chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: my ear and eye got really hot; running low grade fever; body aches; very fatigued; really swollen lymph nodes; throat hurts; extreme pain in my arm, neck, ear, and eye; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), PAIN (extreme pain in my arm, neck, ear, and eye), ABNORMAL SENSATION IN EYE (my ear and eye got really hot) and PYREXIA (running low grade fever) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PAIN (extreme pain in my arm, neck, ear, and eye). On an unknown date, the patient experienced LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), ABNORMAL SENSATION IN EYE (my ear and eye got really hot), PYREXIA (running low grade fever), MYALGIA (body aches) and FATIGUE (very fatigued). At the time of the report, LYMPHADENOPATHY (really swollen lymph nodes), OROPHARYNGEAL PAIN (throat hurts), PAIN (extreme pain in my arm, neck, ear, and eye), ABNORMAL SENSATION IN EYE (my ear and eye got really hot), PYREXIA (running low grade fever), MYALGIA (body aches) and FATIGUE (very fatigued) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. The treatment reported was Tylenol which helped with the pain, sore throat, and fever.; Sender's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnant and received first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received first dose) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome since 2019. Concomitant products included METFORMIN for Polycystic ovarian syndrome, 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 an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 26-Dec-2020 and the estimated date of delivery was 30-Sep-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourth week of the pregnancy.  On 22-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pregnancy test: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment information provided; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Injection site erythema, Injection site swelling
Clinical narrative: fatigue; a fast heartbeat that went away shorted after it started; flat headache; redness at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (a fast heartbeat that went away shorted after it started), HEADACHE (flat headache), INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and FATIGUE (fatigue) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Seafood allergy). Concomitant products included DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Allergy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced HEART RATE INCREASED (a fast heartbeat that went away shorted after it started), HEADACHE (flat headache), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE SWELLING (swelling at the injection site). On 10-Jan-2021, the patient experienced FATIGUE (fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 09-Jan-2021, HEART RATE INCREASED (a fast heartbeat that went away shorted after it started) had resolved. On 12-Jan-2021, INJECTION SITE ERYTHEMA (redness at the injection site), INJECTION SITE SWELLING (swelling at the injection site) and FATIGUE (fatigue) had resolved. At the time of the report, HEADACHE (flat headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: pretty little itchy rash on my arm; pretty little itchy rash on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (pretty little itchy rash on my arm) and VACCINATION SITE RASH (pretty little itchy rash on my arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (pretty little itchy rash on my arm) and VACCINATION SITE RASH (pretty little itchy rash on my arm). At the time of the report, VACCINATION SITE PRURITUS (pretty little itchy rash on my arm) and VACCINATION SITE RASH (pretty little itchy rash on my arm) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported. The treatment reported was prednisone, Benadryl, hydrocortisone cream and ice.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Left side of face is swollen; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SWELLING FACE (Left side of face is swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Facial swelling in 2020.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced SWELLING FACE (Left side of face is swollen). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Left side of face is swollen) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that, patient was taking medical history and was on medications.,  Treatment for the event included diphenhydramine HCl.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 31-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage on 15-May-2020. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 13-Jan-2021 at 10:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 10-Aug-2020 and the estimated date of delivery was 17-May-2021. On 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Sep-2020, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal for both.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication was not reported.  This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: 35.5 weeks pregnant and just received my first dose of your vaccine; This spontaneous prospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPOSURE DURING PREGNANCY (35.5 weeks pregnant and just received my first dose of your vaccine) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 21-Feb-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (35.5 weeks pregnant and just received my first dose of your vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 22-Jan-2021, EXPOSURE DURING PREGNANCY (35.5 weeks pregnant and just received my first dose of your vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Polymerase chain reaction, SARS-CoV-2 antibody test, Vaccination site cellulitis
