chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration
Clinical narrative: 14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot) in a 19-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (After vaccination, he told the pharmacist that he was COVID positive).    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot). On 04-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 days post COVID positive test received 1st shot,14 days post Monoclonal antibody infusion received 1st shot) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, COVID-19: positive (Positive) positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and Treatment was not specified. Patient stated that after vaccination, he told the pharmacist that he was COVID positive and received Monoclonal antibodies 14 days ago.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of expired vaccine/HCP asking for recommendation if a patient is administered a vaccine after the beyond use date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use was unknown Treatment information was unknown
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Inflammation, Musculoskeletal discomfort, Pain, Tremor
Clinical narrative: Knees give out when walking; Slight tremors,tremors,whole body shakes quickly; Pain/aches; Feeling inflamed,like lightening from buttocks down legs across groins; Painful to walk; Can't move left shoulder without excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins) and GAIT DISTURBANCE (Painful to walk) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) 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 DABIGATRAN ETEXILATE MESILATE (PRADAXA), AMIODARONE, CLOPIDOGREL and QUETIAPINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins), GAIT DISTURBANCE (Painful to walk) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move left shoulder without excruciating pain). The patient was treated with DICLOFENAC SODIUM (topical) for Analgesic therapy, at a dose of 1 percent and ACETAMINOPHEN for Analgesic therapy, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins), GAIT DISTURBANCE (Painful to walk) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move left shoulder without excruciating pain) had not resolved.            Patient had visited the doctor who prescribed him a steroid which didn't totally work and two creams Diclofenac sodium topical 1% rugby pain relieving cream. Patient reported taking acetaminophen as well.   This case was linked to MOD-2021-341049 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site movement impairment
Clinical narrative: Knees give out when walking; Slight tremors,tremors,whole body shakes quickly; Pain/aches; Feeling inflamed,like lightening from buttocks down legs across groins; Painful to walk; Can't move left shoulder without excruciating pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins) and GAIT DISTURBANCE (Painful to walk) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 047A21A) 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 DABIGATRAN ETEXILATE MESILATE (PRADAXA), AMIODARONE, CLOPIDOGREL and QUETIAPINE for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins), GAIT DISTURBANCE (Painful to walk) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move left shoulder without excruciating pain). The patient was treated with DICLOFENAC SODIUM (topical) for Analgesic therapy, at a dose of 1 percent and ACETAMINOPHEN for Analgesic therapy, at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL DISCOMFORT (Knees give out when walking), TREMOR (Slight tremors,tremors,whole body shakes quickly), PAIN (Pain/aches), INFLAMMATION (Feeling inflamed,like lightening from buttocks down legs across groins), GAIT DISTURBANCE (Painful to walk) and VACCINATION SITE MOVEMENT IMPAIRMENT (Can't move left shoulder without excruciating pain) had not resolved.            Patient had visited the doctor who prescribed him a steroid which didn't totally work and two creams Diclofenac sodium topical 1% rugby pain relieving cream. Patient reported taking acetaminophen as well.   This case was linked to MOD-2021-341049 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables) 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 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables). At the time of the report, DYSPNOEA (I can hardly breathe/having labored breathing on the phone. She could not speak in full sentences and was unable to say her name without breathing in between syllables) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was mentioned. No treatment medication was mentioned.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Uterine cancer
Clinical narrative: diagnosed with uterine cancer; This spontaneous case was reported by a physician and describes the occurrence of UTERINE CANCER in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21, 040C21A, and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced UTERINE CANCER (seriousness criterion medically significant). The patient was treated with Surgery (Underwent emergency surgery of hysterectomy was done by mid Apr 2021) for Uterine cancer. At the time of the report, UTERINE CANCER outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on 08-Sep-2021, SARS-CoV-2 antibody test 0 antibody levels SARS-Cov2 antibody IgG nucleocap and IgM spike were reported as zero.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reported stated the patient was not on any medications before she got the vaccine. The patient had a radiation therapy post six weeks of vaccine administration and not chemotherapy. Treatment information was not provided.  