chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Didn't receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included LOSARTAN for Blood pressure high.    On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose). On 11-Jan-2021, PRODUCT DOSE OMISSION ISSUE (Didn't receive the second dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication not provided
Sex: M
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) 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 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). At the time of the report, SINUSITIS (sinus infection) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient mentioned having a sinus infection and his HCP putting him on an antibiotic, caller wanted to know if the antibiotic would interfere with his covid vaccine? He is inbetween doses. When I attempted to gather more information from the caller, he insisted that his sinus infection was not from the vaccine and was not able to discuss further.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Swelling face, Swollen tongue
Clinical narrative: swollen face; swollen tongue; swollen throat; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (swollen face), SWOLLEN TONGUE (swollen tongue) and PHARYNGEAL SWELLING (swollen throat) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced SWELLING FACE (swollen face), SWOLLEN TONGUE (swollen tongue) and PHARYNGEAL SWELLING (swollen throat). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. On 10-Mar-2021, SWELLING FACE (swollen face), SWOLLEN TONGUE (swollen tongue) and PHARYNGEAL SWELLING (swollen throat) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided.    Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up information received on 05-Aug-2021 and contains no new information.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Itchy dollar sized rash on her mid-back; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Itchy dollar sized rash on her mid-back) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced RASH (Itchy dollar sized rash on her mid-back). At the time of the report, RASH (Itchy dollar sized rash on her mid-back) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant and treatment drugs were provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Erythema, Pain in extremity, Rash
Clinical narrative: Rash is back and is on throat; rash is back and is above breast; chest broke out (bumpy); Arm was red and puffy and traveled down arm (like when get bee sting and you can see venom going down arm); arm got red; arm pain; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (arm pain), ERYTHEMA (arm got red), DISCOMFORT (Arm was red and puffy and traveled down arm (like when get bee sting and you can see venom going down arm)), RASH (Rash is back and is on throat) and RASH (rash is back and is above breast) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was provided.).    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain). On 07-Mar-2021, the patient experienced ERYTHEMA (arm got red). On 12-Mar-2021, the patient experienced DISCOMFORT (Arm was red and puffy and traveled down arm (like when get bee sting and you can see venom going down arm)) and RASH (chest broke out (bumpy)). On 31-Mar-2021, the patient experienced RASH (Rash is back and is on throat) and RASH (rash is back and is above breast). At the time of the report, PAIN IN EXTREMITY (arm pain), ERYTHEMA (arm got red), DISCOMFORT (Arm was red and puffy and traveled down arm (like when get bee sting and you can see venom going down arm)), RASH (Rash is back and is on throat), RASH (rash is back and is above breast) and RASH (chest broke out (bumpy)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment information was provided for the events.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity
Clinical narrative: Sore Arm to the touch and when moving; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm to the touch and when moving) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer in 2018. Concurrent medical conditions included Neuropathy. Concomitant products included PREGABALIN for Neuropathy, DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL (TYLENOL EXTRA) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced CHILLS (Chills). On 26-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm to the touch and when moving). On 19-Mar-2021, CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore Arm to the touch and when moving) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Relevant concomitant medication also included muscle relaxer. Treatment information was not provided. Patient said she is feeling better now and has nothing else to report and that her symptoms cleared up quickly.   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Follow-up information received on 13 MAY 2021 and does not contain any new information.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Animal bite
