chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Malaise, Myalgia
Clinical narrative: Tiredness; Headache; Muscle and joint aches; Muscle and joint aches; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 19Feb2021 13:00 (Batch/Lot Number: EL3247) as dose 2, single at 59 years old for COVID-19 immunization at a workplace clinic.  Medical history included hypertension and hyperlipidaemia from an unknown date. Concomitant medications included hydrochlorothiazide, triamterene (DYAZIDE) and atorvastatin both taken for an unspecified indication, start and stop date were not reported. The patient previously took Zoloft and experienced drug allergy. The patient previously received the first dose of bnt162b2 (lot number: EL3247) on 29Jan2021 at 01:30 PM on the left arm at 59 years old for COVID-19 immunization. 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 20Feb2021, the patient experienced tiredness, headache, muscle and joint aches, and was feeling unwell. The reporter assessed the events as non-serious. The events did not result in death or life threatening condition, hospitalization, disability, or congenital anomaly. No treatment was received. The outcome of the events was recovering.   Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Fatigue, Headache, Migraine, Pain
Clinical narrative: Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; Massive headache/migraine, tiredness, apathy, body aches; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient). A 29-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: E28982), via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:15 (at the age of 29-years-old) as dose 2, single for COVID-19 immunisation. Medical history included atopic dermatitis, anxiety, OCPD (Obsessive-compulsive personality disorder), Known allergies: Nickel, Known allergies: Grass/trees from an unknown date and unknown if ongoing. Concomitant medications included sertraline (SERTRALINE), dupilumab (DUPILUMAB), ethinylestradiol, levonorgestrel (AVIANE), ergocalciferol (VIT D) taken for an unspecified indication, start and stop date were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: E13302) via an unspecified route of administration, administered in Arm Left on 21Jan2021 10:30 AM (at the age of 29-years-old) as dose 1, single for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, did not patient been tested for COVID-19. The patient experienced massive headache/migraine, tiredness, apathy, body aches on 11Feb2021 14:00. The outcome of the events was reported as not recovered.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle pain; tiredness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 40-years-oldnon-pregnant female patient received first dose of bnt162b2 (covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Right on 04Feb2021 (at the age of 40-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing Other medical history: No. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. The patient's concomitant medications were not reported. On 04Feb2021, the patient experienced muscle pain, tiredness. Therapeutic measures were taken as a result of muscle pain (myalgia), tiredness (fatigue).The outcome of the events was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: Lympnode under left arm is swollen.; Some pain; This is a spontaneous report from a contactable consumer. This 72-year-old male consumer reported that he received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL9264) via an unspecified route of administration on 08Feb2021 (at 72-year-old) on left arm as dose 2, single for COVID-19 immunization. The medical history of the patient included penicillin allergy and hypertension. It was mentioned that patient did not receive any other vaccine in four weeks, did not have covid prior vaccination and was not tested for covid post vaccination. The concomitant medications included indapamide, amlodipine and finasteride all taken at unknown dose, start date and stop date unknown) taken for unknown indication. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL 3747) via an unspecified route of administration on 17Jan2021 at 01:30 PM (at 72-year-old) on left arm as dose 1, single for COVID-19 immunization. On 11Feb2021 at 06:00 Am the patient noticed swelling and exposed vein and experienced lymphadenopathy and pain. No treatment was received, and patient had not recovered.  Follow-up attempts were completed. No further information was expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Nausea, Pain
