chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Scan with contrast, Toothache, Trigeminal neuralgia
Clinical narrative: EAR ACHE; SORE ARM; TOOTHACHE; TRIGEMINAL NEURALGIA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced trigeminal neuralgia. On MAR-2021, the subject experienced toothache. On 07-MAR-2021, the subject experienced ear ache. On 07-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-MAR-2021, had not recovered from ear ache, and toothache, and the outcome of trigeminal neuralgia was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Pain in extremity, Toothache, Trigeminal neuralgia
Clinical narrative: EAR ACHE; SORE ARM; TOOTHACHE; TRIGEMINAL NEURALGIA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included pollen allergy, non alcohol user, and non-smoker, and other pre-existing medical conditions included the patient did not have any drug abuse/illicit drug use.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, expiry: UNKNOWN) dose was not reported, administered on 06-MAR-2021 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 2021, the subject experienced trigeminal neuralgia. On MAR-2021, the subject experienced toothache. On 07-MAR-2021, the subject experienced ear ache. On 07-MAR-2021, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm on 08-MAR-2021, had not recovered from ear ache, and toothache, and the outcome of trigeminal neuralgia was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non serious.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysmenorrhoea, Feeling abnormal, Heavy menstrual bleeding, Menstrual disorder
Clinical narrative: it's 10 times worse than when I normally used to have periods.; it's way heavier than ever and I just noticed the little lump on my collar bone this morning; I don't normally get my period because I continuously take my pills  and I have been bleeding ever since the next day; I have been bleeding ever since the next day and I found a lump on my collar bone, I found a marble sized lump on my collar bone that keeps moving around; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 18Mar2021 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included allergy from an unknown date. Concomitant medications included montelukast taken for hypersensitivity, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; birth control pills and multivitamins. The patient reported that she got her first shot of the Pfizer Covid vaccine on 18Mar2021 and since then she don't normally get my period because she continuously take her pills  and she have been bleeding ever since the next day and she found a lump on her collar bone, she found a marble sized lump on her collar bone that keeps moving around. The period started on 19Mar2021 still goin and it's way heavier than ever and she just noticed the little lump on her collar bone this morning. Her birth control was either Drospire /Ethestr /Lev tab (for further clarification) and she takes it one pill a day. She called her gynecologists yesterday since she was bleeding and they told her to stop taking it the birth control until Sunday and then restart it that's the only thing. She was still experiencing the event and it's 10 times worse than when she normally used to have periods. The patient did not recover from menstrual cycle abnormal and bleeding menstrual heavy while unknown for the other events.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Heavy menstrual bleeding, Lymphadenopathy, Menstrual disorder
Clinical narrative: it's 10 times worse than when I normally used to have periods.; it's way heavier than ever and I just noticed the little lump on my collar bone this morning; I don't normally get my period because I continuously take my pills  and I have been bleeding ever since the next day; I have been bleeding ever since the next day and I found a lump on my collar bone, I found a marble sized lump on my collar bone that keeps moving around; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose at the age of 46-years-old via an unspecified route of administration, administered in arm left on 18Mar2021 (Batch/Lot Number: ER2613) as single dose for covid-19 immunisation. Medical history included allergy from an unknown date. Concomitant medications included montelukast taken for hypersensitivity, start and stop date were not reported; cetirizine hydrochloride (ZYRTEC) taken for hypersensitivity, start and stop date were not reported; birth control pills and multivitamins. The patient reported that she got her first shot of the Pfizer Covid vaccine on 18Mar2021 and since then she don't normally get my period because she continuously take her pills  and she have been bleeding ever since the next day and she found a lump on her collar bone, she found a marble sized lump on her collar bone that keeps moving around. The period started on 19Mar2021 still goin and it's way heavier than ever and she just noticed the little lump on her collar bone this morning. Her birth control was either Drospire /Ethestr /Lev tab (for further clarification) and she takes it one pill a day. She called her gynecologists yesterday since she was bleeding and they told her to stop taking it the birth control until Sunday and then restart it that's the only thing. She was still experiencing the event and it's 10 times worse than when she normally used to have periods. The patient did not recover from menstrual cycle abnormal and bleeding menstrual heavy while unknown for the other events.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Disturbance in attention, Dyspnoea, Fatigue, Headache