Clinical narrative: On 30Mar-2021 received a tetanus shot due to a dog bite; This spontaneous case was reported by an other health care professional and describes the occurrence of ANIMAL BITE (On 30Mar-2021 received a tetanus shot due to a dog bite) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced ANIMAL BITE (On 30Mar-2021 received a tetanus shot due to a dog bite). At the time of the report, ANIMAL BITE (On 30Mar-2021 received a tetanus shot due to a dog bite) outcome was unknown. Not Provided      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 product use was not provided by the reporter.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: His arm was sore for 2 days after receiving 1st dose; He felt little tired on 2nd day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (His arm was sore for 2 days after receiving 1st dose) and FATIGUE (He felt little tired on 2nd day) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced FATIGUE (He felt little tired on 2nd day). On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (His arm was sore for 2 days after receiving 1st dose). At the time of the report, PAIN IN EXTREMITY (His arm was sore for 2 days after receiving 1st dose) and FATIGUE (He felt little tired on 2nd day) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       treatment taken was not reported concomitant medications were not reported
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Fatigue, Nasopharyngitis, Somnolence
Clinical narrative: jittery colds; slept all day long because; tired; urine is color brown; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (jittery colds), SOMNOLENCE (slept all day long because), FATIGUE (tired) and CHROMATURIA (urine is color brown) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urine color abnormal (urine is colored brown, like colored tea or beer). Concomitant products included DILTRAZEM, SPIRONOLACTONE, CETIRIZINE, FLUTICASONE and IBUPROFEN for an unknown indication.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (jittery colds), SOMNOLENCE (slept all day long because), FATIGUE (tired) and CHROMATURIA (urine is color brown). At the time of the report, NASOPHARYNGITIS (jittery colds), SOMNOLENCE (slept all day long because), FATIGUE (tired) and CHROMATURIA (urine is color brown) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Myalgia, Vaccination site bruising, Vaccination site mass
Clinical narrative: feels tired; fatigued; very drained; lethargic; thought a bolt of lightning struck her because she had very severe arm soreness; knot at the injection site; looks slightly bruised; little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), MYALGIA (little bit sore), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site) and VACCINATION SITE BRUISING (looks slightly bruised) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VITAMIN D [VITAMIN D NOS] for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, LATANOPROST, ATORVASTATIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and MAGNESIUM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VITAMIN D [VITAMIN D NOS] (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (little bit sore). On 31-Mar-2021, the patient experienced LETHARGY (lethargic), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE BRUISING (looks slightly bruised), FATIGUE (fatigued) and FATIGUE (very drained). On an unknown date, the patient experienced FATIGUE (feels tired). At the time of the report, LETHARGY (lethargic), MYALGIA (little bit sore), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE BRUISING (looks slightly bruised), FATIGUE (feels tired), FATIGUE (fatigued) and FATIGUE (very drained) outcome was unknown. Not Provided      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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: feels tired; fatigued; very drained; lethargic; thought a bolt of lightning struck her because she had very severe arm soreness; knot at the injection site; looks slightly bruised; little bit sore; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic), MYALGIA (little bit sore), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site) and VACCINATION SITE BRUISING (looks slightly bruised) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product VITAMIN D [VITAMIN D NOS] for an unknown indication.    The patient's past medical history included No adverse event. Concomitant products included METFORMIN, AMLODIPINE, LISINOPRIL, LATANOPROST, ATORVASTATIN, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and MAGNESIUM for an unknown indication.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started VITAMIN D [VITAMIN D NOS] (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced MYALGIA (little bit sore). On 31-Mar-2021, the patient experienced LETHARGY (lethargic), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE BRUISING (looks slightly bruised), FATIGUE (fatigued) and FATIGUE (very drained). On an unknown date, the patient experienced FATIGUE (feels tired). At the time of the report, LETHARGY (lethargic), MYALGIA (little bit sore), VACCINATION SITE PAIN (thought a bolt of lightning struck her because she had very severe arm soreness), VACCINATION SITE MASS (knot at the injection site), VACCINATION SITE BRUISING (looks slightly bruised), FATIGUE (feels tired), FATIGUE (fatigued) and FATIGUE (very drained) outcome was unknown. Not Provided      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.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (sinus infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infection). The patient was treated with AMOXICILLIN for Sinus infection, at a dose of 1 dosage form. At the time of the report, SINUSITIS (sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: Sore arm; Received second dose in 23 days window; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose in 23 days window) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) and ATOMOXETINE HYDROCHLORIDE (STRATTERA) for an unknown indication.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 PAIN IN EXTREMITY (Sore arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose in 23 days window). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received second dose in 23 days window) had resolved. Not Provided          No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow up received included reporter contact details (email ID updated).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; arm around the site of injection was red, swollen, itchy, sore, and hot to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE SWELLING (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE PRURITUS (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) and VACCINATION SITE WARMTH (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE SWELLING (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE PRURITUS (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) and VACCINATION SITE WARMTH (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch). At the time of the report, VACCINATION SITE ERYTHEMA (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE SWELLING (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch), VACCINATION SITE PRURITUS (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) and VACCINATION SITE WARMTH (arm around the site of injection was red, swollen, itchy, sore, and hot to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  No treatment medication was reported.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash, Vaccination site rash
Clinical narrative: She experienced rash  in other parts of body; She experienced rash below the injection site; She did not feel good; This spontaneous case was reported by a non-health professional and describes the occurrence of FEELING ABNORMAL (She did not feel good), VACCINATION SITE RASH (She experienced rash below the injection site) and RASH (She experienced rash  in other parts of body) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Mar-2021, the patient experienced FEELING ABNORMAL (She did not feel good). On 07-Mar-2021, the patient experienced VACCINATION SITE RASH (She experienced rash below the injection site). On 09-Mar-2021, the patient experienced RASH (She experienced rash  in other parts of body). At the time of the report, FEELING ABNORMAL (She did not feel good), VACCINATION SITE RASH (She experienced rash below the injection site) and RASH (She experienced rash  in other parts of body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Reporter did not allow further contact
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth, Fatigue, Headache, Peripheral swelling, Swollen tongue
Clinical narrative: Dry mouth; Hands feel like two balloons; Tongue felt swollen; Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Dry mouth), PERIPHERAL SWELLING (Hands feel like two balloons), SWOLLEN TONGUE (Tongue felt swollen), FATIGUE (Tired) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     Concurrent medical conditions included Epilepsy and Acromegaly.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced DRY MOUTH (Dry mouth), PERIPHERAL SWELLING (Hands feel like two balloons), SWOLLEN TONGUE (Tongue felt swollen), FATIGUE (Tired) and HEADACHE (Headache). At the time of the report, DRY MOUTH (Dry mouth), PERIPHERAL SWELLING (Hands feel like two balloons), SWOLLEN TONGUE (Tongue felt swollen), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Somnolence
Clinical narrative: Waves of weakness; Waves of dizziness; in bed all day; Tired; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Mar-2021 and was forwarded to Moderna on 31-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (in bed all day), FATIGUE (Tired), HEADACHE (Headache), DIZZINESS (Waves of light headiness) and ASTHENIA (Waves of weakness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced SOMNOLENCE (in bed all day), FATIGUE (Tired) and HEADACHE (Headache). On 07-Mar-2021, the patient experienced DIZZINESS (Waves of light headiness), ASTHENIA (Waves of weakness) and DIZZINESS (Waves of dizziness). At the time of the report, SOMNOLENCE (in bed all day), FATIGUE (Tired), HEADACHE (Headache), DIZZINESS (Waves of light headiness), ASTHENIA (Waves of weakness) and DIZZINESS (Waves of dizziness) outcome was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Burning on the injection site; rash on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning on the injection site) and VACCINATION SITE RASH (rash on the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced VACCINATION SITE PAIN (Burning on the injection site) and VACCINATION SITE RASH (rash on the injection site). At the time of the report, VACCINATION SITE PAIN (Burning on the injection site) and VACCINATION SITE RASH (rash on the injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided Treatment medication was not provided by the reporter     Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Nonsignificant Followup appended on 14-MAY-2021
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Migraine, Myalgia, Pain in extremity
Clinical narrative: an hour or two migraine; arm right hurt/arm pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (an hour or two migraine), PAIN IN EXTREMITY (arm right hurt/arm pain) and MYALGIA (muscle pain) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 MIGRAINE (an hour or two migraine), PAIN IN EXTREMITY (arm right hurt/arm pain) and MYALGIA (muscle pain). At the time of the report, MIGRAINE (an hour or two migraine), PAIN IN EXTREMITY (arm right hurt/arm pain) and MYALGIA (muscle pain) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications reported.  No treatment information was provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Oral candidiasis, Stomatitis
