chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: concerning problems after the second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (concerning problems after the second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (concerning problems after the second shot). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Vaccination adverse reaction, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (concerning problems after the second shot) outcome was unknown.            Concomitant medication of the patient was not reported.  The patient took 1000 mg of Tylenol 8 hours after the 2nd dose of his Moderna COVID-19 vaccine. He then took another 1000 mg of Acetaminophen 6 hours after the first Acetaminophen dose.
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: Fluorouracil cream; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (Fluorouracil cream) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (Fluorouracil cream). The patient was treated with FLUOROURACIL at an unspecified dose and frequency. At the time of the report, UNEVALUABLE EVENT (Fluorouracil cream) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.  Consumer received the first shot of the Moderna vaccine on Tuesday. He has been put on Fluorouracil cream by his doctor and wants to know if he should hold on until he gets the second shot?
Sex: U
Vaccine: COVID19
Symptoms: Knee operation
Clinical narrative: knee surgery after first dose; This spontaneous case was reported by a consumer and describes the occurrence of KNEE OPERATION (knee surgery after first dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced KNEE OPERATION (knee surgery after first dose). At the time of the report, KNEE OPERATION (knee surgery after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided.  Patient took Tylenol, Prednisone, Celecoxib and aspirn.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vaccination site bruising, Vaccination site erythema, Vaccination site swelling
Clinical narrative: General malaise; Bruise with a 6 inch radius at the injection site/It was bruised for 4-5 days; Swelling at the injection site; Fever; Redness at the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (General malaise), VACCINATION SITE BRUISING (Bruise with a 6 inch radius at the injection site/It was bruised for 4-5 days), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Redness at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 029L20A and 039K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Dec-2021, the patient experienced MALAISE (General malaise), VACCINATION SITE BRUISING (Bruise with a 6 inch radius at the injection site/It was bruised for 4-5 days), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Redness at the injection site). In December 2021, VACCINATION SITE BRUISING (Bruise with a 6 inch radius at the injection site/It was bruised for 4-5 days) had resolved. At the time of the report, MALAISE (General malaise), VACCINATION SITE SWELLING (Swelling at the injection site), PYREXIA (Fever) and VACCINATION SITE ERYTHEMA (Redness at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vials were being used past the recommended 12 hour post puncture time; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vials were being used past the recommended 12 hour post puncture time) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vials were being used past the recommended 12 hour post puncture time). On 29-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vials were being used past the recommended 12 hour post puncture time) had resolved. Not Provided      The dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was decreased.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: patients were given shots during excursions; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 065F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Nov-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions). On 11-Nov-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (patients were given shots during excursions) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided. Patient had taken first and second shot of vaccine.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received a dose of a vial after 12 hours of initial puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose of a vial after 12 hours of initial puncture) in a 40-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose of a vial after 12 hours of initial puncture). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (patient received a dose of a vial after 12 hours of initial puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Lot 047C21A Vial punctured 6/1/21. Vial stored in refrigerator once punctured, in freezer prior to puncture. One dose given 6/1/21 at time of puncture. No Concomitant medications were reported. No Treatment information was reported.   This case was linked to MOD-2021-418964 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I have been sick for 7 days from booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ILLNESS (I have been sick for 7 days from booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (I have been sick for 7 days from booster). At the time of the report, ILLNESS (I have been sick for 7 days from booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: bronchitis; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (bronchitis) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced BRONCHITIS (bronchitis). The patient was treated with AMOXICILLIN ongoing from February 2021 for Bronchitis, at an unspecified dose and frequency. At the time of the report, BRONCHITIS (bronchitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not provided by the reporter  It was reported that on 11Feb2021 have the appointment for the second shot of moderna covid-19 vaccine. Patient asked if she can get the vaccine with this antibiotic, if the antibiotic will make any difference. Patient asked if she can postpone the date and administer it a week later.
