chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling, Vision blurred
Clinical narrative: Blurred vision; It is very itchy on and around the injection site; Severe headache; Severe swelling on and around the injection site; Redness on and around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), VACCINATION SITE PRURITUS (It is very itchy on and around the injection site), HEADACHE (Severe headache), VACCINATION SITE SWELLING (Severe swelling on and around the injection site) and VACCINATION SITE ERYTHEMA (Redness on and around the injection site) 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 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 VISION BLURRED (Blurred vision), VACCINATION SITE PRURITUS (It is very itchy on and around the injection site), HEADACHE (Severe headache), VACCINATION SITE SWELLING (Severe swelling on and around the injection site) and VACCINATION SITE ERYTHEMA (Redness on and around the injection site). At the time of the report, VISION BLURRED (Blurred vision), VACCINATION SITE PRURITUS (It is very itchy on and around the injection site), HEADACHE (Severe headache), VACCINATION SITE SWELLING (Severe swelling on and around the injection site) and VACCINATION SITE ERYTHEMA (Redness on and around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 11-Jan-2021: Follow up received include an additional event swollen shoulder after receiving the vaccine.; 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: Abdominal distension, Arthralgia, Back pain, Blood test, Diarrhoea
Clinical narrative: Leg pain for 3-4 hours; Itchiness at the injection site; Pain at injection site; Redness at injection site; Swelling at the injection site; Bloating; Flatulance; Neck pain; Back pain; Shoulder pain; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2020, the patient experienced DIARRHOEA (Diarrhea). On 27-Dec-2020, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Back pain) and ARTHRALGIA (Shoulder pain). On 03-Jan-2021, the patient experienced ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance). On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain for 3-4 hours). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Jan-2021, PAIN IN EXTREMITY (Leg pain for 3-4 hours), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Flatulance) and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Polymerase chain reaction: unknown PCR test for covid-19. On an unknown date, Blood test: unknown bloodwork. On an unknown date, Viral test: unknown stool sample.     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: Flatulence, Neck pain, Pain in extremity, Polymerase chain reaction, Vaccination site erythema
Clinical narrative: Leg pain for 3-4 hours; Itchiness at the injection site; Pain at injection site; Redness at injection site; Swelling at the injection site; Bloating; Flatulance; Neck pain; Back pain; Shoulder pain; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2020, the patient experienced DIARRHOEA (Diarrhea). On 27-Dec-2020, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Back pain) and ARTHRALGIA (Shoulder pain). On 03-Jan-2021, the patient experienced ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance). On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain for 3-4 hours). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Jan-2021, PAIN IN EXTREMITY (Leg pain for 3-4 hours), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Flatulance) and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Polymerase chain reaction: unknown PCR test for covid-19. On an unknown date, Blood test: unknown bloodwork. On an unknown date, Viral test: unknown stool sample.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site swelling, Viral test
Clinical narrative: Leg pain for 3-4 hours; Itchiness at the injection site; Pain at injection site; Redness at injection site; Swelling at the injection site; Bloating; Flatulance; Neck pain; Back pain; Shoulder pain; Diarrhea; This spontaneous case was reported by a pharmacist and describes the occurrence of NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2020, the patient experienced DIARRHOEA (Diarrhea). On 27-Dec-2020, the patient experienced NECK PAIN (Neck pain), BACK PAIN (Back pain) and ARTHRALGIA (Shoulder pain). On 03-Jan-2021, the patient experienced ABDOMINAL DISTENSION (Bloating) and FLATULENCE (Flatulance). On 04-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site). On an unknown date, the patient experienced PAIN IN EXTREMITY (Leg pain for 3-4 hours). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 07-Jan-2021, PAIN IN EXTREMITY (Leg pain for 3-4 hours), VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE PAIN (Pain at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) had resolved. At the time of the report, NECK PAIN (Neck pain), BACK PAIN (Back pain), DIARRHOEA (Diarrhea), ABDOMINAL DISTENSION (Bloating), FLATULENCE (Flatulance) and ARTHRALGIA (Shoulder pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Polymerase chain reaction: unknown PCR test for covid-19. On an unknown date, Blood test: unknown bloodwork. On an unknown date, Viral test: unknown stool sample.     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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Pruritus
