chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: mind was very foggy; Her arm is throbbing; developed cellulitis at the vaccine site; the cellulitis was traveling down her arm; booster; Body ache; High fever/Temperature went up; This is a spontaneous report from a contactable consumer (patient).  A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 3 via an unspecified route of administration, administered in arm right on 12Nov2021 (Batch/Lot Number: FD0809) (age at vaccination 52-year-old) as dose 3 (booster), 0.3 ml single for covid-19 immunisation. Medical history included was reported as no. Concomitant medications included tamoxifen and propanol taken for an unspecified indication, start and stop date were not reported. The patient received other vaccines within four weeks prior to the vaccination included Flu shot an unspecified route of administration, on 04Oct2021 (Batch/Lot Number: not reported) (age at vaccination 52-year-old) for immunization. The patient received historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 04Feb2021 (Batch/Lot Number: 3247) as dose 1, experienced body aches, dose 2 via an unspecified route of administration on 25Feb2021 (Batch/Lot Number: 3247) as dose 2 single for covid-19 immunisation, experienced body aches. The patient had booster on 12Nov2021, body ache, high fever on Nov2021, developed cellulitis at the vaccine site; the cellulitis was traveling down her arm on 16Nov2021, her arm is throbbing, mind was very foggy on an unspecified date. The patient underwent lab tests and procedures which included blood test: everything is fine on 2021 had blood work done, don't know how recent, in September probably, body temperature: went up this evening 102.5 on 14Nov2021. Therapeutic measures included antibiotics were taken as a result of developed cellulitis at the vaccine site; the cellulitis was traveling down her arm, Ibuprofen for body ache and high fever. The outcome of the event developed cellulitis at the vaccine site; the cellulitis was traveling down her arm was recovering, body ache, high fever not recovered, her arm is throbbing, mind was very foggy was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Magnetic resonance imaging, Pupils unequal
Clinical narrative: One pupil dilated, other pupil not.; This is a spontaneous report from a contactable consumer or other non-healthcare professional.  A 43-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Batch No. not available/lot Number: FH8030) via intramuscular route, administered on 08Nov2021 (at the age of 43-years-old) as dose 1, single for covid-19 immunization at Pharmacy or Drug Store. The patient medical history, known allergies and other medications in two weeks were unknown. Patient did not receive any other vaccine in four weeks. No covid prior vaccination. Unknown if covid tested post vaccination. On 13Nov2021, the patient experienced one pupil dilated, other pupil not. The patient underwent lab tests and procedures which included CAT scan and MRI on an unknown date with unknown Results. The therapeutic measures were taken as a result of events. Event treatment reported as CAT scan and MRI. AE resulted in the Emergency room/department or urgent care. The outcome of the event was recovered on an unknown date in 2021.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia
Clinical narrative: One rushed to hospital months ago . Says still feeling weak. In this case it was acknowledged "vaccine" was the cause.; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a patient (One rushed to hospital months ago) that, a patient of unspecified age and gender received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number, unknown single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced one rushed to hospital months ago. The patient says still feeling weak. In this case it was acknowledged vaccine was the cause. Reporter said that I know three people who had had major adverse effects since being injected with the nonvaccine. One rushed to hospital months ago. Says still feeling weak. In this case it was acknowledged vaccine was the cause. Two others have blood clots. Regular visits to hospital. Both told they will need to be treated for life. In their case, apparently developing this life-changing condition shortly after the vaccine was just a coincidence. (I still know not a single person who has had Covid.) And it is of course just a coincidence that an ever-increasing number of younger sports people have heart attacks, on the pitch, or whilst exercising before our very eyes. It's just a coincidence that there are hundreds, if not thousands of videos in alternative media showing people dying, collapsing and in pain and terror shortly after receiving the vaccines.  The event outcome was reported as unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Two others have blood clots; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unknown route of administration on an unspecified date in 2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have Covid-19. On an unspecified date in 2021, the patient had blood clots. Therefore, the patient had Regular visits to hospital and was told to be treated for life. The patient apparently developed life-changing condition shortly after the vaccine. Event was assessed serious (Medically significant). Outcome of event was not recovered.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This is a spontaneous report from a contactable consumer. A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date: not reported), via an unknown route of administration on an unspecified date, as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient did not have Covid-19. On an unspecified date, the patient had blood clots. Therefore, the patient had Regular visits to hospital and was told to be treated for life. The patient apparently developed life-changing condition shortly after the "vaccine". Event was assessed serious (Medically significant). Therapeutic measures were taken as a result of the events. Outcome of event was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness, Immunisation, Nausea, Pyrexia
