chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: Shaky; Achy; Fever 101°F; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky), PAIN (Achy), PYREXIA (Fever 101°F), CHILLS (Chills) and HEADACHE (Headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced TREMOR (Shaky), PAIN (Achy), PYREXIA (Fever 101°F), CHILLS (Chills) and HEADACHE (Headache). On 09-Mar-2021, PAIN (Achy), PYREXIA (Fever 101°F), CHILLS (Chills) and HEADACHE (Headache) had resolved. At the time of the report, TREMOR (Shaky) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: patient got the first dose of the Moderna vaccine on 18Jan2021 but still has not gotten the second dose.; A Spontaneous  report was received from a consumer concerning a 76-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and event is patient got the first dose of the Moderna vaccine on 18Jan2021 but still has not gotten the second dose   No medical history was provided/no adverse event.  Concomitant medications were reported.  On 18 Jan 2021, the patient received their  first  of two planned doses of mRNA-1273 (lot number 039K20A) intramuscularly for prophylaxis of COVID-19 infection.  Pharmacist  called because a patient was asking to get their second dose of the Moderna vaccine but has gotten the first dose on18Jan2021.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event missed dose is considered Unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Scratch, Vaccination complication, Vaccination site erythema, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: a place on my arm got red; it's fevered; it started itching; I scratched it; Tiny bumps above injection site, bumps went away but not sure when.; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (a place on my arm got red), VACCINATION SITE WARMTH (it's fevered), VACCINATION SITE PRURITUS (it started itching), SCRATCH (I scratched it) and VACCINATION COMPLICATION (Tiny bumps above injection site, bumps went away but not sure when.) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes mellitus (for the past three or four years) and Allergy. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), ROSUVASTATIN CALCIUM (CRESTOR), FISH OIL and METFORMIN for an unknown indication.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (a place on my arm got red), VACCINATION SITE WARMTH (it's fevered), VACCINATION SITE PRURITUS (it started itching), SCRATCH (I scratched it) and VACCINATION COMPLICATION (Tiny bumps above injection site, bumps went away but not sure when.). On 08-Mar-2021, VACCINATION SITE PRURITUS (it started itching) had resolved. At the time of the report, VACCINATION SITE ERYTHEMA (a place on my arm got red), VACCINATION SITE WARMTH (it's fevered) and SCRATCH (I scratched it) outcome was unknown and VACCINATION COMPLICATION (Tiny bumps above injection site, bumps went away but not sure when.) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications also included unspecified allergy medication, sleep medication and nerve medication.  Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Pale pink the size of a nickel at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE RASH (Pale pink the size of a nickel at the injection site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE RASH (Pale pink the size of a nickel at the injection site). At the time of the report, INJECTION SITE RASH (Pale pink the size of a nickel at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. The patient described it as a pale pink and the size of nickel that comes and goes. No treatment was administered.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Somnolence
Clinical narrative: Sleepy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy) and HEADACHE (Headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced SOMNOLENCE (Sleepy) and HEADACHE (Headache). On 09-Mar-2021, HEADACHE (Headache) had resolved. On 10-Mar-2021, SOMNOLENCE (Sleepy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Shoulder tightened; 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 MUSCULOSKELETAL STIFFNESS (Shoulder tightened) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Shoulder tightened). At the time of the report, MUSCULOSKELETAL STIFFNESS (Shoulder tightened) outcome was unknown.            Concomitant Product information was not provided.  No treatment information is provided. Action taken with mRNA-123 is not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Rash
Clinical narrative: Soreness at injection and redness; Soreness at injection and redness; Rash under arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Soreness at injection and redness), INJECTION SITE ERYTHEMA (Soreness at injection and redness) and RASH (Rash under arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for an unknown indication.  No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced INJECTION SITE PAIN (Soreness at injection and redness). 09-Mar-2021, the patient experienced INJECTION SITE ERYTHEMA (Soreness at injection and redness) and RASH (Rash under arm). At the time of the report, INJECTION SITE PAIN (Soreness at injection and redness), INJECTION SITE ERYTHEMA (Soreness at injection and redness) and RASH (Rash under arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter. Treatment included hydrocortisone cream
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Pyrexia, Red blood cell sedimentation rate increased, Thyroiditis, Thyroxine
