chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Insomnia
Clinical narrative: muscle discomfort on my left arm and leg; rapid heartbeat 106-120 sporadically; nausea; lightheadedness & tightness; lightheadedness & tightness; random dizzy episodes; intermittent muscle pains in my left arm & left leg; BP is high then low; fatigue; Sleeping is irregular; pressure headache/pressure pounding headaches; my booster 19Aug2021; my booster 19Aug2021; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer (patient) reported that:  A 48-year-old female (Non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in arm left on 19Aug2021 as dose 3, (age at the time of vaccination 48-years-old), single for covid-19 immunization. The patient previously took first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 22Jan2021 12:00 PM as dose 1, and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration, administered in arm left on 12Feb2021 (age at the time of vaccination 47-years-old), single for covid-19 immunization. The patient medical history included Thyroid. Patient was known allergies to PCN and Tramadol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks RX by my doctor. I have been having symptoms since my booster 19Aug2021. I was able to manage the first few days after my shot because I knew/researched what is expected. On 20Aug2021 07:00AM, the patient stated my pressure pounding headaches are continuous, rapid heartbeat 106-120 sporadically with nausea, lightheadedness and tightness, random dizzy episodes, and intermittent muscle pains in my left arm & left leg-same side as my shot, my BP is high then low. Sleeping is irregular/fatigue. This symptoms come in different phases and not all at once. As combination of shot 1 and 2, but this time its weeks not 48 hours. I had a CT scan just to check, it is normal. I am not worried because it is better then getting COVID. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date, the events were recovered with sequel. At the time of reporting, the events muscle discomfort on my left arm and leg and pressure headache/pressure pounding headaches was not recovered and event my booster 19Aug2021 was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle discomfort, Myalgia, Nausea, Off label use, Tension headache
Clinical narrative: muscle discomfort on my left arm and leg; rapid heartbeat 106-120 sporadically; nausea; lightheadedness & tightness; lightheadedness & tightness; random dizzy episodes; intermittent muscle pains in my left arm & left leg; BP is high then low; fatigue; Sleeping is irregular; pressure headache/pressure pounding headaches; my booster 19Aug2021; my booster 19Aug2021; This is a spontaneous report from a contactable consumer. This 48-year-old female consumer (patient) reported that:  A 48-year-old female (Non pregnant) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: FC3183) via an unspecified route of administration, administered in arm left on 19Aug2021 as dose 3, (age at the time of vaccination 48-years-old), single for covid-19 immunization. The patient previously took first dose of received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9262) via an unspecified route of administration, administered in arm left on 22Jan2021 12:00 PM as dose 1, and dose 2 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EL9266) via an unspecified route of administration, administered in arm left on 12Feb2021 (age at the time of vaccination 47-years-old), single for covid-19 immunization. The patient medical history included Thyroid. Patient was known allergies to PCN and Tramadol. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks RX by my doctor. I have been having symptoms since my booster 19Aug2021. I was able to manage the first few days after my shot because I knew/researched what is expected. On 20Aug2021 07:00AM, the patient stated my pressure pounding headaches are continuous, rapid heartbeat 106-120 sporadically with nausea, lightheadedness and tightness, random dizzy episodes, and intermittent muscle pains in my left arm & left leg-same side as my shot, my BP is high then low. Sleeping is irregular/fatigue. This symptoms come in different phases and not all at once. As combination of shot 1 and 2, but this time its weeks not 48 hours. I had a CT scan just to check, it is normal. I am not worried because it is better then getting COVID. No treatment was received in response to the adverse events. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. On an unspecified date, the events were recovered with sequel. At the time of reporting, the events muscle discomfort on my left arm and leg and pressure headache/pressure pounding headaches was not recovered and event my booster 19Aug2021 was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: My husband & I both received our Covid-19 vaccines between 26March - 01May2021. We both tested positive for Covid-19 last week; My husband & I both received our Covid-19 vaccines between 26March - 01May2021. We both tested positive for Covid-19 last week; This is a spontaneous report from a contactable consumer (Patient). A female patient of an unspecified age received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 01May2021 as single dose and first dose of (BNT162B2, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 26Mar2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced my husband & i both received our covid-19 vaccines between 26march - 01may2021. we both tested positive for covid-19 last week. On an unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test positive results. The outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101193487 Same reporter/drug/AE, different patient