Clinical narrative: Cellulitis; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Cellulitis) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20ZA) for COVID-19 vaccination.     The patient's past medical history included Hyperthyroidism (10 years. Started during pregnancy. Treated with methimazole for 3 years.), Hives (Under stress), Asthma (Under stress), Pregnant (Twice.  One pregnancy at the age of 25.), Radioactive iodine therapy (Ablation with radioactive iodine 3 years ago.) and PPD skin test (First one done when young.  Another test at 23 years old. The reaction was 10 inches, warm and swollen at the test site. The third time, 25 years old and pregnant. Whole arm was swollen, red and painful.). Concurrent medical conditions included Hypothyroidism (Has been taking Levothyroxine.). Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Cellulitis). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (Cellulitis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Polymerase chain reaction: negative (Negative) Nasal. On 22-Jan-2021, SARS-CoV-2 antibody test: pos and reactive Total Ab w/rflx IgG.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  Treatment medication also included an antibiotic.; Sender's Comments: This case is under data review.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site cellulitis, Vaccination site rash
Clinical narrative: looked like cellulitis; rash at 7 days at the injection site; A spontaneous report was received from a physician concerning a 47-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a rash at 7 days at the injection site and looked like cellulitis.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the physician called to report that the patient got a rash at the injection site 7 days after receiving the vaccine. It was a delayed reaction that looked like cellulitis. Treatment for the events included a steroid, oral prednisone for 5 days with the reaction resolving within 48 hours.  Action taken with mRNA-1273 in response to the events was not reported.   The events, rash at 7 days at the injection site and looked like cellulitis, resolved on unknown date.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: Mild fever; Sore arm; Difficulty sleeping; Pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Difficulty sleeping), VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Mild fever) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical condition reported.).    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 INSOMNIA (Difficulty sleeping) and VACCINATION SITE PAIN (Pain at injection site). On 12-Jan-2021, the patient experienced PYREXIA (Mild fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INSOMNIA (Difficulty sleeping), VACCINATION SITE PAIN (Pain at injection site) and PYREXIA (Mild fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment medication included Tylenol.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site pain
Clinical narrative: headache; little bit of nausea; fatigue; arm was sore; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache), NAUSEA (little bit of nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2ALCHD) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced HEADACHE (headache), NAUSEA (little bit of nausea), FATIGUE (fatigue) and VACCINATION SITE PAIN (arm was sore). At the time of the report, HEADACHE (headache), NAUSEA (little bit of nausea) and FATIGUE (fatigue) had resolved and VACCINATION SITE PAIN (arm was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were provided No concomitant medication was provided.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Gingival blister, Gingival erythema, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Injection site swollen; Injection site itchy; Redness in her gums; Blisters in her gums; Painful injection site; Redness at the injection site which was circular (3in); This spontaneous case was reported by a physician and describes the occurrence of GINGIVAL ERYTHEMA (Redness in her gums), GINGIVAL BLISTER (Blisters in her gums), VACCINATION SITE PAIN (Painful injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)) and VACCINATION SITE SWELLING (Injection site swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Painful injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)). On 06-Jan-2021, the patient experienced GINGIVAL ERYTHEMA (Redness in her gums) and GINGIVAL BLISTER (Blisters in her gums). On 12-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site itchy). The patient was treated with BENZOCAINE (ORAJEL) at an unspecified dose and frequency and AZITHROMYCIN at a dose of 250 milligram twice a day. On 08-Jan-2021, VACCINATION SITE PAIN (Painful injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)) had resolved. At the time of the report, GINGIVAL ERYTHEMA (Redness in her gums) and GINGIVAL BLISTER (Blisters in her gums) was resolving and VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with Orajel, unspecified antibiotic ointment and Azithromycin 250 mg (3 doses); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Injection site swollen; Injection site itchy; Redness in her gums; Blisters in her gums; Painful injection site; Redness at the injection site which was circular (3in); This spontaneous case was reported by a physician and describes the occurrence of GINGIVAL ERYTHEMA (Redness in her gums), GINGIVAL BLISTER (Blisters in her gums), VACCINATION SITE PAIN (Painful injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)) and VACCINATION SITE SWELLING (Injection site swollen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (Painful injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)). On 06-Jan-2021, the patient experienced GINGIVAL ERYTHEMA (Redness in her gums) and GINGIVAL BLISTER (Blisters in her gums). On 12-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site itchy). The patient was treated with BENZOCAINE (ORAJEL) at an unspecified dose and frequency and AZITHROMYCIN at a dose of 250 milligram twice a day. On 08-Jan-2021, VACCINATION SITE PAIN (Painful injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site which was circular (3in)) had resolved. At the time of the report, GINGIVAL ERYTHEMA (Redness in her gums) and GINGIVAL BLISTER (Blisters in her gums) was resolving and VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was treated with Orajel, unspecified antibiotic ointment and Azithromycin 250 mg (3 doses); Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site pain