Clinical narrative: Vaccine appeared to intensify cardiac sx; Fever; aches; chills; fatigue; headaches; tachycardia/racing heart; racing heart, pounding heart; shortness of breath; skipped beats; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6202), via unspecified route of administration in right arm on 25Feb2021 at 4:00 pm (at the age of 45-year-old) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at pharmacy or drug store. It was reported that patient was not pregnant at the time of vaccination and at the time of event. The patient's medical history included known allergies to sulfa drugs, seasonal allergies, insulin dependent diabetes mellitus (IDDM), obesity (BMI 36), acid reflux, mild kidney disease, had COVID in Nov2020. The patient's concomitant medications received within two weeks of vaccination included insulin aspart (NOVOLOG), triamcinolone acetonide (NASACORT), omeprazole, bupropion hydrocholoride (WELLBUTRIN), steroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 11:00 pm 7 hours later vaccination the patient experienced fever, aches, chills, fatigue, headaches, and tachycardia/racing heart, pounding heart, shortness of breath, skipped beats. She had COVID in Nov2020, in Dec2020 began having above symptoms (sx) daily. Vaccine appeared to intensify cardiac sx. The events were reported as non-serious. No treatment was received for the events. Patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise, Myalgia, Palpitations, Pyrexia, Sleep disorder
Clinical narrative: Vaccine appeared to intensify cardiac sx; Fever; aches; chills; fatigue; headaches; tachycardia/racing heart; racing heart, pounding heart; shortness of breath; skipped beats; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6202), via unspecified route of administration in right arm on 25Feb2021 at 4:00 pm (at the age of 45-year-old) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at pharmacy or drug store. It was reported that patient was not pregnant at the time of vaccination and at the time of event. The patient's medical history included known allergies to sulfa drugs, seasonal allergies, insulin dependent diabetes mellitus (IDDM), obesity (BMI 36), acid reflux, mild kidney disease, had COVID in Nov2020. The patient's concomitant medications received within two weeks of vaccination included insulin aspart (NOVOLOG), triamcinolone acetonide (NASACORT), omeprazole, bupropion hydrocholoride (WELLBUTRIN), steroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 11:00 pm 7 hours later vaccination the patient experienced fever, aches, chills, fatigue, headaches, and tachycardia/racing heart, pounding heart, shortness of breath, skipped beats. She had COVID in Nov2020, in Dec2020 began having above symptoms (sx) daily. Vaccine appeared to intensify cardiac sx. The events were reported as non-serious. No treatment was received for the events. Patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tachycardia
Clinical narrative: Vaccine appeared to intensify cardiac sx; Fever; aches; chills; fatigue; headaches; tachycardia/racing heart; racing heart, pounding heart; shortness of breath; skipped beats; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6202), via unspecified route of administration in right arm on 25Feb2021 at 4:00 pm (at the age of 45-year-old) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at pharmacy or drug store. It was reported that patient was not pregnant at the time of vaccination and at the time of event. The patient's medical history included known allergies to sulfa drugs, seasonal allergies, insulin dependent diabetes mellitus (IDDM), obesity (BMI 36), acid reflux, mild kidney disease, had COVID in Nov2020. The patient's concomitant medications received within two weeks of vaccination included insulin aspart (NOVOLOG), triamcinolone acetonide (NASACORT), omeprazole, bupropion hydrocholoride (WELLBUTRIN), steroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 11:00 pm 7 hours later vaccination the patient experienced fever, aches, chills, fatigue, headaches, and tachycardia/racing heart, pounding heart, shortness of breath, skipped beats. She had COVID in Nov2020, in Dec2020 began having above symptoms (sx) daily. Vaccine appeared to intensify cardiac sx. The events were reported as non-serious. No treatment was received for the events. Patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body mass index, Cardiac disorder, Chills, Dyspnoea, Extrasystoles
