chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dysphonia, Nervousness, SARS-CoV-2 antibody test, SARS-CoV-2 test
Clinical narrative: Dry cough; Throat irritation/throat felt raw; last month and a half I have gotten hoarse; Felt the heeby jeeby; Felt the heeby jeeby; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse), the second episode of NERVOUSNESS (Felt the heeby jeeby) and the first episode of NERVOUSNESS (Felt the heeby jeeby) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 03K20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, Barrett's esophagus (Patient had irritation in her hroat) and Hypertension (on medication). Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), METFORMIN, COLECALCIFEROL (VITAMIN D3), PRAVASTATIN, MAGNESIUM, ZINC, CALCIUM and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of NERVOUSNESS (Felt the heeby jeeby). On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of NERVOUSNESS (Felt the heeby jeeby). On an unknown date, the patient experienced COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw) and DYSPHONIA (last month and a half I have gotten hoarse). At the time of the report, COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse) and the last episode of NERVOUSNESS (Felt the heeby jeeby) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 08-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant also included OTC vitamins.  Treatment medication was not provided by the reporter.  Patient doesn't recall being sick with COVID or being infected previously.  She stated that she had a history of GERD and Barrett's Esophagus, so she always had irritation in her throat. However, a month ago she started having dry cough which she said was new and her throat felt very irritated and raw. She also stated that her voice became hoarse in the last month. She said that she did not really have any side effects from both doses except that she felt the heeby jeeby.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Dry cough; Throat irritation/throat felt raw; last month and a half I have gotten hoarse; Felt the heeby jeeby; Felt the heeby jeeby; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse), the second episode of NERVOUSNESS (Felt the heeby jeeby) and the first episode of NERVOUSNESS (Felt the heeby jeeby) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 03K20A) for COVID-19 vaccination.     Concurrent medical conditions included GERD, Barrett's esophagus (Patient had irritation in her hroat) and Hypertension (on medication). Concomitant products included AMLODIPINE for Hypertension, OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]), METFORMIN, COLECALCIFEROL (VITAMIN D3), PRAVASTATIN, MAGNESIUM, ZINC, CALCIUM and GLYCERYL TRINITRATE (NITROGLYCERIN) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of NERVOUSNESS (Felt the heeby jeeby). On 12-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced the second episode of NERVOUSNESS (Felt the heeby jeeby). On an unknown date, the patient experienced COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw) and DYSPHONIA (last month and a half I have gotten hoarse). At the time of the report, COUGH (Dry cough), THROAT IRRITATION (Throat irritation/throat felt raw), DYSPHONIA (last month and a half I have gotten hoarse) and the last episode of NERVOUSNESS (Felt the heeby jeeby) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) Positive. On 08-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.         Concomitant also included OTC vitamins.  Treatment medication was not provided by the reporter.  Patient doesn't recall being sick with COVID or being infected previously.  She stated that she had a history of GERD and Barrett's Esophagus, so she always had irritation in her throat. However, a month ago she started having dry cough which she said was new and her throat felt very irritated and raw. She also stated that her voice became hoarse in the last month. She said that she did not really have any side effects from both doses except that she felt the heeby jeeby.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Hyperhidrosis, Illness, Migraine
Clinical narrative: Arm was sore; arm where they injected the vaccine was still red; left arm  puffy with baseball size lump; This morning she had bad sweats; body ache /arm was sore; woke up really sick the next day; migraine; feels really bad; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats) and PAIN (body ache /arm was sore) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FB8448 and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MAGNESIUM GLYCINATE (MAGNESIUM GUMMIES) for an unknown indication.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), PAIN (body ache /arm was sore), CHILLS (chills) and PYREXIA (fever). On 12-Sep-2021, the patient experienced HYPERHIDROSIS (This morning she had bad sweats), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm  puffy with baseball size lump). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats), PAIN (body ache /arm was sore), PAIN IN EXTREMITY (Arm was sore), CHILLS (chills), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm  puffy with baseball size lump) outcome was unknown and PYREXIA (fever) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Pyrexia, Vaccination site erythema, Vaccination site swelling
Clinical narrative: Arm was sore; arm where they injected the vaccine was still red; left arm  puffy with baseball size lump; This morning she had bad sweats; body ache /arm was sore; woke up really sick the next day; migraine; feels really bad; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats) and PAIN (body ache /arm was sore) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FB8448 and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included MAGNESIUM GLYCINATE (MAGNESIUM GUMMIES) for an unknown indication.   On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Sep-2021, the patient experienced ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), PAIN (body ache /arm was sore), CHILLS (chills) and PYREXIA (fever). On 12-Sep-2021, the patient experienced HYPERHIDROSIS (This morning she had bad sweats), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm  puffy with baseball size lump). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was sore). At the time of the report, ILLNESS (woke up really sick the next day), MIGRAINE (migraine), FEELING ABNORMAL (feels really bad), HYPERHIDROSIS (This morning she had bad sweats), PAIN (body ache /arm was sore), PAIN IN EXTREMITY (Arm was sore), CHILLS (chills), VACCINATION SITE ERYTHEMA (arm where they injected the vaccine was still red) and VACCINATION SITE SWELLING (left arm  puffy with baseball size lump) outcome was unknown and PYREXIA (fever) had resolved.            No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pyrexia