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Peripheral swelling
Clinical narrative: difficulty walking; severe swelling of the feet; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2, Solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GAIT DISTURBANCE (non-serious), outcome unknown, described as difficulty walking; PERIPHERAL SWELLING (non-serious), outcome unknown, described as severe swelling of the feet.  Additional information: Caller also stated that the patient was scared to receive the second dose. Caller told a regulatory agent that he was wondering if Pfizer could offer some services to his family member to monitor the patient or screen for why this reaction happened. A regulatory agent states she told caller that he would have to speak to his doctor as Pfizer probably does not offer this type of service. Caller disconnected call before warm transfer could be made and did not provide any contact information for me to call him back.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Diarrhoea, Dyspnoea, Ear discomfort, Muscle spasms
Clinical narrative: feeling severe tightness in my chest; shortness of breath; diarrhea; ears popping; few shooting pains (cramps) in chest (not constant); few shooting pains (cramps) in chest (not constant); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 19:30 (Lot number: FC3180) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "total thyroidectomy" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot number=FA7484, Lot unknown=False, Administration date=31Jul2021, Administration time=03:00 PM, Dose number=1, Vaccine location=Left arm), administration date: 31Jul2021, when the patient was 29 years old, for Covid-19 immunisation. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "feeling severe tightness in my chest"; DYSPNOEA (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "shortness of breath"; DIARRHOEA (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "diarrhea"; EAR DISCOMFORT (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "ears popping"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 26Aug2021 22:00, outcome "not recovered" and all described as "few shooting pains (cramps) in chest (not constant)". The events "feeling severe tightness in my chest", "diarrhea", "ears popping", "few shooting pains (cramps) in chest (not constant)" and "few shooting pains (cramps) in chest (not constant)" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest discomfort, dyspnoea, diarrhoea, ear discomfort, pain, muscle spasms.  Additional information: The patient did not have any other vaccine in four weeks and the did not have any known allergies. The patient tested negative for Covid test on 27Aug2021 done by nasal swab. Clinical course: It was reported that patient received the second dose of the vaccine around 7:30pm Thursday 26Aug2021. Around 10pm started feeling severe tightness in her chest and shortness of breath. Woke up the next morning a bit worse. Went to walk in sent to ER. Vitals and test look ok but no explanation for chest tightness and SOB. Still feeling it was of 28Aug2021 12pm. Other smaller symptoms were diarrhea, ears popping and few shooting pains (cramps) in chest (not constant).  No follow-up attempts are possible. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: feeling severe tightness in my chest; shortness of breath; diarrhea; ears popping; few shooting pains (cramps) in chest (not constant); few shooting pains (cramps) in chest (not constant); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Aug2021 19:30 (Lot number: FC3180) at the age of 29 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid cancer" (unspecified if ongoing); "total thyroidectomy" (unspecified if ongoing); "thyroid disease" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Product=COVID 19, Brand=Pfizer, Lot number=FA7484, Lot unknown=False, Administration date=31Jul2021, Administration time=03:00 PM, Dose number=1, Vaccine location=Left arm), administration date: 31Jul2021, when the patient was 29 years old, for Covid-19 immunisation. The following information was reported: CHEST DISCOMFORT (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "feeling severe tightness in my chest"; DYSPNOEA (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "shortness of breath"; DIARRHOEA (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "diarrhea"; EAR DISCOMFORT (non-serious) with onset 26Aug2021 22:00, outcome "not recovered", described as "ears popping"; PAIN (non-serious), MUSCLE SPASMS (non-serious) all with onset 26Aug2021 22:00, outcome "not recovered" and all described as "few shooting pains (cramps) in chest (not constant)". The events "feeling severe tightness in my chest", "diarrhea", "ears popping", "few shooting pains (cramps) in chest (not constant)" and "few shooting pains (cramps) in chest (not constant)" were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest discomfort, dyspnoea, diarrhoea, ear discomfort, pain, muscle spasms.  