chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: episodes of dizziness; offbalance; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (episodes of dizziness) and BALANCE DISORDER (offbalance) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (episodes of dizziness) and BALANCE DISORDER (offbalance). At the time of the report, DIZZINESS (episodes of dizziness) and BALANCE DISORDER (offbalance) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Consumer answered yes when asked if they experienced any side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects). At the time of the report, VACCINATION COMPLICATION (Consumer answered yes when asked if they experienced any side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Ear infection, Ear pain, Head discomfort
Clinical narrative: Intercranial hypertension; Swooshing was worse after the second shot; Condition aggravated; Dizziness/things like that; Pressure in my head; She was treated for an ear infection; her right ear started hurting bad; Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension) (seriousness criterion medically significant), TINNITUS (Swooshing was worse after the second shot), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness/things like that), HEAD DISCOMFORT (Pressure in my head), EAR INFECTION (She was treated for an ear infection), EAR PAIN (her right ear started hurting bad) and HEADACHE (Headaches). At the time of the report, INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension), TINNITUS (Swooshing was worse after the second shot), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness/things like that), HEAD DISCOMFORT (Pressure in my head), EAR INFECTION (She was treated for an ear infection), EAR PAIN (her right ear started hurting bad) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) no brain tumor or blood flow issues..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided. Patient had seen a neurologist and he told that all her symptoms were due to intracranial hypertension. Patient was scheduled for spinal tap on 14-Sep-2021.  Company Comment: 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 MOD-2021-307195 (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 event, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Intracranial pressure increased, Magnetic resonance imaging, Tinnitus
Clinical narrative: Intercranial hypertension; Swooshing was worse after the second shot; Condition aggravated; Dizziness/things like that; Pressure in my head; She was treated for an ear infection; her right ear started hurting bad; Headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension) (seriousness criterion medically significant), TINNITUS (Swooshing was worse after the second shot), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness/things like that), HEAD DISCOMFORT (Pressure in my head), EAR INFECTION (She was treated for an ear infection), EAR PAIN (her right ear started hurting bad) and HEADACHE (Headaches). At the time of the report, INTRACRANIAL PRESSURE INCREASED (Intercranial hypertension), TINNITUS (Swooshing was worse after the second shot), CONDITION AGGRAVATED (Condition aggravated), DIZZINESS (Dizziness/things like that), HEAD DISCOMFORT (Pressure in my head), EAR INFECTION (She was treated for an ear infection), EAR PAIN (her right ear started hurting bad) and HEADACHE (Headaches) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: normal (normal) no brain tumor or blood flow issues..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medications were not reported. The treatment information was not provided. Patient had seen a neurologist and he told that all her symptoms were due to intracranial hypertension. Patient was scheduled for spinal tap on 14-Sep-2021.  Company Comment: 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 MOD-2021-307195 (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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: two vials that experienced a temperature excursion where use to administer doses to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (two vials that experienced a temperature excursion where use to administer doses to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (two vials that experienced a temperature excursion where use to administer doses to patients). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (two vials that experienced a temperature excursion where use to administer doses to patients) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was not provided   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: Blindness; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (Blindness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Not Provided) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (Blindness) (seriousness criterion medically significant). At the time of the report, BLINDNESS (Blindness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.  Patient also reported "this temp" with no measurement or date given.  Based on the current available information, a causal relationship cannot be excluded. Further information is not expected as reporter refused to be contacted.   Reporter did not allow further contact; Sender's Comments: Based on the current available information, a causal relationship cannot be excluded. Further information is not expected as reporter refused to be contacted.
Sex: U
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: One of his friend was paralyzed after taking moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (One of his friend was paralyzed after taking moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARALYSIS (One of his friend was paralyzed after taking moderna vaccine) (seriousness criterion medically significant). At the time of the report, PARALYSIS (One of his friend was paralyzed after taking moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  Company comment: Based on the currently available information, this case is invalid. Due to the paucity of information, a causality assessment appears not possible.; Sender's Comments: Based on the currently available information, this case is invalid. Due to the paucity of information, a causality assessment appears not possible.
