chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased
Clinical narrative: Blood sugar levels were doubling in count; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE INCREASED (Blood sugar levels were doubling in count) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 125K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced BLOOD GLUCOSE INCREASED (Blood sugar levels were doubling in count). At the time of the report, BLOOD GLUCOSE INCREASED (Blood sugar levels were doubling in count) 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 reported that on 28DEC2020 he received the vaccine in his right arm and on 04JAN2021 he noticed that his blood sugar levels were doubling in count. His average blood sugar is 120-135 on average and since taking the vaccine his blood sugar has been reading 280-300. Patient stated that he does not feel bad.; 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: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by reporter.  Concomitant products included CLOPIDOGREL for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medications were not provided by reporter.; Reporter'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: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity
Clinical narrative: Arm soreness; Body chills; Nausea; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), CHILLS (Body chills) and NAUSEA (Nausea) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 125K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced PAIN IN EXTREMITY (Arm soreness), CHILLS (Body chills) and NAUSEA (Nausea). On 29-Dec-2020, PAIN IN EXTREMITY (Arm soreness), CHILLS (Body chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was reported.  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.; 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of FATIGUE (Feeling tired) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer. Concomitant products included DENOSUMAB for Osteoporosis.    On 07-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 FATIGUE (Feeling tired). At the time of the report, FATIGUE (Feeling tired) 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.   Treatment medication not provided.  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.; Reporter'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: Epistaxis, Migraine, Photophobia
Clinical narrative: Light sensitivity; Nose bleeding; Migraine headache; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Migraine headache), PHOTOPHOBIA (Light sensitivity) and EPISTAXIS (Nose bleeding) in a 58-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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced MIGRAINE (Migraine headache). On 08-Jan-2021, the patient experienced PHOTOPHOBIA (Light sensitivity) and EPISTAXIS (Nose bleeding). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine headache), PHOTOPHOBIA (Light sensitivity) and EPISTAXIS (Nose bleeding) 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 erythema, Vaccination site pruritus
Clinical narrative: Redness of 2x3 in the injection site; Itching at injection site; A spontaneous report was received from a healthcare professional concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and developed itching on the vaccination site (Vaccination site pruritic) and redness of 2x3 in the injection site (Vaccination site erythema).   The patient's medical history was not provided. Concomitant product use was not provided.   The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 31-Dec-2020 for prophylaxis of COVID-19 infection.    On 07-Jan-2021, a healthcare professional reported having itching at the vaccination site that lasted a couple of hours.    On 08-Jan-2021, she reported waking up with redness at the injection site that measured 2x3.    Treatment information was not provided   Action taken with mRNA-1273 in response to the events was not provided.    The event, itching on the vaccination site, was considered resolved on 07-Jan-2021. The event redness of 2x3 in the injection site, was considered unknown.    The reporter did not provide an assessment of the events, itching on the vaccination site and redness of 2x3 in the injection site.; Reporter'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: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Hypertension. Concomitant products included OMEPRAZOLE for Gastric disorder, LISINOPRIL (SINOPRIL [LISINOPRIL]) and AMLODIPINE for Hypertension.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm sore). On 05-Jan-2021, PAIN IN EXTREMITY (arm sore) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details 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: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Influenza like illness, Vomiting
Clinical narrative: Has loose stools; Feels like he has the flu; He woke up, he is fatigued; Been throwing up for about 3 hours; Has a bad headache; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Has loose stools), INFLUENZA LIKE ILLNESS (Feels like he has the flu), FATIGUE (He woke up, he is fatigued), VOMITING (Been throwing up for about 3 hours) and HEADACHE (Has a bad headache) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced DIARRHOEA (Has loose stools), INFLUENZA LIKE ILLNESS (Feels like he has the flu), FATIGUE (He woke up, he is fatigued), VOMITING (Been throwing up for about 3 hours) and HEADACHE (Has a bad headache). On 09-Jan-2021, VOMITING (Been throwing up for about 3 hours) had resolved. At the time of the report, DIARRHOEA (Has loose stools), INFLUENZA LIKE ILLNESS (Feels like he has the flu), FATIGUE (He woke up, he is fatigued) and HEADACHE (Has a bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: Injection site is itching; Injection site is red; Headache; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site is itching), HEADACHE (Headache), FATIGUE (Felt tired) and INJECTION SITE ERYTHEMA (Injection site is red) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. O11J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported) and Herpes zoster immunization (Patient took Shingles vaccine 3 months before on same area.).    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced HEADACHE (Headache) and FATIGUE (Felt tired). On 07-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Injection site is itching) and INJECTION SITE ERYTHEMA (Injection site is red). On 30-Dec-2020, HEADACHE (Headache) and FATIGUE (Felt tired) had resolved. At the time of the report, INJECTION SITE PRURITUS (Injection site is itching) and INJECTION SITE ERYTHEMA (Injection site is red) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case concerns a 79-year-old female who experienced nonserious expected events of injection site erythema, injection site pruritus, fatigue and headache.  Event onset occurred Day 1 after the first dose of mRNA-1273, followed by injection site reaction on Day 10. Treatment not reported. Injection site reaction ongoing. Based on 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.; Reporter's Comments: This case concerns a 79-year-old female who experienced nonserious expected events of injection site erythema, injection site pruritus, fatigue and headache.  Event onset occurred Day 1 after the first dose of mRNA-1273, followed by injection site reaction on Day 10. Treatment not reported. Injection site reaction ongoing. Based on 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Eating disorder, Fatigue, Gait disturbance
