chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: pretty severe rash had broken out on both of lower legs. Not itchy but stings a bit; headache; joint pain the next day; booster dose; For the booster shot, I had chills that night; A few days later I had a few episodes of vertigo; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration, administered in arm right on 09Oct2021 11:15 (Batch/Lot Number: 301358A) as single dose for covid-19 immunisation (age at vaccination was 56-year-old). Medical history included allergies: scallops. There were no concomitant medications. Patient was not pregnant. The patient previously took erythromycin and experienced drug allergy. Historical vaccine included 1st dose BNT162B2 (Batch/Lot No: SW6208) on 19Mar2021 at 11:00 am in arm left and 2nd dose BNT162B2 (Batch/Lot No: EN6208) on 09Apr2021 at 11:00 am in arm left, both for COVID-19 immunization and experienced pain at site for a couple of days. For the booster shot, patient had chills that night (09Oct2021), headache, joint pain the next day (10Oct2021). A few days later (Oct2021) patient had a few episodes of vertigo. Patient had never experienced this before. No further episodes since. Then, 2 weeks later (25Oct2021), a pretty severe rash had broken out on both of lower legs. Not itchy but stings a bit. Patient took two diphenhydramine hydrochloride (BENADRYL) and nothing. Last night (26Oct2021) patient took two more diphenhydramine hydrochloride and it seemed to be getting better. Patient received treatment for severe rash had broken out on both of lower legs, not itchy but stings a bit. No treatment was received for other events. Outcome of vertigo was resolved. Outcome of other events was resolving.   Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Herpes zoster, Neuropathy peripheral, Pruritus
Clinical narrative: several neuropathy attacks in my feet; Turns out it was the shingles; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: FC3184) via an unspecified route of administration, administered in Arm Left on 11Sep2021 11:30, at the age of 39-year-old, as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included breast cancer in remission (3 years since no evidence of disease). The patient had no known allergies. The patient had no concomitant medications.  The patient did not receive other vaccine in four weeks and no other medications in two weeks. The patent has not been diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. On 18Sep2021, on day 7, the patient started to itch on her chest -along the collarbone as a red spot appeared and became worse. Then another spot and another spot. It was a rash in a circular pattern. On 21Sep2021, by day 10, the patient experienced pain and the spot was raised with blisters. It turned out it was the shingles. In addition, the patient experienced several neuropathy attacks in her feet on the same day of 21Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Neuropathy peripheral
Clinical narrative: several neuropathy attacks in my feet; Turns out it was the shingles; This is a spontaneous report from a contactable consumer (patient).  A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: FC3184) via an unspecified route of administration, administered in Arm Left on 11Sep2021 11:30, at the age of 39-year-old, as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included breast cancer in remission (3 years since no evidence of disease). The patient had no known allergies. The patient had no concomitant medications.  The patient did not receive other vaccine in four weeks and no other medications in two weeks. The patent has not been diagnosed with COVID prior vaccination and was not tested for COVID post vaccination. On 18Sep2021, on day 7, the patient started to itch on her chest -along the collarbone as a red spot appeared and became worse. Then another spot and another spot. It was a rash in a circular pattern. On 21Sep2021, by day 10, the patient experienced pain and the spot was raised with blisters. It turned out it was the shingles. In addition, the patient experienced several neuropathy attacks in her feet on the same day of 21Sep2021. The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment in response to the events. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19
Symptoms: Extra dose administered, Fatigue, Headache, Mobility decreased, Pain