Clinical narrative: Dizzines; Fever like simptoms; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms) 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 11-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Sep-2021, the patient experienced DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DIZZINESS (Dizzines) and PYREXIA (Fever like simptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest discomfort, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Drenched in sweat; Feels like there was an elephant sitting on her chest; Tremors; Head hurt; Every part of the body hurts; Fever at 101.6F at 3am - current temperature now is at 101.3F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt) and MYALGIA (Every part of the body hurts) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (sulfa based drug).    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 2 tabs and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) ongoing since an unknown date for Adverse event, at a dose of 2 tabs. At the time of the report, HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Body temperature: 101.3f (High) 101.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Drenched in sweat; Feels like there was an elephant sitting on her chest; Tremors; Head hurt; Every part of the body hurts; Fever at 101.6F at 3am - current temperature now is at 101.3F; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt) and MYALGIA (Every part of the body hurts) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy (sulfa based drug).    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 2 tabs and IBUPROFEN SODIUM (IBUPROFEN [IBUPROFEN SODIUM]) ongoing since an unknown date for Adverse event, at a dose of 2 tabs. At the time of the report, HYPERHIDROSIS (Drenched in sweat), CHEST DISCOMFORT (Feels like there was an elephant sitting on her chest), TREMOR (Tremors), HEADACHE (Head hurt), MYALGIA (Every part of the body hurts) and PYREXIA (Fever at 101.6F at 3am - current temperature now is at 101.3F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Sep-2021, Body temperature: 101.3f (High) 101.3F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Expired product administered, Headache, Inappropriate schedule of product administration
Clinical narrative: Chills; Headache; expired vaccine used; received 2 doses on same day; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), HEADACHE (Headache), EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses on same day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Sep-2021, the patient experienced CHILLS (Chills), HEADACHE (Headache), EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses on same day). On 10-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received 2 doses on same day) had resolved. On 12-Sep-2021, CHILLS (Chills) had resolved. At the time of the report, HEADACHE (Headache) had not resolved.            No concomitant medication provided.  No treatment information provided.  The patient said that the first dose was an expired dose and therefore on the same day, another dose was injected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased
Clinical narrative: heart rate still up; felt horrible; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt horrible) and HEART RATE INCREASED (heart rate still up) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (felt horrible) and HEART RATE INCREASED (heart rate still up). At the time of the report, FEELING ABNORMAL (felt horrible) was resolving and HEART RATE INCREASED (heart rate still up) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: high (High) High.         No concomitant medications were reported.  No treatment medications were reported.    Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: strong reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (strong reaction) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A, 029L20A and 038C21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2008.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Sep-2021, received third 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 (strong reaction). At the time of the report, VACCINATION COMPLICATION (strong reaction) outcome was unknown.            In 2008 patient had breast cancer for which she was performed a Mastectomy, though didn't receive Radiation nor Chemo   This case was linked to MOD-2021-318449 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Feeling abnormal, Headache, Influenza like illness, Lethargy
Clinical narrative: e had a bad reaction where she she had a whopping COVID arm; Purple arm that lasted for a week; Felt terrible; Flu-like symptoms; lethargy; mild upset stomach; Headache so bad that she could hardly lift her head off the pillow; Was a tad nauseous but not enough to vomit; Had a little fever but nothing crazy/101+ degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and LETHARGY (lethargy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included IBD, Migraine, Seizure since an unknown date, Myocardial infarction (Myocardial bridge), Tachycardia, Lymph node abscess (with lymph node dissection ) on 26-Jan-2021, St. Louis encephalitis (when she was 15 years old and had a high fever and was in a coma for 5 days. ) and Radiation therapy. Concurrent medical conditions included Blood pressure high and Cancer since December 2020. Concomitant products included PARACETAMOL (TYLENOL) for Pain, LETROZOLE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees). At the time of the report, VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received: Added new events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, Skin discolouration, Vaccination complication