Clinical narrative: Fever the whole month; diagnosed with inflammation on the thyroid gland S.thyroiditis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis) and PYREXIA (Fever the whole month) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) 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 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis). On an unknown date, the patient experienced PYREXIA (Fever the whole month). The patient was treated with PREDNISONE from 05-Mar-2021 to 15-Mar-2021 for Thyroiditis, at a dose of 20 mg once a day. At the time of the report, THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis) outcome was unknown and PYREXIA (Fever the whole month) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Blood thyroid stimulating hormone (0.5-3.74):. On 20-Feb-2021, Red blood cell sedimentation rate increased: elevated (abnormal) elevated. On 03-Mar-2021, Blood thyroid stimulating hormone (0.5-3.74): 0.011 (Low) TSH (0.011). On 03-Mar-2021, Thyroxine: free t4 : 1.85 milligram per decilitre (Inconclusive) Free T4 : 1.85 mg/dl. On 04-Mar-2021, Red blood cell sedimentation rate increased:. On 04-Mar-2021, Ultrasound thyroid: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound thyroid
Clinical narrative: Fever the whole month; diagnosed with inflammation on the thyroid gland S.thyroiditis; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis) and PYREXIA (Fever the whole month) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) 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 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis). On an unknown date, the patient experienced PYREXIA (Fever the whole month). The patient was treated with PREDNISONE from 05-Mar-2021 to 15-Mar-2021 for Thyroiditis, at a dose of 20 mg once a day. At the time of the report, THYROIDITIS (diagnosed with inflammation on the thyroid gland S.thyroiditis) outcome was unknown and PYREXIA (Fever the whole month) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Feb-2021, Blood thyroid stimulating hormone (0.5-3.74):. On 20-Feb-2021, Red blood cell sedimentation rate increased: elevated (abnormal) elevated. On 03-Mar-2021, Blood thyroid stimulating hormone (0.5-3.74): 0.011 (Low) TSH (0.011). On 03-Mar-2021, Thyroxine: free t4 : 1.85 milligram per decilitre (Inconclusive) Free T4 : 1.85 mg/dl. On 04-Mar-2021, Red blood cell sedimentation rate increased:. On 04-Mar-2021, Ultrasound thyroid: inconclusive (Inconclusive) Inconclusive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Rash, Rash macular, Rash pruritic
Clinical narrative: bruise at the injection site; blotchy redness around the bruise; like a rash in different areas of her shoulder; rash a little itchy; bruise getting greener/bruise still kind of purple; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy) and SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE for Heartburn, HYDROCODONE for Osteoporosis, DILTIAZEM and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy), SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN for Headache, at an unspecified dose and frequency. At the time of the report, CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy), SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) and HEADACHE (headache) 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.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: bruise at the injection site; blotchy redness around the bruise; like a rash in different areas of her shoulder; rash a little itchy; bruise getting greener/bruise still kind of purple; headache; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy) and SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PANTOPRAZOLE for Heartburn, HYDROCODONE for Osteoporosis, DILTIAZEM and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy), SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) and HEADACHE (headache). The patient was treated with ACETAMINOPHEN for Headache, at an unspecified dose and frequency. At the time of the report, CONTUSION (bruise at the injection site), RASH MACULAR (blotchy redness around the bruise), RASH (like a rash in different areas of her shoulder), RASH PRURITIC (rash a little itchy), SKIN DISCOLOURATION (bruise getting greener/bruise still kind of purple) and HEADACHE (headache) 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.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered the first dose of the Moderna COVID-19 vaccine to a 16 years old patient; A spontaneous report was received from a pharmacist concerning a 16-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and administered the first dose of the Moderna COVID-19 vaccine to a 16 years old patient/inappropriate age at vaccine administration.  The patient's medical history was not provided. No relevant concomitant medications were not reported.  On 10 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot/batch number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 10 Mar 2021, a 16 years old patient administered the first dose of the Moderna COVID-19 vaccine. No treatment information was reported.  Action taken with mRNA-1273 in response to the event was not reported.   The event administered the first dose of the Moderna COVID-19 vaccine to a 16 years old patient was considered resolved on 10 Mar 2021.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age for mRNA-1273, lot # unknown  with no associated AEs.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: NOSE BLEED; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (NOSE BLEED) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EPISTAXIS (NOSE BLEED). At the time of the report, EPISTAXIS (NOSE BLEED) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Reportedly, nose bleed stopped after about 10 minutes.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dizziness, Feeling abnormal, Head discomfort