Additional information: The patient did not have any other vaccine in four weeks and the did not have any known allergies. The patient tested negative for Covid test on 27Aug2021 done by nasal swab. Clinical course: It was reported that patient received the second dose of the vaccine around 7:30pm Thursday 26Aug2021. Around 10pm started feeling severe tightness in her chest and shortness of breath. Woke up the next morning a bit worse. Went to walk in sent to ER. Vitals and test look ok but no explanation for chest tightness and SOB. Still feeling it was of 28Aug2021 12pm. Other smaller symptoms were diarrhea, ears popping and few shooting pains (cramps) in chest (not constant).  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: If I perfumed I can''t smell it; if I eat the food I can''t taste it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 17Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANOSMIA (non-serious) with onset Sep2021, outcome "unknown", described as "If I perfumed I can''t smell it"; AGEUSIA (non-serious) with onset Sep2021, outcome "unknown", described as "if I eat the food I can''t taste it". Additional information: Consumer stated, "had got the vaccine like first shot probably three days ago, don't know if its normal to loose my (Incomplete Sentence).  Follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Haematoma, Polymerase chain reaction, SARS-CoV-2 test
Clinical narrative: Large raised hematoma on my right forearmAnd small raised hematoma on my left forearm; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Feb2021 09:30 (Lot number: EL9266) at the age of 60 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "MEN II A Multiple endocrine neoplasia" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; BUPROPION. Past drug history included: Peniclilin, notes: Penicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EL9265   , Anatomical Location: Arm right at 09:30 AM), administration date: 02Feb2021. The following information was reported: HAEMATOMA (non-serious) with onset 23Feb2021 16:00, outcome "recovered" (2021), described as "Large raised hematoma on my right forearmAnd small raised hematoma on my left forearm". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of haematoma.   Additional information:The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included: Levothyroxine,  Bupropion and The patient was not diagnosed with SARS-CoV-2 infection before or after vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cough, Decreased appetite, Dry throat, Fatigue
Clinical narrative: lying in bed sleeping; throat is dry.; swollen lymph nodes under her arms; muscle soreness; soreness (injection site); headache; coughing; tiredness; her chest hurts with exertion; fever; low appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Lot number: FF2588) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19", start date: 27Aug2021 (unspecified if ongoing), notes: she had symptoms of Covid on 27AUG2021, and tested positive on 01SEP2021; "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 22Sep2021, outcome "not recovered", described as "headache"; COUGH (non-serious) with onset 22Sep2021, outcome "not recovered", described as "coughing"; FATIGUE (non-serious) with onset 22Sep2021, outcome "not recovered", described as "tiredness"; CHEST PAIN (non-serious) with onset 22Sep2021, outcome "not recovered", described as "her chest hurts with exertion"; PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "fever"; DECREASED APPETITE (non-serious) with onset 22Sep2021, outcome "unknown", described as "low appetite"; LYMPHADENOPATHY (non-serious) with onset 23Sep2021, outcome "unknown", described as "swollen lymph nodes under her arms"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021, outcome "recovering", described as "soreness (injection site)"; MYALGIA (non-serious) with onset 23Sep2021, outcome "not recovered", described as "muscle soreness"; SOMNOLENCE (non-serious), outcome "unknown", described as "lying in bed sleeping"; DRY THROAT (non-serious), outcome "unknown", described as "throat is dry.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was patient was diagnosed with covid, Since the vaccination, patient has been tested for covid   Follow-up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Myalgia, Pyrexia, SARS-CoV-2 test
Clinical narrative: lying in bed sleeping; throat is dry.; swollen lymph nodes under her arms; muscle soreness; soreness (injection site); headache; coughing; tiredness; her chest hurts with exertion; fever; low appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Lot number: FF2588) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19", start date: 27Aug2021 (unspecified if ongoing), notes: she had symptoms of Covid on 27AUG2021, and tested positive on 01SEP2021; "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 22Sep2021, outcome "not recovered", described as "headache"; COUGH (non-serious) with onset 22Sep2021, outcome "not recovered", described as "coughing"; FATIGUE (non-serious) with onset 22Sep2021, outcome "not recovered", described as "tiredness"; CHEST PAIN (non-serious) with onset 22Sep2021, outcome "not recovered", described as "her chest hurts with exertion"; PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "fever"; DECREASED APPETITE (non-serious) with onset 22Sep2021, outcome "unknown", described as "low appetite"; LYMPHADENOPATHY (non-serious) with onset 23Sep2021, outcome "unknown", described as "swollen lymph nodes under her arms"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021, outcome "recovering", described as "soreness (injection site)"; MYALGIA (non-serious) with onset 23Sep2021, outcome "not recovered", described as "muscle soreness"; SOMNOLENCE (non-serious), outcome "unknown", described as "lying in bed sleeping"; DRY THROAT (non-serious), outcome "unknown", described as "throat is dry.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was patient was diagnosed with covid, Since the vaccination, patient has been tested for covid   Follow-up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Vaccination site pain