Clinical narrative: left arm soreness; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; This is a spontaneous report from a contactable other hcp and Pharmacists.   A 68-years-old female patient received bnt162b2 (COMIRNATY), dose 4 intramuscular, administered in Deltoid Left on 25Oct2021 18:45 (at age of 68 years old) (Lot Number: FF2593; Expiration Date: Dec2021, NDC 59267-1000-01) as DOSE 4, 0.3ML SINGLE for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), intramuscular from 25Oct2021 (Lot Number: 312853; Expiration Date: 17Jun2022, NDC 70461-0121-03) to 25Oct2021, at unspecified dose via intramuscular at left deltoid for an unspecified indication.  The patient medical history was none.   The patient received a booster dose around 01Oct2021 so this would be a fourth dose for the patient. Pfizer BioNTech Covid Vaccine 1st dose and 2nd dose was given sometime in Mar2021.There were no concomitant medications.  The patient experienced a flu shot but accidentally administered a pfizer covid 19 vaccine in error because she had both a flu vaccine and a covid vaccine ready to be administered on 25Oct2021 18:45 with outcome of recovered on 25Oct2021, left arm soreness on 25Oct2021 19:00 with outcome of not recovered.  Clinical course as reported: The pharmacy technician was supposed to give the patient a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered.  However, she did not have the exact dates to provide. Patient got the third dose on 01Oct 2021. No Emergency Room and Physician Office involved. Verbatim event relatedness: Pfizer Covid vaccine: left arm soreness- Related.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: left arm soreness; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; This is a spontaneous report from a contactable other hcp and Pharmacists.   A 68-years-old female patient received bnt162b2 (COMIRNATY), dose 4 intramuscular, administered in Deltoid Left on 25Oct2021 18:45 (at age of 68 years old) (Lot Number: FF2593; Expiration Date: Dec2021, NDC 59267-1000-01) as DOSE 4, 0.3ML SINGLE for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), intramuscular from 25Oct2021 (Lot Number: 312853; Expiration Date: 17Jun2022, NDC 70461-0121-03) to 25Oct2021, at unspecified dose via intramuscular at left deltoid for an unspecified indication.  The patient medical history was none.   The patient received a booster dose around 01Oct2021 so this would be a fourth dose for the patient. Pfizer BioNTech Covid Vaccine 1st dose and 2nd dose was given sometime in Mar2021.There were no concomitant medications.  The patient experienced a flu shot but accidentally administered a pfizer covid 19 vaccine in error because she had both a flu vaccine and a covid vaccine ready to be administered on 25Oct2021 18:45 with outcome of recovered on 25Oct2021, left arm soreness on 25Oct2021 19:00 with outcome of not recovered.  Clinical course as reported: The pharmacy technician was supposed to give the patient a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered.  However, she did not have the exact dates to provide. Patient got the third dose on 01Oct 2021. No Emergency Room and Physician Office involved. Verbatim event relatedness: Pfizer Covid vaccine: left arm soreness- Related.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 68.0
Sex: F
Vaccine: COVID19, FLUA4, COVID19
Symptoms: Extra dose administered, Pain in extremity, Product use issue, Wrong product administered
Clinical narrative: left arm soreness; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered; This is a spontaneous report from a contactable other hcp and Pharmacists.   A 68-years-old female patient received bnt162b2 (COMIRNATY), dose 4 intramuscular, administered in Deltoid Left on 25Oct2021 18:45 (at age of 68 years old) (Lot Number: FF2593; Expiration Date: Dec2021, NDC 59267-1000-01) as DOSE 4, 0.3ML SINGLE for covid-19 immunisation; influenza vaccine inact sag 3v (FLUAD), intramuscular from 25Oct2021 (Lot Number: 312853; Expiration Date: 17Jun2022, NDC 70461-0121-03) to 25Oct2021, at unspecified dose via intramuscular at left deltoid for an unspecified indication.  The patient medical history was none.   The patient received a booster dose around 01Oct2021 so this would be a fourth dose for the patient. Pfizer BioNTech Covid Vaccine 1st dose and 2nd dose was given sometime in Mar2021.There were no concomitant medications.  The patient experienced a flu shot but accidentally administered a pfizer covid 19 vaccine in error because she had both a flu vaccine and a covid vaccine ready to be administered on 25Oct2021 18:45 with outcome of recovered on 25Oct2021, left arm soreness on 25Oct2021 19:00 with outcome of not recovered.  Clinical course as reported: The pharmacy technician was supposed to give the patient a flu shot but accidentally administered a Pfizer Covid 19 vaccine in error because she had both a flu vaccine and a Covid vaccine ready to be administered.  However, she did not have the exact dates to provide. Patient got the third dose on 01Oct 2021. No Emergency Room and Physician Office involved. Verbatim event relatedness: Pfizer Covid vaccine: left arm soreness- Related.; Sender's Comments: Based on the information provided in the narrative, a causal association between the suspect drug and the events cannot be completely excluded.