chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: 10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature) 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 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature). At the time of the report, PRODUCT STORAGE ERROR (10 doses administered after 15 minutes of vial going from frozen to thawed state thawed for only 15 minutes at room temperature) had resolved. Not Provided      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 provided by the reporter.  No treatment was provided by the reporter.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Heart disorder.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PRURITUS (itchy). At the time of the report, PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications included diabetes, cholesterol and heart medicines.  No treatment information was provided.   This case was linked to MOD-2021-218372 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cholesterol and Diabetes.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced PRURITUS (itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest). At the time of the report, PRURITUS (itchy skin on her neck, both arms and chest / itchy skin on her neck, both arms and chest) had not resolved.            Other concomitant medications included diabetes, cholesterol and heart medicines. No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-218368 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, SARS-CoV-2 test, Throat irritation
Clinical narrative: throat irritation; runny nose; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (throat irritation) and RHINORRHOEA (runny nose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 14-Apr-2021, the patient experienced THROAT IRRITATION (throat irritation) and RHINORRHOEA (runny nose). At the time of the report, THROAT IRRITATION (throat irritation) and RHINORRHOEA (runny nose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: unknown (Negative) Negative and unknown (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment information not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Vaccination site inflammation
Clinical narrative: Inflammation at the injection site in the right arm; difficulty to move the right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflammation at the injection site in the right arm) and HYPOKINESIA (difficulty to move the right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Apr-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflammation at the injection site in the right arm) and HYPOKINESIA (difficulty to move the right arm). At the time of the report, VACCINATION SITE INFLAMMATION (Inflammation at the injection site in the right arm) and HYPOKINESIA (difficulty to move the right arm) outcome was unknown.            No concomitant medication was reported.  Treatment information not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   Reporter did not allow further contact
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Myalgia, Osteoarthritis
Clinical narrative: osteoarthritis; muscle pains in his shoulders; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (osteoarthritis) and MYALGIA (muscle pains in his shoulders) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced MYALGIA (muscle pains in his shoulders). On an unknown date, the patient experienced OSTEOARTHRITIS (osteoarthritis). At the time of the report, OSTEOARTHRITIS (osteoarthritis) and MYALGIA (muscle pains in his shoulders) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Heart rate: increased (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant information was reported.  Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2021: Event outcome information updated.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.; 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 INCORRECT DOSE ADMINISTERED (Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.) 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 17-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 milliliter. On 17-Apr-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.). At the time of the report, INCORRECT DOSE ADMINISTERED (Pharmacist administered a 1ml dose of the Moderna Covid 19 Vaccine to a patient.) 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.   Patient's Demographics were lost due to a glitch   No concomitant medications were given.  No treatment information was provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Hiccups
Clinical narrative: Exhausting hiccups that last for up to an hour or more at a time, these symptoms are still ongoing; This spontaneous case was reported by a consumer and describes the occurrence of HICCUPS (Exhausting hiccups that last for up to an hour or more at a time, these symptoms are still ongoing) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HICCUPS (Exhausting hiccups that last for up to an hour or more at a time, these symptoms are still ongoing). The patient was treated with IBUPROFEN for Adverse event, at a dose of UNK dosage form; HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN) for Adverse event, at a dose of 1 dosage form; FAMOTIDINE (PEPCID [FAMOTIDINE]) for Muscle relaxant, at a dose of 1 dosage form and FENTANYL CITRATE (NARCO) for Adverse event, at an unspecified dose and frequency. At the time of the report, HICCUPS (Exhausting hiccups that last for up to an hour or more at a time, these symptoms are still ongoing) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Treatment medication updated.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Hypersomnia, Illness, Influenza like illness, Muscular weakness