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: My husband & I both received our Covid-19 vaccines between 26Mar-01May2021. We both tested positive for Covid-19 last week; My husband & I both received our Covid-19 vaccines between 26Mar-01May2021. We both tested positive for Covid-19 last week; This is a spontaneous report from a contactable consumer (patient wife). A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), 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 first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient and his wife both received COVID-19 vaccines between 26Mar2021-01May2021. They both tested positive for COVID-19 last week, on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test: positive. Outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101193383 Same reporter/drug/AE, different patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node at neck/shoulder of right side; This is a spontaneous report from a non-contactable consumer, the patient. A 59-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Unknown) via an unspecified route of administration in the right arm on 23Aug2021 at 07:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 24Aug2021, the patient had swollen lymph node at neck/shoulder of right side. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph node at neck/shoulder of right side was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspepsia
Clinical narrative: Acid indigestion; Cholesterol is high; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 07Apr2021(at the age of 58-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were reported as not applicable (Na). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 22Apr2021, the patient experienced acid indigestion since the vaccination and the patient did not have it before. Also, the cholesterol was high which the patient never had it high before. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events acid indigestion and cholesterol is high was unknown at the time of this report.    The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Nasal congestion, Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: positive Covid-19 test; positive Covid-19 test; She has sniffles; Nose congestion/Stuffy nose; Stuffy nose and I think she might have little scratchy throat type of; This is a spontaneous report from a contactable consumer (Patient's Parent). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: EP6955), via an unspecified route of administration on 13Apr2021, as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: EP6955), via an unspecified route of administration on 23Mar2021 (age at vaccination was 17 years), as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were not taken other products. The patient stated that she had sniffles on Sep2021 and tested and day before reporting, she received a positive Covid-19 test on 11Sep2021 and there were just sniffles, just like nose congestion on Sep2021 if anything else she would call back. No that was it at the moment she had no other symptom besides that actually like stuffy nose and she thought she might had little scratchy throat type on Sep2021. She did not receive treatment for adverse events. The outcome of event covid-19 was unknown and outcome of other events was not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination failure
Clinical narrative: positive Covid-19 test; positive Covid-19 test; She has sniffles; Nose congestion/Stuffy nose; Stuffy nose and I think she might have little scratchy throat type of; This is a spontaneous report from a contactable consumer (Patient's Parent). A 17-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: EP6955), via an unspecified route of administration on 13Apr2021, as dose 2, single and first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, batch number: EP6955), via an unspecified route of administration on 23Mar2021 (age at vaccination was 17 years), as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. There were not taken other products. The patient stated that she had sniffles on Sep2021 and tested and day before reporting, she received a positive Covid-19 test on 11Sep2021 and there were just sniffles, just like nose congestion on Sep2021 if anything else she would call back. No that was it at the moment she had no other symptom besides that actually like stuffy nose and she thought she might had little scratchy throat type on Sep2021. She did not receive treatment for adverse events. The outcome of event covid-19 was unknown and outcome of other events was not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Fatigue, Headache