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: instead of giving me 30 micrograms they have given me 150 microgram (OVERDOSE) in error; instead of giving me 30 micrograms they have given me 150 microgram (OVERDOSE) in error; I am really nervous; I had some swelling from the injection; This is a spontaneous report from a contactable consumer(patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FG3527) via an unspecified route of administration in Deltoid Left on 27Oct2021 10:50 (age at vaccination 66-years-old) as DOSE 3 (BOOSTER), 150 ug SINGLE for covid-19 immunisation. Patient received influenza shot (Further not clarified hence captured as unspecified shot) with booster Pfizer dose. Medical history includes Diabetes, Blood pressure, Triglycerides high and anxiety from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN), losartan (LOSARTAN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE), simvastatin (SIMVASTATIN), colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, escitalopram oxalate (LEXAPRO) taken for anxiety start and stop date were not reported. Previously received vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration (age at vaccination: 65-year-old) on 05Mar2021 as dose 1, single and 02Apr2021 as dose 2, single for covid-19 immunization. On 27Oct2021 10:50 patient was injected 0.3 ml of COVID vaccine from Pfizer as booster shot/ instead of giving me 30 micrograms, they have given me 150 (overdose) micrograms in error. It seem original vial and not been diluted with 1.8 ml of saline. On 27Oct2021 at 20:00 pharmacist called and informed patient that she received more doses of vaccine than originally intended. Patient also want to know what I should expect from this high dose you know, I am very nervous. Patient stated, I am just taking Tylenol to keep swelling. I had some swelling from the injection, 'vaccination' site injection and I am taking Tylenol but nothing else. The clinical outcome of the events was unknown.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nervousness, Overdose, Product preparation error, Vaccination site swelling
Clinical narrative: instead of giving me 30 micrograms they have given me 150 microgram (OVERDOSE) in error; instead of giving me 30 micrograms they have given me 150 microgram (OVERDOSE) in error; I am really nervous; I had some swelling from the injection; This is a spontaneous report from a contactable consumer(patient). A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: FG3527) via an unspecified route of administration in Deltoid Left on 27Oct2021 10:50 (age at vaccination 66-years-old) as DOSE 3 (BOOSTER), 150 ug SINGLE for covid-19 immunisation. Patient received influenza shot (Further not clarified hence captured as unspecified shot) with booster Pfizer dose. Medical history includes Diabetes, Blood pressure, Triglycerides high and anxiety from an unknown date and unknown if ongoing. Concomitant medication included metformin (METFORMIN), losartan (LOSARTAN); hydrochlorothiazide (HYDROCHLOROTHIAZIDE), simvastatin (SIMVASTATIN), colecalciferol (VITAMIN D [COLECALCIFEROL]) taken for an unspecified indication, escitalopram oxalate (LEXAPRO) taken for anxiety start and stop date were not reported. Previously received vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration (age at vaccination: 65-year-old) on 05Mar2021 as dose 1, single and 02Apr2021 as dose 2, single for covid-19 immunization. On 27Oct2021 10:50 patient was injected 0.3 ml of COVID vaccine from Pfizer as booster shot/ instead of giving me 30 micrograms, they have given me 150 (overdose) micrograms in error. It seem original vial and not been diluted with 1.8 ml of saline. On 27Oct2021 at 20:00 pharmacist called and informed patient that she received more doses of vaccine than originally intended. Patient also want to know what I should expect from this high dose you know, I am very nervous. Patient stated, I am just taking Tylenol to keep swelling. I had some swelling from the injection, 'vaccination' site injection and I am taking Tylenol but nothing else. The clinical outcome of the events was unknown.  Follow-Up (01Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy, Human chorionic gonadotropin abnormal, Pregnancy test positive, Vaginal haemorrhage
Clinical narrative: Positive home pregnancy test 26th OCT; Positive home pregnancy test 26th OCT but vaginal bleeding later that AM with BM; increase in bleeding and cramping; Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping; breast soreness; nausea; leukorrhea; food cravings; This is a spontaneous report from a contactable nurse (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Oct2021 08:00 (Lot Number: FF2589) at age of 31 years old as DOSE 1, SINGLE for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration in arm left on 04Oct2021 at DOSE 1, SINGLE for an unspecified indication.  The patient was pregnant at vaccination. Patient last menstrual period date was 27Sep2021. Pregnancy Due Date was 06Jul2022. Medical history included Factor V Leiden Heterozygous, miscarriage in early Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included vitamin d; paracetamol (TYLENOL) and lidod (unspecified). On 26Oct2021 9:00, the patient experienced normal period September 27th and then timed conception efforts with ovulation dates. Forced by workplace to get 1st shot on 12Oct2021. Positive home pregnancy test 26Oct2021 but vaginal bleeding later that AM with BM. Home pregnancy test taken as experiencing nausea, leukorrhea, food cravings, and breast soreness all consistent with past pregnancies. Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received. Since the vaccination, the patient has been tested for COVID-19. Lab test included Blood testing on unspecified date, Nasal Swab on 03Nov2021 and the result is pending. The outcome was recovering. This case was reports as serious - Life threatening and Congenital anomaly/birth defect.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Breast pain, Human chorionic gonadotropin decreased, Increased appetite, Maternal exposure during pregnancy