Clinical narrative: Vomiting; very high fevers; extreme fatigue; so sick; nausea; Booster; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (neighbour). A 65-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3(BOOSTER), SINGLE for covid-19 immunisation. Medical history included osteoarthritis. The patient's concomitant medications were not reported.Patient was healthy before vaccination. Historical vaccine included Covid-19 vaccine as dose 1 and dose 2(Manufacturere unknown) for covid-19 immunisation. It was reported that patient had minimal side effects with previous 2 doses. The patient experienced vomiting for 3 days, very high fevers, extreme fatigue, so sick, nausea for 10 days, reported booster on an unspecified date It was further reported that For patient it was mandatory to get the vaccines 2 weeks ago and had the booster dose and suffered from side effects for one full week. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; very high fevers; extreme fatigue; so sick; nausea; Booster; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for a female patient (neighbour). A 65-years-old female patient received bnt162b2 (COMIRNATY, solution for injection, Lot number was not reported), dose 3 via an unspecified route of administration on an unspecified date as DOSE 3(BOOSTER), SINGLE for covid-19 immunisation. Medical history included osteoarthritis. The patient's concomitant medications were not reported.Patient was healthy before vaccination. Historical vaccine included Covid-19 vaccine as dose 1 and dose 2(Manufacturere unknown) for covid-19 immunisation. It was reported that patient had minimal side effects with previous 2 doses. The patient experienced vomiting for 3 days, very high fevers, extreme fatigue, so sick, nausea for 10 days, reported booster on an unspecified date It was further reported that For patient it was mandatory to get the vaccines 2 weeks ago and had the booster dose and suffered from side effects for one full week. The outcome of events was not recovered.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Breakthrough covid case; Breakthrough covid case; This is a spontaneous report from a contactable consumer (Patient). A 26-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received previously first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The reason for Lot number unknown was reported as not available/provided to reporter at the time of dose 1 and 2 report completion. Facility type vaccine was reported as workplace clinic. The patient did not receive any other vaccine in four weeks and unknown if any other medications in two weeks. The patient was not COVID prior vaccination and tested COVID post vaccination (confirmed by Rapid Test). On 14Nov2021, the patient experienced COVID-19 (Adverse event Breakthrough COVID) due to drug ineffectiveness. On 14Nov2021, the patient underwent lab tests and procedures which included SARS-CoV-2 test (Rapid test): positive. The patient did not receive treatment for the events. The clinical outcome of event was recovering.   No follow up attempts are possible. Information on Lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 RNA, Vaccination failure
Clinical narrative: Tested positive for COVID on 15Nov2021 based on a test taken on 14Nov2021; Tested positive for COVID on 15Nov2021 based on a test taken on 14Nov2021; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient).   A 55-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EP 6955), intramuscular, administered in Arm Right on 26Mar2021 as dose 2, single and received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL 3247) intramuscular, administered in Arm Right on 05Mar2021 as dose 1, single for both covid-19 immunisation (age at the time of vaccination was 55 years). The patient medical history and concomitant medications were not reported. The patient had no known allergies. No other vaccine was received in four weeks. The patient did not have covid prior vaccination. On 13Nov2021, the patient experienced tested positive for covid on 15Nov2021 based on a test taken on 14nov2021. On 14Nov2021, the patient underwent lab tests and procedures which included sars-cov-2 rna: positive (Nasal swab, Sars-cov-2 rna, ql naat, rtpcr/tma). No treatment was received for AE. Reportedly, the AE resulted in Doctor or other healthcare professional office/clinic visit. The patient was tested for covid post vaccination. The outcome of the events was reported to be recovering.    Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Immunisation
