chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Couldn't eat or taste; Excruciating pain in feet and hands; Couldn't eat or taste; Arm swollen the size of a cantaloupe; Felt like she had covid; Out of breathe; Couldn't walk; Fever; Chills; Muscle pain in right shoulder; Shoulder feels heavy; Shoulder feels like bumblebees are inside; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe) and FEELING ABNORMAL (Felt like she had covid) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, HYDROCHLOROTHIAZIDE, LOSARTAN, VITAMIN D [VITAMIN D NOS] and BIOTIN for an unknown indication.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever), CHILLS (Chills), MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 500 mg three times a day. On 05-May-2021, DECREASED APPETITE (Couldn't eat or taste), PAIN IN EXTREMITY (Excruciating pain in feet and hands), AGEUSIA (Couldn't eat or taste), PERIPHERAL SWELLING (Arm swollen the size of a cantaloupe), FEELING ABNORMAL (Felt like she had covid), DYSPNEA (Out of breathe), GAIT DISTURBANCE (Couldn't walk), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. At the time of the report, MYALGIA (Muscle pain in right shoulder), ARTHRALGIA (Shoulder feels heavy) and ARTHRALGIA (Shoulder feels like bumblebees are inside) outcome was unknown.            This case was linked to MOD-2021-201239 (Patient Link).
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Myalgia, Weight decreased
Clinical narrative: Became very weak; lost muscle mass; lost 8 lbs; when he moves it hurts; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Became very weak), WEIGHT DECREASED (lost muscle mass), WEIGHT DECREASED (lost 8 lbs) and MYALGIA (when he moves it hurts) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 018B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Became very weak), WEIGHT DECREASED (lost muscle mass), WEIGHT DECREASED (lost 8 lbs) and MYALGIA (when he moves it hurts). The patient was treated with CELECOXIB (CELEBREX) at a dose of UNK dosage form and CYCLOBENZAPRINUM at a dose of UNK dosage form. At the time of the report, ASTHENIA (Became very weak), WEIGHT DECREASED (lost muscle mass), WEIGHT DECREASED (lost 8 lbs) and MYALGIA (when he moves it hurts) outcome was unknown.            Concomitant medications were not provided.   This case was linked to MOD-2021-200648 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Headache; Dizziness; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache), DIZZINESS (Dizziness) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Nausea
Clinical narrative: I have a severe headache and feeling nauseated; I'm nauseated and have a severe headache after getting the vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (I have a severe headache and feeling nauseated) and NAUSEA (I'm nauseated and have a severe headache after getting 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, the patient experienced HEADACHE (I have a severe headache and feeling nauseated) and NAUSEA (I'm nauseated and have a severe headache after getting the vaccine). At the time of the report, HEADACHE (I have a severe headache and feeling nauseated) and NAUSEA (I'm nauseated and have a severe headache after getting the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Treatment medications information were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: Weight gain (around my bra area toward my back on the side); This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT INCREASED (Weight gain (around my bra area toward my back on the side)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 031M20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain (around my bra area toward my back on the side)). At the time of the report, WEIGHT INCREASED (Weight gain (around my bra area toward my back on the side)) outcome was unknown.            No concomitant medications was reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: added reporter demographic details and contact information. patients Gender height weight and race  was added current condition was added dose1& dose2 information was added
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Feel cranky; 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 FEELING ABNORMAL (Feel cranky) 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 FEELING ABNORMAL (Feel cranky). At the time of the report, FEELING ABNORMAL (Feel cranky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided.  No treatment information provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Tremor
Clinical narrative: Shake; Cold; Chills; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shake), NASOPHARYNGITIS (Cold) and CHILLS (Chills) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 015M20A) for COVID-19 vaccination.     The patient's past medical history included Hormone replacement therapy. Concurrent medical conditions included Blood pressure and Diabetes.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Mar-2021, the patient experienced TREMOR (Shake), NASOPHARYNGITIS (Cold) and CHILLS (Chills). At the time of the report, TREMOR (Shake), NASOPHARYNGITIS (Cold) and CHILLS (Chills) outcome was unknown.            The patient is taking medicines for treatment of blood pressure, diabetes, and hormone replacement therapy. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up was received and contains no significant information. On 27-Jul-2021: Follow-up was received and contains no new information.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Induration, Peripheral swelling, Pruritus
