chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic attack, Paraesthesia, Rash erythematous, Sensory disturbance, Sleep disorder
Clinical narrative: constant muscle twitches in both thighs which progressed to all over body twitches; tightening of the chest; tightening of the throat; rapid heartbeat; lightheaded/ dizzy; burning sensations; a red rash on my left arm; I felt like I  was in a "fog"/ a sensation of my nerves being "amped"; problems sleeping; a constant sensation of my body vibrating internally; panic attacks; pins and needles sensations in both feet which then started affecting my hands.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: FC3182, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 27Aug2021 at 10:00 (at the age of 46 years old) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included asthma, depression and headaches - all from an unknown date. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included spironolactone (SPIRONOLACTONE) and multivitamin - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. On 27Aug2021 at 10:30, reported as within 20 minutes of the injection, the patient experienced tightening of the chest and throat, rapid heartbeat and felt lightheaded. Three days later, on 30Aug2021, the patient started experiencing constant muscle twitches in both thighs which progressed to all over body twitches. On an unspecified date in 2021, the patient developed pins and needles sensations in both feet which then started affecting the patient's hands. Furthermore, the patient started experiencing burning sensations as well as rapid heartbeat and panic attacks which resulted in multiple ER and doctor visits, also on an unspecified date in 2021. The patient developed a red rash on her left arm on an unspecified date in 2021 that lasted a few days. The patient felt like she was in a "fog" and dizzy on an unspecified date in 2021. The patient reported that it had been 5 weeks and she was still having a sensation of her nerves being "amped" (as reported), twitches in arms legs and body, problems sleeping and a constant sensation of my body vibrating internally, which started in an unspecified date in 2021. Since vaccination, the patient has not been tested for COVID-19. Events resulted doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and sisability or permanent damage (as reported). Multiple medication was given as treatment to the events. The patient underwent lab tests and procedures which included EKG (electrocardiogram), blood tests, X-ray, and EMG (electromyogram) - all on an unspecified date in 2021 with an unknown results. Outcome of all events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, X-ray
Clinical narrative: constant muscle twitches in both thighs which progressed to all over body twitches; tightening of the chest; tightening of the throat; rapid heartbeat; lightheaded/ dizzy; burning sensations; a red rash on my left arm; I felt like I  was in a "fog"/ a sensation of my nerves being "amped"; problems sleeping; a constant sensation of my body vibrating internally; panic attacks; pins and needles sensations in both feet which then started affecting my hands.; This is a spontaneous report from a contactable consumer (patient). A 46-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: FC3182, Expiration Date: not reported) via an unspecified route of administration, administered in left arm on 27Aug2021 at 10:00 (at the age of 46 years old) as dose 1, single for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included asthma, depression and headaches - all from an unknown date. The patient has no known allergies and prior to vaccination was not diagnosed with COVID-19. Concomitant medications included spironolactone (SPIRONOLACTONE) and multivitamin - all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines in 4 weeks. On 27Aug2021 at 10:30, reported as within 20 minutes of the injection, the patient experienced tightening of the chest and throat, rapid heartbeat and felt lightheaded. Three days later, on 30Aug2021, the patient started experiencing constant muscle twitches in both thighs which progressed to all over body twitches. On an unspecified date in 2021, the patient developed pins and needles sensations in both feet which then started affecting the patient's hands. Furthermore, the patient started experiencing burning sensations as well as rapid heartbeat and panic attacks which resulted in multiple ER and doctor visits, also on an unspecified date in 2021. The patient developed a red rash on her left arm on an unspecified date in 2021 that lasted a few days. The patient felt like she was in a "fog" and dizzy on an unspecified date in 2021. The patient reported that it had been 5 weeks and she was still having a sensation of her nerves being "amped" (as reported), twitches in arms legs and body, problems sleeping and a constant sensation of my body vibrating internally, which started in an unspecified date in 2021. Since vaccination, the patient has not been tested for COVID-19. Events resulted doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care and sisability or permanent damage (as reported). Multiple medication was given as treatment to the events. The patient underwent lab tests and procedures which included EKG (electrocardiogram), blood tests, X-ray, and EMG (electromyogram) - all on an unspecified date in 2021 with an unknown results. Outcome of all events was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Retinogram, Vitreous detachment, Vitreous floaters
