chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Head discomfort, Headache, Insomnia, Myalgia
Clinical narrative: Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; This is a spontaneous report from other health professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1686, via an unspecified route of administration from 06Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included Sulfa sensitivity (but allergy not confirmed). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, from  18Dec2020 for covid-19 immunization (1st dose). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) and drospirenone, ethinylestradiol (OCELLA), drospirenone, ethinylestradiol (YASMIN).  On 06Jan2021 12:00, the patient experienced muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo. The patient underwent lab tests and procedures on 26Aug2020 which included Nasal Swab/ Covid test with negative result; then on 18Dec2020, COVID Antibody Test and COVID Antibody Test both with negative results. The outcome of event was not recovered. No treatment was received/required due to the events.   No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; This is a spontaneous report from other health professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1686, via an unspecified route of administration from 06Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included Sulfa sensitivity (but allergy not confirmed). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, from  18Dec2020 for covid-19 immunization (1st dose). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) and drospirenone, ethinylestradiol (OCELLA), drospirenone, ethinylestradiol (YASMIN).  On 06Jan2021 12:00, the patient experienced muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo. The patient underwent lab tests and procedures on 26Aug2020 which included Nasal Swab/ Covid test with negative result; then on 18Dec2020, COVID Antibody Test and COVID Antibody Test both with negative results. The outcome of event was not recovered. No treatment was received/required due to the events.   No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Dizziness, Head discomfort, Headache, Myalgia
Clinical narrative: Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; This is a spontaneous report from other health professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1686, via an unspecified route of administration from 06Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included Sulfa sensitivity (but allergy not confirmed). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, from  18Dec2020 for covid-19 immunization (1st dose). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) and drospirenone, ethinylestradiol (OCELLA), drospirenone, ethinylestradiol (YASMIN).  On 06Jan2021 12:00, the patient experienced muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo. The patient underwent lab tests and procedures on 26Aug2020 which included Nasal Swab/ Covid test with negative result; then on 18Dec2020, COVID Antibody Test and COVID Antibody Test both with negative results. The outcome of event was not recovered. No treatment was received/required due to the events.   No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 antibody test, SARS-CoV-2 test, Vertigo
Clinical narrative: Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; Muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo; This is a spontaneous report from other health professional. A 34-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EJ1686, via an unspecified route of administration from 06Jan2021 11:00 at a single dose for covid-19 immunization. Medical history included Sulfa sensitivity (but allergy not confirmed). Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number: EH9899, from  18Dec2020 for covid-19 immunization (1st dose). Concomitant medication included lisdexamfetamine mesilate (VYVANSE) and drospirenone, ethinylestradiol (OCELLA), drospirenone, ethinylestradiol (YASMIN).  On 06Jan2021 12:00, the patient experienced muscle pain, joint pain, body ache, headache, head pressure, and intermittent dizziness/vertigo. The patient underwent lab tests and procedures on 26Aug2020 which included Nasal Swab/ Covid test with negative result; then on 18Dec2020, COVID Antibody Test and COVID Antibody Test both with negative results. The outcome of event was not recovered. No treatment was received/required due to the events.   No follow-up attempts possible. No further information expected. Information on the batch number has been obtained.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lip swelling, Swelling face, Swollen tongue, Urticaria
Clinical narrative: had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dysgeusia, Swollen tongue
Clinical narrative: had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dysgeusia, Dyspnoea, Swollen tongue, Tachycardia, Urticaria
Clinical narrative: had a metallic taste; turned to swollen tongue; hives around chest and neck; difficult to breathe; tachycardia; This is a spontaneous report from a contactable other HCP (Patient). A 33-year-old non-pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL 3248), via an unspecified route of administration at right arm on 07Jan2021 16:15 at single dose for covid-19 immunization. Vaccine was administered at hospital. Known allergies included cyclobenzaprine and dairy latex. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 10 mg, gabapentin 300 mg, venlafaxine 150 mg. No other vaccine in four weeks. Three minutes after vaccination the patient had a metallic taste, turned to swollen tongue, hives around chest and neck, difficult to breathe, and tachycardia on 07Jan2021 16:18. The events resulted in Emergency room/department or urgent care. Treatment received included Epinephrine, methylprednisolone sodium succinate (SOLU-ME dork) and famotidine (PEPCID) also diphenhydramine HCl (BENADRYL). The outcome of the events was unknown.; Sender's Comments: Based on temporal association, a possible contributory role of suspect BNT162B2 cannot be excluded for events metallic taste, swollen tongue, hives, difficulty breathing and tachycardia. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 72.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient very stable on hospice + got vaccine about noon + found dead in room at 4:40 am next morning