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT and CHILLS 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.  No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT, CHILLS, PYREXIA  and NAUSEA. At the time of the report, FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT, CHILLS, PYREXIA and NAUSEA had not resolved. Concomitant product used was not provided by the reporter. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT and CHILLS 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.  No Medical History information was reported. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT, CHILLS, PYREXIA  and NAUSEA. At the time of the report, FEELING ABNORMAL, DIZZINESS, COUGH, HEAD DISCOMFORT, CHILLS, PYREXIA and NAUSEA had not resolved. Concomitant product used was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain, Diarrhoea, Headache, Myalgia, Nausea
Clinical narrative: Myalgias; Fever 101.2; Headache; Vomiting; Nausea; Diarrhea; Abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), MYALGIA (Myalgias), PYREXIA (Fever 101.2) and HEADACHE (Headache) in a patient of an unknown age and gender 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 information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), PYREXIA (Fever 101.2), HEADACHE (Headache), VOMITING (Vomiting) and NAUSEA (Nausea). an unknown date, the patient experienced MYALGIA (Myalgias). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), MYALGIA (Myalgias), PYREXIA (Fever 101.2), HEADACHE (Headache), VOMITING (Vomiting) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.2 101.2.         Concomitant product used not provided by the reporter.  The patient reported they had a pretty intense reaction to the second vaccine. They had diarrhea for about two weeks. They had to take two days off from work.   Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Myalgias; Fever 101.2; Headache; Vomiting; Nausea; Diarrhea; Abdominal cramping; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), MYALGIA (Myalgias), PYREXIA (Fever 101.2) and HEADACHE (Headache) in a patient of an unknown age and gender 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 information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), PYREXIA (Fever 101.2), HEADACHE (Headache), VOMITING (Vomiting) and NAUSEA (Nausea). an unknown date, the patient experienced MYALGIA (Myalgias). At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL PAIN (Abdominal cramping), MYALGIA (Myalgias), PYREXIA (Fever 101.2), HEADACHE (Headache), VOMITING (Vomiting) and NAUSEA (Nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 101.2 101.2.         Concomitant product used not provided by the reporter.  The patient reported they had a pretty intense reaction to the second vaccine. They had diarrhea for about two weeks. They had to take two days off from work.   Treatment information was not provided.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy spells) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizzy spells). At the time of the report, DIZZINESS (Dizzy spells) outcome was unknown.            Concomitant product used was not provided by the reporter.  Treatment information was not provided.     Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Follow-up received on 04-May-2021 included no new information.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysgeusia, Oropharyngeal pain, Pain in extremity, Taste disorder
Clinical narrative: Her throat get closed, it was very painful; Her throat get closed, it was very painful; She was really worried; Arm didn't get sore until the next Thursday afternoon; Legs was shaken a little; She felt a terrible taste (may be from a gum) metallic and chemical taste; Extreme taste in her lips and out side on her mouth; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), TREMOR (Legs was shaken a little), DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste) and TASTE DISORDER (Extreme taste in her lips and out side on her mouth) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and METOPROLOL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TREMOR (Legs was shaken a little). 02-Mar-2021, the patient experienced DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste) and TASTE DISORDER (Extreme taste in her lips and out side on her mouth). On 04-Mar-2021, the patient experienced THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), ANXIETY (She was really worried) and PAIN IN EXTREMITY (Arm didn't get sore until the next Thursday afternoon). At the time of the report, THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), TREMOR (Legs was shaken a little), DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste), ANXIETY (She was really worried) and PAIN IN EXTREMITY (Arm didn't get sore until the next Thursday afternoon) outcome was unknown and TASTE DISORDER (Extreme taste in her lips and out side on her mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness, Tremor