Clinical narrative: Vaccine appeared to intensify cardiac sx; Fever; aches; chills; fatigue; headaches; tachycardia/racing heart; racing heart, pounding heart; shortness of breath; skipped beats; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6202), via unspecified route of administration in right arm on 25Feb2021 at 4:00 pm (at the age of 45-year-old) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at pharmacy or drug store. It was reported that patient was not pregnant at the time of vaccination and at the time of event. The patient's medical history included known allergies to sulfa drugs, seasonal allergies, insulin dependent diabetes mellitus (IDDM), obesity (BMI 36), acid reflux, mild kidney disease, had COVID in Nov2020. The patient's concomitant medications received within two weeks of vaccination included insulin aspart (NOVOLOG), triamcinolone acetonide (NASACORT), omeprazole, bupropion hydrocholoride (WELLBUTRIN), steroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 11:00 pm 7 hours later vaccination the patient experienced fever, aches, chills, fatigue, headaches, and tachycardia/racing heart, pounding heart, shortness of breath, skipped beats. She had COVID in Nov2020, in Dec2020 began having above symptoms (sx) daily. Vaccine appeared to intensify cardiac sx. The events were reported as non-serious. No treatment was received for the events. Patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Pain, Palpitations, Pyrexia
Clinical narrative: Vaccine appeared to intensify cardiac sx; Fever; aches; chills; fatigue; headaches; tachycardia/racing heart; racing heart, pounding heart; shortness of breath; skipped beats; This is a spontaneous report received from a contactable consumer (patient). A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN 6202), via unspecified route of administration in right arm on 25Feb2021 at 4:00 pm (at the age of 45-year-old) at single dose for COVID-19 immunization. The most recent COVID-19 vaccine was administered at pharmacy or drug store. It was reported that patient was not pregnant at the time of vaccination and at the time of event. The patient's medical history included known allergies to sulfa drugs, seasonal allergies, insulin dependent diabetes mellitus (IDDM), obesity (BMI 36), acid reflux, mild kidney disease, had COVID in Nov2020. The patient's concomitant medications received within two weeks of vaccination included insulin aspart (NOVOLOG), triamcinolone acetonide (NASACORT), omeprazole, bupropion hydrocholoride (WELLBUTRIN), steroid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 25Feb2021 at 11:00 pm 7 hours later vaccination the patient experienced fever, aches, chills, fatigue, headaches, and tachycardia/racing heart, pounding heart, shortness of breath, skipped beats. She had COVID in Nov2020, in Dec2020 began having above symptoms (sx) daily. Vaccine appeared to intensify cardiac sx. The events were reported as non-serious. No treatment was received for the events. Patient had not been tested for COVID-19 since vaccination. The outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Diarrhoea, Headache, Vomiting
Clinical narrative: Roaring headache; vomiting; diarrhea; This is a spontaneous report received from a contactable Consumer (patient). A 65-year-old Female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: En6199) via an unspecified route of administration, administered in Arm Left on 08Mar2021 at 15:15 at a single dose for covid-19 immunisation. Medical history known allergies to sulfa and mefloquine hydrochloride. The patient's concomitant medications were not reported. The patient previously took mefloquine hydrochloride for known allergies. The patient experienced Roaring headache, vomiting and diarrhea. Duration 2 hours on 11Mar2021 at 15:00. The event was considered as non-serious. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. 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. Patient did not receive other medications within 2 weeks of vaccination. No treatment was received for the adverse event. The patient recovered from all the events on 11Mar2021 at 17:00.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypotension, Injection site pain, Syncope, Unresponsive to stimuli
Clinical narrative: 17 minutes after injection, I experienced Nausea, Sweats, Dizziness, Lightheadness, and Fainting occurred.  BP dropped to 80/39 per EMT arriving at Pharmacy site.  Did EKG, Sugar Level, and administered fluids.  EMTs took me to the hospital for treatment.    ER staff noted vitals and bloodwork were alright and could not determine if Anaphylaxis reaction.  ER Doctor ruled it a Vaso Vagal Syncope suspected response to vaccine as body saw it as foreign substance that rejected and severe reaction response occurred after 15 minutes.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure decreased, Blood test, Dizziness, Electrocardiogram, Hyperhidrosis
