chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in both ears; patient previously was not diagnosed with tinnitus and did not have the moderate level disturbance patient have now.; This is a spontaneous report received from a contactable consumer. A 55-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 26Mar2021 15:15 (at 55-years age) as single dose for covid-19 immunization. Medical history included depression and patient was allergic to antibiotic Muscinex. Concomitant medication(s) included citalopram (CITALOPRAM) 40mg daily. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 07:00 patient experienced ringing in both ears started 2 days after the injection and has not stopped as of the date of this report (30-Mar-2021). Patient previously was not diagnosed with tinnitus and did not have the moderate level disturbance patient had now. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Ringing in both ears; patient previously was not diagnosed with tinnitus and did not have the moderate level disturbance patient have now.; This is a spontaneous report received from a contactable consumer. A 55-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 26Mar2021 15:15 (at 55-years age) as single dose for covid-19 immunization. Medical history included depression and patient was allergic to antibiotic Muscinex. Concomitant medication(s) included citalopram (CITALOPRAM) 40mg daily. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 29Mar2021 07:00 patient experienced ringing in both ears started 2 days after the injection and has not stopped as of the date of this report (30-Mar-2021). Patient previously was not diagnosed with tinnitus and did not have the moderate level disturbance patient had now. No treatment received for reported adverse event. Patient not tested for COVID-19 after the vaccination. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Fatigue
Clinical narrative: Severe headache; chills; fatigue; muscle and joint pain; stiffness; diarrhea; low fever; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-year-old female patient (non-pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), via an unspecified route of at the age of 56-year-old at arm left on 26Mar2021 14:00 at single dose for COVID-19 immunization. Medical history included Lifelong asthmatic. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) administered in arm left on 08Mar2021 12:00 PM for COVID-19 immunisation. The patient experienced severe headache, chills, fatigue, muscle and joint pain and stiffness, diarrhea, low fever on 27Mar2021 01:00 AM. There was no other vaccine in four weeks. There was nothing new other medications in two weeks. Same medications for 6 plus months. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There was no treatment received for the adverse events. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Insomnia, Myalgia, Pyrexia
Clinical narrative: Severe headache; chills; fatigue; muscle and joint pain; stiffness; diarrhea; low fever; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-year-old female patient (non-pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), via an unspecified route of at the age of 56-year-old at arm left on 26Mar2021 14:00 at single dose for COVID-19 immunization. Medical history included Lifelong asthmatic. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) administered in arm left on 08Mar2021 12:00 PM for COVID-19 immunisation. The patient experienced severe headache, chills, fatigue, muscle and joint pain and stiffness, diarrhea, low fever on 27Mar2021 01:00 AM. There was no other vaccine in four weeks. There was nothing new other medications in two weeks. Same medications for 6 plus months. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There was no treatment received for the adverse events. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Severe headache; chills; fatigue; muscle and joint pain; stiffness; diarrhea; low fever; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-year-old female patient (non-pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), via an unspecified route of at the age of 56-year-old at arm left on 26Mar2021 14:00 at single dose for COVID-19 immunization. Medical history included Lifelong asthmatic. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) administered in arm left on 08Mar2021 12:00 PM for COVID-19 immunisation. The patient experienced severe headache, chills, fatigue, muscle and joint pain and stiffness, diarrhea, low fever on 27Mar2021 01:00 AM. There was no other vaccine in four weeks. There was nothing new other medications in two weeks. Same medications for 6 plus months. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There was no treatment received for the adverse events. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Pyrexia
