chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Went into a seizure; Completely unconscious; Extreme arm pain; Arm swelling; Woke up freezing; Did not feel well; Body aches; Felt tiredness; Felt like fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (Went into a seizure) and LOSS OF CONSCIOUSNESS (Completely unconscious) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Apr-2021, the patient experienced SEIZURE (Went into a seizure) (seriousness criteria hospitalization and medically significant), LOSS OF CONSCIOUSNESS (Completely unconscious) (seriousness criteria hospitalization and medically significant), PAIN IN EXTREMITY (Extreme arm pain), PERIPHERAL SWELLING (Arm swelling), FEELING COLD (Woke up freezing), MALAISE (Did not feel well), PAIN (Body aches), FATIGUE (Felt tiredness), PYREXIA (Felt like fever) and CHILLS (Chills). At the time of the report, SEIZURE (Went into a seizure), LOSS OF CONSCIOUSNESS (Completely unconscious), PAIN IN EXTREMITY (Extreme arm pain), PERIPHERAL SWELLING (Arm swelling), FEELING COLD (Woke up freezing), MALAISE (Did not feel well), PAIN (Body aches), FATIGUE (Felt tiredness), PYREXIA (Felt like fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Apr-2021, Body temperature: 99.5 (High) 99.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included paracetamol.  Based on the current available information and temporal association between the use of the product and the start date of these 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 these events, a causal relationship cannot be excluded.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Computerised tomogram, Hypoaesthesia, Swelling face, Swollen tongue
Clinical narrative: face felt droopy/diagnosed with Bell's Palsy; felt like her face was swollen; face became physically swollen and numb; left side of her face and the left "part of her tongue" became swollen; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PARALYSIS (face felt droopy/diagnosed with Bell's Palsy) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history reported).    On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, the patient experienced FACIAL PARALYSIS (face felt droopy/diagnosed with Bell's Palsy) (seriousness criterion medically significant), SWELLING FACE (felt like her face was swollen), HYPOAESTHESIA (face became physically swollen and numb) and SWOLLEN TONGUE (left side of her face and the left "part of her tongue" became swollen). At the time of the report, FACIAL PARALYSIS (face felt droopy/diagnosed with Bell's Palsy), SWELLING FACE (felt like her face was swollen), HYPOAESTHESIA (face became physically swollen and numb) and SWOLLEN TONGUE (left side of her face and the left "part of her tongue" became swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Computerised tomogram: negative negative for evidence of stroke.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient reports she was negative for respiratory distress or difficulty breathing.  Treatment included two unknown oral antibiotics and oral steroids.; 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Meniere's disease, Muscle spasms, Nausea, Pruritus
Clinical narrative: Meniere's disease; Leg cramp; Itching; Restlessness; Rash; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 65-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.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOZAPINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, MENIERE'S DISEASE (Meniere's disease), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant medications included sleep aid.  Treatment for the event included the reporter will consult HCP if symptoms persist.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  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. Further information has been requested.; 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. Further information has been requested.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Restlessness
Clinical narrative: Meniere's disease; Leg cramp; Itching; Restlessness; Rash; Nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of MENIERE'S DISEASE (Meniere's disease) in a 65-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.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CLOZAPINE for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced MENIERE'S DISEASE (Meniere's disease) (seriousness criterion medically significant), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, MENIERE'S DISEASE (Meniere's disease), MUSCLE SPASMS (Leg cramp), PRURITUS (Itching), RESTLESSNESS (Restlessness), RASH (Rash), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown. Not Provided          Concomitant medications included sleep aid.  Treatment for the event included the reporter will consult HCP if symptoms persist.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  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. Further information has been requested.; 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. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Body temperature, Cerebrovascular accident, Computerised tomogram, Dizziness
