coated tablet, Strength: 5 mg, Batch/Lot number was not reported; Expiration Date: 31Jul2023), oral from 29Nov2020 to 04Mar2021, at 5 mg, twice daily (5 mg, Every 12 hours) for an unspecified indication; pembrolizumab (KEYTRUDA, Infusion) via an unspecified route of administration on 05Mar2021 at an unknown dose and frequency for an unspecified indication. The patient medical history was not reported. Concomitant medications included simvastatin (formulation: Tablet, strength:10mg), lisinopril (Formulation: Tablet, strength:2.5 mg), colecalciferol (VITAMIN D, Tablet), acetylsalicylic acid (ASPIRIN (E.C.), Chewable tablet, strength: 81 Mg). It was reported that The Patient reports, Inlyta was on hold for 2 Weeks Beginning on 04Mar2021 due to Elevated Liver tests (AST) on an unknown date in Mar2021. Patient previously 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 an unspecified date as dose 1 single for COVID-19 immunization. The Patient Stated that he took his Second Covid Injection on 01March2021 and had Keytruda Infusion on 05Mar2021. Patient Stated that he felt ill on Mar2021 after taking his second Covid Injection. He stated that he had an MD Appt on 12March and Labs were still Elevated in Mar2021 His next appointment was on 19March, there was no change in Lab Results. Patient stated that his MD feels Keytruda and Inlyta are contributing to this. He stated that his MD gave him steroids and he developed rashes on his legs but he was still on the Steroids. He stated that his next appointment with MD is on Friday for Labs. He said that he was feeling fine now. He has medication on hand for 2 weeks and will call to schedule delivery once he resumes taking it. The action taken in response to the event of axitinib was Temporarily Withdrawn on 04Mar2021 and pembrolizumab was unknown. Outcome of the events was unknown at the time of reporting.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Myalgia, Pyrexia
Clinical narrative: fever; muscle pain at the vaccination side; experienced a temperature of 99.9 that lasted through Saturday and was gone by Monday; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for 2 patients (Reporter self and Daughter). This is for reporter self.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Family history included pemphigus vulgaris. The patient did not have any autoimmune disease. Historical Vaccine included bnt162b2 for covid-19 immunisation. On an unspecified date, the patient experienced fever, muscle pain at the vaccination side, experienced a temperature of 99.9 that lasted through saturday and was gone by monday.  The patient underwent lab tests and procedures which included body temperature: 99.9 experienced a temperature of 99.9 that lasted through Saturday and was gone by Monday. The patient reported she felt like doing nothing. She did not take Tylenol for it. She wanted to know about taking Tylenol for the side effects. She wanted to know if that would compromise the efficacy of the vaccine. She herself did not have any lasting side effects. she reported that she really was disappointed in Pfizer because she informed that the clinical trials for the Pfizer BioNTech COVID-19 vaccine excluded people with autoimmune disease but now people with autoimmune disease are being given the vaccine. She said that sounds malpractice. She also stated that she spoke with a friend who has an autoimmune disease and received Moderna as her vaccine was told that one of the side effects they experienced, which was stomach diarrhea, does last longer than expected. Outcome of the events were recovered.   Follow-up (26Mar2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported information included new event and outcome of the events.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.