chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Cough, Hypoaesthesia, Neuralgia
Clinical narrative: NUMBNESS FACIAL; COUGH; NERVE PAIN; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis.  No concomitant medications were reported. On an unspecified date, the subject experienced numbness facial, cough, and nerve pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from numbness facial, cough, and nerve pain. This report was non-serious.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Meningitis viral, Psychotic disorder
Clinical narrative: Diagnosed with viral meningitis; gout (legs hurts when touched); He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MENINGITIS VIRAL (Diagnosed with viral meningitis), GOUT (gout (legs hurts when touched)) and PSYCHOTIC DISORDER (He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 001B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL HCTZ) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced PSYCHOTIC DISORDER (He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping) (seriousness criterion hospitalization). On 04-Apr-2021, the patient experienced MENINGITIS VIRAL (Diagnosed with viral meningitis) (seriousness criteria hospitalization and medically significant) and GOUT (gout (legs hurts when touched)) (seriousness criterion hospitalization). The patient was hospitalized on 04-Apr-2021 due to GOUT, MENINGITIS VIRAL and PSYCHOTIC DISORDER. At the time of the report, MENINGITIS VIRAL (Diagnosed with viral meningitis), GOUT (gout (legs hurts when touched)) and PSYCHOTIC DISORDER (He was "gone", "what the heck is wrong with dad", wierd things happen when he's sleeping) had not resolved.            On 4th April 2021 the patient looked like he was dying, replies but not very coherent, After 2nd shot 7-8 days later he was "gone", "Little weird things" that would happen when he's sleeping.  No concomitant medication included.  Very limited information regarding these events has been provided at this time.  Further information has been requested  Antibiotics are added as treatment medications.   This case was linked to MOD-2021-072700 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 20-Apr-2021: Seriousness criteria upgraded.Events updated; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Epstein-Barr virus infection reactivation, Fatigue, Hypersomnia, Muscular weakness, Product dose omission issue
Clinical narrative: CEDV chronic (EpsteinBarr virus) underlying condition it made; muscle weakness specially in face/feet that lasted for 10 weeks; very severe fatigue lasted for 10 weeks/very severe fatigue; haven't received the 2nd shot more than 36 days; She slept for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (EpsteinBarr virus) underlying condition it made) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Epstein-Barr virus infection (CEDV chronic (EpsteinBarr virus)), Allergy to chemicals NOS (Chemical allergy. For which is she is taking phenobarbital and TB tine.) and Guillain Barre syndrome. Concomitant products included PHENOBARBITAL and TUBERCULIN PPD (TUBERSOL) for Allergy to chemicals.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced HYPERSOMNIA (She slept for 3 days) and PRODUCT DOSE OMISSION ISSUE (haven't received the 2nd shot more than 36 days). On 15-Feb-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness specially in face/feet that lasted for 10 weeks) and FATIGUE (very severe fatigue lasted for 10 weeks/very severe fatigue). On an unknown date, the patient experienced EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (EpsteinBarr virus) underlying condition it made) (seriousness criterion medically significant). On 11-Feb-2021, PRODUCT DOSE OMISSION ISSUE (haven't received the 2nd shot more than 36 days) had resolved. At the time of the report, EPSTEIN-BARR VIRUS INFECTION REACTIVATION (CEDV chronic (EpsteinBarr virus) underlying condition it made) and HYPERSOMNIA (She slept for 3 days) outcome was unknown and MUSCULAR WEAKNESS (muscle weakness specially in face/feet that lasted for 10 weeks) and FATIGUE (very severe fatigue lasted for 10 weeks/very severe fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, this patient's underlying medical condition remains a confounder.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, this patient's underlying medical condition remains a confounder.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased activity, Deep vein thrombosis, Dizziness, Feeling abnormal
