chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood calcium increased, Blood pressure increased, Chest pain
Clinical narrative: Calcium score test indicates that 18% of my soft plaque has developed within the past year, some calcification of a valve; Chest pain; gradually increasing along with blood pressure; This is a spontaneous report from a contactable consumer or other non HCP (The patient reported for self). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, Batch/Lot Number: en6207), via an unspecified route of administration, administered in left arm on 23Mar2021 14:00 (at the age of 68-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Tobacco user from an unknown date and unknown if ongoing (former smoker). No known allergies. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, Batch/Lot Number: en6201) via an unspecified route of administration, administered in left arm on 02Mar2021 as dose 2, single for COVID-19 immunisation. No other vaccine in four weeks. Concomitant medication(s) /Other medications in two weeks included: Aminobenzoic acid, BIOTIN, Calcium Pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate (B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE; CYANOCOBALAMIN; FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]); Colecalciferol (D3) both taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest pain, gradually increasing along with blood pressure on 06Apr2021, Calcium score test indicates that 18% of my soft plaque has developed within the past year, some calcification of a valve on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: Gradually increasing on Apr2021 peaked in April, Investigation: 18% of my soft plaque has developed within the on past year, some calcification of a valve. Therapeutic measures were taken as Lisinopril and statin for the events. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Chest pain, Heart valve calcification, Investigation
Clinical narrative: Calcium score test indicates that 18% of my soft plaque has developed within the past year, some calcification of a valve; Chest pain; gradually increasing along with blood pressure; This is a spontaneous report from a contactable consumer or other non HCP (The patient reported for self). A 68-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, Batch/Lot Number: en6207), via an unspecified route of administration, administered in left arm on 23Mar2021 14:00 (at the age of 68-years-old) as dose 2, single for COVID-19 immunisation. Medical history included Tobacco user from an unknown date and unknown if ongoing (former smoker). No known allergies. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; FORMULATION: solution for injection, Batch/Lot Number: en6201) via an unspecified route of administration, administered in left arm on 02Mar2021 as dose 2, single for COVID-19 immunisation. No other vaccine in four weeks. Concomitant medication(s) /Other medications in two weeks included: Aminobenzoic acid, BIOTIN, Calcium Pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine Hydrochloride, Riboflavin, Thiamine Mononitrate (B COMPLEX [AMINOBENZOIC ACID;BIOTIN;CALCIUM PANTOTHENATE;CHOLINE BITARTRATE; CYANOCOBALAMIN; FOLIC ACID;INOSITOL;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;THIAMINE MONONITRATE]); Colecalciferol (D3) both taken for an unspecified indication, start and stop date were not reported. The patient experienced Chest pain, gradually increasing along with blood pressure on 06Apr2021, Calcium score test indicates that 18% of my soft plaque has developed within the past year, some calcification of a valve on an unspecified date. The patient underwent lab tests and procedures which included blood pressure measurement: Gradually increasing on Apr2021 peaked in April, Investigation: 18% of my soft plaque has developed within the on past year, some calcification of a valve. Therapeutic measures were taken as Lisinopril and statin for the events. The patient did not have Covid prior vaccination and was not Covid tested post vaccination. AE resulted in: Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood iron decreased, Blood test abnormal, Heavy menstrual bleeding, Uterine leiomyoma
Clinical narrative: Bleeding; Pink tissue is gushing out of her; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Left arm on 25Jul2021 (48-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included fibroids from Feb2012 to an unknown date Diagnosed while pregnant, covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) 500 mg daily from feb2020 which is ongoing for covid, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) from feb2020, 2000 iU, daily which was ongoing, Multivitamin taken all for covid-19 from Feb2020 and ongoing. The patient previously took BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EWD181 or EW0181), via an unspecified route of administration, administered in Arm Left on 03Jul2021 (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient received the second dose of the Pfizer Covid 19 vaccine on 25Jul2021. She received the first dose on 03Jul2021. She was calling to report a side effect. She was bleeding on 26Jul2021. Pink tissue was gushing out of her on unspecified date of Jul2021. She went to the emergency room. They ran a complete blood test and she had an ultrasound on unspecified date in Jul2021. She was told to follow up with her doctor. They said she needs to see a gynecologist. The clinic does not accept her insurance. The doctor said it was coming from the shot. She has had fibroids in the past. An ultrasound in the past showed that the fibroids are real tiny. The patient underwent lab tests and procedures which included blood test: unknown results on Jul2021, sars-cov-2 test: positive, ultrasound scan: fibroids are real tiny on an unspecified date on 2021. The ultrasound at the emergency room indicated that the fibroids were small on unspecified date on Jul2021. The clinical outcome of event bleeding was not recovered, and pink tissue is gushing out of her was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Haemorrhage, SARS-CoV-2 test, Tissue rupture, Ultrasound scan
Clinical narrative: Bleeding; Pink tissue is gushing out of her; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: FA7484), via an unspecified route of administration, administered in Left arm on 25Jul2021 (48-year-old at the time of vaccination) as dose 2, single for covid-19 immunisation. Medical history included fibroids from Feb2012 to an unknown date Diagnosed while pregnant, covid-19 from an unknown date and unknown if ongoing. Concomitant medication(s) included vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) 500 mg daily from feb2020 which is ongoing for covid, vitamin d [vitamin d nos] (VITAMIN D [VITAMIN D NOS]) from feb2020, 2000 iU, daily which was ongoing, Multivitamin taken all for covid-19 from Feb2020 and ongoing. The patient previously took BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: EWD181 or EW0181), via an unspecified route of administration, administered in Arm Left on 03Jul2021 (48-year-old at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient received the second dose of the Pfizer Covid 19 vaccine on 25Jul2021. She received the first dose on 03Jul2021. She was calling to report a side effect. She was bleeding on 26Jul2021. Pink tissue was gushing out of her on unspecified date of Jul2021. She went to the emergency room. They ran a complete blood test and she had an ultrasound on unspecified date in Jul2021. She was told to follow up with her doctor. They said she needs to see a gynecologist. The clinic does not accept her insurance. The doctor said it was coming from the shot. She has had fibroids in the past. An ultrasound in the past showed that the fibroids are real tiny. The patient underwent lab tests and procedures which included blood test: unknown results on Jul2021, sars-cov-2 test: positive, ultrasound scan: fibroids are real tiny on an unspecified date on 2021. The ultrasound at the emergency room indicated that the fibroids were small on unspecified date on Jul2021. The clinical outcome of event bleeding was not recovered, and pink tissue is gushing out of her was unknown.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test normal, Bone pain, Cardiac flutter, Chest pain, Diarrhoea
Clinical narrative: nerve prickling in extremities and chest like electrical shocks that move all over body.; nervous rapid heart beat; nervous rapid heart beat; red spot appeared on my left arm; diahrrea; vomit; pain in joints; awake at night; very scary; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0168), via an unspecified route in the left arm on 23May2021 at 14:00 (age at vaccination: 52-year-old), as a single dose for covid-19 immunization. Medical history included asthma, hormone replacement, adrenal fatigue, anxiety and known allergies with penicillan, sulfa and mold. The patient concomitant medications were not reported. Past drug events included allergy to avelox, cipro, lidocaine Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 31May2021, patient experienced multiple effects but the most worrisome is nerve prickling in extremities and chest like electrical shocks that move all over body. Also, nervous rapid heartbeat as though too much caffeine. None of this happened to her until day 8 after vaccine when the red spot appeared on left arm and she had other horrible side effects for two days: diarrhea, vomit, pain in joints, nervous heartbeat. The other effects subsided but this prickly nerve stuff keeps her awake at night and was very scary awake at night. Patient did not receive any treatment for the events. The clinical outcome of red spot appeared on left arm, nervous, rapid heartbeat, diarrhea, vomit, pain in joints was subsided, but nerve prickling in extremities and chest like electrical shocks that move all over body keeps her awake at night and was very scary/not recovered.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea haemorrhagic, Electrocardiogram normal, Fear, Haemorrhoids, Heart rate increased