Clinical narrative: Flu like symptoms; Fever; Started feeling sick from the next day; no appetite; hypersomnia sleepy at work; blurred vision; inability to go exercise therapy because his muscles are too weak; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started feeling sick from the next day), INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work) and VISION BLURRED (blurred vision) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included TEMAZEPAM (RESTORIL [TEMAZEPAM]) and CLONAZEPAM for Sleep disorder, OMEPRAZOLE for Stomach discomfort, DEXTROAMPHETAMINE [DEXAMFETAMINE] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (Started feeling sick from the next day), DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work), VISION BLURRED (blurred vision) and MUSCULAR WEAKNESS (inability to go exercise therapy because his muscles are too weak). On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 01-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, ILLNESS (Started feeling sick from the next day) had not resolved and DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work), VISION BLURRED (blurred vision) and MUSCULAR WEAKNESS (inability to go exercise therapy because his muscles are too weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   The patient had been sick, no appetite, hypersomnia sleepy at work, blurred vision, inability to go exercise therapy because his muscles was too weak.   This case was linked to MOD-2021-218567 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received: New events (blurred vision and muscular weakness) were added.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Vision blurred
Clinical narrative: Flu like symptoms; Fever; Started feeling sick from the next day; no appetite; hypersomnia sleepy at work; blurred vision; inability to go exercise therapy because his muscles are too weak; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Started feeling sick from the next day), INFLUENZA LIKE ILLNESS (Flu like symptoms), DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work) and VISION BLURRED (blurred vision) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included TEMAZEPAM (RESTORIL [TEMAZEPAM]) and CLONAZEPAM for Sleep disorder, OMEPRAZOLE for Stomach discomfort, DEXTROAMPHETAMINE [DEXAMFETAMINE] for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021 at 4:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced ILLNESS (Started feeling sick from the next day), DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work), VISION BLURRED (blurred vision) and MUSCULAR WEAKNESS (inability to go exercise therapy because his muscles are too weak). On 06-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever). The patient was treated with ELECTROLYTES NOS, GLUCOSE (PEDIALYTE [ELECTROLYTES NOS;GLUCOSE]) at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 01-Apr-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) and PYREXIA (Fever) had resolved. At the time of the report, ILLNESS (Started feeling sick from the next day) had not resolved and DECREASED APPETITE (no appetite), HYPERSOMNIA (hypersomnia sleepy at work), VISION BLURRED (blurred vision) and MUSCULAR WEAKNESS (inability to go exercise therapy because his muscles are too weak) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and 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.   The patient had been sick, no appetite, hypersomnia sleepy at work, blurred vision, inability to go exercise therapy because his muscles was too weak.   This case was linked to MOD-2021-218567 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up received: New events (blurred vision and muscular weakness) were added.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to the patient after beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after beyond use date) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after beyond use date). On 02-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient after beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Vaccine was administered to the patient after the beyond use date of the vial. The vial was received on 23-APR-2021 and stored in the fridge and the vaccine was administered after 30 days. No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine was administered to patient after the beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after the beyond use date) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after the beyond use date). On 02-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient after the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. Concomitant and treatment information not provided Moderna COVID-19 Vaccine was administered to THREE Patients on 2Jun2021 after the beyond use date of the vial. the vial was received on 23Apr2021 and stored in the fridge and the vaccine was administered after 30 days.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Illness
Clinical narrative: Sickness; Cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and COUGH (Cough) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (Sickness) and COUGH (Cough). The patient was treated with AMOXICILLIN for Cough, at an unspecified dose and frequency. At the time of the report, ILLNESS (Sickness) outcome was unknown and COUGH (Cough) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment also includes the cough syrup. Patient is due for second shot. concomitant medications were not provided.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Muscle spasms, Nausea
Clinical narrative: Nauseous; Felt dizzy; Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), DIZZINESS (Felt dizzy), MUSCLE SPASMS (Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination.     No Medical History.     On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced NAUSEA (Nauseous), DIZZINESS (Felt dizzy), MUSCLE SPASMS (Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm) and HEADACHE (Headache). At the time of the report, NAUSEA (Nauseous), DIZZINESS (Felt dizzy), MUSCLE SPASMS (Left arm was catching a cramp/Fingers are also catching cramps/could not hold anything up with left arm) and HEADACHE (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 medications were taken by the patient. Treatment Medication was not provided. Action taken with mRNA-1273 in response to the events was not applicable.  The patient provided consent to safety for follow up with himself via phone and his doctor but was unable to provide contact phone number for his doctor.