Clinical narrative: Hard muscle feeling; Itching; Redness; A spontaneous report was received from a clinic manager concerning a 66-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching, redness and induration, all in the arm.    The patient's medical history, as provided by the reporter, included Hashimoto's thyroiditis and hypertension. Concomitant medications reported included levothyroxine sodium, vitamin D, naproxen sodium, turmeric and an unspecified blood pressure medication.    On 30-DEC-2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch Number: 025J20A) in the left shoulder for prophylaxis of COVID-19 infection.   On 01-JAN-2021, the patient experienced itching, redness and hard muscle feeling a medically significant event. The events subsided and came back on 07-JAN-2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, itching, redness and induration was not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: Migraine; This spontaneous case was reported by a health care professional and describes the occurrence of MIGRAINE (Migraine) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical reported history).    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 MIGRAINE (Migraine). The patient was treated with PARACETAMOL (TYLENOL) (oral) at a dose of 1000 milligram. At the time of the report, MIGRAINE (Migraine) 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 reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: NNI On 26-Mar-2021: NNI On 29-Mar-2021: No specific follow-up information recorded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Kinda warm; son draw a sign arround the redness and grow along the borderline during the night; Redness; Swelling; Tender; A spontaneous report was received from a Nurse, concerning about 58-year-old, female patient who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced redness/injection site erythema, swelled/injection site swelling, tender/injection site pain, warm/injection site warmth and swelling/injection site swelling.  The patient's medical history was not reported. Concomitant medications were included Aveeno cream.   On 29 Dec 2020, the patient received their first dose of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 06 Jan 2021, the patient reported she had redness, swelling, tenderness, warmth and swelling at the injection site. The patient's son drew a circle around the swelling. The patient had an appointment with her doctor who prescribed clotrimazole cream.   Action taken with Moderna's COVID-19 Vaccine was reported as unknown.  The outcome of the events redness/injection site erythema, swelled/injection site swelling, tender/injection site pain, warm/injection site warmth and swelling/injection site swelling, were reported as unknown.; Reporter's Comments: This case concerns a 58-year-old female who had NS unexpected injection site inflammation and injection site warmth and NS expected injection site erythema, injection site pain, injection site swelling.  Event onset occurred 1 days after the first dose of mRNA-1273. Treatment with clotrimazole cream. Event outcomes unknown. 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.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Axillary pain/tenderness; LN swelling; A spontaneous report was received from a physician who was also a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced axillary pain/tenderness/LN swelling.  The patient's medical history was not provided. Products known to have been used by the patient were not provided.  On unknown date, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On unknown date, approximately 14 days after vaccination,  the patient had difficulty getting the axillary pain to completely go away.   Treatment information was not provided.   Action taken with mRNA-1273 was not reported.  The outcome of the events, eye irritation and a little diarrhea, were resolving. The outcome of the events, being a little bit tired and injection site sore and hard, was not provided. The outcome of event, axillary pain/tenderness/LN swelling was not reported.; Reporter's Comments: Very limited information regarding these events of axillary pain and lymphadenopathy has been provided at this time.  Further information has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: injection site warmth; injection site induration; injection site erythema; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (injection site induration) and VACCINATION SITE ERYTHEMA (injection site erythema) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (injection site induration) and VACCINATION SITE ERYTHEMA (injection site erythema). At the time of the report, VACCINATION SITE WARMTH (injection site warmth), VACCINATION SITE INDURATION (injection site induration) and VACCINATION SITE ERYTHEMA (injection site erythema) 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.   Concomitant product use was not provided by the reporter.  Per report, al the events occurred about one week after vaccination.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: Events outcome 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.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain, Pain in extremity, Pyrexia, Urinary incontinence
