chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea, Dysphonia, Dyspnoea
Clinical narrative: Positive for covid-19; Shortness of breath / difficulty breathing; Can't talk much, has trouble with her voice; Diarrhea; She got sick; Ongoing cough; Experienced chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for covid-19), DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea) and ILLNESS (She got sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 prior medical history were reported.).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea), ILLNESS (She got sick), COUGH (Ongoing cough) and CHILLS (Experienced chills). On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for covid-19), DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea), ILLNESS (She got sick), COUGH (Ongoing cough) and CHILLS (Experienced chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test positive: (Positive) Covid-19 rapid test positive was reported..     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 medications reported by investigator o No treatment medications provided by the reporter.; 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. However, the event COVID-19 positive is unlikely related to mRNA-1273 .
Sex: F
Vaccine: COVID19
Symptoms: Illness, SARS-CoV-2 test positive
Clinical narrative: Positive for covid-19; Shortness of breath / difficulty breathing; Can't talk much, has trouble with her voice; Diarrhea; She got sick; Ongoing cough; Experienced chills; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for covid-19), DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea) and ILLNESS (She got sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) 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 prior medical history were reported.).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea), ILLNESS (She got sick), COUGH (Ongoing cough) and CHILLS (Experienced chills). On 10-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for covid-19). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for covid-19), DYSPNOEA (Shortness of breath / difficulty breathing), DYSPHONIA (Can't talk much, has trouble with her voice), DIARRHOEA (Diarrhea), ILLNESS (She got sick), COUGH (Ongoing cough) and CHILLS (Experienced chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test positive: (Positive) Covid-19 rapid test positive was reported..     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 medications reported by investigator o No treatment medications provided by the reporter.; 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. However, the event COVID-19 positive is unlikely related to mRNA-1273 .
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: After receiving the vaccine the patient tested positive for Covid; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of SARS-COV-2 TEST POSITIVE (After receiving the vaccine the patient tested positive for Covid) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (After receiving the vaccine the patient tested positive for Covid). At the time of the report, SARS-COV-2 TEST POSITIVE (After receiving the vaccine the patient tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.     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. No treatment information was provided.; Sender's Comments: Very limited information regarding this event has been provided at this time. However, the event COVID-19 Positive is unlikely related to m-RNA-1273.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. H012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure and Drug allergy (Allergic to Demerol.).    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection site). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included for Blood pressure. Treatment information was not 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site nodule, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Hot to the touch right around the injection site; Very large knot right around the injection site; Itchiness right around the injection site; Redness right around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch right around the injection site), VACCINATION SITE NODULE (Very large knot right around the injection site), VACCINATION SITE PRURITUS (Itchiness right around the injection site) and VACCINATION SITE ERYTHEMA (Redness right around the injection site) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     Concomitant products included EPINEPHRINE BITARTRATE (ASTHMAHALER) for Asthma, LABETALOL for an unknown indication.    On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch right around the injection site), VACCINATION SITE NODULE (Very large knot right around the injection site), VACCINATION SITE PRURITUS (Itchiness right around the injection site) and VACCINATION SITE ERYTHEMA (Redness right around the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency and LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot to the touch right around the injection site), VACCINATION SITE PRURITUS (Itchiness right around the injection site) and VACCINATION SITE ERYTHEMA (Redness right around the injection site) was resolving and VACCINATION SITE NODULE (Very large knot right around the injection site) had 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 assessments.   Treatment information provide as put ice on injection site; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Vaccination site pain
Clinical narrative: Lower back pain that suddenly went away; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Lower back pain that suddenly went away) and VACCINATION SITE PAIN (Soreness of the arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart rate irregular. Concurrent medical conditions included Asthma. Concomitant products included METOPROLOL SUCCINATE (TOPROL) for Heart beat abnormal neonatal, LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced VACCINATION SITE PAIN (Soreness of the arm). On 30-Dec-2020, the patient experienced BACK PAIN (Lower back pain that suddenly went away). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) ongoing since an unknown date at an unspecified dose and frequency. On 30-Dec-2020, VACCINATION SITE PAIN (Soreness of the arm) had resolved. On 11-Jan-2021, BACK PAIN (Lower back pain that suddenly went away) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication included asthma inhaler.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up was received on 03 jun 2021 non significant case included back pain recovered.and no new information.; 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Hypoaesthesia, Nausea