Clinical narrative: Severe headache; chills; fatigue; muscle and joint pain; stiffness; diarrhea; low fever; muscle and joint pain; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-year-old female patient (non-pregnant) received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: ER8732), via an unspecified route of at the age of 56-year-old at arm left on 26Mar2021 14:00 at single dose for COVID-19 immunization. Medical history included Lifelong asthmatic. The patient wasn't allergies to medications, food, or other products. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6205) administered in arm left on 08Mar2021 12:00 PM for COVID-19 immunisation. The patient experienced severe headache, chills, fatigue, muscle and joint pain and stiffness, diarrhea, low fever on 27Mar2021 01:00 AM. There was no other vaccine in four weeks. There was nothing new other medications in two weeks. Same medications for 6 plus months. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. There was no treatment received for the adverse events. The outcome of events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours; body feels like hit with mac truck; tired; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm at age 64 years, on 29Mar2021 14:25 (Batch/Lot Number: ER8732) as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation as a pre-existing condition that normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most and overweight from unspecified date but working on it. Only she has heart history in her family. The patient's concomitant medications was none. Patient historically took first dose of BNT162B2 (Lot: EN6199) with anatomical Location of left arm on 08Mar2021 around 1300 for COVID-19 immunization and flu vaccine received back in 2020 for immunisation.  Patient reported that she had the second dose of the Pfizer COVID Vaccine on Monday, 29Mar2021 and three hours later, her heart started fibrillating for 36 hours. She has a pre-existing condition of atrial fibrillation and normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours. Patient contacted the doctor right away via phone. Her doctor, an electrophysiologist, stated not to eat or drink anything after midnight and of patient was still in atrial fibrillation in the morning they would have to perform a cardioversion, with the paddles. Doctor believed this could happen and said its a delicate balance when you put anything else into the system that it could affect persons. On 31Mar2021 at 05:15 that morning, the patient went out of atrial fibrillation and back into normal sinus rhythm. Patient only called the doctor and would have had to go in today if the fibrillation did not stop. Patient also stated that well, it was not a good thing to fibrillate for that long, with due time it can cause congestive heart failure and stated its dangerous. Patient was resting at the time of report and was relieved she is not fibrillating anymore. Patient reported that her body feels like it was hit with a mac truck on Mar2021. Heart fibrillating for 36 hours makes you really tired. The outcome of the event 'heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours' was recovered on 31Mar2021 at 05:15 in the morning, while for the rest of the events it was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Atrial fibrillation, Fatigue, Feeling abnormal
Clinical narrative: heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours; body feels like hit with mac truck; tired; This is a spontaneous report received from a contactable consumer (patient herself). A 64-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 2 via an unspecified route of administration, administered in left arm at age 64 years, on 29Mar2021 14:25 (Batch/Lot Number: ER8732) as single dose, for COVID-19 immunisation. Medical history included atrial fibrillation as a pre-existing condition that normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most and overweight from unspecified date but working on it. Only she has heart history in her family. The patient's concomitant medications was none. Patient historically took first dose of BNT162B2 (Lot: EN6199) with anatomical Location of left arm on 08Mar2021 around 1300 for COVID-19 immunization and flu vaccine received back in 2020 for immunisation.  Patient reported that she had the second dose of the Pfizer COVID Vaccine on Monday, 29Mar2021 and three hours later, her heart started fibrillating for 36 hours. She has a pre-existing condition of atrial fibrillation and normally she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours. Patient contacted the doctor right away via phone. Her doctor, an electrophysiologist, stated not to eat or drink anything after midnight and of patient was still in atrial fibrillation in the morning they would have to perform a cardioversion, with the paddles. Doctor believed this could happen and said its a delicate balance when you put anything else into the system that it could affect persons. On 31Mar2021 at 05:15 that morning, the patient went out of atrial fibrillation and back into normal sinus rhythm. Patient only called the doctor and would have had to go in today if the fibrillation did not stop. Patient also stated that well, it was not a good thing to fibrillate for that long, with due time it can cause congestive heart failure and stated its dangerous. Patient was resting at the time of report and was relieved she is not fibrillating anymore. Patient reported that her body feels like it was hit with a mac truck on Mar2021. Heart fibrillating for 36 hours makes you really tired. The outcome of the event 'heart started fibrillating for 36 hours/she would be in atrial fibrillation for 3-8 hours, or maybe 10 hours, sometimes 12 hours at the most, never 36 hours' was recovered on 31Mar2021 at 05:15 in the morning, while for the rest of the events it was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Deafness unilateral, Magnetic resonance imaging, Tinnitus, Vertigo
