chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pain in extremity
Clinical narrative: Left arm and its joint still hurts; Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left arm and its joint still hurts), ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) and FATIGUE (fatigue) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-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 VACCINATION SITE PAIN (Left arm and its joint still hurts), ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) and FATIGUE (fatigue). The patient was treated with PARACETAMOL (ACETAMINOFEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Left arm and its joint still hurts) and ARTHRALGIA (Feels like his left arm will pop out or fall out of the joint/Left arm and its joint still hurts) was resolving and FATIGUE (fatigue) outcome was unknown.            No concomitant medications was given.   This case was linked to MOD-2021-324333 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement
Clinical narrative: High blood pressure; 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 BLOOD PRESSURE INCREASED (High blood pressure) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 BLOOD PRESSURE INCREASED (High blood pressure) (seriousness criterion hospitalization). At the time of the report, BLOOD PRESSURE INCREASED (High blood pressure) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) High.         Concomitant medication information not provided.  Treatment information not provided.  Company comment: This case concerns a patient of unknown age and gender, who experienced the unexpected event of high blood pressure with seriousness criteria of hospitalization. The event occurred an unknown time after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the 2nd dose. It is to note that very limited information has been provided for this case report. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender, who experienced the unexpected event of high blood pressure with seriousness criteria of hospitalization. The event occurred an unknown time after the second dose of mRNA-1273. The rechallenge was not applicable since the event occurred after the 2nd dose. It is to note that very limited information has been provided for this case report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain of skin, Rash pruritic, Swelling
Clinical narrative: Leg she had a small itchy rash which has since spread to her arms, torso and both legs; Swelling; Skin was tender; Skin allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs), SWELLING (Swelling), PAIN OF SKIN (Skin was tender) and HYPERSENSITIVITY (Skin allergic reaction) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs), SWELLING (Swelling), PAIN OF SKIN (Skin was tender) and HYPERSENSITIVITY (Skin allergic reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, RASH PRURITIC (Leg she had a small itchy rash which has since spread to her arms, torso and both legs) and PAIN OF SKIN (Skin was tender) had not resolved and SWELLING (Swelling) and HYPERSENSITIVITY (Skin allergic reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medication was mentioned.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Rhinorrhoea
Clinical narrative: Positive for Covid after vaccine; Lack of drug effect; sniffles for one week; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Positive for Covid after vaccine), DRUG INEFFECTIVE (Lack of drug effect) and RHINORRHOEA (sniffles for one week) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced COVID-19 (Positive for Covid after vaccine). 17-Aug-2021, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). On an unknown date, the patient experienced RHINORRHOEA (sniffles for one week). At the time of the report, COVID-19 (Positive for Covid after vaccine) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown and RHINORRHOEA (sniffles for one week) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medication was mentioned. No treatment medication was mentioned.; Sender's Comments: This case concerns a 69-years-old, male patient with no medical history, who experienced the unexpected event of Covid-19 with associated non-serious event of rhinorrhoea. Drug ineffective was also considered as an additional event since, the events occurred approximately six months after the second dose of mRNA-1273, Moderna COVID-19 Vaccine. Events were considered non-serious as per the reporter. The rechallenge was considered not applicable. The reporter did not provide a causality assessment. The benefit-risk relationship of mRNA-1273, Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administration of expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Electric shock sensation, Muscular weakness, Paraesthesia
Clinical narrative: left arm is weak; weakness comes and goes; after a week or two, the dizziness was intermittent; the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way; tingling; electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak) and ASTHENIA (weakness comes and goes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling) and ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day). On an unknown date, the patient experienced MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes: OTC Supplements and OTC Allergy medicine