Clinical narrative: where my eye site was blacked out in half my eye.; a vitreous detachment; vitreous detachment / retina detachment; seeing floating spots and floaters in my left eye; This is a spontaneous report from a contactable HCP (patient). A 52-year-old male patient received the first dose of BNT162B2 (COVID-19 Pfizer) via intramuscular on right arm on 27Aug2021 at 17:45 (Lot Number: FC3181) at the age of 52-year-old as single dose for COVID-19 immunization. Medical history was not reported. The patient didn't received other vaccine in four week. COVID prior vaccination was none. COVID tested post vaccination was none. Concomitant medication included finasteride and acetylsalicylic acid (EQUATE DAILY). The patient previously received Cipro and experienced allergy. Within 18 hrs of first vaccination at 11:45 AM on 28Aug2021, the patient started seeing floating spots and floaters in lefteye. Went to eye doc on 30Aug2021 and said had a vitreous detachment and come back if symptoms worsen. On 12Sep2021 symptoms worsened where eye site was blacked out in half eye. Went back to eye doc on 13Sep2021 and confirmed retina detachment. Had emergency surgery on 14Sep2021 to re-attach retina. Never had trauma to the left eye or issue like this previously. Issue occurred after receiving first Pfizer vaccination. The patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 17Sep2021 at 09:45 AM as single dose for COVID-19 immunization. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received included retina re-attachment surgery. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events Retinal detachment, Chorioretinitis, Hemianopia, Vitreous detachment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chorioretinitis, Hemianopia, Retinal detachment, Vitreous detachment
Clinical narrative: where my eye site was blacked out in half my eye.; a vitreous detachment; vitreous detachment / retina detachment; seeing floating spots and floaters in my left eye; This is a spontaneous report from a contactable HCP (patient). A 52-year-old male patient received the first dose of BNT162B2 (COVID-19 Pfizer) via intramuscular on right arm on 27Aug2021 at 17:45 (Lot Number: FC3181) at the age of 52-year-old as single dose for COVID-19 immunization. Medical history was not reported. The patient didn't received other vaccine in four week. COVID prior vaccination was none. COVID tested post vaccination was none. Concomitant medication included finasteride and acetylsalicylic acid (EQUATE DAILY). The patient previously received Cipro and experienced allergy. Within 18 hrs of first vaccination at 11:45 AM on 28Aug2021, the patient started seeing floating spots and floaters in lefteye. Went to eye doc on 30Aug2021 and said had a vitreous detachment and come back if symptoms worsen. On 12Sep2021 symptoms worsened where eye site was blacked out in half eye. Went back to eye doc on 13Sep2021 and confirmed retina detachment. Had emergency surgery on 14Sep2021 to re-attach retina. Never had trauma to the left eye or issue like this previously. Issue occurred after receiving first Pfizer vaccination. The patient received the second dose of BNT162B2 via an unspecified route of administration on the right arm on 17Sep2021 at 09:45 AM as single dose for COVID-19 immunization. The events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment was received included retina re-attachment surgery. The outcome of events was not recovered.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 vaccine can not be excluded for the reported events Retinal detachment, Chorioretinitis, Hemianopia, Vitreous detachment. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified), high blood pressure and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), cyanocobalamin (B 12), calcium (MANUFACTURER UNKNOWN) and Multi Vitamin (MANUFACTURER UNKNOWN); all for an unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 09Feb2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021, the patient experienced ringing in ears, that started the day after the second vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, 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 ringing in ears was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in ears; This is a spontaneous report from a contactable consumer, the patient. A 67-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6199) via an unspecified route of administration in the right arm on 12Mar2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy (unspecified), high blood pressure and allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included valsartan (MANUFACTURER UNKNOWN), cyanocobalamin (B 12), calcium (MANUFACTURER UNKNOWN) and Multi Vitamin (MANUFACTURER UNKNOWN); all for an unknown indications from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 09Feb2021 (at the age of 67-years-old) as a single dose for COVID-19 immunisation. On 13Mar2021, the patient experienced ringing in ears, that started the day after the second vaccination. The event did not result in doctor or other healthcare professional office/clinic visit, 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 ringing in ears was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA4
Symptoms: Swollen tongue
