chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: Fell on left shoulder; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FALL (Fell on left shoulder) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination.     The patient's past medical history included Arthritis. Concurrent medical conditions included Borderline diabetes, Cholesterol high and Blood pressure high.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, the patient experienced FALL (Fell on left shoulder) (seriousness criterion medically significant). At the time of the report, FALL (Fell on left shoulder) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes medication for diabetes, cholesterol and blood pressure. Treatment medication includes ice packs, took Tylenol and put her left arm in a sling.  Based on the 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.; Sender's Comments: Based on the 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: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Infection
Clinical narrative: infection aggravated; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFECTION (infection aggravated) in a 94-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), PARACETAMOL (TYLENOL 8 HOUR), PROPRANOLOL, CALCIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ASCORBIC ACID, TOCOPHERYL ACETATE, XANTOFYL, ZEAXANTHIN, ZINC (AREDS) 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 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced INFECTION (infection aggravated) (seriousness criterion hospitalization). On 27-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). The patient was hospitalized on 30-Mar-2021 due to INFECTION. On 27-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, INFECTION (infection aggravated) outcome was unknown.            No laboratory details was given. Treatment information was mentioned as the patient undergo a "sural" to right ankle as her infection did not get heal on 13 Apr 2021. Before the first dose of vaccination she was hospitalized as she felt and broke her ankle. She was admitted on 19 Feb 2021 and get discharged to a nursing home on 25 Feb 2021. During the first dose of vaccination she also received two antibiotics for her wound infection. She received second dose 7 weeks later as she had to go back to hospital on 30 Mar 2021 due to the infected hardware that they put in.  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 the patient has a history of broken ankle, wound infection with hospitalization right before the first dose which is a potential 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 the patient has a history of broken ankle, wound infection with hospitalization right before the first dose which is a potential confounder.
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: Dropped dead of a heart attack; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MYOCARDIAL INFARCTION (Dropped dead of a heart attack) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYOCARDIAL INFARCTION (Dropped dead of a heart attack) (seriousness criteria death and medically significant). The reported cause of death was Heart attack. It is unknown if an autopsy was performed.            No concomitant medication was reported. No treatment information was reported.  It was reported that patient's funeral was on 11 May 2021.  Based on the 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.   This case was linked to MOD21-090166, US-MODERNATX, INC.-MOD-2021-128463, US-MODERNATX, INC.-MOD-2021-128999 (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 event, a causal relationship cannot be excluded. MOD21-090166: US-MODERNATX, INC.-MOD-2021-128463:Same reporter US-MODERNATX, INC.-MOD-2021-128999:; Reported Cause(s) of Death: Heart attack
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Aggression, Chills, Malaise, Neuropathy peripheral, Vaccination site pain
Clinical narrative: Worsening peripheral neuropathy; Aggressive temperament; Malaise; Sore arm; Chills; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Worsening peripheral neuropathy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Peripheral neuropathy.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced NEUROPATHY PERIPHERAL (Worsening peripheral neuropathy) (seriousness criterion medically significant), AGGRESSION (Aggressive temperament), MALAISE (Malaise), VACCINATION SITE PAIN (Sore arm) and CHILLS (Chills). At the time of the report, NEUROPATHY PERIPHERAL (Worsening peripheral neuropathy) and AGGRESSION (Aggressive temperament) had not resolved and MALAISE (Malaise), VACCINATION SITE PAIN (Sore arm) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medications reported.  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
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Bell's palsy; Tingling on right side of the tongue; Numbness on the right side of the tongue; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bell's palsy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006N20A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-May-2021, the patient experienced BELL'S PALSY (Bell's palsy) (seriousness criterion medically significant), PARAESTHESIA ORAL (Tingling on right side of the tongue) and HYPOAESTHESIA ORAL (Numbness on the right side of the tongue). At the time of the report, BELL'S PALSY (Bell's palsy), PARAESTHESIA ORAL (Tingling on right side of the tongue) and HYPOAESTHESIA ORAL (Numbness on the right side of the tongue) was resolving.            Prednisone was prescribed but patient did not take the prescribed medication. Patient declined to provide the list of her maintenance medications. 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.
