chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periarthritis, Ultrasound scan
Clinical narrative: Pain was felt time the needle entered  upper arm and when it was taken out; Lost some mobility in arm; Swelling is there and arm is a half inch larger than left.; This is a spontaneous report from a contactable other healthcare professional, the patient. A 56-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 12Mar2021 at 13:15 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin and latex tape. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 12Mar2021, the patient felt vaccine was administered into the nerve of the right arm and the patient experienced pain when the needle entered upper arm and when it was taken out, to date patient was in pain. The patient lost some mobility in the arm and swelling was there in the arm. The patient stated the arm was a half inch larger than the left arm and the patient was unable to raise arm to full capacity or reach back. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with orthopaedic doctor. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain was felt when the needle entered upper arm and when it was taken out, lost some mobility in arm and swelling was there in the arm was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Urticaria
Clinical narrative: hives; sore arm; This is a spontaneous report from a contactable consumer (patient herself).  A non-pregnant female patient of an unspecified age received first dose of bnt162b2 (Solution injection; Batch/Lot Number: EW0177), via an unspecified route of administration, administered in Arm Left on 17May2021 at 12:00 as single dose for covid-19 immunisation. Medical history included hypothyroidism and allergy from gluten, penicillin, dust and mold. Concomitant medications included levothyroxine sodium (TIROSINT) taken for hypothyroidism. The patient previously took penicillin and experienced hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced hives and sore arm on an unspecified date. Patient reported that it was unclear if hives was from his external and food allergies or the shot. Patient started taking antihistamines prior to Dose 2 and the hives cleared up. Therapeutic measures were taken as a result of hives and sore arm and patient was on Claritan. The outcome of the events was reported as not recovered.  Follow-up attempts were needed. Information on Lot/Batch number was available, additional in-formation has been requested
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: Nausea; Fever; Headache; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1076) via an unspecified route of administration in the right arm on 11Jun2021 at 16:00(at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high and sulfonamide allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW1076) via an unspecified route of administration in the right arm on 21May2021 at 16:00(at the age of 64-year-old) as a single dose for COVID-19 immunisation. On 12Jun2021 at 16:00, after 24 hours of vaccination, the patient experienced fever and headache. On 14Jun2021 at 06:00, after 62 hours of vaccination, the patient experienced nausea. Since the vaccination, the patient had not been tested for COVID-19. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events Fever and headache after 24 hours, Stomach and Nausea 62 hours later were not resolved at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Rash, SARS-CoV-2 test
Clinical narrative: Herpes outbreak orally; Rashes all over arms; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 04May2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included chronic vestibular migraines from presumed COVID-19. The patient had no known allergies. Concomitant medications were not reported. On 04Sep2020, the patient underwent nasal swab test for COVID-19 and the result was negative. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the left arm on 13Apr2021 at 12: 30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25May2021, within 3 weeks of vaccination, the patient had a trigger in herpes outbreak orally, which the patient thought would be of material interest regarding adverse events. It had not yet gone away so that had lasted almost 4 weeks and had no signs of subsiding despite treatment. The patient also had rashes all over arms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment with unspecified antivirals and antibiotics. The clinical outcome of the events herpes outbreak orally and rashes all over arms were not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Loss of personal independence in daily activities, Neck pain, Pain in extremity
Clinical narrative: Shooting pain from injection area; The pain goes down my left arm and across my chest and into my neck.; The pain goes down my left arm and across my chess and into my neck; The pain goes down my left arm and across my chess and into my neck; The pain also goes behind the shoulder; I can not lift my arm or carrying anything in my left hand; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, chronic myeloid leukaemia from an unknown date and unknown if ongoing, bronchopulmonary aspergillosis allergic from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Patient took other medications within 2 weeks prior vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EZ6199), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 02:30 PM (at the age of 57-year-old) as dose 1, single for covid-19 immunisation within four weeks from dose 2. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 07:00, the patient experienced shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder, can not lift arm or carrying anything in left hand. It is a constant pain patient can't get rid of. Patient had tired heating pad, massages and acupuncture. Therapeutic measures were taken as a result of shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder included aleve twice a day for the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were not recovered.   