chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling abnormal, Myalgia
Clinical narrative: Fever by the next morning\ fever of 101 F; Felt fatigue; General weakness; Felt bad for 48 hours; Achiness; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (General weakness), FEELING ABNORMAL (Felt bad for 48 hours), MYALGIA (Achiness), PYREXIA (Fever by the next morning\ fever of 101 F) and FATIGUE (Felt fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain, Joint pain, Meningitis in 2014, Memory disturbance (Neurological memory issues) and Traumatic brain injury. Concurrent medical conditions included Bone spur (Bone spurs in her back, neck and joint pain at baseline.) and ADHD. Concomitant products included OMEPRAZOLE, LISDEXAMFETAMINE MESILATE (VYVANSE), BUPROPION, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS, TRAMADOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2020, the patient experienced ASTHENIA (General weakness), FEELING ABNORMAL (Felt bad for 48 hours), MYALGIA (Achiness) and FATIGUE (Felt fatigue). On 27-Dec-2020, the patient experienced PYREXIA (Fever by the next morning\ fever of 101 F). At the time of the report, ASTHENIA (General weakness), MYALGIA (Achiness), PYREXIA (Fever by the next morning\ fever of 101 F) and FATIGUE (Felt fatigue) outcome was unknown and FEELING ABNORMAL (Felt bad for 48 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-326897 (Patient Link).; Sender's Comments: This case concerns a 42 year old female with a history of chronic pain, neck and joint pain, traumatic brain injury, meningitis 2014 and memory problems since then who experienced the non-serious unlisted events of Asthenia, Feeling abnormal and the non-serious listed event of Pyrexia, Myalgia and Fatigue. The events began at an unreported time after the first dose of Moderna COVID-19 vaccine. Re-challenge was positive as the patient reported the same events recurred with the second dose. The history of joint pain, back and neck pain, traumatic brain injury and general pain remain confounders as all can cause similar symptoms as the events reported. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever by the next morning\ fever of 101 F; Felt fatigue; General weakness; Felt bad for 48 hours; Achiness; This spontaneous case was reported by a nurse and describes the occurrence of ASTHENIA (General weakness), FEELING ABNORMAL (Felt bad for 48 hours), MYALGIA (Achiness), PYREXIA (Fever by the next morning\ fever of 101 F) and FATIGUE (Felt fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Pain, Joint pain, Meningitis in 2014, Memory disturbance (Neurological memory issues) and Traumatic brain injury. Concurrent medical conditions included Bone spur (Bone spurs in her back, neck and joint pain at baseline.) and ADHD. Concomitant products included OMEPRAZOLE, LISDEXAMFETAMINE MESILATE (VYVANSE), BUPROPION, MULTIVITAMIN [VITAMINS NOS], VITAMIN D NOS, TRAMADOL and PARACETAMOL (TYLENOL) for an unknown indication.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2020, the patient experienced ASTHENIA (General weakness), FEELING ABNORMAL (Felt bad for 48 hours), MYALGIA (Achiness) and FATIGUE (Felt fatigue). On 27-Dec-2020, the patient experienced PYREXIA (Fever by the next morning\ fever of 101 F). At the time of the report, ASTHENIA (General weakness), MYALGIA (Achiness), PYREXIA (Fever by the next morning\ fever of 101 F) and FATIGUE (Felt fatigue) outcome was unknown and FEELING ABNORMAL (Felt bad for 48 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 (High) 101F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-326897 (Patient Link).; Sender's Comments: This case concerns a 42 year old female with a history of chronic pain, neck and joint pain, traumatic brain injury, meningitis 2014 and memory problems since then who experienced the non-serious unlisted events of Asthenia, Feeling abnormal and the non-serious listed event of Pyrexia, Myalgia and Fatigue. The events began at an unreported time after the first dose of Moderna COVID-19 vaccine. Re-challenge was positive as the patient reported the same events recurred with the second dose. The history of joint pain, back and neck pain, traumatic brain injury and general pain remain confounders as all can cause similar symptoms as the events reported. Benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Mobility decreased, Muscle spasms, Myalgia
Clinical narrative: bad reaction after both doses; Heart was raced; arm was pain; head was pain; felt like all her inside organs were painful; Could not use the arm; Pain and sore in the muscle; two legs had pain and sore; had like period cramps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain) and PAIN (felt like all her inside organs were painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOBILITY DECREASED (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps). At the time of the report, VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOBILITY DECREASED (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment medications were provided   This case was linked to MOD-2021-326867 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination complication
