chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second Dose Administered 18 days after the First Shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Administered 18 days after the First Shot) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Administered 18 days after the First Shot). On 14-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second Dose Administered 18 days after the First Shot) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Significant FU Correspondence mail - Patient stated no adverse reactions.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: two 16 year old patients that received the Moderna covid vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two 16 year old patients that received the Moderna covid vaccination) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 02B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.  On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form.   On 03-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two 16 year old patients that received the Moderna covid vaccination). On 03-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (two 16 year old patients that received the Moderna covid vaccination) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-067524 (Patient Link).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, SARS-CoV-2 test, Swelling of eyelid
Clinical narrative: swelling under the left eye; slight swelling of her upper eyelid; This spontaneous case was reported by an other health care professional and describes the occurrence of EYE SWELLING (swelling under the left eye) and SWELLING OF EYELID (slight swelling of her upper eyelid) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Long QT. Concurrent medical conditions included Allergy NOS (common allergies). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE SWELLING (swelling under the left eye) and SWELLING OF EYELID (slight swelling of her upper eyelid). The patient was treated with LORATADINE (CLARITINE) for Swelling, at a dose of Claritin at night; FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Swelling, at a dose of Flonase in the morning, one spray in each nostril; CORTISONE for Swelling, at a dose of Cortisone cream and PARACETAMOL (TYLENOL) for Swelling, at a dose of 1 UNK. At the time of the report, EYE SWELLING (swelling under the left eye) and SWELLING OF EYELID (slight swelling of her upper eyelid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Relevant concomitant medications also included natarol. Patient experienced swelling under the left eye which progressed to her left upper eyelid. 4-5 days later the right eyelid and under the right eye started to swell.She had seen a physician where they did a throat culture, covid test, blood work and immunology studies.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: What are the typical side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (What are the typical 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (What are the typical side effects). At the time of the report, VACCINATION COMPLICATION (What are the typical side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided. No concomitant medications reported.
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder
Clinical narrative: Weird taste in my mouth and it starts in my sinuses after the 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Weird taste in my mouth and it starts in my sinuses after the 2nd dose) 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 TASTE DISORDER (Weird taste in my mouth and it starts in my sinuses after the 2nd dose). At the time of the report, TASTE DISORDER (Weird taste in my mouth and it starts in my sinuses after the 2nd dose) outcome was unknown.            No concomitant medications were provided. No treatment was reported for the events.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, Chills, Headache, Heart rate
Clinical narrative: Shivering, shaking; Headache; Shivering, shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shivering, shaking), HEADACHE (Headache), CHILLS (Shivering, shaking) and PYREXIA (Fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 13-Apr-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 13-Apr-2021, the patient experienced CHILLS (Shivering, shaking) and PYREXIA (Fever). On an unknown date, the patient experienced TREMOR (Shivering, shaking) and HEADACHE (Headache). At the time of the report, TREMOR (Shivering, shaking), HEADACHE (Headache) and CHILLS (Shivering, shaking) outcome was unknown and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: high (High) High. On 13-Apr-2021, Body temperature: 100.7 (High) fever 100.7. On 13-Apr-2021, Heart rate: 155 per minute (High) 155/ Min. On 13-Apr-2021, Oxygen saturation: low (Low) Low.         Steroid inhaler was taken as concomitant medication. No treatment information was provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Pyrexia, Tremor