Clinical narrative: nerve prickling in extremities and chest like electrical shocks that move all over body.; nervous rapid heart beat; nervous rapid heart beat; red spot appeared on my left arm; diahrrea; vomit; pain in joints; awake at night; very scary; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0168), via an unspecified route in the left arm on 23May2021 at 14:00 (age at vaccination: 52-year-old), as a single dose for covid-19 immunization. Medical history included asthma, hormone replacement, adrenal fatigue, anxiety and known allergies with penicillan, sulfa and mold. The patient concomitant medications were not reported. Past drug events included allergy to avelox, cipro, lidocaine Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 31May2021, patient experienced multiple effects but the most worrisome is nerve prickling in extremities and chest like electrical shocks that move all over body. Also, nervous rapid heartbeat as though too much caffeine. None of this happened to her until day 8 after vaccine when the red spot appeared on left arm and she had other horrible side effects for two days: diarrhea, vomit, pain in joints, nervous heartbeat. The other effects subsided but this prickly nerve stuff keeps her awake at night and was very scary awake at night. Patient did not receive any treatment for the events. The clinical outcome of red spot appeared on left arm, nervous, rapid heartbeat, diarrhea, vomit, pain in joints was subsided, but nerve prickling in extremities and chest like electrical shocks that move all over body keeps her awake at night and was very scary/not recovered.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Neck pain, Pain, Pain in extremity
Clinical narrative: nerve prickling in extremities and chest like electrical shocks that move all over body.; nervous rapid heart beat; nervous rapid heart beat; red spot appeared on my left arm; diahrrea; vomit; pain in joints; awake at night; very scary; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0168), via an unspecified route in the left arm on 23May2021 at 14:00 (age at vaccination: 52-year-old), as a single dose for covid-19 immunization. Medical history included asthma, hormone replacement, adrenal fatigue, anxiety and known allergies with penicillan, sulfa and mold. The patient concomitant medications were not reported. Past drug events included allergy to avelox, cipro, lidocaine Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 31May2021, patient experienced multiple effects but the most worrisome is nerve prickling in extremities and chest like electrical shocks that move all over body. Also, nervous rapid heartbeat as though too much caffeine. None of this happened to her until day 8 after vaccine when the red spot appeared on left arm and she had other horrible side effects for two days: diarrhea, vomit, pain in joints, nervous heartbeat. The other effects subsided but this prickly nerve stuff keeps her awake at night and was very scary awake at night. Patient did not receive any treatment for the events. The clinical outcome of red spot appeared on left arm, nervous, rapid heartbeat, diarrhea, vomit, pain in joints was subsided, but nerve prickling in extremities and chest like electrical shocks that move all over body keeps her awake at night and was very scary/not recovered.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash erythematous, Sleep disorder, Vomiting, X-ray limb normal
Clinical narrative: nerve prickling in extremities and chest like electrical shocks that move all over body.; nervous rapid heart beat; nervous rapid heart beat; red spot appeared on my left arm; diahrrea; vomit; pain in joints; awake at night; very scary; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0168), via an unspecified route in the left arm on 23May2021 at 14:00 (age at vaccination: 52-year-old), as a single dose for covid-19 immunization. Medical history included asthma, hormone replacement, adrenal fatigue, anxiety and known allergies with penicillan, sulfa and mold. The patient concomitant medications were not reported. Past drug events included allergy to avelox, cipro, lidocaine Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 31May2021, patient experienced multiple effects but the most worrisome is nerve prickling in extremities and chest like electrical shocks that move all over body. Also, nervous rapid heartbeat as though too much caffeine. None of this happened to her until day 8 after vaccine when the red spot appeared on left arm and she had other horrible side effects for two days: diarrhea, vomit, pain in joints, nervous heartbeat. The other effects subsided but this prickly nerve stuff keeps her awake at night and was very scary awake at night. Patient did not receive any treatment for the events. The clinical outcome of red spot appeared on left arm, nervous, rapid heartbeat, diarrhea, vomit, pain in joints was subsided, but nerve prickling in extremities and chest like electrical shocks that move all over body keeps her awake at night and was very scary/not recovered.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Erythema, Fear, Heart rate increased