Sex: M
Vaccine: COVID19
Symptoms: Feeding disorder, Haemorrhage, Oropharyngeal pain, Pancreatitis, Retching
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (inflamed pancreas) and HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (inflamed pancreas) (seriousness criterion medically significant), HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed) (seriousness criterion medically significant), RETCHING (dry heaves), OROPHARYNGEAL PAIN (throat very sore from vomiting), FEEDING DISORDER (had not eaten in 4-5 days and was on liquid diet) and VOMITING (severe vomiting). At the time of the report, PANCREATITIS (inflamed pancreas), HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed), RETCHING (dry heaves), OROPHARYNGEAL PAIN (throat very sore from vomiting), FEEDING DISORDER (had not eaten in 4-5 days and was on liquid diet) and VOMITING (severe vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had gone to hospital twice and now he has to see a specialist. The patient received first dose of vaccine sometime in Apr-2021. No treatment and concomitant medications were reported.  Action taken with mRNA-1273 in response to the event 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. However, very limited information on the event Pancreatitis and hemorrhage has been provided at this time. No further information is expected.   This case was linked to US-MODERNATX, INC.-MOD, US-MODERNATX, INC.-MOD.; 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, very limited information on the event Pancreatitis and hemorrhage has been provided at this time. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PANCREATITIS (inflamed pancreas) and HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PANCREATITIS (inflamed pancreas) (seriousness criterion medically significant), HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed) (seriousness criterion medically significant), RETCHING (dry heaves), OROPHARYNGEAL PAIN (throat very sore from vomiting), FEEDING DISORDER (had not eaten in 4-5 days and was on liquid diet) and VOMITING (severe vomiting). At the time of the report, PANCREATITIS (inflamed pancreas), HAEMORRHAGE (severe vomiting that affected pancreas and cause him to bleed), RETCHING (dry heaves), OROPHARYNGEAL PAIN (throat very sore from vomiting), FEEDING DISORDER (had not eaten in 4-5 days and was on liquid diet) and VOMITING (severe vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the patient had gone to hospital twice and now he has to see a specialist. The patient received first dose of vaccine sometime in Apr-2021. No treatment and concomitant medications were reported.  Action taken with mRNA-1273 in response to the event 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. However, very limited information on the event Pancreatitis and hemorrhage has been provided at this time. No further information is expected.   This case was linked to US-MODERNATX, INC.-MOD, US-MODERNATX, INC.-MOD.; 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, very limited information on the event Pancreatitis and hemorrhage has been provided at this time. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Fibromyalgia, Headache, Infectious mononucleosis, Neck pain
Clinical narrative: "Polymyelitis rheumatica"; Re-visitation of pain from her neck injury; Fibromyalgia; Re-visitation of mono; Horrible headaches; Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polymyalgia rheumatica ("polymyelitis rheumatica"), Infectious mononucleosis, Neck injury (car accident) in 1980, Headache, Fibromyalgia and Chronic fatigue.   On 02-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 05-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica") (seriousness criterion medically significant), NECK PAIN (Re-visitation of pain from her neck injury), FIBROMYALGIA (Fibromyalgia), INFECTIOUS MONONUCLEOSIS (Re-visitation of mono), HEADACHE (Horrible headaches) and FATIGUE (Chronic fatigue). At the time of the report, POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica"), NECK PAIN (Re-visitation of pain from her neck injury), FIBROMYALGIA (Fibromyalgia), INFECTIOUS MONONUCLEOSIS (Re-visitation of mono), HEADACHE (Horrible headaches) and FATIGUE (Chronic fatigue) outcome was unknown.            Treatment information included a tapering dose of 60mg of prednisone for past 7 day. Patient was taking unspecified concomitant medications.  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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: "Polymyelitis rheumatica"; Re-visitation of pain from her neck injury; Fibromyalgia; Re-visitation of mono; Horrible headaches; Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Polymyalgia rheumatica ("polymyelitis rheumatica"), Infectious mononucleosis, Neck injury (car accident) in 1980, Headache, Fibromyalgia and Chronic fatigue.   On 02-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 05-Mar-2021, the patient experienced POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica") (seriousness criterion medically significant), NECK PAIN (Re-visitation of pain from her neck injury), FIBROMYALGIA (Fibromyalgia), INFECTIOUS MONONUCLEOSIS (Re-visitation of mono), HEADACHE (Horrible headaches) and FATIGUE (Chronic fatigue). At the time of the report, POLYMYALGIA RHEUMATICA ("Polymyelitis rheumatica"), NECK PAIN (Re-visitation of pain from her neck injury), FIBROMYALGIA (Fibromyalgia), INFECTIOUS MONONUCLEOSIS (Re-visitation of mono), HEADACHE (Horrible headaches) and FATIGUE (Chronic fatigue) outcome was unknown.            Treatment information included a tapering dose of 60mg of prednisone for past 7 day. Patient was taking unspecified concomitant medications.  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: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Multiple sclerosis, Pain, Paraesthesia