Clinical narrative: Swelling arm; Itching; Hardness; Which feels like she was getting a cold; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), INDURATION (Hardness), FEELING COLD (Which feels like she was getting a cold) and FATIGUE (Tired) 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) (Intramuscular) 1 dosage form. In 2021, the patient experienced PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), INDURATION (Hardness), FEELING COLD (Which feels like she was getting a cold) and FATIGUE (Tired). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Swelling arm), PRURITUS (Itching), INDURATION (Hardness), FEELING COLD (Which feels like she was getting a cold) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Additional information received vis Telephone contact report: Updated event onset dates. Consent to follow up updated to denied.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Shin pain; 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 PAIN IN EXTREMITY (Shin pain) 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 PAIN IN EXTREMITY (Shin pain). At the time of the report, PAIN IN EXTREMITY (Shin pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, Pyrexia
Clinical narrative: It has been 8 weeks since the patient received the 1st dose; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (It has been 8 weeks since the patient received the 1st dose) and PYREXIA (Fever) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, the patient experienced PYREXIA (Fever). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (It has been 8 weeks since the patient received the 1st dose). On 16-Apr-2021, PYREXIA (Fever) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (It has been 8 weeks since the patient received the 1st dose) 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.   Concomitant medications included unspecified birth control medications.   At the time of this report, the patient did not get her second dose.  The patient did not take any medication to treat her symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effect / YES; 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 (Side effect / YES) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effect / YES). At the time of the report, VACCINATION COMPLICATION (Side effect / YES) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. No treatment drugs are not provided by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Lacrimation increased, Sinusitis
Clinical narrative: sinus drainage; Watery Eyes; 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 SINUSITIS (sinus drainage) and LACRIMATION INCREASED (Watery Eyes) 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 SINUSITIS (sinus drainage) and LACRIMATION INCREASED (Watery Eyes). At the time of the report, SINUSITIS (sinus drainage) and LACRIMATION INCREASED (Watery Eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications information were not reported.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Haematoma, Joint noise, Myalgia
Clinical narrative: large hematoma on my bicep; clicking; discomfort; burning sensation; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOMA (large hematoma on my bicep), JOINT NOISE (clicking), MYALGIA (discomfort) and BURNING SENSATION (burning sensation) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery (4 years ago to repair a torn labrum in that shoulder).   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, 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 HAEMATOMA (large hematoma on my bicep), JOINT NOISE (clicking), MYALGIA (discomfort) and BURNING SENSATION (burning sensation). At the time of the report, HAEMATOMA (large hematoma on my bicep), JOINT NOISE (clicking), MYALGIA (discomfort) and BURNING SENSATION (burning sensation) outcome was unknown.            No concomitant medication was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.            Concomitant medications were not reported.  Treatment medication information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Pruritus
Clinical narrative: Sweating; Getting hot quickly; Itching; 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 HYPERHIDROSIS (Sweating), FEELING HOT (Getting hot quickly) and PRURITUS (Itching) 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 HYPERHIDROSIS (Sweating), FEELING HOT (Getting hot quickly) and PRURITUS (Itching). At the time of the report, HYPERHIDROSIS (Sweating), FEELING HOT (Getting hot quickly) and PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported.   Treatment information not reported.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Feel dizziness; 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 DIZZINESS (Feel dizziness) 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 31-May-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 DIZZINESS (Feel dizziness). At the time of the report, DIZZINESS (Feel dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported  Treatment medication information not provided
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age vaccine administration) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 021C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age vaccine administration). On 29-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age vaccine administration) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   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 provided.   This case was linked to MOD-2021-271069 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Follow-up  received on 08-JUL-2021, updated information includes:Reporter information, patient's second dose details were provided. On 28-Jul-2021: Non-significant Follow up appended for document attachement