Clinical narrative: nerve prickling in extremities and chest like electrical shocks that move all over body.; nervous rapid heart beat; nervous rapid heart beat; red spot appeared on my left arm; diahrrea; vomit; pain in joints; awake at night; very scary; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0168), via an unspecified route in the left arm on 23May2021 at 14:00 (age at vaccination: 52-year-old), as a single dose for covid-19 immunization. Medical history included asthma, hormone replacement, adrenal fatigue, anxiety and known allergies with penicillan, sulfa and mold. The patient concomitant medications were not reported. Past drug events included allergy to avelox, cipro, lidocaine Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 31May2021, patient experienced multiple effects but the most worrisome is nerve prickling in extremities and chest like electrical shocks that move all over body. Also, nervous rapid heartbeat as though too much caffeine. None of this happened to her until day 8 after vaccine when the red spot appeared on left arm and she had other horrible side effects for two days: diarrhea, vomit, pain in joints, nervous heartbeat. The other effects subsided but this prickly nerve stuff keeps her awake at night and was very scary awake at night. Patient did not receive any treatment for the events. The clinical outcome of red spot appeared on left arm, nervous, rapid heartbeat, diarrhea, vomit, pain in joints was subsided, but nerve prickling in extremities and chest like electrical shocks that move all over body keeps her awake at night and was very scary/not recovered.  Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Middle insomnia, Nervousness, Paraesthesia, Vomiting
Clinical narrative: nerve prickling in extremities and chest like electrical shocks that move all over body.; nervous rapid heart beat; nervous rapid heart beat; red spot appeared on my left arm; diahrrea; vomit; pain in joints; awake at night; very scary; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer covid-19 vaccine, Solution for injection, Lot number: EW0168), via an unspecified route in the left arm on 23May2021 at 14:00 (age at vaccination: 52-year-old), as a single dose for covid-19 immunization. Medical history included asthma, hormone replacement, adrenal fatigue, anxiety and known allergies with penicillan, sulfa and mold. The patient concomitant medications were not reported. Past drug events included allergy to avelox, cipro, lidocaine Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 31May2021, patient experienced multiple effects but the most worrisome is nerve prickling in extremities and chest like electrical shocks that move all over body. Also, nervous rapid heartbeat as though too much caffeine. None of this happened to her until day 8 after vaccine when the red spot appeared on left arm and she had other horrible side effects for two days: diarrhea, vomit, pain in joints, nervous heartbeat. The other effects subsided but this prickly nerve stuff keeps her awake at night and was very scary awake at night. Patient did not receive any treatment for the events. The clinical outcome of red spot appeared on left arm, nervous, rapid heartbeat, diarrhea, vomit, pain in joints was subsided, but nerve prickling in extremities and chest like electrical shocks that move all over body keeps her awake at night and was very scary/not recovered.  Follow-up attempts completed. No further information expected.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fall, Gait disturbance, Hypoaesthesia, Magnetic resonance imaging
Clinical narrative: Lower body nerves weakess; muscles extraordinary weakness; causing legs to give out; then unexpected severe falls; This is a spontaneous report from a contactable consumer (patient). An 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9262, expiration date was not reported), via an unspecified route of administration in Right arm on 29Jan2021 at 13:30 (at the age of 80-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included Tomato sauce allergy. Concomitant medications (received within 2 weeks of vaccination) included amlodipine (AMLODIPINE); finasteride (FINASTERIDE); simvastatin (SIMVASTATIN); losartan (LOSARTAN), Ta all taken for an unspecified indication. At other facility the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Feb2021 at 14:30, the patient experienced Lower body nerves weakness and muscles extraordinary weakness causing legs to give out and then unexpected severe falls. Events resulted in physician office/clinic visit, disability or permanent damage. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient received no treatment for the adverse event. The outcome of all the events was not recovered.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia, Walking aid user, Wheelchair user