Clinical narrative: severe Sudden Sensineural Hearing Loss in his left ear; Vertigo; loud tinnitus developed in both ears; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via an unspecified route of administration at left arm on 20Mar2021 at 13:15 (63-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included epilepsy and chronic urticaria. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included lamotrigine, hydroxyzine, and omalizumab (XOLAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 8 hours of receiving vaccine (at 21:15 on 20Mar2021), loud tinnitus developed in both ears. Next morning (on 21Mar2021) he had severe sudden sensineural hearing loss in his left ear and vertigo. Seriousness criteria was reported as disability. Receiving steroid injections and oral steroids. Vertigo and tinnitus continue. Adverse events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deafness neurosensory, Tinnitus, Vertigo
Clinical narrative: severe Sudden Sensineural Hearing Loss in his left ear; Vertigo; loud tinnitus developed in both ears; This is a spontaneous report received from a contactable consumer (patient). A 63-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER2613) via an unspecified route of administration at left arm on 20Mar2021 at 13:15 (63-year-old at time of vaccination), at single dose, for COVID-19 immunization. The patient's medical history included epilepsy and chronic urticaria. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food, or other products. Concomitant medications received within 2 weeks of vaccination included lamotrigine, hydroxyzine, and omalizumab (XOLAIR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Within 8 hours of receiving vaccine (at 21:15 on 20Mar2021), loud tinnitus developed in both ears. Next morning (on 21Mar2021) he had severe sudden sensineural hearing loss in his left ear and vertigo. Seriousness criteria was reported as disability. Receiving steroid injections and oral steroids. Vertigo and tinnitus continue. Adverse events result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Deep vein thrombosis, Thrombosis, Ultrasound scan abnormal
Clinical narrative: Developed a blood clot behind the left knee; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jan2021 16:00 (Batch/Lot Number: EL3246) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Feathers. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. On 22Mar2021 18:00, the patient Developed a blood clot behind the left Knee. Ae resulted in : [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient received treatment for the event: Blood Thinner Meds and Compression Stocking. The outcome of the event was not recovered. The patient did not have covid prior vaccination, and the patient was not COVID tested post vaccination.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Thrombosis
Clinical narrative: Developed a blood clot behind the left knee; This is a spontaneous report from a contactable consumer. A 72-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 18Jan2021 16:00 (Batch/Lot Number: EL3246) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 17Feb2021 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunisation. Medical history included Known allergies: Feathers. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. On 22Mar2021 18:00, the patient Developed a blood clot behind the left Knee. Ae resulted in : [Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care]. The patient received treatment for the event: Blood Thinner Meds and Compression Stocking. The outcome of the event was not recovered. The patient did not have covid prior vaccination, and the patient was not COVID tested post vaccination.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy endometrium normal, Platelet count normal, Postmenopausal haemorrhage, Ultrasound scan normal
Clinical narrative: Post menopausal bleeding; vaginal bleeding; This is a spontaneous report from a contactable physician (patient) reported for herself. A 57-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9266, expiration date unknown) via unspecified route of administration at arm right on 16Feb2021 16:15 at age of 57-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included hypertension, allergic to Cipro. Patient previously received 1st dose of BNT162B2 on 21Jan2021 at 02:00 PM (Lot number: EL3246) at single dose for COVID-19 immunisation. Concomitant medications included lisinopril, biotin/ cyanocobalamin/ folic acid (MVI 3), vitamin D3. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. LMP 7/2018 No significant gynecological history other than pregnancies/childbirth. No prior abnormal vaginal/uterine bleeding. No known history pf uterine fibroids. No h/o bleeding/coagulation disorder. On 18Feb2021, patient experienced vaginal bleeding began with light flow and gradually increased with use of pads and tampons. There was no clots. Menstrual period lasted until 23Feb2021. (This appeared to be similar to menstrual periods in the past except there was no cramping on the first day and in the past would have expected to end on 22Feb2021. No further vaginal/uterine bleed or spotting since 23Feb2021. On 19Feb2021, platelet was 349 (normal range: 150-450). On 16Mar2021, endometrial biopsy was negative. On 16Mar2021, Pap (Smear cervix) was negative. On 16Mar2021, ultrasound showed endometrial thickness within normal range 4 mm, 2 small fibroids 1 cm, 2 cm, normal ovary sizes, small L ovarian cyst. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 by COVID-19 PCR (SARS-CoV-2) saliva with unknown results. It was reported that patient experienced Post menopausal bleeding on 18Feb2021 at 12:30 and vaginal bleeding on 18Feb2021 at 12:30. Outcome of events was recovered on 23Feb2021. Events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events.; Sender's Comments: Based on the information provided, reported events are not related to suspect product. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Biopsy endometrium, Platelet count, Postmenopausal haemorrhage, SARS-CoV-2 test, Smear cervix