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Gout, Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: had a gout flare up, it lasted a week then went away but came back worse; Severe gout attack; Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.; Sore arm injection site; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (had a gout flare up, it lasted a week then went away but came back worse), GOUT (Severe gout attack), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.) and VACCINATION SITE PAIN (Sore arm injection site) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026621A and 049821A) for COVID-19 vaccination.     Concurrent medical conditions included Gout attack.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.) and VACCINATION SITE PAIN (Sore arm injection site). On 23-May-2021, the patient experienced GOUT (had a gout flare up, it lasted a week then went away but came back worse). 23-May-2021, the patient experienced GOUT (Severe gout attack). The patient was treated with CELERY SEED EXTRACT at an unspecified dose and frequency; PRUNUS CERASUS (CHERRYXTRA) at an unspecified dose and frequency and APPLE CIDER VINEGAR ongoing since an unknown date for Gout attack, at an unspecified dose and frequency. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received second dose of the Moderna COVID-19 vaccine on day 24 after first dose.) had resolved. On 16-May-2021, VACCINATION SITE PAIN (Sore arm injection site) had resolved. On 26-May-2021, GOUT (Severe gout attack) had resolved. At the time of the report, GOUT (had a gout flare up, it lasted a week then went away but came back worse) outcome was unknown.            Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Significant Follow up received on 01/JUL/2021, added new events and updated treatment medications. On 06-Jul-2021: TCR form attached. Consent declined.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Headaches from the lower back of his head towards sinuses; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Headaches from the lower back of his head towards sinuses) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SINUS HEADACHE (Headaches from the lower back of his head towards sinuses). At the time of the report, SINUS HEADACHE (Headaches from the lower back of his head towards sinuses) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant product information was not reported. The patient had a negative scan of his sinuses and received treatment for migraines. He reported that the headache is still happening on and off.   This case was linked to MOD-2021-201458 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow up received on 30 Jun 2021 contains non significant information
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Told her no more treatment for Leukemia; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia) 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 THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Told her no more treatment for Leukemia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment details were provided.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: a sore arm that lasted for only a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (a sore arm that lasted for only a couple of days) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (a sore arm that lasted for only a couple of days). At the time of the report, MYALGIA (a sore arm that lasted for only a couple of days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medications were not provided.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-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 12-Mar-2021, the patient experienced SINUS HEADACHE (Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off). At the time of the report, SINUS HEADACHE (Had aches from the lower back of his head towards sinuses/sinus headache still happens on and off) had not resolved.            Concomitant medications were not reported  Patient took migraine treatment but sinus headache still happens on and off. He went to doctors and he did scan of sinuses and were clear     This case was linked to MOD-2021-201458, MOD-2021-201439 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Yeast infection; This spontaneous case was reported by a patient and describes the occurrence of FUNGAL INFECTION (Yeast infection) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Yeast infection.    On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, the patient experienced FUNGAL INFECTION (Yeast infection). At the time of the report, FUNGAL INFECTION (Yeast infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications includes medication for irregular heart beat, cholesterol medication and medication for an infection  Treatment medication includes cream   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Went through some unpleasant times; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Went through some unpleasant times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Went through some unpleasant times). At the time of the report, VACCINATION COMPLICATION (Went through some unpleasant times) outcome was unknown.            No concomitant medications were reported.  No treatment details were reported.   Reporter did not allow further contact
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on leg from reaction to something; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on leg from reaction to something) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-May-2021, the patient experienced RASH (Rash on leg from reaction to something). The patient was treated with CEFALEXIN (CEPHALEXINE) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH (Rash on leg from reaction to something) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: Although rash is consistent with the product known safety profile base don he information provided suggesting that the rash was due to something, causal relationship with mRNA-1273 use cannot be confirmed.; Sender's Comments: Although rash is consistent with the product known safety profile base don he information provided suggesting that the rash was due to something, causal relationship with mRNA-1273 use cannot be confirmed.