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, first dose (lot number: EL0140) on 18Dec2020 at single dose then second dose (lot number: EK9231) on 07Jan2021 18:45 at single dose for COVID-19 vaccination. Medical history included hypertension, depression, osteoarthritis (OA) and known allergies to ACE inhibitors and sulfa eye drops, on unspecified dates. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have COVID-19 prior to vaccination. Concomitant medications in 2 weeks included losartan, bupropion, fluoxetine hydrochloride (PROZAC), triamcinolone acetonide (NASACORT), naproxen sodium (ALEVE), and colecalciferol (VITAMIN D) from unspecified dates. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient experienced fever 101.2 orally, chills, body aches, headache, nausea, vomiting on 08Jan2021, 5 hrs 15 min onset from last dose on 07Jan2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes paracetamol (TYLENOL), ondansetron (ZOFRAN). Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101.2 (unit unknown) on 08Jan2021, and SARs-CoV-2 test (COVID test) with unknown results on an unspecified date. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, first dose (lot number: EL0140) on 18Dec2020 at single dose then second dose (lot number: EK9231) on 07Jan2021 18:45 at single dose for COVID-19 vaccination. Medical history included hypertension, depression, osteoarthritis (OA) and known allergies to ACE inhibitors and sulfa eye drops, on unspecified dates. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have COVID-19 prior to vaccination. Concomitant medications in 2 weeks included losartan, bupropion, fluoxetine hydrochloride (PROZAC), triamcinolone acetonide (NASACORT), naproxen sodium (ALEVE), and colecalciferol (VITAMIN D) from unspecified dates. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient experienced fever 101.2 orally, chills, body aches, headache, nausea, vomiting on 08Jan2021, 5 hrs 15 min onset from last dose on 07Jan2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes paracetamol (TYLENOL), ondansetron (ZOFRAN). Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101.2 (unit unknown) on 08Jan2021, and SARs-CoV-2 test (COVID test) with unknown results on an unspecified date. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, first dose (lot number: EL0140) on 18Dec2020 at single dose then second dose (lot number: EK9231) on 07Jan2021 18:45 at single dose for COVID-19 vaccination. Medical history included hypertension, depression, osteoarthritis (OA) and known allergies to ACE inhibitors and sulfa eye drops, on unspecified dates. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have COVID-19 prior to vaccination. Concomitant medications in 2 weeks included losartan, bupropion, fluoxetine hydrochloride (PROZAC), triamcinolone acetonide (NASACORT), naproxen sodium (ALEVE), and colecalciferol (VITAMIN D) from unspecified dates. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient experienced fever 101.2 orally, chills, body aches, headache, nausea, vomiting on 08Jan2021, 5 hrs 15 min onset from last dose on 07Jan2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes paracetamol (TYLENOL), ondansetron (ZOFRAN). Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101.2 (unit unknown) on 08Jan2021, and SARs-CoV-2 test (COVID test) with unknown results on an unspecified date. The outcome of the events was not recovered.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Vomiting
Clinical narrative: Fever 101.2 orally; chills; body aches; headache; nausea; vomiting; first dose on 18Dec2020, second dose on 07Jan2021; This is a spontaneous report from a contactable nurse. A 45-year-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 VACCINE), via an unspecified route of administration on the left arm, first dose (lot number: EL0140) on 18Dec2020 at single dose then second dose (lot number: EK9231) on 07Jan2021 18:45 at single dose for COVID-19 vaccination. Medical history included hypertension, depression, osteoarthritis (OA) and known allergies to ACE inhibitors and sulfa eye drops, on unspecified dates. The patient is not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, did not have COVID-19 prior to vaccination. Concomitant medications in 2 weeks included losartan, bupropion, fluoxetine hydrochloride (PROZAC), triamcinolone acetonide (NASACORT), naproxen sodium (ALEVE), and colecalciferol (VITAMIN D) from unspecified dates. Facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient experienced fever 101.2 orally, chills, body aches, headache, nausea, vomiting on 08Jan2021, 5 hrs 15 min onset from last dose on 07Jan2021. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events includes paracetamol (TYLENOL), ondansetron (ZOFRAN). Since the vaccination, the patient has not been tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101.2 (unit unknown) on 08Jan2021, and SARs-CoV-2 test (COVID test) with unknown results on an unspecified date. The outcome of the events was not recovered.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient also developed weakness, fatigue and had chills unknown if she had fever  Patient was seen by family MD after a few days of swelling