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Shooting pain from injection area; The pain goes down my left arm and across my chest and into my neck.; The pain goes down my left arm and across my chess and into my neck; The pain goes down my left arm and across my chess and into my neck; The pain also goes behind the shoulder; I can not lift my arm or carrying anything in my left hand; This is a spontaneous report from a contactable consumer or other non hcp. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8737), dose 2 via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 57-year-old) as dose 2, single for covid-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing, chronic myeloid leukaemia from an unknown date and unknown if ongoing, bronchopulmonary aspergillosis allergic from an unknown date and unknown if ongoing, drug hypersensitivity from an unknown date and unknown if ongoing. Patient took other medications within 2 weeks prior vaccination. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EZ6199), dose 1 via an unspecified route of administration, administered in Arm Left on 15Mar2021 02:30 PM (at the age of 57-year-old) as dose 1, single for covid-19 immunisation within four weeks from dose 2. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Jun2021 07:00, the patient experienced shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder, can not lift arm or carrying anything in left hand. It is a constant pain patient can't get rid of. Patient had tired heating pad, massages and acupuncture. Therapeutic measures were taken as a result of shooting pain from injection area, the pain goes down my left arm and across my chest and into my neck, the pain also goes behind the shoulder included aleve twice a day for the pain. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events were not recovered.   Follow-Up (15Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (30Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aldolase, Aspartate aminotransferase, Biopsy muscle, Blood bilirubin
Clinical narrative: Mild discomfort after first dose; This is a spontaneous report from a contactable Physician. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 11Apr2021 as (At the age of 48-years) DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing Right shoulder pain, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic/chromosomal abnormalities from an unknown date, diabetes from an unknown date, obesity from an unknown and ongoing migraine headaches. Concomitant medication included caffeine, paracetamol (excedrin [caffeine; paracetamol]) taken for migraine from an unspecified start date and ongoing. The patient experienced Mild discomfort after first dose on an unknown date. On 02May2021 patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration as (At the age of 48-years) dose 2, 0.3ml, single for COVID-19 immunization. The patient underwent lab tests and procedures which included alanine aminotransferase: 151 on 28May2021, alanine aminotransferase: 75 on 01Jun2021, alanine aminotransferase: 280 on 05Jun2021, alanine aminotransferase: 194 on 08Jun2021, aldolase: 8.3 on 29May2021, aspartate aminotransferase: 63 on 28May2021, aspartate aminotransferase: 168 on 05Jun2021, aspartate aminotransferase: 35 on 08Jun2021, biopsy muscle: no significant inflammatory component on 02Jun2021, blood bilirubin: 1.2 on 28May2021, blood bilirubin: 1.5 on 31May2021, blood creatine phosphokinase: normal on 28May2021, blood creatine phosphokinase: normal on 29May2021, lyme disease: unknown on 25May2021,lyme disease: negative on 28May2021. The outcome of event was unknown.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Blood creatine phosphokinase, Discomfort, Lyme disease, SARS-CoV-2 test
Clinical narrative: Mild discomfort after first dose; This is a spontaneous report from a contactable Physician. A 48-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 11Apr2021 as (At the age of 48-years) DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. Medical history included ongoing Right shoulder pain, diagnosed allergies from an unknown date, compromised immune status from an unknown date, respiratory illness from an unknown date, genetic/chromosomal abnormalities from an unknown date, diabetes from an unknown date, obesity from an unknown and ongoing migraine headaches. Concomitant medication included caffeine, paracetamol (excedrin [caffeine; paracetamol]) taken for migraine from an unspecified start date and ongoing. The patient experienced Mild discomfort after first dose on an unknown date. On 02May2021 patient received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration as (At the age of 48-years) dose 2, 0.3ml, single for COVID-19 immunization. The patient underwent lab tests and procedures which included alanine aminotransferase: 151 on 28May2021, alanine aminotransferase: 75 on 01Jun2021, alanine aminotransferase: 280 on 05Jun2021, alanine aminotransferase: 194 on 08Jun2021, aldolase: 8.3 on 29May2021, aspartate aminotransferase: 63 on 28May2021, aspartate aminotransferase: 168 on 05Jun2021, aspartate aminotransferase: 35 on 08Jun2021, biopsy muscle: no significant inflammatory component on 02Jun2021, blood bilirubin: 1.2 on 28May2021, blood bilirubin: 1.5 on 31May2021, blood creatine phosphokinase: normal on 28May2021, blood creatine phosphokinase: normal on 29May2021, lyme disease: unknown on 25May2021,lyme disease: negative on 28May2021. The outcome of event was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia, Urticaria