Clinical narrative: Tested positive for COVID-19; Extreme nausea; Fatigue; Headache; Head spinning; Numbness in arms and hands; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and NAUSEA (Extreme nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced DIARRHOEA (Severe diarrhea). On 04-Jan-2021, the patient experienced VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), NAUSEA (Extreme nausea), FATIGUE (Fatigue) and HEADACHE (Headache). On 05-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, DIARRHOEA (Severe diarrhea) was resolving and VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NAUSEA (Extreme nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included baby aspirin, ibuprofen and aspirin, sodium bicarbonate, anhydrous citric acid. Concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, other than testing positive for Covid-19 , a causal relationship cannot be excluded.  Testing positive for Covid-19 is unrelated to receiving COVID-19 vaccine (mRNA-1273)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vertigo
Clinical narrative: Tested positive for COVID-19; Extreme nausea; Fatigue; Headache; Head spinning; Numbness in arms and hands; Severe diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Severe diarrhea), VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and NAUSEA (Extreme nausea) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L2OA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced DIARRHOEA (Severe diarrhea). On 04-Jan-2021, the patient experienced VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), NAUSEA (Extreme nausea), FATIGUE (Fatigue) and HEADACHE (Headache). On 05-Jan-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). At the time of the report, DIARRHOEA (Severe diarrhea) was resolving and VERTIGO (Head spinning), HYPOAESTHESIA (Numbness in arms and hands), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19), NAUSEA (Extreme nausea), FATIGUE (Fatigue) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, SARS-CoV-2 test positive: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medications included baby aspirin, ibuprofen and aspirin, sodium bicarbonate, anhydrous citric acid. Concomitant medications were not provided by reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, other than testing positive for Covid-19 , a causal relationship cannot be excluded.  Testing positive for Covid-19 is unrelated to receiving COVID-19 vaccine (mRNA-1273)
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: Warm to the touch injection site; 2" Rash on the injection site is back 6-7 days after the injection, gets worst at night; A spontaneous report was received from a consumer concerning a 32-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA -1273) and experienced events, two inches rash on the injection site/injection site rash and injection site was warm to the touch/injection site warmth.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 06 Jan 2021, approximately a day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the deltoid muscle of the left arm for prophylaxis of COVID-19 infection.  On 06 Jan 2021, the patient received the vaccine and on 07 Jan 2021, she experienced two inches rash on the injection site. The rash lasted two to three days and the rash disappeared, but now it is coming back six to seven days later on 11 Jan 2021 and she felt the injection site was warm to touch. Treatment for the events included steroids.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event 2" rash on the injection site was not resolved. The event outcome injection site was warm to the touch 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: Exposure during pregnancy, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 32-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 2029K20A and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Cipro-class of drugs). Concomitant products included 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] and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 30-May-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jan-2020, Ultrasound scan: normal (normal) Normal.     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 details was provided.  Previous pregnancy with live full-term birth as a outcome was reported on 01-Aug-2019.; 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: arm  still red after 7 days; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm  still red after 7 days) 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 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced ERYTHEMA (arm  still red after 7 days). At the time of the report, ERYTHEMA (arm  still red after 7 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information was not provided.  Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded; Sender's Comments: Limited information regarding the events has been provided at this time and a causal relationship cannot be excluded
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site mass
Clinical narrative: injection site is red - about 1.5 inches; injection site is itchy; there is a bump at the injection site; A spontaneous report was received from a consumer concerning a 79 years old female patient who developed injection site is red - about 1.5 inches/ injection site erythema, injection site is itchy/ injection site pruritus, there is a bump at the injection site/ vaccination site mass.  The patient's medical history included hypertension, cholesterol, diabetes, and bursitis. Products known to have been used by the patient, within two weeks prior to the event, included Candesartan, Pravastatin, Gabapentin, Metformin, Omeprazole, HCTZ, Trazodone, Acetylsalicylic acid, Docusate Sodium, Coenzyme qQ0 [ubidecarenone], Colecalciferol, Magnesium, Krill oil, Apoaequorin, Milk thistle [Silybum Marianum], Ubidecarenone.   The patient received their unknown dose of two planned doses of mRNA-1273 (Batch number: 026L20A) on 13 Jan 2021 intramuscularly at left arm for prophylaxis of COVID-19 infection.    On 13 Jan 2021 the patient reported the injection site is red, itchy and there is a bump at the site. reported the injection site is red, itchy and there is a bump at the site. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event(s) was not provided.  