Clinical narrative: tired; Chills; Achy; little dizzy; little nausea; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 14:15 (Age at vaccination: 46 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing migraine. Additional Information for Other Conditions was 20 years. Concomitant medications included botulinum toxin type a (BOTOX) taken for migraine from 04Feb2021 to 04Feb2021; Dexamethasone taken for migraine from 06Feb2021 to Feb2021. she only took it for 3 days and that dosing pack has been completed. She was trying to break the migraine cycle and hence she was having. Prior vaccinations within 4 weeks were None. The patient experienced tired, chills, achy, little dizzy, little nausea on 08Feb2021. she was a teacher who got her first vaccine on Friday, 05Feb2021. She was tired over the weekend and more flu like on Tuesday. She went to take a COVID test that was negative on the rapid test and then it was sent off. Her question, since her neurologist gave the steroid and she took Botox for her migraines, could that effect the efficacy of the vaccine. She didn't think about the fact she was prescribed a steroid and that she had been given Botox by her neurologist after the vaccine. The school nurse wanted her to call and report this since she was still experiencing side effects on the 5th and 6th day after the shot. The shot was given on the 05Feb2021 at 2:15pm. The tiredness started Sunday the 08Feb2021, she was feeling got worse and she was feeling pretty lethargic most of Tuesday evening and Tuesday night into Wednesday. It was better now but still ongoing. Chills- This started Sunday, they were better. Achy- This started Sunday but the worst of it was Tuesday and Wednesday. A little dizzy and nausea- this started Sunday and was less today. Rapid tests were done Wednesday, 10Feb2021 which was negative; the test was sent away for the PCR and she should get results back in 3-5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. The outcome of the events was recovering.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tired; Chills; Achy; little dizzy; little nausea; This is a spontaneous report from a contactable consumer (Patient). A 46-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809), dose 1 via an unspecified route of administration, administered in Arm Left on 05Feb2021 at 14:15 (Age at vaccination: 46 years) as dose 1, single for covid-19 immunisation. Medical history included ongoing migraine. Additional Information for Other Conditions was 20 years. Concomitant medications included botulinum toxin type a (BOTOX) taken for migraine from 04Feb2021 to 04Feb2021; Dexamethasone taken for migraine from 06Feb2021 to Feb2021. she only took it for 3 days and that dosing pack has been completed. She was trying to break the migraine cycle and hence she was having. Prior vaccinations within 4 weeks were None. The patient experienced tired, chills, achy, little dizzy, little nausea on 08Feb2021. she was a teacher who got her first vaccine on Friday, 05Feb2021. She was tired over the weekend and more flu like on Tuesday. She went to take a COVID test that was negative on the rapid test and then it was sent off. Her question, since her neurologist gave the steroid and she took Botox for her migraines, could that effect the efficacy of the vaccine. She didn't think about the fact she was prescribed a steroid and that she had been given Botox by her neurologist after the vaccine. The school nurse wanted her to call and report this since she was still experiencing side effects on the 5th and 6th day after the shot. The shot was given on the 05Feb2021 at 2:15pm. The tiredness started Sunday the 08Feb2021, she was feeling got worse and she was feeling pretty lethargic most of Tuesday evening and Tuesday night into Wednesday. It was better now but still ongoing. Chills- This started Sunday, they were better. Achy- This started Sunday but the worst of it was Tuesday and Wednesday. A little dizzy and nausea- this started Sunday and was less today. Rapid tests were done Wednesday, 10Feb2021 which was negative; the test was sent away for the PCR and she should get results back in 3-5 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. The outcome of the events was recovering.   Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, COVID-19, Movement disorder, Pain
Clinical narrative: 3 days later had facial; The night of vaccine was unable to move my entire left side untill next morning and just felt as if got ran over with body aches; The night of vaccine was unable to move my entire left side untill next morning and just felt as if got ran over with body aches. 3days later had facial; This is a spontaneous report from a contactable other hcp reported for herself. A 44-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot Number and Expiration date was not reported), via an unspecified route of administration, administered in Arm Left on 15Jan2021 14:00 (at the age of 44-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included none. Had no known allergies. The patient's concomitant medications were not reported. No other vaccine in four weeks and in two weeks. No covid prior vaccination and covid was tested post vaccination. The patient experienced the night of vaccine was unable to move her entire left side until next morning and just felt as if got ran over with body aches on 15Jan2021 14:00, 3 days later had facial on 18Jan2021. The patient underwent lab tests and procedures which included covid-19 (Rapid antigen nasal swab): negative on 30Jan2021. No treatment received for AE. Clinical outcome of event was recovered on an unspecified date.  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: still have pain in left arm; This is a spontaneous report from a contactable consumer (reported for herself). A 44-years-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in arm left on 02Feb2021 at 10:00 (at the age of 44-years-old) as dose 1, single for covid-19 immunisation at workplace clinic. Medical history included ongoing hypersensitivity (Known allergies: Yes). Concomitant medication included estradiol (ESTRADIOL) 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 not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Feb2021, the patient experienced still have pain in left arm. The reporter stated the event result in Doctor or other healthcare professional office/clinic visit. No treatment was given for the events. The outcome of the event was resolving.