Clinical narrative: MS symptoms; Tingling; Pain; Felt like crap; Constantly tired; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS symptoms) in a 62-year-old patient of an unknown gender 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 Psoriatic arthritis. Concomitant products included ADALIMUMAB (HUMIRA) for Psoriatic arthritis.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MULTIPLE SCLEROSIS (MS symptoms) (seriousness criterion medically significant), PARAESTHESIA (Tingling), PAIN (Pain), MALAISE (Felt like crap) and FATIGUE (Constantly tired). At the time of the report, MULTIPLE SCLEROSIS (MS symptoms), PARAESTHESIA (Tingling), PAIN (Pain), MALAISE (Felt like crap) and FATIGUE (Constantly tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication Adalimumab is temporarily with held for next six weeks. No treatment information was provided.  Very limited information regarding the events have been provided at this time. No Further information is expected.   This case was linked to MOD-2021-139280 (Patient Link).; Sender's Comments: Very limited information regarding the events have been provided at this time. No Further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Pyrexia, Seizure, Vaccination site pain
Clinical narrative: one episode of seizure attack while sleeping; low grade fever of 100F; injection arm soreness; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (one episode of seizure attack while sleeping) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy. Concomitant products included PHENOBARBITAL (PHENOBARBITONE COX) and LEVETIRACETAM for Seizure, ZONISAMIDE and PARACETAMOL (TYLENOL) for an unknown indication.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021, the patient experienced VACCINATION SITE PAIN (injection arm soreness) and FATIGUE (tiredness). On 15-May-2021, the patient experienced PYREXIA (low grade fever of 100F). On 17-May-2021, the patient experienced SEIZURE (one episode of seizure attack while sleeping) (seriousness criterion medically significant). At the time of the report, SEIZURE (one episode of seizure attack while sleeping), VACCINATION SITE PAIN (injection arm soreness), FATIGUE (tiredness) and PYREXIA (low grade fever of 100F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 °F (High) 100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment information included Tylenol.  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: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: found dead; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (found dead) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032m20a) for COVID-19 vaccination.     Concurrent medical conditions included Traumatic brain injury, Movement disorder, Seizures (since she was a baby at 11 months old) and Speech loss. Concomitant products included CLONAZEPAM, OXCARBAZEPINE (TRILEPTAL) and GABAPENTIN for an unknown indication.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Death occurred on 04-Apr-2021 The patient died on 04-Apr-2021. The cause of death was not reported. An autopsy was not performed.            Reporter stated that death certificate said the cause of death was natural causes. She did have her yearly physical exam after her first dose with her physician prior to her death and no other health issues were noted at the time of the exam.  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: Natural causes
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 022C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Apr-2021, the patient experienced BELL'S PALSY (Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Bell's Palsy after receiving their first dose of the Moderna Covid-19 Vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was not reported. Treatment information was not reported.   It was noted that the patient eventually went to the emergency room where the Bell's Palsy was diagnosed.  Based on the 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. 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 event, a causal relationship cannot be excluded. Further information has been requested
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Migraine, SARS-CoV-2 test