Clinical narrative: bad reaction after both doses; Heart was raced; arm was pain; head was pain; felt like all her inside organs were painful; Could not use the arm; Pain and sore in the muscle; two legs had pain and sore; had like period cramps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain) and PAIN (felt like all her inside organs were painful) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOBILITY DECREASED (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps). At the time of the report, VACCINATION COMPLICATION (bad reaction after both doses), HEART RATE INCREASED (Heart was raced), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOBILITY DECREASED (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment medications were provided   This case was linked to MOD-2021-326867 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Vaccination complication
Clinical narrative: It hurt too much; Couldn't sleep; It was a little bit harder/The first night was very hard; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It hurt too much), INSOMNIA (Couldn't sleep) and VACCINATION COMPLICATION (It was a little bit harder/The first night was very hard) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN (It hurt too much), INSOMNIA (Couldn't sleep) and VACCINATION COMPLICATION (It was a little bit harder/The first night was very hard). On 11-Feb-2021, INSOMNIA (Couldn't sleep) had resolved. At the time of the report, PAIN (It hurt too much) and VACCINATION COMPLICATION (It was a little bit harder/The first night was very hard) had resolved.            Patient was on "High Blood pressure medication" and "Cholesterol medication"  No treatment medications were provided.    This case was linked to MOD-2021-008217.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Movement disorder, Muscle spasms, Myalgia
Clinical narrative: bad reaction after both doses; arm was pain; head was pain; felt like all her inside organs were painful; Could not use the arm; Pain and sore in the muscle; two legs had pain and sore; had like period cramps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful) and MOVEMENT DISORDER (Could not use the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOVEMENT DISORDER (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps). At the time of the report, VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOVEMENT DISORDER (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Heart rate increased.         No concomitant medication information were provided. No treatment information were provided.   This case was linked to MOD-2021-326800 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination complication
Clinical narrative: bad reaction after both doses; arm was pain; head was pain; felt like all her inside organs were painful; Could not use the arm; Pain and sore in the muscle; two legs had pain and sore; had like period cramps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful) and MOVEMENT DISORDER (Could not use the arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 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 VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOVEMENT DISORDER (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps). At the time of the report, VACCINATION COMPLICATION (bad reaction after both doses), PAIN IN EXTREMITY (arm was pain), HEADACHE (head was pain), PAIN (felt like all her inside organs were painful), MOVEMENT DISORDER (Could not use the arm), MYALGIA (Pain and sore in the muscle), PAIN IN EXTREMITY (two legs had pain and sore) and MUSCLE SPASMS (had like period cramps) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) Heart rate increased.         No concomitant medication information were provided. No treatment information were provided.   This case was linked to MOD-2021-326800 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: COVID (19) was in the building; 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 COVID-19 ("COVID (19) was in the building") in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included Unknown for an unknown indication.    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 COVID-19 ("COVID (19) was in the building"). At the time of the report, COVID-19 ("COVID (19) was in the building") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: A patient of unknown age reported that the she leaves in government housing and the Moderna COVID-19 vaccine series was given to the residents that live at the government housing building.  The patient stated that recently "COVID (19) was in the building". No additional details provided. It is unclear if the patient had COVID 19. The case will be reassessed once additional information is provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Pain
Clinical narrative: a lot of pain; numbness on her whole left side of her body; numbness in her leg; having trouble walking; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN (a lot of pain), HYPOAESTHESIA (numbness on her whole left side of her body), HYPOAESTHESIA (numbness in her leg) and GAIT DISTURBANCE (having trouble walking) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (a lot of pain), HYPOAESTHESIA (numbness on her whole left side of her body), HYPOAESTHESIA (numbness in her leg) and GAIT DISTURBANCE (having trouble walking). At the time of the report, PAIN (a lot of pain), HYPOAESTHESIA (numbness on her whole left side of her body), HYPOAESTHESIA (numbness in her leg) and GAIT DISTURBANCE (having trouble walking) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported  No Treatment medications were reported