Clinical narrative: lying in bed sleeping; throat is dry.; swollen lymph nodes under her arms; muscle soreness; soreness (injection site); headache; coughing; tiredness; her chest hurts with exertion; fever; low appetite; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 51-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Sep2021 16:00 (Lot number: FF2588) at the age of 51 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid-19", start date: 27Aug2021 (unspecified if ongoing), notes: she had symptoms of Covid on 27AUG2021, and tested positive on 01SEP2021; "overweight" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 22Sep2021, outcome "not recovered", described as "headache"; COUGH (non-serious) with onset 22Sep2021, outcome "not recovered", described as "coughing"; FATIGUE (non-serious) with onset 22Sep2021, outcome "not recovered", described as "tiredness"; CHEST PAIN (non-serious) with onset 22Sep2021, outcome "not recovered", described as "her chest hurts with exertion"; PYREXIA (non-serious) with onset 22Sep2021, outcome "unknown", described as "fever"; DECREASED APPETITE (non-serious) with onset 22Sep2021, outcome "unknown", described as "low appetite"; LYMPHADENOPATHY (non-serious) with onset 23Sep2021, outcome "unknown", described as "swollen lymph nodes under her arms"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2021, outcome "recovering", described as "soreness (injection site)"; MYALGIA (non-serious) with onset 23Sep2021, outcome "not recovered", described as "muscle soreness"; SOMNOLENCE (non-serious), outcome "unknown", described as "lying in bed sleeping"; DRY THROAT (non-serious), outcome "unknown", described as "throat is dry.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache. Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was patient was diagnosed with covid, Since the vaccination, patient has been tested for covid   Follow-up (14Oct2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: one of the worst headache of my life that lasted almost the entire day / terrible headache; a low grade fever; body aches; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 23Mar2021 10:15 (Lot number: ER8730) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "stents in heart" (unspecified if ongoing); "Aorta Blocked", start date: Sep2000 (unspecified if ongoing), notes: Angioplasty with 2 stunts; "Arthritis" (unspecified if ongoing). Family history included: "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: DICLOFENAC taken for arthritis (ongoing); ATORVASTATIN CALCIUM taken for blood cholesterol increased (ongoing). Vaccination history included: Bnt162b2 (product=COVID 19,, lot number=EN6198,, administration time=10:15 AM, Dose number=1, vaccine location=Left arm, Route of administration: Intramuscular), administration date: 02Mar2021, for COVID-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "one of the worst headache of my life that lasted almost the entire day / terrible headache"; PYREXIA (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "a low grade fever"; PAIN (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "body aches"; CHILLS (non-serious) with onset 23Mar2021 04:00, outcome "recovered" (24Mar2021), described as "chills". Therapeutic measures were not taken as a result of headache, pyrexia, pain, chills.  Additional information: medications the patient received within 2 weeks of vaccination was Lipitor. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient's Mother died age 77 of heart disease and Father died age 89 of heart disease. No known allergies. On 28Sep2021 I received the Pfizer Booster. Here is the data on that Vaccine - Pfizer 301458A.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site hypoaesthesia
