chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: 3 other people who came in with similar symptoms, after receiving COVID-19 vaccine; 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 VACCINATION COMPLICATION (3 other people who came in with similar symptoms, after receiving COVID-19 vaccine) 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 VACCINATION COMPLICATION (3 other people who came in with similar symptoms, after receiving COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (3 other people who came in with similar symptoms, after receiving COVID-19 vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided No treatment medication information was provided
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; 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 HERPES ZOSTER (shingles) 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) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) 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.   In April 2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: Nose is runny; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHEA (Nose is runny) 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 16-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHEA (Nose is runny). At the time of the report, RHINORRHEA (Nose is runny) had not resolved.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicable.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: i have side chest pain.; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (i have side chest pain.) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (i have side chest pain.). At the time of the report, CHEST PAIN (i have side chest pain.) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: high temperature; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high temperature) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high temperature). At the time of the report, PYREXIA (high temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was included.  No treatment drug details was provided.
Sex: U
Vaccine: COVID19
Symptoms: Cough, Suspected COVID-19, Vomiting
Clinical narrative: actually think I got virus; It is so bad I end up throwing up; cough; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    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 COUGH (cough), SUSPECTED COVID-19 (actually think I got virus) and VOMITING (It is so bad I end up throwing up) 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 COUGH (cough), SUSPECTED COVID-19 (actually think I got virus) and VOMITING (It is so bad I end up throwing up). At the time of the report, COUGH (cough), SUSPECTED COVID-19 (actually think I got virus) and VOMITING (It is so bad I end up throwing up) 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 reported.    Reporter did not allow further contact
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Pain in hand; Vaccination site pain; This spontaneous case was reported by a physician and describes the occurrence of PAIN IN EXTREMITY (Pain in hand) and VACCINATION SITE PAIN (Vaccination site pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included HYDROQUINONE for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in hand) and VACCINATION SITE PAIN (Vaccination site pain). At the time of the report, PAIN IN EXTREMITY (Pain in hand) was resolving and VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided by the reporter.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Severe muscle pain; 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 MYALGIA (Severe muscle pain) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Severe muscle pain). At the time of the report, MYALGIA (Severe muscle pain) outcome was unknown.            The patient had severe muscle pain after receiving the second dose.  No Concomitant product use was reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Limb discomfort
Clinical narrative: arm slightly sore but not like the first vaccine; slightly tired for about 5 days; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (arm slightly sore but not like the first vaccine) and FATIGUE (slightly tired for about 5 days) 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 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 LIMB DISCOMFORT (arm slightly sore but not like the first vaccine) and FATIGUE (slightly tired for about 5 days). At the time of the report, LIMB DISCOMFORT (arm slightly sore but not like the first vaccine) and FATIGUE (slightly tired for about 5 days) outcome was unknown.            No concomitant medications reported. Treatment information not reported.   This case was linked to MOD-2021-053332 (Patient Link).
