chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Illness, Pyrexia
Clinical narrative: fever 101 ºF; in bed for 5 days; taste of metal in their mouth; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever 101 ºF), ILLNESS (in bed for 5 days) and DYSGEUSIA (taste of metal in their mouth) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported). Concomitant products included PRIDINOL HCL (PRIDINOL HCL 300 mg ER) for Back pain, CLONAZEPAM, CEFIXIME (FLEXERIL [CEFIXIME]), DULOXETINE (DULOXETINE 60 mg) and AMLODIPINE BESILATE (AMLODIPINE (ALS BESILAAT) SANDOZ) for an unknown indication.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced PYREXIA (fever 101 ºF), ILLNESS (in bed for 5 days) and DYSGEUSIA (taste of metal in their mouth). At the time of the report, PYREXIA (fever 101 ºF), ILLNESS (in bed for 5 days) and DYSGEUSIA (taste of metal in their mouth) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-046906 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Fatigue, Pain in extremity
Clinical narrative: her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in; Fatigue; arm hurt only for 2 day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt only for 2 day), BREAST TENDERNESS (her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in) and FATIGUE (Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 PAIN IN EXTREMITY (arm hurt only for 2 day), BREAST TENDERNESS (her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (arm hurt only for 2 day) had resolved, BREAST TENDERNESS (her breast is tender on both sides, like when you have babies, breastfeeding, before your period comes in) had not resolved and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.   Treatment information was not reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Myoclonus, Pain in extremity
Clinical narrative: I felt like I was falling and I screamed; weird dizziness/light-headed; soreness in my left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in my left arm), DIZZINESS (weird dizziness/light-headed) and MYOCLONUS (I felt like I was falling and I screamed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced PAIN IN EXTREMITY (soreness in my left arm). On 08-Mar-2021, the patient experienced DIZZINESS (weird dizziness/light-headed). On an unknown date, the patient experienced MYOCLONUS (I felt like I was falling and I screamed). On 07-Mar-2021, PAIN IN EXTREMITY (soreness in my left arm) had resolved. At the time of the report, DIZZINESS (weird dizziness/light-headed) and MYOCLONUS (I felt like I was falling and I screamed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication included  thyroid medicine and blood pressure medicine was reported   No treatment medication reported
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Vaccination site pain
Clinical narrative: arm hot to the touch; aching arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (arm hot to the touch) and VACCINATION SITE PAIN (aching arm) 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 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced FEELING HOT (arm hot to the touch) and VACCINATION SITE PAIN (aching arm). At the time of the report, FEELING HOT (arm hot to the touch) and VACCINATION SITE PAIN (aching arm) outcome was unknown. Not Provided          No relevant concomitant medications were provided by the reporter. Treatment information was not provided.   This case was linked to MOD-2021-046612 (Patient Link).
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Ageusia, Arthralgia, Fatigue, Myalgia
Clinical narrative: loss of taste; stomach pains; body pain; joint pains; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), MYALGIA (body pain), ARTHRALGIA (joint pains) and NAUSEA (nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), MYALGIA (body pain), ARTHRALGIA (joint pains), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), MYALGIA (body pain), ARTHRALGIA (joint pains), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.            No treatment information provided By Reporter.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: loss of taste; stomach pains; body pain; joint pains; nausea; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), MYALGIA (body pain), ARTHRALGIA (joint pains) and NAUSEA (nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), MYALGIA (body pain), ARTHRALGIA (joint pains), NAUSEA (nausea) and FATIGUE (fatigue). At the time of the report, AGEUSIA (loss of taste), ABDOMINAL PAIN UPPER (stomach pains), MYALGIA (body pain), ARTHRALGIA (joint pains), NAUSEA (nausea) and FATIGUE (fatigue) outcome was unknown.            No treatment information provided By Reporter.   