Clinical narrative: DVT (blood clot) in leg/her leg started to hurt; Dizziness; Headache; Fever; Chills; Didn't feel well; felt bad; had to go to bed for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well), PYREXIA (Fever) and CHILLS (Chills). On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). In April 2021, the patient experienced FEELING ABNORMAL (felt bad) and DECREASED ACTIVITY (had to go to bed for 3 days). On 18-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt) (seriousness criterion medically significant). On 04-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt), DIZZINESS (Dizziness), FEELING ABNORMAL (felt bad) and HEADACHE (Headache) outcome was unknown and VACCINATION COMPLICATION (Didn't feel well) and DECREASED ACTIVITY (had to go to bed for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not feel well for a couple of days. The events, fever and chills lasted for a day and half. On 07 Apr 2021 or 08 Apr 2021, the patient felt bad, experienced headaches and dizziness, and she had to go to bed for 3 days. On13 Apr 2021, the patient's leg started to hurt and she ended up going to hospital. On 18 Apr 2021, the patient was diagnosed with DVT  in her leg.  Concomitant medications reported included drug unspecified for blood pressure.  Treatment for the event included blood thinners.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination complication
Clinical narrative: DVT (blood clot) in leg/her leg started to hurt; Dizziness; Headache; Fever; Chills; Didn't feel well; felt bad; had to go to bed for 3 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure abnormal.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced VACCINATION COMPLICATION (Didn't feel well), PYREXIA (Fever) and CHILLS (Chills). On 08-Apr-2021, the patient experienced DIZZINESS (Dizziness) and HEADACHE (Headache). In April 2021, the patient experienced FEELING ABNORMAL (felt bad) and DECREASED ACTIVITY (had to go to bed for 3 days). On 18-Apr-2021, the patient experienced DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt) (seriousness criterion medically significant). On 04-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, DEEP VEIN THROMBOSIS (DVT (blood clot) in leg/her leg started to hurt), DIZZINESS (Dizziness), FEELING ABNORMAL (felt bad) and HEADACHE (Headache) outcome was unknown and VACCINATION COMPLICATION (Didn't feel well) and DECREASED ACTIVITY (had to go to bed for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient did not feel well for a couple of days. The events, fever and chills lasted for a day and half. On 07 Apr 2021 or 08 Apr 2021, the patient felt bad, experienced headaches and dizziness, and she had to go to bed for 3 days. On13 Apr 2021, the patient's leg started to hurt and she ended up going to hospital. On 18 Apr 2021, the patient was diagnosed with DVT  in her leg.  Concomitant medications reported included drug unspecified for blood pressure.  Treatment for the event included blood thinners.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, Further information has been requested.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Crepitations, Dyspnoea paroxysmal nocturnal
Clinical narrative: Shortness of breath wakes him up from his sleep; Crackling in my throat; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA PAROXYSMAL NOCTURNAL (Shortness of breath wakes him up from his sleep) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced DYSPNOEA PAROXYSMAL NOCTURNAL (Shortness of breath wakes him up from his sleep) (seriousness criterion medically significant) and CREPITATIONS (Crackling in my throat). On 23-Apr-2021, DYSPNOEA PAROXYSMAL NOCTURNAL (Shortness of breath wakes him up from his sleep) had resolved. At the time of the report, CREPITATIONS (Crackling in my throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was unknown.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COPD. Concurrent medical conditions included Immunocompromised. Concomitant products included OXYGEN for an unknown indication.    On 12-Apr-2021 at 12:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 12-Apr-2021 The patient died on 12-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No treatment information were reported.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded; Reported Cause(s) of Death: Unknown cause of death
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arrhythmia, Blood pressure measurement, Electrocardiogram ambulatory, Hypertensive crisis
Clinical narrative: Heart arrhythmia; Blood Pressure went up to as high as 230-220 over 160-130.; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Heart arrhythmia) and HYPERTENSIVE CRISIS (Blood Pressure went up to as high as 230-220 over 160-130.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included LOSARTAN, METOPROLOL, SOTALOL, POTASSIUM CHLORIDE (KLOR-CON), APIXABAN (ELIQUIS) and FUROSEMIDE for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Apr-2021, the patient experienced ARRHYTHMIA (Heart arrhythmia) (seriousness criterion medically significant) and HYPERTENSIVE CRISIS (Blood Pressure went up to as high as 230-220 over 160-130.) (seriousness criterion medically significant). At the time of the report, ARRHYTHMIA (Heart arrhythmia) outcome was unknown and HYPERTENSIVE CRISIS (Blood Pressure went up to as high as 230-220 over 160-130.) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Apr-2021, Blood pressure measurement: 220-230 over 130-160 (High) 220-230 over 130-160 and 111/60 (Inconclusive) 111/60. On 18-Apr-2021, Electrocardiogram ambulatory: abnormal (abnormal) showed premature ventricular contractions.         Patient reported that his usual blood pressure was around 140/78-84". His doctor advised him to go to the hospital. He was given clonidine in the ER and his blood pressure dropped to 111/60. The caller was also hooked to a Holter monitor and it showed PVC. Once the blood pressure went down, he was sent home.  The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Hypotension, Laboratory test, Myalgia