Clinical narrative: Swollen tongue; This spontaneous case was retrieved on 04-Oct-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1674964-1), reported by other health professional and concerned a 65-year-old, male patient.  The patient's medical history and concomitant medications were not reported.  On 04-Sep-2021, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, mf59; dose: reported as one, route of administration: intramuscular, anatomical location: left arm and indication: not reported). The batch number reported was 312832.  On 05-Sep-2021, one day after receiving Flaud Quadrivalent, the patient developed swollen tongue upon waking up from a nap.   The outcome of the event was unknown.  The reporter did not provide a causality assessment.   The event was considered to be medically significant by Physician within Seqirus' Pharmacovigilance and Risk Management Department.  Company comment: A 65-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Flaud Quadrivalent, the patient developed swollen tongue. Causality is assessed as possibly related, considering plausible chronology and no alternative aetiology provided.; Sender's Comments: A 65-year-old patient was vaccinated with Fluad Quadrivalent. One day after receiving Flaud Quadrivalent, the patient developed swollen tongue. Causality is assessed as possibly related, considering plausible chronology and no alternative aetiology provided.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying
Clinical narrative: Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Having these like crying spells out of nowhere; Mood swings; Emotional wreck; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2588; Expiration date was not reported), intramuscular on the left deltoid on 04Sep2021 (13:00) as dose 1, single, for COVID-19 immunization at the pharmacy/drug store. Medical history included ongoing anxiety from 16Dec2014; ongoing depression from 16Dec2014; post-partum depression; and a family history of heavy flow and clotting at time of menses and swollen cervix (patient's sister). There were no concomitant medications. On 05Sep2021 (09:00), the patient was having these like crying spells out of nowhere, and mood swings. On 05Sep2021, the patient had an emotional wreck. On 11Sep2021, the patient's menstrual cycle was a week early with unusually heavy flow, and clotting and pain. The events were reported to be serious (important medical event), and had led to an emergency room visit. The patient did not receive any treatment for 'having these like crying spells out of nowhere' and emotional wreck. The outcome of the events was not recovered for mood swings; and was unknown for all the other events. The patient believed that there was a correlation between the COVID-19 vaccine and the reported female hormonal changes.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Crying, Dysmenorrhoea, Emotional disorder, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Having these like crying spells out of nowhere; Mood swings; Emotional wreck; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2588; Expiration date was not reported), intramuscular on the left deltoid on 04Sep2021 (13:00) as dose 1, single, for COVID-19 immunization at the pharmacy/drug store. Medical history included ongoing anxiety from 16Dec2014; ongoing depression from 16Dec2014; post-partum depression; and a family history of heavy flow and clotting at time of menses and swollen cervix (patient's sister). There were no concomitant medications. On 05Sep2021 (09:00), the patient was having these like crying spells out of nowhere, and mood swings. On 05Sep2021, the patient had an emotional wreck. On 11Sep2021, the patient's menstrual cycle was a week early with unusually heavy flow, and clotting and pain. The events were reported to be serious (important medical event), and had led to an emergency room visit. The patient did not receive any treatment for 'having these like crying spells out of nowhere' and emotional wreck. The outcome of the events was not recovered for mood swings; and was unknown for all the other events. The patient believed that there was a correlation between the COVID-19 vaccine and the reported female hormonal changes.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Mood swings, Thrombosis
Clinical narrative: Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Menstrual cycle was a week early with unusually heavy flow and clotting and pain; Having these like crying spells out of nowhere; Mood swings; Emotional wreck; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: FF2588; Expiration date was not reported), intramuscular on the left deltoid on 04Sep2021 (13:00) as dose 1, single, for COVID-19 immunization at the pharmacy/drug store. Medical history included ongoing anxiety from 16Dec2014; ongoing depression from 16Dec2014; post-partum depression; and a family history of heavy flow and clotting at time of menses and swollen cervix (patient's sister). There were no concomitant medications. On 05Sep2021 (09:00), the patient was having these like crying spells out of nowhere, and mood swings. On 05Sep2021, the patient had an emotional wreck. On 11Sep2021, the patient's menstrual cycle was a week early with unusually heavy flow, and clotting and pain. The events were reported to be serious (important medical event), and had led to an emergency room visit. The patient did not receive any treatment for 'having these like crying spells out of nowhere' and emotional wreck. The outcome of the events was not recovered for mood swings; and was unknown for all the other events. The patient believed that there was a correlation between the COVID-19 vaccine and the reported female hormonal changes.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: cancer on her leg; petechiae eye and it progressed; This is a spontaneous report from a contactable consumer (patient).  An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was an 85-year-old female but she was 84-years-old when she had her event. She had her first dose of BNT162B2 in Feb2021. She developed petechiae eye in Feb2021 and it progressed. She also had cancer on her leg in Feb2021 that started after she got her first dose. Her vaccinator provider told her to call Pfizer for a blue card exempting her from getting the second dose. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye haemorrhage, Neoplasm malignant