Clinical narrative: Shivering, shaking; Headache; Shivering, shaking; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shivering, shaking), HEADACHE (Headache), CHILLS (Shivering, shaking) and PYREXIA (Fever) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 13-Apr-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 13-Apr-2021, the patient experienced CHILLS (Shivering, shaking) and PYREXIA (Fever). On an unknown date, the patient experienced TREMOR (Shivering, shaking) and HEADACHE (Headache). At the time of the report, TREMOR (Shivering, shaking), HEADACHE (Headache) and CHILLS (Shivering, shaking) outcome was unknown and PYREXIA (Fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Apr-2021, Blood pressure measurement: high (High) High. On 13-Apr-2021, Body temperature: 100.7 (High) fever 100.7. On 13-Apr-2021, Heart rate: 155 per minute (High) 155/ Min. On 13-Apr-2021, Oxygen saturation: low (Low) Low.         Steroid inhaler was taken as concomitant medication. No treatment information was provided.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Got 1st shot at 17yrs; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got 1st shot at 17yrs) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got 1st shot at 17yrs). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Got 1st shot at 17yrs) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported.   Patient was due for 2nd shot 14-Jun-2021.  Treatment information not reported.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: first dose administered 41 days ago 4May2021; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (first dose administered 41 days ago 4May2021) 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 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose administered 41 days ago 4May2021). On 04-May-2021, PRODUCT DOSE OMISSION ISSUE (first dose administered 41 days ago 4May2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information not reported.   Reporter did not allow further contact
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Discomfort, Feeling abnormal, Head discomfort, Headache
Clinical narrative: whole body weakness; felt like having a flu; migraine; head felt like it is going to explode; arms felt like inflamed; feeling he is going to die; thirsty all the time; felt body was messed up; whole body hurts; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (whole body weakness), INFLUENZA LIKE ILLNESS (felt like having a flu), MIGRAINE (migraine), HEAD DISCOMFORT (head felt like it is going to explode) and PERIPHERAL SWELLING (arms felt like inflamed) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced ASTHENIA (whole body weakness), INFLUENZA LIKE ILLNESS (felt like having a flu), MIGRAINE (migraine), HEAD DISCOMFORT (head felt like it is going to explode), PERIPHERAL SWELLING (arms felt like inflamed), FEELING ABNORMAL (feeling he is going to die), THIRST (thirsty all the time), DISCOMFORT (felt body was messed up), MYALGIA (whole body hurts) and HEADACHE (headache). On 25-Apr-2021, ASTHENIA (whole body weakness), INFLUENZA LIKE ILLNESS (felt like having a flu), MIGRAINE (migraine), HEAD DISCOMFORT (head felt like it is going to explode), PERIPHERAL SWELLING (arms felt like inflamed), FEELING ABNORMAL (feeling he is going to die), THIRST (thirsty all the time), DISCOMFORT (felt body was messed up), MYALGIA (whole body hurts) and HEADACHE (headache) had resolved.            Patient used to take his mental health medications but has stopped 2-3 months from the time reporting.  No concomitant medications reported.  Patient did not take any medication for the symptoms.   This case was linked to MOD-2021-221087 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza like illness, Migraine, Myalgia, Peripheral swelling, Thirst
Clinical narrative: whole body weakness; felt like having a flu; migraine; head felt like it is going to explode; arms felt like inflamed; feeling he is going to die; thirsty all the time; felt body was messed up; whole body hurts; headache; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (whole body weakness), INFLUENZA LIKE ILLNESS (felt like having a flu), MIGRAINE (migraine), HEAD DISCOMFORT (head felt like it is going to explode) and PERIPHERAL SWELLING (arms felt like inflamed) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032621A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Penicillin allergy.    On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Apr-2021, the patient experienced ASTHENIA (whole body weakness), INFLUENZA LIKE ILLNESS (felt like having a flu), MIGRAINE (migraine), HEAD DISCOMFORT (head felt like it is going to explode), PERIPHERAL SWELLING (arms felt like inflamed), FEELING ABNORMAL (feeling he is going to die), THIRST (thirsty all the time), DISCOMFORT (felt body was messed up), MYALGIA (whole body hurts) and HEADACHE (headache). On 25-Apr-2021, ASTHENIA (whole body weakness), INFLUENZA LIKE ILLNESS (felt like having a flu), MIGRAINE (migraine), HEAD DISCOMFORT (head felt like it is going to explode), PERIPHERAL SWELLING (arms felt like inflamed), FEELING ABNORMAL (feeling he is going to die), THIRST (thirsty all the time), DISCOMFORT (felt body was messed up), MYALGIA (whole body hurts) and HEADACHE (headache) had resolved.            Patient used to take his mental health medications but has stopped 2-3 months from the time reporting.  No concomitant medications reported.  Patient did not take any medication for the symptoms.   This case was linked to MOD-2021-221087 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: severe diarrhea 3 days after his second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (severe diarrhea 3 days after his second vaccine) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (severe diarrhea 3 days after his second vaccine). At the time of the report, DIARRHOEA (severe diarrhea 3 days after his second vaccine) outcome was unknown.            No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up report received included no new information. On 15-Jun-2021: Reporter's Email address was updated.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient missed second dose on 01MAY2021; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed second dose on 01MAY2021) 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 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed second dose on 01MAY2021). On 14-Jun-2021, PRODUCT DOSE OMISSION ISSUE (Patient missed second dose on 01MAY2021) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Blood pressure measurement, Dyspnoea, Palpitations