Clinical narrative: sores in her mouth; mouth became inflamed her dentist said it was probably thrush; This spontaneous case was reported by a consumer and describes the occurrence of ORAL CANDIDIASIS (mouth became inflamed her dentist said it was probably thrush) and STOMATITIS (sores in her mouth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 immunisation.     Concurrent medical conditions included Burning tongue. Concomitant products included ATENOLOL, ATORVASTATIN, OMEPRAZOLE, VITAMINS NOS and HYDROCHLOROTHIAZIDE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced ORAL CANDIDIASIS (mouth became inflamed her dentist said it was probably thrush). On an unknown date, the patient experienced STOMATITIS (sores in her mouth). The patient was treated with NYSTATIN at an unspecified dose and frequency. At the time of the report, ORAL CANDIDIASIS (mouth became inflamed her dentist said it was probably thrush) and STOMATITIS (sores in her mouth) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Vaccination site swelling
Clinical narrative: Raditaing pain towards neck and arm; swelling which is size of golf ball on injection site; Raditaing pain towards neck and arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Raditaing pain towards neck and arm), VACCINATION SITE SWELLING (swelling which is size of golf ball on injection site) and NECK PAIN (Raditaing pain towards neck and arm) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) 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) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced PAIN IN EXTREMITY (Raditaing pain towards neck and arm) and NECK PAIN (Raditaing pain towards neck and arm). 29-Mar-2021, the patient experienced VACCINATION SITE SWELLING (swelling which is size of golf ball on injection site). At the time of the report, PAIN IN EXTREMITY (Raditaing pain towards neck and arm), VACCINATION SITE SWELLING (swelling which is size of golf ball on injection site) and NECK PAIN (Raditaing pain towards neck and arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysuria, Myalgia, Pyrexia
Clinical narrative: Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours; After receiving 1st dose, he had slight soreness in the injected arm; After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 048A21A) for COVID-19 vaccination.     Concurrent medical conditions included BPH. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours) outcome was unknown.               Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Live follow up received on 13-May-2021: Non-significant follow up appended; Sender's Comments:
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dysuria, Myalgia, Pyrexia
Clinical narrative: Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours; After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours; After receiving 1st dose, he had slight soreness in the injected arm; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     Concurrent medical conditions included Enlarged prostate. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) for Asthma.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm). On 12-Mar-2021, the patient experienced PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours). On an unknown date, the patient experienced DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PYREXIA (After 2nd dose, he had high fever that started 12 hours later and continued for about 6 hours), MYALGIA (After receiving 1st dose, he had slight soreness in the injected arm) and DYSURIA (Starting 12 hours after 1st dose, and continuing for additional 6 hours he had difficulty urinating with a weak stream which cleared up after about 6 hours) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-064099 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 13-May-2021: Contact information updated. Non significant.; Sender's Comments:  MOD-2021-064099:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Urticaria
Clinical narrative: Itches; Hives and a red hive very hot to touch; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), URTICARIA (Hives and a red hive very hot to touch) and PYREXIA (slight fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Tylenol.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PRURITUS (Itches), URTICARIA (Hives and a red hive very hot to touch) and PYREXIA (slight fever). At the time of the report, PRURITUS (Itches), URTICARIA (Hives and a red hive very hot to touch) and PYREXIA (slight fever) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: While on the phone, patient mentioned she fell; This spontaneous case was reported by a consumer and describes the occurrence of FALL (While on the phone, patient mentioned she fell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (While on the phone, patient mentioned she fell). At the time of the report, FALL (While on the phone, patient mentioned she fell) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fall
Clinical narrative: Almost fell in the bathroom; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and FALL (Almost fell in the bathroom) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-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 29-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 30-Mar-2021, the patient experienced FALL (Almost fell in the bathroom). On 29-Mar-2021, DIZZINESS (Dizziness) had resolved. On 30-Mar-2021, FALL (Almost fell in the bathroom) had resolved. Not Provided          No concomitant medication was provided.  Treatment medication was not provided. Action taken with mRNA-1273 in response to the events were not applicable.  Action taken with mRNA-1273 Moderna vaccine was Not applicable
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Bedridden, Diarrhoea, Dysphagia