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: a few hrs. after receiving the vaccine patient had swelling to bilateral hands and feet. patient also developed weakness, fatigue and had chills unknown if she had fever  Patient was seen by family MD after a few days of swelling
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Headache, Photopsia
Clinical narrative: Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Care Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tremor
Clinical narrative: Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Care Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Headache, Tremor
Clinical narrative: Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Care Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Anxiety; Headache; Seeing stars; Chest tightness; Hand tremor; SOB; This is a spontaneous report from a contactable pharmacist. A 40-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284; Expiration date was not reported), intramuscularly on the left arm on 06Jan2021 (10:15) at a single dose for COVID-19 immunization at the hospital. Medical history included migraines; heart murmur with surgery; grand mal seizure that has resolved; and contrast dye allergy. Concomitant medications included sumatriptan and norethindrone [norethisterone]. The patient previously took phenytoin, iodine, terconazole, tramadol and cetirizine; and had allergies with these medications. On 06Jan2021 (10:15), the patient was seeing stars; had chest tightness; hand tremor; and shortness of breath (SOB). The patient was referred to the Urgent Care Clinic due to these events. On 06Jan2021 (12:30), at the Urgent Care Clinic, the patient had anxiety and headache. The patient had received acetaminophen, diphenhydramine, ibuprofen and water as treatment for the events, 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was provided with education on managing anxiety. The outcome of the events was recovered in Jan2021 for 'seeing stars', 'chest tightness', 'hand tremor' and 'shortness of breath'; and was unknown for 'headache' and 'anxiety'. The patient did not have COVID-19 prior to vaccination, and was not tested post-vaccination.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal pain, Diarrhoea
Clinical narrative: Abdominal cramping; watery diarrhea; loose stools; This is a spontaneous report from a contactable nurse reporting for herself. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EK5730/expiration date: not provided), via intramuscular route of administration, on 21Dec2020 01:30 PM (at the age of 56 years old) as a single dose in the left arm for COVID-19 vaccination. Relevant medical history included rosacea. The patient did not have any known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication was not provided. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Dec2020, the patient experienced abdominal cramping followed by watery diarrhea for 2-3 days. Then on an unspecified date in Dec2020, the patient experienced abdominal cramping followed by non-watery loose stools for 4-5 days. The patient did not receive any treatment for these events. The outcome of the events abdominal cramping, watery diarrhea and non-watery loose stools was recovered on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin
Clinical narrative: Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient).  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
Age: 61.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster, Hyperaesthesia
Clinical narrative: Shingles type reaction without a rash or redness; Extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site.; This is a spontaneous report from a contactable pharmacist (patient).  A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number: EJ1685), via an unspecified route of administration on the left arm on 22Dec2020 07:45 at SINGLE DOSE for COVID-19 immunization at the hospital. Medical history included diabetes and hypertension (HTN). It was also reported that the patient had allergies with quinolones. Concomitant medications included metformin (METFORMIN), cetirizine hydrochloride (ZYRTEC), semaglutide (OZEMPIC), simvastatin (ZOCOR), levothyroxine sodium (SYNTHROID) and "elav". On 01Jan2021 19:00, the patient had extreme skin sensitivity on torso (chest and back) on left side of body parallel to injection site. The patient also had shingles type reaction without a rash or redness. Prior to vaccination the patient was not diagnosed with COVID-19 and since the vaccination, has not been tested for COVID-19. The patient did not receive any treatment for the events. Outcome of the events were not recovered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral, Tinea capitis
Clinical narrative: Numbness and tingling in left side of face starting on morning on 08Jan.; Numbness and tingling in left side of face starting on morning on 08Jan.; This is a spontaneous report from a contactable Nurse, the patient. This 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK9231) dose #2, via an unspecified route of administration in the left arm on 06Jan2021 at 08:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. Medical history included guillain-barre syndrome from 2017 (reported as not related to a vaccine) and unknown if ongoing, asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing known, environmental allergy (unspecified) from an unknown date and unknown if ongoing known and an allergy to metals from an unknown date and unknown if ongoing known. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), montelukast sodium (SINGULAIR), drospirenone, ethinylestradiol betadex clathrate (YAZ), omeprazole (PROTONIX [OMEPRAZOLE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and mometasone furoate (FLONASE [MOMETASONE FUROATE]). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK5730), dose #1, via an unspecified route of administration in the left arm on an 19Dec2020 at 08:15 as a single dose for COVID-19 vaccination. On 08Jan2021 at 05:00, the patient experienced numbness and tingling in left side of face. No therapeutic measures were taken as a result of the events. The clinical outcome of numbness and tingling in left side of face was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in left side of face starting on morning on 08Jan.; Numbness and tingling in left side of face starting on morning on 08Jan.; This is a spontaneous report from a contactable Nurse, the patient. This 39-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Lot number: EK9231) dose #2, via an unspecified route of administration in the left arm on 06Jan2021 at 08:30 (at the age of 39-years-old) as a single dose for COVID-19 vaccination. Medical history included guillain-barre syndrome from 2017 (reported as not related to a vaccine) and unknown if ongoing, asthma from an unknown date and unknown if ongoing, attention deficit hyperactivity disorder from an unknown date and unknown if ongoing, latex allergy from an unknown date and unknown if ongoing known, environmental allergy (unspecified) from an unknown date and unknown if ongoing known and an allergy to metals from an unknown date and unknown if ongoing known. Concomitant medication included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), montelukast sodium (SINGULAIR), drospirenone, ethinylestradiol betadex clathrate (YAZ), omeprazole (PROTONIX [OMEPRAZOLE]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and mometasone furoate (FLONASE [MOMETASONE FUROATE]). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient was not pregnant at the time of vaccination. The patient previously received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (lot number: EK5730), dose #1, via an unspecified route of administration in the left arm on an 19Dec2020 at 08:15 as a single dose for COVID-19 vaccination. On 08Jan2021 at 05:00, the patient experienced numbness and tingling in left side of face. No therapeutic measures were taken as a result of the events. The clinical outcome of numbness and tingling in left side of face was not resolved. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Musculoskeletal pain
Clinical narrative: Patient complains of left rib pain that started 3 hours after getting her first COVID 19 vaccine on 1/4/2021.  Patient did have a chest xray that showed lower left penumonia and was started on antibiotics.  Patient returned to PCP on 1/8/21 with continued complaint of left rib pain that had not gotten better.  Chest Xray clear on 1/8/21.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest X-ray abnormal, Chest X-ray normal, Musculoskeletal chest pain, Pneumonia
Clinical narrative: Patient complains of left rib pain that started 3 hours after getting her first COVID 19 vaccine on 1/4/2021.  Patient did have a chest xray that showed lower left penumonia and was started on antibiotics.  Patient returned to PCP on 1/8/21 with continued complaint of left rib pain that had not gotten better.  Chest Xray clear on 1/8/21.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness to left little toe; This is a spontaneous report from a contactable physician.  A 55-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration, at the left arm on arm on 17Dec2020 10:15  at single dose for COVID-19 immunization at a hospital. Medical history included prostatitis.  No known drug allergy. Concomitant medication included clindamycin hcl. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Dec2020 08:00, a few days after first shot patient noticed numbness to left little toe. This progressed slowly to 3rd and 4th digit. After second shot (day 2), patient noticed this now extended to both feet, digits 3-5, sole of feet, and outside edge of feet. No pain just numbness. The patient was not tested for it since the vaccination. The patient took the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL1283), on 07Jan2021 at the left arn for COVID-19 immunization. The patient did not received any treatment for the event. The patient has not recovered from the event.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: on Day 8 (1/12/21)-  approximately  3x5 inch, slightly warm ,bright red  appeared and increased in size as the day progressed  to the size of 4 x 8 inches. No other symptoms occurred other than redness and being slightly warm to touch. CBC obtained    On Day 9- the redness had faded to a light purple/rash color but increased in size to about 5 x 10 inches. Again, no other symptoms were present and not warm to touch.   Day  10 ( 1/14/21)  CBC returned totally normal, site has faint redness, almost normal, with slight itching now, no other symptoms.  Patient did take Benedryl every night and Allegra every morning when it started.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Full blood count normal, Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: on Day 8 (1/12/21)-  approximately  3x5 inch, slightly warm ,bright red  appeared and increased in size as the day progressed  to the size of 4 x 8 inches. No other symptoms occurred other than redness and being slightly warm to touch. CBC obtained    On Day 9- the redness had faded to a light purple/rash color but increased in size to about 5 x 10 inches. Again, no other symptoms were present and not warm to touch.   Day  10 ( 1/14/21)  CBC returned totally normal, site has faint redness, almost normal, with slight itching now, no other symptoms.  Patient did take Benedryl every night and Allegra every morning when it started.