Clinical narrative: Palpitations; Shortness of Breath; Loss of memory; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Palpitations), DYSPNOEA (Shortness of Breath) and AMNESIA (Loss of memory) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Palpitations), DYSPNOEA (Shortness of Breath) and AMNESIA (Loss of memory). At the time of the report, PALPITATIONS (Palpitations), DYSPNOEA (Shortness of Breath) and AMNESIA (Loss of memory) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-May-2021, Blood pressure measurement: dropped (Low) Decreased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vaccination site pain
Clinical narrative: aches for a short period of time; Chills/ body chills; soreness in the arm from the needle; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches for a short period of time), CHILLS (Chills/ body chills) and VACCINATION SITE PAIN (soreness in the arm from the needle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMINS [VITAMINS NOS] for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches for a short period of time), CHILLS (Chills/ body chills) and VACCINATION SITE PAIN (soreness in the arm from the needle). At the time of the report, MYALGIA (aches for a short period of time), CHILLS (Chills/ body chills) and VACCINATION SITE PAIN (soreness in the arm from the needle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-221084 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: can i get the second vaccine now; COVID; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 14-Jun-2021 and was forwarded to Moderna on 14-Jun-2021.    This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID) and PRODUCT DOSE OMISSION ISSUE (can i get the second vaccine now) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, the patient experienced COVID-19 (COVID). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (can i get the second vaccine now). The patient was treated with MONOCLONAL ANTIBODIES (intravenous) ongoing from 13-Mar-2021 for COVID-19, at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID) and PRODUCT DOSE OMISSION ISSUE (can i get the second vaccine now) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Mar-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.   Reporter did not allow further contact
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Pyrexia, Vaccination site pain
Clinical narrative: temperature of 100.2 deg. F; Nauseas; arm is in horrible pain on the injection site.; right after the vaccination she felt dizzy; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (temperature of 100.2 deg. F), DIZZINESS (right after the vaccination she felt dizzy), NAUSEA (Nauseas) and VACCINATION SITE PAIN (arm is in horrible pain on the injection site.) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, the patient experienced DIZZINESS (right after the vaccination she felt dizzy). On 07-Feb-2021, the patient experienced PYREXIA (temperature of 100.2 deg. F), NAUSEA (Nauseas) and VACCINATION SITE PAIN (arm is in horrible pain on the injection site.). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 3 dosage form. At the time of the report, PYREXIA (temperature of 100.2 deg. F), DIZZINESS (right after the vaccination she felt dizzy), NAUSEA (Nauseas) and VACCINATION SITE PAIN (arm is in horrible pain on the injection site.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. Patient took Advil as a treatment drug. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: should my chest be hurting; This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (should my chest be hurting) 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 (should my chest be hurting). At the time of the report, CHEST PAIN (should my chest be hurting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported by the reporter. No treatment medications were reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Peripheral swelling
Clinical narrative: severe allergic reaction; started out on my top tip swelling up an the bottom of my feet an the palm of my hand swelling; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (severe allergic reaction) and PERIPHERAL SWELLING (started out on my top tip swelling up an the bottom of my feet an the palm of my hand swelling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERSENSITIVITY (severe allergic reaction) and PERIPHERAL SWELLING (started out on my top tip swelling up an the bottom of my feet an the palm of my hand swelling). At the time of the report, HYPERSENSITIVITY (severe allergic reaction) and PERIPHERAL SWELLING (started out on my top tip swelling up an the bottom of my feet an the palm of my hand swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: CHILLS; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and HEADACHE (Headache) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHILLS (CHILLS) and HEADACHE (Headache). At the time of the report, CHILLS (CHILLS) and HEADACHE (Headache) had resolved. Unknown          No concomitant medications were reported.  No treatment medications were provided.    This case was linked to MOD-2021-016944 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: serious issues after second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (serious issues after second shot) 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 VACCINATION COMPLICATION (serious issues after second shot). At the time of the report, VACCINATION COMPLICATION (serious issues after second shot) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Rash macular, Vaccination complication