Clinical narrative: Post menopausal bleeding; vaginal bleeding; This is a spontaneous report from a contactable physician (patient) reported for herself. A 57-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9266, expiration date unknown) via unspecified route of administration at arm right on 16Feb2021 16:15 at age of 57-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included hypertension, allergic to Cipro. Patient previously received 1st dose of BNT162B2 on 21Jan2021 at 02:00 PM (Lot number: EL3246) at single dose for COVID-19 immunisation. Concomitant medications included lisinopril, biotin/ cyanocobalamin/ folic acid (MVI 3), vitamin D3. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. LMP 7/2018 No significant gynecological history other than pregnancies/childbirth. No prior abnormal vaginal/uterine bleeding. No known history pf uterine fibroids. No h/o bleeding/coagulation disorder. On 18Feb2021, patient experienced vaginal bleeding began with light flow and gradually increased with use of pads and tampons. There was no clots. Menstrual period lasted until 23Feb2021. (This appeared to be similar to menstrual periods in the past except there was no cramping on the first day and in the past would have expected to end on 22Feb2021. No further vaginal/uterine bleed or spotting since 23Feb2021. On 19Feb2021, platelet was 349 (normal range: 150-450). On 16Mar2021, endometrial biopsy was negative. On 16Mar2021, Pap (Smear cervix) was negative. On 16Mar2021, ultrasound showed endometrial thickness within normal range 4 mm, 2 small fibroids 1 cm, 2 cm, normal ovary sizes, small L ovarian cyst. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 by COVID-19 PCR (SARS-CoV-2) saliva with unknown results. It was reported that patient experienced Post menopausal bleeding on 18Feb2021 at 12:30 and vaginal bleeding on 18Feb2021 at 12:30. Outcome of events was recovered on 23Feb2021. Events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events.; Sender's Comments: Based on the information provided, reported events are not related to suspect product. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ultrasound uterus, Vaginal haemorrhage
Clinical narrative: Post menopausal bleeding; vaginal bleeding; This is a spontaneous report from a contactable physician (patient) reported for herself. A 57-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number: EL9266, expiration date unknown) via unspecified route of administration at arm right on 16Feb2021 16:15 at age of 57-year-old at single dose for COVID-19 immunisation. Patient was not pregnant at time of vaccination. Medical history included hypertension, allergic to Cipro. Patient previously received 1st dose of BNT162B2 on 21Jan2021 at 02:00 PM (Lot number: EL3246) at single dose for COVID-19 immunisation. Concomitant medications included lisinopril, biotin/ cyanocobalamin/ folic acid (MVI 3), vitamin D3. Patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. LMP 7/2018 No significant gynecological history other than pregnancies/childbirth. No prior abnormal vaginal/uterine bleeding. No known history pf uterine fibroids. No h/o bleeding/coagulation disorder. On 18Feb2021, patient experienced vaginal bleeding began with light flow and gradually increased with use of pads and tampons. There was no clots. Menstrual period lasted until 23Feb2021. (This appeared to be similar to menstrual periods in the past except there was no cramping on the first day and in the past would have expected to end on 22Feb2021. No further vaginal/uterine bleed or spotting since 23Feb2021. On 19Feb2021, platelet was 349 (normal range: 150-450). On 16Mar2021, endometrial biopsy was negative. On 16Mar2021, Pap (Smear cervix) was negative. On 16Mar2021, ultrasound showed endometrial thickness within normal range 4 mm, 2 small fibroids 1 cm, 2 cm, normal ovary sizes, small L ovarian cyst. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient been tested for COVID-19 by COVID-19 PCR (SARS-CoV-2) saliva with unknown results. It was reported that patient experienced Post menopausal bleeding on 18Feb2021 at 12:30 and vaginal bleeding on 18Feb2021 at 12:30. Outcome of events was recovered on 23Feb2021. Events resulted in doctor or other healthcare professional office/clinic visit. There was no treatment for the events.; Sender's Comments: Based on the information provided, reported events are not related to suspect product. Case will be reassessed when additional information is available. The impact of this report on the benefit/risk profile of the Pfizer drug 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: Caesarean section, Exposure during pregnancy, Foetal death, Foetal heart rate decreased, Foetal hypokinesia
Clinical narrative: Baby was delivered with apgars of 0 and ultimately fetal demise; This is a spontaneous report from a contactable pharmacist.  This pharmacist reported information for both mother and fetus/baby. This is a maternal report.    A 31-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 16Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Patient presented to physician office 2 weeks after covid vaccine, with complaints of decreased fetal movement. Patient was taken to emergency c-section due to decreased fetal heart tones in the office. Baby was delivered with apgars of 0 and ultimately fetal demise. Patient was 34 weeks pregnant and had an otherwise uncomplicated pregnancy. Due to the event, the patient with doctor or other healthcare professional office/clinic visit and was hospitalization for 3 days. The mother was 34 weeks pregnant at the onset of the event. The mother delivered the pregnancy on an unknown date via cesarean delivery.  APGAR Score 1 was 0, APGAR Score 2 and APGAR Score 3 was not provided. The fetal outcome is neonatal death. The outcome of the event was unknown.; Sender's Comments: Based on the available information and a temporal association, a causal relationship between the event fetal demise and BNT162B2 cannot be completely excluded.  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.,Linked Report(s) : PFIZER INC-2021363057 baby case
