chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vasodilatation
Clinical narrative: Developed a huge rash at injection site; Itchy rash; swollen glands; 103.7 fever; nauseous; pain in head; Delirium; confusion; couldn't get out of bed i had no known coverage; Ear hurt; Throat hurt; weak; Migraine; sweating; Vein burst in left wrist and stomach; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (Delirium) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Broken bones and Surgery. Concurrent medical conditions included Neck pain. Concomitant products included OXYCODONE from 05-Jan-2021 to an unknown date for Neck pain.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced DELIRIUM (Delirium) (seriousness criterion medically significant), CONFUSIONAL STATE (confusion), MOBILITY DECREASED (couldn't get out of bed i had no known coverage), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head). On 31-Jan-2021, the patient experienced RASH PRURITIC (Itchy rash) and INJECTION SITE RASH (Developed a huge rash at injection site). On 05-Feb-2021, MOBILITY DECREASED (couldn't get out of bed i had no known coverage) had resolved with sequelae, INJECTION SITE RASH (Developed a huge rash at injection site) had resolved. At the time of the report, DELIRIUM (Delirium), CONFUSIONAL STATE (confusion), EAR PAIN (Ear hurt), OROPHARYNGEAL PAIN (Throat hurt), ASTHENIA (weak), MIGRAINE (Migraine), HYPERHIDROSIS (sweating), VASODILATATION (Vein burst in left wrist and stomach), LYMPHADENOPATHY (swollen glands), PYREXIA (103.7 fever), NAUSEA (nauseous) and HEADACHE (pain in head) was resolving and RASH PRURITIC (Itchy rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.7.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Treatment information was not provided.   This case was linked to MOD-2021-280549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Upon follow-up receipt: New events were added. Product second dose added, Concomitant medication information added. Patient demographics added.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received the 2nd dose 20 days after their first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 030B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose). On 20-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received the 2nd dose 20 days after their first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: sore jaw; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (sore jaw) 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 PAIN IN JAW (sore jaw). At the time of the report, PAIN IN JAW (sore jaw) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash side effect; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (rash side effect). At the time of the report, RASH (rash side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    The patient's past medical history included Prostatectomy (Patient got prostate removed 6 years ago and followed up immediately with radiation).   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 PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine). At the time of the report, PROSTATIC SPECIFIC ANTIGEN INCREASED (I had my PSA jump from O.01 to 1.8  after receiving my second Moderna covid vaccine dose/PSA was 0 for 6 years after having my prostate removed reappeared after receiving the vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Prostatic specific antigen: 1.8 (High) High.   No concomitant drugs were reported. No treatment medications were reported.  Patient reported that the Prostate specific antigen reading was less than 0.01 for 6 years.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow-up document received. Added information about the start date of the event (prostate specific antigen increased).
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Chapped lips, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: sores in mouth; chapped lips; fever; chills; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: sores in mouth; chapped lips; fever; chills; body ache; headache; This spontaneous case was reported by a consumer and describes the occurrence of STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills) and MYALGIA (body ache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache). At the time of the report, STOMATITIS (sores in mouth), CHAPPED LIPS (chapped lips), PYREXIA (fever), CHILLS (chills), MYALGIA (body ache) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drugs were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Right arm has a lump on it; The right arm got sore; Right arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen). At the time of the report, VACCINATION SITE MASS (Right arm has a lump on it), VACCINATION SITE PAIN (The right arm got sore) and VACCINATION SITE SWELLING (Right arm is swollen) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Magnetic resonance imaging: abnormal (abnormal) Seems to be an abscess.         Patient was on concomitant medications blood pressure medications and  diabetes medications.  Treatment medication was not provided
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a sore arm) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced MYALGIA (a sore arm). At the time of the report, MYALGIA (a sore arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: soreness still flares up at the chest; 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 CHEST PAIN (soreness still flares up at the chest) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (soreness still flares up at the chest). The patient was treated with PARACETAMOL (TYLENOL) for Chest pain, at a dose of UNK dosage form. At the time of the report, CHEST PAIN (soreness still flares up at the chest) outcome was unknown.            It was reported that the patient's concomitant medications included unspecified diabetes medications and unspecified blood pressure medications.   This case was linked to MOD-2021-220389 (Dose 1) (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: covid positive; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (covid positive) 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 SARS-COV-2 TEST POSITIVE (covid positive). At the time of the report, SARS-COV-2 TEST POSITIVE (covid positive) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: missed the window for dose 2 of the vaccine/one week past the 42 day; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed the window for dose 2 of the vaccine/one week past the 42 day) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: my arm my left side of my body this is not normal,this is so very painful; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my arm my left side of my body this is not normal,this is so very painful), CHILLS (chills) and PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (my arm my left side of my body this is not normal,this is so very painful), CHILLS (chills) and PYREXIA (fever). At the time of the report, MYALGIA (my arm my left side of my body this is not normal,this is so very painful), CHILLS (chills) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant information provided. Patient had vaccine  shot over 2 weeks ago. No treatment information provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Peripheral swelling, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of peripheral swelling (arm is swollen), pain in extremity (arm has broken out a little bit), inappropriate schedule of product administration (first dose in November 2020; second dose on June 11, 2021) and rash on the arm in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. Concomitant products included potassium and vitamins (NOS) for an unknown indication. November 2020, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. On an unknown date, patient had peripheral swelling (arm is swollen), pain in extremity (arm has broken out a little bit), inappropriate schedule of product administration (first dose in November 2020; second dose on June 11, 2021) and rash on the arm. At the time of the report, peripheral swelling (arm is swollen), pain in extremity (arm has broken out a little bit) and rash on the arm outcome: unknown; and inappropriate schedule of product administration (first dose in November 2020; second dose on June 11, 2021) resolved. For the swelling on her arm, she used an icepack as a treatment. This case linked to MOD-2021-220945 (patient link).