Clinical narrative: e had a bad reaction where she she had a whopping COVID arm; Purple arm that lasted for a week; Felt terrible; Flu-like symptoms; lethargy; mild upset stomach; Headache so bad that she could hardly lift her head off the pillow; Was a tad nauseous but not enough to vomit; Had a little fever but nothing crazy/101+ degrees; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and LETHARGY (lethargy) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included IBD, Migraine, Seizure since an unknown date, Myocardial infarction (Myocardial bridge), Tachycardia, Lymph node abscess (with lymph node dissection ) on 26-Jan-2021, St. Louis encephalitis (when she was 15 years old and had a high fever and was in a coma for 5 days. ) and Radiation therapy. Concurrent medical conditions included Blood pressure high and Cancer since December 2020. Concomitant products included PARACETAMOL (TYLENOL) for Pain, LETROZOLE for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees). At the time of the report, VACCINATION COMPLICATION (e had a bad reaction where she she had a whopping COVID arm), SKIN DISCOLOURATION (Purple arm that lasted for a week), FEELING ABNORMAL (Felt terrible), INFLUENZA LIKE ILLNESS (Flu-like symptoms), LETHARGY (lethargy), ABDOMINAL DISCOMFORT (mild upset stomach), HEADACHE (Headache so bad that she could hardly lift her head off the pillow), NAUSEA (Was a tad nauseous but not enough to vomit) and PYREXIA (Had a little fever but nothing crazy/101+ degrees) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Follow up received: Added new events.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: severe itching at the injection site; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (severe itching at the injection site) and VACCINATION SITE RASH (rash at 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 an unknown date, the patient experienced VACCINATION SITE PRURITUS (severe itching at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, VACCINATION SITE PRURITUS (severe itching at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details were provided. No treatment medication details were provided.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Gastric ulcer, Muscle spasms, Vomiting
Clinical narrative: Stomach ulcer came back; Had been throwing up and was throwing up again; Back spasms; This spontaneous case was reported by a consumer and describes the occurrence of GASTRIC ULCER (Stomach ulcer came back) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Stomach ulcer (he had been diagnosed with a stomach ulcer in March 2021) in 2021.    On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced MUSCLE SPASMS (Back spasms). On 13-Sep-2021, the patient experienced GASTRIC ULCER (Stomach ulcer came back) (seriousness criterion medically significant) and VOMITING (Had been throwing up and was throwing up again). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Stomach ulcer, at an unspecified dose and frequency; ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM HYDROXIDE, SIMETICONE (MYLANTA [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM HYDROXIDE;SIMETICONE]) for Stomach ulcer, at an unspecified dose and frequency and FAMOTIDINE (PEPCID [FAMOTIDINE]) for Stomach ulcer, at an unspecified dose and frequency. At the time of the report, GASTRIC ULCER (Stomach ulcer came back), MUSCLE SPASMS (Back spasms) and VOMITING (Had been throwing up and was throwing up again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant drug details not provided.  Company Comment: This case concerns a 59-year-old, male patient with relevant medical history of stomach ulcer, who experienced the unexpected event of stomach ulcer The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. However, the patient's medical history and concomitant use of Advil, remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 59-year-old, male patient with relevant medical history of stomach ulcer, who experienced the unexpected event of stomach ulcer The event occurred approximately 3 days after the first dose of Spikevax. The rechallenge was not applicable, as the event happened after the first dose. The event was considered related to the product per the reporter's assessment. However, the patient's medical history and concomitant use of Advil, remains a contributory factor. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I missed my second dose. I had my first in April; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April) 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 PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I missed my second dose. I had my first in April) had resolved.            No concomitant medications were not reported. No treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Skin haemorrhage
Clinical narrative: Legs are bloody and stuff; Legs are bloody and stuff; This spontaneous case was reported by a consumer and describes the occurrence of SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff). At the time of the report, SKIN HAEMORRHAGE (Legs are bloody and stuff) and LIMB DISCOMFORT (Legs are bloody and stuff) outcome was unknown.            The Concomitant medications and Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: After about a week following the first shot the patient experienced eczema all over her body; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (After about a week following the first shot the patient experienced eczema all over her body) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-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 ECZEMA (After about a week following the first shot the patient experienced eczema all over her body). At the time of the report, ECZEMA (After about a week following the first shot the patient experienced eczema all over her body) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant was reported by reporter.  The patient stated that about  3 months ago , her dermatologist prescribed a steroid cream.   This case was linked to MOD-2021-319068 (Patient Link).