Clinical narrative: Chills; Dose number 3/Booster dose; This is a spontaneous report received from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: FF8841 and expiry date was not reported) via intramuscular, administered into the arm left, on 15Nov2021 9:30, at the age of 47-year-old, as dose 3 (Booster), single for COVID-19 immunization in workplace clinic. The patient medical history was not reported. Historical vaccine included BNT162B2 (PFIER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EP6955 and expiry date were not reported) via intramuscular, administered into the arm left, on 18Mar2021 14:00, at the age of 46-year-old, as dose 1, single and then second dose of BNT162B2 (PFIER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EP6955 and expiry date were not reported) via intramuscular, administered into the arm left, on 08Apr2021 09:30, at the age of 46-year-old, as dose 2, single both for COVID-19 immunization. The patient other medications within two weeks included Atorvastatin 40 mg and Escitalopram 10 mg. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Nov2021 12:30 AM, the patient experienced chills. The patient didn't receive any treatment in response to the event. The outcome of the event was recovered on an unspecified date in Nov2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: hair breakage; excessive hair loss; This is a spontaneous report from a contactable consumer. This consumer reported similar events for 3 patients. This is a 1st of 3 reports. This female consumer (patient) reported that: A 71-year-old female patient received bnt162b2 (BNT162B2, formulation: Solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On an unspecified date the patient experienced hair breakage and excessive hair loss. It was reported that the patient states that a friend of hers also had the Pfizer Covid 19 vaccine and her friend, who is female, experienced the same issue with excessive hair loss and hair breakage. The clinical outcome of the events was unknown  The lot number for [BNT162B2], was not provided and will be requested during follow up; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101599235 same reporter/drug/event, different pt;US-PFIZER INC-202101599236 same reporter/drug/event, different pt
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Trichorrhexis
Clinical narrative: hair breakage; excessive hair loss; This is a spontaneous report from a contactable consumer. This consumer reported for a patient that: A patient of an unspecified age and gender received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On an unspecified date, the patient experienced excessive hair loss and hair breakage. It was reported that consumer asked if anyone had reported excessive hair loss and hair breakage more than usual since she also experienced that with the Pfizer Biontech COVID19 vaccine. Consumer stated she called her local county in which one nurse mentioned that a patient mentioned having a similar experience but was unsure which covid vaccine, added that she had a friend who also expressed the same thing to her regarding the vaccine. All the events were considered as non-serious as per the reporter. Outcome of the events was unknown.  The lot number for the vaccine, [COMIRNATY] was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101595686 same reporter/drug/event, different pt;US-PFIZER INC-202101599236 same reporter/drug/event, different pt
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal dreams, Arthralgia, Body temperature, Chills, Fatigue
Clinical narrative: stabbing joint pain; headache; vivid dreams; brain fog; Lymphadenopathy; malaise; tiredness; chills; fever of 101F; Muscle pain/Muscle aches; booster; This is a spontaneous report from a contactable Consumer (Patient) . A 44-year-old non pregnant female patient received third dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: FF8841) via unspecified route on right arm on 15Nov2021 1:00 PM as dose 3 (booster), single for covid-19 immunisation (age at vaccination: 44-years-old). The patient's medical history included Asthma. Concomitant medications were not reported. The patient received 1st dose of BNT162B2 on 26Jan2021 (lot number: EL3247) and dose 2 on 16Feb2021 11::00 AM  (lot number: EL3247) on left arm for covid-19 immunisation (age at 43-years-old). On 16Nov2021 04:00 AM, patient had  stabbing joint pain, headache, vivid dreams. On 15Nov2021 7:00 PM, patient had  Lymphadenopathy, muscle aches, chills, fever of 101F, malaise, tiredness, brain fog. Lymphadenopathy still persists. No Covid prior vaccination, not tested for Covid post vaccination, No other vaccine in four weeks, Other medications in two weeks was No. No treatment received for the events. Outcome of all events was recovering.  Follow-Up (23Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Immunisation, Lymphadenopathy, Malaise