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 year-old was given the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old was given the Moderna vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Sep-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old was given the Moderna vaccine). On 17-Sep-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year-old was given the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose because she was sick; Patient hasn't received 2nd dose because she was sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Patient hasn't received 2nd dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because she was sick) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-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 ILLNESS (Patient hasn't received 2nd dose because she was sick) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because she was sick). At the time of the report, ILLNESS (Patient hasn't received 2nd dose because she was sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose because she was sick) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant medication was reported.  No Treatment medication was reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Neck pain, Pain, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Throbbing throughout the right arm/pain in the Right arm; Pain in the Right arm and right side of the neck; Warm to the touch injection site; pain woke her up last night; Red injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Throbbing throughout the right arm/pain in the Right arm), NECK PAIN (Pain in the Right arm and right side of the neck), VACCINATION SITE WARMTH (Warm to the touch injection site), INSOMNIA (pain woke her up last night) and VACCINATION SITE ERYTHEMA (Red injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced PAIN (Throbbing throughout the right arm/pain in the Right arm), NECK PAIN (Pain in the Right arm and right side of the neck), VACCINATION SITE WARMTH (Warm to the touch injection site), INSOMNIA (pain woke her up last night) and VACCINATION SITE ERYTHEMA (Red injection site). At the time of the report, PAIN (Throbbing throughout the right arm/pain in the Right arm), NECK PAIN (Pain in the Right arm and right side of the neck), VACCINATION SITE WARMTH (Warm to the touch injection site), INSOMNIA (pain woke her up last night) and VACCINATION SITE ERYTHEMA (Red injection site) 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 was reported No treatment medication was reported
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (left injection site arm was sore) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042120A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (left injection site arm was sore). At the time of the report, VACCINATION SITE PAIN (left injection site arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-327913, MOD-2021-327934 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Fatigue, Headache
Clinical narrative: received  6 doses of Moderna COVID-19 vaccine in one shot; Headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), FATIGUE (very tired) and ACCIDENTAL OVERDOSE (received  6 doses of Moderna COVID-19 vaccine in one shot) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A or 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Sep-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Sep-2021, the patient experienced HEADACHE (Headache), FATIGUE (very tired) and ACCIDENTAL OVERDOSE (received  6 doses of Moderna COVID-19 vaccine in one shot). On 20-Sep-2021, ACCIDENTAL OVERDOSE (received  6 doses of Moderna COVID-19 vaccine in one shot) had resolved. At the time of the report, HEADACHE (Headache) and FATIGUE (very tired) was resolving.     Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The reporter reported, on vaccination card, in the lot number, the 3 is crossed and 7 was written on it (first vaccine).  As of 22-Sep-2021, the patient felt a little better.
Sex: U
Vaccine: COVID19
Symptoms: Accidental exposure to product
Clinical narrative: had employee have splash of vaccine in eye; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL EXPOSURE TO PRODUCT (had employee have splash of vaccine in eye) 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 ACCIDENTAL EXPOSURE TO PRODUCT (had employee have splash of vaccine in eye). At the time of the report, ACCIDENTAL EXPOSURE TO PRODUCT (had employee have splash of vaccine in eye) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Diarrhoea, Fatigue, Headache, Myalgia
Clinical narrative: Diarrhea; Couldn't get out of bed; Temperature was 99.5 F and back to 96.5 F/temperature was fluctuating; Shooting headache; Muscles were achy; Extremely fatigue; She decided not to take 2nd dose because of side effects; Really bad rash all over her chest; She started throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), RASH (really bad rash all over her chest), VOMITING (she started throwing up) and PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (she started throwing up). On 08-Jan-2021, the patient experienced RASH (really bad rash all over her chest). On an unknown date, the patient experienced DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating), HEADACHE (shooting headache), MYALGIA (muscles were achy), FATIGUE (extremely fatigue) and PRODUCT DOSE OMISSION ISSUE (She decided not to take 2nd dose because of side effects). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), RASH (really bad rash all over her chest), VOMITING (she started throwing up), PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating), HEADACHE (shooting headache), MYALGIA (muscles were achy) and FATIGUE (extremely fatigue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She decided not to take 2nd dose because of side effects) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) 99.5 F and 96.5 f (normal) 96.5 F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient decided not to take 2nd dose because of side effects. The patient wanted to take half of the second dose because she thought that her system can't tolerate the full dose.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, Rash, Vomiting