Clinical narrative: This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches), FATIGUE (Fatigue), GAIT DISTURBANCE (cant walk) and BALANCE DISORDER (Lost control of body). On an unknown date, the patient experienced SITTING DISABILITY (cant sit up) and EATING DISORDER (cant eat). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches), FATIGUE (Fatigue), SITTING DISABILITY (cant sit up), EATING DISORDER (cant eat), GAIT DISTURBANCE (cant walk) and BALANCE DISORDER (Lost control of body) 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 products were reported.  Treatment medications include meloxicam and steroid shots.; 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: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia, Sitting disability
Clinical narrative: This spontaneous case was reported by a patient family member or friend (subsequently medically confirmed) and describes the occurrence of CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.     On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches), FATIGUE (Fatigue), GAIT DISTURBANCE (cant walk) and BALANCE DISORDER (Lost control of body). On an unknown date, the patient experienced SITTING DISABILITY (cant sit up) and EATING DISORDER (cant eat). The patient was treated with MELOXICAM at an unspecified dose and frequency. At the time of the report, CHILLS (Extreme chills), PYREXIA (Fever that went to 103.5), PAIN (Extreme body aches), MYALGIA (Muscle aches), FATIGUE (Fatigue), SITTING DISABILITY (cant sit up), EATING DISORDER (cant eat), GAIT DISTURBANCE (cant walk) and BALANCE DISORDER (Lost control of body) 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 products were reported.  Treatment medications include meloxicam and steroid shots.; 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema
Clinical narrative: injection site is red with a 3-inch oval red mark; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (injection site is red with a 3-inch oval red mark) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site is red with a 3-inch oval red mark). At the time of the report, INJECTION SITE ERYTHEMA (injection site is red with a 3-inch oval red mark) 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 relevant concomitant medications were 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: Generally terrible; low grade temperature ranging from 99-101; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Generally terrible) and PYREXIA (low grade temperature ranging from 99-101) 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 (No medical history reported).    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced FEELING ABNORMAL (Generally terrible) and PYREXIA (low grade temperature ranging from 99-101). At the time of the report, FEELING ABNORMAL (Generally terrible) and PYREXIA (low grade temperature ranging from 99-101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, Body temperature: 99-101.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       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.; 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: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant woman was given the vaccine; This spontaneous pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant woman was given the vaccine) in a 30-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included Miscarriage in 2020 and Alcohol use (social drinking). Concomitant products included DOCUSATE SODIUM (COLACE) for Constipation, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication.    On 09-Jan-2021 at 12:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 05-Jul-2021. On 09-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant woman was given the vaccine). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 09-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant woman was given the vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided.; Sender's Comments: Based on the current available information and the temporal association between the use of the product and the start date of the event a causal relationship cannot be excluded.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Alpha 1 foetoprotein, Glucose tolerance test, Maternal exposure during pregnancy, Pregnancy test, Ultrasound uterus
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (7 weeks pregnant) in a 45-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.  The patient's past medical history included Fertility decreased (only indication for low fertility is age and took intrauterine insemination as fertility treatment on Jun-2017 twice.), Alcohol use (occassional) on 13-Nov-2020, Nicotine abuse (1 pack/week) on 01-Dec-2003 and Induced abortion (1 elective abortion 20 years ago.) on 13-May-2001. Previously administered products included for an unreported indication: MARIJUANA until 01-Aug-1999. Family history included Down's syndrome (Down's syndrome - maternal uncle) since an unknown date. Concomitant products included GLYBURIDE from 23-Apr-2021 to an unknown date for Gestational diabetes mellitus, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 26-Dec-2020 to an unknown date and ASPIRIN [ACETYLSALICYLIC ACID] from 14-Feb-2021 to an unknown date for Pregnancy.  On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-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 13-Nov-2020 and the estimated date of delivery was 20-Aug-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (7 weeks pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the seventh week of the pregnancy. On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (7 weeks pregnant) had resolved.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Dec-2020, Pregnancy test: positive (Positive) positive. On 04-Jan-2021, Ultrasound uterus: 1-fetus (normal) Pregnancy confirmation ultrasound. 1-fetus. In March 2021, Alpha 1 foetoprotein: normal (normal) normal. On 24-May-2021, Ultrasound uterus: normal (normal) Normal. On 04-Jun-2021, Glucose tolerance test: abnormal (abnormal) abnormal.     Treatment information was not provided.  The estimated date of conception was reported as 20-Nov-2020. The patient had maternal history of subfertility due to age and had established prenatal care. There was no complications or acute illness reported during tis pregnancy. Number of fetuses was reported as 1.  Most recent FOLLOW-UP information incorporated above includes: On 29-Jun-2021: Added concomitant drug, lab data and 2nd dose of Moderna, history added, due date updated, positive pregnancy date updated.  Reporter's Comments: Based on the current available information and the temporal association between the product use and the start date of the event a causal relationship cannot be excluded.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash
Clinical narrative: Vaccination site erythema; Vaccination site pain; Vaccination site rash; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (his arm was tender and red and had a rash on it), VACCINATION SITE ERYTHEMA (his arm was tender and red and had a rash on it) and VACCINATION SITE RASH (his arm was tender and red and had a rash on it) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  No medical history was provided by the reporter.   On 04-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 VACCINATION SITE PAIN (his arm was tender and red and had a rash on it), VACCINATION SITE ERYTHEMA (his arm was tender and red and had a rash on it) and VACCINATION SITE RASH (his arm was tender and red and had a rash on it). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (his arm was tender and red and had a rash on it), VACCINATION SITE ERYTHEMA (his arm was tender and red and had a rash on it) and VACCINATION SITE RASH (his arm was tender and red and had a rash on it) was resolving.   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 included Benadryl.  Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up was received on 03 Jun 2021 included reporter details was updated.  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: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema
Clinical narrative: Itching started on Friday; Two pin pricks with two little red dots one may be injection and one is next to it; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching started on Friday) and VACCINATION SITE ERYTHEMA (Two pin pricks with two little red dots one may be injection and one is next to it) in a 77-year-old male 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) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced PRURITUS (Itching started on Friday) and VACCINATION SITE ERYTHEMA (Two pin pricks with two little red dots one may be injection and one is next to it). At the time of the report, PRURITUS (Itching started on Friday) and VACCINATION SITE ERYTHEMA (Two pin pricks with two little red dots one may be injection and one is next to it) 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 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 these events, a causal relationship cannot be excluded.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Induration, Pruritus, Skin warm, Swelling, Vaccination site cellulitis
Clinical narrative: Could be a bacteria related or cellulitis; Had a rash at the injection site that has continued to get worse; Redness at injection site; Itchy; Warm / hot; Hard; Got larger size of baseball; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis), PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard) and SWELLING (Got larger size of baseball) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis) and VACCINATION SITE RASH (Had a rash at the injection site that has continued to get worse). In January 2021, the patient experienced PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard), SWELLING (Got larger size of baseball) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis), PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard), SWELLING (Got larger size of baseball), VACCINATION SITE RASH (Had a rash at the injection site that has continued to get worse) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was 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: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site rash
Clinical narrative: Could be a bacteria related or cellulitis; Had a rash at the injection site that has continued to get worse; Redness at injection site; Itchy; Warm / hot; Hard; Got larger size of baseball; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis), PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard) and SWELLING (Got larger size of baseball) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis) and VACCINATION SITE RASH (Had a rash at the injection site that has continued to get worse). In January 2021, the patient experienced PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard), SWELLING (Got larger size of baseball) and VACCINATION SITE ERYTHEMA (Redness at injection site). At the time of the report, VACCINATION SITE CELLULITIS (Could be a bacteria related or cellulitis), PRURITUS (Itchy), SKIN WARM (Warm / hot), INDURATION (Hard), SWELLING (Got larger size of baseball), VACCINATION SITE RASH (Had a rash at the injection site that has continued to get worse) and VACCINATION SITE ERYTHEMA (Redness at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was 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.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Vaccination site pain, Vomiting
Clinical narrative: sore arm; body ache; Bad headache; vomiting; chills; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), MYALGIA (body ache), HEADACHE (Bad headache), VOMITING (vomiting) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 VACCINATION SITE PAIN (sore arm), MYALGIA (body ache), HEADACHE (Bad headache), VOMITING (vomiting) and CHILLS (chills). At the time of the report, VACCINATION SITE PAIN (sore arm), MYALGIA (body ache), HEADACHE (Bad headache), VOMITING (vomiting) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication history was not provided. Treatment for these events were not provided.     Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Musculoskeletal disorder, Pain in extremity, Peripheral swelling, Vaccination site erythema