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: had second shot on April 16th and same thing continued.Diarrhea; This spontaneous case was reported by a physician and describes the occurrence of DIARRHOEA (had second shot on April 16th and same thing continued.Diarrhea) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047821A and 033821A) for COVID-19 vaccination.     Concurrent medical conditions included Irritable bowel syndrome.   On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DIARRHOEA (had second shot on April 16th and same thing continued.Diarrhea). The patient was treated with LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, DIARRHOEA (had second shot on April 16th and same thing continued.Diarrhea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lymphadenopathy, Peripheral swelling, Swelling
Clinical narrative: lump on her right groin 2 to 2.5 inches in size; hard lump underneath her arms, size of a quarter; lymph nodes from said areas are swollen, hard and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (lump on her right groin 2 to 2.5 inches in size), PERIPHERAL SWELLING (hard lump underneath her arms, size of a quarter) and LYMPHADENOPATHY (lymph nodes from said areas are swollen, hard and warm to touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039321A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING (lump on her right groin 2 to 2.5 inches in size), PERIPHERAL SWELLING (hard lump underneath her arms, size of a quarter) and LYMPHADENOPATHY (lymph nodes from said areas are swollen, hard and warm to touch). At the time of the report, SWELLING (lump on her right groin 2 to 2.5 inches in size), PERIPHERAL SWELLING (hard lump underneath her arms, size of a quarter) and LYMPHADENOPATHY (lymph nodes from said areas are swollen, hard and warm to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 96.6 (Inconclusive) 96.6 in Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: major issue since getting vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (major issue since getting vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first 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 COMPLICATION (major issue since getting vaccine). At the time of the report, VACCINATION COMPLICATION (major issue since getting vaccine) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not applicable. Treatment information was not provided. Concomitant medication was not reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pyrexia
Clinical narrative: big red bum; fever; This spontaneous case was reported by a patient and describes the occurrence of ERYTHEMA (big red bum) and PYREXIA (fever) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jun-2021, the patient experienced ERYTHEMA (big red bum) and PYREXIA (fever). At the time of the report, ERYTHEMA (big red bum) and PYREXIA (fever) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was reported.    Reporter did not allow further contact
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site erythema, Vaccination site mass
Clinical narrative: little bump on arm; redness on arm; fever; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (little bump on arm), VACCINATION SITE ERYTHEMA (redness on arm), the first episode of PYREXIA (fever), MYALGIA (body aches) and the second episode of PYREXIA (fever) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced the first episode of PYREXIA (fever), MYALGIA (body aches) and the second episode of PYREXIA (fever). On 06-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness on arm). On 07-Mar-2021, the patient experienced VACCINATION SITE MASS (little bump on arm). On 06-Feb-2021, MYALGIA (body aches) and the last episode of PYREXIA (fever) had resolved. At the time of the report, VACCINATION SITE MASS (little bump on arm) and VACCINATION SITE ERYTHEMA (redness on arm) outcome was unknown.            No treatment medication provided. No concomitant medication was reported by the reporter.   This case was linked to MOD-2021-037275 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: TCR : AE outcome/ patient don't want to further follow-ups.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itching is unbearable; Rash spread to the shoulder, upper back, lower back, stomach, front and back of legs; rash starts at the upper neck and continues down the legs; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Itching is unbearable) and RASH (Rash spread to the shoulder, upper back, lower back, stomach, front and back of legs; rash starts at the upper neck and continues down the legs) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 036L20A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AMLODIPINE, APIXABAN (ELIQUIS), METOPROLOL SUCCINATE (TOPROL XL) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced RASH (Rash spread to the shoulder, upper back, lower back, stomach, front and back of legs; rash starts at the upper neck and continues down the legs). On an unknown date, the patient experienced PRURITUS (Itching is unbearable). The patient was treated with TRIAMCINOLONE at a dose of 0.1 %. At the time of the report, PRURITUS (Itching is unbearable) and RASH (Rash spread to the shoulder, upper back, lower back, stomach, front and back of legs; rash starts at the upper neck and continues down the legs) outcome was unknown.            Concomitant medications included nitrol patch daily.  Patient reported treatment of steroid cream prescribed from dermatologist helps temporarily.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-037085 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Groin pain, Limb discomfort, Muscle spasms
