chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Diarrhea; glucose also shot up to 208 without eating; light headedness; Cheeks are pink; feeling little abnormal not better than last night; small rash on her injection site; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink) and FEELING ABNORMAL (feeling little abnormal not better than last night) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Heart failure (Due to blockage) in August 2019, Corona virus infection (UK H1 Coronavirus) in March 2018, Pneumonia (she was on oxygen therapy in ICU and took months to recover, almost died.) in March 2018 and Oxygen therapy in March 2018. Concurrent medical conditions included Diabetes, Asthma, Heart disorder (Heart condition, heart damage due to COVID), Myelomalacia and UTI (she is takin Augmentin for her UTI from last 9 days).    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink), FEELING ABNORMAL (feeling little abnormal not better than last night) and VACCINATION SITE RASH (small rash on her injection site). At the time of the report, DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink), FEELING ABNORMAL (feeling little abnormal not better than last night) and VACCINATION SITE RASH (small rash on her injection site) 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.   Patient takes Blood thinner 3 mg daily concomitantly, and is on Augmentin for her Urinary tract infection for last 9 days, but according to patient she did not have diarrhea with Augmentin. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: itchy rash at the injection site 3 inches in diameter; itchy rash at the injection site 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter). At the time of the report, VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) 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.  No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter). At the time of the report, VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) 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.  No treatment details were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia, Delirium, Fatigue, Feeling of body temperature change, Headache
Clinical narrative: felt like when I had the flu; Dark urine/Red urine; Tired; Fever; headache; right lymphedema arm also swelled up; arm pain.; delirious; Kidney pains; wheezy; hot and cold feeling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delirious) in a 55-year-old female patient 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 Breast cancer and Lymphedema. Concurrent medical conditions included COPD and Immunocompromised. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TAMOXIFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-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 DELIRIUM (delirious) (seriousness criterion medically significant), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), CHROMATURIA (Dark urine/Red urine), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like when I had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DELIRIUM (delirious), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), INFLUENZA LIKE ILLNESS (felt like when I had the flu), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.) outcome was unknown and CHROMATURIA (Dark urine/Red urine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow up received by safety 19-Aug-2021 includes added concomitant medications, treatment medications, added new events, outcome of event red urine changed from unknown to 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymphadenopathy, Pyrexia, Renal pain, Vaccination site pain
Clinical narrative: felt like when I had the flu; Dark urine/Red urine; Tired; Fever; headache; right lymphedema arm also swelled up; arm pain.; delirious; Kidney pains; wheezy; hot and cold feeling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delirious) in a 55-year-old female patient 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 Breast cancer and Lymphedema. Concurrent medical conditions included COPD and Immunocompromised. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TAMOXIFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-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 DELIRIUM (delirious) (seriousness criterion medically significant), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), CHROMATURIA (Dark urine/Red urine), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like when I had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DELIRIUM (delirious), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), INFLUENZA LIKE ILLNESS (felt like when I had the flu), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.) outcome was unknown and CHROMATURIA (Dark urine/Red urine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow up received by safety 19-Aug-2021 includes added concomitant medications, treatment medications, added new events, outcome of event red urine changed from unknown to 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.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: felt like when I had the flu; Dark urine/Red urine; Tired; Fever; headache; right lymphedema arm also swelled up; arm pain.; delirious; Kidney pains; wheezy; hot and cold feeling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delirious) in a 55-year-old female patient 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 Breast cancer and Lymphedema. Concurrent medical conditions included COPD and Immunocompromised. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TAMOXIFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ALPRAZOLAM (XANAX) for an unknown indication.    On 13-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 DELIRIUM (delirious) (seriousness criterion medically significant), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), CHROMATURIA (Dark urine/Red urine), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like when I had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DELIRIUM (delirious), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), INFLUENZA LIKE ILLNESS (felt like when I had the flu), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.) outcome was unknown and CHROMATURIA (Dark urine/Red urine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow up received by safety 19-Aug-2021 includes added concomitant medications, treatment medications, added new events, outcome of event red urine changed from unknown to 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: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test, Ultrasound scan