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site warm; The redness and itching came back; The redness and itching came back; Little bit of redness at the injection site that itched; Little bit of redness at the injection site that itched; Sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (The redness and itching came back), VACCINATION SITE PRURITUS (Little bit of redness at the injection site that itched) and VACCINATION SITE ERYTHEMA (The redness and itching came back) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), METFORMIN, LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN and PROPRANOLOL for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Little bit of redness at the injection site that itched) and VACCINATION SITE ERYTHEMA (Little bit of redness at the injection site that itched). On 07-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (The redness and itching came back) and VACCINATION SITE ERYTHEMA (The redness and itching came back). On an unknown date, the patient experienced VACCINATION SITE WARMTH (Injection site warm). The patient was treated with BACITRACIN ongoing since an unknown date at an unspecified dose and frequency; CORTISONE ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. On 01-Mar-2021, PAIN IN EXTREMITY (Sore arm), VACCINATION SITE PRURITUS (Little bit of redness at the injection site that itched) and VACCINATION SITE ERYTHEMA (Little bit of redness at the injection site that itched) had resolved. At the time of the report, VACCINATION SITE WARMTH (Injection site warm), VACCINATION SITE PRURITUS (The redness and itching came back) and VACCINATION SITE ERYTHEMA (The redness and itching came back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Diarrhoea, Headache, Nausea
Clinical narrative: Diarrhea all night; Didn't even want to eat because of the nausea; Achy all over from neck to nipples; Chilly at night; Headaches; Arm hurt where she got the shot; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Clostridium difficile infection, Anxiety and Depression. Concomitant products included VANCOMYCIN for Clostridium difficile infection.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night), HEADACHE (Headaches), VACCINATION SITE PAIN (Arm hurt where she got the shot) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night), HEADACHE (Headaches), VACCINATION SITE PAIN (Arm hurt where she got the shot) and NAUSEA (Nausea) had resolved.            Concomitant products used included anxiety medication and depression medication   The patient stated the events lasted a couple of days and then cleared up. patient was feeling very bad for two days and wanted to emphasize the severity of  feeling.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up received and event outcome is updated as recovered
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: Diarrhea all night; Didn't even want to eat because of the nausea; Achy all over from neck to nipples; Chilly at night; Headaches; Arm hurt where she got the shot; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night) and HEADACHE (Headaches) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A and 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Clostridium difficile infection, Anxiety and Depression. Concomitant products included VANCOMYCIN for Clostridium difficile infection.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night), HEADACHE (Headaches), VACCINATION SITE PAIN (Arm hurt where she got the shot) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIARRHOEA (Diarrhea all night), DECREASED APPETITE (Didn't even want to eat because of the nausea), PAIN (Achy all over from neck to nipples), CHILLS (Chilly at night), HEADACHE (Headaches), VACCINATION SITE PAIN (Arm hurt where she got the shot) and NAUSEA (Nausea) had resolved.            Concomitant products used included anxiety medication and depression medication   The patient stated the events lasted a couple of days and then cleared up. patient was feeling very bad for two days and wanted to emphasize the severity of  feeling.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up received and event outcome is updated as recovered
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Pain in extremity, Somnolence
Clinical narrative: sugar level is high at 225; arm is hurting; feeling drowsy; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (sugar level is high at 225), PAIN IN EXTREMITY (arm is hurting) and SOMNOLENCE (feeling drowsy) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic and Bladder disorder NOS. Concomitant products included LISINOPRIL, DULOXETINE and OMEPRAZOLE for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced BLOOD GLUCOSE INCREASED (sugar level is high at 225), PAIN IN EXTREMITY (arm is hurting) and SOMNOLENCE (feeling drowsy). At the time of the report, BLOOD GLUCOSE INCREASED (sugar level is high at 225), PAIN IN EXTREMITY (arm is hurting) and SOMNOLENCE (feeling drowsy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose increased: 225 (High) sugar level is high at 225.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain
Clinical narrative: sweating; Aches; chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), PAIN (Aches), CHILLS (chills) and HEADACHE (Headaches) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-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 14-Mar-2021, the patient experienced HYPERHIDROSIS (sweating), PAIN (Aches), CHILLS (chills) and HEADACHE (Headaches). On 15-Mar-2021, HYPERHIDROSIS (sweating), PAIN (Aches) and CHILLS (chills) had resolved. At the time of the report, HEADACHE (Headaches) outcome was unknown.            No concomitant was provided. Patient treatment information was not provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Fatigue, Headache, Hypertension, Myalgia