Clinical narrative: trouble holding bladder; sick; body pain; sore and ache; arm sore; threw up; fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache) and PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache), PAIN IN EXTREMITY (arm sore), VOMITING (threw up) and PYREXIA (fever). At the time of the report, URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache), PAIN IN EXTREMITY (arm sore), VOMITING (threw up) and PYREXIA (fever) had resolved.        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.  Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Adverse Event  outcome were updated.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: trouble holding bladder; sick; body pain; sore and ache; arm sore; threw up; fever; This spontaneous case was reported by a consumer and describes the occurrence of URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache) and PAIN IN EXTREMITY (arm sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history was reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache), PAIN IN EXTREMITY (arm sore), VOMITING (threw up) and PYREXIA (fever). At the time of the report, URINARY INCONTINENCE (trouble holding bladder), ILLNESS (sick), PAIN (body pain), PAIN (sore and ache), PAIN IN EXTREMITY (arm sore), VOMITING (threw up) and PYREXIA (fever) had resolved.        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.  Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Adverse Event  outcome were updated.; Reporter's Comments: Based on the current available information which includes a strong temporal association between the use of the product and the start date of the reported event, and excluding any other etiology, a causal relationship with the event cannot be excluded.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: Side where the shot was administered was hot; Side where the shot was administered was hard; Chilling; Pain has moved back to the scapula area; Side where the shot was administered was red; Side where the shot was administered was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Side where the shot was administered was hot), VACCINATION SITE INDURATION (Side where the shot was administered was hard), CHILLS (Chilling), ARTHRALGIA (Pain has moved back to the scapula area) and VACCINATION SITE ERYTHEMA (Side where the shot was administered was red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Side where the shot was administered was red) and VACCINATION SITE PAIN (Side where the shot was administered was sore). On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Side where the shot was administered was hot), VACCINATION SITE INDURATION (Side where the shot was administered was hard), CHILLS (Chilling) and ARTHRALGIA (Pain has moved back to the scapula area). At the time of the report, VACCINATION SITE WARMTH (Side where the shot was administered was hot), VACCINATION SITE INDURATION (Side where the shot was administered was hard), CHILLS (Chilling), ARTHRALGIA (Pain has moved back to the scapula area), VACCINATION SITE ERYTHEMA (Side where the shot was administered was red) and VACCINATION SITE PAIN (Side where the shot was administered was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment included ice pack as needed.  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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Side where the shot was administered was hot; Side where the shot was administered was hard; Chilling; Pain has moved back to the scapula area; Side where the shot was administered was red; Side where the shot was administered was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Side where the shot was administered was hot), VACCINATION SITE INDURATION (Side where the shot was administered was hard), CHILLS (Chilling), ARTHRALGIA (Pain has moved back to the scapula area) and VACCINATION SITE ERYTHEMA (Side where the shot was administered was red) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE ERYTHEMA (Side where the shot was administered was red) and VACCINATION SITE PAIN (Side where the shot was administered was sore). On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Side where the shot was administered was hot), VACCINATION SITE INDURATION (Side where the shot was administered was hard), CHILLS (Chilling) and ARTHRALGIA (Pain has moved back to the scapula area). At the time of the report, VACCINATION SITE WARMTH (Side where the shot was administered was hot), VACCINATION SITE INDURATION (Side where the shot was administered was hard), CHILLS (Chilling), ARTHRALGIA (Pain has moved back to the scapula area), VACCINATION SITE ERYTHEMA (Side where the shot was administered was red) and VACCINATION SITE PAIN (Side where the shot was administered was sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment included ice pack as needed.  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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Fatigue, Pain in extremity
Clinical narrative: vaccine exposure during pregnancy; Fatigue; Arm soreness; This spontaneous prospective pregnancy case was reported by a health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) and FATIGUE (Fatigue) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Allergy to Flagyl).    On 09-Jan-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 06-Nov-2020 and the estimated date of delivery was 30-Aug-2021. On 09-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). 09-Jan-2021, the patient experienced FATIGUE (Fatigue). On 09-Jan-2021 at 9:30 AM, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth week of the pregnancy.  On 09-Jan-2021 at 9:30 AM, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) had resolved. On 11-Jan-2021, PAIN IN EXTREMITY (Arm soreness) and FATIGUE (Fatigue) 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 provided. No treatment information provided.