Clinical narrative: stabbing joint pain; headache; vivid dreams; brain fog; Lymphadenopathy; malaise; tiredness; chills; fever of 101F; Muscle pain/Muscle aches; booster; This is a spontaneous report from a contactable Consumer (Patient) . A 44-year-old non pregnant female patient received third dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: FF8841) via unspecified route on right arm on 15Nov2021 1:00 PM as dose 3 (booster), single for covid-19 immunisation (age at vaccination: 44-years-old). The patient's medical history included Asthma. Concomitant medications were not reported. The patient received 1st dose of BNT162B2 on 26Jan2021 (lot number: EL3247) and dose 2 on 16Feb2021 11::00 AM  (lot number: EL3247) on left arm for covid-19 immunisation (age at 43-years-old). On 16Nov2021 04:00 AM, patient had  stabbing joint pain, headache, vivid dreams. On 15Nov2021 7:00 PM, patient had  Lymphadenopathy, muscle aches, chills, fever of 101F, malaise, tiredness, brain fog. Lymphadenopathy still persists. No Covid prior vaccination, not tested for Covid post vaccination, No other vaccine in four weeks, Other medications in two weeks was No. No treatment received for the events. Outcome of all events was recovering.  Follow-Up (23Nov2021): Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: stabbing joint pain; headache; vivid dreams; brain fog; Lymphadenopathy; malaise; tiredness; chills; fever of 101F; Muscle pain/Muscle aches; booster; This is a spontaneous report from a contactable Consumer (Patient) . A 44-year-old non pregnant female patient received third dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: FF8841) via unspecified route on right arm on 15Nov2021 1:00 PM as dose 3 (booster), single for covid-19 immunisation (age at vaccination: 44-years-old). The patient's medical history included Asthma. Concomitant medications were not reported. The patient received 1st dose of BNT162B2 on 26Jan2021 (lot number: EL3247) and dose 2 on 16Feb2021 11::00 AM  (lot number: EL3247) on left arm for covid-19 immunisation (age at 43-years-old). On 16Nov2021 04:00 AM, patient had  stabbing joint pain, headache, vivid dreams. On 15Nov2021 7:00 PM, patient had  Lymphadenopathy, muscle aches, chills, fever of 101F, malaise, tiredness, brain fog. Lymphadenopathy still persists. No Covid prior vaccination, not tested for Covid post vaccination, No other vaccine in four weeks, Other medications in two weeks was No. No treatment received for the events. Outcome of all events was recovering.  Follow-Up (23Nov2021): Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Diabetes mellitus, Fatigue, Feeling abnormal, Neck pain
Clinical narrative: achey neck; soreness in the upper body; fatigue; brain fog; Type 2 Diabetic/issues maintaining blood glucose levels/flared up again/BG levels were erratic; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single ad received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus and covid-19 from an unknown date. The patient's concomitant medications were not reported. On 07Jul2021, type 2 diabetic/issues maintaining blood glucose levels/flared up again/bg levels were erratic, achey neck, soreness in the upper body, fatigue and brain fog. The patient was a long distance cyclist so he got his fair share of exercise. He eat moderately good and was a Type 2 Diabetic. After his COVID infection in February it took months for my blood sugar to stabilize. He could eat perfect and exercise and would wake up with bizarre fasting Blood Glucose levels. This settled down and then flared up again after he had the first dose of the Pfizer vaccine. For 3 weeks my BG levels were erratic and then every so often they would be erratic or he would have to be so much more religious to get the levels down to manageable levels. After his second vaccine he had the same exact symptoms. BG levels were all over the place. In addition, both times he got the vaccine and it brought on the same exact COVID symptoms with the achey neck, soreness in the upper body and fatigue as well as brain fog. After meeting with His endocrinologist a couple of weeks ago he said that the majority of patients have found that they were not able to control their BG levels for 1-3 weeks after getting vaccinated. The patient underwent lab tests and procedures which included blood glucose: unknown (For 3 weeks, erratic and then every so often they would be erratic, blood glucose: unknown (After his second vaccine he had the same exact symptoms. BG levels were all over the place ), blood glucose: unknown (wake up with bizarre fasting Blood Glucose levels). The outcome of events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: achey neck; soreness in the upper body; fatigue; brain fog; Type 2 Diabetic/issues maintaining blood glucose levels/flared up again/BG levels were erratic; This is a spontaneous report from a contactable consumer. A 51-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single ad received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0196), via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing diabetes mellitus and covid-19 from an unknown date. The patient's concomitant medications were not reported. On 07Jul2021, type 2 diabetic/issues maintaining blood glucose levels/flared up again/bg levels were erratic, achey neck, soreness in the upper body, fatigue and brain fog. The patient was a long distance cyclist so he got his fair share of exercise. He eat moderately good and was a Type 2 Diabetic. After his COVID infection in February it took months for my blood sugar to stabilize. He could eat perfect and exercise and would wake up with bizarre fasting Blood Glucose levels. This settled down and then flared up again after he had the first dose of the Pfizer vaccine. For 3 weeks my BG levels were erratic and then every so often they would be erratic or he would have to be so much more