Clinical narrative: my right arm went numb like it went to sleep; a fewsharp pains in fingers went away, odd shooting pain in my right fingers comes and goes as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 29Aug2021 13:00 (Lot number: BC3180) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 01, Lot  number: EW0191, Administration time: 01:00 PM, Vaccine Location: Left arm), administration date: 03Aug2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE HYPOAESTHESIA (non-serious) with onset 29Aug2021 13:15, outcome "not recovered", described as "my right arm went numb like it went to sleep"; PAIN IN EXTREMITY (non-serious) with onset 29Aug2021 13:15, outcome "not recovered", described as "a fewsharp pains in fingers went away, odd shooting pain in my right fingers comes and goes as well". Therapeutic measures were not taken as a result of vaccination site hypoaesthesia, pain in extremity.  Additional information: Patient has no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19.  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. It was reported that minutes after the shot was given half of patient's right arm went numb like it went to sleep, a few sharp pains in fingers went away. The numbness kept coming and going and the odd shooting pain in her right fingers comes and goes as well. Sometimes together sometimes not and only in the right arm. Patient was hoping it would go away but it continued and was annoying. Events did not result to both emergency room visit and physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: The period lasted 2 weeks.; After the vaccine, my menstrual period have not been the same. I get it up to two times in a month. My menstrual is now abnormal.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 10:45 (Lot number: EW0167) at the age of 40 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Anaemia" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported.  The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious) with onset 25Jun2021, outcome "unknown", described as "The period lasted 2 weeks."; MENSTRUAL DISORDER (non-serious) with onset 25Jun2021, outcome "unknown", described as "After the vaccine, my menstrual period has not been the same. I get it up to two times in a month. My menstrual is now abnormal.". The events "the period lasted 2 weeks." and "after the vaccine, my menstrual period have not been the same. i get it up to two times in a month. my menstrual is now abnormal." were evaluated at the physician office visit. Therapeutic measures were not taken as a result of heavy menstrual bleeding, menstrual disorder.  Additional information: patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was patient was diagnosed with covid, Since the vaccination, patient has been tested for covid.  Follow-Up (29Sep2021): Follow-up attempts are completed. No further information is expected. Follow-up(12Oct2021): This is a follow-up spontaneous report from a contactable consumer.This consumer reported in response to Hcp letter sent that included  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test, Vaccination site pain, Vomiting
Clinical narrative: headache; vomiting; soreness at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 12 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 (Lot number: FA6780) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Lot number: ER8731, Vaccine Location: Left arm), administration date: 23Jul2021, when the patient was 12 years old, for COVID-19 immunisation, reaction(s): "1st vaccine with a temperature excursion", "1st vaccine with a temperature excursion". The following information was reported: HEADACHE (non-serious) with onset 14Aug2021, outcome "recovered", described as "headache"; VOMITING (non-serious) with onset 14Aug2021, outcome "recovered", described as "vomiting"; VACCINATION SITE PAIN (non-serious) with onset 14Aug2021, outcome "recovered", described as "soreness at injection site". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, vomiting, vaccination site pain.  Additional information: The patient had not received any other vaccines within 4 weeks and had not been diagnosed with COVID-19 prior vaccination. Since the vaccination the patient had been tested for COVID-19. It was reported that the vaccine administered was kept in the freezer too long.    No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Protein urine present, Urine analysis
Clinical narrative: Pain in my back; I have CYP proteins in my urine each time; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Kidney transplant" (unspecified if ongoing); "CYP proteins in urine" (unspecified if ongoing); "Laminectomy" (unspecified if ongoing); "Nerve problem" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown", described as "Pain in my back"; PROTEIN URINE PRESENT (non-serious), outcome "unknown", described as "I have CYP proteins in my urine each time". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of back pain.  Additional information: Codeine, another unspecified pain pill, and unspecified muscle relaxer was taken as treatment of the event.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain
Clinical narrative: A little bit body ache; Tired; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Sep2021 (Lot number: FF2588) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tension Headache" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D [COLECALCIFEROL]. Past drug history included: Lorazepam for Tension headache, notes: 0.5 mg; Tylenol for Tension Headache, notes: 200 mg. The following information was reported: PAIN (non-serious) with onset 02Sep2021, outcome "unknown", described as "A little bit body ache"; FATIGUE (non-serious) with onset 02Sep2021, outcome "unknown", described as "Tired". Therapeutic measures were taken as a result of pain, fatigue.  Additional information: Patient also had unspecified multivitamins as concomitant medication. Tylenol was taken as treatment of the events.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hypersensitivity, Unevaluable event, Vomiting