The outcome of the event(s) injection site is red - about 1.5 inches, injection site is itchy, there is a bump at the injection site was not reported.; 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: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy; This spontaneous case was reported by a physician and describes the occurrence of LYMPHADENOPATHY (Lymphadenopathy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-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 LYMPHADENOPATHY (Lymphadenopathy). At the time of the report, LYMPHADENOPATHY (Lymphadenopathy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant details were not reported by the reporter. Treatment details was not reported by the reporter.; 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: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: severe pain in the left buttocks running down the back of the left thigh; shoulder was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (severe pain in the left buttocks running down the back of the left thigh) and ARTHRALGIA (shoulder was sore) 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 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 ARTHRALGIA (shoulder was sore). On 10-Jan-2021, the patient experienced PAIN (severe pain in the left buttocks running down the back of the left thigh). At the time of the report, PAIN (severe pain in the left buttocks running down the back of the left thigh) outcome was unknown and ARTHRALGIA (shoulder was sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication not provided. Concomitant medication not 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.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site induration, Rash, Rash pruritic, Vaccination site pain
Clinical narrative: Rash that itches on the arm; Little bit rash last for 2 days; Area is harder than it should be near the site; Arm just below where received injection hurts to the touch; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Rash that itches on the arm), INJECTION SITE INDURATION (Area is harder than it should be near the site), RASH (Little bit rash last for 2 days) and VACCINATION SITE PAIN (Arm just below where received injection hurts to the touch) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-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 RASH PRURITIC (Rash that itches on the arm), INJECTION SITE INDURATION (Area is harder than it should be near the site), RASH (Little bit rash last for 2 days) and VACCINATION SITE PAIN (Arm just below where received injection hurts to the touch). At the time of the report, RASH PRURITIC (Rash that itches on the arm), INJECTION SITE INDURATION (Area is harder than it should be near the site), RASH (Little bit rash last for 2 days) and VACCINATION SITE PAIN (Arm just below where received injection hurts to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment details were not reported by the reporter.; 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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling at the injection site; Redness at the injection site; Tenderness at the injection site; A spontaneous report was received from other health care professional concerning a 37-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swelling, redness and tenderness at injection site.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A, Expiry date: Jun-2021) intramuscularly in the left arm deltoid for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient experienced swelling, redness and tenderness at the injection site and took Tylenol (paracetamol).  Action taken with mRNA-1273 in response to the events was not reported.   The events, swelling, redness and tenderness at injection site were ongoing (not recovered).; Reporter'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: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Urticaria
Clinical narrative: Experiencing swollen lips; Hives 15-20 minutes after receiving vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of LIP SWELLING (Experiencing swollen lips) and URTICARIA (Hives 15-20 minutes after receiving vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced LIP SWELLING (Experiencing swollen lips) and URTICARIA (Hives 15-20 minutes after receiving vaccine). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and STEROIDS ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, LIP SWELLING (Experiencing swollen lips) and URTICARIA (Hives 15-20 minutes after receiving vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Upper-airway cough syndrome
Clinical narrative: Post nasal drip in throat; This spontaneous case was reported by a consumer and describes the occurrence of UPPER-AIRWAY COUGH SYNDROME (Post nasal drip in throat) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2OA) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UPPER-AIRWAY COUGH SYNDROME (Post nasal drip in throat). At the time of the report, UPPER-AIRWAY COUGH SYNDROME (Post nasal drip in throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not 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 event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Mastication disorder, Pain, Pain in extremity
Clinical narrative: her eyes were small and puffy; felt very tired this morning; numbness on the right side of her face by the eye socket; pain on her TMJ, but on her right side of her face; She had a hard time to chew; usual pain in the arm after injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew), PAIN IN EXTREMITY (usual pain in the arm after injection) and PERIORBITAL SWELLING (her eyes were small and puffy) in a 51-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 past medical history included Anaphylactic shock. Concurrent medical conditions included TMJ syndrome.    On 13-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 HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew) and PAIN IN EXTREMITY (usual pain in the arm after injection). On 14-Jan-2021, the patient experienced PERIORBITAL SWELLING (her eyes were small and puffy) and FATIGUE (felt very tired this morning). At the time of the report, HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew), PAIN IN EXTREMITY (usual pain in the arm after injection), PERIORBITAL SWELLING (her eyes were small and puffy) and FATIGUE (felt very tired this morning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: her eyes were small and puffy; felt very tired this morning; numbness on the right side of her face by the eye socket; pain on her TMJ, but on her right side of her face; She had a hard time to chew; usual pain in the arm after injection; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew), PAIN IN EXTREMITY (usual pain in the arm after injection) and PERIORBITAL SWELLING (her eyes were small and puffy) in a 51-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 past medical history included Anaphylactic shock. Concurrent medical conditions included TMJ syndrome.    On 13-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 HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew) and PAIN IN EXTREMITY (usual pain in the arm after injection). On 14-Jan-2021, the patient experienced PERIORBITAL SWELLING (her eyes were small and puffy) and FATIGUE (felt very tired this morning). At the time of the report, HYPOAESTHESIA (numbness on the right side of her face by the eye socket), PAIN (pain on her TMJ, but on her right side of her face), MASTICATION DISORDER (She had a hard time to chew), PAIN IN EXTREMITY (usual pain in the arm after injection), PERIORBITAL SWELLING (her eyes were small and puffy) and FATIGUE (felt very tired this morning) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site inflammation, Vaccination site pruritus