This case concerns a 64 year-old female patient with no reported medical history, who experienced the unexpected serious event of Uterine cancer. The event occurred an unknown number of days after an unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: felt kind of sick; sore; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt kind of sick) and PAIN (sore) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced ILLNESS (felt kind of sick) and PAIN (sore). On 22-Jan-2021, ILLNESS (felt kind of sick) and PAIN (sore) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       It was reported that the patient had second dose of vaccine on 15Feb2021 in the same facility with lot number 013M20A.  No concomitant medications were reported.  No treatment medications were reported.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 1st dose administered to 14 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old). On 01-Oct-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (1st dose administered to 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   No treatment medications were provided.  Pharmacy accidentally administered a 1st Moderna dose to a 14 year old
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Polymerase chain reaction
Clinical narrative: breakthrough scare--flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (breakthrough scare--flu like symptoms) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Polymerase chain reaction: negative (Negative) negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment information was provided.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Endoscopy, Gastritis, Gastrointestinal disorder, Nausea
Clinical narrative: All the sudden she didn't feel well intestinally/still not feeling right; Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping; Has some nausea in the morning; Little bit of constipation; This spontaneous case was reported by a consumer and describes the occurrence of CONSTIPATION (Little bit of constipation), GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right), GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 012A21A) 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 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CONSTIPATION (Little bit of constipation). On an unknown date, the patient experienced GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right), GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning). The patient was treated with ESOMEPRAZOLE MAGNESIUM TRIHYDRATE (NEXIUM [ESOMEPRAZOLE MAGNESIUM TRIHYDRATE]) ongoing since an unknown date for Gastritis, at an unspecified dose and frequency. At the time of the report, CONSTIPATION (Little bit of constipation) and GASTROINTESTINAL DISORDER (All the sudden she didn't feel well intestinally/still not feeling right) had not resolved and GASTRITIS (Gastritis/Inflammation of the lining in her stomach/started having indigestion, dyspepsia/abdominal pain and cramping) and NAUSEA (Has some nausea in the morning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Endoscopy: abnormal (abnormal) endoscopy showed inflammation of the lining in her stomach.         No concomitant medication was reported by reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Arm hurt but it didn't bother me; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm hurt but it didn't bother me) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Lupus syndrome (Her lupus in 20 years hasn't progressed too much but it has now; it has gone to her lungs.), Drug allergy (Aspirin), Pneumonia, COPD and Non-tobacco user. Concomitant products included BIOTIN for Dry skin, AMLODIPINE for Hypertension, HYDROXYCHLOROQUINE for Lupus syndrome, OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Stomach discomfort, COLECALCIFEROL (VITAMIN D3), METOPROLOL, ESTRADIOL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MONTELUKAST SODIUM (SINGULAIR) and OXYCODONE HYDROCHLORIDE, OXYCODONE TEREPHTHALATE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;OXYCODONE TEREPHTHALATE;PARACETAMOL]) for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm hurt but it didn't bother me). At the time of the report, VACCINATION SITE PAIN (Arm hurt but it didn't bother me) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) 3-4 times per week as the disease progresses. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Treatment medications were reported.   This case was linked to MOD-2021-341062 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Product dose omission issue, Tinnitus
Clinical narrative: Very bad headache; Progressed into tinnitus; Didn't receive a 2nd shot; 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 HEADACHE (Very bad headache), TINNITUS (Progressed into tinnitus) and PRODUCT DOSE OMISSION ISSUE (Didn't receive a 2nd shot) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Very bad headache), TINNITUS (Progressed into tinnitus) and PRODUCT DOSE OMISSION ISSUE (Didn't receive a 2nd shot). At the time of the report, HEADACHE (Very bad headache), TINNITUS (Progressed into tinnitus) and PRODUCT DOSE OMISSION ISSUE (Didn't receive a 2nd shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned. No treatment details were reported. Reporter stated that the patient didn't receive a 2nd shot, because it was not mandated to receive a shot. Reporter stated that the patient has not got COVID.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ears are ringing / tinnitus /ears are so loud some days; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ears are ringing / tinnitus /ears are so loud some days) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced TINNITUS (Ears are ringing / tinnitus /ears are so loud some days). At the time of the report, TINNITUS (Ears are ringing / tinnitus /ears are so loud some days) outcome was unknown.            The patient would like to get the booster, her gynecologist recommended it but she was afraid of it.  No concomitant medications were reported  No treatment information was provided