religious to get the levels down to manageable levels. After his second vaccine he had the same exact symptoms. BG levels were all over the place. In addition, both times he got the vaccine and it brought on the same exact COVID symptoms with the achey neck, soreness in the upper body and fatigue as well as brain fog. After meeting with His endocrinologist a couple of weeks ago he said that the majority of patients have found that they were not able to control their BG levels for 1-3 weeks after getting vaccinated. The patient underwent lab tests and procedures which included blood glucose: unknown (For 3 weeks, erratic and then every so often they would be erratic, blood glucose: unknown (After his second vaccine he had the same exact symptoms. BG levels were all over the place ), blood glucose: unknown (wake up with bizarre fasting Blood Glucose levels). The outcome of events were unknown.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular, SARS-CoV-2 test
Clinical narrative: My periods (I've had 4) since the shot have been extremely and abnormally heavy; My periods (I've had 4) since the shot have been extremely and abnormally heavy; Days of painful cramps which turn into a dull heavy feeling in my uterus; Covid test result - Positive Date 09Aug2021; Covid test result - Positive Date 09Aug2021; This is a spontaneous report from a contactable consumer (patient herself). A 47-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number EW0181, Expiration Date: Unknown), via intramuscular route of administration in Right Arm on 26Jul2021 11:00 AM (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included Cyst for which I take nuvaring to keep under control from an unknown date and unknown if ongoing. Patient had Penicillin allergy. The concomitant medications included Flonase Nuvaring from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient received other medications within 2 weeks of vaccination was reported as Flonase Nuvaring. On 09Aug2021, the patient experienced drug ineffective, suspected COVID-19, on 18Aug2021 07:30, the patient experienced, heavy menstrual bleeding, menstrual irregular, and dysmenorrhea. Her periods since the shot have been extremely and abnormally heavy. She never had periods like this before. Days of painful cramps which turn into a dull heavy feeling in her uterus. The cramps start about 2 days before she starts bleeding which was not normal for her. On 09Aug2021 the patient underwent lab tests and procedures which included COVID-19 test results Positive, Technique: Nasal Swab. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for adverse event reported that she will have a pelvic ultrasound on December 10. The outcome of all the events was reported as Not Recovered.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: My periods (I've had 4) since the shot have been extremely and abnormally heavy; My periods (I've had 4) since the shot have been extremely and abnormally heavy; Days of painful cramps which turn into a dull heavy feeling in my uterus; Covid test result - Positive Date 09Aug2021; Covid test result - Positive Date 09Aug2021; This is a spontaneous report from a contactable consumer (patient herself). A 47-years-old non-pregnant female patient received bnt162b2 (COMIRNATY, Formulation: Solution for injection, Lot number EW0181, Expiration Date: Unknown), via intramuscular route of administration in Right Arm on 26Jul2021 11:00 AM (at the age of 47-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history included Cyst for which I take nuvaring to keep under control from an unknown date and unknown if ongoing. Patient had Penicillin allergy. The concomitant medications included Flonase Nuvaring from an unknown date and unknown if ongoing. The patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19. The patient received other medications within 2 weeks of vaccination was reported as Flonase Nuvaring. On 09Aug2021, the patient experienced drug ineffective, suspected COVID-19, on 18Aug2021 07:30, the patient experienced, heavy menstrual bleeding, menstrual irregular, and dysmenorrhea. Her periods since the shot have been extremely and abnormally heavy. She never had periods like this before. Days of painful cramps which turn into a dull heavy feeling in her uterus. The cramps start about 2 days before she starts bleeding which was not normal for her. On 09Aug2021 the patient underwent lab tests and procedures which included COVID-19 test results Positive, Technique: Nasal Swab. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for adverse event reported that she will have a pelvic ultrasound on December 10. The outcome of all the events was reported as Not Recovered.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Limb mass, Lymphadenopathy, Peripheral swelling