Clinical narrative: Diarrhea; Couldn't get out of bed; Temperature was 99.5 F and back to 96.5 F/temperature was fluctuating; Shooting headache; Muscles were achy; Extremely fatigue; She decided not to take 2nd dose because of side effects; Really bad rash all over her chest; She started throwing up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), RASH (really bad rash all over her chest), VOMITING (she started throwing up) and PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Jan-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (she started throwing up). On 08-Jan-2021, the patient experienced RASH (really bad rash all over her chest). On an unknown date, the patient experienced DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating), HEADACHE (shooting headache), MYALGIA (muscles were achy), FATIGUE (extremely fatigue) and PRODUCT DOSE OMISSION ISSUE (She decided not to take 2nd dose because of side effects). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHOEA (diarrhea), BEDRIDDEN (couldn't get out of bed), RASH (really bad rash all over her chest), VOMITING (she started throwing up), PYREXIA (temperature was 99.5 F and back to 96.5 F/temperature was fluctuating), HEADACHE (shooting headache), MYALGIA (muscles were achy) and FATIGUE (extremely fatigue) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (She decided not to take 2nd dose because of side effects) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.5 (High) 99.5 F and 96.5 f (normal) 96.5 F.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.       Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  The patient decided not to take 2nd dose because of side effects. The patient wanted to take half of the second dose because she thought that her system can't tolerate the full dose.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypertension, Pyrexia, Tachycardia
Clinical narrative: heart rate of 105; Blood pressure of 156/70; fever; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (heart rate of 105), HYPERTENSION (Blood pressure of 156/70) and PYREXIA (fever) 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 21-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Sep-2021, the patient experienced TACHYCARDIA (heart rate of 105), HYPERTENSION (Blood pressure of 156/70) and PYREXIA (fever). At the time of the report, TACHYCARDIA (heart rate of 105), HYPERTENSION (Blood pressure of 156/70) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Sep-2021, Blood pressure measurement: 156/70 (High) 156/70. On 21-Sep-2021, Heart rate: 105 (High) 105.         Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   Reporter did not allow further contact
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Sluggishness, Somnolence
Clinical narrative: sluggish; wanted to sleep a lot; like he had something, like the flu; felt knocked down for a day or 2 meaning tired; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (sluggish), SOMNOLENCE (wanted to sleep a lot), INFLUENZA LIKE ILLNESS (like he had something, like the flu) and FATIGUE (felt knocked down for a day or 2 meaning tired) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-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 SLUGGISHNESS (sluggish), SOMNOLENCE (wanted to sleep a lot), INFLUENZA LIKE ILLNESS (like he had something, like the flu) and FATIGUE (felt knocked down for a day or 2 meaning tired). At the time of the report, SLUGGISHNESS (sluggish), SOMNOLENCE (wanted to sleep a lot), INFLUENZA LIKE ILLNESS (like he had something, like the flu) and FATIGUE (felt knocked down for a day or 2 meaning tired) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19
Clinical narrative: covid; weak; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid) and ASTHENIA (weak) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hearing disability and Heart disorder.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced COVID-19 (covid) and ASTHENIA (weak). At the time of the report, COVID-19 (covid) and ASTHENIA (weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information provided.; Sender's Comments: This case concerns a 80-year-old, male patient with relevant medical history of heart disorder, who experienced the unexpected event of COVID 19. The event occurred after the dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable since no information about the dose number was disclosed. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 3 to 5 patients received expired Moderna Covid-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3 to 5 patients received expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (3 to 5 patients received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (3 to 5 patients received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the reporter's facility also had been using a Moderna COVID-19 vaccine with a lot number of 021C21A with an expiration date of 21-Oct-2021.  Some of the vaccine administrators mixed up the expiration dates of the two vaccines and vaccines that expired on 18-Sept-2021 were administered to 3 to 5 patients on 21-Sept-2021 and 22-Sep-2021  No relevant concomitant medications were reported.  