Clinical narrative: stroke; Couldn't keep his balance; severe dizziness,; nausea; he kept throwing up constantly and couldn't keep his balance.; temperature of 101°F; fatigue; severe headache on one side of is head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for Cholesterol, FINASTERIDE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (temperature of 101°F), FATIGUE (fatigue) and HEADACHE (severe headache on one side of is head). On 01-Apr-2021, the patient experienced GAIT DISTURBANCE (Couldn't keep his balance), DIZZINESS (severe dizziness,) and NAUSEA (nausea). On 03-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced VOMITING (he kept throwing up constantly and couldn't keep his balance.). The patient was hospitalized on 03-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (Couldn't keep his balance), DIZZINESS (severe dizziness,), PYREXIA (temperature of 101°F), FATIGUE (fatigue), HEADACHE (severe headache on one side of is head), NAUSEA (nausea) and VOMITING (he kept throwing up constantly and couldn't keep his balance.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) degrees Farenheit. On an unknown date, Computerised tomogram: cva (Inconclusive) Narrowed artery in cerebellum.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 03-Apr-2021 patient went to urgent care facility and was transferred to a hospital. Upon discharge he was given a prescription for 40mg of a statin.; 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. Further information has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: stroke; Couldn't keep his balance; severe dizziness,; nausea; he kept throwing up constantly and couldn't keep his balance.; temperature of 101°F; fatigue; severe headache on one side of is head; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Apr-2021 and was forwarded to Moderna on 13-Apr-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CEREBROVASCULAR ACCIDENT (stroke) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol. Concomitant products included NYSTATIN (STATIN [NYSTATIN]) for Cholesterol, FINASTERIDE for an unknown indication.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (temperature of 101°F), FATIGUE (fatigue) and HEADACHE (severe headache on one side of is head). On 01-Apr-2021, the patient experienced GAIT DISTURBANCE (Couldn't keep his balance), DIZZINESS (severe dizziness,) and NAUSEA (nausea). On 03-Apr-2021, the patient experienced CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion hospitalization). On an unknown date, the patient experienced VOMITING (he kept throwing up constantly and couldn't keep his balance.). The patient was hospitalized on 03-Apr-2021 due to CEREBROVASCULAR ACCIDENT. At the time of the report, CEREBROVASCULAR ACCIDENT (stroke), GAIT DISTURBANCE (Couldn't keep his balance), DIZZINESS (severe dizziness,), PYREXIA (temperature of 101°F), FATIGUE (fatigue), HEADACHE (severe headache on one side of is head), NAUSEA (nausea) and VOMITING (he kept throwing up constantly and couldn't keep his balance.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (Inconclusive) degrees Farenheit. On an unknown date, Computerised tomogram: cva (Inconclusive) Narrowed artery in cerebellum.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 03-Apr-2021 patient went to urgent care facility and was transferred to a hospital. Upon discharge he was given a prescription for 40mg of a statin.; 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. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peptic ulcer haemorrhage
Clinical narrative: Spontaneous Peptic ulcer bleed; Left arm became sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PEPTIC ULCER HAEMORRHAGE (Spontaneous Peptic ulcer bleed) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 211M28-9 and 022M20A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure (Heart failure  7years ago ha sreolved by its own but was placed on entresto at that time), Cardiac disorder, Headache since an unknown date, General body pain and Left atrial appendage occlusion (to treat atrial fibrillation and prevent clots.) in 2019. Concurrent medical conditions included Edema legs (Fluid in feets), High cholesterol and Hypotensive (Mild hypotensive). Concomitant products included CARVEDILOL (COREG), HCTZ, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN) and PARACETAMOL (TYLENOL) for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced PAIN IN EXTREMITY (Left arm became sore). On an unknown date, the patient experienced PEPTIC ULCER HAEMORRHAGE (Spontaneous Peptic ulcer bleed) (seriousness criterion hospitalization). The patient was hospitalized from 24-Feb-2021 to 12-Mar-2021 due to PEPTIC ULCER HAEMORRHAGE. On 04-Feb-2021, PAIN IN EXTREMITY (Left arm became sore) had resolved. At the time of the report, PEPTIC ULCER HAEMORRHAGE (Spontaneous Peptic ulcer bleed) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Consumer reported that she had a TEE (Transesophageal echocardiogram ) on  around 06 feb (exact date unknown).  Treatment medication included Eliquis twice a day.   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.   This case was linked to MOD-2021-075255 (Patient Link).; 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: 49.0