Clinical narrative: Fainted 2 times; low blood pressure; dizzy; tachycardia; vertigo; nystagmus; body aches; fatigue; Felt nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted 2 times) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Allergy (anything cold.). Concomitant products included NSAIDS for Back pain, LEVOTHYROXINE for Hypothyroidism.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SYNCOPE (Fainted 2 times) (seriousness criterion medically significant), HYPOTENSION (low blood pressure), DIZZINESS (dizzy), TACHYCARDIA (tachycardia), VERTIGO (vertigo), NYSTAGMUS (nystagmus), MYALGIA (body aches), FATIGUE (fatigue) and NAUSEA (Felt nauseas). At the time of the report, SYNCOPE (Fainted 2 times), HYPOTENSION (low blood pressure), DIZZINESS (dizzy), TACHYCARDIA (tachycardia), VERTIGO (vertigo), NYSTAGMUS (nystagmus), MYALGIA (body aches), FATIGUE (fatigue) and NAUSEA (Felt nauseas) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Laboratory test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included, meclizine 25 mg and metoclopramide was provided for vertigo and nystagmus.; Sender's Comments: This case concerns a 50-year-old female with a serious unexpected event of syncope, and nonserious unexpected hypotension, dizziness, tachycardia, vertigo, nystagmus, and expected myalgia, fatigue, nausea. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Nystagmus, Syncope, Tachycardia, Vertigo
Clinical narrative: Fainted 2 times; low blood pressure; dizzy; tachycardia; vertigo; nystagmus; body aches; fatigue; Felt nauseas; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted 2 times) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Hypothyroidism. Concurrent medical conditions included Allergy (anything cold.). Concomitant products included NSAIDS for Back pain, LEVOTHYROXINE for Hypothyroidism.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced SYNCOPE (Fainted 2 times) (seriousness criterion medically significant), HYPOTENSION (low blood pressure), DIZZINESS (dizzy), TACHYCARDIA (tachycardia), VERTIGO (vertigo), NYSTAGMUS (nystagmus), MYALGIA (body aches), FATIGUE (fatigue) and NAUSEA (Felt nauseas). At the time of the report, SYNCOPE (Fainted 2 times), HYPOTENSION (low blood pressure), DIZZINESS (dizzy), TACHYCARDIA (tachycardia), VERTIGO (vertigo), NYSTAGMUS (nystagmus), MYALGIA (body aches), FATIGUE (fatigue) and NAUSEA (Felt nauseas) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Laboratory test: normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included, meclizine 25 mg and metoclopramide was provided for vertigo and nystagmus.; Sender's Comments: This case concerns a 50-year-old female with a serious unexpected event of syncope, and nonserious unexpected hypotension, dizziness, tachycardia, vertigo, nystagmus, and expected myalgia, fatigue, nausea. Event onset the same day as first dose mRNA-1273. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: Clots; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Clots) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, the patient experienced THROMBOSIS (Clots) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 25-Apr-2021 due to THROMBOSIS. At the time of the report, THROMBOSIS (Clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.  No treatment information provided.; Sender's Comments: Limited information regarding the event has been provided at this time and a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Hospitalisation, Product dose omission issue
Clinical narrative: hospitalized; Patient had first dose on 03Mar2021 and has yet to get second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (hospitalized) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     There was no medical history provided.     On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient had first dose on 03Mar2021 and has yet to get second dose). On an unknown date, the patient experienced HOSPITALISATION (hospitalized) (seriousness criterion hospitalization). In April 2021, PRODUCT DOSE OMISSION ISSUE (Patient had first dose on 03Mar2021 and has yet to get second dose) had resolved. At the time of the report, HOSPITALISATION (hospitalized) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment details were not provided. No details for events leading to hospitalization was provided.  Company comment:Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.; Sender's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: Her heart beat faster, it 'went up and down' all day; This is a spontaneous report from a sponsored program. A contactable female patient of an unspecified age received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number was not reported), via an unspecified route of administration on 07Jan2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, on the day of her scheduled second dose, her heartbeat faster, it went up and down all day. The outcome was reported as unknown.  Information about lot/batch number has been requested.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Vaccination site pain