Clinical narrative: cancer on her leg; petechiae eye and it progressed; This is a spontaneous report from a contactable consumer (patient).  An 84-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration in Feb2021 at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient was an 85-year-old female but she was 84-years-old when she had her event. She had her first dose of BNT162B2 in Feb2021. She developed petechiae eye in Feb2021 and it progressed. She also had cancer on her leg in Feb2021 that started after she got her first dose. Her vaccinator provider told her to call Pfizer for a blue card exempting her from getting the second dose. Outcome of events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 3rd dose (booster); 3rd dose (booster); This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3184 and expiration date was not reported) via an unspecified route of administration at left arm on 30Aug2021 12:15 pm (age at vaccination 62-year-old) as dose 3 (booster), single for covid-19 immunization. The patient medical history included Sicca Syndrome and DLBCL - remission from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The other medications in two weeks included nortriptyline, nadolol, omeprazole, vitamin C (ascorbic acid), vitamin D (vitamin D NOS) taken for an unspecified indication, start and stop date were not reported. The patient received historical vaccine included dose 1 and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported) via an unspecified route on an unknown date of 2021 single for covid-19 immunization. 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 experienced 2 weeks after receiving vaccine developed shingles from nose to lips and swollen area in jaw on 13Sep2021 07:00 am. Therapeutic measures included valacyclovir for 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw. The outcome of the events 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Burning sensation, Dizziness, Headache, Inflammation, SARS-CoV-2 antibody test
Clinical narrative: 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 3rd dose (booster); 3rd dose (booster); This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3184 and expiration date was not reported) via an unspecified route of administration at left arm on 30Aug2021 12:15 pm (age at vaccination 62-year-old) as dose 3 (booster), single for covid-19 immunization. The patient medical history included Sicca Syndrome and DLBCL - remission from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The other medications in two weeks included nortriptyline, nadolol, omeprazole, vitamin C (ascorbic acid), vitamin D (vitamin D NOS) taken for an unspecified indication, start and stop date were not reported. The patient received historical vaccine included dose 1 and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported) via an unspecified route on an unknown date of 2021 single for covid-19 immunization. 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 experienced 2 weeks after receiving vaccine developed shingles from nose to lips and swollen area in jaw on 13Sep2021 07:00 am. Therapeutic measures included valacyclovir for 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw. The outcome of the events 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Herpes zoster, Immunisation, Off label use, Swelling face
Clinical narrative: 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw.; 3rd dose (booster); 3rd dose (booster); This is a spontaneous report from a contactable consumer (patient). A 62-year-old non-pregnant female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: FC3184 and expiration date was not reported) via an unspecified route of administration at left arm on 30Aug2021 12:15 pm (age at vaccination 62-year-old) as dose 3 (booster), single for covid-19 immunization. The patient medical history included Sicca Syndrome and DLBCL - remission from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The other medications in two weeks included nortriptyline, nadolol, omeprazole, vitamin C (ascorbic acid), vitamin D (vitamin D NOS) taken for an unspecified indication, start and stop date were not reported. The patient received historical vaccine included dose 1 and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported) via an unspecified route on an unknown date of 2021 single for covid-19 immunization. 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 experienced 2 weeks after receiving vaccine developed shingles from nose to lips and swollen area in jaw on 13Sep2021 07:00 am. Therapeutic measures included valacyclovir for 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw. The outcome of the events 2 weeks after receiving developed shingles from nose to lips and swollen area in jaw was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypotonia
Clinical narrative: Really bad dizzy spells; yesterday I start with more dizziness; Have been sleeping for a couple of days; It was like a floppy arm like I could not get to do anything; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: EN6200 and expiry date was not reported), via an unspecified route of administration on 17Feb2021 (age at vaccination 66-year-old), as dose 2, single for COVID-19 immunization. The patient medical history and concurrent conditions included Asthma. Concomitant medications included Fluticasone propionate (FLOVENT). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and expiry date were not reported) on an unspecified date (age at vaccination 66-year-old), as dose 1, single for COVID-19 immunization. The patient stated she had her second dose of the vaccine on Wednesday the 17Feb2021 and overall, she did really well. That night she had some really bad dizzy spells and then she went to sleep, and she had been sleeping for a couple of days. Yesterday she started with more dizziness and then when she was doing dishes that day then she had where her arm went like it was like a floppy arm like she could not get to do anything it only lasted may be a minute and then it went away. And so then she was trying to determine is this kind of a normal thing that you guys had or is it something she need to go and be seen for." The patient did not receive treatment for events. Outcome of the event It was like a floppy arm like I could not get to do anything was recovered on an unspecified date in 2021 and outcome of Really bad dizzy spells; yesterday I start with more dizziness and have been sleeping for a couple of days was unknown.  Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Muscular weakness, Somnolence
Clinical narrative: Really bad dizzy spells; yesterday I start with more dizziness; Have been sleeping for a couple of days; It was like a floppy arm like I could not get to do anything; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, batch/lot number: EN6200 and expiry date was not reported), via an unspecified route of administration on 17Feb2021 (age at vaccination 66-year-old), as dose 2, single for COVID-19 immunization. The patient medical history and concurrent conditions included Asthma. Concomitant medications included Fluticasone propionate (FLOVENT). Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and expiry date were not reported) on an unspecified date (age at vaccination 66-year-old), as dose 1, single for COVID-19 immunization. The patient stated she had her second dose of the vaccine on Wednesday the 17Feb2021 and overall, she did really well. That night she had some really bad dizzy spells and then she went to sleep, and she had been sleeping for a couple of days. Yesterday she started with more dizziness and then when she was doing dishes that day then she had where her arm went like it was like a floppy arm like she could not get to do anything it only lasted may be a minute and then it went away. And so then she was trying to determine is this kind of a normal thing that you guys had or is it something she need to go and be seen for." The patient did not receive treatment for events. Outcome of the event It was like a floppy arm like I could not get to do anything was recovered on an unspecified date in 2021 and outcome of Really bad dizzy spells; yesterday I start with more dizziness and have been sleeping for a couple of days was unknown.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Cough, Decreased appetite, Headache
Clinical narrative: Migraine lasting at least 2 days; Ocular migraine; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 02Mar2021 at 16:00, the patient experienced migraine which lasted at least 2 days, ocular migraine and nausea. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events migraine lasted at least 2 days, ocular migraine and nausea was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza like illness, Migraine, Myalgia, Nausea, Ophthalmic migraine
Clinical narrative: Migraine lasting at least 2 days; Ocular migraine; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 02Mar2021 at 16:00, the patient experienced migraine which lasted at least 2 days, ocular migraine and nausea. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events migraine lasted at least 2 days, ocular migraine and nausea was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Migraine lasting at least 2 days; Ocular migraine; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 02Mar2021 at 16:00, the patient experienced migraine which lasted at least 2 days, ocular migraine and nausea. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events migraine lasted at least 2 days, ocular migraine and nausea was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Migraine, Nausea, Ophthalmic migraine
Clinical narrative: Migraine lasting at least 2 days; Ocular migraine; Nausea; This is a spontaneous report from a non-contactable consumer, the patient. A 52-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 02Mar2021 at 11:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not take any concomitant medications. On 02Mar2021 at 16:00, the patient experienced migraine which lasted at least 2 days, ocular migraine and nausea. The events did not result in doctor or other healthcare professional office/clinic, and emergency room/department or urgent care. therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of events migraine lasted at least 2 days, ocular migraine and nausea was resolving at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Back pain, Herpes zoster, Hypoaesthesia, Muscle spasms, Pain