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Foetal death
Clinical narrative: Baby was delivered with apgars of 0 and ultimately fetal demise; This is a spontaneous report from a contactable pharmacist.  This pharmacist reported information for both mother and fetus/baby. This is a maternal report.    A 31-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via intramuscular on 16Mar2021 as SINGLE DOSE for covid-19 immunisation. Medical history included none. The patient's concomitant medications were not reported. Patient presented to physician office 2 weeks after covid vaccine, with complaints of decreased fetal movement. Patient was taken to emergency c-section due to decreased fetal heart tones in the office. Baby was delivered with apgars of 0 and ultimately fetal demise. Patient was 34 weeks pregnant and had an otherwise uncomplicated pregnancy. Due to the event, the patient with doctor or other healthcare professional office/clinic visit and was hospitalization for 3 days. The mother was 34 weeks pregnant at the onset of the event. The mother delivered the pregnancy on an unknown date via cesarean delivery.  APGAR Score 1 was 0, APGAR Score 2 and APGAR Score 3 was not provided. The fetal outcome is neonatal death. The outcome of the event was unknown.; Sender's Comments: Based on the available information and a temporal association, a causal relationship between the event fetal demise and BNT162B2 cannot be completely excluded.  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.,Linked Report(s) : PFIZER INC-2021363057 baby case
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Mouth ulceration, Somnolence
Clinical narrative: Mouth Ulcer developed on roof of mouth after day 3 and still presents; Very tired; headaches/headache still continues; Sleepiness; This is a spontaneous report from a contactable consumer(patient). This 65-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Mar2021 12:15 PM at age of 65-year-old right arm as single dose for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Breast Cancer, high blood pressure, inflammatory arthropathy. Allergies to Sulfa drugs. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, she experienced very tired headaches, sleepiness. Sleepiness and headache still continue. Mouth ulcer developed on roof of mouth after day 3 and still presents. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event. Outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Mouth ulceration, Somnolence
Clinical narrative: Mouth Ulcer developed on roof of mouth after day 3 and still presents; Very tired; headaches/headache still continues; Sleepiness; This is a spontaneous report from a contactable consumer(patient). This 65-year-old female no pregnant patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), on 23Mar2021 12:15 PM at age of 65-year-old right arm as single dose for COVID-19 immunisation. No pregnant at the time of vaccination. Medical history included Breast Cancer, high blood pressure, inflammatory arthropathy. Allergies to Sulfa drugs. Prior to vaccination, was the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 24Mar2021, she experienced very tired headaches, sleepiness. Sleepiness and headache still continue. Mouth ulcer developed on roof of mouth after day 3 and still presents. Since the vaccination, the patient had not been tested for COVID-19. No treatment received for the adverse event. Outcome of events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Arthralgia, Dysstasia, Mobility decreased, Myalgia, Pain
Clinical narrative: Joints pain/knees hurt like hell/Shoulder sockets hurt I couldn't move/Right Elbow pained; Muscle pain; Muscle weakness; tendon pain; Shoulder sockets hurt I couldn't move; Have no Lifting process from my Legs trying to rise from sitting; whole body hurt from 7-10; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 07:00 (Batch/Lot Number: EN6208)( Age at vaccination: 71 years old) as SINGLE DOSE for covid-19 immunization.  Medical history included diabeties 2. Concomitant medication(s) included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced joints pain, muscle pain, muscle weakness, tendon pain, both knees hurt like heck, his shoulder sockets hurt he couldn't move, have no lifting process from his legs trying to rise from sitting but walking pretty good, whole body hurt from 7-10, right elbow pained. The events were reported as serious due to disability. Steriods pills received for the events. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Tendon pain
