chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Felt sore in the arm and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Felt sore in the arm and pain) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0z7Cz1A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included SALBUTAMOL SULFATE (VENEX [SALBUTAMOL SULFATE]) for Blood pressure abnormal.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PAIN IN EXTREMITY (Felt sore in the arm and pain). At the time of the report, PAIN IN EXTREMITY (Felt sore in the arm and pain) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details was not reported by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ageusia, Rhinorrhoea
Clinical narrative: Runny nose; Have no taste; 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 RHINORRHOEA (Runny nose) and AGEUSIA (Have no taste) 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 RHINORRHOEA (Runny nose) and AGEUSIA (Have no taste). At the time of the report, RHINORRHOEA (Runny nose) and AGEUSIA (Have no taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Weight decreased
Clinical narrative: Weight loss; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Weight loss) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) 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 WEIGHT DECREASED (Weight loss). At the time of the report, WEIGHT DECREASED (Weight loss) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: negative (Negative) No antibodies from vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Insomnia, Pain in extremity
Clinical narrative: their hart beating really fast; not being available to sleep; soar arm; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (their hart beating really fast), INSOMNIA (not being available to sleep) and PAIN IN EXTREMITY (soar arm) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037c21a and 037c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (soar arm). On 28-Aug-2021, the patient experienced HEART RATE INCREASED (their hart beating really fast) and INSOMNIA (not being available to sleep). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. At the time of the report, HEART RATE INCREASED (their hart beating really fast), INSOMNIA (not being available to sleep) and PAIN IN EXTREMITY (soar arm) outcome was unknown.            Concomitant drugs were not provided.   This case was linked to MOD-2021-300344 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Pain severe enough to affect my movements such as from chairs and bed; had a significant increase in muscular and joint related pain in the time since my second vaccination; had a significant increase in muscular and joint related pain in the time since my second vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain severe enough to affect my movements such as from chairs and bed), MYALGIA (had a significant increase in muscular and joint related pain in the time since my second vaccination) and ARTHRALGIA (had a significant increase in muscular and joint related pain in the time since my second vaccination) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain severe enough to affect my movements such as from chairs and bed), MYALGIA (had a significant increase in muscular and joint related pain in the time since my second vaccination) and ARTHRALGIA (had a significant increase in muscular and joint related pain in the time since my second vaccination). At the time of the report, PAIN (Pain severe enough to affect my movements such as from chairs and bed), MYALGIA (had a significant increase in muscular and joint related pain in the time since my second vaccination) and ARTHRALGIA (had a significant increase in muscular and joint related pain in the time since my second vaccination) outcome was unknown.            No concomitant product use was provided by the reporter.   No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: stroke; 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 CEREBROVASCULAR ACCIDENT (stroke) 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 CEREBROVASCULAR ACCIDENT (stroke) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (stroke) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   Very limited information regarding this event has been provided at this time. No further information is expected at this time; Sender's Comments: Very limited information regarding this event has been provided at this time. No further information is expected at this time
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: I received my first dose of moderna and was diagnosed with Covid the following week.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I received my first dose of moderna and was diagnosed with Covid the following week.) 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, the patient experienced COVID-19 (I received my first dose of moderna and was diagnosed with Covid the following week.). At the time of the report, COVID-19 (I received my first dose of moderna and was diagnosed with Covid the following week.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Diagnosed with Covid..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  No treatment information was provided.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: she doesn't feel good at all; terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (she doesn't feel good at all) and HEADACHE (terrible headache) in a 90-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced MALAISE (she doesn't feel good at all) and HEADACHE (terrible headache). At the time of the report, MALAISE (she doesn't feel good at all) and HEADACHE (terrible headache) outcome was unknown.            Concomitant product was not provided  Treatment information was not provided