Clinical narrative: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jun-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant products were not provided.  No treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache
Clinical narrative: Fatigue; Headache; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Discomfort, Fatigue, Headache, Vaccination site pain
Clinical narrative: Nerve sensation (finger, nose, toes); chills; pain at injection site (L); headache; fatigue; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (Nerve sensation (finger, nose, toes)), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (L)) in a 47-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 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site (L)). On 29-Dec-2020, the patient experienced CHILLS (chills). On 11-Jan-2021, the patient experienced DISCOMFORT (Nerve sensation (finger, nose, toes)). On 01-Jan-2021, CHILLS (chills) had resolved. On 06-Jan-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 07-Jan-2021, VACCINATION SITE PAIN (pain at injection site (L)) had resolved. On 21-Jan-2021, DISCOMFORT (Nerve sensation (finger, nose, toes)) 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.   No concomitant medications were provided No treatment information provided   Reporter did not allow further contact
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pruritus, Skin discomfort, Vaccination site pruritus
Clinical narrative: itchiness all over her back and body, itchiness on her spine area; uncomfortable sensation of skin; Itchiness started from injection site; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness all over her back and body, itchiness on her spine area), SKIN DISCOMFORT (uncomfortable sensation of skin), VACCINATION SITE PRURITUS (Itchiness started from injection site) and FATIGUE (feeling tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (itchiness all over her back and body, itchiness on her spine area), SKIN DISCOMFORT (uncomfortable sensation of skin), VACCINATION SITE PRURITUS (Itchiness started from injection site) and FATIGUE (feeling tired). At the time of the report, PRURITUS (itchiness all over her back and body, itchiness on her spine area), SKIN DISCOMFORT (uncomfortable sensation of skin), VACCINATION SITE PRURITUS (Itchiness started from injection site) and FATIGUE (feeling tired) 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.   No concomitant medications were provided.  No treatment information provided
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular
Clinical narrative: continued to grow together; rash on my arm after taking the moderna; Red bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my arm after taking the moderna), Red bumps and continued to grow together in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No medical history is provided, concomitant drugs are provided.  Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced RASH (rash on my arm after taking the moderna) and Red bumps. On an unknown date, the patient experienced continued to grow together. At the time of the report, RASH (rash on my arm after taking the moderna) was resolving and Red bumps and continued to grow together outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: updated concomitant meds, added additional 3 events updated events start date
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Pyrexia
Clinical narrative: Could hardly walk; Felt dizzy; Pyrexia; Temperature spiked up to 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Pyrexia). At the time of the report, PYREXIA (Pyrexia) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       felt like covid-19 in events
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Ear discomfort, Tinnitus
Clinical narrative: her left ear is full; feeling pressure; tinnitus; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of   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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      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.   Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Pain, Pyrexia
Clinical narrative: Diarrhea; Archy; Chills; Fever; Stomach Pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain). At the time of the report, DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain) was resolving. Possible      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication include Tylenol for pain. No concomitant medications were provided by reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, PROGESTERONE and TRAZODONE.    On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together). At the time of the report, VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), 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: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: pain in the arm; headache; A Spontaneous report was received from a Consumer concerning a female patient of unknown age who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, headache, pain in extremity.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 26 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch:unknown) for prophylaxis of COVID-19 infection.   On 26 Jan 2021, the patient reported she had pain in the arm and headache the first day and nothing after that.  Laboratory details were not provided.  Treatment details were not provided.  Action taken with mRNA-1273 in response to the events was not reported.  On date of this report, the outcome of the events of patient experiencing events, headache, pain in extremity was recovered/ resolved.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication included oral medication for diabetes No treatment information provided   This case was linked to MOD-2021-014421, MOD-2021-014394 (Linked Report).; Sender's Comments:  MOD-2021-014421:Same reporter, different patient MOD-2021-014394:Same reporter, different patient