Clinical narrative: having headaches again which she attributes to the high blood pressure; muscle pain; eye pain; arm soreness; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue), HEADACHE (headache) and HEADACHE (having headaches again which she attributes to the high blood pressure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not provided.  Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced EYE PAIN (eye pain), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and MYALGIA (muscle pain). 17-Feb-2021, the patient experienced HEADACHE (headache). On 19-Mar-2021, the patient experienced HEADACHE (having headaches again which she attributes to the high blood pressure). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, EYE PAIN (eye pain), PAIN IN EXTREMITY (arm soreness), HEADACHE (having headaches again which she attributes to the high blood pressure) and MYALGIA (muscle pain) outcome was unknown and FATIGUE (fatigue) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Hypertension: high (High) blood pressure was elevated.         Patient did not start  medications for BP but has told  to monitor and return in a month for re-evaluation.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: follow-up received and Additional event (headache), event outcome and laboratory test were updated.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: having headaches again which she attributes to the high blood pressure; muscle pain; eye pain; arm soreness; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (eye pain), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue), HEADACHE (headache) and HEADACHE (having headaches again which she attributes to the high blood pressure) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's medical history was not provided.  Concomitant products included BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET) for an unknown indication.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Feb-2021, the patient experienced EYE PAIN (eye pain), PAIN IN EXTREMITY (arm soreness), FATIGUE (fatigue) and MYALGIA (muscle pain). 17-Feb-2021, the patient experienced HEADACHE (headache). On 19-Mar-2021, the patient experienced HEADACHE (having headaches again which she attributes to the high blood pressure). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, EYE PAIN (eye pain), PAIN IN EXTREMITY (arm soreness), HEADACHE (having headaches again which she attributes to the high blood pressure) and MYALGIA (muscle pain) outcome was unknown and FATIGUE (fatigue) and HEADACHE (headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Mar-2021, Hypertension: high (High) blood pressure was elevated.         Patient did not start  medications for BP but has told  to monitor and return in a month for re-evaluation.   Most recent FOLLOW-UP information incorporated above includes: On 19-Mar-2021: follow-up received and Additional event (headache), event outcome and laboratory test were updated.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Erythema, Pain of skin
Clinical narrative: red sores all over scalp; scalp hurts; hair is falling out where the spots are; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red sores all over scalp), PAIN OF SKIN (scalp hurts) and ALOPECIA (hair is falling out where the spots are) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced ERYTHEMA (red sores all over scalp), PAIN OF SKIN (scalp hurts) and ALOPECIA (hair is falling out where the spots are). At the time of the report, ERYTHEMA (red sores all over scalp), PAIN OF SKIN (scalp hurts) and ALOPECIA (hair is falling out where the spots are) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-May-2021: Follow-up received and contains no new information .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm). At the time of the report, VACCINATION SITE PAIN (sore arm) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.   Treatment information was not provided.    This case was linked to MOD-2021-046539 (E2B Linked Report).; Sender's Comments:  MOD-2021-046539:second dose case
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concomitant products included DOXYLAMINE SUCCINATE, PYRIDOXINE HYDROCHLORIDE (BONJESTA) for Prophylaxis of nausea and vomiting, PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation, ONDANSETRON (ZOFRAN MELT) for Vomiting.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 24-Aug-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. Not Provided          Patient called to be added to the Pregnancy Registry.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: arm is swollen; hot to touch; redness is spreading down to her arm; arm is pain and sore; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (arm is swollen), SKIN WARM (hot to touch), ERYTHEMA (redness is spreading down to her arm) and PAIN IN EXTREMITY (arm is pain and sore) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027L20A and 031L20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, PANTOPRAZOLE, TOPIRAMATE, CITALOPRAM, ALLOPURINOL and RIZATRIPTAN for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PERIPHERAL SWELLING (arm is swollen), SKIN WARM (hot to touch), ERYTHEMA (redness is spreading down to her arm) and PAIN IN EXTREMITY (arm is pain and sore). At the time of the report, PERIPHERAL SWELLING (arm is swollen), SKIN WARM (hot to touch), ERYTHEMA (redness is spreading down to her arm) and PAIN IN EXTREMITY (arm is pain and sore) outcome was unknown.            No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Pain, Pain in extremity