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Rash, Rash macular
Clinical narrative: black spots on his skin; His anxiety is so severe; rash all over his arms; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (black spots on his skin), ANXIETY (His anxiety is so severe) and RASH (rash all over his arms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (black spots on his skin), ANXIETY (His anxiety is so severe) and RASH (rash all over his arms). At the time of the report, RASH MACULAR (black spots on his skin), ANXIETY (His anxiety is so severe) and RASH (rash all over his arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   This case was linked to MOD-2021-073191, MOD-2021-074893, MOD-2021-223506 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow up 01-SEP-2021,  contain no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Massive headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Aug-2021 and was forwarded to Moderna on 28-Aug-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of HEADACHE (Massive headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced HEADACHE (Massive headache). At the time of the report, HEADACHE (Massive headache) 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 medication details were provided.  No treatment information was mentioned.   This case was linked to MOD-2021-300853 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chest X-ray, Chest pain, Electrocardiogram, Fatigue
Clinical narrative: Woke up in the middle of the night like I've been hit by a hammer; Like a lightbulb went off, odd sensation; Chest pain; Not up for doing my more normal active self; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Woke up in the middle of the night like I've been hit by a hammer), FEELING ABNORMAL (Like a lightbulb went off, odd sensation), CHEST PAIN (Chest pain) and FATIGUE (Not up for doing my more normal active self) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Woke up in the middle of the night like I've been hit by a hammer), FEELING ABNORMAL (Like a lightbulb went off, odd sensation), CHEST PAIN (Chest pain) and FATIGUE (Not up for doing my more normal active self). At the time of the report, PAIN (Woke up in the middle of the night like I've been hit by a hammer) and FEELING ABNORMAL (Like a lightbulb went off, odd sensation) had resolved, CHEST PAIN (Chest pain) was resolving and FATIGUE (Not up for doing my more normal active self) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Electrocardiogram: normal (normal) normal. On an unknown date, Blood pressure measurement: increased (High) Increased. On an unknown date, Chest X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided. Saw acupuncturist on 23-MAR-2021 and had several sessions and acupuncture was continued.   This case was linked to MOD-2021-300844 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain
Clinical narrative: Woke up in the middle of the night like I've been hit by a hammer; Like a lightbulb went off, odd sensation; Chest pain; Not up for doing my more normal active self; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN (Woke up in the middle of the night like I've been hit by a hammer), FEELING ABNORMAL (Like a lightbulb went off, odd sensation), CHEST PAIN (Chest pain) and FATIGUE (Not up for doing my more normal active self) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Woke up in the middle of the night like I've been hit by a hammer), FEELING ABNORMAL (Like a lightbulb went off, odd sensation), CHEST PAIN (Chest pain) and FATIGUE (Not up for doing my more normal active self). At the time of the report, PAIN (Woke up in the middle of the night like I've been hit by a hammer) and FEELING ABNORMAL (Like a lightbulb went off, odd sensation) had resolved, CHEST PAIN (Chest pain) was resolving and FATIGUE (Not up for doing my more normal active self) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Apr-2021, Electrocardiogram: normal (normal) normal. On an unknown date, Blood pressure measurement: increased (High) Increased. On an unknown date, Chest X-ray: normal (normal) normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications were not provided. Treatment information was not provided. Saw acupuncturist on 23-MAR-2021 and had several sessions and acupuncture was continued.   This case was linked to MOD-2021-300844 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Wanted to report additional side effect; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Wanted to report additional side effect) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Wanted to report additional side effect). At the time of the report, VACCINATION COMPLICATION (Wanted to report additional side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Off label use
Clinical narrative: Received a 3rd dose while not being immunocompromised; The 3rd dose was from another company; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Received a 3rd dose while not being immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (The 3rd dose was from another company) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Received a 3rd dose while not being immunocompromised) and INTERCHANGE OF VACCINE PRODUCTS (The 3rd dose was from another company). At the time of the report, OFF LABEL USE (Received a 3rd dose while not being immunocompromised) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (The 3rd dose was from another company) had resolved.            No relevant concomitant medications were reported.  No treatment information was provided.  The patient was fully vaccinated and she went to get a 3rd dose. She went to the pharmacy to get a 3rd dose and they did gave her Pfizer. She says that she is not immunocompromised (no cancer treatment, no organ transplant, etc.)