Clinical narrative: 17 minutes after injection, I experienced Nausea, Sweats, Dizziness, Lightheadness, and Fainting occurred.  BP dropped to 80/39 per EMT arriving at Pharmacy site.  Did EKG, Sugar Level, and administered fluids.  EMTs took me to the hospital for treatment.    ER staff noted vitals and bloodwork were alright and could not determine if Anaphylaxis reaction.  ER Doctor ruled it a Vaso Vagal Syncope suspected response to vaccine as body saw it as foreign substance that rejected and severe reaction response occurred after 15 minutes.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Presyncope, Syncope
Clinical narrative: 17 minutes after injection, I experienced Nausea, Sweats, Dizziness, Lightheadness, and Fainting occurred.  BP dropped to 80/39 per EMT arriving at Pharmacy site.  Did EKG, Sugar Level, and administered fluids.  EMTs took me to the hospital for treatment.    ER staff noted vitals and bloodwork were alright and could not determine if Anaphylaxis reaction.  ER Doctor ruled it a Vaso Vagal Syncope suspected response to vaccine as body saw it as foreign substance that rejected and severe reaction response occurred after 15 minutes.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Inappropriate schedule of product administration, Off label use, Vaccination site pain
Clinical narrative: fatigued; sore arm; This is a spontaneous report from a contactable consumer. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history not reported. Concomitant medication was Lipitor. Patient historical vaccination was first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) on 01Feb2021 in Left arm for covid-19 immunisation. Patient indicated on 22Feb2021 evening they felt fatigued (mild) and was not sure if it was from the vaccination on18Feb21 also experienced sore arm. No treatment received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovering.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: fatigued; sore arm; This is a spontaneous report from a contactable consumer. A 57-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL9266), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 as single dose for covid-19 immunisation. The patient medical history not reported. Concomitant medication was Lipitor. Patient historical vaccination was first dose of vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9262) on 01Feb2021 in Left arm for covid-19 immunisation. Patient indicated on 22Feb2021 evening they felt fatigued (mild) and was not sure if it was from the vaccination on18Feb21 also experienced sore arm. No treatment received. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The outcome of the events was recovering.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Electrocardiogram, Palpitations, Pyrexia, Sinus arrhythmia
Clinical narrative: heart palpitations; high fever; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 16Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at hospital. Medical history included type 2 diabetes mellitus, penicillin allergy, asthma, hypertension (HTN), and degenerative disc disease (DDD). The patient had COVID-19 prior to vaccination noted on an unknown date. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on the left arm on 23Feb2021 15:00 (batch/Lot number was not reported) for COVID-19 immunization. The patient received the 2nd dose of vaccine on 16Mar2021 15:00. On Day 1 (16Mar2021), the patient high fever until day 5 (21Mar2021). On 22Mar2021 (day 6) at 3: 30 pm, the patient was awakened by heart palpitations went to the ER of hospital. The patient received "0.1 NaCl (as reported)" thru IV Line as treatment. The patient recovered from the event of fever on 21Mar2021 and was recovering from the palpitations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sleep disorder
Clinical narrative: heart palpitations; high fever; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 16Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at hospital. Medical history included type 2 diabetes mellitus, penicillin allergy, asthma, hypertension (HTN), and degenerative disc disease (DDD). The patient had COVID-19 prior to vaccination noted on an unknown date. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on the left arm on 23Feb2021 15:00 (batch/Lot number was not reported) for COVID-19 immunization. The patient received the 2nd dose of vaccine on 16Mar2021 15:00. On Day 1 (16Mar2021), the patient high fever until day 5 (21Mar2021). On 22Mar2021 (day 6) at 3: 30 pm, the patient was awakened by heart palpitations went to the ER of hospital. The patient received "0.1 NaCl (as reported)" thru IV Line as treatment. The patient recovered from the event of fever on 21Mar2021 and was recovering from the palpitations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: heart palpitations; high fever; This is a spontaneous report from a contactable consumer (patient).  