Clinical narrative: Diarrhea; Severe stomach pain; Couldn't eat nor drink anything; Down in bed for 4 days; Couldn't eat nor drink anything; No strength; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), DYSPHAGIA (Couldn't eat nor drink anything), BEDRIDDEN (Down in bed for 4 days) and FEEDING DISORDER (Couldn't eat nor drink anything) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), DYSPHAGIA (Couldn't eat nor drink anything), BEDRIDDEN (Down in bed for 4 days), FEEDING DISORDER (Couldn't eat nor drink anything) and ASTHENIA (No strength). Not Provided
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Feeding disorder
Clinical narrative: Diarrhea; Severe stomach pain; Couldn't eat nor drink anything; Down in bed for 4 days; Couldn't eat nor drink anything; No strength; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), DYSPHAGIA (Couldn't eat nor drink anything), BEDRIDDEN (Down in bed for 4 days) and FEEDING DISORDER (Couldn't eat nor drink anything) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for an unknown indication. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Severe stomach pain), DYSPHAGIA (Couldn't eat nor drink anything), BEDRIDDEN (Down in bed for 4 days), FEEDING DISORDER (Couldn't eat nor drink anything) and ASTHENIA (No strength). Not Provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: arm started itching; red rash around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE RASH (red rash around injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE RASH (red rash around injection site). At the time of the report, VACCINATION SITE PRURITUS (arm started itching) and VACCINATION SITE RASH (red rash around injection site) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       relevant concomitant products usage were not reported by the reporter. Treatment details not included.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: pain in the arm of the injection that spread up to her axillary in contact with her chest; pain in the arm of the injection that spread up to her axillary in contact with her chest; headache; nausea; a lot of tiredness; itchiness at the injection site; a little redness at the injection site; warm to touch as if i had received the vaccine again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm of the injection that spread up to her axillary in contact with her chest), CHEST PAIN (pain in the arm of the injection that spread up to her axillary in contact with her chest), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (a lot of tiredness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Hypertension.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (a little redness at the injection site) and VACCINATION SITE WARMTH (warm to touch as if i had received the vaccine again). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm of the injection that spread up to her axillary in contact with her chest), CHEST PAIN (pain in the arm of the injection that spread up to her axillary in contact with her chest), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (a lot of tiredness). On 20-Mar-2021, PAIN IN EXTREMITY (pain in the arm of the injection that spread up to her axillary in contact with her chest), CHEST PAIN (pain in the arm of the injection that spread up to her axillary in contact with her chest), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (a lot of tiredness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (a little redness at the injection site) and VACCINATION SITE WARMTH (warm to touch as if i had received the vaccine again) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes diabetics pills and blood pressure medicines.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: pain in the arm of the injection that spread up to her axillary in contact with her chest; pain in the arm of the injection that spread up to her axillary in contact with her chest; headache; nausea; a lot of tiredness; itchiness at the injection site; a little redness at the injection site; warm to touch as if i had received the vaccine again; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm of the injection that spread up to her axillary in contact with her chest), CHEST PAIN (pain in the arm of the injection that spread up to her axillary in contact with her chest), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (a lot of tiredness) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic and Hypertension.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (a little redness at the injection site) and VACCINATION SITE WARMTH (warm to touch as if i had received the vaccine again). On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in the arm of the injection that spread up to her axillary in contact with her chest), CHEST PAIN (pain in the arm of the injection that spread up to her axillary in contact with her chest), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (a lot of tiredness). On 20-Mar-2021, PAIN IN EXTREMITY (pain in the arm of the injection that spread up to her axillary in contact with her chest), CHEST PAIN (pain in the arm of the injection that spread up to her axillary in contact with her chest), HEADACHE (headache), NAUSEA (nausea) and FATIGUE (a lot of tiredness) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itchiness at the injection site), VACCINATION SITE ERYTHEMA (a little redness at the injection site) and VACCINATION SITE WARMTH (warm to touch as if i had received the vaccine again) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication includes diabetics pills and blood pressure medicines.