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus after getting the Moderna COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (tinnitus after getting the Moderna COVID-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced TINNITUS (tinnitus after getting the Moderna COVID-19 vaccine). At the time of the report, TINNITUS (tinnitus after getting the Moderna COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: after receiving their second dose, they felt itchy all over; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (after receiving their second dose, they felt itchy all over) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043l20a and 025l20) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.   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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRURITUS (after receiving their second dose, they felt itchy all over). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (after receiving their second dose, they felt itchy all over) outcome was unknown.            This case was linked to MOD-2021-300374 (Patient Link).
Age: 15.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine applied to a 15 years old person; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine applied to a 15 years old person) in a 15-year-old patient of an unknown 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine applied to a 15 years old person). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine applied to a 15 years old person) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by reporter. No Treatment information was reported by reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose 47 days past first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose 47 days past first dose) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose 47 days past first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose 47 days past first dose) had resolved.        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.   Relevant concomitant medications were not provided. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccination after temperature excursion of more than 12hs at room temperature) and EXPIRED PRODUCT ADMINISTERED (voluntarily took these expired doses as their 3rd dose booster after the recommended 12-hour refrigerated storage period) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccination after temperature excursion of more than 12hs at room temperature) and EXPIRED PRODUCT ADMINISTERED (voluntarily took these expired doses as their 3rd dose booster after the recommended 12-hour refrigerated storage period). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccination after temperature excursion of more than 12hs at room temperature) and EXPIRED PRODUCT ADMINISTERED (voluntarily took these expired doses as their 3rd dose booster after the recommended 12-hour refrigerated storage period) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment history was reported. Reporter did not allow further contact; Most recent FOLLOW-UP information incorporated above includes: On 03-Sep-2021: Follow up received: Updated reporter name and email address. Added dose number and new event.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: shoulder pain; Inappropriate route of vaccination; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (shoulder pain) and INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery, Aortic valve replacement (Replacement of Aortic & mitral Valve) on 23-Sep-2019 and Mitral valve replacement (Replacement of Aortic & mitral Valve) on 23-Sep-2019. Concurrent medical conditions included Dermal psoriasis since 2009, Penicillin allergy (PCN), Drug allergy (Fentanyl) and Diabetes mellitus (Diet Controlled DM) since 1990. Concomitant products included TORSEMIDE from 2010 to an unknown date for Edema, APIXABAN (ELIQUIS) from 01-Feb-2021 to an unknown date for Heart valve replacement, SECUKINUMAB (COSENTYX) from 2017 to an unknown date for Psoriasis, METOPROLOL SUCCINATE from 23-Sep-2019 to an unknown date for an unknown indication.    On 22-Jan-2021 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) 1 dosage form. On 22-Jan-2021, the patient experienced ARTHRALGIA (shoulder pain). 22-Jan-2021, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination). On 22-Jan-2021, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (Inappropriate route of vaccination) had resolved. At the time of the report, ARTHRALGIA (shoulder pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Subcutaneous), the reporter did not provide any causality assessments.   The treatment information were unknown. Concomitant medication Potassium cler with frequency 10meq by oral route of admiration with a start date of 23-OCT-2019 was reported.   This case was linked to MOD-2021-301025 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received and contains : Updated Reporter information, Patient demographics, Dose information, medical history, Concomitant medications and new event "Inappropriate route of vaccination"
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Feeling abnormal, Headache, Inappropriate schedule of product administration