Clinical narrative: hives; headache; low fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 44-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: FA6780, Expiration date: Not reported), via an unspecified route of administration, administered in arm left on 08Jun2021 12:00 (age at vaccination: 44-years-old) as dose 2, single for covid-19 immunization. Medical history included hypothyroidism, allergy to dust, mold, gluten, penicillin allergy, food allergies, allergies to medications. Concomitant medications included levothyroxine sodium (TIROSINT), received within 2 weeks of vaccination. The patient was not pregnant at time 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 has not been tested for COVID-19. The patient historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot Number: EW0177), via an unspecified route of administration, administered in arm left on 17May2021 12:00 (age at vaccination: 44-years-old) as dose 1, single for covid-19 immunization and the patient had hives after dose 1 however it was unclear if the hives are from my external and food allergies or the shot. The patient started taking antihistamines prior to dose 2 and the hives cleared up and also had a sore arm after dose 1. On 12Jun2021, the hives appeared again after shot 2 and also had common reactions of headache, low fever, and body aches from about 24 hours after to 60 hours after. Therapeutic measures were taken as a result of all reported events and treatment included Claritian, which was continuing for 2 weeks. The seriousness was not reported. Outcome of the events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Can't really taste anything; Feel really bad; Sick all days; My throat is like swollen; Lymph nodes is swollen like right now it's difficult for me to swallow; Headache; I do not feel well; I am tired, all I wanna do is sleep; Fever; Chills; My throat, lymph node they are swollen like it is making it difficult for me to swallow; looks like diarrheal/Little diarrhea; I am very weak; I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk; This is a spontaneous report from a contactable consumer (patient). This 34-years-Adult-female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0169),via an unspecified route of administration on 11Jun2021 at 09:30(at the age of 34-years) as Dose 1,Single for COVID-19 immunization. The patient's medical history included hypertension. Concomitant medications included MULTIVITAMINS, I was taking, but since I have not been feeling well, I have not been taking it. No other vaccine taken previously, this is 1st one. On 12Jun2021 the patient experienced headache, do not feel well, am tired, all wanna do is sleep, fever, chills, my throat, lymph node they are swollen like it is making it difficult for me to swallow, looks like diarrheal/little diarrhea, very weak, not able to do hardly anything, like have been taking medication all day for soothing my throat so that able to talk, can't really taste anything, feel really bad, sick all days, my throat is like swollen, lymph nodes is swollen like right now it's difficult for me to swallow. Therapeutic measures were taken as a result of, sick all days (illness), Since I have been sick, I was taking Tylenol and I have been taking Brilaroxazine, with my food and honey. When probed for having any medical enquiry Consumer stated, "I was told if I had this to report it, there was somebody would check upon me. Yes, I am calling to report so that they would know what is going on. I need to know how long this is going to last because I have got this vaccine since Friday and here is Monday and I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk." Scheduled date for second shot on 09Jul2021. The outcome for all event was unknown.  Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Illness, Lymphadenopathy, Malaise
Clinical narrative: Can't really taste anything; Feel really bad; Sick all days; My throat is like swollen; Lymph nodes is swollen like right now it's difficult for me to swallow; Headache; I do not feel well; I am tired, all I wanna do is sleep; Fever; Chills; My throat, lymph node they are swollen like it is making it difficult for me to swallow; looks like diarrheal/Little diarrhea; I am very weak; I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk; This is a spontaneous report from a contactable consumer (patient). This 34-years-Adult-female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0169),via an unspecified route of administration on 11Jun2021 at 09:30(at the age of 34-years) as Dose 1,Single for COVID-19 immunization. The patient's medical history included hypertension. Concomitant medications included MULTIVITAMINS, I was taking, but since I have not been feeling well, I have not been taking it. No other vaccine taken previously, this is 1st one. On 12Jun2021 the patient experienced headache, do not feel well, am tired, all wanna do is sleep, fever, chills, my throat, lymph node they are swollen like it is making it difficult for me to swallow, looks like diarrheal/little diarrhea, very weak, not able to do hardly anything, like have been taking medication all day for soothing my throat so that able to talk, can't really taste anything, feel really bad, sick all days, my throat is like swollen, lymph nodes is swollen like right now it's difficult for me to swallow. Therapeutic measures were taken as a result of, sick all days (illness), Since I have been sick, I was taking Tylenol and I have been taking Brilaroxazine, with my food and honey. When probed for having any medical enquiry Consumer stated, "I was told if I had this to report it, there was somebody would check upon me. Yes, I am calling to report so that they would know what is going on. I need to know how long this is going to last because I have got this vaccine since Friday and here is Monday and I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk." Scheduled date for second shot on 09Jul2021. The outcome for all event was unknown.  Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Pyrexia, Throat irritation