Clinical narrative: Fatigue; mild soreness at injection side; moderate headache; This is a spontaneous report from a contactable consumer (patient). A 47-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot number: EL3247, Expiration date was not reported), via an unspecified route of administration on 26Jan2021 13:00 left arm as single dose for covid-19 immunisation. The patient medical history was not reported. Allergies to medications, food, or other products reported as no. Concomitant medications included sertraline hydrochloride (ZOLOFT), vitamins nos (MULTIVITAMINUM), desogestrel, ethinylestradiol (VOLNEA) and doxycycline all are taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced mild soreness at injection side, moderate headache, fatigue on 27Jan2021. As per the reporter seriousness criteria reported as non-serious. Patient did not received treatment for the adverse events. The outcome of the events was recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Chills, Dyspepsia, Dyspnoea
Clinical narrative: chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness of breath; This is a spontaneous report from a contactable consumer(patient). A 47-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown) on 21Jan2021 at 04:00 PM via an unspecified route of administration in left arm at single dose for covid-19 immunization. Patient was 47 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Patient did not receive any other medications in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination. On 21Jan2021 at 8PM patient had shortness of breath, chest pain, heart burn, chills, fever, body pains, terrible headache, tired, and weak. It lasted until 10AM the next day. Effects lasted for 12 hours. On 06Jan2021 patient tested for covid post vaccination with test name Saliva and result received was negative. The outcome of the events was recovered.   Information on the lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: chest pain; heart burn; chills; fever; body pains; terrible headache; tired; weak.; I had shortness of breath; This is a spontaneous report from a contactable consumer(patient). A 47-year-old non pregnant female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiry date unknown) on 21Jan2021 at 04:00 PM via an unspecified route of administration in left arm at single dose for covid-19 immunization. Patient was 47 years old at the time of vaccination. Patient medical history and concomitant medications were not reported. Patient did not have any known allergies. Patient did not receive any other medications in two weeks. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination. On 21Jan2021 at 8PM patient had shortness of breath, chest pain, heart burn, chills, fever, body pains, terrible headache, tired, and weak. It lasted until 10AM the next day. Effects lasted for 12 hours. On 06Jan2021 patient tested for covid post vaccination with test name Saliva and result received was negative. The outcome of the events was recovered.   Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Swelling
Clinical narrative: armpit is swollen; lymph nodes are huge; pain in armpit radiating down my arm & bicep and thru my shoulder blade; This is a spontaneous report from a contactable health professional reporting for herself. A 39-years-old female patient received second dose of BNT162B2 (Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in right arm on 25Jan2021 as a single dose for COVID-19 immunization. The patient was not pregnant. Historical vaccine included first dose of BNT162B2 on 05Jan2021 at 09:00 AM. The patient medical history and concomitant medications were not reported. The patient had no allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. No covid test post vaccination. The patient didn't receive other medication in two weeks. On 25Jan2021 patient experienced armpit is swollen, lymph nodes are huge and pain in armpit radiating down my arm and bicep and through my shoulder blade. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Vaccination site pain