Clinical narrative: Could not move arm, couldn't stand pain; upper extremity dysfunction; Big pain at the injection site; Redness at the injection site; Pregnant patient received first dose of vaccine; swollen arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine), PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (Could not move arm, couldn't stand pain), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Big pain at the injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0272AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Big pain at the injection site) and MUSCULOSKELETAL DISORDER (upper extremity dysfunction). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Could not move arm, couldn't stand pain). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 09-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (Could not move arm, couldn't stand pain), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Big pain at the injection site) and MUSCULOSKELETAL DISORDER (upper extremity dysfunction) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided was muscle rub cream in the injection side; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Could not move arm, couldn't stand pain; upper extremity dysfunction; Big pain at the injection site; Redness at the injection site; Pregnant patient received first dose of vaccine; swollen arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine), PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (Could not move arm, couldn't stand pain), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE PAIN (Big pain at the injection site) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0272AA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     no medical history reported.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy.    On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. The patient's last menstrual period was on 29-Sep-2020 and the estimated date of delivery was 07-Jul-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine), PERIPHERAL SWELLING (swollen arm), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Big pain at the injection site) and MUSCULOSKELETAL DISORDER (upper extremity dysfunction). On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Could not move arm, couldn't stand pain). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 09-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnant patient received first dose of vaccine) had resolved. At the time of the report, PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (Could not move arm, couldn't stand pain), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Big pain at the injection site) and MUSCULOSKELETAL DISORDER (upper extremity dysfunction) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information provided was muscle rub cream in the injection side; Sender's Comments: Based on the current available information and the temporal association between the product use and the start date of the events a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Eye pain
Clinical narrative: Stingingness in the right eye; Blister on the right eye; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (Stingingness in the right eye) and EYE DISORDER (Blister on the right eye) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EYE PAIN (Stingingness in the right eye) and EYE DISORDER (Blister on the right eye). At the time of the report, EYE PAIN (Stingingness in the right eye) and EYE DISORDER (Blister on the right eye) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Hypoaesthesia
Clinical narrative: mild cold sweat; left side of my face felt like a prickly numbness; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of COLD SWEAT (mild cold sweat) and HYPOAESTHESIA (left side of my face felt like a prickly numbness) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011LZ0A) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 COLD SWEAT (mild cold sweat) and HYPOAESTHESIA (left side of my face felt like a prickly numbness). On 13-Jan-2021, COLD SWEAT (mild cold sweat) and HYPOAESTHESIA (left side of my face felt like a prickly numbness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were 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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Ultrasound scan
Clinical narrative: I would like to report a pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I would like to report a pregnancy) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L2A) for COVID-19 vaccination.     The patient's past medical history included ADHD (No medications during pregnancy) in 2010 and Alcohol use (Ver rarely, during holidays or celebrations.). Previously administered products included for ADHD: Vyvanse. Concurrent medical conditions included Nickel sensitivity and Morning sickness (during current pregnancy).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 08-Nov-2020 and the estimated date of delivery was 14-Aug-2021. On 13-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I would like to report a pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 13-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (I would like to report a pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 05-Jan-2021, Ultrasound scan: abnormal (abnormal) Chronic bump on ultrasound, estimated gestational age.     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 was provided.; Sender's Comments: Based on the current available information and the temporal association between the product sue and the start date of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, COVID-19, Cough, Headache
Clinical narrative: Loss of taste; Headache; Mild cough; Tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event). Concurrent medical conditions included Asthma.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID-19). At the time of the report, COVID-19 (Tested positive for COVID-19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, COVID-19: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection is assessed as unlikely related to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the events of headache, ageusia and cough, a causal relationship cannot be excluded
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy rash on face; itchy rash on face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy rash on face) and RASH (itchy rash on face) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) 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) dosage form. On 09-Jan-2021, the patient experienced PRURITUS (itchy rash on face) and RASH (itchy rash on face). At the time of the report, PRURITUS (itchy rash on face) and RASH (itchy rash on face) 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 medications taken by the patient were not provided.   Treatment information events 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 events, a causal relationship cannot be excluded.