Clinical narrative: terrible Gastric pain for a week; aching of arm; body aches; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (terrible Gastric pain for a week), PAIN IN EXTREMITY (aching of arm), PAIN (body aches) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (terrible Gastric pain for a week), PAIN IN EXTREMITY (aching of arm), PAIN (body aches) and CHILLS (Chills). On 04-Mar-2021, ABDOMINAL PAIN UPPER (terrible Gastric pain for a week) had resolved. At the time of the report, PAIN IN EXTREMITY (aching of arm), PAIN (body aches) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided.Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nasopharyngitis, Pyrexia
Clinical narrative: cold; high fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold) and PYREXIA (high fever) 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 NASOPHARYNGITIS (cold) and PYREXIA (high fever). At the time of the report, NASOPHARYNGITIS (cold) and PYREXIA (high fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 100.3F.         No concomitant medications reported.  No treatment medications provided by the reporter.  Action taken with mRNA-1273 in response to events was not applicable.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Erythema, Rash, Vaccination site reaction
Clinical narrative: moderna arm; rash all over both hands; skin is blistering; fingers are red/not going away and spreading more; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (moderna arm), RASH (rash all over both hands), BLISTER (skin is blistering) and ERYTHEMA (fingers are red/not going away and spreading more) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.    On 02-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 VACCINATION SITE REACTION (moderna arm), RASH (rash all over both hands), BLISTER (skin is blistering) and ERYTHEMA (fingers are red/not going away and spreading more). At the time of the report, VACCINATION SITE REACTION (moderna arm), RASH (rash all over both hands), BLISTER (skin is blistering) and ERYTHEMA (fingers are red/not going away and spreading more) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment took an antihistamine and used Benadryl cream.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Noninfective gingivitis, Pruritus
Clinical narrative: red inflamed gums and feel unhealthy; itchy all over but mostly on her head; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (itchy all over but mostly on her head) and NONINFECTIVE GINGIVITIS (red inflamed gums and feel unhealthy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PRURITUS (itchy all over but mostly on her head). On an unknown date, the patient experienced NONINFECTIVE GINGIVITIS (red inflamed gums and feel unhealthy). At the time of the report, PRURITUS (itchy all over but mostly on her head) and NONINFECTIVE GINGIVITIS (red inflamed gums and feel unhealthy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Concomitant products included blood pressure pills and heart pills. Patient rinsed mouth with salt and water for the treatment as per health care professional.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pyrexia, Vaccination site pain
Clinical narrative: red arm; sore arm; fever; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red arm), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (red arm), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever). At the time of the report, ERYTHEMA (red arm), VACCINATION SITE PAIN (sore arm) and PYREXIA (fever) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medication information was provided.  No treatment information was provided.   This case was linked to MOD-2021-238268 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Underdose, Wrong technique in device usage process
Clinical narrative: Don't know how much for sure but the nurse thinks almost half went to the floor; Hard time inserting the needle into the arm; This spontaneous case was reported by a consumer and describes the occurrence of UNDERDOSE (Don't know how much for sure but the nurse thinks almost half went to the floor) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Hard time inserting the needle into the arm) 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 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced UNDERDOSE (Don't know how much for sure but the nurse thinks almost half went to the floor) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Hard time inserting the needle into the arm). On 15-Mar-2021, UNDERDOSE (Don't know how much for sure but the nurse thinks almost half went to the floor) and WRONG TECHNIQUE IN DEVICE USAGE PROCESS (Hard time inserting the needle into the arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided by reporter. Treatment medications were not provided by reporter.; Sender's Comments: This report refers to a case of wrong techniques in device usage process and accidental underdose for mRNA-1273, with unknown lot number.  with no associated AEs.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated, Musculoskeletal discomfort, Myalgia
