chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included ROSUVASTATIN and VITAMINS NOS for an unknown indication.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jul-2021, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.        No treatment information was reported.  The patient had an appointment on the 24th with PCP, to discuss the recommendation she was given to take J&J's vaccine as a second dose. She was hesitant of taking it while still having symptoms.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Loss of consciousness, Product dose omission issue, Pyrexia
Clinical narrative: Did not get second dose in the series/ Scared to get the second dose; Fainted / collapsed; Passed out / unconscious; Fell face down; Black and blue bruising; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted / collapsed) and LOSS OF CONSCIOUSNESS (Passed out / unconscious) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Unspecified pan shot).    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (Fever). On 05-May-2021, the patient experienced SYNCOPE (Fainted / collapsed) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Passed out / unconscious) (seriousness criterion medically significant), FALL (Fell face down) and CONTUSION (Black and blue bruising). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose in the series/ Scared to get the second dose). At the time of the report, SYNCOPE (Fainted / collapsed), LOSS OF CONSCIOUSNESS (Passed out / unconscious), FALL (Fell face down), CONTUSION (Black and blue bruising), PRODUCT DOSE OMISSION ISSUE (Did not get second dose in the series/ Scared to get the second dose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on no concomitant medications.  Treatment medication was not provided by the reporter.  Patient did not go the emergency room or hospital for evaluation. She decided not to get the second dose in the series at that time. The caller stated his wife was scared to get the second dose.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Did not get second dose in the series/ Scared to get the second dose; Fainted / collapsed; Passed out / unconscious; Fell face down; Black and blue bruising; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SYNCOPE (Fainted / collapsed) and LOSS OF CONSCIOUSNESS (Passed out / unconscious) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Unspecified pan shot).    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PYREXIA (Fever). On 05-May-2021, the patient experienced SYNCOPE (Fainted / collapsed) (seriousness criterion medically significant), LOSS OF CONSCIOUSNESS (Passed out / unconscious) (seriousness criterion medically significant), FALL (Fell face down) and CONTUSION (Black and blue bruising). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not get second dose in the series/ Scared to get the second dose). At the time of the report, SYNCOPE (Fainted / collapsed), LOSS OF CONSCIOUSNESS (Passed out / unconscious), FALL (Fell face down), CONTUSION (Black and blue bruising), PRODUCT DOSE OMISSION ISSUE (Did not get second dose in the series/ Scared to get the second dose) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was on no concomitant medications.  Treatment medication was not provided by the reporter.  Patient did not go the emergency room or hospital for evaluation. She decided not to get the second dose in the series at that time. The caller stated his wife was scared to get the second dose.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Broke out in rash, had to take Benadryl; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Broke out in rash, had to take Benadryl) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 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 RASH (Broke out in rash, had to take Benadryl). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Rash, at a dose of 1 dosage form. At the time of the report, RASH (Broke out in rash, had to take Benadryl) 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.   Concomitant medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine) 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 THROMBOSIS (he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (he read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications reported.  no treatment medications reported.  Reporter read in the newspaper about a man who had a blood clot after receiving the Moderna Covid-19 Vaccine.  Company comment: Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event has been provided at this time.  However, based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Pain, Pyrexia
Clinical narrative: Body aches,soreness; Back Aches; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches,soreness), BACK PAIN (Back Aches), CHILLS (Chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-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) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN (Body aches,soreness), BACK PAIN (Back Aches), CHILLS (Chills) and PYREXIA (Fever). On 28-Feb-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 01-Mar-2021, PAIN (Body aches,soreness) and BACK PAIN (Back Aches) had resolved.            No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-027213 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hyperhidrosis, Pain in extremity