Clinical narrative: site soreness; headache; major chills/chills and more chills; fatigue; This is a spontaneous report from a contactable consumer (patient himself). An elderly male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 27Jan2021 (at the age of 67-year-old) as SINGLE DOSE for covid-19 immunization. Medical history included High blood pressure. Allergies to medications, food, or other products was not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any other medications within 2 weeks of vaccination. Concomitant medications were reported as none. On an unspecified date, the patient experienced site soreness, headache, major chills/chills and more chills and fatigue. Seriousness criteria reported as none. Patient not diagnosed COVID 19 prior to vaccination. Since the vaccination, patient not been tested for COVID-19. Patient did not received any treatment for the adverse event. At the time of this report event outcome was recovering.  Information on the lot/batch number has been requested.  Follow-up (15Apr2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made.   Follow-up attempts have been completed and no further information is expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Irritable bowel syndrome, SARS-CoV-2 test
Clinical narrative: I have IBS and have never experienced a flare up before. I had a flare up after receiving my second dose and went 10 days without a bowel movement.; This is a spontaneous report received from a contactable physician (patient). A 29-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscularly in Arm Right on 09Jan2021 at 09:15 (Lot Number: EL3302) as SINGLE DOSE for covid-19 immunisation. Medical history included anxiety and gastrooesophageal reflux disease (GERD). No known allergies were reported. Concomitant medications included sertraline 100mg (SERTRALINE) and omeprazole 40mg (OMEPRAZOLE). The patient received dose 1 of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via intramuscularly in Arm Right on 19Dec2020 at 09:00 AM (Lot Number: EJ1685) for covid-19 immunisation. 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 been tested for COVID-19. On 09Jan2021 at 18:00, The patient reported that, i have IBS (irritable bowel syndrome) and had never experienced a flare up before. I had a flare up after receiving my second dose and went 10 days without a bowel movement. On 19Jan2021, The patient underwent lab tests and procedures which included SARS 2 COVID rapid test: negative. Therapeutic measures were taken as a result of the reported event with Magnesium Citrate, Miralax, Metamucil, Mineral Oil Enema, Amitiza. The event was considered as non-serious. The outcome of the event was recovered on unspecified date in Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Malaise, Memory impairment, Myalgia, Pain in extremity
Clinical narrative: Aching legs; Gradually getting worse; Her memory is affected; Muscle aches and pains; Felt out of sorts; Arm was sore; This is a spontaneous report from a contactable other hcp (nurse). A 74-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in arm right on 18Jan2021 at 09:00 (Lot Number: EL3247, Expiration Date: Apr2021) as single dose for COVID-19 immunization. The patient's medical history included spinal fusion surgery from 2019 to an unknown date. The patient previously received 1st Shingrix injection and experienced her arm turned really red and swelled up (so her doctor told her not to take the 2nd injection). There were no concomitant medications. On 19Jan2021, the patient experienced arm was sore. On 21Jan2021, the patient felt out of sorts. On 22Jan2021, the patient experienced muscle aches and pains. She is not sure if the muscle aches are due to her just getting old or from the vaccine. The muscle aches are especially in her legs. On an unspecified date, the patient experienced aching legs, gradually getting worse and her memory is affected. She is gradually getting worse, but doesn't know if it's the weather, or is it a possibility that it's the vaccine. The patient's memory is affected, then clarified that it has nothing to do with the vaccine, she is just getting old. She asked if people have reported muscle aches and pains for weeks after. She is due to have the second injection on 08Feb2021. No family medical history relevant to events. The events did not result in emergency room visit or physician office visit. The outcome of the muscle aches and pains was not recovered and was unknown for the rest of the events.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: headache; couldn't pick up my arm, that lasted for a day; This is a spontaneous report from a contactable consumer (patient, self-reported). A 67-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, solution for injection, lot number and expiry date were not provided), via an unspecified route of administration, on 09Jan2021, as a single dose for COVID-19 immunization. Patient's medical history included high blood pressure. Concomitant medications were not provided. The patient reported that after he got the shot, on an unknown date in Jan2021, he couldn't pick up his arm, that lasted for a day. The next week, he got a headache, and he didn't get headaches. He would get a slight headache every now and then, off and on for 3 or 4 days above his eyebrow. He took Tylenol and it went away. He heard that he would get really bad side effects with the second shot and he was just concerned. Patient's second dose was scheduled on 29Jan2021. Outcome of the event was recovered on an unknown date in Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pain in extremity