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillitis
Clinical narrative: Feels like she has tonsillitis; This spontaneous case was reported by a consumer and describes the occurrence of TONSILLITIS (Feels like she has tonsillitis) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced TONSILLITIS (Feels like she has tonsillitis). At the time of the report, TONSILLITIS (Feels like she has tonsillitis) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Colon cancer, Computerised tomogram, Mass, Muscle spasms, Pain
Clinical narrative: Colon cancer; Cramping with sit ups/ The crunches or sit-ups aggravated the mass in his colon, and this went on for 2-3 weeks; Aggravated the mass in his colon; Pain; This spontaneous case was reported by a consumer and describes the occurrence of Colon cancer in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COLON CANCER (seriousness criteria hospitalization and medically significant), MUSCLE SPASMS, MASS, and PAIN. The patient was hospitalized for 14 days due to COLON CANCER. The patient was treated with Surgery for Colon cancer. At the time of the report, COLON CANCER, MUSCLE SPASMS, MASS, and PAIN outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Computerised tomogram (abnormal) CT scan showed the cancer.         No concomitant medications and treatment medications were provided.  This case concerns a 70-year-old, male patient with no previous relevant medical history reported, who experienced the unexpected even of colon cancer. The event occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033B21A and 025C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Jul-2021, the patient experienced TINNITUS (Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing). At the time of the report, TINNITUS (Within minutes after the first dose my ears started ringing/It never stopped/The ringing is constant since the first dose/Thirty days later the ears were still ringing) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient takes concomitant medication but not willing to disclose. No treatment medications were provided.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Pain in extremity, Pyrexia
Clinical narrative: stomach a little bit upset/ stomach was a little upset for a little bit.; soreness in the arm; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach a little bit upset/ stomach was a little upset for a little bit.), PAIN IN EXTREMITY (soreness in the arm) and PYREXIA (little bit of fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-341167, MOD-2021-341203 (Patient Link).
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Adverse event, Body temperature, Myalgia, Pyrexia
Clinical narrative: stomach a little bit upset; Typical side effects; soreness in the arm; little bit of fever; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A, 027C21A and 016M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever). At the time of the report, ABDOMINAL DISCOMFORT (stomach a little bit upset), ADVERSE EVENT (Typical side effects), MYALGIA (soreness in the arm) and PYREXIA (little bit of fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: other little bit.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-341194, MOD-2021-341167 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: TCR attached-significant patient age, event added, out come of the events provided.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Malaise
Clinical narrative: not feeling well /feel a little bit off; feel sort of in a cloud; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud). At the time of the report, MALAISE (not feeling well /feel a little bit off) and FEELING ABNORMAL (feel sort of in a cloud) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Patient has heard from several places that Moderna will recommend a booster shot which is half dose. Patient has not been feeling well lately and he would like to know if a third full dose can affect him adversely. Patient feels a little off and sort of in a cloud.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received dose from vial punctured days before; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received dose from vial punctured days before) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter reported number of doses/vials was 1 vial, 1 dose. Date the vial was initially stored in the refrigerator was 03 Sep 2021. Date and time vial was first punctured was 07 Sep 2021 at 3.20pm. The vial did not under gone to temperature excursion.  No concomitant medications were mentioned. No treatment details were reported.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: sore arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore arm) and FATIGUE (tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical  history for patient was reported.  Concomitant products included AZATHIOPRINE SODIUM (IMURAN [AZATHIOPRINE SODIUM]) for Lupus anticoagulant.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (sore arm) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form and IBUPROFEN for Adverse event, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (sore arm) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   The patient taken medication for suspected cellulitis it was not cellulitis at injection site and  steroid cream.   This case was linked to MOD-2021-341229, MOD-2021-341213 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; tired; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028B21A and 003A21A) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus. Concomitant products included AZATHIOPRINE (IMURAN [AZATHIOPRINE]) for Systemic lupus erythematosus.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (sore arm) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-341218, MOD-2021-341213 (Patient Link).