A 71-year-old female patient received the 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration administered on arm left on 16Mar2021 15:00 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization at hospital. Medical history included type 2 diabetes mellitus, penicillin allergy, asthma, hypertension (HTN), and degenerative disc disease (DDD). The patient had COVID-19 prior to vaccination noted on an unknown date. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had received the first dose of PFIZER-BIONTECH COVID-19 VACCINE on the left arm on 23Feb2021 15:00 (batch/Lot number was not reported) for COVID-19 immunization. The patient received the 2nd dose of vaccine on 16Mar2021 15:00. On Day 1 (16Mar2021), the patient high fever until day 5 (21Mar2021). On 22Mar2021 (day 6) at 3: 30 pm, the patient was awakened by heart palpitations went to the ER of hospital. The patient received "0.1 NaCl (as reported)" thru IV Line as treatment. The patient recovered from the event of fever on 21Mar2021 and was recovering from the palpitations.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Injection site pain, Injection site warmth, Nausea
Clinical narrative: Sore injection site; Headache; Tired; vomiting; Immediate burning at injection site.; chills; achey; fever 99.5-100.5; nausea; Subsided after 1 hour into sore arm; This is a spontaneous report from a contactable consumer or other health Care Professional received from COVAES. A 32-years old female consumer reported for herself that received second dose of BNT162B2 (solution for injection; Batch/Lot Number: ER2613) via an unspecified route of administration in right arm on 20Mar2021 09:30 as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The Patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included food allergy, Known allergies: Shellfish, historical vaccine included BNT162B2 (Product=COVID 19; Proprietary medicinal product name: Pfizer-BioNTech; Batch/lot number: EN6200; Date of start of drug: 02Mar2021; Administration time=06:30 PM; Anatomical Location: Arm Right; Dose Number: 1) as single dose for covid-19 immunisation. On 20Mar2021 22:00, the patient experienced Immediate burning at injection site. Subsided after 1 hour into sore arm, chills, achey, fever Fever 99.5-100.5, and nausea, On 20Mar2021 22:20-530 am vomiting, every 30 minutes, on 21Mar2021 Headache, tried, on 25Mar2021 sore injection site. No treatment received for the adverse events. The outcome of the events (Immediate burning at injection site, Subsided after 1 hour into sore arm, chills, nausea) recovered on unknown date, vomiting was recovered on 20Mar2021 5:30, achey, fever 99.5-100.5 was recovered on 23Mar2021, headache was recovered on 24Mar2021, tired, sore injection site was recovered on 25Mar2021.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Sore injection site; Headache; Tired; vomiting; Immediate burning at injection site.; chills; achey; fever 99.5-100.5; nausea; Subsided after 1 hour into sore arm; This is a spontaneous report from a contactable consumer or other health Care Professional received from COVAES. A 32-years old female consumer reported for herself that received second dose of BNT162B2 (solution for injection; Batch/Lot Number: ER2613) via an unspecified route of administration in right arm on 20Mar2021 09:30 as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The Patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included food allergy, Known allergies: Shellfish, historical vaccine included BNT162B2 (Product=COVID 19; Proprietary medicinal product name: Pfizer-BioNTech; Batch/lot number: EN6200; Date of start of drug: 02Mar2021; Administration time=06:30 PM; Anatomical Location: Arm Right; Dose Number: 1) as single dose for covid-19 immunisation. On 20Mar2021 22:00, the patient experienced Immediate burning at injection site. Subsided after 1 hour into sore arm, chills, achey, fever Fever 99.5-100.5, and nausea, On 20Mar2021 22:20-530 am vomiting, every 30 minutes, on 21Mar2021 Headache, tried, on 25Mar2021 sore injection site. No treatment received for the adverse events. The outcome of the events (Immediate burning at injection site, Subsided after 1 hour into sore arm, chills, nausea) recovered on unknown date, vomiting was recovered on 20Mar2021 5:30, achey, fever 99.5-100.5 was recovered on 23Mar2021, headache was recovered on 24Mar2021, tired, sore injection site was recovered on 25Mar2021.