Clinical narrative: 3 days after second vaccine started with headaches which got worse on day 5 after vaccine; I went to ER for migraine and high blood pressure of 163/113; I went to ER for migraine and high blood pressure of 163/113; This is a spontaneous report from a contactable Nurse (patient). A 49-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EN5318) via unknown route of administration on 27Jan2021 14:00 at right arm as a single dose for Covid-19 immunization. The patients medical history included Gastrooesophageal reflux disease (GERD), irritable bowel syndrome (IBS) and anxiety. No Known allergies were reported. Concomitant medications included famotidine (PEPCID), calcium, multivitamin and Birth control pills. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received first dose of bnt162b2 on 06Jan2021 14:00 (Lot Number: EL0142) at right arm as a single dose for Covid-19 immunization. It was stated that 3 days after second vaccine started with headaches on 30Jan2021 12:00 PM which got worse on day 5 after vaccine I went to ER for migraine and high blood pressure of 163/113 on an unknown date in 2021. Was given IV meds for migraine and help Bp come down to 144/98 on an unknown date in 2021. The patient had taken covid test post vaccination, test type was reported as Nasal Swab and covid test name post vaccination was reported as Rapid with covid test result as negative on 01Feb2021. The outcome of headache was not recovered and for other events was unknown.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the information currently available,The casual association between the reported events and suspected vaccine BNT162B2 cannot be completely excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Chills, Dry mouth, Dysphonia, Erythema
Clinical narrative: chills/terrible chills; throat raspy was with a dry mouth; throat raspy was with a dry mouth; headache; "red puffed up" fingers/her finger tips got red and she had swollen red hands; "red puffed up" fingers; muscles hurting; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer via a medical information team. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL1283; Expiration Date: 30Apr2021), via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer survive (diagnosed in 2008), Allergies: latex, Allergies: sulfa. There were no concomitant medications. The patient previously took ciprofloxacin [CIPRO] and experienced Allergies, influenza vaccine (FLU VACCINE VII) (flu shot) for immunization and experienced no adverse event. The patient experienced headache on 22Jan2021 10:10, "red puffed up" fingers/her finger tips got red and she had swollen red hands on 22Jan2021 10:10, "red puffed up" fingers on 22Jan2021 10:10, chills/terrible chills on 22Jan2021 11:00, throat raspy was with a dry mouth on 22Jan2021 10:20, muscles hurting on 22Jan2021. It was reported on the COVID vaccine that the patient got the first shot on 22Jan2021 and was sent an email that her second dose was scheduled for 05Feb2021, was that ok. It was also noted when she got the first vaccine they held her up at the location because she has allergies. After getting the shot, her finger tips got red, her throat got raspy, and she got a headache. When she got home she had terrible chills and her muscles hurt. It was clarified that her finger tips got red and she had swollen red hands- this started 10 minutes after the injection was given and continued on and off for about a week. Throat raspy was with a dry mouth- this started 20 minutes after getting the shot and lasted about a week and a half. Headache - this started 10 minutes after getting the shot and lasted 3-4 days. Terrible chills- this started about an hour after getting the shot and lasted about 5 hours. Muscles hurting- this started that day and lasted 2 days. She reports she went to the emergency room 2 days later on 24Jan2021 and was given an antihistamine and told to take 2 Benadryl before the second shot. Since she was told she had an allergic reaction to the vaccine she was nervous about getting the second shot, what should she do. The outcome of the events headache, "red puffed up" fingers/her finger tips got red and she had swollen red hands, "red puffed up" fingers, throat raspy was with a dry mouth and allergic reaction to the vaccine was recovered on an unspecified date in 2021 and the events chills/terrible chills was recovered on 22Jan2021 16:00, muscles hurting was recovered on 24Jan2021.  Follow-up attempts are completed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Peripheral swelling
Clinical narrative: chills/terrible chills; throat raspy was with a dry mouth; throat raspy was with a dry mouth; headache; "red puffed up" fingers/her finger tips got red and she had swollen red hands; "red puffed up" fingers; muscles hurting; allergic reaction to the vaccine; This is a spontaneous report from a contactable consumer via a medical information team. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: EL1283; Expiration Date: 30Apr2021), via an unspecified route of administration, administered in Arm Left on 22Jan2021 10:00 as SINGLE DOSE for COVID-19 immunization. Medical history included breast cancer survive (diagnosed in 2008), Allergies: latex, Allergies: sulfa. There were no concomitant medications. The patient previously took ciprofloxacin [CIPRO] and experienced Allergies, influenza vaccine (FLU VACCINE VII) (flu shot) for immunization and experienced no adverse event. The patient experienced headache on 22Jan2021 10:10, "red puffed up" fingers/her finger tips got red and she had swollen red hands on 22Jan2021 10:10, "red puffed up" fingers on 22Jan2021 10:10, chills/terrible chills on 22Jan2021 11:00, throat raspy was with a dry mouth on 22Jan2021 10:20, muscles hurting on 22Jan2021. It was reported on the COVID vaccine that the patient got the first shot on 22Jan2021 and was sent an email that her second dose was scheduled for 05Feb2021, was that ok. It was also noted when she got the first vaccine they held her up at the location because she has allergies. After getting the shot, her finger tips got red, her throat got raspy, and she got a headache. When she got home she had