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: left arm is weak; weakness comes and goes; after a week or two, the dizziness was intermittent; the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way; tingling; electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak) and ASTHENIA (weakness comes and goes) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was reported.  Concomitant products included VITAMIN D NOS for an unknown indication.    On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling) and ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day). On an unknown date, the patient experienced MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent). The patient was treated with DIMENHYDRINATE (DRAMAMINE) for Adverse event, at an unspecified dose and frequency. At the time of the report, VERTIGO (the next day I was experiencing vertigo/my head was spinning one way and the room was spinning the other way), PARAESTHESIA (tingling), ELECTRIC SHOCK SENSATION (electrical feeling in left arm where I had vaccination/the electrical feeling happens 2-3 times a day), MUSCULAR WEAKNESS (left arm is weak), ASTHENIA (weakness comes and goes) and DIZZINESS (after a week or two, the dizziness was intermittent) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication includes: OTC Supplements and OTC Allergy medicine
Sex: F
Vaccine: COVID19
Symptoms: Intracranial aneurysm
Clinical narrative: brain aneurism; This spontaneous case was reported by an other health care professional and describes the occurrence of INTRACRANIAL ANEURYSM (brain aneurism) in an adult 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTRACRANIAL ANEURYSM (brain aneurism) (seriousness criteria death and medically significant). The reported cause of death was brain aneurism. It is unknown if an autopsy was performed.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication details were provided.  It was reported that the person around it's 30's died from a brain aneurism right after receiving the Moderna Vaccine.   No treatment information was mentioned.  This case concerns female patient of unknown age with no relevant medical history reported, who experienced the unexpected event of intracranial aneurysm. The event occurred on an unknown number of days after the first dose of mRNA-1273 and had a fatal outcome on an unknown date. No autopsy report was provided. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Further information was requested.; Sender's Comments: This case concerns female patient of unknown age with no relevant medical history reported, who experienced the unexpected event of intracranial aneurysm. The event occurred on an unknown number of days after the first dose of mRNA-1273 and had a fatal outcome on an unknown date. No autopsy report was provided. The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.  Further information was requested.; Reported Cause(s) of Death: brain aneurism
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Product temperature excursion issue
Clinical narrative: she not applied vaccine to patient till 20 mint and the enjection in her hand; out side temperature that time 38 centi grade; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade). At the time of the report, PRODUCT ADMINISTRATION ERROR (she not applied vaccine to patient till 20 mint and the enjection in her hand) and PRODUCT TEMPERATURE EXCURSION ISSUE (out side temperature that time 38 centi grade) had resolved.            It was reported that the patients went to hospital for moderna vaccine 2nd dose. There was one nurse, she took moderna vaccine to fill the injection. After filling injection she not applied vaccine to patient till 20 minutes and the injection in her hand ,outside temperature that time 38 centi grade.  Concomitant medications were not reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle; This spontaneous case was reported by a nurse and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A, 012M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) dosage was changed to 1 dosage form. On 17-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle). On 17-Sep-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Vaccine administered subcutaneously not intramuscularly/given in the wrong tissue/booster did not go into muscle) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   Health care professional (HCP) nurse got two doses of moderna covid 19 vaccine 1st and 2nd dose in left upper arm deltoid muscle. On 17-Sep-2021, nurse got the booster which was her third dose, however, it was administered subcutaneously not intramuscular, in her left arm below the deltoid muscle. She stated that she read that the efficacy was different, because she got her booster vaccine subcutaneously and stated the efficacy cannot be determined since it was given in the wrong tissue.  