Clinical narrative: Can't really taste anything; Feel really bad; Sick all days; My throat is like swollen; Lymph nodes is swollen like right now it's difficult for me to swallow; Headache; I do not feel well; I am tired, all I wanna do is sleep; Fever; Chills; My throat, lymph node they are swollen like it is making it difficult for me to swallow; looks like diarrheal/Little diarrhea; I am very weak; I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk; This is a spontaneous report from a contactable consumer (patient). This 34-years-Adult-female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number EW0169),via an unspecified route of administration on 11Jun2021 at 09:30(at the age of 34-years) as Dose 1,Single for COVID-19 immunization. The patient's medical history included hypertension. Concomitant medications included MULTIVITAMINS, I was taking, but since I have not been feeling well, I have not been taking it. No other vaccine taken previously, this is 1st one. On 12Jun2021 the patient experienced headache, do not feel well, am tired, all wanna do is sleep, fever, chills, my throat, lymph node they are swollen like it is making it difficult for me to swallow, looks like diarrheal/little diarrhea, very weak, not able to do hardly anything, like have been taking medication all day for soothing my throat so that able to talk, can't really taste anything, feel really bad, sick all days, my throat is like swollen, lymph nodes is swollen like right now it's difficult for me to swallow. Therapeutic measures were taken as a result of, sick all days (illness), Since I have been sick, I was taking Tylenol and I have been taking Brilaroxazine, with my food and honey. When probed for having any medical enquiry Consumer stated, "I was told if I had this to report it, there was somebody would check upon me. Yes, I am calling to report so that they would know what is going on. I need to know how long this is going to last because I have got this vaccine since Friday and here is Monday and I am not able to do hardly anything like I have been taking medication all day for soothing my throat so that I am able to talk." Scheduled date for second shot on 09Jul2021. The outcome for all event was unknown.  Further probing could not be done as the consumer was unwilling to share any further information. Hence limited information available over the call.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Bad Joint pain fingers; This is a spontaneous report from a non-contactable consumer, the patient. A non-pregnant female patient of an unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25May2021 at 15:00 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient experienced bad Joint pain fingers, never had pain before. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the event. The clinical outcome of the event bad Joint pain fingers was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness postural, Fall, Loss of personal independence in daily activities, Nausea, Vertigo
Clinical narrative: Debilitating dizziness/I cannot look at the ground (while standing) without falling over/I have a general "hum" of dizziness in my head at all times; Debilitating dizziness/I cannot look at the ground (while standing) without falling over/I have a general "hum" of dizziness in my head at all times; I cannot get into or out of bed without nauseating vertigo; I cannot get into or out of bed without nauseating vertigo; I cannot use stairs without leaning on the wall; This is a spontaneous report from a contactable consumer or other non hcp (patient, self-reporting). A 53-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ew0185), dose 2 via an unspecified route of administration in arm left on 20May2021 at 10:45 (Age at vaccination 53 Years old) as single dose for COVID-19 immunisation. Medical history included diabetes mellitus from an unknown date and unknown if ongoing. Concomitant medication included insulin lispro (HUMALOG), insulin detemir (LEVEMIR) taken for an unspecified indication, start and stop date were not reported. On 29-APR-2021 patient Historical vaccine first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: ew0170 and expiration dates were not reported), dose 1 via an unspecified route of administration in left arm on 29Apr2021 at 10:45 am as single dose for COVID-19 immunisation. If treatment ae Meclizine, plus "exercises" for vertigo. No COVID prior vaccination and no COVID tested post vaccination, Known allergies. On 21May2021 the patient experienced debilitating dizziness. Patient cannot look at the ground (while standing) without falling over. Patient cannot get into or out of bed leaning on the wall and cannot get into or out of bed without nauseating vertigo. Patient have a general "hum" of dizziness in his head at all times. It was awful. No other vaccine in four weeks. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the adverse event. Outcome of events was not recovered.   No follow-up attempts are possible; information about lot/batch without nauseating vertigo. Patient cannot use stairs without number cannot be obtained
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Hives and rashes developed on thighs, stomach and legs; Hives and rashes developed; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the  right arm on 11Jun2021 at 11:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient had no known allergies to food, medications or other products. 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 medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 14Jun2021 at 08:00, the patient experienced hives and rashes developed on thighs, stomach and legs. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. The clinical outcome of the event hives and rashes developed on thighs, stomach and legs was recovering at the time of this report.  The batch/lot numbers for BNT162b2, were not provided and will be requested during follow up.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Enuresis