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Sore injection site; Headache; Tired; vomiting; Immediate burning at injection site.; chills; achey; fever 99.5-100.5; nausea; Subsided after 1 hour into sore arm; This is a spontaneous report from a contactable consumer or other health Care Professional received from COVAES. A 32-years old female consumer reported for herself that received second dose of BNT162B2 (solution for injection; Batch/Lot Number: ER2613) via an unspecified route of administration in right arm on 20Mar2021 09:30 as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The Patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included food allergy, Known allergies: Shellfish, historical vaccine included BNT162B2 (Product=COVID 19; Proprietary medicinal product name: Pfizer-BioNTech; Batch/lot number: EN6200; Date of start of drug: 02Mar2021; Administration time=06:30 PM; Anatomical Location: Arm Right; Dose Number: 1) as single dose for covid-19 immunisation. On 20Mar2021 22:00, the patient experienced Immediate burning at injection site. Subsided after 1 hour into sore arm, chills, achey, fever Fever 99.5-100.5, and nausea, On 20Mar2021 22:20-530 am vomiting, every 30 minutes, on 21Mar2021 Headache, tried, on 25Mar2021 sore injection site. No treatment received for the adverse events. The outcome of the events (Immediate burning at injection site, Subsided after 1 hour into sore arm, chills, nausea) recovered on unknown date, vomiting was recovered on 20Mar2021 5:30, achey, fever 99.5-100.5 was recovered on 23Mar2021, headache was recovered on 24Mar2021, tired, sore injection site was recovered on 25Mar2021.  Information on the lot/batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Pyrexia, Vaccination site pain, Vomiting
Clinical narrative: Sore injection site; Headache; Tired; vomiting; Immediate burning at injection site.; chills; achey; fever 99.5-100.5; nausea; Subsided after 1 hour into sore arm; This is a spontaneous report from a contactable consumer or other health Care Professional received from COVAES. A 32-years old female consumer reported for herself that received second dose of BNT162B2 (solution for injection; Batch/Lot Number: ER2613) via an unspecified route of administration in right arm on 20Mar2021 09:30 as single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The Patient did not received other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Medical history included food allergy, Known allergies: Shellfish, historical vaccine included BNT162B2 (Product=COVID 19; Proprietary medicinal product name: Pfizer-BioNTech; Batch/lot number: EN6200; Date of start of drug: 02Mar2021; Administration time=06:30 PM; Anatomical Location: Arm Right; Dose Number: 1) as single dose for covid-19 immunisation. On 20Mar2021 22:00, the patient experienced Immediate burning at injection site. Subsided after 1 hour into sore arm, chills, achey, fever Fever 99.5-100.5, and nausea, On 20Mar2021 22:20-530 am vomiting, every 30 minutes, on 21Mar2021 Headache, tried, on 25Mar2021 sore injection site. No treatment received for the adverse events. The outcome of the events (Immediate burning at injection site, Subsided after 1 hour into sore arm, chills, nausea) recovered on unknown date, vomiting was recovered on 20Mar2021 5:30, achey, fever 99.5-100.5 was recovered on 23Mar2021, headache was recovered on 24Mar2021, tired, sore injection site was recovered on 25Mar2021.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Arthralgia, Dehydration, Depressed level of consciousness, Ear pain
Clinical narrative: Possible seizure; Swelling inside brain frontal cortex; Brain hurts; Loss of short term memory; Tremors; Heart rate elevated upon movement; Loud tinnitis; Ears hurt; Teeth hurt; Neurological symptoms; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via unspecified route of administration in the left arm 16Mar2021 12:15 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included Spinal degeneration and Red Yeast Rice (Mycotoxins-Citrinin) from an unknown date and unknown if ongoing. Concomitant medication includes Tramadol 0.25 occasionally but quit all 3 days prior. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient experienced Neurological symptoms, loss of short term memory, tremors, possible seizure, heart rate elevated upon movement, loud tinnitus, swelling inside brain frontal cortex, ears hurt, teeth hurt, brain hurts on 16Mar2021 00:45. Mycotoxin alert Citrinin - needs to check their source for the lipids to see if red yeast rice is used or any derivative. The patient visited physicians office. The treatment included Tylenol every 6 hours helped, but EEG may be order. The outcome of the event was recovering.  Information on the lot/batch number was available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Fine motor skill dysfunction, Head discomfort, Headache, Heart rate increased