Clinical narrative: Pain in my left arm at the joints/joint pain in the right arm; Pain in left arm pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in my left arm at the joints/joint pain in the right arm) and VACCINATION SITE PAIN (Pain in left arm pain) in a 69-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 (No adverse event history).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced ARTHRALGIA (Pain in my left arm at the joints/joint pain in the right arm) and VACCINATION SITE PAIN (Pain in left arm pain). On 10-Jan-2021, VACCINATION SITE PAIN (Pain in left arm pain) had resolved. On 13-Jan-2021, ARTHRALGIA (Pain in my left arm at the joints/joint pain in the right arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported by investigator No treatment medications provided by the reporter.    Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: Receive vaccine while pregnant; This spontaneous prospective pregnancy case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant) 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-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided.   On 26-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant). On 26-Dec-2020, EXPOSURE DURING PREGNANCY (Receive vaccine while pregnant) 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.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Apr-2021: Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: itching at the injection site; swelling that is a bit raised at the injection site; redness at the injection site; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included DEXTROAMPHETAMINE SULFATE for an unknown indication.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site). The patient was treated with IBUPROFEN ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, VACCINATION SITE SWELLING (swelling that is a bit raised at the injection site), VACCINATION SITE ERYTHEMA (redness at the injection site) and VACCINATION SITE PRURITUS (itching at the injection site) was resolving. 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: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Injection site joint pain, Myalgia, Pruritus, Swelling
Clinical narrative: Left arm is itchy; Swelling; Local pain; Triceps pain; A spontaneous report was received from a consumer concerning a 60years old, male patient who developed/experienced local pain injection site joint pain), triceps pain(myalgia), itchy left arm (pruritus) and swelling (swelling).  The patient's medical history was not provided.  Products known to have been used by the patient, within two weeks prior to the event, included Cholesterol pills, Aspirin, Vitamins.  On 11-Jan-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 013L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 11-Jan-2021, the patient experienced local pain and triceps pain. On 19-Jan-2021,  the patient experienced his left arm was itchy and swelling.No treatment was received for the events.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events were not reported.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Chills, Cough, Fatigue, Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19), HOT FLUSH (Hot flash), COUGH (Cough), HEADACHE (Headache) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced NAUSEA (Nausea). On 12-Jan-2021, the patient experienced HOT FLUSH (Hot flash), COUGH (Cough), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. On 13-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID-19), HOT FLUSH (Hot flash), COUGH (Cough), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: additional information received; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Nausea
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID-19), HOT FLUSH (Hot flash), COUGH (Cough), HEADACHE (Headache) and CHILLS (Chills) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced NAUSEA (Nausea). On 12-Jan-2021, the patient experienced HOT FLUSH (Hot flash), COUGH (Cough), HEADACHE (Headache), CHILLS (Chills) and FATIGUE (Fatigue). On 13-Jan-2021, the patient experienced COVID-19 (Diagnosed with COVID-19). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK, bid. On 13-Jan-2021, HEADACHE (Headache) had resolved. At the time of the report, COVID-19 (Diagnosed with COVID-19), HOT FLUSH (Hot flash), COUGH (Cough), CHILLS (Chills), FATIGUE (Fatigue) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, COVID-19: (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.    Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: additional information received; Sender's Comments: Very limited information regarding these events has been provided at this time. The patient probably experienced asymptomatic COVID-19 infection before being administered with the mRNA-1273 vaccine.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Site of injection is itchy; Area is kind of reddish more like pinkish towards inner arm above and down the site of injection; Pain at site of injection on the same day, still hurting at site of injection; A spontaneous report was received from a consumer concerning herself, a 65-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced VACCINATION SITE PRURITUS  (site of injection was itchy ), VACCINATION SITE PAIN  (pain at site of injection on the same day, still hurting at site of injection) and VACCINATION SITE ERYTHEMA  (area is kind of reddish more like pinkish towards inner arm above and down the site of injection)  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the patient experienced pain at the site of injection. On the same day she got relieved from the pain when she applied cold compression over that area.  On 13 Jan 2021, at mid night the patient felt like a mosquito bite and then noticed that the site of injection was itchy with a kind of reddish more like pinkish towards inner arm above and down the site of injection towards her breast and experienced a lot of pain. She also tried using cold pack, patient noted that it still hurting. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, site of injection was itchy, area is kind of reddish more like pinkish towards inner arm above and down the site of injection, was considered as unknown. The outcome of the event, pain at site of injection on the same day, still hurting at site of injection, was not recovered.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itching underneath of where I had the vaccine; kind of big rash; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching underneath of where I had the vaccine), VACCINATION SITE RASH (kind of big rash) and VACCINATION SITE SWELLING (Swelling) in a  patient of an unknown age and gender who received mRNA-1273 for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On 11-Jan-2021, the patient received first dose of mRNA-1273 (unknown route) at an unspecified dose. On 12-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itching underneath of where I had the vaccine), VACCINATION SITE RASH (kind of big rash) and VACCINATION SITE SWELLING (Swelling). At the time of the report, VACCINATION SITE PRURITUS (itching underneath of where I had the vaccine), VACCINATION SITE RASH (kind of big rash) and VACCINATION SITE SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Unknown) was unknown.       Upon in internal review on  21 -May 2021, the age was corrected to unknown  years.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Flushing, Nausea, Pain, Vomiting