Clinical narrative: vomiting; diarrhea; dizziness; Tiredness; Fever; Headache; Chills; This is a spontaneous report from a contactable consumer reported for herself. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3182, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 10Sep2021 (age at vaccination was 31 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. On 11Sep2021 on Saturday patient woke up with a headache that last with the whole day, dizziness, tiredness, Chills and Fever, candex diarrhea and vomiting at night. On 11Sep2021, after the second dose the patient experienced vomiting, diarrhea, dizziness, tiredness, fever, headache and chills. The medication that patient took was pain medication, over the counter pain medication just one pill but it didn't help it is Acetaminophen and it was 500 milligrams. Therapeutic measures were taken as a result of vomiting, diarrhea, dizziness, tiredness, fever, headache and chills. The outcome of the events was unknown.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: vomiting; diarrhea; dizziness; Tiredness; Fever; Headache; Chills; This is a spontaneous report from a contactable consumer reported for herself. A 31-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: FC3182, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 10Sep2021 (age at vaccination was 31 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: was not reported) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date as dose 1, single for COVID-19 immunization. On 11Sep2021 on Saturday patient woke up with a headache that last with the whole day, dizziness, tiredness, Chills and Fever, candex diarrhea and vomiting at night. On 11Sep2021, after the second dose the patient experienced vomiting, diarrhea, dizziness, tiredness, fever, headache and chills. The medication that patient took was pain medication, over the counter pain medication just one pill but it didn't help it is Acetaminophen and it was 500 milligrams. Therapeutic measures were taken as a result of vomiting, diarrhea, dizziness, tiredness, fever, headache and chills. The outcome of the events was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Headache, Hyperhidrosis, Illness
Clinical narrative: Extreme fatigue; Pain and swelling on the  left arm pit; Pain and swelling moved to my left arm pit.; General sickness; Threw up a little and got all sweaty; Threw up a little and got all sweaty; Headache; Body aches; Left arm became swollen and very painful.; Left arm swollen and very painful; Slept for about 20 hours getting up for a couple hours then becoming so tired I went back to sleep; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 01Sep2021 at 15:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease of ileum. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), buspirone hydrochloride (BUSPAR) and vedolizumab (ENTYVIO) all for an unknown indication from an unknown date and unknown if ongoing (also reported as 09Aug). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Sep2021 at 00:00, night after the vaccination, the patient experienced headache and body aches, left arm was swollen and very painful. The patient could not sleep if it got touched or gravity was pulling on it at all and would wake up with a sharp pain. On 03Sep2021 (reported as the following day), the patient experienced extreme fatigue and was tired. The patient slept for about 20 hours and got up for a couple of hours then became so tired and went back to sleep. On the same day, the patient threw up a little and got all sweaty. On day 2, 03Sep2021 after the vaccination, the patient's arm was less swollen but the pain and swelling moved to the left armpit and general sickness and body aches but less than the previous day. It was reported that each following day it got better and swelling went down over the course of the next week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of the events headache, body aches, left arm swollen and painful  which included unspecified pain medication which helped her to get to sleep but it did not take all the pain away. No therapeutic measures were taken as a result of the events extreme fatigue, tired, threw up a little and got all sweaty, left arm swollen, pain and swelling of the left arm pit and general sickness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, extreme fatigue, tired, threw up a little and got all sweaty, left arm swollen and very painful, pain and swelling of the left arm pit and general sickness were resolved on an unknown date in Sep2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain, Pain in extremity, Peripheral swelling, Somnolence
Clinical narrative: Extreme fatigue; Pain and swelling on the  left arm pit; Pain and swelling moved to my left arm pit.; General sickness; Threw up a little and got all sweaty; Threw up a little and got all sweaty; Headache; Body aches; Left arm became swollen and very painful.; Left arm swollen and very painful; Slept for about 20 hours getting up for a couple hours then becoming so tired I went back to sleep; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 01Sep2021 at 15:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease of ileum. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), buspirone hydrochloride (BUSPAR) and vedolizumab (ENTYVIO) all for an unknown indication from an unknown date and unknown if ongoing (also reported as 09Aug). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Sep2021 at 00:00, night after the vaccination, the patient experienced headache and body aches, left arm was swollen and very painful. The patient could not sleep if it got touched or gravity was pulling on it at all and would wake up with a sharp pain. On 03Sep2021 (reported as the following day), the patient experienced extreme fatigue and was tired. The patient slept for about 20 hours and got up for a couple of hours then became so tired and went back to sleep. On the same day, the patient threw up a little and got all sweaty. On day 2, 03Sep2021 after the vaccination, the patient's arm was less swollen but the pain and swelling moved to the left armpit and general sickness and body aches but less than the previous day. It was reported that each following day it got better and swelling went down over the course of the next week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of the events headache, body aches, left arm swollen and painful  which included unspecified pain medication which helped her to get to sleep but it did not take all the pain away. No therapeutic measures were taken as a result of the events extreme fatigue, tired, threw up a little and got all sweaty, left arm swollen, pain and swelling of the left arm pit and general sickness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, extreme fatigue, tired, threw up a little and got all sweaty, left arm swollen and very painful, pain and swelling of the left arm pit and general sickness were resolved on an unknown date in Sep2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Extreme fatigue; Pain and swelling on the  left arm pit; Pain and swelling moved to my left arm pit.; General sickness; Threw up a little and got all sweaty; Threw up a little and got all sweaty; Headache; Body aches; Left arm became swollen and very painful.; Left arm swollen and very painful; Slept for about 20 hours getting up for a couple hours then becoming so tired I went back to sleep; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0169) via an unspecified route of administration in the left arm on 01Sep2021 at 15:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease of ileum. The patient did not have any known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included sertraline hydrochloride (ZOLOFT), lisdexamfetamine mesilate (VYVANSE), buspirone hydrochloride (BUSPAR) and vedolizumab (ENTYVIO) all for an unknown indication from an unknown date and unknown if ongoing (also reported as 09Aug). The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02Sep2021 at 00:00, night after the vaccination, the patient experienced headache and body aches, left arm was swollen and very painful. The patient could not sleep if it got touched or gravity was pulling on it at all and would wake up with a sharp pain. On 03Sep2021 (reported as the following day), the patient experienced extreme fatigue and was tired. The patient slept for about 20 hours and got up for a couple of hours then became so tired and went back to sleep. On the same day, the patient threw up a little and got all sweaty. On day 2, 03Sep2021 after the vaccination, the patient's arm was less swollen but the pain and swelling moved to the left armpit and general sickness and body aches but less than the previous day. It was reported that each following day it got better and swelling went down over the course of the next week. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures taken as a result of the events headache, body aches, left arm swollen and painful  which included unspecified pain medication which helped her to get to sleep but it did not take all the pain away. No therapeutic measures were taken as a result of the events extreme fatigue, tired, threw up a little and got all sweaty, left arm swollen, pain and swelling of the left arm pit and general sickness. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, body aches, extreme fatigue, tired, threw up a little and got all sweaty, left arm swollen and very painful, pain and swelling of the left arm pit and general sickness were resolved on an unknown date in Sep2021.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness at injection site; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 08Sep2021 at 10:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Sep2021, approximately 6 hours later, the patient experienced soreness at injection site which lasted for 2 to 3 days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event soreness at injection site was resolved on an unknown date in Sep2021.  No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation irregular
Clinical narrative: Started bleeding later that evening after the shot.; Also started having severe menstual cramps; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration on 08Sep2021 at 16:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable (N/A). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for birth control from an unknown date and was ongoing. On 08Sep2021 at 22:30, in the evening the patient started bleeding after the shot. The patient was on birth control in a very strict schedule. On the day of the COVID-19 shot, the patient was on day ten of the cycle (taking active pills). The patient also started having severe menstrual cramps. Both the bleeding and the cramping had not subsided even though the patient had continued to taking birth control at the exact same time every day. Prior to getting the COVID shot the patient had a full gynaecological work up and everything was normal, so the only variable was the COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started bleeding later that evening after the shot and also started having severe menstrual cramps were not resolved at the time of this report.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Rash, Skin exfoliation, Skin reaction