Clinical narrative: Lower body nerves weakess; muscles extraordinary weakness; causing legs to give out; then unexpected severe falls; This is a spontaneous report from a contactable consumer (patient). An 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9262, expiration date was not reported), via an unspecified route of administration in Right arm on 29Jan2021 at 13:30 (at the age of 80-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included Tomato sauce allergy. Concomitant medications (received within 2 weeks of vaccination) included amlodipine (AMLODIPINE); finasteride (FINASTERIDE); simvastatin (SIMVASTATIN); losartan (LOSARTAN), Ta all taken for an unspecified indication. At other facility the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Feb2021 at 14:30, the patient experienced Lower body nerves weakness and muscles extraordinary weakness causing legs to give out and then unexpected severe falls. Events resulted in physician office/clinic visit, disability or permanent damage. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient received no treatment for the adverse event. The outcome of all the events was not recovered.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Limb discomfort, Muscular weakness, Nerve injury
Clinical narrative: Lower body nerves weakess; muscles extraordinary weakness; causing legs to give out; then unexpected severe falls; This is a spontaneous report from a contactable consumer (patient). An 80-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot number: EL9262, expiration date was not reported), via an unspecified route of administration in Right arm on 29Jan2021 at 13:30 (at the age of 80-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included Tomato sauce allergy. Concomitant medications (received within 2 weeks of vaccination) included amlodipine (AMLODIPINE); finasteride (FINASTERIDE); simvastatin (SIMVASTATIN); losartan (LOSARTAN), Ta all taken for an unspecified indication. At other facility the most recent COVID-19 vaccine was administered. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 16Feb2021 at 14:30, the patient experienced Lower body nerves weakness and muscles extraordinary weakness causing legs to give out and then unexpected severe falls. Events resulted in physician office/clinic visit, disability or permanent damage. The adverse event result in Doctor or other healthcare professional office/clinic visit. The patient received no treatment for the adverse event. The outcome of all the events was not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Culture, Enterococcus test positive, Erythema, Erythema of eyelid
Clinical narrative: 36hrs after shot burning; Painful joints entire body; Burning rash around both eyes; Incision became infected hole and is still under treatment; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included autoimmune disorder (verbatim: 5 autoimmune diseases active), rubber sensitivity, drug hypersensitivity (Known allergies: Sulfa), iodine allergy (Known allergies: Iodine), surgery (1 wk old surgical incision ruptured). The patient previously took bnt162b2 for covid-19 immunisation (lot number: EP7553, vaccine location: Left arm) on 13APR2021 at 10:00 AM, singulair and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment on 06May2021 at 04:00. Therapeutic measures were taken as a result of 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was not recovered.  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eyelid irritation, Eyelid pain, Eyelid rash, Gram stain, Gram stain positive
Clinical narrative: 36hrs after shot burning; Painful joints entire body; Burning rash around both eyes; Incision became infected hole and is still under treatment; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included autoimmune disorder (verbatim: 5 autoimmune diseases active), rubber sensitivity, drug hypersensitivity (Known allergies: Sulfa), iodine allergy (Known allergies: Iodine), surgery (1 wk old surgical incision ruptured). The patient previously took bnt162b2 for covid-19 immunisation (lot number: EP7553, vaccine location: Left arm) on 13APR2021 at 10:00 AM, singulair and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment on 06May2021 at 04:00. Therapeutic measures were taken as a result of 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was not recovered.  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Incision site haemorrhage, Incisional drainage, Pain of skin, Peripheral swelling, Postoperative wound infection