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Headache; nausea; Soreness at the injection site; This is a spontaneous report from a contactable consumer. A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in left arm on 11Feb2021 at 11:45 (at the of the 43-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history reported as none. No concomitant medication was reported. The patient was not pregnant at the time of vaccination. Patient had no known allergies. No other vaccine in four weeks. Other medications in two weeks: Birth Control. No COVID prior vaccination. On 11Feb2021 at 20:00, the patient experienced headache, nausea and soreness at the injection site. No treatment received for the adverse event. No COVID tested post vaccination. The outcome of the events were recovered on 2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: the vaccinated area as being swollen; This is a spontaneous report from a Non-contactable consumer (patient). A 81-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 09Feb2021 as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included she suffered a stroke in Feb2020 (affected left side mobility), contracted COVID last April and fully recovered in early May. She is taking medications for diabetes, high blood pressure, cholesterol, thyroid and gout sometimes. The patient concomitant medications were not reported. On unspecified date, the patient experienced the vaccinated area as being swollen but manageable. The outcome of event 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: Injection site discomfort
Clinical narrative: I didn't feel anything more than a mosquito bite sensation when I got the second shot.; This is a spontaneous report from a contactable consumer or other non hcp. A male patient of an unspecified age received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 11Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced I didn't feel anything more than a mosquito bite sensation when I got the second shot on an unspecified date. The outcome of the event injection site discomfort was unknown.  Information on batch/lot number was requested.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable Consumer (patient's wife). A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown), via unspecified route of administration, on an unknown date, as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter asked regarding the schedule for her second covid vaccine 28 days after the first is recommended by Pfizer. Caller reported that the facility where she received her vaccination told her that the recommendation by the CDC is now up to 6 weeks from the first dose. During this call she also mentioned that her husband on an unknown date, experienced like out of it with fatigue for 3 days after getting the first dose and asked if that was normal and are symptoms expected to be worse with his second dose. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Ear pain, Headache, Pyrexia
Clinical narrative: earache (ear pain); Low grade fever (pyrexia); chills; headache; joint pain (arthralgia); This is a spontaneous report from a contactable consumer (patient). A 40-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EN5318), via an unspecified route of administration, administered in the right arm on 19Feb2021 12:00 (at the age of 40-year-old) as single dose for covid-19 immunisation. Medical history included intravenous iodine allergy. The patient was not diagnosed with covid-19 prior to vaccination, did not receive any other vaccines within 4 weeks prior to the covid vaccine, and did not received any other medications within two weeks of vaccination. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (lot number: EN5318), via unspecified route of administration in the right arm on 27Jan2021 for COVID19 immunisation. The patient experienced earache (ear pain), low grade fever (pyrexia), chills, headache, joint pain (arthralgia) on 20Feb2021 at 02:00 am. The patient did not receive any treatment for the events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from earache (ear pain), low grade fever (pyrexia), chills, headache, joint pain (arthralgia) on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: She began lightheaded; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for Covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date the patient experienced she began lightheaded. The outcome of event was unknown.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Limb injury