Clinical narrative: Skin reaction, which never had before; It first looked like a rash, then skin started peeling; It first looked like a rash, then skin started peeling; Headache; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 27Aug2021 at 14:30 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0175) via an unspecified route of administration in the left arm on 06Aug2021 at 14:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. On 28Aug2021, the day after the second dose, the patient experienced headache. On 02Sep2021 at 14:00, a week after the second dose, the patient experienced skin reaction, that the patient had never before. The reaction first looked like a rash, then the patient's skin started peeling. The patient thought it would go away in no time but it was then on the belly, breasts, back, and arms. 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 taken as a result of the events skin reaction, rash, and skin peeling which included treatment with petroleum jelly but did not know what action to be taken. The clinical outcome of the events skin reaction, which never had before, it first looked like a rash, then skin started peeling and headache were not recovered at the time of this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Psoriasis which I have all over my body started clearing up/also have psoriatic arthritis It seems to have eased it some; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 22Aug2021 (at the age of 50-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia, psoriatic arthritis, and psoriasis. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 22Aug2021, immediately after the first dose of the vaccine, psoriasis which the patient had all over the body started clearing up. The vaccine had worked better than any medicine that the patient had ever tried and the patient had psoriasis since she was 18-years-old. The patient also had psoriatic arthritis which seemed to have eased it some. The patient received the second dose on 12Sep2021 and would see the affect as time goes on. 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 event. The clinical outcome of the event psoriasis which the patient had all over body started clearing up/also had psoriatic arthritis which seemed to have eased it some was unknown. The patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration on 12Sep2021 (at the age of 51-years-old) as a single dose for COVID-19 immunisation.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling abnormal, Formication, Lacrimation increased
Clinical narrative: Head felt like things were crawling all over; Eyes started watering; Forehead started to get red; Felt like something burst inside head/ head still feels weird; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 24Aug2021 at 15:00 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received metformin (MANUFACTURER UNKNOWN) for an unspecified indication on unknown date and experienced drug allergy. On 24Aug2021 at 15:00, within just a few seconds of receiving the shot, the patient felt like something burst inside her head and within minutes her head felt like things were crawling all over, also eyes started watering and forehead started to get red. The patient's head still felt weird where that "pop" happened. Therapeutic measure was taken as a result of the events which included treatment with diphenhydramine (BENADRYL) given by pharmacist and the patient waited around another 15 minutes or so. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events head felt like things were crawling all over, eyes started watering, forehead started to get red was unknown; whereas the event felt like something burst inside head/ head still feels weird was not resolved at the time of this report.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging thoracic, Neurological eyelid disorder, Pulmonary function test, SARS-CoV-2 test, Scan brain
Clinical narrative: Right eye neurologically closed, eventually opening and stayed 1/4 closed all the time; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 08Feb2021 at 12:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 18Jan2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. On 08Mar2021, about 30 days after the second shot of Pfizer for COVID, the patient's right eye was neurologically closed, eventually opening and stayed 1/4 closed all the time. The eye doctor referred the patient to a neurologist and the patient underwent a brain scan, magnetic resonance imaging (MRI) of the chest and a pulmonary exam and all came back clean. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 16Mar2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were taken as a result of the event which included treatment with pyridostigmine bromide (MANUFACTURER UNKNOWN) 60 milligram tablet twice a day to keep the eye open.  The clinical outcome of the event right eye neurologically closed, eventually opening and stayed 1/4 closed all the time was resolving at the time of the report.