Clinical narrative: 36hrs after shot burning; Painful joints entire body; Burning rash around both eyes; Incision became infected hole and is still under treatment; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included autoimmune disorder (verbatim: 5 autoimmune diseases active), rubber sensitivity, drug hypersensitivity (Known allergies: Sulfa), iodine allergy (Known allergies: Iodine), surgery (1 wk old surgical incision ruptured). The patient previously took bnt162b2 for covid-19 immunisation (lot number: EP7553, vaccine location: Left arm) on 13APR2021 at 10:00 AM, singulair and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment on 06May2021 at 04:00. Therapeutic measures were taken as a result of 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was not recovered.  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin warm, Staphylococcus test positive, White blood cell count
Clinical narrative: 36hrs after shot burning; Painful joints entire body; Burning rash around both eyes; Incision became infected hole and is still under treatment; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included autoimmune disorder (verbatim: 5 autoimmune diseases active), rubber sensitivity, drug hypersensitivity (Known allergies: Sulfa), iodine allergy (Known allergies: Iodine), surgery (1 wk old surgical incision ruptured). The patient previously took bnt162b2 for covid-19 immunisation (lot number: EP7553, vaccine location: Left arm) on 13APR2021 at 10:00 AM, singulair and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment on 06May2021 at 04:00. Therapeutic measures were taken as a result of 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was not recovered.  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Burning sensation, Infection, Rash
Clinical narrative: 36hrs after shot burning; Painful joints entire body; Burning rash around both eyes; Incision became infected hole and is still under treatment; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 04May2021 at 10:00 as DOSE 2, SINGLE for covid-19 immunisation. Medical history included autoimmune disorder (verbatim: 5 autoimmune diseases active), rubber sensitivity, drug hypersensitivity (Known allergies: Sulfa), iodine allergy (Known allergies: Iodine), surgery (1 wk old surgical incision ruptured). The patient previously took bnt162b2 for covid-19 immunisation (lot number: EP7553, vaccine location: Left arm) on 13APR2021 at 10:00 AM, singulair and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment on 06May2021 at 04:00. Therapeutic measures were taken as a result of 36hrs after shot burning, painful joints entire body, burning rash around both eyes, incision became infected hole and is still under treatment. Adverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Outcome of the events was not recovered.  Follow-Up (11Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Urticaria
Clinical narrative: swelling of throat; Severe hives; This is a spontaneous report from a contactable consumer (Patient). A 31-years-old Non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0198, Expiry date was not reported), via intramuscular route of administration on 24Jul2021 11:00 (at the age of 31-years-old) in Arm right as dose 2, single for COVID-19 immunization. The patient Medical history included irritable bowel syndrome from an unknown date and unknown if ongoing, cat scan dye from an unknown date and unknown if ongoing, honey bee venom from an unknown date and unknown if ongoing. Concomitant medication(s) included eluxadoline (VIBERZI); omeprazole (OMEPRAZOLE); lamotrigine (LAMICTAL); pancreatin (CREON); dicyclomine (DICYCLOMINE) all taken for an unspecified indication, start and stop date were not reported. The patient previously took Latuda medication. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EW0176 and Expiry date was not reported), via intramuscular route of administration on 03Jul2021 12:00pm (at the age of 31-years-old) in Arm left as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not received any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and post vaccination patient was not tested for COVID-19. On 26JUL2021 10:40, the patient experienced severe hives, On 27Jul2021 the patient experienced swelling of throat. Therapeutic measures were taken as a result of severe hives, swelling of throat with Prednisone, Benedryl , hydroxyzine, Zyrtec, steroid cream. The outcome for the events was not recovered.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Headache, Nausea, Pain