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, SARS-CoV-2 test negative
Clinical narrative: died 3 days after receiving the vaccine/Death cause: Pneumonia per doctor; This is a spontaneous report from a contactable consumer. An 85-year-old non-pregnant female patient (reporter's mother) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunization. Medical history included dementia from an unknown date. The patient's concomitant medications were not reported. The patient died 3 days after receiving the vaccine on 10Jan2021 11:00, death cause was pneumonia per doctor. The event was reported as serious as resulted in death. It was unknown if the patient received treatment for the event. 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 it was unknow if the patient has been tested for COVID-19 since the vaccination. The patient died on 10Jan2021. It was not reported if an autopsy was performed.   Information about lot/batch number has been requested.; Reported Cause(s) of Death: Pneumonia
Age: 85.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Death, Pneumonia
Clinical narrative: died 3 days after receiving the vaccine/Death cause: Pneumonia per doctor; This is a spontaneous report from a contactable consumer. An 85-year-old non-pregnant female patient (reporter's mother) received the first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 07Jan2021 at single dose for covid-19 immunization. Medical history included dementia from an unknown date. The patient's concomitant medications were not reported. The patient died 3 days after receiving the vaccine on 10Jan2021 11:00, death cause was pneumonia per doctor. The event was reported as serious as resulted in death. It was unknown if the patient received treatment for the event. 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 it was unknow if the patient has been tested for COVID-19 since the vaccination. The patient died on 10Jan2021. It was not reported if an autopsy was performed.   Information about lot/batch number has been requested.; Reported Cause(s) of Death: Pneumonia
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cough, Decreased appetite, Diarrhoea, Eye pruritus
Clinical narrative: diarrhea; I had fatigue and weakness; I had fatigue and weakness; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included coeliac disease from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported: "after having the second vaccine, I had fatigue and weakness; the weakness was much greater it seems than what would be considered a normal reaction. I have bad diarrhea and I had to miss work". The patient outcome of the events was unknown.  Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Injection site pain, Morose, Pain in extremity, Pyrexia
Clinical narrative: diarrhea; I had fatigue and weakness; I had fatigue and weakness; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included coeliac disease from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported: "after having the second vaccine, I had fatigue and weakness; the weakness was much greater it seems than what would be considered a normal reaction. I have bad diarrhea and I had to miss work". The patient outcome of the events was unknown.  Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test, Taste disorder
Clinical narrative: diarrhea; I had fatigue and weakness; I had fatigue and weakness; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included coeliac disease from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported: "after having the second vaccine, I had fatigue and weakness; the weakness was much greater it seems than what would be considered a normal reaction. I have bad diarrhea and I had to miss work". The patient outcome of the events was unknown.  Information on lot number/batch number was requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue
Clinical narrative: diarrhea; I had fatigue and weakness; I had fatigue and weakness; This is a spontaneous report from a contactable nurse (patient) received via Medical Information Team.  A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history included coeliac disease from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient reported: "after having the second vaccine, I had fatigue and weakness; the weakness was much greater it seems than what would be considered a normal reaction. I have bad diarrhea and I had to miss work". The patient outcome of the events was unknown.  Information on lot number/batch number was requested.