chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Fatigue, Feeling cold, Insomnia, Pain in extremity
Clinical narrative: for a fewhours she had a really icy feet; Over cold, was really icy cold the whole time; Sore arm; Could not sleep; Next day she was just really tired, has been really tired for a fewdays, she's still tired; Heart rumbling and beating really fast, a fast heart beating; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating), PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep) in a 70-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 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating). On an unknown date, the patient experienced PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm), INSOMNIA (Could not sleep) and FATIGUE (Next day she was just really tired, has been really tired for a fewdays, she's still tired). On 20-Aug-2021, TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating) had resolved. At the time of the report, PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep) outcome was unknown and FATIGUE (Next day she was just really tired, has been really tired for a fewdays, she's still tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) blood pressure was really high and then it lower up a little bit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included mild hormone. Treatment information was not provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral coldness, Tachycardia
Clinical narrative: for a fewhours she had a really icy feet; Over cold, was really icy cold the whole time; Sore arm; Could not sleep; Next day she was just really tired, has been really tired for a fewdays, she's still tired; Heart rumbling and beating really fast, a fast heart beating; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating), PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep) in a 70-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 20-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating). On an unknown date, the patient experienced PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm), INSOMNIA (Could not sleep) and FATIGUE (Next day she was just really tired, has been really tired for a fewdays, she's still tired). On 20-Aug-2021, TACHYCARDIA (Heart rumbling and beating really fast, a fast heart beating) had resolved. At the time of the report, PERIPHERAL COLDNESS (for a fewhours she had a really icy feet), FEELING COLD (Over cold, was really icy cold the whole time), PAIN IN EXTREMITY (Sore arm) and INSOMNIA (Could not sleep) outcome was unknown and FATIGUE (Next day she was just really tired, has been really tired for a fewdays, she's still tired) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: high (High) blood pressure was really high and then it lower up a little bit..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included mild hormone. Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site mass, Vaccination site pruritus
Clinical narrative: She had her arm a little sore for the first couple of days; a little bump size of a quarter appeared; Last night her arm started itching at the injection site; a red spot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (She had her arm a little sore for the first couple of days), VACCINATION SITE MASS (a little bump size of a quarter appeared), VACCINATION SITE PRURITUS (Last night her arm started itching at the injection site) and VACCINATION SITE ERYTHEMA (a red spot) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included DULOXETINE, CLONAZEPAM, GABAPENTIN and AMOXICILLIN for an unknown indication.    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced VACCINATION SITE MASS (a little bump size of a quarter appeared), VACCINATION SITE PRURITUS (Last night her arm started itching at the injection site) and VACCINATION SITE ERYTHEMA (a red spot). On an unknown date, the patient experienced PAIN IN EXTREMITY (She had her arm a little sore for the first couple of days). At the time of the report, PAIN IN EXTREMITY (She had her arm a little sore for the first couple of days) and VACCINATION SITE PRURITUS (Last night her arm started itching at the injection site) had resolved, VACCINATION SITE MASS (a little bump size of a quarter appeared) had not resolved and VACCINATION SITE ERYTHEMA (a red spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Relevant concomitant medication also includes Inhaler.  It was stated that pharmacist recommended Benadryl cream which she could not use
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Illness, Influenza like illness
Clinical narrative: very sore arm; Swollen arm; Could not get out of bed; Flu like symptoms; Night sweats and was waking up soaking wet head to toe; She got really sick; Nausea; Chills; Fever of 103F; very tired; Arm red as a beet; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet). At the time of the report, PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: high (High) 103 F.         Patient had her first Moderns vaccine on 13 Jan2021 in her right arm with no side effects.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-294660 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Night sweats, Pain in extremity, Peripheral swelling
Clinical narrative: very sore arm; Swollen arm; Could not get out of bed; Flu like symptoms; Night sweats and was waking up soaking wet head to toe; She got really sick; Nausea; Chills; Fever of 103F; very tired; Arm red as a beet; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet). At the time of the report, PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: high (High) 103 F.         Patient had her first Moderns vaccine on 13 Jan2021 in her right arm with no side effects.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-294660 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema
Clinical narrative: very sore arm; Swollen arm; Could not get out of bed; Flu like symptoms; Night sweats and was waking up soaking wet head to toe; She got really sick; Nausea; Chills; Fever of 103F; very tired; Arm red as a beet; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet). At the time of the report, PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (She got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever of 103F), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm red as a beet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Feb-2021, Body temperature: high (High) 103 F.         Patient had her first Moderns vaccine on 13 Jan2021 in her right arm with no side effects.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-294660 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Erythema, Fatigue, Illness