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Hyperhidrosis, Pyrexia
Clinical narrative: sweating; his stomach hurt if he ate or drank anything/Stomach hurting a bit; had a really high fever/Still has fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (his stomach hurt if he ate or drank anything/Stomach hurting a bit), HYPERHIDROSIS (sweating) and PYREXIA (had a really high fever/Still has fever) 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 11-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jun-2021, the patient experienced PYREXIA (had a really high fever/Still has fever). On 13-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (his stomach hurt if he ate or drank anything/Stomach hurting a bit). On 14-Jun-2021, the patient experienced HYPERHIDROSIS (sweating). At the time of the report, ABDOMINAL PAIN UPPER (his stomach hurt if he ate or drank anything/Stomach hurting a bit) and PYREXIA (had a really high fever/Still has fever) had not resolved and HYPERHIDROSIS (sweating) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was included. No treatment drug details was provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dry throat, Fatigue, Headache
Clinical narrative: No energy; Flu like symptoms; Dry throat which makes patient cough a lot; Runny nose; Dry throat which makes patient cough a lot; Fatigue; Head aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose) and COUGH (Dry throat which makes patient cough a lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose), COUGH (Dry throat which makes patient cough a lot), FATIGUE (Fatigue) and HEADACHE (Head aches). At the time of the report, ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose), COUGH (Dry throat which makes patient cough a lot), FATIGUE (Fatigue) and HEADACHE (Head aches) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Rhinorrhoea
Clinical narrative: No energy; Flu like symptoms; Dry throat which makes patient cough a lot; Runny nose; Dry throat which makes patient cough a lot; Fatigue; Head aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose) and COUGH (Dry throat which makes patient cough a lot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received 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 ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose), COUGH (Dry throat which makes patient cough a lot), FATIGUE (Fatigue) and HEADACHE (Head aches). At the time of the report, ASTHENIA (No energy), INFLUENZA LIKE ILLNESS (Flu like symptoms), DRY THROAT (Dry throat which makes patient cough a lot), RHINORRHOEA (Runny nose), COUGH (Dry throat which makes patient cough a lot), FATIGUE (Fatigue) and HEADACHE (Head aches) outcome was unknown.            Concomitant medication information not provided.  Treatment information not provided.  Action taken with mRNA-1273 in response to the event/s was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines constant; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (migraines constant) 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 MIGRAINE (migraines constant). At the time of the report, MIGRAINE (migraines constant) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site discolouration, Vaccination site warmth
Clinical narrative: Injection site is hot; Injection site is a bit blotchy; Felt terrible; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site is hot), VACCINATION SITE DISCOLOURATION (Injection site is a bit blotchy) and FEELING ABNORMAL (Felt terrible) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jun-2021, the patient experienced FEELING ABNORMAL (Felt terrible). On 14-Jun-2021, the patient experienced VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE DISCOLOURATION (Injection site is a bit blotchy). At the time of the report, VACCINATION SITE WARMTH (Injection site is hot) and VACCINATION SITE DISCOLOURATION (Injection site is a bit blotchy) outcome was unknown and FEELING ABNORMAL (Felt terrible) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter.  Treatment medication was not provided by the reporter.    Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: non stop vomiting; non stop diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (non stop vomiting) and DIARRHOEA (non stop diarrhea) 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 VOMITING (non stop vomiting) and DIARRHOEA (non stop diarrhea). At the time of the report, VOMITING (non stop vomiting) and DIARRHOEA (non stop diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient's concomitant medication was not reported.  No treatment medication was reported.