Clinical narrative: flush; nausea (noxious); Could not keep anything down; soreness; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (flush), PAIN (soreness), NAUSEA (nausea (noxious)) and VOMITING (Could not keep anything down) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced PAIN (soreness). On 13-Jan-2021, the patient experienced FLUSHING (flush), NAUSEA (nausea (noxious)) and VOMITING (Could not keep anything down). At the time of the report, FLUSHING (flush), PAIN (soreness) and VOMITING (Could not keep anything down) outcome was unknown and NAUSEA (nausea (noxious)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jan-2021, Body temperature: 97.8 Inconclusive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment was received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Influenza like illness, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: started to shake; felt like she was getting the flu; Dizzy; didn't feel right; arm hurt a bit; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy), FATIGUE (didn't feel right) and VACCINATION SITE PAIN (arm hurt a bit) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (prior covid-19 infection.) from 24-Nov-2020 to 15-Dec-2020.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm hurt a bit). On 10-Jan-2021, the patient experienced TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy) and FATIGUE (didn't feel right). On 13-Jan-2021, TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy), FATIGUE (didn't feel right) and VACCINATION SITE PAIN (arm hurt a bit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test positive: positive Positive. On 15-Dec-2020, SARS-CoV-2 test negative: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Tremor, Vaccination site pain
Clinical narrative: started to shake; felt like she was getting the flu; Dizzy; didn't feel right; arm hurt a bit; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy), FATIGUE (didn't feel right) and VACCINATION SITE PAIN (arm hurt a bit) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (prior covid-19 infection.) from 24-Nov-2020 to 15-Dec-2020.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm hurt a bit). On 10-Jan-2021, the patient experienced TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy) and FATIGUE (didn't feel right). On 13-Jan-2021, TREMOR (started to shake), INFLUENZA LIKE ILLNESS (felt like she was getting the flu), DIZZINESS (Dizzy), FATIGUE (didn't feel right) and VACCINATION SITE PAIN (arm hurt a bit) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test positive: positive Positive. On 15-Dec-2020, SARS-CoV-2 test negative: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   No treatment information was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Visual field defect, Visual impairment
Clinical narrative: at the side sight the patient sees rainbows; vision changes in the peripheral sight; This spontaneous case was reported by a nurse and describes the occurrence of VISUAL IMPAIRMENT (at the side sight the patient sees rainbows) and VISUAL FIELD DEFECT (vision changes in the peripheral sight) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (at the side sight the patient sees rainbows) and VISUAL FIELD DEFECT (vision changes in the peripheral sight). At the time of the report, VISUAL IMPAIRMENT (at the side sight the patient sees rainbows) and VISUAL FIELD DEFECT (vision changes in the peripheral sight) outcome was unknown.        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.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hypokinesia, Nausea, Pyrexia
Clinical narrative: Couldn't move head; Fever of 103; Nausea; Chills; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Couldn't move head), PYREXIA (Fever of 103), NAUSEA (Nausea) and CHILLS (Chills) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history were reported.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced HYPOKINESIA (Couldn't move head), PYREXIA (Fever of 103), NAUSEA (Nausea) and CHILLS (Chills). At the time of the report, HYPOKINESIA (Couldn't move head), PYREXIA (Fever of 103), NAUSEA (Nausea) and CHILLS (Chills) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take Bayer aspirin as a treatment medication.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Swelling, Vaccination site cellulitis, Vaccination site rash
Clinical narrative: Intense  swelling; Red; Rash at 7 days at the injection site and Looked like cellulitis; Looked like cellulitis; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Looked like cellulitis), SWELLING (Intense  swelling), ERYTHEMA (Red) and VACCINATION SITE RASH (Rash at 7 days at the injection site and Looked like cellulitis) in a 25-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 (No prior medical history were reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE CELLULITIS (Looked like cellulitis), SWELLING (Intense  swelling), ERYTHEMA (Red) and VACCINATION SITE RASH (Rash at 7 days at the injection site and Looked like cellulitis). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (Looked like cellulitis) had resolved and SWELLING (Intense  swelling), ERYTHEMA (Red) and VACCINATION SITE RASH (Rash at 7 days at the injection site and Looked like cellulitis) outcome was unknown.        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.   Treatment drug included oral prednisone and was taken for five days.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.