Clinical narrative: First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021; very sore arm; Swollen arm; Could not get out of bed; Flu like symptoms; Night sweats and was waking up soaking wet head to toe; got really sick; Nausea; Chills; Fever; very tired; Arm  red as a beet; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), FATIGUE (very tired), VACCINATION SITE ERYTHEMA (Arm  red as a beet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021). On 18-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021) had resolved. On 22-Aug-2021, PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm  red as a beet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Body temperature: high (High) 101 F.         Patient had her first Moderns vaccine on 13-Jan-2021 in her right arm with no side effects. She had her second injection 10-Feb-2021 lot was 015M20A again in the right arm.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-294643 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Malaise, Nausea, Night sweats
Clinical narrative: First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021; very sore arm; Swollen arm; Could not get out of bed; Flu like symptoms; Night sweats and was waking up soaking wet head to toe; got really sick; Nausea; Chills; Fever; very tired; Arm  red as a beet; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), FATIGUE (very tired), VACCINATION SITE ERYTHEMA (Arm  red as a beet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021). On 18-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021) had resolved. On 22-Aug-2021, PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm  red as a beet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Body temperature: high (High) 101 F.         Patient had her first Moderns vaccine on 13-Jan-2021 in her right arm with no side effects. She had her second injection 10-Feb-2021 lot was 015M20A again in the right arm.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-294643 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021; very sore arm; Swollen arm; Could not get out of bed; Flu like symptoms; Night sweats and was waking up soaking wet head to toe; got really sick; Nausea; Chills; Fever; very tired; Arm  red as a beet; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms) and NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), FATIGUE (very tired), VACCINATION SITE ERYTHEMA (Arm  red as a beet) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021). On 18-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 13-JAN-2021 and second dose on 10Feb2021 and third dose on 18Aug2021) had resolved. On 22-Aug-2021, PAIN IN EXTREMITY (very sore arm), PERIPHERAL SWELLING (Swollen arm), MALAISE (Could not get out of bed), INFLUENZA LIKE ILLNESS (Flu like symptoms), NIGHT SWEATS (Night sweats and was waking up soaking wet head to toe), ILLNESS (got really sick), NAUSEA (Nausea), CHILLS (Chills), PYREXIA (Fever), FATIGUE (very tired) and VACCINATION SITE ERYTHEMA (Arm  red as a beet) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Body temperature: high (High) 101 F.         Patient had her first Moderns vaccine on 13-Jan-2021 in her right arm with no side effects. She had her second injection 10-Feb-2021 lot was 015M20A again in the right arm.  No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   This case was linked to MOD-2021-294643 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Fatigue, Pain, Vaccination site pain
Clinical narrative: it's very hot to the touch; discomfort when breathing, not hard to breath but discomfort; shooting pain in the head; pain; very itchy/unbelievably itchy and that is a very large area; swollen under and around the injection site; the first days was very tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it's very hot to the touch), DYSPNEA (discomfort when breathing, not hard to breath but discomfort), PAIN (shooting pain in the head), VACCINATION SITE PAIN (pain) and VACCINATION SITE PRURITUS (very itchy/unbelievably itchy and that is a very large area) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Aug-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 VACCINATION SITE WARMTH (it's very hot to the touch), DYSPNEA (discomfort when breathing, not hard to breath but discomfort), PAIN (shooting pain in the head), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (very itchy/unbelievably itchy and that is a very large area), VACCINATION SITE SWELLING (swollen under and around the injection site), FATIGUE (the first days was very tired) and CHILLS (chills). At the time of the report, VACCINATION SITE WARMTH (it's very hot to the touch), DYSPNEA (discomfort when breathing, not hard to breath but discomfort), PAIN (shooting pain in the head), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (very itchy/unbelievably itchy and that is a very large area), FATIGUE (the first days was very tired) and CHILLS (chills) outcome was unknown and VACCINATION SITE SWELLING (swollen under and around the injection site) was resolving.        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.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: it's very hot to the touch; discomfort when breathing, not hard to breath but discomfort; shooting pain in the head; pain; very itchy/unbelievably itchy and that is a very large area; swollen under and around the injection site; the first days was very tired; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (it's very hot to the touch), DYSPNEA (discomfort when breathing, not hard to breath but discomfort), PAIN (shooting pain in the head), VACCINATION SITE PAIN (pain) and VACCINATION SITE PRURITUS (very itchy/unbelievably itchy and that is a very large area) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 19-Aug-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 VACCINATION SITE WARMTH (it's very hot to the touch), DYSPNEA (discomfort when breathing, not hard to breath but discomfort), PAIN (shooting pain in the head), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (very itchy/unbelievably itchy and that is a very large area), VACCINATION SITE SWELLING (swollen under and around the injection site), FATIGUE (the first days was very tired) and CHILLS (chills). At the time of the report, VACCINATION SITE WARMTH (it's very hot to the touch), DYSPNEA (discomfort when breathing, not hard to breath but discomfort), PAIN (shooting pain in the head), VACCINATION SITE PAIN (pain), VACCINATION SITE PRURITUS (very itchy/unbelievably itchy and that is a very large area), FATIGUE (the first days was very tired) and CHILLS (chills) outcome was unknown and VACCINATION SITE SWELLING (swollen under and around the injection site) was resolving.        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.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test