Clinical narrative: Small seizures; Extreme vaginal bleeding; Vomiting; Difficulty breathing; Severe body cramping; This is a spontaneous report from a contactable consumer (the patient).   A 16-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: fa7484), via an unspecified route of administration, in the right arm, on 29Jul2021 at 11:00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. The patient's medical history none. No known allergies. The patient received other medicine within 2 weeks of vaccination included ciprofloxacin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient's historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ep7533), via an unspecified route of administration, in the right arm, on 08Jul2021 at 11: 00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. On an unknown date in 2021, patient woke up with extreme vaginal bleeding, vomiting, difficulty breathing, severe body cramping and small seizures. Events resulted in emergency room/department or urgent care visit. No treatment for events. Outcome of the events was recovering.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Seizure, Vaginal haemorrhage
Clinical narrative: Small seizures; Extreme vaginal bleeding; Vomiting; Difficulty breathing; Severe body cramping; This is a spontaneous report from a contactable consumer (the patient).   A 16-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: fa7484), via an unspecified route of administration, in the right arm, on 29Jul2021 at 11:00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. The patient's medical history none. No known allergies. The patient received other medicine within 2 weeks of vaccination included ciprofloxacin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient's historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ep7533), via an unspecified route of administration, in the right arm, on 08Jul2021 at 11: 00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. On an unknown date in 2021, patient woke up with extreme vaginal bleeding, vomiting, difficulty breathing, severe body cramping and small seizures. Events resulted in emergency room/department or urgent care visit. No treatment for events. Outcome of the events was recovering.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Muscle spasms, Seizure, Vaginal haemorrhage, Vomiting
Clinical narrative: Small seizures; Extreme vaginal bleeding; Vomiting; Difficulty breathing; Severe body cramping; This is a spontaneous report from a contactable consumer (the patient).   A 16-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: fa7484), via an unspecified route of administration, in the right arm, on 29Jul2021 at 11:00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. The patient's medical history none. No known allergies. The patient received other medicine within 2 weeks of vaccination included ciprofloxacin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient's historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: ep7533), via an unspecified route of administration, in the right arm, on 08Jul2021 at 11: 00 (at the age of 16-year-old), as single dose, for COVID-19 immunization. On an unknown date in 2021, patient woke up with extreme vaginal bleeding, vomiting, difficulty breathing, severe body cramping and small seizures. Events resulted in emergency room/department or urgent care visit. No treatment for events. Outcome of the events was recovering.   This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Gait disturbance, Gait inability, Motor dysfunction, Pain in extremity
Clinical narrative: lost feeling in right leg with no feeling whatsoever in right foot; numbness in right arm cannot hold on to items; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jul2021 at 15:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes since an unspecified date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin glargine (LANTUS), gabapentin (GABAPENTINA) and tramadol (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 04:00, the patient lost feeling in right leg with no feeling whatsoever in right foot, also numbness in right arm could not hold on to items. Therapeutic measures were not taken as a result of adverse event. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost feeling in right leg with no feeling whatsoever in right foot also numbness in right arm could not hold on to items was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: lost feeling in right leg with no feeling whatsoever in right foot; numbness in right arm cannot hold on to items; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 28Jul2021 at 15:00 (at the age of 64-year-old) as a single dose for COVID-19 immunisation. Medical history included diabetes since an unspecified date. The patient did not have any allergies to food, medications, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included insulin glargine (LANTUS), gabapentin (GABAPENTINA) and tramadol (MANUFACTURER UNKNOWN); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Jul2021 at 04:00, the patient lost feeling in right leg with no feeling whatsoever in right foot, also numbness in right arm could not hold on to items. Therapeutic measures were not taken as a result of adverse event. The event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lost feeling in right leg with no feeling whatsoever in right foot also numbness in right arm could not hold on to items was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.