Clinical narrative: she injured her foot since she slipped through the ice.; she injured her foot since she slipped through the ice.; This is a spontaneous report from contactable female consumer (patient) and from Pfizer. A female patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On unspecified date, the patient experienced injured her foot since she slipped through the ice. Patient asked for re scheduling of the second dose of Covid-19 vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Had bruise on arm only with the first covax; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had bruise on arm only with the first covax on an unspecified date. The patient stated, "Can you take Tylenol before the vaccine. Had bruise on arm only with the first covax, no other problems but had a friend that took Tylenol before the vaccine and did not get sick. So she is asking with her second covax will Tylenol be ok to take." The outcome of the event was unknown.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Nausea
Clinical narrative: fever; chills; slight nausea; headache; loss of appetite; tiredness; This is a spontaneous report from a contactable consumer (patient) other non-healthcare professional. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 19Feb2021,01:45 PM (age at vaccination: 28), in left arm as dose 2, single for COVID-19 immunization. The patient's medical history included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 27Jan2021, 02:15 PM (age at vaccination: 28), in left arm as dose 1, single for COVID-19 immunization. No concomitant medication was reported. Known allergies reported as no and other medical history reported as none. The patient reported no other vaccines taken in four weeks and no other medication taken in two weeks. Patient reported no covid prior vaccination and not tested for covid post vaccination. On 19Feb2021, 05:00 PM Within 3 hours of vaccination, experienced tiredness and felt ok on next day, then the patient had fever, chills, slight nausea, headache, loss of appetite, and tiredness. No treatment was taken. The clinical outcome of all events were recovered on 21Feb2021.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; chills; slight nausea; headache; loss of appetite; tiredness; This is a spontaneous report from a contactable consumer (patient) other non-healthcare professional. A 28-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 19Feb2021,01:45 PM (age at vaccination: 28), in left arm as dose 2, single for COVID-19 immunization. The patient's medical history included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: Unknown), via an unspecified route of administration, on 27Jan2021, 02:15 PM (age at vaccination: 28), in left arm as dose 1, single for COVID-19 immunization. No concomitant medication was reported. Known allergies reported as no and other medical history reported as none. The patient reported no other vaccines taken in four weeks and no other medication taken in two weeks. Patient reported no covid prior vaccination and not tested for covid post vaccination. On 19Feb2021, 05:00 PM Within 3 hours of vaccination, experienced tiredness and felt ok on next day, then the patient had fever, chills, slight nausea, headache, loss of appetite, and tiredness. No treatment was taken. The clinical outcome of all events were recovered on 21Feb2021.   No follow-up attempts are Possible. Information on Lot/batch number cannot be obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Cognitive disorder, Cold sweat, Decreased appetite
Clinical narrative: cold sweats still occurring going into day 3; very excessive amount of sweating soaking through clothes sheets, comforters; Debilitating consistent headache; light sensitivity as well as continuous double vision; light sensitivity as well as continuous double vision; Muscle pain like sand paper; sharp joint pain; loss of appetite and cognitive function; loss of appetite and cognitive function; Fever first night and next day off and on no higher that 101.3; This is a spontaneous report from a contactable consumer (Patient). A 32-year-old male patient received bnt162b2 (BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 06:15 AM (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 32-year-old) for covid-19 immunisation. The patient medical history was not reported and had no allergies. Historical vaccine included BNT162B2 dose 1 for covid-19 immunization on an unknown date. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. On 19Feb2021 14:00, patient experienced loss of appetite and cognitive function. Fever first night and next day off and on no higher than 101.3, cold sweats still occurring going into day 3, very excessive amount of sweating soaking through clothes sheets, comforters, debilitating consistent headache, light sensitivity as well as continuous double vision, muscle pain like sand paper, sharp joint pain. Patient did not receive treatment for adverse events. On 19Feb2021, patient underwent lab tests which included body temperature: 101.3. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of evets was reported as recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Headache, Hyperhidrosis, Myalgia, Photophobia