Clinical narrative: Vomiting; she is miserable; Cold chills; Allergic reaction; patient had second dose of the Pfizer Covid-19 vaccine but having a bad reaction reaction to it like there is, her wife had allergy with metal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Metal allergy" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL. Vaccination history included: Bnt162b2 (Dose Number: 01), for Covid-19 Immunization.The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting"; FEELING ABNORMAL (noserious), outcome "unknown", described as "she is miserable"; CHILLS (non-serious), outcome "unknown", described as "Cold chills"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction"; UNEVALUABLE EVENT (non-serious), outcome "unknown", described as "second dose of the Pfizer Covid-19 vaccine but having a bad reaction to it like there is, her wife had allergy with metal (further not clarified) and then he put metal on the injection site it sticks in to it aside".  Information on lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body height, Cardiac disorder, Diarrhoea, Laboratory test
Clinical narrative: lost a considerable amount of weight; stomach pain; diarrhea; vomiting; malaise; Nausea; they found something with his heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney transplant", start date: 1998 (unspecified if ongoing), notes: kidney transplant 23 years ago, so he is immunocompromised. The patient's concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost a considerable amount of weight"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "stomach pain"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomiting"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "malaise"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "they found something with his heart". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper.  Additional information: Reporter said that the stomach pain and vomiting started right after the vaccine but she did not know when, they were talking to his doctor and she had not realized that he started having these things after his vaccine. She says his weight dropped a lot, which she started seeing as alarming and contacted a GI doctor. Reporter said they gave him a new medication as a treatment to try three weeks ago that was helping, then it stopped helping him. She says it is called Bentyl. She says they gave him that medication for stomach pain and it helped like a week and a half. The patient did not start any new meds. She said he was a kidney transplant patient and had been on the same meds for a long time, other than two years ago they had him start some other medication for common things people take. No further details provided this other medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Nausea, Vomiting, Weight, Weight decreased
Clinical narrative: lost a considerable amount of weight; stomach pain; diarrhea; vomiting; malaise; Nausea; they found something with his heart; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 63 year-old male patient received bnt162b2 (BNT162B2), administration date 26Feb2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "kidney transplant", start date: 1998 (unspecified if ongoing), notes: kidney transplant 23 years ago, so he is immunocompromised. The patient's concomitant medications were not reported. The following information was reported: WEIGHT DECREASED (non-serious) with onset 2021, outcome "unknown", described as "lost a considerable amount of weight"; ABDOMINAL PAIN UPPER (non-serious) with onset 2021, outcome "unknown", described as "stomach pain"; DIARRHOEA (non-serious) with onset 2021, outcome "unknown", described as "diarrhea"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "vomiting"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "malaise"; NAUSEA (non-serious) with onset 2021, outcome "unknown", described as "Nausea"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "they found something with his heart". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of abdominal pain upper.  Additional information: Reporter said that the stomach pain and vomiting started right after the vaccine but she did not know when, they were talking to his doctor and she had not realized that he started having these things after his vaccine. She says his weight dropped a lot, which she started seeing as alarming and contacted a GI doctor. Reporter said they gave him a new medication as a treatment to try three weeks ago that was helping, then it stopped helping him. She says it is called Bentyl. She says they gave him that medication for stomach pain and it helped like a week and a half. The patient did not start any new meds. She said he was a kidney transplant patient and had been on the same meds for a long time, other than two years ago they had him start some other medication for common things people take. No further details provided this other medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.