Clinical narrative: peed on sleep; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0178) via an unspecified route of administration in the left arm on 25May2021 at 18:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Medical history included pollen allergy. The patient did not receive any medications within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, the patient peed on his sleep, it never happened in his life before. The patient reported that if the patient had a need to pee while sleeping he suddenly wake up and go to pee, after 3 days of first dose he peed on his sleep and it happened only one time. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event peed on sleep was recovered on 28May2021.  No follow-up attempts are possible. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Headache, Night sweats, Oropharyngeal pain, Pain
Clinical narrative: Fever; Bad sore throat; Coughing; Sweating at night; Headache; Body sore; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Jun2021 at 15:00(at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient had no other health issues and the patient was allergic to amoxicillin (MANUFACTURER UNKNOWN). The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 22May2021 at 11:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Patient didn't have covid-19 prior to the vaccination, and patient didn't have covid test post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jun2021 at 06:00 the patient experienced fever which lasted about 12 hours, still having very bad sore throat and coughing on day three after the vaccination, sweating at night, headache and body sore. The patient reported that the symptoms were not noticeably improving. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken included treatment with Tylenol Cold and Flu. The clinical outcome of the event fever was recovered on 13Jun2021 at 18:00 and the clinical outcome the events bad sore throat, coughing, sweating at night, headache and body sore was not recovered at the time of this report.   The 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: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; Bad sore throat; Coughing; Sweating at night; Headache; Body sore; This is a spontaneous report from a contactable consumer, the patient. A 14-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 12Jun2021 at 15:00(at the age of 14-years-old) as a single dose for COVID-19 immunisation. The patient had no other health issues and the patient was allergic to amoxicillin (MANUFACTURER UNKNOWN). The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE;Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 22May2021 at 11:00 (at the age of 14-years-old) as a single dose for COVID-19 immunisation. Patient didn't have covid-19 prior to the vaccination, and patient didn't have covid test post vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 13Jun2021 at 06:00 the patient experienced fever which lasted about 12 hours, still having very bad sore throat and coughing on day three after the vaccination, sweating at night, headache and body sore. The patient reported that the symptoms were not noticeably improving. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken included treatment with Tylenol Cold and Flu. The clinical outcome of the event fever was recovered on 13Jun2021 at 18:00 and the clinical outcome the events bad sore throat, coughing, sweating at night, headache and body sore was not recovered at the time of this report.   The 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: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymph node swelling; This is a spontaneous report from a contactable consumer, the patient. A 19-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 25May2021 at 15:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 26May2021 at 15:00, the patient experienced lymph node swelling. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lymph node swelling was resolved on an unknown date in 2021. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Jun2021 at 17:30 (at the age of 19-years-old) as a single dose for COVID-19 immunisation.  The batch/lot numbers for BNT162b2 were not provided and will be requested during follow up.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Condition aggravated, Dyspnoea, Gait disturbance
Clinical narrative: I woke up with even more swelling but into my ankles/The joint pain has gotten worse. Now it's in both arms from just below the elbows into the fingers. And both legs from my knees into my feet.; I could hardly walk; very painful stinging; hardly being able to breathe; Blood pressure has also been very high; headache; Pain in joints; swelling in wrists and fingers; racing heart; pain and pressure from fingers to shoulder; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACINE, Solution for injection, Batch/Lot Number: W0178), via an unspecified route of administration, administered in Arm Right on 05Jun2021 12:00 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. Medical history included fibromyalgia, obesity, spondylitis grade 3 all from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. patient did not receive any other vaccine within four weeks. Patient was not diagnosed with covid-19 prior to vaccination. It was reported that within 10 mins of shot on 05jun2021 swelling in wrists and fingers. Pain in joints, headache, racing heart, pain and pressure from fingers to shoulder. As of Monday 10Jun2021 she woke up with even more swelling but into her ankles which were so severe she could hardly walk, also very painful stinging. The joint pain has gotten worse. Now it in both arms from just below the elbows into the fingers. And both legs from her knees into her feet. This was constant swelling and pain. Also woke up to hardly being able to breathe. And still having headaches. Blood pressure has also been very high as well since the covid vaccine. Adverse events resulted In Doctor or other healthcare professional office/clinic visit. Since the vaccination patient was not tested with covid-19. The patient underwent lab tests and procedures which included blood pressure measurement: very high on 10Jun2021. Therapeutic measures were taken as a result of events with Lasix. The outcome for the events was reported as not resolved at the time of this report.   Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.  Follow-up (04Aug2021): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Joint swelling, Pain, Palpitations