Clinical narrative: cold sweats still occurring going into day 3; very excessive amount of sweating soaking through clothes sheets, comforters; Debilitating consistent headache; light sensitivity as well as continuous double vision; light sensitivity as well as continuous double vision; Muscle pain like sand paper; sharp joint pain; loss of appetite and cognitive function; loss of appetite and cognitive function; Fever first night and next day off and on no higher that 101.3; This is a spontaneous report from a contactable consumer (Patient). A 32-year-old male patient received bnt162b2 (BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 06:15 AM (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 32-year-old) for covid-19 immunisation. The patient medical history was not reported and had no allergies. Historical vaccine included BNT162B2 dose 1 for covid-19 immunization on an unknown date. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. On 19Feb2021 14:00, patient experienced loss of appetite and cognitive function. Fever first night and next day off and on no higher than 101.3, cold sweats still occurring going into day 3, very excessive amount of sweating soaking through clothes sheets, comforters, debilitating consistent headache, light sensitivity as well as continuous double vision, muscle pain like sand paper, sharp joint pain. Patient did not receive treatment for adverse events. On 19Feb2021, patient underwent lab tests which included body temperature: 101.3. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of evets was reported as recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: cold sweats still occurring going into day 3; very excessive amount of sweating soaking through clothes sheets, comforters; Debilitating consistent headache; light sensitivity as well as continuous double vision; light sensitivity as well as continuous double vision; Muscle pain like sand paper; sharp joint pain; loss of appetite and cognitive function; loss of appetite and cognitive function; Fever first night and next day off and on no higher that 101.3; This is a spontaneous report from a contactable consumer (Patient). A 32-year-old male patient received bnt162b2 (BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 19Feb2021 06:15 AM (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 32-year-old) for covid-19 immunisation. The patient medical history was not reported and had no allergies. Historical vaccine included BNT162B2 dose 1 for covid-19 immunization on an unknown date. There were no concomitant medications. The patient did not receive other vaccine in four weeks. The patient did not receive other medications in two weeks. On 19Feb2021 14:00, patient experienced loss of appetite and cognitive function. Fever first night and next day off and on no higher than 101.3, cold sweats still occurring going into day 3, very excessive amount of sweating soaking through clothes sheets, comforters, debilitating consistent headache, light sensitivity as well as continuous double vision, muscle pain like sand paper, sharp joint pain. Patient did not receive treatment for adverse events. On 19Feb2021, patient underwent lab tests which included body temperature: 101.3. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Outcome of evets was reported as recovering.    No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: joint pain was in her jaw on the left side; This is a spontaneous report from a contactable consumer (patient's husband). A 66-years-old female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EM9809, NDC number, expiry date: unknown) via an unspecified route of administration in deltoid right (shoulder) on 10Feb2021 at 13:30 (at the age of 66-years-old) as a single dose for covid-19 immunization. Medical history (including any illness at time of vaccination) included ongoing breathing problem. She had for about 3 years and uses a nebulizer machine. History of all previous immunization with the Pfizer vaccine considered as suspect, additional vaccines administered on same date of the Pfizer suspect, prior vaccinations (within 4 weeks), adverse events following prior vaccinations, family medical history relevant to adverse events were reported as none. There were no concomitant medications. The patient experienced joint pain in her jaw on the left side on 10Feb2021. It started that night but the next day she was fine, it was gone. Duration of event was 0 day. The patient did not require emergency room or physician office visit. Investigation assessment was not reported. Relevant tests were reported as none. The outcome of the event at the time of last observation was resolved on 10Feb2021.  Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Soreness in arm; Headache; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that: A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK9231), via an unspecified route of administration on 21Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. Medical history included liver disease from an unknown date and unknown if ongoing. Concomitant medication(s) included ursodiol (URSODIOL) taken for an unspecified indication, start and stop date were not reported. Patient stated, I have a couple of questions about the vaccination. The first one I had on the 21Jan2021, I had very little reaction like the soreness in the arm and maybe a little headache on an unspecified date, but then this past Thursday I had the second one and I had quite a reaction and I was wondering are they different Is one dose different than the other when confirmed the vaccine as Pfizer's COVID-19 Vaccine, consumer stated, correct. Patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EN6201), via an unspecified route of administration on Feb2021 as single dose for covid-19 immunisation and experienced Fever, I was weak, Tired, and Hurt all over; every muscle in my body, every joint hurt. Therapeutic measures were taken as a result of the events with Advil. The outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort
Clinical narrative: I am having problems with 'loose' bowels, going to the bathroom; This is a spontaneous report from a contactable consumer. A 81-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 3L3246), dose 1 via an unspecified route of administration, administered in Arm Left on an unspecified date as a single dose for covid-19 immunization. Medical history included diabetes mellitus. Concomitant medication(s) included metformin hydrochloride, sitagliptin (JANUMET [METFORMIN HYDROCHLORIDE;SITAGLIPTIN]) taken for diabetes mellitus. The patient experienced problems with 'loose' bowels, going to the bathroom on an unspecified date. The patient receive treatment with some Imodium and 'Pepto Bismol' and yet not visited to emergency room/ Physician Office. Outcome of the event was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes in underarm, outer breast area of side where vaccine was administered; This is a spontaneous report from a contactable consumer (patient). A 43-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EM9809, patient was 43-year-old at the time of vaccination), via an unspecified route of administration, administered in Arm Right on 09Feb2021 at 03:45 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included Hashimotos, PCOS, High Blood pressure, asthma, penicillin allergy, thyroid. Patient received unspecified medication for BP Meds, Birth Control, Thyroid in two weeks. It was reported that no other vaccine received in four weeks. No covid reported prior vaccination, not tested for covid post vaccination. On 10Feb2021, the patient experienced swollen lymph nodes in underarm, outer breast area of side where vaccine was administered. No treatment was received for event. The outcome of event was not recovered.  Information on the batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: Headache; body aches; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported that: A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL9264 and Expiry date was not reported), dose 1 via an unspecified route of administration in arm left on 11Feb2021 10:00 AM (age at vaccination was 77-year-old) as dose 1, single dose for covid-19 immunisation. Medical history was not reported. Concomitant medications were not reported. She was calling to reporting an adverse event from the Pfizer Covid vaccine, she received yesterday at 10am. She states late last night around 9 or 10 PM it started with huge body aches, states this morning she had a headache and body aches. States she treated with Ty-lenol. States the body aches somewhat subsided and the headache is still lingering. On 11 Feb2021, the patient experienced body aches. On 12Feb2021, the patient experienced headache. The patient did not visit Emergency Room and Physician Office for AE. The patient was not hospitalized, how many days was the hospital stay was no. Treatment received for the events. Outcome of the event body aches was recovering, and headache was not recovered.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Crepitations, Lacrimation increased, Sinusitis
Clinical narrative: Sinus infection; Watery eyes; Crackling; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient stated that patient got finished second dose of the Pfizer vaccine a few days ago and then, it was nothing to do with the shot. Patient got those all time, patient had a sinus infection, got the watery eyes, the crackling, patient got them quite a bit because patient had to go see a sinus guy. Patient wanted to ask about antibiotics, if it was safe to take an antibiotic after getting a shot. The clinical outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vaccination site pain
Clinical narrative: very bad pain on the side of her neck from ear to shoulder; right in there, both shots were in left arm, that's where the pain is; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 05Feb2021 (at the age of 76-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) in left arm for COVID-19 immunization. It was reported that, the patient had problems. The patient had both shots. She had second dose on 05Feb2021, and for last 4 days (on an unspecified date in Feb2021) she had "very bad pain on the side of her neck from ear to shoulder" "right in there, both shots were in left arm, that's where the pain is". The patient reported that it was quite painful. The patient declined to contact recommended doctor as she was contacting her doctor anyway. The patient did not want to proceed with the report, as she did not see where this helps her, as far as her hurting. Investigation assessment was not provided. The outcome of the events was reported as unknown.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood pressure systolic, Chest discomfort, Circumstance or information capable of leading to medication error, Dyspnoea