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: he died; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (he died) in a 49-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 03-Apr-2021 The patient died on 03-Apr-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.  Very limited information regarding this event has been provided at this time.  Further information has been requested; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: Unknown cause of death
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Malaise, Tremor
Clinical narrative: checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night; not feel well on 08APR2021; Chills after second dose; usual Shaking; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE INCREASED (checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TREMOR (usual Shaking) and CHILLS (Chills after second dose). On 08-Apr-2021, the patient experienced BLOOD PRESSURE INCREASED (checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night) (seriousness criterion medically significant) and MALAISE (not feel well on 08APR2021). At the time of the report, BLOOD PRESSURE INCREASED (checked her blood pressure it was 193/115 mmHg.blood pressure spiked up again last night), TREMOR (usual Shaking), MALAISE (not feel well on 08APR2021) and CHILLS (Chills after second dose) outcome was unknown.            On 08Apr2021 evening, patient was not felt well. When she checked her blood pressure it was 193/115 mmHg. She had gone to the emergency room. She was prescribed with Atenolol 25mg and Amlodipine 5 mg as needed.  Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. Further information has been requested.   This case was linked to MOD-2021-019463 (E2B Linked Report).; Sender's Comments: Although a temporal association exists, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. Further information has been requested. MOD-2021-019463:First dose of vaccine case.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Autoimmune disorder, Condition aggravated, Epididymitis, Neuralgia, Testicular pain
Clinical narrative: Chronic Epididymitis; Autoimmune disorder; Nerve pain; Condition worsened; Testicular pain; This spontaneous case was reported by a consumer and describes the occurrence of EPIDIDYMITIS (Chronic Epididymitis) and AUTOIMMUNE DISORDER (Autoimmune disorder) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No Historical Condition reported.).   On 23-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jan-2021, the patient experienced TESTICULAR PAIN (Testicular pain). On an unknown date, the patient experienced EPIDIDYMITIS (Chronic Epididymitis) (seriousness criterion medically significant), AUTOIMMUNE DISORDER (Autoimmune disorder) (seriousness criterion medically significant), NEURALGIA (Nerve pain) and CONDITION AGGRAVATED (Condition worsened ). At the time of the report, EPIDIDYMITIS (Chronic Epididymitis), AUTOIMMUNE DISORDER (Autoimmune disorder), TESTICULAR PAIN (Testicular pain), NEURALGIA (Nerve pain) and CONDITION AGGRAVATED (Condition worsened ) outcome was unknown.            Treatment medication - Antibiotics, pain killers, Gabapentin, Tramadol, Hydrocodone, Celebrex.  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.   This case was linked to US-MODERNATX, INC.-MOD-2021-076172 (E2B Linked Report).; 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. US-MODERNATX, INC.-MOD-2021-076172:CROSSLINKED WITH DOSE 1
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PYREXIA (Fever) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     The patient's past medical history included Aspiration pneumonia from 12-Mar-2021 to 16-Mar-2021. Concurrent medical conditions included Cerebral palsy, Spastic quadriplegia, Seizures and Mental disability.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization). The patient was hospitalized from 27-Mar-2021 to 05-Apr-2021 due to PYREXIA. On 05-Apr-2021, PYREXIA (Fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PYREXIA (Fever) to be related.    No concomitant medications were reported. Reported confirmed patient was transferred to a long term acute care hospital for antibiotics treatment.  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.   