terrible chills and her muscles hurt. It was clarified that her finger tips got red and she had swollen red hands- this started 10 minutes after the injection was given and continued on and off for about a week. Throat raspy was with a dry mouth- this started 20 minutes after getting the shot and lasted about a week and a half. Headache - this started 10 minutes after getting the shot and lasted 3-4 days. Terrible chills- this started about an hour after getting the shot and lasted about 5 hours. Muscles hurting- this started that day and lasted 2 days. She reports she went to the emergency room 2 days later on 24Jan2021 and was given an antihistamine and told to take 2 Benadryl before the second shot. Since she was told she had an allergic reaction to the vaccine she was nervous about getting the second shot, what should she do. The outcome of the events headache, "red puffed up" fingers/her finger tips got red and she had swollen red hands, "red puffed up" fingers, throat raspy was with a dry mouth and allergic reaction to the vaccine was recovered on an unspecified date in 2021 and the events chills/terrible chills was recovered on 22Jan2021 16:00, muscles hurting was recovered on 24Jan2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: her arm hurt/had a sore arm; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunisation. Relevant medical history and concomitant medications were not reported. The patient reported that after the shot her arm was hurting/had a sore arm. The outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Fatigue, Feeling abnormal, Headache, Limb discomfort
Clinical narrative: muscle ache; decrease smell; Arm immediately became heavy; headache; brain fog; complete exhaustion; This is a spontaneous report from a contactable other HCP.   A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 22Jan2021 14:00 (Lot Number: EL3302) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced arm immediately became heavy (and lasted for apprx 24 hours) on 22Jan2021 14:30. Within 20-30 min of injection patient developed headache (circular around head -temple level), brain fog, complete exhaustion all on 22Jan2021. All symptoms lasted for 6 days. The events recovered on 28Jan2021. Other brief 2-3 hour symptoms were muscle ache between neck and shoulders, decrease smell. These last events recovered on an unknown date  No follow-up attempts are possible. No further information is expected
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: muscle ache; decrease smell; Arm immediately became heavy; headache; brain fog; complete exhaustion; This is a spontaneous report from a contactable other HCP.   A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in arm right on 22Jan2021 14:00 (Lot Number: EL3302) as single dose for covid-19 immunisation. Medical history included covid-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other vaccine in four weeks. No covid tested post vaccination. The patient experienced arm immediately became heavy (and lasted for apprx 24 hours) on 22Jan2021 14:30. Within 20-30 min of injection patient developed headache (circular around head -temple level), brain fog, complete exhaustion all on 22Jan2021. All symptoms lasted for 6 days. The events recovered on 28Jan2021. Other brief 2-3 hour symptoms were muscle ache between neck and shoulders, decrease smell. These last events recovered on an unknown date  No follow-up attempts are possible. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; Headache; Extremely tired all day; sleeping most of it; Baby aches; This is a spontaneous report from a contactable Other HCP (patient herself).  This 54-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the left arm, on 17Feb2021 11:45 (at the age of 54-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 in Apr2020 (mild case). The patient did not have allergies. No relevant concomitant medications were provided. On 17Feb2021 at 22:00, she started with baby aches. On 18Feb2021 at 03:00, she woke up with 99.2 F fever, with extreme body aches and headache. She ran a low fever throughout the day getting as high as 100 F. Extremely tired all day sleeping most of it. Mild case. The patient was not treated for the events. The patient had recovered with sequelae from the events on unknown date in 2021.  Information about batch/lot number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Fever; Headache; Extremely tired all day; sleeping most of it; Baby aches; This is a spontaneous report from a contactable Other HCP (patient herself).  This 54-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route in the left arm, on 17Feb2021 11:45 (at the age of 54-year-old) at single dose for COVID-19 immunisation. No other vaccine was received in four weeks. Relevant medical history included COVID-19 in Apr2020 (mild case). The patient did not have allergies. No relevant concomitant medications were provided. On 17Feb2021 at 22:00, she started with baby aches. On 18Feb2021 at 03:00, she woke up with 99.2 F fever, with extreme body aches and headache. She ran a low fever throughout the day getting as high as 100 F. Extremely tired all day sleeping most of it. Mild case. The patient was not treated for the events. The patient had recovered with sequelae from the events on unknown date in 2021.  Information about batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling