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal chest pain, Vaccination site pain
Clinical narrative: Muscle pain in ribs; Cramps; Pain at the injection site; A spontaneous report was received from consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site pain, muscle pain in the ribs and cramps.   The patient's medical history was not reported. No relevant concomitant medications were reported.   On 07 Jan 2021, the patient received their first of two planned doses of mRNA-1273  intramuscularly for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient began to experience pain at the injection site, muscle pain in the ribs and cramps. Patient reported experiencing a lot of pain.     Treatment for the event included a heating pad.     Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events was unknown.; Reporter's Comments: This case concerns a 60-year-old female who experienced nonserious events of unexpected musculoskeletal chest pain and muscle spasms and expected vaccination site pain.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event 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: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pregnancy test
Clinical narrative: vaccine exposure during pregrenancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregrenancy) in a 31-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011j20A) for COVID-19 vaccination.     The patient's past medical history included C-section (placental abruptions,low line placenta, live full term birth) on 01-Jun-2017 and C-section (high risk pregnancy, low line placenta,live full term birth) on 01-May-2019. Concurrent medical conditions included Drug allergy (flajyl), Asthma (late onset; flare up during second pregnancy) since 01-Jan-2006 and Allergy (Seasonal). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Allergy, SALBUTAMOL (ALBUTEROL HFA) and MONTELUKAST SODIUM (SINGULAIR) for Asthma, CAVAN EC SOD DHA PRENATAL VITAMINS and 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 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 15-Nov-2020 and the estimated date of delivery was 22-Aug-2021. On 21-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregrenancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  eighth week of the pregnancy.  On 21-Dec-2020, MATERNAL EXPOSURE DURING PREGNANCY (vaccine exposure during pregrenancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Pregnancy test: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Estimated date of conception was 15 Nov 2020 . treatment information provided.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 31-year-old female patient. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: red circle around injection site; hard lump; red circle does get itchy; arm was very sore/arm was achy; fatigued at night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was very sore/arm was achy), FATIGUE (fatigued at night), VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (hard lump) and VACCINATION SITE PRURITUS (red circle does get itchy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergy to Claritin.). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (BLISOVI 24 FE) for Birth control, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 31-Dec-2020 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced PAIN IN EXTREMITY (arm was very sore/arm was achy). 31-Dec-2020, the patient experienced FATIGUE (fatigued at night). On 01-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (hard lump) and VACCINATION SITE PRURITUS (red circle does get itchy). At the time of the report, PAIN IN EXTREMITY (arm was very sore/arm was achy), FATIGUE (fatigued at night), VACCINATION SITE ERYTHEMA (red circle around injection site), VACCINATION SITE SWELLING (hard lump) and VACCINATION SITE PRURITUS (red circle does get itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Hot flush, Myalgia
Clinical narrative: Nausea and vomiting; Nausea and vomiting; severe muscle pain; Fatigue; Severe Diarrhea; Hot Flushes; Chills; A spontaneous report was received from a consumer, concerning a 33 year old female patient who was participating in the mRNA-1273 Emergency Use Program and developed diarrhea, hot flushes, chills, muscle pain, fatigue, nausea, and vomiting   The patient's medical history and relevant concomitant medications were not reported.   On 03 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025I20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced severe diarrhea, hot flushes, and chills on 06 Jan 2021.  On 07 Jan 2021 she experienced muscle pain and fatigue.  On 08 Jan 2021 she felt nauseous and experienced vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events diarrhea, hot flushes, chills, muscle pain, fatigue, nausea, and vomiting were not reported.; 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: Nausea, Vomiting
Clinical narrative: Nausea and vomiting; Nausea and vomiting; severe muscle pain; Fatigue; Severe Diarrhea; Hot Flushes; Chills; A spontaneous report was received from a consumer, concerning a 33 year old female patient who was participating in the mRNA-1273 Emergency Use Program and developed diarrhea, hot flushes, chills, muscle pain, fatigue, nausea, and vomiting   The patient's medical history and relevant concomitant medications were not reported.   On 03 Jan 2021, approximately three days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot number 025I20A) intramuscularly for prophylaxis of COVID-19 infection.   The patient experienced severe diarrhea, hot flushes, and chills on 06 Jan 2021.  On 07 Jan 2021 she experienced muscle pain and fatigue.  On 08 Jan 2021 she felt nauseous and experienced vomiting.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events diarrhea, hot flushes, chills, muscle pain, fatigue, nausea, and vomiting were not reported.; 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: Maternal exposure during pregnancy, Pain, Pyrexia