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Thrombosis
Clinical narrative: Blood clots; a pain in leg near right knee; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS in an 80-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 Baker's cyst (Right knee), Clot blood (in lower leg), and Factor V Leiden mutation.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (seriousness criterion medically significant) and PAIN IN EXTREMITY (in leg near right knee). The patient was treated with XARELTO at an unspecified dose and frequency and WARFARIN at an unspecified dose and frequency. At the time of the report, THROMBOSIS and PAIN IN EXTREMITY (in leg near right knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  Patient had received a cortisone shot in her knee a month or 2 earlier for Baker's cyst in her right knee.  This case concerns a 80-year-old, female patient with relevant medical history of Baker's cyst, Clot blood, and Factor V Leiden mutation, who experienced the unexpected events of Thrombosis and Pain in extremity. The events occurred on an unknown date after a dose of Moderna CoviD-19 Vaccine. The rechallenge was unknown since no information about the events of the first dose was disclosed. The patient's medical history of Baker's cyst, Clot blood, and Factor V Leiden mutation remain as confounders for the occurrence of the events. The benefit-risk relationship of Moderna CoviD-19 Vaccine is not affected by this report. Case is assessed as Serious since Thrombosis is on the list and the outcome of the events is still unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: primary said she thought I had gotten covid before I got the second shot; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CALCIUM, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN CALCIUM (LIPITOR), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DENOSUMAB (PROLIA) for an unknown indication.    On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot). At the time of the report, SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided   This case was linked to MOD-2021-341159 (Patient Link).; Sender's Comments: This case concerns a 68 year old female with no reported medical history , who experienced the unexpected event of Suspected Covid 19 which occurred on an unknown date after vaccination with the 1st dose of mRNA-1273 (Moderna). The rechallenge is not applicable since only information of the 1st dose is reported. The age of the patient may be considered as a confounder( since the elderly group are prone to Covid 19 infection) for this case. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Obesity, Swelling
Clinical narrative: weight gain; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of OBESITY (weight gain) and SWELLING (swelling) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety and Obesity. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Feb-2021 to an unknown date and BUSPIRONE HYDROCHLORIDE (BUSPAR) from 12-Mar-2021 to an unknown date for Anxiety, SILDENAFIL CITRATE (VIAGRA) for Pulmonary hypertension.   On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OBESITY (weight gain) and SWELLING (swelling). At the time of the report, OBESITY (weight gain) and SWELLING (swelling) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication details were reported.   This case was linked to MOD-2021-326423 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after manufacture date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039821A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information was provided.  Moderna cannot guarantee patients received full protection against the COVID-19 Virus.   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received and contains non significant information.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown.            Treatment included: Regeneron. No Concomitant medications were reported.; Sender's Comments: This report concerns a 91 year old female patient with no relevant medical history who experienced non-serious unexpected event of COVID-19 infection. The event occurred approximately 8 months after vaccination with second dose of mRNA-1273. The re-challenge is not applicable as the event happened after the second dose. The outcome of the event is unknown at the time of this report. The benefit-risk relationship of mRNA-1273 is not affected by this report. There is incomplete information about the second dose of the vaccine and the latency between the doses.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pyrexia, Vaccination site discolouration
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025821A and 044A21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient experienced vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks). At the time of the report, vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks) outcome: unknown. No concomitant medications or treatment information reported. The patient stated the black and blue mark went away after 2 weeks and then came back in late September. This case linked to MOD-2021-066619 (patient link).
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine administered to an underage patient.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Asthenia, Expired product administered, Pain, Pain in extremity
Clinical narrative: arm was sore; she was probably in bed with overwhelming low energy; general achiness; vertigo/ vertigo was pretty severe/ vertigo was on and off; she thinks she received expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ASTHENIA (she was probably in bed with overwhelming low energy), PAIN (general achiness), VERTIGO (vertigo/ vertigo was pretty severe/ vertigo was on and off) and EXPIRED PRODUCT ADMINISTERED (she thinks she received expired vaccine) 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 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (she thinks she received expired vaccine). On 03-Apr-2021, the patient experienced VERTIGO (vertigo/ vertigo was pretty severe/ vertigo was on and off). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ASTHENIA (she was probably in bed with overwhelming low energy) and PAIN (general achiness). On 30-Mar-2021, EXPIRED PRODUCT ADMINISTERED (she thinks she received expired vaccine) had resolved. In August 2021, VERTIGO (vertigo/ vertigo was pretty severe/ vertigo was on and off) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), ASTHENIA (she was probably in bed with overwhelming low energy) and PAIN (general achiness) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) IgG and IgM, negative, was explained patient has zero antibodies and negative (Negative) IgG and IgM, negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Patient had to use medication for the vertigo.