Clinical narrative: side effects continuously; aching glands - armpits, groin; feeling of cramping in my feet; tight calves; aching backs of knees; aching glands - armpits, groin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves) and ARTHRALGIA (aching backs of knees) 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 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves), ARTHRALGIA (aching backs of knees) and AXILLARY PAIN (aching glands - armpits, groin). At the time of the report, VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves), ARTHRALGIA (aching backs of knees) and AXILLARY PAIN (aching glands - armpits, groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects continuously; aching glands - armpits, groin; feeling of cramping in my feet; tight calves; aching backs of knees; aching glands - armpits, groin; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves) and ARTHRALGIA (aching backs of knees) 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 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves), ARTHRALGIA (aching backs of knees) and AXILLARY PAIN (aching glands - armpits, groin). At the time of the report, VACCINATION COMPLICATION (side effects continuously), GROIN PAIN (aching glands - armpits, groin), MUSCLE SPASMS (feeling of cramping in my feet), LIMB DISCOMFORT (tight calves), ARTHRALGIA (aching backs of knees) and AXILLARY PAIN (aching glands - armpits, groin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Relevant concomitant medications was reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Tachycardia
Clinical narrative: Tachycardia; Rapid heart rate; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia) and HEART RATE INCREASED (Rapid heart rate) 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 TACHYCARDIA (Tachycardia) and HEART RATE INCREASED (Rapid heart rate). At the time of the report, TACHYCARDIA (Tachycardia) and HEART RATE INCREASED (Rapid heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided. Action taken with mRNA-1273 in response to the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Nausea, Tongue discomfort
Clinical narrative: nausea; taste buds off; tongue feels weird; This spontaneous case was reported by a non-health professional and describes the occurrence of NAUSEA (nausea), AGEUSIA (taste buds off) and TONGUE DISCOMFORT (tongue feels weird) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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) (unknown route) 2 dosage form. On an unknown date, the patient experienced NAUSEA (nausea), AGEUSIA (taste buds off) and TONGUE DISCOMFORT (tongue feels weird). At the time of the report, NAUSEA (nausea), AGEUSIA (taste buds off) and TONGUE DISCOMFORT (tongue feels weird) outcome was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed the 42 day window; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed the 42 day window) 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 PRODUCT DOSE OMISSION ISSUE (Missed the 42 day window). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed the 42 day window) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No Treatment medication was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Yet to receive second dose more than 42 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Yet to receive second dose more than 42 days after first dose) 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 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Yet to receive second dose more than 42 days after first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Yet to receive second dose more than 42 days after first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was reported.
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Platelet count
Clinical narrative: Severe Period Bleeding after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Severe Period Bleeding after vaccination) 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.    In 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HEAVY MENSTRUAL BLEEDING (Severe Period Bleeding after vaccination). At the time of the report, HEAVY MENSTRUAL BLEEDING (Severe Period Bleeding after vaccination) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 5 (Low) low.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Relevant concomitant medications was reported.  Treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood chloride increased, Blood creatinine normal, Blood glucose normal, Blood potassium normal
Clinical narrative: Chill x1week, fever x1 week, fatigue x1 month, joint aches x2-3 months, lymph node pain 3 weeks, headache x4 months and ongoing, dehydration x1 week
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Blood sodium normal, Blood urea normal, Carbon dioxide normal, Chills, Computerised tomogram head
Clinical narrative: Chill x1week, fever x1 week, fatigue x1 month, joint aches x2-3 months, lymph node pain 3 weeks, headache x4 months and ongoing, dehydration x1 week
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Fatigue, Glomerular filtration rate normal, Headache, Influenza A virus test negative