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: Blood in stool; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOCHEZIA (Blood in stool) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HAEMATOCHEZIA (Blood in stool) (seriousness criterion medically significant). At the time of the report, HAEMATOCHEZIA (Blood in stool) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The  concomitant medications on use were not provided. No treatment information was provided.  Patient got vaccine two days before reporting and had blood in stool.  Company comment: Very limited information regarding this event has been provided at this time. Further information is not expected as reporter refused to be contacted.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information is not expected as reporter refused to be contacted.
Sex: U
Vaccine: COVID19
Symptoms: Death, Poor quality product administered, Product contamination physical
Clinical narrative: Two people died after taking the vaccine because of metal in the vials; Product contamination metal; Poor quality product administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Two people died after taking the vaccine because of metal in the vials) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DEATH (Two people died after taking the vaccine because of metal in the vials) (seriousness criteria death and medically significant), PRODUCT CONTAMINATION PHYSICAL (Product contamination metal) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). The patient died on an unknown date. The reported cause of death was two people died after taking the vaccine because of metal in the vials. It is unknown if an autopsy was performed. At the time of death, PRODUCT CONTAMINATION PHYSICAL (Product contamination metal) outcome was unknown and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved.            Concomitant product use was not provided by the reporter.   The patient was clearly venting his frustration. The patient also states that two people died after taking the vaccine  because of metal in the vials.  No treatment information was provided.  Company Comment: Very limited information regarding this events has been provided at this time.  However, 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.   This case was linked to MOD-2021-307513 (Patient Link).; Sender's Comments: Very limited information regarding this events has been provided at this time.  However, 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.; Reported Cause(s) of Death: Two people died after taking the vaccine because of metal in the vials
Sex: U
Vaccine: COVID19
Symptoms: Blindness, Carditis, Eye disorder, Hepatitis, Renal disorder
Clinical narrative: got blind; Hepatitis; heart inflammation; Eye problem; Kidney problem; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (got blind), HEPATITIS (Hepatitis) and CARDITIS (heart inflammation) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLINDNESS (got blind) (seriousness criterion medically significant), HEPATITIS (Hepatitis) (seriousness criterion medically significant), CARDITIS (heart inflammation) (seriousness criterion medically significant), EYE DISORDER (Eye problem) and RENAL DISORDER (Kidney problem). At the time of the report, BLINDNESS (got blind), HEPATITIS (Hepatitis), CARDITIS (heart inflammation), EYE DISORDER (Eye problem) and RENAL DISORDER (Kidney problem) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.  Patient reported "225 people got blind after vaccination. There are also other reports on hepatitis, eye problem, kidney problem, and heart inflammation. People are dying".  Very limited information regarding these events has been provided at this time.  Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination, Insomnia
Clinical narrative: Hallucinations; He started to have trouble sleeping; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (Hallucinations) in a 19-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.     No Medical History information was reported.    In August 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 HALLUCINATION (Hallucinations) (seriousness criterion medically significant) and INSOMNIA (He started to have trouble sleeping). At the time of the report, HALLUCINATION (Hallucinations) and INSOMNIA (He started to have trouble sleeping) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment medication was not provided by the reporter.   Reporter did not allow further contact; 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 is not expected (contact FU denied)
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID19 positive on 26thMay2021. Hospitalized for 7 days; Lack of drug ineffect; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID19 positive on 26thMay2021. Hospitalized for 7 days) in an 89-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.     Concurrent medical conditions included Chronic leukemia (IVIG globulin treatment received on 2 sept2021).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, the patient experienced COVID-19 (COVID19 positive on 26thMay2021. Hospitalized for 7 days) (seriousness criterion hospitalization) and DRUG INEFFECTIVE (Lack of drug ineffect). The patient was hospitalized for 7 days due to COVID-19. On 26-May-2021, DRUG INEFFECTIVE (Lack of drug ineffect) outcome was unknown. On 01-Jul-2021, COVID-19 (COVID19 positive on 26thMay2021. Hospitalized for 7 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-May-2021, SARS-CoV-2 test: positive (Positive) COVID19 positive on 26thMay2021. Hospitalized for 7 days.