Clinical narrative: sore arm; hot flashes have come back; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient (Non-Pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration in left arm on 08Jan2021 at 10:30 as a single dose for COVID-19 immunization. The patients medical history and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine; Prior to vaccination, was the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. The patient experienced sore arm hot flashes have come back. No treatment was received for the event. The outcome of the event was recovered in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Diarrhoea, Headache, Pyrexia
Clinical narrative: Diarrhea; Cramping; Fever/Fever: started between 8:00PM and 9:00PM. Highest temperature reached was 100.2 degrees. Think it subsided. Temperature this morning was 99.1 degrees; Headache; This is a spontaneous report from a Contactable consumer (patient). A 54-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. EL8982, expiry date 31May2021) via unspecified route of administration in right arm on 27Jan2021 at 12:40 as single dose for COVID-19 immunisation. Medical history included diabetes. Family history included diabetes runs in both side of family. Both parents passed away and had diabetes. Concomitant medication included pioglitazone 15mg tablet once in the morning and vitamins given by her nutritionist. No other vaccine in four weeks. Previously patient took metformin (but no longer) for diabetes. Patient experienced fever, headache on 27Jan2021, diarrhea and cramping on 28Jan2021. It was stated that, she received the Pfizer Covid 19 vaccine yesterday at university. She reports the following side effects: fever and headache yesterday and really bad diarrhea and cramping this morning. Is the diarrhea a side effect? she received a copy of the Fact Sheet for Recipients and caregivers and did not see it listed there. She states she ate breakfast and took her vitamins this morning and the symptoms have subsided. She wants to report a side effect. Got the injection at (Hospital name). Did get a little fever, which was normal, correct? Woke up this morning with diarrhea and wanted to report that. Would diarrhea be a side effect also. Clarified product as: Pfizer BioNTech COVID-19 Vaccine. Fever was last night. Diarrhea this morning as she woke. Noticed listing of side effects doesn't have diarrhea. Statue diarrhea was one of the ones from COVID so she could get a form of diarrhea after the COVID-19 Vaccine. Is assuming that's what it was. Her family members too also had a little diarrhea. Confirmed she had no NDC/Lot/Exp for either family member's COVID-19 Vaccine. Stated her family members live somewhere else. Patient received COVID-19 Vaccine on 27Jan2021 at a little after 12:40PM. Goes back to hospital on 17Feb2021 for the second dose. Fever started between 8:00PM and 9:00PM. Highest temperature reached was 100.2 degrees. Think it subsided. Temperature this morning was 99.1 degrees. Diarrhea is ongoing as of right now. Just ate breakfast but didn't want to. Hasn't had to go to the restroom yet. This morning she had to go to the restroom a couple times, and it was like water. Had been drinking water and noticed afterwards she had to go right away. She stated is a pastor from a church. Had a press release from main pastor. Had a press conference. Wants to get her community willing to be vaccinated. No COVID prior vaccination. Seriousness reported as non-serious. The outcome of event diarrhea was not recovered, whereas other events were recovered on 28Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Delusional perception
Clinical narrative: her mom has been delusional saying that "things aren't real and has been agitated/ Became extremely delusional; This is a spontaneous report from a contactable consumer (patient's daughter) via medical information team. A 84-year-old female patient (mother) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date were not reported) via an unspecified route on an unspecified date at single dose for covid-19 immunization. Medical history included dementia. The patient concomitant medications were not reported. On an unknown date, the patient received the first dose of the Pfizer Covid vaccine 2 weeks ago. It was stated since then, patient had been delusional saying that things were not real and had been agitated. It was also stated that patient was allergic to the pneumonia vaccine. Patient was older and had other medical conditions and took other medications, became extremely delusional after taking it. It was possible she was exposed to the virus because she lived in an assisted living facility. She never tested positive though. The outcome of the events was unknown.   Information on the Lot/Batch number has been requested.  Follow-up activities closed no further information expected.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Hypertension, Pyrexia