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchiness; raised bubbles in their rash; A spontaneous report was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness and raised bubbles in the rash.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 15-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection.  The patient experienced itchiness and raised bubbles in the rash.  Laboratory details was not provided. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events was unknown.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014539:same reporter, different patient
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Injection site hurts; Headache; A spontaneous report  was received from a (Consumer) concerning a  72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (fever, injection site hurts, headache) list.      The patient's medical history was not provided. No relevant concomitant medications were reported.      On 25-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Left Upper Arm for prophylaxis of COVID-19 infection.    On 26-JAN-2021, The patient experienced the events list (fever, injection site hurts, headache).    Laboratory details was not provided.    No treatment information was provided.     Action taken with mRNA-1273 in response to the events was not reported.     At the time of this report, the outcome of the event(s) (fever, injection site hurts, headache) was <unknown>.    The reporter assessed the event(s), [fever, injection site hurts, headache], as related to study drug.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Vaccination site urticaria
Clinical narrative: Swollen arm; Rash on the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE URTICARIA (Rash on the site of the injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE URTICARIA (Rash on the site of the injection). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE URTICARIA (Rash on the site of the injection) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash pruritic, Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Vaccination site rash; Vaccination site pruritis; Vaccination site warmth; sore arm; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and VACCINATION SITE PRURITUS (Vaccination site pruritis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash). On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritis). At the time of the report, RASH PRURITIC (Itchy rash) and VACCINATION SITE PRURITUS (Vaccination site pruritis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingle outbreak; A spontaneous report was received from a pharmacist concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingle outbreak.  The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter.   On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection.   On unknown date, prior to receiving mRNA-1273, the patient experienced shingle outbreak. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, shingle outbreak considered unknown.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Influenza like illness
Clinical narrative: really bad diarrhea; felt like having flu like symptoms; A spontaneous report was received from a consumer, concerning a  female patient of   85 years age male patient , who received Moderna's COVID-19 vaccine and experienced diarrohea and flu symptoms The patient's medical history was provided that diabetes and heart conditions. Concomitant product use was not provided by the reporter. Lab data was not provided. Treatment medication was provided that he took pepto bismol. On 12-FEB-2021 prior to the onset of events, the patient received their First dose  of mRNA-1273 (batch no. 031M20A )via unknown route to the left arm for COVID-19 infection prophylaxis.   Action taken with mRNA-1273 in response to the event was known. The outcome of the event, was considered to be unknown at the time of this report.; Sender's Comments:  MOD21-030784:Crosslinked
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: incredible headaches the entire day; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (incredible headaches the entire day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (incredible headaches the entire day). The patient was treated with PARACETAMOL (TYLENOL) on 17-Feb-2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (incredible headaches the entire day) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: late for second dose; Covid-19; A spontaneous report (United states) was received from a pharmacist concerning patient who received Moderna's COVID-19 vaccine (mRNA-1273) late for second dose / Product dose omission issue because the patient developed COVID -19  The patient's medical history was not provided. Concomitant product use was not provided by reporter.   The patient was due to receive their second of two planned doses of mRNA-1273  (batch number not provided) on 08 Feb 2021.Due to having COVID, the patient missed the second dose. No treatment information was provided.   Action taken with the dose of mRNA-1273 vaccine was unknown.   The outcome for the event late for second dose / Product dose omission issue and COVID-19 was considered as unknown.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender wo experienced   late for second dose or mRNA-1273 (Inappropriate schedule of vaccine administered) due COVID-19 infection. Based on the known etiology of the disease and the profile of mRNA-1273  vaccine, a causal association between the event and mRNA-1273 is assessed as unlikely.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Amniocentesis, Exposure during pregnancy, Pregnancy test, Ultrasound scan, Vaccination site pain