Clinical narrative: I woke up with even more swelling but into my ankles/The joint pain has gotten worse. Now it's in both arms from just below the elbows into the fingers. And both legs from my knees into my feet.; I could hardly walk; very painful stinging; hardly being able to breathe; Blood pressure has also been very high; headache; Pain in joints; swelling in wrists and fingers; racing heart; pain and pressure from fingers to shoulder; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 52-years-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACINE, Solution for injection, Batch/Lot Number: W0178), via an unspecified route of administration, administered in Arm Right on 05Jun2021 12:00 (Age at vaccination: 52-years-old) as single dose for covid-19 immunization. Medical history included fibromyalgia, obesity, spondylitis grade 3 all from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. patient did not receive any other vaccine within four weeks. Patient was not diagnosed with covid-19 prior to vaccination. It was reported that within 10 mins of shot on 05jun2021 swelling in wrists and fingers. Pain in joints, headache, racing heart, pain and pressure from fingers to shoulder. As of Monday 10Jun2021 she woke up with even more swelling but into her ankles which were so severe she could hardly walk, also very painful stinging. The joint pain has gotten worse. Now it in both arms from just below the elbows into the fingers. And both legs from her knees into her feet. This was constant swelling and pain. Also woke up to hardly being able to breathe. And still having headaches. Blood pressure has also been very high as well since the covid vaccine. Adverse events resulted In Doctor or other healthcare professional office/clinic visit. Since the vaccination patient was not tested with covid-19. The patient underwent lab tests and procedures which included blood pressure measurement: very high on 10Jun2021. Therapeutic measures were taken as a result of events with Lasix. The outcome for the events was reported as not resolved at the time of this report.   Follow-up (19Jul2021): Follow-up attempts completed. No further information expected.  Follow-up (04Aug2021): Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: With the first shot, I experienced mild nausea about 30 minutes after the shot. With the 2nd shot, the nausea came on really strong the following day and persisted all day.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 21Mar2021 at 11:15 (at the age of 46-years-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 11Apr2021 at 15:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. The patient did not receive any concomitant medications within two weeks of the COVID vaccine. The patient previously took amoxicillin (MANUFACTURER UNKNOWN) and clindamycin (MANUFACTURER UNKNOWN) for unknown indications and on unknown dates and experienced drug allergy.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Apr2021, the patient reported that with the first shot, he experienced mild nausea about 30 minutes after the shot. With the 2nd shot, the nausea came on really strong the following day and persisted all day. About 2 weeks after the 2nd shot, he began feeling nausea every day. Some days were very mild. Some were more severe - similar to the day after the 2nd shot. But, it was pretty much with him all the time now, to some degree. The reason he wrote was because it was not something that he normally experienced. He was not sure what to make of it but thought he would pass on the information in case it was necessary to know.  On 10May2021, the patient underwent Covid-19 test (nasal swab) and the result was negative. The event did not result in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event nausea was not recovered at the time of this report.  The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Terrible headache came on suddenly that was severe pressure or vise like squeezing in the whole back half of head; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 12May2021 at 16:00 (at the age of 49-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic pain and depression, since unknown date. The patient did not have any allergies to food, medications, or other products. 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. Concomitant medications included antidepressants (MANUFACTURER UNKNOWN), muscle relaxers (MANUFACTURER UNKNOWN) and pain medications (MANUFACTURER UNKNOWN), all on unknown date for unknown indication and unknown if ongoing. On 01Jun2021 at 19:00, the patient had a terrible headache came on suddenly that was severe pressure or vise like squeezing in the whole back half of head, this came on suddenly during sexual activities and had never happened to before and the headache had lasted over a week and the same exact pain comes and goes throughout the day app day every day. The patient did not receive any treatment for the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event terrible headache came on suddenly that was severe pressure or vise like squeezing in the whole back half of head was not recovered at the time of this report. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 02Jun2021 at 16:00 (at the age of 49-year-old), as a single dose for COVID-19 immunisation  The lot number for the vaccine BNT162b2 was not provided and will be requested during follow up.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19