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eye movement disorder, Magnetic resonance imaging, Neurological symptom, Pulmonary function test, Scan brain
Clinical narrative: Right eye neurologically closed, eventually opening and stayed 1/4 closed all the time; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9262) via an unspecified route of administration in the left arm on 08Feb2021 at 12:00 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284) via an unspecified route of administration in the left arm on 18Jan2021 (at the age of 76-years-old) as a single dose for COVID-19 immunisation. On 08Mar2021, about 30 days after the second shot of Pfizer for COVID, the patient's right eye was neurologically closed, eventually opening and stayed 1/4 closed all the time. The eye doctor referred the patient to a neurologist and the patient underwent a brain scan, magnetic resonance imaging (MRI) of the chest and a pulmonary exam and all came back clean. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had been tested for COVID-19. On 16Mar2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were taken as a result of the event which included treatment with pyridostigmine bromide (MANUFACTURER UNKNOWN) 60 milligram tablet twice a day to keep the eye open.  The clinical outcome of the event right eye neurologically closed, eventually opening and stayed 1/4 closed all the time was resolving at the time of the report.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Intermenstrual bleeding, Menstruation irregular
Clinical narrative: Cramping; Spotting; Not supposed to start period for another week; This is a spontaneous report from a contactable other healthcare professional, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 11Sep2021 at 10:30 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included human immunodeficiency virus syndrome (HIV). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included emtricitabine, tenofovir disoproxil fumarate, rilpivirine hydrochloride (COMPLERA) for an unknown indication from an unknown date and unknown if ongoing. On 12Sep2021 at 09:00, the patient was not supposed to start period for another week, however she had uncomfortable cramping and spotting which were still ongoing two days after. The patient never had these symptoms before. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events cramping, spotting and not supposed to start period for another week were not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Eye inflammation, Eye pruritus, Eye swelling, Rash
Clinical narrative: rash all over his body; inflamed, swollen, itchy spot under his eyes; inflamed, swollen, itchy spot under his eyes; inflamed, swollen, itchy spot under his eyes; This is a spontaneous report from a contactable consumer or other non hcp (Reporter's son) via medical information team. A 27-year-old male patient received second dose of bnt162b2 (COMIRNATY, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration on 16May2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 for COVID-19 immunization. On an unspecified date in 2021, the patient experienced rash all over his body, inflamed, swollen, itchy spot under his eyes. Reporter is calling on behalf of her 27-year-old, Male, Son, who got the 2nd dose of the COMIRNATY vaccine on 16May2021. Post-vaccination, he observed a rash all over his body (like a little red spot) and has been there for a while now (a month). Also, reporter reported that his son developed an inflamed, swollen, itchy spot under his eyes and it is not going away (also described as extremely bad). Reporter even acknowledged it to look like an allergic reaction but not particular if it was caused by the vaccine. In line with this, reporter would like to know if these types of reactions are reported AE post vaccination and if these are expected to stay and last that long. Reporter mentioned that he already filed a safety report regarding this AE. Outcome of all the events was unknown.  The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow-up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Insomnia, Musculoskeletal stiffness, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 18:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Sep2021, the patient experienced stiff neck, headache, fatigue, nausea, muscle pain, insomnia and vision issues- bright light discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stiff neck, headache, fatigue, nausea, muscle pain, insomnia and vision issues- bright light discomfort was not resolved at the time of this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular discomfort
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on an unknown date in Sep2021 at 18:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included lyme. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 08Sep2021, the patient experienced stiff neck, headache, fatigue, nausea, muscle pain, insomnia and vision issues- bright light discomfort. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events stiff neck, headache, fatigue, nausea, muscle pain, insomnia and vision issues- bright light discomfort was not resolved at the time of this report.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity
Clinical narrative: Chills; Tenderness in arm; Whole body hurting; This is a spontaneous report from a contactable consumer (mother) reported for a 14-year-old male patient. A 14-year-old male patient received unknown dose of bnt162b2 (Pfizer COVID-19 Vaccine, Solution for injection, Batch/lot number: Not Provided, Expiry date: Not provided), via an unspecified route on 12Sep2021 as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, patient mother was looking on the website at the symptoms that could occur. Patient age at the onset of events was 14-year-old. She stated that he does have chills. She saw tenderness in the arm as a side effect, which he does have. However, also, his whole body was hurting. She wants to know if that was normal. The clinical outcome of the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.