This case was linked to MOD-2021-078392 (Patient Link).; 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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: hives on my neck and on my upper torso; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration in right arm on 26Jan2021 12:15 as single dose for covid-19 immunisation. Patient had historical vaccine BNT162B2, first dose for COVID-19 immunisation. The patient was allergic to seafood. The patient's concomitant medications were not reported. The patient had not received any other vaccine prior to the COVID vaccine and not tested for COVID-19 after vaccination. The patient experienced hives on her neck and on her upper torso on 27Jan2021 19:00. No treatment received for the reported adverse event. The outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: Blood pressure became elevated after 6-7 days and stayed high; This is a spontaneous report from a contactable consumer (patient). A 75-years-old male patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration, administered in arm right on 19Jan2021 at 09:00 as SINGLE DOSE for covid-19 immunization. Medical history included cardiac disorder, diabetes mellitus, hypertension. The patient previously took lisinopril and experienced drug hypersensitivity. On 25Jan2021, the patient experienced blood pressure became elevated after 6-7 days and stayed high. The patient underwent lab tests and procedures which included blood pressure measurement was elevated on 25Jan2021. The outcome of event was recovering.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Malaise
Clinical narrative: injection site pain; tiredness; joint pain; slight fever (<100F); chills; nausea; feeling unwell; This is a spontaneous report received from a contactable consumer or other non hcp reporting for herself. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in left arm on 28Jan2021 19:15 at a single dose for COVID-19 immunization. Medical history included hypertension and thyroidectomy. Concomitant medications included sertraline, pravastatin, cranberry and losartan potassium.T he patient experienced injection site pain, tiredness, joint pain, slight fever, chills, nausea and feeling unwell on 29Jan2021. The patient underwent lab tests and procedures which included body temperature as less than 100 Fahrenheit on 29Jan2021. The outcome of the event was not recovered.  No follow-up attempts possible. No further information expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: injection site pain; tiredness; joint pain; slight fever (<100F); chills; nausea; feeling unwell; This is a spontaneous report received from a contactable consumer or other non hcp reporting for herself. A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9262), via an unspecified route of administration, in left arm on 28Jan2021 19:15 at a single dose for COVID-19 immunization. Medical history included hypertension and thyroidectomy. Concomitant medications included sertraline, pravastatin, cranberry and losartan potassium.T he patient experienced injection site pain, tiredness, joint pain, slight fever, chills, nausea and feeling unwell on 29Jan2021. The patient underwent lab tests and procedures which included body temperature as less than 100 Fahrenheit on 29Jan2021. The outcome of the event was not recovered.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: Caller would like to know if it is possible that she contracted the virus while at her daughter's home; This is a spontaneous report from a Pfizer-sponsored program . A contactable 73-year-old female consumer (patient) reported that she received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 29Jan2021 at a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced caller would like to know if it is possible that she contracted the virus while at her daughter's home on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: she had a low grade fever of 99.5 degrees; body ache; felt feverish, but had no fever; Back pain; she said she had pain in her arm, and the pain went away after the first day; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EL1284) via an unspecified route of administration in right deltoid on 26Jan2021 at 10:30 as single dose for covid-19 immunisation. Medical history included anxiety. Concomitant medications included on 27Jan2021 at a dose of 50 mg once a day for anxiety.On26Jan2021,the patient experienced on pain in her arm, and the pain went away after the first day, body aches, particularly severe back pain and feeling feverish on 29Jan2021, she had a low grade fever of 99.5 degrees on 31Jan2021, treatment received for this events with she took Tylenol and Motrin and this morning she felt better. The patient underwent lab test included body temperature Body temperature 99.5 Fahrenheit. The outcome of the events pyrexia was unknown and for pain in extremity was resolved, body ache, feeling abnormal, back pain was not recovered.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: she had a low grade fever of 99.5 degrees; body ache; felt feverish, but had no fever; Back pain; she said she had pain in her arm, and the pain went away after the first day; This is a spontaneous report from a contactable other health Care Professional. A 51-years-old female patient received first dose of bnt162b2 (COMIRNATY, solution for injection, Lot Number: EL1284) via an unspecified route of administration in right deltoid on 26Jan2021 at 10:30 as single dose for covid-19 immunisation. Medical history included anxiety. Concomitant medications included on 27Jan2021 at a dose of 50 mg once a day for anxiety.On26Jan2021,the patient experienced on pain in her arm, and the pain went away after the first day, body aches, particularly severe back pain and feeling feverish on 29Jan2021, she had a low grade fever of 99.5 degrees on 31Jan2021, treatment received for this events with she took Tylenol and Motrin and this morning she felt better. The patient underwent lab test included body temperature Body temperature 99.5 Fahrenheit. The outcome of the events pyrexia was unknown and for pain in extremity was resolved, body ache, feeling abnormal, back pain was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, SARS-CoV-2 test