Clinical narrative: Inappropriate Schedule of Vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Smoker in 2013 and COVID-19 on 15-Jan-2021. Concurrent medical conditions included Depression since 01-Jun-2000, Anxiety since 01-Jun-2000, Hypertension since 01-Jan-2005, Atherosclerosis since 01-Jan-2013, Penicillin allergy and Fish allergy. Concomitant products included CLONAZEPAM from 01-Jan-2013 to an unknown date for Anxiety, ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Jan-2005 to an unknown date for Cardiovascular disease, unspecified, AMLODIPINE from 01-Jan-2016 to an unknown date for Hypertension, VITAMINS NOS from 01-Jan-1980 to an unknown date for Supplementation therapy.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate Schedule of Vaccine administered) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2021, SARS-CoV-2 test: postive (Positive) Positive. On 19-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. On 07-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative. On 16-Aug-2021, SARS-CoV-2 test: negative (Negative) Negative.         The patient stated that he received first dose of Moderna 13 January 2021 and second dose on 20 April 2021.  The patient stated that he got COVID-19 after first dose on 15 January 2021 and experienced cough for 7 days, chills for 3 days, myalgia for 3 days, and fever for 3 days with temperature 100.5 fahrenheit. The patient also stated that he used Bamlanivimab IV on 22 Jan 2021 and Ibuprofen, 400 mg, TID, oral from 15 Jan 2021 to 19 Jan 2021 during COVID-19.   This case was linked to MOD-2021-010840 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Fatigue
Clinical narrative: Slight chest pains; More tired than usual; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Slight chest pains) and FATIGUE (More tired than usual) 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 CHEST PAIN (Slight chest pains) and FATIGUE (More tired than usual). At the time of the report, CHEST PAIN (Slight chest pains) and FATIGUE (More tired than usual) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient had taken the first dose and was about to take the second dose. but felt chest pain before second dose and got confusion.  Treatment medication was  not reported. Relevant concomitant medications were not provided by the reporter.   Reporter did not allow further contact
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: have all had break-thru cases; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (have all had break-thru cases) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In February 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (have all had break-thru cases). At the time of the report, INFECTION (have all had break-thru cases) outcome was unknown. Not Provided          Relevant concomitant medications were not reported.  The treatment information was  not provided.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Infection
Clinical narrative: have all had break-thru cases; This spontaneous case was reported by a consumer and describes the occurrence of INFECTION (have all had break-thru cases) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFECTION (have all had break-thru cases). At the time of the report, INFECTION (have all had break-thru cases) outcome was unknown. Not Provided          Concomitant medication were not reported. Treatment medication were not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy breast, Breast pain, Inflammation, Mammogram, Neuralgia
Clinical narrative: Dental nerve pain; more reactive to inflammation; Sore breast; This spontaneous case was reported by an other health care professional and describes the occurrence of BREAST PAIN (Sore breast), NEURALGIA (Dental nerve pain) and INFLAMMATION (more reactive to inflammation) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) 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) (unknown route) 1 dosage form. In 2021, the patient experienced BREAST PAIN (Sore breast) and INFLAMMATION (more reactive to inflammation). On an unknown date, the patient experienced NEURALGIA (Dental nerve pain). At the time of the report, BREAST PAIN (Sore breast) and NEURALGIA (Dental nerve pain) had resolved and INFLAMMATION (more reactive to inflammation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jul-2021, Biopsy breast: benign Results were benign. On 27-Jul-2021, Mammogram: benign Results were benign.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered INFLAMMATION (more reactive to inflammation) to be possibly related. No further causality assessments were provided for BREAST PAIN (Sore breast) and NEURALGIA (Dental nerve pain).    No concomitant medication information was provided. No treatment information was provided. After the second dose, patient had dental nerve pain that lasted about 2 to 3 weeks. For 2-3 weeks both breast were sore. She thought that the vaccine made her body more reactive to inflammation. She also thought could have taken Aleve to help with symptoms.   This case was linked to MOD-2021-286588 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: Hair falling out after both shots; 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 ALOPECIA (Hair falling out after both shots) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ALOPECIA (Hair falling out after both shots). At the time of the report, ALOPECIA (Hair falling out after both shots) outcome was unknown.            No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-294688 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Sporadic itchy spots on her body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Sporadic itchy spots on her body) in an elderly 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 PRURITUS (Sporadic itchy spots on her body). At the time of the report, PRURITUS (Sporadic itchy spots on her body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Food allergy, Product dose omission issue, SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Patient has not received 2nd dose.; tested positive for COVID19 on 21-Jul-2021; Had COVID19 symptoms; Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.; This spontaneous case was reported by a consumer and describes the occurrence of FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.), SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021), COVID-19 (Had COVID19 symptoms) and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.) 