Clinical narrative: Possible seizure; Swelling inside brain frontal cortex; Brain hurts; Loss of short term memory; Tremors; Heart rate elevated upon movement; Loud tinnitis; Ears hurt; Teeth hurt; Neurological symptoms; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via unspecified route of administration in the left arm 16Mar2021 12:15 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included Spinal degeneration and Red Yeast Rice (Mycotoxins-Citrinin) from an unknown date and unknown if ongoing. Concomitant medication includes Tramadol 0.25 occasionally but quit all 3 days prior. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient experienced Neurological symptoms, loss of short term memory, tremors, possible seizure, heart rate elevated upon movement, loud tinnitus, swelling inside brain frontal cortex, ears hurt, teeth hurt, brain hurts on 16Mar2021 00:45. Mycotoxin alert Citrinin - needs to check their source for the lipids to see if red yeast rice is used or any derivative. The patient visited physicians office. The treatment included Tylenol every 6 hours helped, but EEG may be order. The outcome of the event was recovering.  Information on the lot/batch number was available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Hypersomnia, Neck pain, Pain in extremity, Paranasal sinus hyposecretion
Clinical narrative: Possible seizure; Swelling inside brain frontal cortex; Brain hurts; Loss of short term memory; Tremors; Heart rate elevated upon movement; Loud tinnitis; Ears hurt; Teeth hurt; Neurological symptoms; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via unspecified route of administration in the left arm 16Mar2021 12:15 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included Spinal degeneration and Red Yeast Rice (Mycotoxins-Citrinin) from an unknown date and unknown if ongoing. Concomitant medication includes Tramadol 0.25 occasionally but quit all 3 days prior. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient experienced Neurological symptoms, loss of short term memory, tremors, possible seizure, heart rate elevated upon movement, loud tinnitus, swelling inside brain frontal cortex, ears hurt, teeth hurt, brain hurts on 16Mar2021 00:45. Mycotoxin alert Citrinin - needs to check their source for the lipids to see if red yeast rice is used or any derivative. The patient visited physicians office. The treatment included Tylenol every 6 hours helped, but EEG may be order. The outcome of the event was recovering.  Information on the lot/batch number was available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Slow speech, Time perception altered, Tinnitus, Toothache, Tremor
Clinical narrative: Possible seizure; Swelling inside brain frontal cortex; Brain hurts; Loss of short term memory; Tremors; Heart rate elevated upon movement; Loud tinnitis; Ears hurt; Teeth hurt; Neurological symptoms; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via unspecified route of administration in the left arm 16Mar2021 12:15 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included Spinal degeneration and Red Yeast Rice (Mycotoxins-Citrinin) from an unknown date and unknown if ongoing. Concomitant medication includes Tramadol 0.25 occasionally but quit all 3 days prior. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient experienced Neurological symptoms, loss of short term memory, tremors, possible seizure, heart rate elevated upon movement, loud tinnitus, swelling inside brain frontal cortex, ears hurt, teeth hurt, brain hurts on 16Mar2021 00:45. Mycotoxin alert Citrinin - needs to check their source for the lipids to see if red yeast rice is used or any derivative. The patient visited physicians office. The treatment included Tylenol every 6 hours helped, but EEG may be order. The outcome of the event was recovering.  Information on the lot/batch number was available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urinary retention
Clinical narrative: Possible seizure; Swelling inside brain frontal cortex; Brain hurts; Loss of short term memory; Tremors; Heart rate elevated upon movement; Loud tinnitis; Ears hurt; Teeth hurt; Neurological symptoms; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via unspecified route of administration in the left arm 16Mar2021 12:15 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included Spinal degeneration and Red Yeast Rice (Mycotoxins-Citrinin) from an unknown date and unknown if ongoing. Concomitant medication includes Tramadol 0.25 occasionally but quit all 3 days prior. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient experienced Neurological symptoms, loss of short term memory, tremors, possible seizure, heart rate elevated upon movement, loud tinnitus, swelling inside brain frontal cortex, ears hurt, teeth hurt, brain hurts on 16Mar2021 00:45. Mycotoxin alert Citrinin - needs to check their source for the lipids to see if red yeast rice is used or any derivative. The patient visited physicians office. The treatment included Tylenol every 6 hours helped, but EEG may be order. The outcome of the event was recovering.  Information on the lot/batch number was available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Brain oedema, Ear pain, Headache, Heart rate increased