Clinical narrative: Had covid exposure on 17Jan2021; This is a spontaneous report via Pfizer-sponsored program Pfizer from contactable consumer (patient herself). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via unknown route of administration on unspecified date at single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported as patient was schedule for second dose of vaccine. Had covid exposure on 17Jan2021. Inquiring if she can get her second dose today. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: discovered that her daughter tested positive for Covid-19 and they were together for about 2 hours before the test; This is a spontaneous report from a contactable consumer (patient reported for herself). This 58-year-old female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on 23Jan2021 at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Caller received the first dose of the Pfizer-BioNTech Covid-19 vaccine on 23Jan2021, yesterday discovered that her daughter tested positive for Covid-19 and they were together for about 2 hours before the test. She would like to know if she should be tested for Covid before receiving the second dose of the vaccine. She would like to know if she should wait and receive the second dose of the vaccine. Outcome of the event was unknown.  Information about lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: had a mild fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot no. was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient who got the covid vaccine and over the weekend had a mild fever and was tested negative with covid. Reporter wanted to know if it is safe for patient to get the second shot of the covid vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Swelling of eyelid, Urticaria
Clinical narrative: her eye looks like a bee stung her eyelid, it is swollen; hives on face; rash on her legs and her legs were itching; rash on her legs and her legs were itching; This is a spontaneous report from contactable consumer (patient). A 60-year-old female received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Batch/lot number: EK9231; Expiration Date 30Apr2021) via unspecified route of administration in right on 11Jan2021 at 16:00 as single dose for COVID-19 immunisation. The patient medical history not reported. historical vaccine included BNT162B2 (First dose: 21Dec2021; Lot number: EL0140; Expiration Date: Mar2021) and concomitant medications were not reported. patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jan2021, the patient reported hives on face that were red and bumpy. They are not as bumpy but it is still red like her face looks sunburned red and her eye is swollen, rash on her legs and her legs were itching, on 03Feb2021 her eye looks like a bee stung her eyelid it is swollen. Treatment received for the events with Prednisone. The outcome of the events (Urticaria, rash, pruritus) was unknown, her eye looks like a bee stung her eyelid, it is swollen was not recovered.  Description of Product complaint: Caller was calling about the Pfizer COVID vaccine. She says she wanted to report having a reaction. She had  hives, like a rash and her eye looks like a bee stung her eyelid, it was swollen. She had a rash on her face and her legs and her legs were itching, it was like hives on her face that were red and bumpy. They are not as bumpy but it was still red. She has been taking Prednisone and she was not sure if that is why its getting a little bit better but it was still really red and itching and the swollen eye was a new thing. Her Prednisone was in an amber color pharmacy bottle and does not see an NDC lot or expiration on there.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Off label use, Product use issue, Pyrexia