Clinical narrative: Delayed reaction (After 6 weeks of Vaccine); Blotchy skin; High fever (6 weeks after shot)/fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Delayed reaction (After 6 weeks of Vaccine)), RASH MACULAR (Blotchy skin) and PYREXIA (High fever (6 weeks after shot)/fever) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Delayed reaction (After 6 weeks of Vaccine)), RASH MACULAR (Blotchy skin) and PYREXIA (High fever (6 weeks after shot)/fever). At the time of the report, VACCINATION COMPLICATION (Delayed reaction (After 6 weeks of Vaccine)), RASH MACULAR (Blotchy skin) and PYREXIA (High fever (6 weeks after shot)/fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reporterd by the reporter. No treatment medications were reported by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Nausea, Vomiting
Clinical narrative: Nausea; Fatigue; It was heavy because she had to drink water otherwise, she would have thrown up; It was heavy because she had to drink water otherwise, she would have thrown up; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), FATIGUE (Fatigue), VOMITING (It was heavy because she had to drink water otherwise, she would have thrown up) and DISCOMFORT (It was heavy because she had to drink water otherwise, she would have thrown up) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 039K20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-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 NAUSEA (Nausea), FATIGUE (Fatigue), VOMITING (It was heavy because she had to drink water otherwise, she would have thrown up) and DISCOMFORT (It was heavy because she had to drink water otherwise, she would have thrown up). At the time of the report, NAUSEA (Nausea), FATIGUE (Fatigue), VOMITING (It was heavy because she had to drink water otherwise, she would have thrown up) and DISCOMFORT (It was heavy because she had to drink water otherwise, she would have thrown up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she did not take any medication as she was scared about interaction of  medication with the vaccine.    This case was linked to MOD-2021-221084 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: bad fatigue for 2-3 days; right arm hurts all the time for 1 week; able to stick magnets unto his arm for 4 times; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (bad fatigue for 2-3 days), PAIN IN EXTREMITY (right arm hurts all the time for 1 week) and ADVERSE EVENT FOLLOWING IMMUNISATION (able to stick magnets unto his arm for 4 times) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C214 and 032621A) for COVID-19 vaccination.     The patient's past medical history included Mental disorder NOS (Patient stated that he used to take his mental health medications but has stopped 2-3 months now.). Concurrent medical conditions included Penicillin allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced FATIGUE (bad fatigue for 2-3 days), PAIN IN EXTREMITY (right arm hurts all the time for 1 week) and ADVERSE EVENT FOLLOWING IMMUNISATION (able to stick magnets unto his arm for 4 times). At the time of the report, FATIGUE (bad fatigue for 2-3 days) and PAIN IN EXTREMITY (right arm hurts all the time for 1 week) had resolved and ADVERSE EVENT FOLLOWING IMMUNISATION (able to stick magnets unto his arm for 4 times) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   This case was linked to MOD-2021-221052 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lingered Swollen lymph glands/Throat glands have been swollen; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lingered Swollen lymph glands/Throat glands have been swollen) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (Lingered Swollen lymph glands/Throat glands have been swollen). At the time of the report, LYMPHADENOPATHY (Lingered Swollen lymph glands/Throat glands have been swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient has stated the patient has experienced swollen throat glands, it was lingering but it was not severe. Patient has asked that patient should take the next dose or not. No Concomitant and treatment medication was provided by the Reporter.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Non Significant follow up appended to AER
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Headaches after the vaccine; Muscle pain after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches after the vaccine) and MYALGIA (Muscle pain after the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headaches after the vaccine) and MYALGIA (Muscle pain after the vaccine). At the time of the report, HEADACHE (Headaches after the vaccine) and MYALGIA (Muscle pain after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Cough; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) 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 15-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jun-2021, the patient experienced COUGH (Cough). At the time of the report, COUGH (Cough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided. No treatment information given.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Feeling abnormal
Clinical narrative: stomach began hurting; not feeling like herself; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach began hurting) and FEELING ABNORMAL (not feeling like herself) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     no medical history was reported.  Concomitant products included CYCLOSPORINE, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), ALBUTEROL [SALBUTAMOL], ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ATORVASTATIN, BENZONATATE, CELECOXIB, DULOXETINE, GABAPENTIN and HYDRALAZINE for an unknown indication.    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach began hurting) and FEELING ABNORMAL (not feeling like herself). At the time of the report, ABDOMINAL PAIN UPPER (stomach began hurting) and FEELING ABNORMAL (not feeling like herself) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment drug information was not given.    Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: NNI FU- No new information