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   IVIG globulin treatment received on 2 Sep 2021.  Concomitant product use was not provided by the reporter.  This case concerns a male patient of an unknown age who experienced Covid-19 infection approximately 3 months post second dose of vaccine. Based on the information provided including the established profile for mRNA-1273, and based on biological implausibility a causal association between the event of COVID-19 and the product administration is assessed as unlikely and thus assessed as not applicable.  Treatment information was not provided.   Reporter did not allow further contact; Sender's Comments: This case concerns a male patient of an unknown age who experienced Covid-19 infection approximately 3 months post second dose of vaccine. Based on the information provided including the established profile for mRNA-1273, and based on biological implausibility a causal association between the event of COVID-19 and the product administration is assessed as unlikely and thus assessed as not applicable.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: chest pain that wasn't chest pain but was like my armpit was swollen; uncomfortable pain next to his chest, shoulder, and left arm; uncomfortable pain next to his chest, shoulder, and left arm; uncomfortable pain next to his chest, shoulder, and left arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (chest pain that wasn't chest pain but was like my armpit was swollen), CHEST PAIN (uncomfortable pain next to his chest, shoulder, and left arm), PAIN IN EXTREMITY (uncomfortable pain next to his chest, shoulder, and left arm), ARTHRALGIA (uncomfortable pain next to his chest, shoulder, and left arm) and PYREXIA (fever) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088B21A and 054C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever). On 21-Aug-2021, the patient experienced PERIPHERAL SWELLING (chest pain that wasn't chest pain but was like my armpit was swollen), CHEST PAIN (uncomfortable pain next to his chest, shoulder, and left arm), PAIN IN EXTREMITY (uncomfortable pain next to his chest, shoulder, and left arm) and ARTHRALGIA (uncomfortable pain next to his chest, shoulder, and left arm). At the time of the report, PERIPHERAL SWELLING (chest pain that wasn't chest pain but was like my armpit was swollen), CHEST PAIN (uncomfortable pain next to his chest, shoulder, and left arm), PAIN IN EXTREMITY (uncomfortable pain next to his chest, shoulder, and left arm), ARTHRALGIA (uncomfortable pain next to his chest, shoulder, and left arm) and PYREXIA (fever) outcome was unknown.      No  Concomitant medications were provided.  No Treatment medications were provided.   This case was linked to MOD-2021-250137, MOD-2021-250137 (Patient Link).
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: received both doses when age 16; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received both doses when age 16) outcome was unknown.            No treatment and concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.    This case was linked to MOD-2021-299844, MOD-2021-308656, MOD-2021-299882 (Patient Link).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: little more soreness than the first dose; two days of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (little more soreness than the first dose) and FATIGUE (two days of fatigue) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection NOS, Chronic pancreatitis and Blood pressure management.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (little more soreness than the first dose) and FATIGUE (two days of fatigue). At the time of the report, MYALGIA (little more soreness than the first dose) outcome was unknown and FATIGUE (two days of fatigue) had resolved.            Concomitant drug included HIV Medication, Blood thinner medication, Chronic pancreatitis medication and blood pressure medication. Treatment medication was not reported. its mentioned in the report that patient has taken the 3RD dose of vaccine on 2nd sept 2021 Consumer mentioned that he had soreness in the injection site and fatigue. He said his arm is slightly swollen   This case was linked to MOD-2021-308626.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Initiative Followup received.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Nausea, Vomiting
Clinical narrative: Passed out while vomiting; Nausea; Vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out while vomiting), NAUSEA (Nausea) and VOMITING (Vomiting) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out while vomiting) (seriousness criteria hospitalization and medically significant), NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). The patient was hospitalized from 01-Sep-2021 to 03-Sep-2021 due to LOSS OF CONSCIOUSNESS, NAUSEA and VOMITING. At the time of the report, LOSS OF CONSCIOUSNESS (Passed out while vomiting), NAUSEA (Nausea) and VOMITING (Vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were reported. No treatment information details were reported.  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: F
Vaccine: COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criterion medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product was not provided by the reporter.  Treatment product was not provided by the reporter.  Company comment: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.