Clinical narrative: Joints pain/knees hurt like hell/Shoulder sockets hurt I couldn't move/Right Elbow pained; Muscle pain; Muscle weakness; tendon pain; Shoulder sockets hurt I couldn't move; Have no Lifting process from my Legs trying to rise from sitting; whole body hurt from 7-10; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 07:00 (Batch/Lot Number: EN6208)( Age at vaccination: 71 years old) as SINGLE DOSE for covid-19 immunization.  Medical history included diabeties 2. Concomitant medication(s) included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced joints pain, muscle pain, muscle weakness, tendon pain, both knees hurt like heck, his shoulder sockets hurt he couldn't move, have no lifting process from his legs trying to rise from sitting but walking pretty good, whole body hurt from 7-10, right elbow pained. The events were reported as serious due to disability. Steriods pills received for the events. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Arthralgia, Dysstasia, Movement disorder, Muscular weakness, Myalgia
Clinical narrative: Joints pain/knees hurt like hell/Shoulder sockets hurt I couldn't move/Right Elbow pained; Muscle pain; Muscle weakness; tendon pain; Shoulder sockets hurt I couldn't move; Have no Lifting process from my Legs trying to rise from sitting; whole body hurt from 7-10; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 07:00 (Batch/Lot Number: EN6208)( Age at vaccination: 71 years old) as SINGLE DOSE for covid-19 immunization.  Medical history included diabeties 2. Concomitant medication(s) included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced joints pain, muscle pain, muscle weakness, tendon pain, both knees hurt like heck, his shoulder sockets hurt he couldn't move, have no lifting process from his legs trying to rise from sitting but walking pretty good, whole body hurt from 7-10, right elbow pained. The events were reported as serious due to disability. Steriods pills received for the events. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: UNK, COVID19
Symptoms: Pain, Tendon pain
Clinical narrative: Joints pain/knees hurt like hell/Shoulder sockets hurt I couldn't move/Right Elbow pained; Muscle pain; Muscle weakness; tendon pain; Shoulder sockets hurt I couldn't move; Have no Lifting process from my Legs trying to rise from sitting; whole body hurt from 7-10; This is a spontaneous report from a contactable consumer (Patient). A 71-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 18Mar2021 07:00 (Batch/Lot Number: EN6208)( Age at vaccination: 71 years old) as SINGLE DOSE for covid-19 immunization.  Medical history included diabeties 2. Concomitant medication(s) included insulin glargine (LANTUS) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced joints pain, muscle pain, muscle weakness, tendon pain, both knees hurt like heck, his shoulder sockets hurt he couldn't move, have no lifting process from his legs trying to rise from sitting but walking pretty good, whole body hurt from 7-10, right elbow pained. The events were reported as serious due to disability. Steriods pills received for the events. The outcome of the events was not recovered. Information on Lot/Batch number was available. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Musculoskeletal discomfort, Peripheral swelling
Clinical narrative: Patient developed hives 1 day after first dose of vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Patient developed hives 1 day after first dose of vaccine.
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Rash papular, Rash pruritic, Rash vesicular, Swelling
Clinical narrative: Patient developed hives 1 day after first dose of vaccine.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Back pain, Body temperature increased, Chills, Decreased appetite
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  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: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Headache, Hot flush, Musculoskeletal stiffness
Clinical narrative: This is a spontaneous report from a contactable other health professional (patient) reported that a 28-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 30Mar2021 12:00 (at the age of 28-year-old, not pregnant), at single dose, for COVID-19 immunization. Medical history asthma, heart palpitations, and MTHFR gene mutation. Patient had no COVID prior vaccination. Patient had no known allergies. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), ethinylestradiol, norgestimate (SPRINTEC); ascorbic acid (VITAMIN C); ergocalciferol (VITAMIN D), and multivita. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number and expiration date not provided), via an unspecified route of administration, in left arm, on 09Mar2021 17:00 (at the age of 28-year-old), at single dose, for COVID-19 immunization. The patient experienced feeling like passing out and severe lightheaded, feeling like throwing up, on 31Mar2021 and 12:00 and were serious. On 31Mar2021, at 12:00 to 3:30, patient had severe nausea, severe dizziness, severe lightheaded, feeling like throwing up, feeling like passing out, heart pounding, heart rate 130, abdominal pain and cramps. At 3:30 to 5:30, patient had extreme chills, lightheaded, heart pounding (not as bad), heart rate 125-130, headache, body aches and stiffness. At 5:30 to 8:00, patient had lower back pain, body aches stiffness, headache/head pounding, heat flashes, patient's temperature was 100 degrees F, and heart rate was 130. At 8:00, patient's temperature was 98-99 degrees F. On 31Mar2021 all day, patient had body aches, lower back pain, mild headache, nausea, and lack of appetite. No COVID tested post vaccination. Therapeutic measures were taken as a result of events and included treatment with paracetamol (TYLENOL). The outcome of the events was recovering.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal association a contributory role of BNT162B2 to the reported events cannot  be excluded.  Case will be reassessed if additional information is received.  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.