Sex: U
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  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown.            No concomitant medication reported. No treatment medication reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: We tested positive We must have already had covid when we got the shot although we didn't know it; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it) 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 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it). At the time of the report, COVID-19 (We tested positive We must have already had covid when we got the shot although we didn't know it) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The patient received anti-body on 26-Aug-2021.   This case was linked to MOD-2021-319706 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives with no relief; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives with no relief) 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 URTICARIA (Hives with no relief). At the time of the report, URTICARIA (Hives with no relief) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported by the reporter Treatment drugs were not reported by the reporter Patient has been to several doctors with no relief
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: He states his shoulder pain started with the first shot.; His shoulder was sore, like a Charlie's horse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 017E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Sep-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 ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse). At the time of the report, ARTHRALGIA (He states his shoulder pain started with the first shot.) and MYALGIA (His shoulder was sore, like a Charlie's horse) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   This case was linked to MOD-2021-319007 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Side effect; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effect) 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 ADVERSE EVENT (Side effect). At the time of the report, ADVERSE EVENT (Side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment medication information provided
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose > 35 days before second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose) 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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose). In July 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose > 35 days before second dose) had resolved.            No concomitant medication were reported no treatement of medication were reported
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: I lost my taste after getting the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (I lost my taste after getting the vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Sep-2021, the patient experienced AGEUSIA (I lost my taste after getting the vaccine). At the time of the report, AGEUSIA (I lost my taste after getting 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 medications were reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chest pain, Facial discomfort, Malaise, Myalgia
Clinical narrative: not getting 2nd dose on time; her bottom whip was swollen; fever of 100°F; soreness on the left side of her face; increasing left side chest pain/ pain on her chest; swelling on the left side of her face; feeling really sick; heaviness on the left side of her face; arm pain / pain on her left arm within 1 hour of receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face) and SWELLING (her bottom whip was swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine). On 27-Jun-2021, the patient experienced CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), PYREXIA (fever of 100°F) and MYALGIA (soreness on the left side of her face). On 11-Jul-2021, the patient experienced SWELLING (her bottom whip was swollen). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time). At the time of the report, CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), SWELLING (her bottom whip was swollen), PYREXIA (fever of 100°F), VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine) and MYALGIA (soreness on the left side of her face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2021, Body temperature: 100 (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has not taken second dose due to fear. She had pain in her chest and lower arm. Concomitant medications were not provided. Treatment information was not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia, Swelling, Swelling face, Vaccination site pain
Clinical narrative: not getting 2nd dose on time; her bottom whip was swollen; fever of 100°F; soreness on the left side of her face; increasing left side chest pain/ pain on her chest; swelling on the left side of her face; feeling really sick; heaviness on the left side of her face; arm pain / pain on her left arm within 1 hour of receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face) and SWELLING (her bottom whip was swollen) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051e21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine). On 27-Jun-2021, the patient experienced CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), PYREXIA (fever of 100°F) and MYALGIA (soreness on the left side of her face). On 11-Jul-2021, the patient experienced SWELLING (her bottom whip was swollen). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time). At the time of the report, CHEST PAIN (increasing left side chest pain/ pain on her chest), SWELLING FACE (swelling on the left side of her face), MALAISE (feeling really sick), FACIAL DISCOMFORT (heaviness on the left side of her face), SWELLING (her bottom whip was swollen), PYREXIA (fever of 100°F), VACCINATION SITE PAIN (arm pain / pain on her left arm within 1 hour of receiving the vaccine) and MYALGIA (soreness on the left side of her face) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (not getting 2nd dose on time) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jun-2021, Body temperature: 100 (High) 100°F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has not taken second dose due to fear. She had pain in her chest and lower arm. Concomitant medications were not provided. Treatment information was not provided.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Product dose omission issue, Sensory disturbance
Clinical narrative: had a bad reaction; swollen "giant" arm; redness; hives; when trying to touch the arm "it felt like my hands were knives", "it hurt really bad"; something moving towards her heart and down her back; Did not take second dose (over 6 months now); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, and PAIN IN EXTREMITY in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fruit allergy (bananas) and Alcohol allergy (whisky).    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 VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, SENSORY DISTURBANCE, and PRODUCT DOSE OMISSION ISSUE. At the time of the report, VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, and SENSORY DISTURBANCE outcome was unknown and PRODUCT DOSE OMISSION ISSUE had resolved.            No Concomitants and Treatment medication were reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication
Clinical narrative: had a bad reaction; swollen "giant" arm; redness; hives; when trying to touch the arm "it felt like my hands were knives", "it hurt really bad"; something moving towards her heart and down her back; Did not take second dose (over 6 months now); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, and PAIN IN EXTREMITY in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fruit allergy (bananas) and Alcohol allergy (whisky).    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 VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, SENSORY DISTURBANCE, and PRODUCT DOSE OMISSION ISSUE. At the time of the report, VACCINATION COMPLICATION, PERIPHERAL SWELLING, ERYTHEMA, URTICARIA, PAIN IN EXTREMITY, and SENSORY DISTURBANCE outcome was unknown and PRODUCT DOSE OMISSION ISSUE had resolved.            No Concomitants and Treatment medication were reported.