Concomitant medications were not reported. No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: right arm hurt for 2.5 days after the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     The patient's past medical history included Cataracts, Carpal tunnel syndrome, Tinnitus and Ear injury (Busted ear drums (years ago)). Concurrent medical conditions included Diabetes, Inflammatory arthritis, Blood pressure high, Kidney disorder, Heart disease, unspecified, Allergy NOS and Thyroid disorder. Concomitant products included INSULIN for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection). The patient was treated with PARACETAMOL (TYLENOL) for Vaccination site pain, at an unspecified dose and frequency and ALCOHOL (topical) for Vaccination site pain, at an unspecified dose and frequency. On 28-Feb-2021, VACCINATION SITE PAIN (right arm hurt for 2.5 days after the injection) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Historical condition included other health issues (unspecified).   The right arm hurt for 2.5 days after the injection. The patient was treated with Tylenol and massaged arm with clear rubbing alcohol. The patient reported right arm hurts 90% of the time and stated it is possibly due to diabetes (onset date unknown).  The patient received the flu shot yearly. She stated she takes a lot of medications daily (did not report the names of the medications), including Insulin. She stated that she doesn't consider herself immunocompromised, but stated she is high risk for COVID-19 infection.     This case was linked to MOD-2021-325019 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Apathy, Decreased appetite, Fall, Fatigue, Illness
Clinical narrative: flu-like symptoms; knocked down; no appetite; under the weather; had no motivation; fatigue; more than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather) and APATHY (had no motivation) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perforated eardrum (busted ear drums (years ago)), Tinnitus and Cataract. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Diabetes, Arthritis, Carpal tunnel syndrome, Hypertension, Kidney disorder, Heart disease, unspecified, Allergy NOS and Thyroid disorder. Concomitant products included INSULIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved and FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She stated she takes a lot of medications daily.  She reported that she experienced flu-like symptoms that lasted three weeks after receiving the second dose. She reported she was knocked down and experienced fatigue and no appetite. She stated she was under the weather and wondered what was wrong with her. She reported she also had no motivation. She stated for treatment she took Tylenol. She stated that she did not consider herself immunocompromised, but stated she was high risk for COVID-19 infection.   This case was linked to MOD-2021-325008 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: flu-like symptoms; knocked down; no appetite; under the weather; had no motivation; fatigue; more than 35 days between first and second dose; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather) and APATHY (had no motivation) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Perforated eardrum (busted ear drums (years ago)), Tinnitus and Cataract. Previously administered products included for an unreported indication: FLU VACCINE VII. Concurrent medical conditions included Diabetes, Arthritis, Carpal tunnel syndrome, Hypertension, Kidney disorder, Heart disease, unspecified, Allergy NOS and Thyroid disorder. Concomitant products included INSULIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation), FATIGUE (fatigue) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 02-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 35 days between first and second dose) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms) had resolved and FALL (knocked down), DECREASED APPETITE (no appetite), ILLNESS (under the weather), APATHY (had no motivation) and FATIGUE (fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   She stated she takes a lot of medications daily.  She reported that she experienced flu-like symptoms that lasted three weeks after receiving the second dose. She reported she was knocked down and experienced fatigue and no appetite. She stated she was under the weather and wondered what was wrong with her. She reported she also had no motivation. She stated for treatment she took Tylenol. She stated that she did not consider herself immunocompromised, but stated she was high risk for COVID-19 infection.   This case was linked to MOD-2021-325008 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Disturbance in attention, Feeling hot, Visual impairment
Clinical narrative: changed her vision; having trouble focusing; doesn't have a temperature but she feels hot; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (changed her vision), DISTURBANCE IN ATTENTION (having trouble focusing) and FEELING HOT (doesn't have a temperature but she feels hot) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037F21A and 049E21A) for COVID-19 vaccination.     No Medical History information was reported. On 14-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced VISUAL IMPAIRMENT (changed her vision), DISTURBANCE IN ATTENTION (having trouble focusing) and FEELING HOT (doesn't have a temperature but she feels hot). At the time of the report, VISUAL IMPAIRMENT (changed her vision), DISTURBANCE IN ATTENTION (having trouble focusing) and FEELING HOT (doesn't have a temperature but she feels hot) outcome was unknown.            