Clinical narrative: Stayed in bed all day; Fever; Felt terrible; Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021; Feel Achy/Muscle Aches; Slight Headache; Feeling "run down"; Red, round circle at injection site; Stomach problems/stomach was upset; Feels like she has the flu; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), VACCINATION COMPLICATION (Stayed in bed all day), FEELING ABNORMAL (Felt terrible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Liver cirrhosis (non-alcoholic liver cirrhosis) and Diabetes.    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021), MYALGIA (Feel Achy/Muscle Aches), HEADACHE (Slight Headache), FATIGUE (Feeling "run down") and VACCINATION SITE ERYTHEMA (Red, round circle at injection site). On 29-Aug-2021, the patient experienced FEELING ABNORMAL (Felt terrible). On an unknown date, the patient experienced VACCINATION COMPLICATION (Stayed in bed all day) and PYREXIA (Fever). The patient was treated with PROMETHAZINE for Stomach upset, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), VACCINATION COMPLICATION (Stayed in bed all day), FEELING ABNORMAL (Felt terrible), MYALGIA (Feel Achy/Muscle Aches), HEADACHE (Slight Headache), FATIGUE (Feeling "run down") and VACCINATION SITE ERYTHEMA (Red, round circle at injection site) outcome was unknown and PYREXIA (Fever) had resolved.            No concomitant medications were reported. The patient feels slightly better.   This case was linked to MOD-2021-301037 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Myalgia, Pyrexia, Vaccination complication, Vaccination site erythema
Clinical narrative: Stayed in bed all day; Fever; Felt terrible; Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021; Feel Achy/Muscle Aches; Slight Headache; Feeling "run down"; Red, round circle at injection site; Stomach problems/stomach was upset; Feels like she has the flu; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), VACCINATION COMPLICATION (Stayed in bed all day), FEELING ABNORMAL (Felt terrible) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Liver cirrhosis (non-alcoholic liver cirrhosis) and Diabetes.    On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Aug-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021), MYALGIA (Feel Achy/Muscle Aches), HEADACHE (Slight Headache), FATIGUE (Feeling "run down") and VACCINATION SITE ERYTHEMA (Red, round circle at injection site). On 29-Aug-2021, the patient experienced FEELING ABNORMAL (Felt terrible). On an unknown date, the patient experienced VACCINATION COMPLICATION (Stayed in bed all day) and PYREXIA (Fever). The patient was treated with PROMETHAZINE for Stomach upset, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. On 28-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Third dose into the muscle of her left, upper arm on 28AUG2021, second dose on 10FEB2021) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (Stomach problems/stomach was upset), INFLUENZA LIKE ILLNESS (Feels like she has the flu), VACCINATION COMPLICATION (Stayed in bed all day), FEELING ABNORMAL (Felt terrible), MYALGIA (Feel Achy/Muscle Aches), HEADACHE (Slight Headache), FATIGUE (Feeling "run down") and VACCINATION SITE ERYTHEMA (Red, round circle at injection site) outcome was unknown and PYREXIA (Fever) had resolved.            No concomitant medications were reported. The patient feels slightly better.   This case was linked to MOD-2021-301037 (Patient Link).
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Anxiety, Chest pain, Confusional state, Dyspnoea
Clinical narrative: Chest pain immediately after vaccination; Confused immediately after vaccination; Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination; Very Emotional after vaccination; Anxiety after vaccination; Can not sleep after vaccination; Agitated all the time after vaccination; Body Pain after vaccination; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination) and ANXIETY (Anxiety after vaccination) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination) 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 medications were provided Patients cardio echo and enzymes were normal.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Emotional disorder, Myalgia, Sleep disorder
Clinical narrative: Chest pain immediately after vaccination; Confused immediately after vaccination; Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination; Very Emotional after vaccination; Anxiety after vaccination; Can not sleep after vaccination; Agitated all the time after vaccination; Body Pain after vaccination; This spontaneous case was reported by a physician and describes the occurrence of CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination) and ANXIETY (Anxiety after vaccination) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; IBUPROFEN at an unspecified dose and frequency and METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) at an unspecified dose and frequency. At the time of the report, CHEST PAIN (Chest pain immediately after vaccination), CONFUSIONAL STATE (Confused immediately after vaccination), DYSPNOEA (Shortness Of Breath immediately after vaccination/One time Short Breath at home after vaccination), EMOTIONAL DISORDER (Very Emotional after vaccination), ANXIETY (Anxiety after vaccination), SLEEP DISORDER (Can not sleep after vaccination), AGITATION (Agitated all the time after vaccination) and MYALGIA (Body Pain after vaccination) 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 medications were provided Patients cardio echo and enzymes were normal.