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: I feel like I"m getting a cold after first dose; 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 NASOPHARYNGITIS (I feel like I"m getting a cold after first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (I feel like I"m getting a cold after first dose). At the time of the report, NASOPHARYNGITIS (I feel like I"m getting a cold after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medication information were not provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Painful muscle spasm; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (Painful muscle spasm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MUSCLE SPASMS (Painful muscle spasm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MUSCLE SPASMS (Painful muscle spasm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported.  Patient visited ER but doctor did not seem to understands her. Muscle spasms are still ongoing.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got a rash all over my body on my first 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 RASH (I got a rash all over my body on my first shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 RASH (I got a rash all over my body on my first shot). At the time of the report, RASH (I got a rash all over my body on my first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Renal pain
Clinical narrative: discomfort in the kidneys; 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 RENAL PAIN (discomfort in the kidneys) 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 RENAL PAIN (discomfort in the kidneys). At the time of the report, RENAL PAIN (discomfort in the kidneys) outcome was unknown.            Concomitant medications was not provided by the reporter.  treatment information was  not provided.  The patient stated they are experiencing discomfort in the kidneys and that the second shot seemed to aggravate the kidneys.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Persistent leg pain; Persistent muscle pain; 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 PAIN IN EXTREMITY (Persistent leg pain) and MYALGIA (Persistent muscle pain) 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 PAIN IN EXTREMITY (Persistent leg pain) and MYALGIA (Persistent muscle pain). At the time of the report, PAIN IN EXTREMITY (Persistent leg pain) and MYALGIA (Persistent muscle pain) outcome was unknown.            Concomitant medications were not reported  Treatment medication information was not provided
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Nasopharyngitis, Oropharyngeal pain, Peripheral swelling
Clinical narrative: cold; chills/Shivering; swelling on my upper left arm down to my bicep; Sore throat; Coughing/ thick mucous; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on my upper left arm down to my bicep), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing/ thick mucous), NASOPHARYNGITIS (cold) and CHILLS (chills/Shivering) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 001C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-May-2021, the patient experienced PERIPHERAL SWELLING (swelling on my upper left arm down to my bicep), OROPHARYNGEAL PAIN (Sore throat) and COUGH (Coughing/ thick mucous). On 02-Jun-2021, the patient experienced NASOPHARYNGITIS (cold) and CHILLS (chills/Shivering). At the time of the report, PERIPHERAL SWELLING (swelling on my upper left arm down to my bicep), OROPHARYNGEAL PAIN (Sore throat), COUGH (Coughing/ thick mucous), NASOPHARYNGITIS (cold) and CHILLS (chills/Shivering) outcome was unknown.            No concomitant medication was provided.  Treatment medication include Cough drop.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Parosmia, SARS-CoV-2 test, Taste disorder
Clinical narrative: Vaccine administered to pregnant patient; Altered sense of taste- everything tastes burnt; everything smells burnt,dog food smells sour; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TASTE DISORDER (Altered sense of taste- everything tastes burnt), PAROSMIA (everything smells burnt,dog food smells sour) and EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046B21A and 045B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (rapid test positive) on 19-Feb-2021. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) from 10-Jan-2016 to an unknown date for Anxiety, ESZOPICLONE (LUNESTA) from 12-Mar-2013 to an unknown date for Insomnia, VITAMIN D NOS from 15-Jan-2021 to an unknown date for Vitamin D deficiency.   On 16-Apr-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-May-2021 at 10:45 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-May-2021, the patient experienced TASTE DISORDER (Altered sense of taste- everything tastes burnt) and PAROSMIA (everything smells burnt,dog food smells sour). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). At the time of the report, TASTE DISORDER (Altered sense of taste- everything tastes burnt) and PAROSMIA (everything smells burnt,dog food smells sour) had not resolved and EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient called her primary care provider for clinical advice, however she was told that no treatments could be administered for altered sense of taste or smell.  No treatment was reported for the events.    Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: initial additional. On 08-Jul-2021: contains no new information. On 08-Jul-2021: NNI received.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Family went through some unpleasant times; 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 (Family went through some unpleasant times) 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 (Family went through some unpleasant times). At the time of the report, VACCINATION COMPLICATION (Family went through some unpleasant times) outcome was unknown.            Concomitant medication were not reported.  Treatment medication information were not provided.   Reporter did not allow further contact
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Overweight (have very large arms).    On 20-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021 at 8:00 AM, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle). On 20-Jan-2021 at 8:00 AM, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Don't think the vaccine was correctly administered to me/Needle didn't make it to the muscle) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were reported.  It was reported that the patient received their first dose of the vaccine using a 1 inch needle, which the patient believes was too small. The patient also stated that as a result of the needle being too small, the vaccine was not given intramuscularly.  No treatment details were provided.   This case was linked to MOD-2021-231790 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2021: Follow up received on 22-JUN-2021. Follow-up received and patient information, vaccine information and event details were updated. On 02-Jul-2021: Follow-up received on 02-JUL-2021 and patient's demographics updated.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Very painful joint pain in shoulder/Very painful joint pain in elbow; 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 ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) 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 ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow). At the time of the report, ARTHRALGIA (Very painful joint pain in shoulder/Very painful joint pain in elbow) outcome was unknown.            No concomitant medications were mentioned.  No treatment details were reported.  Patient had joint pain in elbow and shoulder for the first dose also
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine) 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 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced COVID-19 (Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine). At the time of the report, COVID-19 (Diagnosed with COVID 19 virus after 1st dose of Moderna COVID 19vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   Treatment information was not provided.