Clinical narrative: Joints are swollen; This is a spontaneous report from a contactable consumer.   A 71 years old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included allergy to monosodium glutamate. Concomitant medications were not reported. The patient experienced Joints are swollen on an unspecified date with outcome unknown.   No follow-up attempts are possible, information about batch number cannot be obtained
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; fever (99); headache; fatigue; This is a spontaneous case from a contactable consumer (patient herself). A 45-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number En6200) via an unspecified route of administration in left arm on 17Feb2021 at 12:45PM (at the age of 45-year-old) at single dose for COVID-19 immunisation. The patient had COVID prior to vaccination and was not tested for COVID post vaccination. Concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. During the first 24hours the patient had no effects. The day after, on 18Feb2021 at 01:00PM, the patient had chills, fever (99), headache and fatigue. The patient took an Aleve. The events were resolving.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: rash to arms, legs, and back with itching; This is a spontaneous report from a non-contactable nurse.   An 81-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on an unspecified date at single dose intramuscular for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. The patient reported since an unspecified date after vaccination rash to arms, legs, and back with itching, lasting 2 weeks. Patient took Benedryl twice daily for relief. The patient recovered on an unspecified date.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bacterial infection, Hyperhidrosis, Vomiting
Clinical narrative: sweating; vomiting; bacteria in her intestines; This is a spontaneous report from a contactable consumer.   A 94-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as as single dose, for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reported stated that on Tuesday after receiving the shot, her grandmother, who is usually sitting in a wheelchair, was leaning forward while seated and began sweating  "sweating a lot in head and in her hair and then started vomiting" on an unspecified date. The patient was transported to the ER by ambulance for evaluation but was later sent home, they found that she had a bacteria in her intestines. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema, Peripheral swelling, Ultrasound scan
Clinical narrative: Left arm started to swelling.; Lymphedema; This is a spontaneous report from a contactable consumer (patient herself). A 75-year-old female consumer received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration in right arm on an unspecified date, at single dose for COVID-19 immunisation. Relevant medical history included cancer (12 years before). Concomitant medications were not reported. Five days after getting the first shot of vaccine left arm started to swell. The doctor at the Urgent Care performed an ultrasound and said that she had lymphedema. The doctor ad the Urgent Care said that it was not caused by the vaccine. Her oncologist said that there was a 50/50 chance that the lymphedema was caused by the vaccine. The outcome of the event was unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Joint pain; This is a spontaneous report from a Pfizer-sponsored program, received by a contactable consumer (patient herself).  This 69-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number not provided), via an unknown route, on 17Feb2021 at single dose for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. The patient was experiencing joint pain and she was wanting to know if she could take an acetylsalicylic acid (ASPIRIN) or a pain killer. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm after receiving the second shot of the vaccine; This is a spontaneous report from a contactable consumer (patient)   A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported.  The patient experienced had a sore arm after receiving the second shot of the vaccine on an unspecified date. At the time of the reporting event outcome was unknown.    Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Oropharyngeal pain
Clinical narrative: achy joints; mild sore throat; nausea; Fever; chills; shaking; Headache; This is a spontaneous report from a contactable consumer (patient).  A 31-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 18Feb2021 11:45 (Batch/Lot Number: EL3247) as age at vaccination of 31-years-old, as single dose, for covid-19 immunisation. Medical history was none; the patient had no allergy. Patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Right on 28Jan2021 03:00 PM (Batch/Lot Number: EL3247) for covid-19 immunisation. There were no concomitant medications. The patient did not receive other vaccine in four weeks and did not receive other medications in two weeks. Starting at 2 AM on 19Feb2021, the patient experienced achy joints then fever, chills, shaking, headache, nausea and mild sore throat were all experienced.  Therapeutic measures were taken as a result of the events and included administration of ibuprofen. The patient had not covid prior vaccination and was not covid tested post vaccination.  The patient was recovering from the events.   Follow-up attempts completed. No further information expected.