Clinical narrative: low grade fever 99.5F; Soreness; Pregnancy; This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy), PAIN (Soreness) and PYREXIA (low grade fever 99.5F) in a 32-year-old female patient who received mRNA-1273 (batch no. 027L20A) 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 (Intramuscular) at an unspecified dose. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Aug-2021. On 08-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On 07-Jan-2021, the patient experienced PAIN (Soreness). On 10-Jan-2021, the patient experienced PYREXIA (low grade fever 99.5F). The delivery occurred on an unknown date, which was reported as Outcome Pending. For foetus 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy), PAIN (Soreness) and PYREXIA (low grade fever 99.5F) outcome was unknown.        The action taken with mRNA-1273 (Intramuscular) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with  associated AEs for this 32-year-old female. 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.    Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: Pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included High cholesterol. Concomitant products included PRENATAL [ASCORBIC ACID;BETACAROTENE;BIOTIN;CALCIUM CARBONATE;CALCIUM PANTOTHENATE;CHROMIUM;COLECALCIFEROL;COPPER;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;MAGNESIUM OXIDE;MANGANESE;NICOTINAMIDE;POTASSIUM IODIDE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;S for Supplementation therapy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 04-Jan-2021 at 10:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 19-Nov-2020 and the estimated date of delivery was 26-Aug-2021. On 04-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  sixth week of the pregnancy.  On 04-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Dec-2020, Pregnancy test: positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Company Comment: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Reporter's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site pain
Clinical narrative: Itchy; pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy) and VACCINATION SITE PAIN (pain at the injection site) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN).    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 VACCINATION SITE PAIN (pain at the injection site). On 10-Jan-2021, the patient experienced PRURITUS (Itchy). On 07-Jan-2021, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. At the time of the report, PRURITUS (Itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant lab data were reported. No medical treatment 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.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: Warmth at the injection site; Erythema at the injection site; Induration at the injection site; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE ERYTHEMA (Erythema at the injection site) and VACCINATION SITE INDURATION (Induration at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE ERYTHEMA (Erythema at the injection site) and VACCINATION SITE INDURATION (Induration at the injection site). At the time of the report, VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE ERYTHEMA (Erythema at the injection site) and VACCINATION SITE INDURATION (Induration at the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  This case concerned a female of unknown age who experienced expected events of vaccination site warmth, vaccination site erythema, vaccination site induration.  Event onset one week after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. 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.  On an unknown date (approximately one week after vaccination) the patient experienced VACCINATION SITE WARMTH (Warmth at the injection site), VACCINATION SITE ERYTHEMA (Erythema at the injection site) and VACCINATION SITE INDURATION (Induration at the injection site).  It was reported that the events subsided after a few days.  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 25-Mar-2021: Live follow up received on 25-Mar-2021: Event outcome 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.
Sex: U
Vaccine: COVID19
Symptoms: Flushing, Nausea, Pruritus, Urticaria
Clinical narrative: hives to their arms, face, chest and thighs; itching sensation; flushing sensation; nausea; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives to their arms, face, chest and thighs), PRURITUS (itching sensation), FLUSHING (flushing sensation) and NAUSEA (nausea) in a  patient of an unknown age and gender 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 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced URTICARIA (hives to their arms, face, chest and thighs), PRURITUS (itching sensation), FLUSHING (flushing sensation) and NAUSEA (nausea). At the time of the report, URTICARIA (hives to their arms, face, chest and thighs), PRURITUS (itching sensation), FLUSHING (flushing sensation) and NAUSEA (nausea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.  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. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.