Clinical narrative: Her throat get closed, it was very painful; Her throat get closed, it was very painful; She was really worried; Arm didn't get sore until the next Thursday afternoon; Legs was shaken a little; She felt a terrible taste (may be from a gum) metallic and chemical taste; Extreme taste in her lips and out side on her mouth; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), TREMOR (Legs was shaken a little), DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste) and TASTE DISORDER (Extreme taste in her lips and out side on her mouth) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included AMLODIPINE and METOPROLOL for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced TREMOR (Legs was shaken a little). 02-Mar-2021, the patient experienced DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste) and TASTE DISORDER (Extreme taste in her lips and out side on her mouth). On 04-Mar-2021, the patient experienced THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), ANXIETY (She was really worried) and PAIN IN EXTREMITY (Arm didn't get sore until the next Thursday afternoon). At the time of the report, THROAT TIGHTNESS (Her throat get closed, it was very painful), OROPHARYNGEAL PAIN (Her throat get closed, it was very painful), TREMOR (Legs was shaken a little), DYSGEUSIA (She felt a terrible taste (may be from a gum) metallic and chemical taste), ANXIETY (She was really worried) and PAIN IN EXTREMITY (Arm didn't get sore until the next Thursday afternoon) outcome was unknown and TASTE DISORDER (Extreme taste in her lips and out side on her mouth) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        Treatment information was not provided.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Headache, Myalgia
Clinical narrative: Back aches; Headache; joint pain; Muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back aches), HEADACHE (Headache), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No patient medical history was reported.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN) for an unknown indication.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BACK PAIN (Back aches), HEADACHE (Headache), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Back aches), HEADACHE (Headache), ARTHRALGIA (joint pain) and MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Additional concomitant medications included high blood pressure medications and antidepressants.    Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling, Vaccination site warmth
Clinical narrative: rash on the spot where the shot was; swelled up a little; red; itchy; hot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash on the spot where the shot was), VACCINATION SITE SWELLING (swelled up a little), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE WARMTH (hot) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash on the spot where the shot was), VACCINATION SITE SWELLING (swelled up a little), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE WARMTH (hot). At the time of the report, VACCINATION SITE RASH (rash on the spot where the shot was), VACCINATION SITE SWELLING (swelled up a little), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE WARMTH (hot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   Treatment information was not provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pyrexia
Clinical narrative: Nausea; Extreme Fatigue; Felt ill; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt ill), NAUSEA (Nausea) and FATIGUE (Extreme Fatigue) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No past medical history was reported.     On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced MALAISE (Felt ill). On 06-Mar-2021, the patient experienced NAUSEA (Nausea) and FATIGUE (Extreme Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (Felt ill), NAUSEA (Nausea) and FATIGUE (Extreme Fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Mar-2021, Pyrexia: 1001.1 Fever of 100.1 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment Information was included Tylenol. No concomitant product was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Received Vaccine from Prefilled Syringe which was in Temp Excursion; A spontaneous report was received from a pharmacist concerning a 67 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and product storage error was reported.  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 13 Feb 2021, Pharmacist reported that he had received shipment of prefilled syringes shipment   On 23 Feb 2021 prefilled syringe was taken out of Freezer and remained in room temperature for more than 6 hours and placed back in refrigerator for 2 days.   On 25 Feb 2021 the syringes were quarantined. On 1 March 2021, syringes were kept at room temperature and were administered to two patients unintentionally (product storage error). It was unknown if patients experienced any adverse events after receiving this vaccine dose.  On 01 Mar 2021, prior to the onset of the events, the patient received her  planned dose of mRNA-1273 (lot - 031L20A) for prophylaxis of COVID-19 infection.  No laboratory data was provided. Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event product storage error was considered as resolved at the time of the report.; Reporter's Comments: This report refers to a case of Product storage error for mRNA-1273, lot # 031L20A with no associated AEs.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Tachycardia
Clinical narrative: Tachycardia; Director thinks it was an anxiety attack; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (Tachycardia) and ANXIETY (Director thinks it was an anxiety attack) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced TACHYCARDIA (Tachycardia) and ANXIETY (Director thinks it was an anxiety attack). On 10-Mar-2021, TACHYCARDIA (Tachycardia) and ANXIETY (Director thinks it was an anxiety attack) 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.   Treatment information was not provided. NO CONCOMINANT AND TREATMENT MEDICATIONS WERE USED.  Reporter denied to provide further information on any further vaccines   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2021: Additional Info sig