Clinical narrative: right arm hurt when she moved or put it in the air; sweats; massive headache; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm hurt when she moved or put it in the air), HYPERHIDROSIS (sweats), HEADACHE (massive headache) and FATIGUE (fatigue) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (right arm hurt when she moved or put it in the air), HYPERHIDROSIS (sweats), HEADACHE (massive headache) and FATIGUE (fatigue). At the time of the report, PAIN IN EXTREMITY (right arm hurt when she moved or put it in the air), HYPERHIDROSIS (sweats), HEADACHE (massive headache) and FATIGUE (fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was reported.   This case was linked to MOD-2021-283888 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: He did not receive the second one as scheduled; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (He did not receive the second one as scheduled) 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 PRODUCT DOSE OMISSION ISSUE (He did not receive the second one as scheduled). At the time of the report, PRODUCT DOSE OMISSION ISSUE (He did not receive the second one as scheduled) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus
Clinical narrative: injection site is red, itchy; injection site is red,red ring /circle size around it about 3" around injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site is red, itchy) and VACCINATION SITE ERYTHEMA (injection site is red,red ring /circle size around it about 3" around injection site.) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (injection site is red, itchy) and VACCINATION SITE ERYTHEMA (injection site is red,red ring /circle size around it about 3" around injection site.). At the time of the report, VACCINATION SITE PRURITUS (injection site is red, itchy) and VACCINATION SITE ERYTHEMA (injection site is red,red ring /circle size around it about 3" around injection site.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.   Reporter did not allow further contact
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: 16 Year old patient given 1st dose; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (16 Year old patient given 1st dose) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007021A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced OFF LABEL USE (16 Year old patient given 1st dose). On 11-Aug-2021, OFF LABEL USE (16 Year old patient given 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant drugs were provided.   Reporter did not allow further contact.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: The veins going down the arm feel swollen; The veins going down the arm feel tender to the touch; When I stretch my arm out I feel the pain down my veins; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (The veins going down the arm feel swollen), MYALGIA (The veins going down the arm feel tender to the touch) and PAIN IN EXTREMITY (When I stretch my arm out I feel the pain down my veins) 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 PERIPHERAL SWELLING (The veins going down the arm feel swollen), MYALGIA (The veins going down the arm feel tender to the touch) and PAIN IN EXTREMITY (When I stretch my arm out I feel the pain down my veins). At the time of the report, PERIPHERAL SWELLING (The veins going down the arm feel swollen), MYALGIA (The veins going down the arm feel tender to the touch) and PAIN IN EXTREMITY (When I stretch my arm out I feel the pain down my veins) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Feeling cold, Headache
Clinical narrative: light headed; Felt very cold; Every time they coughed they had a pain in their head; Nauseous; Extremely tired; Headache was stronger were they couldn't open their eyes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous) and FATIGUE (Extremely tired) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous), FATIGUE (Extremely tired) and HEADACHE (Headache was stronger were they couldn't open their eyes). At the time of the report, DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous), FATIGUE (Extremely tired) and HEADACHE (Headache was stronger were they couldn't open their eyes) outcome was unknown.            No concomitant medication information was provided.  After the second dose patient couldn't lay on their side.  No treatment medication were provided.   This case was linked to MOD-2021-283875 (Patient Link).
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: light headed; Felt very cold; Every time they coughed they had a pain in their head; Nauseous; Extremely tired; Headache was stronger were they couldn't open their eyes; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous) and FATIGUE (Extremely tired) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous), FATIGUE (Extremely tired) and HEADACHE (Headache was stronger were they couldn't open their eyes). At the time of the report, DIZZINESS (light headed), FEELING COLD (Felt very cold), COUGH (Every time they coughed they had a pain in their head), NAUSEA (Nauseous), FATIGUE (Extremely tired) and HEADACHE (Headache was stronger were they couldn't open their eyes) outcome was unknown.            No concomitant medication information was provided.  After the second dose patient couldn't lay on their side.  No treatment medication were provided.   This case was linked to MOD-2021-283875 (Patient Link).
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Got 1 dose of moderna vaccine after completing the vaccination series with J&J vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Got 1 dose of moderna vaccine after completing the vaccination series with J&J vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Got 1 dose of moderna vaccine after completing the vaccination series with J&J vaccine). On 07-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (Got 1 dose of moderna vaccine after completing the vaccination series with J&J vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  On an unknown date in Mar-2021, the patient completed vaccination series with J & J COVID-19 vaccine.  On 07-Aug-2021, the patient was supposed to get COVID-19 test done. Instead of the COVID test, the patient got first dose of the moderna COVID-19 vaccine.  The patient was currently doing fine.