Clinical narrative: exposure during pregnancy; muscle soreness at injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (Prior use). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, 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 21-Sep-2020 and the estimated date of delivery was 11-Jul-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixteenth week of the pregnancy.  The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. On 14-Jan-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test: positive Positive. On 21-Jan-2021, Amniocentesis: low level 10% of mosaic turner syndrome Low. On 21-Jan-2021, Ultrasound scan: no abnormal findings normal. On 28-Dec-2021, Ultrasound scan: no abnormal findings normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-165269 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test positive, Ultrasound uterus
Clinical narrative: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Pregnancy (Number of fetuses -1) since 01-Nov-2020. 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] for Vitamin supplementation.    On 19-Feb-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 01-Oct-2020 and the estimated date of delivery was 08-Jul-2021. On 19-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twentieth week of the pregnancy.  On 19-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test positive: Positive. On an unknown date, Ultrasound uterus: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       no treatment mentioned
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products TREPROSTINIL SODIUM for Pulmonary arterial hypertension and SELEXIPAG (UPTRAVI) for an unknown indication.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included WARFARIN for an unknown indication.   On 27-Mar-2019, the patient started TREPROSTINIL SODIUM (unknown route) .6 milligram per millilitre four times per day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (UPTRAVI) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided   Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI- Email ack from reporter
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Tremor, Vaccination site pain
Clinical narrative: Nauseated; Vomiting a lot; fever chills; Arm was sore; chills; shaking a lot; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2001, the patient experienced TREMOR (shaking a lot). On 13-Feb-2021, the patient experienced NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills). At the time of the report, NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore), CHILLS (chills) and TREMOR (shaking a lot) 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.
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Nauseated; Vomiting a lot; fever chills; Arm was sore; chills; shaking a lot; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetic.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2001, the patient experienced TREMOR (shaking a lot). On 13-Feb-2021, the patient experienced NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills). At the time of the report, NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore), CHILLS (chills) and TREMOR (shaking a lot) 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.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Malaise
Clinical narrative: feels like hypertension headache; pre flu like symptoms; feels like sickness is approaching / Do not feel well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (feels like hypertension headache), INFLUENZA LIKE ILLNESS (pre flu like symptoms) and MALAISE (feels like sickness is approaching / Do not feel well) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Neck pain.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (feels like hypertension headache), INFLUENZA LIKE ILLNESS (pre flu like symptoms) and MALAISE (feels like sickness is approaching / Do not feel well). At the time of the report, HEADACHE (feels like hypertension headache), INFLUENZA LIKE ILLNESS (pre flu like symptoms) and MALAISE (feels like sickness is approaching / Do not feel well) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Neck pain, Vaccination site pain
Clinical narrative: neck pain; pain in my left arm; headache; A spontaneous report was received from a Healthcare Professional concerning a 76 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, pain in my left arm, neck pain, and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, the patient experienced the events pain in my left arm. On 3 Feb 2021, the patient experienced the events neck pain. On 30 Jan 2021, the patient experienced the events headache.  Action taken with mRNA-1273 in response to the events, pain in my left arm, neck pain, and headache was not reported.   On 30 Jan 2021 the outcome of events, headache was resolved. On an unknown date the outcome of events include, pain in my left arm, neck pain was not reported.; Reporter's Comments: This case concerns a 76-year old female patient who received the first dose of mRNA-1273 and experienced non-serious events pain in my left arm, neck pain, and headache. 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: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Erythema, Peripheral swelling
Clinical narrative: shoulder was swollen/ shoulder was like puffy; there was a lot of redness there; Blood pressure is elevated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (shoulder was swollen/ shoulder was like puffy), ERYTHEMA (there was a lot of redness there) and BLOOD PRESSURE INCREASED (Blood pressure is elevated) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included SIMVASTATIN, LOSARTAN, LEVOTHYROXINE, TAMSULOSIN and metroprocol succinate for an unknown indication.    On 18-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 PERIPHERAL SWELLING (shoulder was swollen/ shoulder was like puffy), ERYTHEMA (there was a lot of redness there) and BLOOD PRESSURE INCREASED (Blood pressure is elevated). The patient was treated with DOXYCYCLINE MONOHYDRATE at a dose of 100 milligram. At the time of the report, PERIPHERAL SWELLING (shoulder was swollen/ shoulder was like puffy), ERYTHEMA (there was a lot of redness there) and BLOOD PRESSURE INCREASED (Blood pressure is elevated) 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.