Clinical narrative: swelling up under the left armpit; booster; little lump; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient) or other non-HCP, who reported for himself.  A 65-years-old male received third dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number was FC3527) via an unspecified route of administration, administered in Arm Left on 10Nov2021, between 11:00 and 12:00 (age at the time of vaccination was 65-years-old) as DOSE 3 (BOOSTER), 0.3ml SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had no prior vaccinations within 4 weeks. The patient had no adverse events following prior vaccinations. The patient had other conditions but nothing to do with the vaccine. The patient had no family medical history relevant to adverse events. Previously, the patient received second dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number was ER8734) via an unspecified route of administration on 31Mar2021 (age at the time of vaccination was 64-years-old) as DOSE 2, SINGLE for COVID-19 immunization. Also, the patient received first dose of bnt162b2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot Number was EN6208) via an unspecified route of administration on 10Mar2021 (age at the time of vaccination was 64-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 10Nov2021, the patient experienced booster. On 15Nov2021, the patient experienced swelling up under the left armpit. On an unspecified date in Nov2021, the patient experienced little lump and swollen lymph nodes No relevant tests were done. The clinical outcome of swelling up under the left armpit was recovering, while the clinical outcome of booster, little lump and swollen lymph nodes was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for Covid; This is a spontaneous report from a contactable nurse.  A 65-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: FC3181) via an unspecified route of administration in her unspecified deltoid on 27Aug2021 as DOSE 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient doesn't think so additional vaccines administered on same date of the Pfizer suspect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. Caller states that she has an employee that received the first dose of the Pfizer COVID vaccine adult formulation purple cap on 27Aug2021 and then tested positive for COVID-19 on 02Sep2021. Caller states the patient has not received the second dose yet. Caller states her human resource person informed her that the patient would need to restart the series and she does not think that the patient needs to restart the series. Caller would like to know if we have information regarding the patient having to restart the series or not. The patient underwent lab tests and procedures which included COVID-19 PCR test: positive on 24Sep2021. At the time of this report, the outcome of events was Unknown.  Conclusion: The complaint for lack of effect of the PFIZERBIONTECH COVID-19 VACCINE lot FC3181 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot FC3181, fill lot EY0567, and the formulated drug product lot FE3195. A complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications.  Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID infection. Covid test result Positive; Breakthrough COVID infection. Covid test result Positive; This is a spontaneous report received from a contactable consumer or other non-health care professional.   A 24-year-old non pregnant female patient received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch/Lot number: not reported) via intramuscularly in left arm on 20Feb2021 10:00 AM (age at the vaccination: 24-year-old) as dose 2, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection and Batch/Lot number: not reported) via intramuscularly in right arm on 30Jan2021 05:00 PM (Age at vaccination: 24-year-old) as dose 1, single for COVID-19 immunization at public health clinic/veterans administration facility. The patient had no other medical history and concomitant medications was not reported. patient had known allergies to mushrooms, olives, olive oil, seasonal/environmental. Patient did not receive any other vaccine within 4 weeks prior COVID 19. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. On 15Nov2021 07:00 AM, patient experienced breakthrough COVID infection. The adverse event result in emergency room/department or urgent care. Events considered as non-serious as per the reporter. On 17Nov2021, patient underwent lab tests and procedure which included Antigen Rapid test with Nasal Swab results positive for Sars-Cov2 infection. Patient did not receive any treatment for event reported. The outcome of the event breakthrough COVID infection was recovering.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Cramping/locking; This is a spontaneous report from a contactable consumer(Patient herself). A 65-year-old female patient received first dose of bnt162b2 (BNT162B2,PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on 2021 as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included wears hearing aids (Caller wears hearing aids) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took hizentra. Reporter stated that, Fever for months sporadically. Six specialists. None of them know what's going on to cause this. People in the hospital, fever? Weakness.  Part of the thing she took infusion. By normal she practically had no side effects with the other two. A couple years ago. Hizentra. She thought she could do them together. The patient experienced cramping/locking on Jul2021. The clinical outcome of event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Ankle fracture
Clinical narrative: Fractured ankle; This is a spontaneous report from a contactable consumer. This consumer (Pfizer employee) reported for a 22-year-old male patient who received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in 2021 as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on an unknown date in 2021 as dose 1, single for COVID-19 immunization. On an unknown date in 2021 the patient had a fractured ankle. The event outcome was unknown.  The lot number for vaccine [BNT162B2] was not provided and would be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lethargy