Clinical narrative: Chill x1week, fever x1 week, fatigue x1 month, joint aches x2-3 months, lymph node pain 3 weeks, headache x4 months and ongoing, dehydration x1 week
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza B virus test, Lymph node pain, Pyrexia, Respiratory syncytial virus test negative, SARS-CoV-2 test negative
Clinical narrative: Chill x1week, fever x1 week, fatigue x1 month, joint aches x2-3 months, lymph node pain 3 weeks, headache x4 months and ongoing, dehydration x1 week
Sex: U
Vaccine: COVID19
Symptoms: Hot flush, Hyperhidrosis
Clinical narrative: Is excessive sweating; hot flashes; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Is excessive sweating) and HOT FLUSH (hot flashes) 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 HYPERHIDROSIS (Is excessive sweating) and HOT FLUSH (hot flashes). At the time of the report, HYPERHIDROSIS (Is excessive sweating) and HOT FLUSH (hot flashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided. No treatment information provided.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia
Clinical narrative: chills; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) 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 16-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form(s). On 16-Jun-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and HEADACHE (headache). At the time of the report, CHILLS (chills), PYREXIA (fever) and HEADACHE (headache) outcome was unknown.            No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not applicabl
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: Soreness of  right arm / Pain in left arm and here and there after the vaccine.; Sharp intense pain at the site of injection / Pain at injection site, sudden and lasts for a second; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of  right arm / Pain in left arm and here and there after the vaccine.) and VACCINATION SITE PAIN (Sharp intense pain at the site of injection / Pain at injection site, sudden and lasts for a second) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Soreness of  right arm / Pain in left arm and here and there after the vaccine.) and VACCINATION SITE PAIN (Sharp intense pain at the site of injection / Pain at injection site, sudden and lasts for a second). At the time of the report, PAIN IN EXTREMITY (Soreness of  right arm / Pain in left arm and here and there after the vaccine.) and VACCINATION SITE PAIN (Sharp intense pain at the site of injection / Pain at injection site, sudden and lasts for a second) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 006M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-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 PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (sore arm) and FATIGUE (Tired) outcome was unknown.            No concomitant medication provided by reporter. No treatment medication provided by reporter.   This case was linked to MOD-2021-225413, MOD-2021-082958 (Patient Link).   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm soreness to the touch for a few weeks after first dose/pain in the arm; Sharp pain for 4 days after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sharp pain for 4 days after first dose) and PAIN IN EXTREMITY (Arm soreness to the touch for a few weeks after first dose/pain in the arm) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-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 PAIN IN EXTREMITY (Sharp pain for 4 days after first dose) and PAIN IN EXTREMITY (Arm soreness to the touch for a few weeks after first dose/pain in the arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CORTISONE at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sharp pain for 4 days after first dose) had resolved and PAIN IN EXTREMITY (Arm soreness to the touch for a few weeks after first dose/pain in the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug information was reported.   This case was linked to MOD-2021-039270 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Lung disorder, Nasopharyngitis
Clinical narrative: got real... real cold; coughing like no tomorrow; minor fleme from my lungs; shivering; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (got real... real cold), COUGH (coughing like no tomorrow), LUNG DISORDER (minor fleme from my lungs) and CHILLS (shivering) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jun-2021, the patient experienced NASOPHARYNGITIS (got real... real cold), COUGH (coughing like no tomorrow), LUNG DISORDER (minor fleme from my lungs) and CHILLS (shivering). At the time of the report, NASOPHARYNGITIS (got real.. real cold), COUGH (coughing like no tomorrow), LUNG DISORDER (minor fleme from my lungs) and CHILLS (shivering) outcome was unknown.            No concomitant medications reported. No treatment information was provided.    Reporter did not allow further contact