Age: 58.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: patient vaccinated with vial where pharmacist not sure if punctured or not; 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 PRODUCT ADMINISTRATION ERROR (patient vaccinated with vial where pharmacist not sure if punctured or not) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (patient vaccinated with vial where pharmacist not sure if punctured or not). At the time of the report, PRODUCT ADMINISTRATION ERROR (patient vaccinated with vial where pharmacist not sure if punctured or not) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant Medication was provided. No treatment  was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion
Clinical narrative: nose was clogged; This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (nose was clogged) 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 NASAL CONGESTION (nose was clogged). At the time of the report, NASAL CONGESTION (nose was clogged) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patients who stated they received the first dose 6 weeks ago or longer; 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 PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) 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 21-Apr-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 (patients who stated they received the first dose 6 weeks ago or longer). At the time of the report, PRODUCT DOSE OMISSION ISSUE (patients who stated they received the first dose 6 weeks ago or longer) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant product were reported  No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: started her period after a year of not having it; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started her period after a year of not having it) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 MENSTRUAL DISORDER (started her period after a year of not having it). At the time of the report, MENSTRUAL DISORDER (started her period after a year of not having it) 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 treatment medication provided by the reporter. No concomitant medication provided by the reporter. No lab data information provided by the reporter   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) outcome was unknown.            Patient took a headache pill to treat symptoms.   Patient takes concomitant medication but did not have them at hand to provide the names.   This case was linked to MOD-2021-283780 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Anger, Hypervigilance
Clinical narrative: Feeling very on edge; Short tempered; This spontaneous case was reported by a consumer and describes the occurrence of HYPERVIGILANCE (Feeling very on edge) and ANGER (Short tempered) 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 HYPERVIGILANCE (Feeling very on edge) and ANGER (Short tempered). At the time of the report, HYPERVIGILANCE (Feeling very on edge) and ANGER (Short tempered) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment medication were reported
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient hasn't received 2nd dose past 36 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose past 36 days) 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 PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose past 36 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient hasn't received 2nd dose past 36 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  No treatment medication reported.  Patient received first dose of vaccine in January and hadn't received  2nd dose past 36 days.   Reporter did not allow further contact
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.) in a 44-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna Covid-19 vaccine was drawn up in a syringe on 10Aug2021 at 8:13a & was administered at 8:20p., I was wondering if there was a medication error.) 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 reported
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: swelling in the right arm; Right arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in the right arm) and PAIN IN EXTREMITY (Right arm hurt) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Drug allergy (Thimerosal) and Allergy multiple. Concomitant products included TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FLUTICASONE FUROATE (ARNUITY ELLIPTA), MONTELUKAST, CETIRIZINE HYDROCHLORIDE (CETIRIZINE HCL) and LORATADINE for an unknown indication.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PERIPHERAL SWELLING (swelling in the right arm) and PAIN IN EXTREMITY (Right arm hurt). In March 2021, PERIPHERAL SWELLING (swelling in the right arm) and PAIN IN EXTREMITY (Right arm hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other Concomitant medication includes ZATIDOR eye drops during allergy season. No Treatment medications were reported.   This case was linked to MOD-2021-284124 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.            No concomitant medications was provided. No treatment medications was provided.   Reporter did not allow further contact
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Myalgia, Pruritus, Urticaria
Clinical narrative: "Big red welts"; Were itchy "as crap.",Itchiness; Worried; Soreness; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness) in a 36-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 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness). At the time of the report, URTICARIA ("Big red welts"), PRURITUS (Were itchy "as crap.",Itchiness), FEELING ABNORMAL (Worried) and MYALGIA (Soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medication were reported.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Myalgia, Pain
Clinical narrative: it's hard to even turn over in bed; it hurts; her arm is still hurting in the muscle, very much/it never really subsided; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (it's hard to even turn over in bed), PAIN (it hurts) and MYALGIA (her arm is still hurting in the muscle, very much/it never really subsided) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOKINESIA (it's hard to even turn over in bed), PAIN (it hurts) and MYALGIA (her arm is still hurting in the muscle, very much/it never really subsided). At the time of the report, HYPOKINESIA (it's hard to even turn over in bed), PAIN (it hurts) and MYALGIA (her arm is still hurting in the muscle, very much/it never really subsided) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication was provided No concomitant medication was provided