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: seizures; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (seizures) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (seizures) (seriousness criterion medically significant). At the time of the report, SEIZURE (seizures) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.  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: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Urticaria
Clinical narrative: hives; swollen lymph nodes; This is a spontaneous report from a contactable consumer (Patient's sister). A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration on 03Feb2021 as dose 1 (at the age of 71 years), single for covid-19 immunization. Medical history included hard of hearing from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced hives, swollen lymph nodes and their physician told them that those were not side effects, those were severe allergic reactions. Reporter wanted to know the efficacy of the vaccine for single dose only. The outcome of the events was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dry mouth, Dysgeusia
Clinical narrative: Metallic taste; Dry mouth in her mouth; experiencing a metallic taste was reported as worsened.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 67-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Right on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation (age at vaccination: 67-years-old). The patient medical history and concomitant medications were not reported. The patient adds that she thinks her COVID vaccine was actually in May2021, in her planner she has that she got a shot on either 05May2021 or 06May2021 but she doesn't know if that is for her 1st dose or her 2nd dose. The patient received dose 1 of bnt162b2 for covid-19 immunisation on an unknown date (Time the Vaccination Was Given: It was around 3:00 in the afternoon for both of the doses, Anatomical Location of Administration of Pfizer vaccine considered as suspect: She thinks they were both in her right arm but she doesn't remember). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced metallic taste, dry mouth in her mouth and experiencing a metallic taste was reported as worsened on an unspecified date. The events did not resulted in emergency room or physician office. Outcome of the events were unknown except metallic taste which was not recovered.  Follow-up (21Jul2021): This is a follow-up spontaneous report from a contactable consumer.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Drug interaction
Clinical narrative: a Possible adverse reaction with the vaccine/ she is currently taking Stelara/ this is a concern with regard to the interaction that happen with the drug and the vaccine; This is a spontaneous report from a Pfizer-sponsored program via a contactable consumer or other non-HCP.  A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 30Jan2021 as DOSE 1, SINGLE, second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 20Feb2021 as DOSE 2, SINGLE for covid-19 immunization; ustekinumab (STELARA, Formulation: unknown, Lot number was not reported), via an unspecified route of administration from an unspecified date and ongoing, at unspecified dose for immunosuppressant drug therapy. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced a possible adverse reaction with the vaccine/ she is currently taking stelara/ this is a concern regarding the interaction that happen with the drug and the vaccine. The outcome of event was unknown.  Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Dizziness, Formication
Clinical narrative: Light-headed; Dizziness; skin feels like it is crawling; cold chills; is really weak; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 20Jul2021 (at the age of 56-year-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 21Jul2021, the patient experienced light-headed. On an unspecified date in Jul2021, patient experienced dizziness, skin feels like it is crawling, cold chills, is really weak. The outcome of the event light-headed was not recovered and the outcome of all other events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Hypersensitivity, Paraesthesia, Pruritus
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unknown age, received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# not reported), via an unknown route of administration, on an unspecified date, single dose, for COVID-19 immunisation. Medical history included heart valve replacement (she has had heart surgery). The patient's concomitant medications not reported. On an unknown date, patient experienced itchiness on her stomach, something under her stomach running (caller described this sensation as tingling) and allergy. The outcome of the events reported: unknown. Information about lot/batch number requested. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer. This consumer reported that a female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (Age at the time of vaccination was not provided) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated he had a female friend, who had the Pfizer Covid 19 vaccine, and had a headache on an unspecified date, after the vaccine, and recovered. The reporter declines to complete a safety report for his female friend. The outcome of the event was reported as recovered on an unspecified date. Reason for no lot number: of Pfizer Covid 19 vaccine: Caller unwilling to complete the report.  Information on lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202100930708 same reporter/product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: and has not received menstrual period since getting first dose; This is a spontaneous report from a contactable consumer or other non hcp from a Pfizer-sponsored program Support. The consumer (Patient) reported that. A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single and received second dose via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On an unknown date the patient experienced and has not received menstrual period since getting first dose. It was reported that patient has an employee who lost their vaccination card. Patient is fully vaccinated and has not received menstrual period since getting first dose. Thinks it is vaccine related due to no other underlying illness and at a healthy age of menstruation not premenapausal. The outcome of the event was unknown. Follow-up attempts are completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: started swelling in different parts of his body within 48 hours; This is a spontaneous report from a contactable consumer or other non-HCP. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date (Age of vaccination: Unknown) as DOSE 1, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date the patient experienced started swelling in different parts of his body within 48 hours. The outcome of event was unknown.  Follow-up (08Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.  No follow-up attempts are possible. Information about lot/batch no cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysphonia, Illness
Clinical narrative: sick; My voice is real weak right now; This is a spontaneous report from a contactable consumer. This 70-year-old consumer (patient) reported that: A 70-years-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, NDC number and Expiry Date: Not Provided, Batch/Lot number was not reported) via s unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical history included cardiac failure congestive, need to get off these cigarettes, got hurt and was in pretty rough shape, patient had 6 heart attacks and had a stroke, diabetes mellitus, rheumatoid arthritis, chronic obstructive pulmonary disease, for all-from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced sick, patient voice was real weak right now. it was reported that phone call received from the patient regarding enrollment in PAP for Chantix. During the call, the patient stated, could not wait 90 days. patient just had congestive heart failure last weekend and ended up in the hospital and need to get off these cigarettes or they're going to kill me. That was patient problem 70-years-old patient been smoking for 60 years. So, obviously, patient in trouble and took Chantix, um, 12 years ago. Patient quit smoking and about 4 1/2 -5 months into it patient was driving down the road. patient stopped at the traffic light and patient got broadsided and got hurt and patient was in pretty rough shape Since then it's been hell. Patient never went back on Chantix because didn't have the money to go back on Chantix, patient had 6 heart attacks and had a stroke. patient got, now, congestive heart failure I've got diabetes, RA, COPD. We can keep going. There's a list I've been in the hospital for every one of these over the years patient voice was real weak right now. Patient sound like patient 103 and have a very weak voice right now It's gotten down, its actually come back this week. Beginning of the week, you couldn't even hear me. patient couldn't talk breathing treatments and all that stuff and it just tore patient throat up and took Chantix. Patient didn't get any side effects and took them for 4 1/2 months. Patient no problems whatsoever. The only thing that happened was in 4 days patient still had 3/4 of a pack left because patient was not smoking and we had your virus shot As sick. patient can't be around someone because patient won't make it. They've already warned me of that again patient didn't want to get the Johnson and Johnson shot and they said let me put your mind at ease we don't have the Johnson and Johnson shot. We've got Pfizer. The outcome of events was reported as unknown. The patients date of birth was not provided on the phone call. The following information was not provided during the call: Patient gender,  No follow up attempts are possible. No additional information expected. Information about Lot/batch number is requested
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: joint pain in both hands; tingling and numbness in the right hand; tingling and numbness in the right hand; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 62-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), first dose via an unspecified route of administration, administered in Arm Left on an unspecified date(at the age of 62 years)single for covid-19 immunization. Medical history included thyroid (Verbatim: thyroid), migraine, cholesterol from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (112 MG), topiramate (TOPAMAX, 100 MG) taken for migraine, atorvastatin (40 MG) taken for cholesterol, start and stop date were not reported. Patient was not involved in Prior Vaccinations (within 4 weeks). On an unspecified date the patient experienced the joint pain in both hands happened 6 hours of the first dose. The tingling and numbness in the right hand it started the next day after the first dose. The pain in the right hand was so severe sometimes it wakes her up in the middle of the night and she has to apply an ice pack. The patient feels tingling all the time and then her right hand goes numb randomly. Time the Vaccination Was Given: 3:00 or 4:00 pm. Adverse events required no visit to Emergency Room, Physician Office. The outcome of the event joint pain in both hands was outcome. While the outcome of the rest of the events was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching all over her body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 39-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Jul2021 (at the age of 39-year-old) as dose 2, single for covid-19 immunisation. The patient medical history included none. Concomitant medications included cyproterone acetate, ethinylestradiol (DIANE-35) taken for contraception, start and stop date were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EW0187), via an unspecified route of administration on 11Jun2021 (at the age of 39-year-old) as dose 1, single for covid-19 immunisation. On 14Jul2021, the patient experienced itching all over her body. It was ongoing, mostly in the mornings and evenings, at is worst. The events did not result in emergency room or physician office visit. No treatment was taken as a result of event. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.