Clinical narrative: Right shoulder is more tender and achy; 2nd shot made him worse, shot might have flared up symptoms; Every part of body is achy; Tender shoulder blade; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Right shoulder is more tender and achy), CONDITION AGGRAVATED (2nd shot made him worse, shot might have flared up symptoms), PAIN (Every part of body is achy) and ARTHRALGIA (Tender shoulder blade) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033A21A) for COVID-19 vaccination.     The patient's past medical history included Concussion, Whiplash injury, Shoulder injury and Back surgery. Concomitant products included VITAMINS NOS for an unknown indication.   On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Right shoulder is more tender and achy), CONDITION AGGRAVATED (2nd shot made him worse, shot might have flared up symptoms), PAIN (Every part of body is achy) and ARTHRALGIA (Tender shoulder blade). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Right shoulder is more tender and achy), CONDITION AGGRAVATED (2nd shot made him worse, shot might have flared up symptoms), PAIN (Every part of body is achy) and ARTHRALGIA (Tender shoulder blade) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication includes Blood pressure Tablets.  The patient spoke with his doctor and his doctor could not pinpoint if the side effects were from the vaccine. The vaccine might have flared up the symptoms the patient had from the concussion and whiplash he had years ago.  Treatment information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up will be processed with the initial report. Follow-up information included the patient contacting his doctor regarding his adverse events.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021 at 4:58 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 15-Mar-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) had resolved. 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.; Sender's Comments: This report refers to a case of Expired product administration, for mRNA-1273, lot #: 014M20A, with no associated AEs.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Fatigue, Insomnia, Myalgia
Clinical narrative: back pain; trouble sleeping; body aches; chills; tired; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain), INSOMNIA (trouble sleeping), MYALGIA (body aches), CHILLS (chills) and FATIGUE (tired) in a 79-year-old female 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (back pain), INSOMNIA (trouble sleeping), MYALGIA (body aches), CHILLS (chills) and FATIGUE (tired). At the time of the report, BACK PAIN (back pain), INSOMNIA (trouble sleeping), MYALGIA (body aches), CHILLS (chills) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications information was reported. No treatment medications were provided.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIRED; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (TIRED) in a 91-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (TIRED). At the time of the report, FATIGUE (TIRED) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-046455, US-MODERNATX, INC.-MOD-2021-046640 (E2B Linked Report).; Sender's Comments:  MOD-2021-046455: US-MODERNATX, INC.-MOD-2021-046640:Aunt case
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19 Symptoms; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 Symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 COVID-19 (COVID-19 Symptoms). At the time of the report, COVID-19 (COVID-19 Symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medication was reported.   This case was linked to MOD-2021-046034 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction, Vaccination site swelling
Clinical narrative: Covid arm; Covid arm was terribly itchy; Covid arm was burning; Covid arm had redness; Covid arm had swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Covid arm was terribly itchy), VACCINATION SITE PAIN (Covid arm was burning), VACCINATION SITE ERYTHEMA (Covid arm had redness) and VACCINATION SITE SWELLING (Covid arm had swelling) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Covid arm was terribly itchy), VACCINATION SITE PAIN (Covid arm was burning), VACCINATION SITE ERYTHEMA (Covid arm had redness) and VACCINATION SITE SWELLING (Covid arm had swelling). At the time of the report, VACCINATION SITE REACTION (Covid arm), VACCINATION SITE PRURITUS (Covid arm was terribly itchy), VACCINATION SITE PAIN (Covid arm was burning), VACCINATION SITE ERYTHEMA (Covid arm had redness) and VACCINATION SITE SWELLING (Covid arm had swelling) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: pain at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.    This case was linked to MOD21-021778, MOD21-025386, MOD21-029062, MOD21-034087, INC.-MOD-2021-030778 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  MOD21-021778: MOD21-025386: MOD21-029062: MOD21-034087: INC.-MOD-2021-030778:1st dose
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Muscular weakness, Vaccination site erythema
Clinical narrative: could not lift arm as high as usual; arm felt weak; Red mark on the back of the arm where received the Injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOKINESIA (could not lift arm as high as usual), MUSCULAR WEAKNESS (arm felt weak) and VACCINATION SITE ERYTHEMA (Red mark on the back of the arm where received the Injection) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-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 an unknown date, the patient experienced HYPOKINESIA (could not lift arm as high as usual), MUSCULAR WEAKNESS (arm felt weak) and VACCINATION SITE ERYTHEMA (Red mark on the back of the arm where received the Injection). At the time of the report, HYPOKINESIA (could not lift arm as high as usual), MUSCULAR WEAKNESS (arm felt weak) and VACCINATION SITE ERYTHEMA (Red mark on the back of the arm where received the Injection) outcome was unknown.            No relevant concomitant medications were provided. No treatment information was provided. The action taken for mRNA-1273 was not applicable.