Clinical narrative: Positive home pregnancy test 26th OCT; Positive home pregnancy test 26th OCT but vaginal bleeding later that AM with BM; increase in bleeding and cramping; Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping; breast soreness; nausea; leukorrhea; food cravings; This is a spontaneous report from a contactable nurse (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Oct2021 08:00 (Lot Number: FF2589) at age of 31 years old as DOSE 1, SINGLE for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration in arm left on 04Oct2021 at DOSE 1, SINGLE for an unspecified indication.  The patient was pregnant at vaccination. Patient last menstrual period date was 27Sep2021. Pregnancy Due Date was 06Jul2022. Medical history included Factor V Leiden Heterozygous, miscarriage in early Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included vitamin d; paracetamol (TYLENOL) and lidod (unspecified). On 26Oct2021 9:00, the patient experienced normal period September 27th and then timed conception efforts with ovulation dates. Forced by workplace to get 1st shot on 12Oct2021. Positive home pregnancy test 26Oct2021 but vaginal bleeding later that AM with BM. Home pregnancy test taken as experiencing nausea, leukorrhea, food cravings, and breast soreness all consistent with past pregnancies. Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received. Since the vaccination, the patient has been tested for COVID-19. Lab test included Blood testing on unspecified date, Nasal Swab on 03Nov2021 and the result is pending. The outcome was recovering. This case was reports as serious - Life threatening and Congenital anomaly/birth defect.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Nausea, Pregnancy test, SARS-CoV-2 test, Vaginal discharge
Clinical narrative: Positive home pregnancy test 26th OCT; Positive home pregnancy test 26th OCT but vaginal bleeding later that AM with BM; increase in bleeding and cramping; Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping; breast soreness; nausea; leukorrhea; food cravings; This is a spontaneous report from a contactable nurse (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Oct2021 08:00 (Lot Number: FF2589) at age of 31 years old as DOSE 1, SINGLE for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration in arm left on 04Oct2021 at DOSE 1, SINGLE for an unspecified indication.  The patient was pregnant at vaccination. Patient last menstrual period date was 27Sep2021. Pregnancy Due Date was 06Jul2022. Medical history included Factor V Leiden Heterozygous, miscarriage in early Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included vitamin d; paracetamol (TYLENOL) and lidod (unspecified). On 26Oct2021 9:00, the patient experienced normal period September 27th and then timed conception efforts with ovulation dates. Forced by workplace to get 1st shot on 12Oct2021. Positive home pregnancy test 26Oct2021 but vaginal bleeding later that AM with BM. Home pregnancy test taken as experiencing nausea, leukorrhea, food cravings, and breast soreness all consistent with past pregnancies. Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received. Since the vaccination, the patient has been tested for COVID-19. Lab test included Blood testing on unspecified date, Nasal Swab on 03Nov2021 and the result is pending. The outcome was recovering. This case was reports as serious - Life threatening and Congenital anomaly/birth defect.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Positive home pregnancy test 26th OCT; Positive home pregnancy test 26th OCT but vaginal bleeding later that AM with BM; increase in bleeding and cramping; Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping; breast soreness; nausea; leukorrhea; food cravings; This is a spontaneous report from a contactable nurse (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 12Oct2021 08:00 (Lot Number: FF2589) at age of 31 years old as DOSE 1, SINGLE for covid-19 immunisation; influenza vaccine (FLU), via an unspecified route of administration in arm left on 04Oct2021 at DOSE 1, SINGLE for an unspecified indication.  The patient was pregnant at vaccination. Patient last menstrual period date was 27Sep2021. Pregnancy Due Date was 06Jul2022. Medical history included Factor V Leiden Heterozygous, miscarriage in early Aug2021. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included vitamin d; paracetamol (TYLENOL) and lidod (unspecified). On 26Oct2021 9:00, the patient experienced normal period September 27th and then timed conception efforts with ovulation dates. Forced by workplace to get 1st shot on 12Oct2021. Positive home pregnancy test 26Oct2021 but vaginal bleeding later that AM with BM. Home pregnancy test taken as experiencing nausea, leukorrhea, food cravings, and breast soreness all consistent with past pregnancies. Pregnancy hcg test in afternoon positive but trended down in two days with increase in bleeding and cramping. Events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received. Since the vaccination, the patient has been tested for COVID-19. Lab test included Blood testing on unspecified date, Nasal Swab on 03Nov2021 and the result is pending. The outcome was recovering. This case was reports as serious - Life threatening and Congenital anomaly/birth defect.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events . The case will be reassessed once new information is available. 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: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Axillary pain, Immunodeficiency, Lymphadenopathy
Clinical narrative: Swollen underarm on injection arm (left) approximately 36 hours after injection; The patient received the third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL6184) via an unspecified route of administration in the left arm on 02Nov2021 at 14:30 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included loratadine (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALTREX) and ethinylestradiol, levonorgestrel (LARISSIA); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 38-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 38-year-old), both as a single dose for COVID-19 immunisation. On 04Nov2021 at 03:00, approximately 36 hours after injection, the patient experienced swollen underarm on injection arm (left). The events did not result in doctor or other healthcare 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 swollen underarm on injection arm (left) was resolving at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Immunisation, Swelling
Clinical narrative: Swollen underarm on injection arm (left) approximately 36 hours after injection; The patient received the third/booster dose of BNT162b2.; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FL6184) via an unspecified route of administration in the left arm on 02Nov2021 at 14:30 (at the age of 39-year-old), as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included loratadine (MANUFACTURER UNKNOWN), valaciclovir hydrochloride (VALTREX) and ethinylestradiol, levonorgestrel (LARISSIA); all for unspecified indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 38-year-old) and second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0170) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 38-year-old), both as a single dose for COVID-19 immunisation. On 04Nov2021 at 03:00, approximately 36 hours after injection, the patient experienced swollen underarm on injection arm (left). The events did not result in doctor or other healthcare 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 swollen underarm on injection arm (left) was resolving at the time of this report.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Intermenstrual bleeding, Migraine, Urine analysis, Vaginal haemorrhage
Clinical narrative: pt experienced vaginal bleeding for both doses. from 1 day to 4 days.
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: pt experienced vaginal bleeding for both doses. from 1 day to 4 days.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea
Clinical narrative: 1- Diarrhea started next day and lasted 8-9 days 2- Nausea (ongoing) 3- Has not had a menstrual cycle since having first shot January 22nd - has recorded her menstrual cycles for the past 3 years and has never missed until receiving this vaccination.  She is not on birth control.  She has also had several pregnancy tests all showing negative results.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Diarrhoea, Nausea, Pregnancy test negative
Clinical narrative: 1- Diarrhea started next day and lasted 8-9 days 2- Nausea (ongoing) 3- Has not had a menstrual cycle since having first shot January 22nd - has recorded her menstrual cycles for the past 3 years and has never missed until receiving this vaccination.  She is not on birth control.  She has also had several pregnancy tests all showing negative results.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphasia, Hypoaesthesia
Clinical narrative: Lost ability to speak, left side of face went numb
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Speech disorder
Clinical narrative: Lost ability to speak, left side of face went numb
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Sleep disorder
Clinical narrative: PT TO ER C/O CHEST PAIN, SHORTNESS OF BREATH, SWOLLEN/PAINFUL LYMPH NODES TO LEFT UNDERARM. SYMTOMS STARTED 1 DAYS AFTER PFIXER BOOSTER SHOT. PT STATES THE FIRST TWO INJECTIONS WERE MODERNA AND SHE HAD FLU LIKE SYMTOMS.  EKG SHOWED PROLONGED QT, DDIMER WAS 306, CXR SHOWED POSSIBLE BRONCHITIS. PT WAS DX WITH PLEURITIS AND GIVEN NAPROXEN FOR INFLAMMATION AND A REFFERAL TO CARDIOLOGIST FOR FOLLOW UP.  PT WAS TOLD THE SYMPTOMS SHE IS EXPERIENCING ARE NORMAL AFTER COVID VACCINATION...