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 06-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jul-2021, the patient experienced FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.). On 18-Jul-2021, the patient experienced COVID-19 (Had COVID19 symptoms). On 21-Jul-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.). The patient was treated with AZITHROMYCIN for Adverse event, at an unspecified dose and frequency. At the time of the report, FOOD ALLERGY (Patient administered a "steroid shot" due to allergic reaction experienced "due to food I ate not from the vaccine" on 14Jul2021.), SARS-COV-2 TEST POSITIVE (tested positive for COVID19 on 21-Jul-2021) and COVID-19 (Had COVID19 symptoms) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient has not received 2nd dose.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Patient administered a steroid shot due to allergic reaction experienced due to food she ate not from the vaccine on 14Jul2021.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Off label use
Clinical narrative: 1st dose of the Moderna Covid-19 Vaccine on 29Jan2021 and has not received the 2nd dose; 1st dose of the Moderna Covid-19 Vaccine on 29Jan2021, then found out that she was pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (1st dose of the Moderna Covid-19 Vaccine on 29Jan2021, then found out that she was pregnant) and OFF LABEL USE (1st dose of the Moderna Covid-19 Vaccine on 29Jan2021 and has not received the 2nd dose) in a 43-year-old female patient (gravida 6) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage (5 miscarriages prior to this pregnancy.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Jan-2021 and the estimated date of delivery was 21-Oct-2021. In February 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (1st dose of the Moderna Covid-19 Vaccine on 29Jan2021, then found out that she was pregnant). On an unknown date, the patient experienced OFF LABEL USE (1st dose of the Moderna Covid-19 Vaccine on 29Jan2021 and has not received the 2nd dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy.  At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (1st dose of the Moderna Covid-19 Vaccine on 29Jan2021, then found out that she was pregnant) and OFF LABEL USE (1st dose of the Moderna Covid-19 Vaccine on 29Jan2021 and has not received the 2nd dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  They will induce labor during the 39th week if the baby is not born sooner.; Sender's Comments: This is a case of product exposure during pregnancy with  associated no AE of 43-year-old female. Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Limb discomfort
Clinical narrative: "one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal"; infall her limbs; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION ("one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal") and LIMB DISCOMFORT (infall her limbs) in a 54-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced CONTUSION ("one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal") and LIMB DISCOMFORT (infall her limbs). At the time of the report, CONTUSION ("one week ago the appearance of bruises like echimoses, infall her limbs, without other symptoms, her CBC including platelets is normal") and LIMB DISCOMFORT (infall her limbs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient's CBC including platelets is normal. No concomitant medications were reported. No treatment medications were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Dizziness; Headache; Low grade fever; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), HEADACHE (headache), PYREXIA (low grade fever) and NAUSEA (nausea) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (6 months ago).    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 DIZZINESS (dizziness), HEADACHE (headache), PYREXIA (low grade fever) and NAUSEA (nausea). At the time of the report, DIZZINESS (dizziness), HEADACHE (headache), PYREXIA (low grade fever) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: Testing positive for covid after receiving covid 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 COVID-19 (Testing positive for covid after receiving covid vaccine) 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 COVID-19 (Testing positive for covid after receiving covid vaccine). At the time of the report, COVID-19 (Testing positive for covid after receiving covid vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Testing positive for COVID after receiving COVID vaccine.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment information was not reported.  It was reported that the reporters friends who received Johnson and Johnson and Pfizer vaccine got infected with COVID 19.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles 4-5 months after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles 4-5 months after vaccination) 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HERPES ZOSTER (Shingles 4-5 months after vaccination). At the time of the report, HERPES ZOSTER (Shingles 4-5 months after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-295070 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: 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 SITE REACTION (magnetic at the injection site/ messed around with their name badges and anything that was magnetic, and it would stick to the 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Aug-2021, the patient experienced VACCINATION SITE REACTION (magnetic at the injection site/ messed around with their name badges and anything that was magnetic, and it would stick to the injection site). At the time of the report, VACCINATION SITE REACTION (magnetic at the injection site/ messed around with their name badges and anything that was magnetic, and it would stick to the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No Treatment information were reported. They messed around with their name badges and anything that was magnetic, and it would stick to the injection site, not the whole arm.