Clinical narrative: Fever at 101 F overnight after second dose; High Blood Pressure 160/50 on second dose; Chills on both First and Second Doses; This is a spontaneous report from a contactable consumer or other non hcp. A 87-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 27Jan2021 23:15 (Batch/Lot Number: EL9262) as single dose for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, hypertension, cardiac pacemaker insertion, aortic stenosis, liver disorder, hip surgery, food allergy, known allergies: pork, food allergy, Shellfish. The patiently previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in arm right on 06Jan2021 24:00 (Batch/Lot Number: EH9899) as single dose for covid-19 immunisation. After first dose, the patient had chills, and high blood pressure at 180/60. Concomitant medication(s) included losartan (LOSARTAN); apixaban (ELIQUIS); montelukast (MONTELUKAST); amlodipine (AMLODIPINE). After second dose, the patient had fever at 101 Fahrenheit overnight and high blood pressure at 160/50. Went away with taking high blood pressure pills. The patient was not covid tested post vaccination. The patient underwent lab tests and procedures which included blood pressure measurement: 160/50 on second dose, body temperature: 101 Fahrenheit. Outcome of events was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Seasonal allergy, Sneezing
Clinical narrative: bad allergies; nose is running; sneezing; This is a spontaneous report from a contactable consumer (patient). A unspecified age of female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown), via an unspecified route of administration, administered on 25Jan2021 at 15:30 as a single dose for COVID-19 immunisation. The patient medical history was not reported. concomitant medication included Flonase. On unknown date the patient experienced; the caller stated she works in the medical field in support services as an equipment specialist. She stated she had the second dose of the vaccine this past Monday, less than 48 hours ago, at 3:30 PM. She stated she has had bad allergies her nose is running, and she has been sneezing. She stated she usually takes Flonase, a glucocorticoid, which is a steroid and she used it and immediately after was worried about the vaccine. She rinsed her nose with saline but asked if this can effect the vaccine. The caller stated she had filled out a survey that asked if she had a headache and other symptoms but know if those were things to include. She stated she called her mom who lives in (state name withheld) and she said hadn't even thought about it but her nose was running yesterday too, and the caller's co-worker said he got a cold for the day. The caller stated she did not want to disclose any information about them. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Lethargy, Pyrexia
Clinical narrative: her temperature from 101.9; lethargic; feels bad all over; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (solution for injection, Batch/lot number and expiration date was not reported), via an unspecified route of administration on 26Jan2021 18:10 as single dose for covid-19 immunization. On an unspecified date, she had a hard time reducing her temperature from 101.9, lethargic, and feels bad all over. Outcome of the events was unknown.   Referenced EUA Prescribing Information Table 3 and Table 4 present the frequency and severity of reported solicited local and systemic reactions, respectively, within 7 days of each dose of Pfizer-BioNTech COVID-19 Vaccine and placebo for participants 56 years of age and older. Across both age groups, the mean duration of pain at the injection site after Dose 2 was 2.5 days (range 1 to 36 days). Information on the Batch/Lot number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Pain in extremity, Rheumatic disorder, Sciatica
Clinical narrative: severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; severe pain in back and right side thigh, knee and leg; rheumatism; sciatica; This is a spontaneous report from a contactable consumer (patient). A 78-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EK5730), via an unspecified route of administration, administered in arm left on 05Jan2021 03:30 as SINGLE DOSE for covid-19 immunization. Medical history included hypertension. Concomitant medications included sotalol (SOTALOL), Olmesartan (OLMESARTAN), Amlodipine (AMLODIPINE), tamsulosin (TAMSULOSIN). On 06Jan2021 at 09:00 the patient experienced severe pain in back and right-side thigh, knee and leg, rheumatism, sciatica. Pain started within one day of shot and has not stopped. I have never experienced this before now. The outcome of event was not recovered.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021107296 same reporter/ drug/ AE, different patient