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation
Clinical narrative: After my 2nd shot Im having burning eyes.; This spontaneous case was reported by a consumer and describes the occurrence of EYE IRRITATION (After my 2nd shot Im having burning eyes.) 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) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Jun-2021, the patient experienced EYE IRRITATION (After my 2nd shot Im having burning eyes.). At the time of the report, EYE IRRITATION (After my 2nd shot Im having burning eyes.) outcome was unknown.            No concomitant medication listed.  No treatment information reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Vaccine reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Vaccine reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Vaccine reaction). At the time of the report, VACCINATION SITE REACTION (Vaccine reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported.  No treatment medication were reported.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: eye swelling 10 days after 1st Moderna shot; 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 EYE SWELLING (eye swelling 10 days after 1st Moderna shot) 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE SWELLING (eye swelling 10 days after 1st Moderna shot). At the time of the report, EYE SWELLING (eye swelling 10 days after 1st Moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks; 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 MYALGIA (Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks) 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 MYALGIA (Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks). At the time of the report, MYALGIA (Arm hurt after 3 weeks/arm hurts to lift it up after 3 weeks) 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness of arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness of arm of injection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included HYDROCHLOROTHIAZIDE, CARVEDILOL, SIMVASTATIN and ESCITALOPRAM for an unknown indication.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness of arm of injection). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form three times a day. At the time of the report, VACCINATION SITE PAIN (soreness of arm of injection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-042638 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Fever of 101.8 °F,Still running fever, but not as hig; Still running fever, but not as high; chills,Light chills at first, but got really bad as day goes by; This spontaneous case was reported by a patient and describes the occurrence of CHILLS (chills,Light chills at first, but got really bad as day goes by), PYREXIA (Fever of 101.8 °F,Still running fever, but not as hig) and PYREXIA (Still running fever, but not as high) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 016M20A) for COVID-19 vaccination.     The patient's past medical history included Asthma. Concurrent medical conditions included Sulfonamide allergy and Penicillin allergy. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (chills,Light chills at first, but got really bad as day goes by). On 10-Feb-2021, the patient experienced PYREXIA (Fever of 101.8 °F,Still running fever, but not as hig) and PYREXIA (Still running fever, but not as high). At the time of the report, CHILLS (chills,Light chills at first, but got really bad as day goes by), PYREXIA (Fever of 101.8 °F,Still running fever, but not as hig) and PYREXIA (Still running fever, but not as high) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.8 °f (Inconclusive) 101.8 °F.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Red,raised, warm spot on my arm ,at where i got the shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Red,raised, warm spot on my arm ,at where i got the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 SITE ERYTHEMA (Red,raised, warm spot on my arm ,at where i got the shot). At the time of the report, VACCINATION SITE ERYTHEMA (Red,raised, warm spot on my arm ,at where i got the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant information  provided. No Treatment information  provided; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered from vials which had been more than 6 hours post initial puncture; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered from vials which had been more than 6 hours post initial puncture) 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 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 4 dosage form. On 11-Feb-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered from vials which had been more than 6 hours post initial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered from vials which had been more than 6 hours post initial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reportedly, 4 Moderna COVID-19 vaccine doses were administered from vials which had been more than 6 hours post initial puncture.  Concomitant medications were not provided by reporter. Treatment information was not provided by reporter.   This case was linked to MOD21-028125 (E2B Linked Report).; Sender's Comments:  MOD21-028125:4 expired vaccines administered, no patient identifiers.