Clinical narrative: redness at the injection site; Injection site a little hard; Injection site a little puffy; Injection site a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE INDURATION (Injection site a little hard), VACCINATION SITE INFLAMMATION (Injection site a little puffy) and VACCINATION SITE PRURITUS (Injection site a little itchy) in a 68-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 No adverse event (No reported medical history).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE INDURATION (Injection site a little hard), VACCINATION SITE INFLAMMATION (Injection site a little puffy) and VACCINATION SITE PRURITUS (Injection site a little itchy). At the time of the report, VACCINATION SITE ERYTHEMA (redness at the injection site), VACCINATION SITE INDURATION (Injection site a little hard), VACCINATION SITE INFLAMMATION (Injection site a little puffy) and VACCINATION SITE PRURITUS (Injection site a little itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Hurts to move or raise her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Hurts to move or raise her arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Hurts to move or raise her arm). At the time of the report, VACCINATION SITE PAIN (Hurts to move or raise her arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not 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.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing, Vaccination site pain
Clinical narrative: Sneezing all day; Nose is running; Pain where she received the injection; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing all day), RHINORRHOEA (Nose is running) and VACCINATION SITE PAIN (Pain where she received the injection) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure. Concomitant products included ANTIHYPERTENSIVES for Blood pressure, LOPERAMIDE HYDROCHLORIDE (IMODIUM) for an unknown indication.    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 SNEEZING (Sneezing all day), RHINORRHOEA (Nose is running) and VACCINATION SITE PAIN (Pain where she received the injection). At the time of the report, SNEEZING (Sneezing all day), RHINORRHOEA (Nose is running) and VACCINATION SITE PAIN (Pain where she received the injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details was not reported by the reporter.; 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: Exposure during pregnancy
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 21-Jan-2021, 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 21-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). On 21-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been reported.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; Vomiting; Headache; Small fever; This spontaneous case was reported by an other health care professional and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Small fever) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Small fever). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), HEADACHE (Headache) and PYREXIA (Small fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medication not provided. Concomitant medication not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: Additional information; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Fever; There is a knot in her arm where she got the shot; It itches; chills all day at work; A spontaneous report  was received from a consumer concerning a female patient of 49 years old, who was received Moderna's COVID-19 vaccine(mRNA-1273) and experienced chills,fever,vaccination site swelling and vaccination site itching.  The patients medical history was not provided .Concomitant medications reported included BAGASLAR,FIAST,METFORMIN,AMITRYPTILINE,ATORVASTATIN,HYDOCHLORTHIAZIDE used for unknown indication.  On 12 jan 2021,prior to the onset of events, the Patient received their first of two planned dose of mRNA-1273(Lot number: 041L20A) vaccine intramuscularly in the left non-dominant arm for prophylaxis of COVID-19 infection.  On 12 jan 2021, She had chills all day at work. There is a knot in her arm where she got the shot. The bump or knot is growing bigger and it itches. She still has the chills every now and then. On 13 jan 2021,patient experienced a fever of 100.8F Treatment for the event included Ibuprofen.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  the event fever were considered resolved on 13 jan 2021.  The outcome of the event chills were considered not resolved.  The outcome of the event vaccination site swelling and vaccination site itching 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: Injection site swelling, Vaccination site cellulitis, Vaccination site erythema, Vaccination site induration, Vaccination site mass
Clinical narrative: Looks like cellulitis; Red; Knot on her arm; hard to the touch; Sore arm; Slight swelling of the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Looks like cellulitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-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 CELLULITIS (Looks like cellulitis). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN & CLAV. POTASSIUM) ongoing since an unknown date at a dose of 875-125 milligram. At the time of the report, VACCINATION SITE CELLULITIS (Looks like cellulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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 pain
Clinical narrative: Looks like cellulitis; Red; Knot on her arm; hard to the touch; Sore arm; Slight swelling of the injection site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Looks like cellulitis) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-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 CELLULITIS (Looks like cellulitis). The patient was treated with AMOXICILLIN TRIHYDRATE, CLAVULANATE POTASSIUM (AMOXICILLIN & CLAV. POTASSIUM) ongoing since an unknown date at a dose of 875-125 milligram. At the time of the report, VACCINATION SITE CELLULITIS (Looks like cellulitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; 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.