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Malaise after second dose of vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 17-Jun-2021 and was forwarded to Moderna on 17-Jun-2021.    This spontaneous case was reported by a physician and describes the occurrence of MALAISE (Malaise after second dose of vaccine) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever, Depression, Insomnia, Drug allergy (Bupropion) and Allergy to antibiotic (Amoxicillin). Concomitant products included VALACYCLOVIR [VALACICLOVIR] from 27-Sep-2019 to 06-Feb-2021, METFORMIN from 27-Sep-2019 to 18-Dec-2020, RANITIDINE HYDROCHLORIDE (ZANTAC) from 27-Sep-2019 to 18-Dec-2020, BIOTIN from 20-Sep-2019 to 18-Dec-2020, GINKGO BILOBA (GINKO BILOBA [GINKGO BILOBA]) from 27-Sep-2019 to 18-Dec-2020, TRAZODONE from 27-Sep-2019 to 06-Feb-2021, ALPRAZOLAM from 27-Sep-2019 to 18-Dec-2020, DULOXETINE HYDROCHLORIDE (CYMBALTA) from 27-Sep-2019 to 18-Dec-2020, LINUM USITATISSIMUM SEED OIL (FLAX SEED OIL) from 27-Sep-2019 to 18-Dec-2020, FAMOTIDINE (PEPCID [FAMOTIDINE]) from 27-Sep-2019 to 17-Sep-2020, TRAMADOL, RALOXIFENE HYDROCHLORIDE (EVISTA) from 27-Sep-2019 to 04-Feb-2020, MACROGOL 3350 (MIRALAX) from 27-Sep-2019 to 06-Feb-2021, MAGNESIUM from 27-Sep-2019 to 06-Feb-2021, CALCIUM from 27-Sep-2019 to 06-Feb-2021, HYDROCORTISONE, OMEPRAZOLE from 17-Sep-2020 to 18-Dec-2020, MELOXICAM from 27-Sep-2019 to 04-Feb-2020 and DENOSUMAB (PROLIA) from 04-Feb-2020 to 06-Feb-2021 for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Malaise after second dose of vaccine). At the time of the report, MALAISE (Malaise after second dose of vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported. Concomitant medications include  stool softener, multivitamin, Vitamin D, Diclofenac Gel.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. However, the patient's medical history of depression is a confounder for malaise.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; 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 PYREXIA (Fever) 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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication and Lab data information was provided. No Treatment medication information was provided   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Vertigo
Clinical narrative: vertigo; condition aggravated; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) and CONDITION AGGRAVATED (condition aggravated) in a 61-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo) and CONDITION AGGRAVATED (condition aggravated). At the time of the report, VERTIGO (vertigo) and CONDITION AGGRAVATED (condition aggravated) had not resolved. Not Provided          No concomitant medications was provided by the reporter.  No treatment information was reported.   This case was linked to MOD-2021-083465 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Outcome of the event was updated to not recovered.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Metabolic function test, SARS-CoV-2 test
Clinical narrative: positive for SARS-CoV-2 infection; lack of drug effect; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (positive for SARS-CoV-2 infection) in a 71-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.     The patient's past medical history included Hypertension and Kidney transplant. Concomitant products included TRIAMCINOLONE, MYCOPHENOLATE MOFETIL (MMF) and PREDNISONE for an unknown indication.   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 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (positive for SARS-CoV-2 infection) (seriousness criteria hospitalization and medically significant) and DRUG INEFFECTIVE (lack of drug effect). The patient was hospitalized from sometime in 2021 to sometime in 2021 due to COVID-19. The patient was treated with DEXAMETHASONE for Adverse event, at a dose of 1 dosage form and REMDESIVIR for Adverse event, at a dose of 1 dosage form. At the time of the report, COVID-19 (positive for SARS-CoV-2 infection) was resolving and DRUG INEFFECTIVE (lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Metabolic function test: 20.85 (normal) 20.85. In 2021, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (positive for SARS-CoV-2 infection) to be possibly related. No further causality assessment was provided for DRUG INEFFECTIVE (lack of drug effect).    Part of a retrospective, observational study of SOTR patients who received SARS-CoV-2 vaccine  that was conducted at a Hospital by chart review. Severity of COVID-19 classified by authors as "severe."  Company comment: This is a case of lack of efficacy of the product in an immunosuppressed transplant patient.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Report contains no significant information.; Sender's Comments: This is a case of lack of efficacy of the product in an immunosuppressed transplant patient.  Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) in a 70-year-old male patient 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 FATIGUE (Felt tired). At the time of the report, FATIGUE (Felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Different vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Different vaccine administered) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Congestive heart failure, BP raised, Diabetes, Allergy and Stomach ache.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 09-Jun-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Different vaccine administered). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at a dose of 1 dosage form. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Different vaccine administered) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) positive. On an unknown date, Cardiovascular examination: unknown (Inconclusive) unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medication was reported.    No treatment information was provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: event outcome updated.