Clinical narrative: terrible headache; chills; fever for 24 hours; Other vaccine on 28Jan2021; Other vaccine on 28Jan2021; This is a spontaneous report received from a contactable consumer (patient herself). A non-pregnant female unspecified aged patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection; lot number: unknown) via an unspecified route of administration to the Left arm on 28Jan2021 at 13:00 at a single dose for COVID-19 immunization. Medical history included Allergies: Adhesive tape. Concomitant medication that the patient received within 2 weeks of vaccination included Simvistatin (SIMVASTATIN) and losartan (LOSARTAN). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the fifth day after received the vaccination at 01Feb2021, the patient experinced that suffered terrible headache, chills, fever for 24 hours. The patient received the Other vaccine of Pfizer on same date 28Jan2021. Prior to vaccination, the patient was not diagnosed with COVID-19, Since the vaccination, has the patient not been tested for COVID-19. Patient reported the seriousness as non-Serious. The patient did not receive any treatment received for the adverse event. The outcome of the events are Recovering.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Chronic obstructive pulmonary disease, Headache, Hypoacusis, Illness
Clinical narrative: pulmonary fiborsis; heart hurt; hearing and eyes are no good and he is old; COPD; hearing and eyes are no good and he is old; arm sore; lungs felt funny and airy but could breathe real good; real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while; change in smell for several days; he is in terrible pain lying in the bed due to dirty things wrong with him; terminally ill; neck pain; This is a spontaneous report from a contactable consumer or other non-health care professional via PPDI. An 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: en5318) via unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included twelve chronic conditions that he has been treated for, for years. Patient mentioned on an unspecified date, he already died once, clarified, it was very sudden and he had a heart attack in his sleep. He had central sleep apnea and he stopped breathing. He has atherosclerosis, his arteries are clogged and he has chronic inflammation, stated it is a can of worms. He has polycystic kidney disease, stated his kidneys are headed that way. He has chronic insomnia, Cerebrovascular accident from 2008, had mini strokes and had heart surgery for blood clots to his brain in 2008. The patient concomitant medications were not reported.   On an unspecified date, the patient experienced pulmonary fiborsis, heart hurt, arm sore, lungs felt funny and airy but could breathe real good, real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while, change in smell for several days, he is in terrible pain lying in the bed due to dirty things wrong with him, terminally ill, hearing and eyes are no good and he is old, copd, hearing and eyes are no good and he is old and neck pain. AE for second dose transmitted. Patient also stated that after the second shot, his arm was sore at the site, swelling and pain more profound and sooner, knot in the arm, arthritic knees and joints became more painful, illusion of a spider walking on the wall, pain in the left arm bicep, lower left back got painful and went down in to the hip and left thigh muscles and had headaches. Patient mentioned his heart and lungs heart a few days after the second shot and had a strange feeling in his lungs. Patient stated he had night sweats and got drenched but this is a symptom of a heart problem which he has. Patient stated his heart beat was skipping around 68-78 and his oxygen was skipping around. Patient stated that he has PVC. Patient stated he had a headache on the top of his head. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Neck pain, Pain, Pain in extremity, Parosmia
Clinical narrative: pulmonary fiborsis; heart hurt; hearing and eyes are no good and he is old; COPD; hearing and eyes are no good and he is old; arm sore; lungs felt funny and airy but could breathe real good; real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while; change in smell for several days; he is in terrible pain lying in the bed due to dirty things wrong with him; terminally ill; neck pain; This is a spontaneous report from a contactable consumer or other non-health care professional via PPDI. An 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: en5318) via unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included twelve chronic conditions that he has been treated for, for years. Patient mentioned on an unspecified date, he already died once, clarified, it was very sudden and he had a heart attack in his sleep. He had central sleep apnea and he stopped breathing. He has atherosclerosis, his arteries are clogged and he has chronic inflammation, stated it is a can of worms. He has polycystic kidney disease, stated his kidneys are headed that way. He has chronic insomnia, Cerebrovascular accident from 2008, had mini strokes and had heart surgery for blood clots to his brain in 2008. The patient concomitant medications were not reported.   