Sex: U
Vaccine: COVID19
Symptoms: Muscle twitching
Clinical narrative: left hand is twitching; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (left hand is twitching) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (left hand is twitching). At the time of the report, MUSCLE TWITCHING (left hand is twitching) outcome was unknown.            No concomitant medication was reported. Treatment Information was not provided by the reporter. It was reported that the patient received the second dose yesterday.  No treatment medication was reported .
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nasopharyngitis, Pain
Clinical narrative: very cold; Headache; Pain; a little pain in the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of NASOPHARYNGITIS (very cold), PAIN (Pain), INJECTION SITE PAIN (a little pain in the injection site) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN (Pain) and INJECTION SITE PAIN (a little pain in the injection site). On 03-Feb-2021, the patient experienced NASOPHARYNGITIS (very cold) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. On 03-Feb-2021, NASOPHARYNGITIS (very cold) and HEADACHE (Headache) had resolved. At the time of the report, PAIN (Pain) and INJECTION SITE PAIN (a little pain in the injection site) outcome was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 002A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Sulfa drug), Drug allergy, Galactose intolerance, Fructose intolerance and Gluten intolerance. Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for Hormone therapy, MULTIVITAMIN [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for Supplementation therapy.   On 27-Feb-2021 at 11:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced TINNITUS (Tinnitus). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Tinnitus, at a dose of 1 UNK. At the time of the report, TINNITUS (Tinnitus) had not resolved.            Patient reported a gradual worsening of the tinnitus until could hear it while talking. Patient stated that doctors exam showed no external ear problems and normal blood pressure. Concomitant medications include lutein and acidophilous.  The patient had galactose, fructose, gluten allergy.   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow-up was received to include reporter's contact information. On 10-Aug-2021: Significant F/UP: Onset date, doctors visit for Dose-2 event,concomitant medications addded
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I had  my first dose 7 weeks ago - is it to late to get the second dose?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I had  my first dose 7 weeks ago - is it to late to get the second 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had  my first dose 7 weeks ago - is it to late to get the second dose?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had  my first dose 7 weeks ago - is it to late to get the second dose?) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No information regarding corrective treatment was reported by the patient.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) 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 DYSPNOEA (Shortness of breath). At the time of the report, DYSPNOEA (Shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: was given the first dose approx. 2 moths ago; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (was given the first dose approx. 2 moths ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    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 (was given the first dose approx. 2 moths ago). At the time of the report, PRODUCT DOSE OMISSION ISSUE (was given the first dose approx. 2 moths ago) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. The patient wanted to know what to do. No treatment medications were provided.  Company Comment: This report refers to a case of Product dose omission for mRNA-1273 in an immunosuppressed patient, with no adverse events.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of Product dose omission for mRNA-1273 in an immunosuppressed patient, with no adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of headache and myalgia (body aches) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Jun 13, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jun 14, 2021, patient experienced headache and myalgia (body aches). At the time of the report, headache and myalgia (body aches): unresolved. No concomitant medication or treatment information reported.
Sex: U
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: coughing; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (coughing) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (coughing). At the time of the report, COUGH (coughing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Nodule, Rash, Rash vesicular
Clinical narrative: bad rash on my arm with blisters in the center; blisters on the back of my tongue; bad rash on my arm with blisters in the center; Arm has a big knot the size of an egg which got bigger; arm  red; Feel very hot to the touch/hotness; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red), FEELING HOT (Feel very hot to the touch/hotness), TONGUE BLISTERING (blisters on the back of my tongue) and RASH VESICULAR (bad rash on my arm with blisters in the center) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red) and FEELING HOT (Feel very hot to the touch/hotness). On 16-Jun-2021, the patient experienced TONGUE BLISTERING (blisters on the back of my tongue) and RASH VESICULAR (bad rash on my arm with blisters in the center). On an unknown date, the patient experienced RASH (bad rash on my arm with blisters in the center). The patient was treated with AZITHROMYCIN (Z-PAK) for Blisters, at an unspecified dose and frequency. At the time of the report, NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red), FEELING HOT (Feel very hot to the touch/hotness) and RASH (bad rash on my arm with blisters in the center) outcome was unknown, TONGUE BLISTERING (blisters on the back of my tongue) had not resolved and RASH VESICULAR (bad rash on my arm with blisters in the center) had resolved.            No concomitant medication was reported.  Action taken with mRNA-1273 in response to the event/s was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Follow up received on 03-Jul-2021. New events were added and Treatment medication were added.