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) 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 MYALGIA (sore arm). At the time of the report, MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: magnets sticking to me; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (magnets sticking to me) and MYALGIA (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (magnets sticking to me) and MYALGIA (sore arm). At the time of the report, FEELING ABNORMAL (magnets sticking to me) and MYALGIA (sore arm) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: More than 36 days have passed since first dose, still did not receive second shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still did not receive second shot) in a female 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 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still did not receive second shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 36 days have passed since first dose, still did not receive second shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient still has not received her second shot and her first shot was on 1-May-2021.  No concomitant medications were reported.  No treatment information was reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Area was hot; Area was red; Area was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Area was hot), VACCINATION SITE ERYTHEMA (Area was red) and VACCINATION SITE PAIN (Area was sore) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 020B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Area was hot), VACCINATION SITE ERYTHEMA (Area was red) and VACCINATION SITE PAIN (Area was sore). On 11-Jun-2021, VACCINATION SITE WARMTH (Area was hot), VACCINATION SITE ERYTHEMA (Area was red) and VACCINATION SITE PAIN (Area was sore) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received included no new significant information.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to two patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The reporter stated that the vaccine vial was left out for 12 hours and then the prefilled syringes expired by 8-10 hours after. She does not know whether the patients are experienced  any symptoms No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered to two patients.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered to two patients.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) 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 reported. No treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: I will receive my 2nd dose tomorrow after 8 weeks apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I will receive my 2nd dose tomorrow after 8 weeks apart) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I will receive my 2nd dose tomorrow after 8 weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (I will receive my 2nd dose tomorrow after 8 weeks apart) had resolved.        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 by the reporter.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Musculoskeletal discomfort, Pain in extremity, Pyrexia
Clinical narrative: Hurt arm/little sore legs; Knees getting up and down; Hardy wake from the bad; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hurt arm/little sore legs), MUSCULOSKELETAL DISCOMFORT (Knees getting up and down), FATIGUE (Hardy wake from the bad) and PYREXIA (Fever) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included FLUOXETINE and DULOXETINE for an unknown indication.    On 13-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, the patient experienced PYREXIA (Fever). On 14-Mar-2021, the patient experienced PAIN IN EXTREMITY (Hurt arm/little sore legs), MUSCULOSKELETAL DISCOMFORT (Knees getting up and down) and FATIGUE (Hardy wake from the bad). The patient was treated with PARACETAMOL (TYLENOL) for Pain in extremity, Discomfort in joints, Fatigue and Fever, at a dose of 1 dosage form. On 14-Mar-2021, PYREXIA (Fever) had resolved. On 15-Mar-2021, PAIN IN EXTREMITY (Hurt arm/little sore legs), MUSCULOSKELETAL DISCOMFORT (Knees getting up and down) and FATIGUE (Hardy wake from the bad) had resolved.            Concomitant medications also included CHOLESTEROL MEDICATION and HIGH BLOOD PRESSURE MEDICATION.   This case was linked to MOD-2021-046214 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy) in a  patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dizziness (dizzy). At the time of the report, dizziness (dizzy) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Patient experienced adverse event from the first dose of 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 VACCINATION COMPLICATION (Patient experienced adverse event from the first dose of the Moderna COVID-19 vaccine.) in a female 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 (Patient experienced adverse event from the first dose of the Moderna COVID-19 vaccine.). At the time of the report, VACCINATION COMPLICATION (Patient experienced adverse event from the first dose of the Moderna COVID-19 vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen gland behind ear, right side; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen gland behind ear, right side) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016A21A) for COVID-19 vaccination.     Concurrent medical conditions included Myasthenia gravis in 2010, Allergy to antibiotic (Allergy to Avelox), Drug allergy (Allergy to Demerol), Drug allergy (Allergy to Lipitor), Drug allergy (Allergy to Nitrofurantoin) and Drug allergy (Allergy to Meperidine). Concomitant products included TELMISARTAN and HYDROCHLOROTHIAZIDE for Blood pressure management, PYRIDOSTIGMINE BROMIDE (PYRIDOSTIGMINE BROMIDE EXTENDED RELEASE) and PYRIDOSTIGMINE BROMIDE (MESTINON TS) for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen gland behind ear, right side). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (Swollen gland behind ear, right side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient has a medical history of Myasthenia gravis from  08-??-2021  Patient has taken Telmisartan (40mg/ tab)as concomitant medication for high blood pressure from  01-??-2007. Ongoing: yes Patient has taken Hydrocholrthiazide (25mg/ tab)as concomitant medication for Water pill for HBP from 01-??-2007. Ongoing: yes Patient has taken Pyridostigmine bromide (60mg/ tab)as concomitant medication for 240mg 3 times a day indication unknown from 08-??-2010 Ongoing: yes Patient has taken Mestinone ER (180mg/ tab)as concomitant medication 1 tab at bedtime indication unknown from 08-??-2010 Ongoing: yes Patient has taken Advair diskus (100/50, cap)as concomitant medication inhale 1 puff indication unknown from 01-??-2010 Ongoing: yes   This case was linked to MOD-2021-218665 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up document contains Reporter details, Patient demographics, medical history,concomitant medication details and event start date were updated.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Lymphadenopathy