It was reported that patient had anxiety, but no Concomitant drug details provided for anxiety. Treatment details were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: heart racing; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (heart racing) 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 PALPITATIONS (heart racing). At the time of the report, PALPITATIONS (heart racing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were unknown. Treatment information was not provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, the patient experienced DIARRHOEA (I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight). At the time of the report, DIARRHOEA (I was experiencing pretty bad diarrhea/it has been consistent since saturday/I've had it for 2 days straight) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The concomitant medication  reported as OTC allergy pill.  The treatment included was Drinking more water, limiting diet.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Ear infection, Vertigo
Clinical narrative: pike on ear infections; dizziness; always spinning; affected equilibrium; This spontaneous case was reported by a consumer and describes the occurrence of EAR INFECTION (pike on ear infections), DIZZINESS (dizziness), VERTIGO (always spinning) and BALANCE DISORDER (affected equilibrium) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018b21a and 037c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-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 EAR INFECTION (pike on ear infections), DIZZINESS (dizziness), VERTIGO (always spinning) and BALANCE DISORDER (affected equilibrium). The patient was treated with OFLOXACIN at an unspecified dose and frequency and MECLIZINE [MECLOZINE] for Dizziness, at an unspecified dose and frequency. At the time of the report, EAR INFECTION (pike on ear infections), DIZZINESS (dizziness), VERTIGO (always spinning) and BALANCE DISORDER (affected equilibrium) had not resolved.            Concomitant medicine reported as a lot of medication   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow up received on 20-Sep-2021 contains no new information.; Reporter's Comments: Med Info  CASE CROSSLINKED MOD-2021-145591 HCP of the patient stated he had seen a pike on ear infections
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 67-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 DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Dyspnoea, Heart rate irregular, Illness, Loss of consciousness
Clinical narrative: couldn't breathe; had a high fever of 101° F; passed out at work; got really sick; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat), DYSPNOEA (couldn't breathe) and PYREXIA (had a high fever of 101° F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E_IA) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat) and PYREXIA (had a high fever of 101° F). On an unknown date, the patient experienced DYSPNOEA (couldn't breathe). At the time of the report, LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat), DYSPNOEA (couldn't breathe) and PYREXIA (had a high fever of 101° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 101° f (High) had a high fever of 101° F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment information was not provided.  The symptoms started on 20-Aug-2021 at about 11 am. the patient "got really sick" and passed out at work, had a high fever of 101° F and started noticing an irregular heartbeat. The patient went to the doctor and they put him on a heart monitor for 48 hours. The patient also stated that he couldn't breathe.; Sender's Comments: This case concerns a 53 year old male with no medical history who experienced the unexpected events of Illness, Loss of consciousness, Heart rate irregular and Dyspnoea and the expected event of Pyrexia 1 day after the first dose of Moderna COVID-19 vaccine. No re-chalenge has been note and no causality reported.  The benefit-risk relationship of Moderna COVID-19 is not affected by this report. The event Loss of consciousness was automatically upgraded to serious as per IME; however, based on medical judgement and the information available the event is assessed as non-serious.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: couldn't breathe; had a high fever of 101° F; passed out at work; got really sick; irregular heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat), DYSPNOEA (couldn't breathe) and PYREXIA (had a high fever of 101° F) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E_IA) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat) and PYREXIA (had a high fever of 101° F). On an unknown date, the patient experienced DYSPNOEA (couldn't breathe). At the time of the report, LOSS OF CONSCIOUSNESS (passed out at work), ILLNESS (got really sick), HEART RATE IRREGULAR (irregular heartbeat), DYSPNOEA (couldn't breathe) and PYREXIA (had a high fever of 101° F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Aug-2021, Body temperature: 101° f (High) had a high fever of 101° F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided. Treatment information was not provided.  The symptoms started on 20-Aug-2021 at about 11 am. the patient "got really sick" and passed out at work, had a high fever of 101° F and started noticing an irregular heartbeat. The patient went to the doctor and they put him on a heart monitor for 48 hours. The patient also stated that he couldn't breathe.; Sender's Comments: This case concerns a 53 year old male with no medical history who experienced the unexpected events of Illness, Loss of consciousness, Heart rate irregular and Dyspnoea and the expected event of Pyrexia 1 day after the first dose of Moderna COVID-19 vaccine. No re-chalenge has been note and no causality reported.  