Sex: U
Vaccine: COVID19
Symptoms: Tongue blistering
Clinical narrative: bad rash on my arm with blisters in the center; blisters on the back of my tongue; bad rash on my arm with blisters in the center; Arm has a big knot the size of an egg which got bigger; arm  red; Feel very hot to the touch/hotness; This spontaneous case was reported by a consumer and describes the occurrence of NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red), FEELING HOT (Feel very hot to the touch/hotness), TONGUE BLISTERING (blisters on the back of my tongue) and RASH VESICULAR (bad rash on my arm with blisters in the center) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 13-Jun-2021 at 11:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In June 2021, the patient experienced NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red) and FEELING HOT (Feel very hot to the touch/hotness). On 16-Jun-2021, the patient experienced TONGUE BLISTERING (blisters on the back of my tongue) and RASH VESICULAR (bad rash on my arm with blisters in the center). On an unknown date, the patient experienced RASH (bad rash on my arm with blisters in the center). The patient was treated with AZITHROMYCIN (Z-PAK) for Blisters, at an unspecified dose and frequency. At the time of the report, NODULE (Arm has a big knot the size of an egg which got bigger), ERYTHEMA (arm  red), FEELING HOT (Feel very hot to the touch/hotness) and RASH (bad rash on my arm with blisters in the center) outcome was unknown, TONGUE BLISTERING (blisters on the back of my tongue) had not resolved and RASH VESICULAR (bad rash on my arm with blisters in the center) had resolved.            No concomitant medication was reported.  Action taken with mRNA-1273 in response to the event/s was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jul-2021: Follow up received on 03-Jul-2021. New events were added and Treatment medication were added.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chills, Heart rate, Pyrexia
Clinical narrative: chest feels tight; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest feels tight), PYREXIA (fever) and CHILLS (chills) 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 04-Feb-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 CHEST DISCOMFORT (chest feels tight), PYREXIA (fever) and CHILLS (chills). At the time of the report, CHEST DISCOMFORT (chest feels tight), PYREXIA (fever) and CHILLS (chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: 92 (Inconclusive) 92 bpm.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drugs were reported. No treatment medication details were provided.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Myalgia, Nerve injury, Paraesthesia
Clinical narrative: Tingling in her hands and bottom of the foot and legs; Nerves are in overdrive; Injection site pain; Tiredness; Body aches; Rash; Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling in her hands and bottom of the foot and legs), NERVE INJURY (Nerves are in overdrive), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness), MYALGIA (Body aches), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PARAESTHESIA (Tingling in her hands and bottom of the foot and legs) and NERVE INJURY (Nerves are in overdrive). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. On 08-May-2021, VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness), MYALGIA (Body aches), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PARAESTHESIA (Tingling in her hands and bottom of the foot and legs) and NERVE INJURY (Nerves are in overdrive) outcome was unknown.            No concomitant medications were provided. No treatment was reported for the events.  Action taken with the drug in response to events was not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Vaccination site pain
Clinical narrative: Tingling in her hands and bottom of the foot and legs; Nerves are in overdrive; Injection site pain; Tiredness; Body aches; Rash; Chills; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA (Tingling in her hands and bottom of the foot and legs), NERVE INJURY (Nerves are in overdrive), VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness), MYALGIA (Body aches), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever). On an unknown date, the patient experienced PARAESTHESIA (Tingling in her hands and bottom of the foot and legs) and NERVE INJURY (Nerves are in overdrive). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. On 08-May-2021, VACCINATION SITE PAIN (Injection site pain), FATIGUE (Tiredness), MYALGIA (Body aches), RASH (Rash), CHILLS (Chills) and PYREXIA (Fever) had resolved. At the time of the report, PARAESTHESIA (Tingling in her hands and bottom of the foot and legs) and NERVE INJURY (Nerves are in overdrive) outcome was unknown.            No concomitant medications were provided. No treatment was reported for the events.  Action taken with the drug in response to events was not applicable.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 042B21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Sulfa drugs) and Drug allergy (Vitamin E topical). Concomitant products included FLUOXETINE from 09-Sep-2000 to an unknown date for an unknown indication.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021 at 4:10 PM, 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 SOMNOLENCE (Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs). At the time of the report, SOMNOLENCE (Since getting the vaccine, I noticed that I need 9-10 hours of sleep a night.  Before, I needed 8 hrs sleep./now I need 10 hrs of sleep each night; before I needed 8 hrs) had not resolved.            No treatment information was provided.  Patient was experienced lethargy and body aches for 2 days after one of the shots.    Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Significant Follow-up received - Patient demographics, reporter details, suspect product, concomitant product details, vaccination facility details and narrative updated. On 04-Aug-2021: Non-Significant Follow up