Clinical narrative: SSwollen painful glands on the back of neck and on Scalp; headache; Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (SSwollen painful glands on the back of neck and on Scalp), EAR PAIN (Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away) and HEADACHE (headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 016A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced EAR PAIN (Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away). On 11-Apr-2021, the patient experienced LYMPHADENOPATHY (SSwollen painful glands on the back of neck and on Scalp). 11-Apr-2021, the patient experienced HEADACHE (headache). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 23-Apr-2021, LYMPHADENOPATHY (SSwollen painful glands on the back of neck and on Scalp) and HEADACHE (headache) had not resolved. At the time of the report, EAR PAIN (Swollen painful glands on the right side behind the ear/right ear flares up and is sore for 1 to 2 days and goes away) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Patient reported that her head and neck hurt for 2 weeks, and it hurt to wash and brush her hair after second dose of vaccine.  It was reported event resolved in 2 weeks.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up was received. Event was added and outcome was updated.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Cough, Malaise, Pyrexia, Rhinorrhoea
Clinical narrative: Cough; Runny nose; Malaise; Chest pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough), RHINORRHOEA (Runny nose), MALAISE (Malaise), CHEST PAIN (Chest pain) and PYREXIA (Fever) 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 COUGH (Cough), RHINORRHOEA (Runny nose), MALAISE (Malaise), CHEST PAIN (Chest pain) and PYREXIA (Fever). At the time of the report, COUGH (Cough), RHINORRHOEA (Runny nose), MALAISE (Malaise), CHEST PAIN (Chest pain) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Ear discomfort, Erythema, Myalgia, Product dose omission issue
Clinical narrative: Scratching all over; Redness all over; Hotness in the ears; Scratching all over the body with bumps; her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine; A patient developed Sore arm on the day of first dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and MYALGIA (A patient developed Sore arm on the day of first dose of vaccination) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history is provided and concomitant drug are mentioned.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MYALGIA (A patient developed Sore arm on the day of first dose of vaccination). On 07-Apr-2021, the patient experienced SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and PRODUCT DOSE OMISSION ISSUE (her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. On 06-Apr-2021, MYALGIA (A patient developed Sore arm on the day of first dose of vaccination) had resolved. On 08-Apr-2021, SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and PRODUCT DOSE OMISSION ISSUE (her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient took Benadryl(dexamethasone) first dose and her bumps got better and took 2nd dose her redness got better. She consulted her pharmacist with the rash images and her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine. Patient provided consent for safety team to follow up.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch
Clinical narrative: Scratching all over; Redness all over; Hotness in the ears; Scratching all over the body with bumps; her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine; A patient developed Sore arm on the day of first dose of vaccination; This spontaneous case was reported by a consumer and describes the occurrence of SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and MYALGIA (A patient developed Sore arm on the day of first dose of vaccination) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history is provided and concomitant drug are mentioned.     On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced MYALGIA (A patient developed Sore arm on the day of first dose of vaccination). On 07-Apr-2021, the patient experienced SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and PRODUCT DOSE OMISSION ISSUE (her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine). The patient was treated with DEXAMETHASONE at an unspecified dose and frequency. On 06-Apr-2021, MYALGIA (A patient developed Sore arm on the day of first dose of vaccination) had resolved. On 08-Apr-2021, SCRATCH (Scratching all over), ERYTHEMA (Redness all over), EAR DISCOMFORT (Hotness in the ears), CYST (Scratching all over the body with bumps) and PRODUCT DOSE OMISSION ISSUE (her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Patient took Benadryl(dexamethasone) first dose and her bumps got better and took 2nd dose her redness got better. She consulted her pharmacist with the rash images and her pharmacist asked her not to take second dose of Moderna Covid-19 vaccine. Patient provided consent for safety team to follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On 18-May-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medication was reported. Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose given from expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given from expired vial) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given from expired vial). On 11-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Dose given from expired vial) 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.