No treatment information was provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021). On 11-Jan-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (short interval between the 2 doses/ 1st dose 29Dec2020; 2nd dose 11Jan2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Significant FU: Reporter city added, Patient race added, Vaccination full details added for dose 1 and dose 2, vaccination record provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: accidently vaccinated expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidently vaccinated expired vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (accidently vaccinated expired vaccine). On 22-Sep-2021, EXPIRED PRODUCT ADMINISTERED (accidently vaccinated expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information were used. No treatment was reported.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS (He could no longer see/ He was blind) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 022M20A and 030L20A) for COVID-19 vaccination. Concomitant products included CARBIDOPA, LEVODOPA (CARBIDOPA LEVODOPA) and PROBENECID for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021 at 11:45 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Sep-2021 at 12:45 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BLINDNESS (He could no longer see/ He was blind) (seriousness criterion medically significant). At the time of the report, BLINDNESS (He could no longer see/ He was blind) outcome was unknown. The patient was blind and he could no longer see after booster dose vaccination. No treatment information was provided. Company Comment: This case concerns a 87-year-old male patient with no reported medical history, under concomitant medications carbidopa-levodopa and probenecid, who experienced the serious unexpected event Blindness. The event occurred more than 6 months after the second dose and 1 hour after the third and most recent dose of mRNA-1273 Moderna vaccine. No information is available regarding medical history that could be confounders for the events.  Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. This case was linked to MOD-2021-327765 (Patient Link).; Sender's Comments: This case concerns a 87-year-old male patient with no reported medical history, under concomitant medications carbidopa-levodopa and probenecid, who experienced the serious  unexpected event Blindness. The event occurred more than 6 months after the second dose and 1 hour  after the third and most recent dose of mRNA-1273 Moderna vaccine. No information is available regarding medical history that could be confounders for the events. Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Feeling abnormal, Paraesthesia
Clinical narrative: face started feeling tingling; left ear burning; She feels it all in her face; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (face started feeling tingling), EAR DISCOMFORT (left ear burning) and FEELING ABNORMAL (She feels it all in her face) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced PARAESTHESIA (face started feeling tingling), EAR DISCOMFORT (left ear burning) and FEELING ABNORMAL (She feels it all in her face). At the time of the report, PARAESTHESIA (face started feeling tingling) and FEELING ABNORMAL (She feels it all in her face) outcome was unknown and EAR DISCOMFORT (left ear burning) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling, Vaccination site coldness, Vaccination site pain, Vaccination site rash
Clinical narrative: There was swelling at the top of the shoulder/it was a different kind of swelling; Ended up getting COVID arm about 8 days later/there was a red bulls eye rash; Had a stinging sensation at the skin level, when the vaccine was being administered; The liquid that was going in felt very cold; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE COLDNESS, SWELLING, VACCINATION SITE RASH and VACCINATION SITE PAIN in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE COLDNESS and VACCINATION SITE PAIN. On 16-Mar-2021, the patient experienced SWELLING and VACCINATION SITE RASH. On 20-Mar-2021, SWELLING and VACCINATION SITE RASH had resolved. At the time of the report, VACCINATION SITE COLDNESS and VACCINATION SITE PAIN outcome was unknown.            No Concomitant medications were reported. No Treatment medications were reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site pain
Clinical narrative: fever of 101.9 °F; chills; arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 101.9 °F), CHILLS (chills) and VACCINATION SITE PAIN (arm was sore at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in October 2020.    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced PYREXIA (fever of 101.9 °F), CHILLS (chills) and VACCINATION SITE PAIN (arm was sore at the injection site). At the time of the report, PYREXIA (fever of 101.9 °F), CHILLS (chills) and VACCINATION SITE PAIN (arm was sore at the injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: high (High) 101.9 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported by the reporter. No treatment was reported by the reporter
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired after the third Moderna COVID-19 dose; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (very tired after the third Moderna COVID-19 dose) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A, 007M20A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Sep-2021, the patient experienced FATIGUE (very tired after the third Moderna COVID-19 dose). At the time of the report, FATIGUE (very tired after the third Moderna COVID-19 dose) outcome was unknown.        Concomitant medication was not reported. Treatment information was not reported.