Clinical narrative: I have been taking Tylenol for my hip replacement that I had in Dec. I take Benadryl at night because we live in an old house./2 months ago I had my hip replaced; I have heaviness around my chest/heavy feeling in my chest; my blood pressure is extremely high./blood pressure go up after receiving the vaccine; I also feel out of breath.; headache/mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809), via an unspecified route of administration on 17Feb2021 (last Wednesday) (age at vaccination: 65 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included hip arthroplasty for which she was on advil 2 to 3 times a day, blood pressure abnormal (husband has blood pressure), spinal fusion surgery 4 months before, sneezing took Benadryl. Concomitant medication(s) included aspirin (acetylsalicylic acid), diazepam (VALIUM) 15mg in the morning and 15mg at night. The patient previously took tylenol and experienced abdominal discomfort and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263) on 27Jan2021 for covid-19 immunisation. On an unknown date, the patient had been taking tylenol for her hip replacement that she had in December2020, take benadryl at night because she lives in an old house, 2 months ago she had my hip replaced, have heaviness around my chest/heavy feeling in my chest (started 24 hours after), her blood pressure was extremely high./blood pressure go up after receiving the vaccine and she also felt out of breath. She didn't have any problem with my first shot. She barely even felt. On 19Feb2021 (2days after the vaccine), the patient experienced headache/mild headache, On an unknown date, the patient's blood pressure measurement was 158/118; blood pressure systolic was 100 (it's little over 100, for a couple of days). She cant take Tylenol as it upsets her stomach. She did not have a rash. She was severely allergic to it. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension
Clinical narrative: I have been taking Tylenol for my hip replacement that I had in Dec. I take Benadryl at night because we live in an old house./2 months ago I had my hip replaced; I have heaviness around my chest/heavy feeling in my chest; my blood pressure is extremely high./blood pressure go up after receiving the vaccine; I also feel out of breath.; headache/mild headache; This is a spontaneous report from a contactable consumer (patient herself). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EM9809), via an unspecified route of administration on 17Feb2021 (last Wednesday) (age at vaccination: 65 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history included hip arthroplasty for which she was on advil 2 to 3 times a day, blood pressure abnormal (husband has blood pressure), spinal fusion surgery 4 months before, sneezing took Benadryl. Concomitant medication(s) included aspirin (acetylsalicylic acid), diazepam (VALIUM) 15mg in the morning and 15mg at night. The patient previously took tylenol and experienced abdominal discomfort and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9263) on 27Jan2021 for covid-19 immunisation. On an unknown date, the patient had been taking tylenol for her hip replacement that she had in December2020, take benadryl at night because she lives in an old house, 2 months ago she had my hip replaced, have heaviness around my chest/heavy feeling in my chest (started 24 hours after), her blood pressure was extremely high./blood pressure go up after receiving the vaccine and she also felt out of breath. She didn't have any problem with my first shot. She barely even felt. On 19Feb2021 (2days after the vaccine), the patient experienced headache/mild headache, On an unknown date, the patient's blood pressure measurement was 158/118; blood pressure systolic was 100 (it's little over 100, for a couple of days). She cant take Tylenol as it upsets her stomach. She did not have a rash. She was severely allergic to it. The outcome of the events was unknown. There was no product quality complaint (PQC) present.  No follow-up attempts are possible. No further information is expected.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fall, Ligament sprain, Mobility decreased
Clinical narrative: weak; fell; sprained her ankle; cannot move; This is a spontaneous report from a contactable consumer reporting for a patient (Reporter's mother) received from a Pfizer-sponsored program COVAX US Support. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261, NDC number and UPC number are unknown, Expiration Date: May2021), via an unspecified route of administration on 25Jan2021 at the age of 90-years-old as dose 1, single for covid-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient's height and weight were not reported. There was no Investigation assessment. It was reported that the reporter has been assisting mom (patient) to get her shot and they had their first one about 3 weeks ago at 'Tier 2' (not clarified). The reporter got shot at that time as well, first one, since the reporter was assisting her. And there were no side effects or anything. She was walking around and just a couple of days ago, on Sunday, 14Feb2021, in the evening, she fell and she sprained her ankle and she cannot move. They have the second shot scheduled for today at 2:45. So, she could not make it. So, couple of things, let her reschedule that and reporter asked, should I get the second shot? It was reported that the patient was supposed to get second dose today but she fell a couple days ago and was weak on an unspecified date. She was unable to get second dose within 3 weeks. The patient did not receive treatment for adverse events. The outcome of events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.