Clinical narrative: Possible seizure; Swelling inside brain frontal cortex; Brain hurts; Loss of short term memory; Tremors; Heart rate elevated upon movement; Loud tinnitis; Ears hurt; Teeth hurt; Neurological symptoms; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via unspecified route of administration in the left arm 16Mar2021 12:15 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included Spinal degeneration and Red Yeast Rice (Mycotoxins-Citrinin) from an unknown date and unknown if ongoing. Concomitant medication includes Tramadol 0.25 occasionally but quit all 3 days prior. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient experienced Neurological symptoms, loss of short term memory, tremors, possible seizure, heart rate elevated upon movement, loud tinnitus, swelling inside brain frontal cortex, ears hurt, teeth hurt, brain hurts on 16Mar2021 00:45. Mycotoxin alert Citrinin - needs to check their source for the lipids to see if red yeast rice is used or any derivative. The patient visited physicians office. The treatment included Tylenol every 6 hours helped, but EEG may be order. The outcome of the event was recovering.  Information on the lot/batch number was available.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neurological symptom, Seizure, Tinnitus, Toothache, Tremor
Clinical narrative: Possible seizure; Swelling inside brain frontal cortex; Brain hurts; Loss of short term memory; Tremors; Heart rate elevated upon movement; Loud tinnitis; Ears hurt; Teeth hurt; Neurological symptoms; This is a spontaneous report received from a contactable consumer (patient herself). A 59-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Expiry date: Unknown) via unspecified route of administration in the left arm 16Mar2021 12:15 at SINGLE DOSE for COVID-19 Immunization. The patients medical history included Spinal degeneration and Red Yeast Rice (Mycotoxins-Citrinin) from an unknown date and unknown if ongoing. Concomitant medication includes Tramadol 0.25 occasionally but quit all 3 days prior. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. The patient experienced Neurological symptoms, loss of short term memory, tremors, possible seizure, heart rate elevated upon movement, loud tinnitus, swelling inside brain frontal cortex, ears hurt, teeth hurt, brain hurts on 16Mar2021 00:45. Mycotoxin alert Citrinin - needs to check their source for the lipids to see if red yeast rice is used or any derivative. The patient visited physicians office. The treatment included Tylenol every 6 hours helped, but EEG may be order. The outcome of the event was recovering.  Information on the lot/batch number was available.
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: C-reactive protein, Catheterisation cardiac normal, Chest pain, Chills, Echocardiogram abnormal
Clinical narrative: moderate heart attack; myocarditis; my heart to get inflamed; Monday evening, 22Mar, I started getting pain in my upper chest; getting pain in my upper chest and throat; I had full body chills; I had full body chills and aches; This is a spontaneous report from a contactable consumer.   A 37-years-old male patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), , administered in Arm Left on 20Mar2021 (Batch/Lot Number: ER2613) as SINGLE DOSE for covid-19 immunisation. Age at vaccination :37 years.The patient received the first dose on 27Feb2021 (Brand Pfizer,Lot number EN6203 , administration time 12:00 PM, Vaccine location Left arm).Medical history included none.     There were no concomitant medications.The clinical course was reported as follows: "I received my second covid vaccine shot Saturday at noon, 20Mar. I had full body chills and aches Saturday and Sunday night. Monday evening, 22Mar, I started getting pain in my upper chest and throat. I woke up at 2:00am with severe chest pain. I called # and rode in an ambulance to the hospital. I spent 3 days in the hospital. I was diagnosed with myocarditis. The cardiologist believes my auto immune response to the vaccine attached my heart and caused my heart to get inflamed. I had a moderate heart attack from the vaccine".Th Adeverse events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Hospitalization, Life threatening illness (immediate risk of death from the event.The patient received treatments for the events (ae treatment medication, cardiac MRI, cardiac catherization).The patient was recovered with sequel from all events.No Covid prior vaccination , No Covid tested post vaccination: Yes (covid test type post vaccination Nasal Swab on 23Mar2021:Negative)