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: back of my ears, Both Knee caps are red and itching.; back of my ears, Both Knee caps are red and itching.; Itchy injection site; Swollen injection site the size of palm of hand; Red injection site, back of ears, and both Knee caps; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (back of my ears, Both Knee caps are red and itching.), PRURITUS (back of my ears, Both Knee caps are red and itching.), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site the size of palm of hand) and VACCINATION SITE ERYTHEMA (Red injection site, back of ears, and both Knee caps) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Anaphylactic shock. Concurrent medical conditions included Food allergy (she had anaphylactic shock following a food allergy).    On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced ERYTHEMA (back of my ears, Both Knee caps are red and itching.), PRURITUS (back of my ears, Both Knee caps are red and itching.), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site the size of palm of hand) and VACCINATION SITE ERYTHEMA (Red injection site, back of ears, and both Knee caps). At the time of the report, ERYTHEMA (back of my ears, Both Knee caps are red and itching.), PRURITUS (back of my ears, Both Knee caps are red and itching.), VACCINATION SITE PRURITUS (Itchy injection site), VACCINATION SITE SWELLING (Swollen injection site the size of palm of hand) and VACCINATION SITE ERYTHEMA (Red injection site, back of ears, and both Knee caps) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment medications were not reported.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Product dose omission issue, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: skipped second dose; skin felt sensitive; allergic reaction; rash all over her abdomen and  back; kind of like a low grade fever sensitivity feeling; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and  back), PYREXIA (kind of like a low grade fever sensitivity feeling) and PRODUCT DOSE OMISSION ISSUE (skipped second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Asthma and Drug allergy (aspirin allergy). Concomitant products included MONTELUKAST, BUDESONIDE (PULMICORT FLEXHALER) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and  back) and PYREXIA (kind of like a low grade fever sensitivity feeling). On 28-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (skipped second dose). On 04-Aug-2021, RASH (rash all over her abdomen and  back) had resolved. At the time of the report, SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction) and PYREXIA (kind of like a low grade fever sensitivity feeling) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (skipped second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was diagnosed with COVID-19 infection January 2021 that caused breathing difficulties. Patient is taking Rescue Inhaler No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up information includes no new information.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Sensitive skin
Clinical narrative: skipped second dose; skin felt sensitive; allergic reaction; rash all over her abdomen and  back; kind of like a low grade fever sensitivity feeling; This spontaneous case was reported by a consumer and describes the occurrence of SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and  back), PYREXIA (kind of like a low grade fever sensitivity feeling) and PRODUCT DOSE OMISSION ISSUE (skipped second dose) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: SHINGRIX. Concurrent medical conditions included Asthma and Drug allergy (aspirin allergy). Concomitant products included MONTELUKAST, BUDESONIDE (PULMICORT FLEXHALER) and FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for an unknown indication.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction), RASH (rash all over her abdomen and  back) and PYREXIA (kind of like a low grade fever sensitivity feeling). On 28-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (skipped second dose). On 04-Aug-2021, RASH (rash all over her abdomen and  back) had resolved. At the time of the report, SENSITIVE SKIN (skin felt sensitive), HYPERSENSITIVITY (allergic reaction) and PYREXIA (kind of like a low grade fever sensitivity feeling) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (skipped second dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was diagnosed with COVID-19 infection January 2021 that caused breathing difficulties. Patient is taking Rescue Inhaler No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Follow-up information includes no new information.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received a dose from a vial with more than 12 hours of punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) 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 EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial with more than 12 hours of punctured) had resolved.        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 medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Sep-2021: Email address added, Fax number added
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Pain; Muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain) and MYALGIA (Muscle aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Liver cirrhosis.   On 10-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 (Pain) and MYALGIA (Muscle aches). At the time of the report, PAIN (Pain) and MYALGIA (Muscle aches) outcome was unknown.            No concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-301000 (Patient Link).