Clinical narrative: My first two doses resulted in only soreness at the site of injection and lethargy; My first two doses resulted in only soreness at the site of injection and lethargy; This is a spontaneous report from a contactable consumer (patient). A 39-years-old female patient received bnt162b2 (BNT162B2, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE, dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunization. Medical history included shoulder surgery from 05Jun2014n to 05Jun2014 capsular release to fix car accident injury, lyme disease (several times) from an unknown date and unknown if ongoing has historically contrilated to joint pain, Bulging disc injury from 07Jul2018 to an unknown date still have nerve compression and muscle tightness, Broken bones from 2013 to Nov2015 Again many in childhood fingers, toes, elbows. Many in car accident: clavicle, scapula, nose, ribs, vertebrae, skull, a few since toes, ribs, polycystic ovarian syndrome from an unknown date and unknown if ongoing, migraine from an unknown date and unknown if ongoing, allergies from an unknown date and unknown if ongoing, gastric reflux from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medication(s) included drospirenone, ethinylestradiol betadex clathrate (YAZ) taken for polycystic ovaries from Oct2006 and ongoing; metformin hydrochloride (METFORMIN [METFORMIN HYDROCHLORIDE]) taken for polycystic ovaries from Oct2006 and ongoing; verapamil taken for migraine from Oct2021 and ongoing; naratriptan hydrochloride (NARATRIPTAN [NARATRIPTAN HYDROCHLORIDE]) taken for migraine from Oct2021 and ongoing; loratadine (CLARITINE) taken for hypersensitivity from Sep2021 and ongoing; famotidine taken for reflux gastritis from May2009 and ongoing; sertraline taken for anxiety from Jul2019 and ongoing. The patient experienced my first two doses resulted in only soreness at the site of injection and lethargy on an unspecified date. The event was reported as non-serious. The clinical outcomes of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Polymenorrhoea, SARS-CoV-2 test
Clinical narrative: metrorrhagia post covid shot; periods every two weeks; periods every two weeks, extremely painful; This is a spontaneous report from a contactable consumer (Patient). A 27-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: EW0158), via an unspecified route of administration, administered in Arm Left on 03May2021 12:00PM (age at vaccine 27-years-old) as dose 2, single for covid-19 immunisation. it was reported that the patient was not a pregnant at the time of vaccination. The patient medical history included anxiety, asthma, covid-19 and covid prior vaccination. If covid tested post vaccination was yes. Concomitant medications included alprazolam (XANAX) amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL). The patient previously took amoxicillin and experienced drug allergy. The patient previously received historical vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Left on 12Apr2021 12:00PM (age at vaccine 27-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced metrorrhagia post covid shot, periods every two weeks and periods every two weeks, extremely painful on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test negative on 10Oct2021. The clinical outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Fatigue, Feeling abnormal
Clinical narrative: Dose received 3/dose number = 3; I had a fever about 102 degrees; Felt absolutely terrible/could not get out of bed; Also started having bad tinnitus that lasted a few months; I had a really bad headache; Was completely exhausted; Couldnt stay awake; Had the chills; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 09Apr2021 (at the age of 32-years-old) and third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Nov2021 at 17:30 (at the age of 32-years-old), both as single doses for COVID-19 immunisation. Medical history included tinnitus and flu. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the right arm on 19Mar2021 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021, immediately after the second shot, the patient started having bad tinnitus that lasted a few months. The patient reported that he had tinnitus earlier in his life, about 15 years before this, but hadn't had it since. On 10Apr2021, the day after his second shot the patient had fever, about 102 degrees, felt absolutely terrible. On an unknown date in 2021, the patient could not get out of bed, had a really bad headache, was completely exhausted and couldn't stay awake, the patient also experienced chills and diarrhea and the patient felt worse than he did when he had the flu a couple of years ago. It was reported that after his booster shot (3rd dose), the patient experienced exact same way all over again. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever, felt absolutely terrible, could not get out of bed, really bad headache, was completely exhausted and couldn't stay awake, chills, diarrhea and tinnitus was resolved on an unknown date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.