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Peripheral swelling, Vaccination site anaesthesia, Vaccination site paraesthesia
Clinical narrative: Tingling Right Arm; Numbness Right Arm; Stiff Right Hand; Swollen Entire Right Arm/swelling of entire right arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (Tingling Right Arm), VACCINATION SITE ANAESTHESIA (Numbness Right Arm), MUSCULOSKELETAL STIFFNESS (Stiff Right Hand) and PERIPHERAL SWELLING (Swollen Entire Right Arm/swelling of entire right arm) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced VACCINATION SITE PARAESTHESIA (Tingling Right Arm), VACCINATION SITE ANAESTHESIA (Numbness Right Arm), MUSCULOSKELETAL STIFFNESS (Stiff Right Hand) and PERIPHERAL SWELLING (Swollen Entire Right Arm/swelling of entire right arm). On 08-Mar-2021, MUSCULOSKELETAL STIFFNESS (Stiff Right Hand) had resolved. At the time of the report, VACCINATION SITE PARAESTHESIA (Tingling Right Arm) and PERIPHERAL SWELLING (Swollen Entire Right Arm/swelling of entire right arm) had not resolved and VACCINATION SITE ANAESTHESIA (Numbness Right Arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medication was reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: NNI- non significant
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: signs of an Herpes simplex on her upper left lip; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ORAL HERPES (signs of an Herpes simplex on her upper left lip) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 immunization.     No Medical History information was reported.   On 09-Mar-2021 at 1:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced ORAL HERPES (signs of an Herpes simplex on her upper left lip). At the time of the report, ORAL HERPES (signs of an Herpes simplex on her upper left lip) 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. No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Non-significant follow up updated on 23-Jun-2021 and updated spelling of patient name and email address
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal  exposure during pregnancy; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) in a 27-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21A) for COVID-19 vaccination.     The patient's past medical history included Pregnancy (Emergency C section gestational diabetes for mother  Live, full-term birth) on 12-Feb-2020. Concurrent medical conditions included Asthma. Concomitant products included BUSPIRONE HYDROCHLORIDE (BUSPAR) and ALBUTEROL [SALBUTAMOL] for Asthma, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Vitamin supplementation.    On 10-Mar-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 an unknown date and the estimated date of delivery was 11-Aug-2021. On 10-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy). On 10-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal  exposure during pregnancy) 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.   Previous pregnancy end date included 12-Feb-2019 with live birth(emergency c- section -gestational diabetes for mother). Treatment information was not provided.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy
Clinical narrative: 14.5 weeks pregnant received first dose; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (14.5 weeks pregnant received first dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included Gestational hypertension (Mother had gestational hypertension and baby had jaundice so Mother was induced at 37 weeks.) on 26-Jul-2019. Concomitant products included DOXYLAMINE SUCCINATE for Nausea in pregnancy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), ACETYLSALICYLIC ACID (BABY ASPIRIN) and DOCUSATE SODIUM (COLACE) for an unknown indication.    On 10-Mar-2021 at 12:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Nov-2020 and the estimated date of delivery was 04-Sep-2021. On 10-Mar-2021, the patient experienced EXPOSURE DURING PREGNANCY (14.5 weeks pregnant received first dose). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (14.5 weeks pregnant received first dose) 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.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Boy friend got his dose 2 weeks after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Boy friend got his dose 2 weeks after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Boy friend got his dose 2 weeks after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Boy friend got his dose 2 weeks after the first dose) had resolved.            Concomitant medications were not reported by the reporter. Treatment details was not reported by the reporter.; Sender's Comments: This report refers to a case of an inappropriate schedule of 2nd dose vaccination of mRNA -1273 (unknown lot number) with no  AEs reported.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Raised Rash/Diamond Shaped Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PAPULAR (Raised Rash/Diamond Shaped Rash) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced RASH PAPULAR (Raised Rash/Diamond Shaped Rash). On 25-Feb-2021, RASH PAPULAR (Raised Rash/Diamond Shaped Rash) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.