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eye pain, Fatigue, Feeding disorder
Clinical narrative: Freezing cold; Arm hurt; Covid arm/covid arm all the way down her hand; Couldn't eat; Couldn't sleep; Left side of her neck was extremely sweaty; Eyes hurt; Can't breathe well; Throat hurt; Nose hurt; Felt like she was going to die; Chills; Fatigued; Massive headache/Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat) and INSOMNIA (Couldn't sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache). At the time of the report, FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache) outcome was unknown.            No concomitant or treatment drug reported by reporter.   This case was linked to MOD-2021-283872 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling cold, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Freezing cold; Arm hurt; Covid arm/covid arm all the way down her hand; Couldn't eat; Couldn't sleep; Left side of her neck was extremely sweaty; Eyes hurt; Can't breathe well; Throat hurt; Nose hurt; Felt like she was going to die; Chills; Fatigued; Massive headache/Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat) and INSOMNIA (Couldn't sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache). At the time of the report, FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache) outcome was unknown.            No concomitant or treatment drug reported by reporter.   This case was linked to MOD-2021-283872 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal discomfort, Oropharyngeal pain, Pain in extremity, Vaccination site reaction
Clinical narrative: Freezing cold; Arm hurt; Covid arm/covid arm all the way down her hand; Couldn't eat; Couldn't sleep; Left side of her neck was extremely sweaty; Eyes hurt; Can't breathe well; Throat hurt; Nose hurt; Felt like she was going to die; Chills; Fatigued; Massive headache/Headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat) and INSOMNIA (Couldn't sleep) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache). At the time of the report, FEELING COLD (Freezing cold), PAIN IN EXTREMITY (Arm hurt), VACCINATION SITE REACTION (Covid arm/covid arm all the way down her hand), FEEDING DISORDER (Couldn't eat), INSOMNIA (Couldn't sleep), HYPERHIDROSIS (Left side of her neck was extremely sweaty), EYE PAIN (Eyes hurt), DYSPNOEA (Can't breathe well), OROPHARYNGEAL PAIN (Throat hurt), NASAL DISCOMFORT (Nose hurt), FEELING ABNORMAL (Felt like she was going to die), CHILLS (Chills), FATIGUE (Fatigued) and HEADACHE (Massive headache/Headache) outcome was unknown.            No concomitant or treatment drug reported by reporter.   This case was linked to MOD-2021-283872 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product dose omission issue
Clinical narrative: I got my first shot on 1-6-21 and did not get my 2nd one; over 6 Months since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I got my first shot on 1-6-21 and did not get my 2nd one) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 Months since first dose) 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 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I got my first shot on 1-6-21 and did not get my 2nd one) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 Months since first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I got my first shot on 1-6-21 and did not get my 2nd one) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (over 6 Months since first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were mentioned by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: non-significant follow up received on 11-AUG-2021 and contains No new information was updated.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Myocardial infarction, Thrombosis
Clinical narrative: blood clots; heart attack; migraine, a definite link between the protein spike from the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clots) and MYOCARDIAL INFARCTION (heart attack) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criterion medically significant), MYOCARDIAL INFARCTION (heart attack) (seriousness criterion medically significant) and MIGRAINE (migraine, a definite link between the protein spike from the vaccine). At the time of the report, THROMBOSIS (blood clots), MYOCARDIAL INFARCTION (heart attack) and MIGRAINE (migraine, a definite link between the protein spike from the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided by the reporter.  Company comment: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this events has been provided at this time. However, based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Pyrexia, Vaccination site erythema, Vaccination site warmth
Clinical narrative: Throat is bothering me; low grade fever; warmness at the right arm injection site; redness at the right arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmness at the right arm injection site), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), VACCINATION SITE ERYTHEMA (redness at the right arm injection site) and PYREXIA (low grade fever) 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 06-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Aug-2021, the patient experienced VACCINATION SITE WARMTH (warmness at the right arm injection site) and VACCINATION SITE ERYTHEMA (redness at the right arm injection site). On 11-Aug-2021, the patient experienced OROPHARYNGEAL DISCOMFORT (Throat is bothering me) and PYREXIA (low grade fever). At the time of the report, VACCINATION SITE WARMTH (warmness at the right arm injection site), OROPHARYNGEAL DISCOMFORT (Throat is bothering me), VACCINATION SITE ERYTHEMA (redness at the right arm injection site) and PYREXIA (low grade fever) outcome was unknown.            No concomitant medication use was reported.  No treatment information was reported.  Action taken with the drug in response to events was not applicable.