On an unspecified date, the patient experienced pulmonary fiborsis, heart hurt, arm sore, lungs felt funny and airy but could breathe real good, real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while, change in smell for several days, he is in terrible pain lying in the bed due to dirty things wrong with him, terminally ill, hearing and eyes are no good and he is old, copd, hearing and eyes are no good and he is old and neck pain. AE for second dose transmitted. Patient also stated that after the second shot, his arm was sore at the site, swelling and pain more profound and sooner, knot in the arm, arthritic knees and joints became more painful, illusion of a spider walking on the wall, pain in the left arm bicep, lower left back got painful and went down in to the hip and left thigh muscles and had headaches. Patient mentioned his heart and lungs heart a few days after the second shot and had a strange feeling in his lungs. Patient stated he had night sweats and got drenched but this is a symptom of a heart problem which he has. Patient stated his heart beat was skipping around 68-78 and his oxygen was skipping around. Patient stated that he has PVC. Patient stated he had a headache on the top of his head. Outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary fibrosis, Visual impairment
Clinical narrative: pulmonary fiborsis; heart hurt; hearing and eyes are no good and he is old; COPD; hearing and eyes are no good and he is old; arm sore; lungs felt funny and airy but could breathe real good; real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while; change in smell for several days; he is in terrible pain lying in the bed due to dirty things wrong with him; terminally ill; neck pain; This is a spontaneous report from a contactable consumer or other non-health care professional via PPDI. An 80-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: en5318) via unspecified route of administration on 06Feb2021 as single dose for COVID-19 immunization. Medical history included twelve chronic conditions that he has been treated for, for years. Patient mentioned on an unspecified date, he already died once, clarified, it was very sudden and he had a heart attack in his sleep. He had central sleep apnea and he stopped breathing. He has atherosclerosis, his arteries are clogged and he has chronic inflammation, stated it is a can of worms. He has polycystic kidney disease, stated his kidneys are headed that way. He has chronic insomnia, Cerebrovascular accident from 2008, had mini strokes and had heart surgery for blood clots to his brain in 2008. The patient concomitant medications were not reported.   On an unspecified date, the patient experienced pulmonary fiborsis, heart hurt, arm sore, lungs felt funny and airy but could breathe real good, real bad frontal headache and the top of the head that were two real strong headaches that lasted quite a while, change in smell for several days, he is in terrible pain lying in the bed due to dirty things wrong with him, terminally ill, hearing and eyes are no good and he is old, copd, hearing and eyes are no good and he is old and neck pain. AE for second dose transmitted. Patient also stated that after the second shot, his arm was sore at the site, swelling and pain more profound and sooner, knot in the arm, arthritic knees and joints became more painful, illusion of a spider walking on the wall, pain in the left arm bicep, lower left back got painful and went down in to the hip and left thigh muscles and had headaches. Patient mentioned his heart and lungs heart a few days after the second shot and had a strange feeling in his lungs. Patient stated he had night sweats and got drenched but this is a symptom of a heart problem which he has. Patient stated his heart beat was skipping around 68-78 and his oxygen was skipping around. Patient stated that he has PVC. Patient stated he had a headache on the top of his head. Outcome of the events was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Patient experienced syncope approximately 7 minutes after injection. Pulse was checked, which was normal. Provided water and patient felt well enough to walk after about 20 minutes of sitting down and drinking water.  Called the patient about 1.5 hours later and they reported feeling okay and recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Dizziness, Dyspnoea, Hypersensitivity, Laboratory test
Clinical narrative: After the injection about 15 minutes afterwards I was getting dizzy I was having trouble breathing. Was given a Benadryl. An ambulance was called. I do not remember being transferred to the hospital. I was given solu- Medrol (methylPREDNI solone succinate 125mg IV and 20 mg Pepcid IV for an allergic reaction to the vaccine. I was prescribed an EpiPen. I am still having side effects from the vaccine. Migraines, dizziness, hives, swollen lymph glands.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Urticaria
Clinical narrative: After the injection about 15 minutes afterwards I was getting dizzy I was having trouble breathing. Was given a Benadryl. An ambulance was called. I do not remember being transferred to the hospital. I was given solu- Medrol (methylPREDNI solone succinate 125mg IV and 20 mg Pepcid IV for an allergic reaction to the vaccine. I was prescribed an EpiPen. I am still having side effects from the vaccine. Migraines, dizziness, hives, swollen lymph glands.