Clinical narrative: I know of a few others who have experinced shingles or female issues directly after the pfizer vaccine.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0150, Expiry date: not reported) via intramuscularly, administered in left arm 03Apr2021 11:00 (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. Second dose BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0181, Expiry date: not reported) via intramuscularly, administered in left arm 09Jul2021 13:00(at the age of 61-year-old) as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder from 1995 and ongoing. The patient's concomitant medications were not reported. Historical vaccine included: The patient had received the first shingles vaccine in 2018 (Shingrix) and did not get the 2nd shot. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine (s) was none. On 08Apr2021 (5 days after the vaccine), the patient experienced shingles (Persistent/Significant disability/ Incapacity). AE resulted in emergency room visit. It has been over 3 weeks and I still have pain, numbness, rash is pretty much gone. patient was still taking pain medication. The pain has changed over the 3 weeks and this past week it was centralized to my lower back and lover pelvic area, as in it felt like my ovaries or other parts down there were cramping and being stomped on. (no, I no longer have a monthly cycle). I know of a few others who have experienced shingles or female issues directly after the Pfizer vaccine. Just reporting this to you as it has been 23 days of living hell and I would have held off of the vaccine if I had known this was a possible side effect until more long term information had been gathered. I am in the minority I am sure, but I know in my case this was directly related to the vaccine. Please be aware this is a thing. The patient received Zovirax: 800mg and Hydrocodone: 5-325 mg treatment for the event. Outcome of the event was recovered with sequelae in Jul2021.  Follow up attempts completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pelvic pain, Rash
Clinical narrative: I know of a few others who have experinced shingles or female issues directly after the pfizer vaccine.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0150, Expiry date: not reported) via intramuscularly, administered in left arm 03Apr2021 11:00 (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. Second dose BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0181, Expiry date: not reported) via intramuscularly, administered in left arm 09Jul2021 13:00(at the age of 61-year-old) as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder from 1995 and ongoing. The patient's concomitant medications were not reported. Historical vaccine included: The patient had received the first shingles vaccine in 2018 (Shingrix) and did not get the 2nd shot. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine (s) was none. On 08Apr2021 (5 days after the vaccine), the patient experienced shingles (Persistent/Significant disability/ Incapacity). AE resulted in emergency room visit. It has been over 3 weeks and I still have pain, numbness, rash is pretty much gone. patient was still taking pain medication. The pain has changed over the 3 weeks and this past week it was centralized to my lower back and lover pelvic area, as in it felt like my ovaries or other parts down there were cramping and being stomped on. (no, I no longer have a monthly cycle). I know of a few others who have experienced shingles or female issues directly after the Pfizer vaccine. Just reporting this to you as it has been 23 days of living hell and I would have held off of the vaccine if I had known this was a possible side effect until more long term information had been gathered. I am in the minority I am sure, but I know in my case this was directly related to the vaccine. Please be aware this is a thing. The patient received Zovirax: 800mg and Hydrocodone: 5-325 mg treatment for the event. Outcome of the event was recovered with sequelae in Jul2021.  Follow up attempts completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: I know of a few others who have experinced shingles or female issues directly after the pfizer vaccine.; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0150, Expiry date: not reported) via intramuscularly, administered in left arm 03Apr2021 11:00 (at the age of 61-year-old) as dose 1, single for COVID-19 immunization. Second dose BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EW0181, Expiry date: not reported) via intramuscularly, administered in left arm 09Jul2021 13:00(at the age of 61-year-old) as dose 2, single for COVID-19 immunization. Medical history included thyroid disorder from 1995 and ongoing. The patient's concomitant medications were not reported. Historical vaccine included: The patient had received the first shingles vaccine in 2018 (Shingrix) and did not get the 2nd shot. List any other vaccinations within four weeks prior to the first administration date of the suspect vaccine (s) was none. On 08Apr2021 (5 days after the vaccine), the patient experienced shingles (Persistent/Significant disability/ Incapacity). AE resulted in emergency room visit. It has been over 3 weeks and I still have pain, numbness, rash is pretty much gone. patient was still taking pain medication. The pain has changed over the 3 weeks and this past week it was centralized to my lower back and lover pelvic area, as in it felt like my ovaries or other parts down there were cramping and being stomped on. (no, I no longer have a monthly cycle). I know of a few others who have experienced shingles or female issues directly after the Pfizer vaccine. Just reporting this to you as it has been 23 days of living hell and I would have held off of the vaccine if I had known this was a possible side effect until more long term information had been gathered. I am in the minority I am sure, but I know in my case this was directly related to the vaccine. Please be aware this is a thing. The patient received Zovirax: 800mg and Hydrocodone: 5-325 mg treatment for the event. Outcome of the event was recovered with sequelae in Jul2021.  Follow up attempts completed. No further information is expected.