The benefit-risk relationship of Moderna COVID-19 is not affected by this report. The event Loss of consciousness was automatically upgraded to serious as per IME; however, based on medical judgement and the information available the event is assessed as non-serious.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Incorrect product storage; A patient received 2nd dose of vaccine from an expired vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received 2nd dose of vaccine from an expired vial) and PRODUCT STORAGE ERROR (Incorrect product storage) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received 2nd dose of vaccine from an expired vial). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Incorrect product storage). On 20-Sep-2021, EXPIRED PRODUCT ADMINISTERED (A patient received 2nd dose of vaccine from an expired vial) had resolved. At the time of the report, PRODUCT STORAGE ERROR (Incorrect product storage) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment medication was provided.  The vial was punctured on 17-Sep-2021. The vial was kept in refrigerator at 39 degree F until 20-Sep-2021. The reporter did not had exact excursion time it was within 72 hours.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, Burning sensation, Confusional state, Dizziness, Pyrexia
Clinical narrative: Got shaky; Dizzy; Was burning up; Sleepy; Bacterial  infection; Viral infection; Talking kind of delirious; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy) and BACTERIAL INFECTION (Bacterial  infection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (He had Covid on April and may), Wound and Surgery. Concurrent medical conditions included Fibrillation, COPD and Lung cancer.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-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 TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy), BACTERIAL INFECTION (Bacterial  infection), VIRAL INFECTION (Viral infection), CONFUSIONAL STATE (Talking kind of delirious) and PYREXIA (Fever). At the time of the report, TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy), BACTERIAL INFECTION (Bacterial  infection), VIRAL INFECTION (Viral infection), CONFUSIONAL STATE (Talking kind of delirious) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Blood thinner.  Patient was prescribed with  antibiotics and tylenol for a bacterial infection or a viral infection, is not sure.  Patient had radiation therapy for lung cancer.  Treatment medications were not reported.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Tremor, Viral infection
Clinical narrative: Got shaky; Dizzy; Was burning up; Sleepy; Bacterial  infection; Viral infection; Talking kind of delirious; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy) and BACTERIAL INFECTION (Bacterial  infection) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 008C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (He had Covid on April and may), Wound and Surgery. Concurrent medical conditions included Fibrillation, COPD and Lung cancer.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-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 TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy), BACTERIAL INFECTION (Bacterial  infection), VIRAL INFECTION (Viral infection), CONFUSIONAL STATE (Talking kind of delirious) and PYREXIA (Fever). At the time of the report, TREMOR (Got shaky), DIZZINESS (Dizzy), BURNING SENSATION (Was burning up), SOMNOLENCE (Sleepy), BACTERIAL INFECTION (Bacterial  infection), VIRAL INFECTION (Viral infection), CONFUSIONAL STATE (Talking kind of delirious) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications include Blood thinner.  Patient was prescribed with  antibiotics and tylenol for a bacterial infection or a viral infection, is not sure.  Patient had radiation therapy for lung cancer.  Treatment medications were not reported.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patient got her both doses; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old patient got her both doses) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old patient got her both doses). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a 16 year old patient got her both doses) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-328274 (Patient Link).
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Somnolence
Clinical narrative: slept all day; very tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all day) and FATIGUE (very tired) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and unknown) for COVID-19 vaccination.     The patient's past medical history included Chemotherapy (The patient has received chemotherapy with her last chemotherapy treatment in July.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Feb-2021, the patient experienced SOMNOLENCE (slept all day) and FATIGUE (very tired). At the time of the report, SOMNOLENCE (slept all day) and FATIGUE (very tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.    No treatment information was provided.