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray, Chest pain, Dyspnoea, Electrocardiogram QT prolonged, Electrocardiogram abnormal
Clinical narrative: PT TO ER C/O CHEST PAIN, SHORTNESS OF BREATH, SWOLLEN/PAINFUL LYMPH NODES TO LEFT UNDERARM. SYMTOMS STARTED 1 DAYS AFTER PFIXER BOOSTER SHOT. PT STATES THE FIRST TWO INJECTIONS WERE MODERNA AND SHE HAD FLU LIKE SYMTOMS.  EKG SHOWED PROLONGED QT, DDIMER WAS 306, CXR SHOWED POSSIBLE BRONCHITIS. PT WAS DX WITH PLEURITIS AND GIVEN NAPROXEN FOR INFLAMMATION AND A REFFERAL TO CARDIOLOGIST FOR FOLLOW UP.  PT WAS TOLD THE SYMPTOMS SHE IS EXPERIENCING ARE NORMAL AFTER COVID VACCINATION...
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibrin D dimer increased, Full blood count, Inflammation, Lymph node pain, Lymphadenopathy
Clinical narrative: PT TO ER C/O CHEST PAIN, SHORTNESS OF BREATH, SWOLLEN/PAINFUL LYMPH NODES TO LEFT UNDERARM. SYMTOMS STARTED 1 DAYS AFTER PFIXER BOOSTER SHOT. PT STATES THE FIRST TWO INJECTIONS WERE MODERNA AND SHE HAD FLU LIKE SYMTOMS.  EKG SHOWED PROLONGED QT, DDIMER WAS 306, CXR SHOWED POSSIBLE BRONCHITIS. PT WAS DX WITH PLEURITIS AND GIVEN NAPROXEN FOR INFLAMMATION AND A REFFERAL TO CARDIOLOGIST FOR FOLLOW UP.  PT WAS TOLD THE SYMPTOMS SHE IS EXPERIENCING ARE NORMAL AFTER COVID VACCINATION...
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Pleurisy
Clinical narrative: PT TO ER C/O CHEST PAIN, SHORTNESS OF BREATH, SWOLLEN/PAINFUL LYMPH NODES TO LEFT UNDERARM. SYMTOMS STARTED 1 DAYS AFTER PFIXER BOOSTER SHOT. PT STATES THE FIRST TWO INJECTIONS WERE MODERNA AND SHE HAD FLU LIKE SYMTOMS.  EKG SHOWED PROLONGED QT, DDIMER WAS 306, CXR SHOWED POSSIBLE BRONCHITIS. PT WAS DX WITH PLEURITIS AND GIVEN NAPROXEN FOR INFLAMMATION AND A REFFERAL TO CARDIOLOGIST FOR FOLLOW UP.  PT WAS TOLD THE SYMPTOMS SHE IS EXPERIENCING ARE NORMAL AFTER COVID VACCINATION...
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acute respiratory failure, COVID-19, Cardiac failure acute, Cough, Diarrhoea
Clinical narrative: hospitalization (non-ICU)
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Fluid intake reduced, Hypophagia, Myalgia
Clinical narrative: hospitalization (non-ICU)
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Oxygen saturation decreased, Productive cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: hospitalization (non-ICU)
Age: 87.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hospitalization (non-ICU)
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient states he received his booster on 11/05/2021 at around 9:30am and about 4 hours later he started to feel pain in his right shoulder.  Over the course of the weekend the pain worsened and he lost range of motion in his right shoulder. He is 5 days post vaccine and still has no range of motion. He went to his PCP who did an xray and gave him a pain shot. His xray follow up is tomorrow.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Joint range of motion decreased, X-ray
Clinical narrative: Patient states he received his booster on 11/05/2021 at around 9:30am and about 4 hours later he started to feel pain in his right shoulder.  Over the course of the weekend the pain worsened and he lost range of motion in his right shoulder. He is 5 days post vaccine and still has no range of motion. He went to his PCP who did an xray and gave him a pain shot. His xray follow up is tomorrow.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, Fatigue, Headache, Pain
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 69.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Error: Incorrect reconstitution.
Age: 7.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect reconstitution.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 58.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was administered.  Expiration date 11/1/2021.  Date of vaccination 11/5/2021.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, Product administration error
Clinical narrative: VACCINE ADMINISTRATION ERROR. PATIENT WHO IS 5 YEARS OLD WAS GIVEN THE ADULT DOSE FOR PFIZER INSTEAD OF THE PEDIATRIC DOSE.
Age: 5.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: VACCINE ADMINISTRATION ERROR. PATIENT WHO IS 5 YEARS OLD WAS GIVEN THE ADULT DOSE FOR PFIZER INSTEAD OF THE PEDIATRIC DOSE.
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No AE/PQC reported; received is first ROTATEQ dose at 15 weeks old; This spontaneous report as received from a patient's mother refers to a 15-week-old male patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.    On 13-OCT-2021, reported as yesterday, the patient was vaccinated with his first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally (exact dose, lot # and expiration date were not reported) for prophylaxis. No adverse event was reported.
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: 99 degree fever and body aches; 99 degree fever and body aches; This spontaneous report as received from a veterinary professional via a company representative refers to a male patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-OCT-2021, reported as on Monday, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.         On 25-OCT-2021, reported as for the past 3 days, the patient experienced 99 degree fever and body aches. It was unknown if the patient received tretament.  The outcome of the events was not reported. Causality assessment was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; the vaccine was administered after expiration; This spontaneous report was received from a pharmacist referring to a patient of unknown gender and age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 28-OCT-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # T017385, expiration date: 01-SEP-2021) 0.5 milliliter administered for prophylaxis. It was mentioned that the vaccine was administered after expiration. It was also mentioned that the vaccine did not have a temperature excursion.
Sex: M
Vaccine: HPV9
Symptoms: Fatigue, Lethargy
Clinical narrative: The boy was lethargic and very tired; The boy was lethargic and very tired; This spontaneous report has been received from a physician, through a field employee, concerning a male patient of unknown age. The patient's concurrent conditions, pertinent medical history and concomitant medications were unknown.    On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, dose, route of administration, lot # and expiration date were not provided) as prophylaxis.   On the same date of vaccination (reported as "all the way through the day and the following day"), the patient was lethargic and very tired.   At the reporting time, the patient had recovered with no incidence from lethargy and tiredness, and it was reported that the employee had "nothing beyond that". It was unknown by the reporter if there was treatment given for the adverse events.   The causal assessment between the patient's lethargy, tiredness, and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blindness, Herpes zoster, Neuralgia, Paraesthesia
Clinical narrative: vision loss; Neuralgia; paresthesia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around October 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles, neuralgia, paresthesia and vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, vision loss was determined to be a medically significant event.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Engerix 2nd Dose; Initial Report Received on 03-Nov-2021  A pharmacist reported that a 30 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received Engerix-B as the second dose.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On 19-Aug-2021, the patient received the first dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), through an unspecified route and site at another pharmacy.  On 03-Oct-2021, 46 days after having been vaccinated with HEPLISAV-B, the patient received Engerix-B (second dose) at the pharmacy.   No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received on 08-Sep-2021 (received by Safety on 02-Nov-2021)  A nurse reported to the pregnancy registry that that a female pregnant patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No relevant medical history was reported.    No relevant concomitant medications were reported.    On an unspecified date, the patient received a dose of HEPLISAV-B (Lot #, expiration date and NDC # not reported), route and site not specified. The nurse with a vaccinating provider had called the registry asking for options to enroll a patient. During the call, the nurse chose to provide the Registry Toll Free number to the participant. Several follow-up attempts were made over 2 months by the Registry to the nurse to confirm if the participant was interested.  No additional information was reported. Permission to follow-up with the healthcare provider's office was not obtained.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.