chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Emotional disorder, Influenza, Myalgia
Clinical narrative: medium grade flu; becoming very emotional; temperature of 103 degrees Fahrenheit; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (medium grade flu), EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included HIV disease, Kidney disorder and Heart disorder. Concomitant products included LOSARTAN, CARVEDILOL, ATORVASTATIN CALCIUM (LIPITOR), VITAMIN B NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA (medium grade flu). The patient was treated with PARACETAMOL (TYLENOL) for Flu, at an unspecified dose and frequency. On 14-Apr-2021, EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, INFLUENZA (medium grade flu) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 103 (High) Patient has temperature of 103 degrees Fahrenheit.         Patient was immuno-compromised  and received  for  booster dose as per advise from cardiologist. Patient took anti viral medication  for unknown indication. Patient reported that medium grade flu which goes away with Tylenol but came back when it wears off about 6 hours.   This case was linked to MOD-2021-308902 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Treatment medication added and event was added
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: medium grade flu; becoming very emotional; temperature of 103 degrees Fahrenheit; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (medium grade flu), EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery. Concurrent medical conditions included HIV disease, Kidney disorder and Heart disorder. Concomitant products included LOSARTAN, CARVEDILOL, ATORVASTATIN CALCIUM (LIPITOR), VITAMIN B NOS and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills). On an unknown date, the patient experienced INFLUENZA (medium grade flu). The patient was treated with PARACETAMOL (TYLENOL) for Flu, at an unspecified dose and frequency. On 14-Apr-2021, EMOTIONAL DISORDER (becoming very emotional), PYREXIA (temperature of 103 degrees Fahrenheit), MYALGIA (body aches) and CHILLS (chills) had resolved. At the time of the report, INFLUENZA (medium grade flu) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: 103 (High) Patient has temperature of 103 degrees Fahrenheit.         Patient was immuno-compromised  and received  for  booster dose as per advise from cardiologist. Patient took anti viral medication  for unknown indication. Patient reported that medium grade flu which goes away with Tylenol but came back when it wears off about 6 hours.   This case was linked to MOD-2021-308902 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Treatment medication added and event was added
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, HIV test, Influenza, Pain
Clinical narrative: medium grade flu; body aches; Chills; Temperature of 103 degrees Fahrenheit; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Sep-2021. The most recent information was received on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (Chills), PYREXIA (Temperature of 103 degrees Fahrenheit) and INFLUENZA (medium grade flu) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 044B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (underwent quadruple bypass surgery). Concurrent medical conditions included Kidney disorder, Heart disorder and HIV positive. Concomitant products included LOSARTAN, CARVEDILOL, VITAMIN B NOS, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PAIN (body aches), CHILLS (Chills) and PYREXIA (Temperature of 103 degrees Fahrenheit). On an unknown date, the patient experienced INFLUENZA (medium grade flu). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (Chills), PYREXIA (Temperature of 103 degrees Fahrenheit) and INFLUENZA (medium grade flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 103 (High) temperature of 103 degrees Fahrenheit. On an unknown date, HIV test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that anti viral medication was taken as a concomitant medication. It was reported that patient does not want to take his pain reliever as he it may effect his kidneys as he had a kidney problem.   This case was linked to MOD-2021-308780.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up information received on 07-SEP-2021 contains significant information. New event medium grade flu is mentioned.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: medium grade flu; body aches; Chills; Temperature of 103 degrees Fahrenheit; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Sep-2021. The most recent information was received on 07-Sep-2021 and was forwarded to Moderna on 07-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (Chills), PYREXIA (Temperature of 103 degrees Fahrenheit) and INFLUENZA (medium grade flu) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A, 044B21A and 045A21A) for COVID-19 vaccination.     The patient's past medical history included Bypass surgery (underwent quadruple bypass surgery). Concurrent medical conditions included Kidney disorder, Heart disorder and HIV positive. Concomitant products included LOSARTAN, CARVEDILOL, VITAMIN B NOS, ATORVASTATIN CALCIUM (LIPITOR) and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced PAIN (body aches), CHILLS (Chills) and PYREXIA (Temperature of 103 degrees Fahrenheit). On an unknown date, the patient experienced INFLUENZA (medium grade flu). The patient was treated with PARACETAMOL (TYLENOL) for Pain relief, at an unspecified dose and frequency. At the time of the report, PAIN (body aches), CHILLS (Chills), PYREXIA (Temperature of 103 degrees Fahrenheit) and INFLUENZA (medium grade flu) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Aug-2021, Body temperature: 103 (High) temperature of 103 degrees Fahrenheit. On an unknown date, HIV test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that anti viral medication was taken as a concomitant medication. It was reported that patient does not want to take his pain reliever as he it may effect his kidneys as he had a kidney problem.   This case was linked to MOD-2021-308780.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up information received on 07-SEP-2021 contains significant information. New event medium grade flu is mentioned.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gingival pain, Headache, Oral pain, Vaccination site erythema
Clinical narrative: on the left arm where she got the vaccine is itching; Gums are throbbing; Roof of mouth like a sore and tender.; Headache; Chills on and off; On the left arm where she got the vaccine its red with a big patch; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off) and VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off) and VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (on the left arm where she got the vaccine is itching). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off), VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch) and VACCINATION SITE PRURITUS (on the left arm where she got the vaccine is itching) outcome was unknown.            Concomitant medications were not reported. It was reported that patient had treated with Tylenol - Unable to provide milligrams however taking medication 2 every six hours as per patient
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: on the left arm where she got the vaccine is itching; Gums are throbbing; Roof of mouth like a sore and tender.; Headache; Chills on and off; On the left arm where she got the vaccine its red with a big patch; This spontaneous case was reported by a consumer and describes the occurrence of GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off) and VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A and 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off) and VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch). On an unknown date, the patient experienced VACCINATION SITE PRURITUS (on the left arm where she got the vaccine is itching). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, GINGIVAL PAIN (Gums are throbbing), ORAL PAIN (Roof of mouth like a sore and tender.), HEADACHE (Headache), CHILLS (Chills on and off), VACCINATION SITE ERYTHEMA (On the left arm where she got the vaccine its red with a big patch) and VACCINATION SITE PRURITUS (on the left arm where she got the vaccine is itching) outcome was unknown.            Concomitant medications were not reported. It was reported that patient had treated with Tylenol - Unable to provide milligrams however taking medication 2 every six hours as per patient
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: a clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (a clot) 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 THROMBOSIS (a clot) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (a clot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment information mentioned. Company Comment :Very limited information regarding this event has been provided at this time. However, 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. Further information can't be requested.   Reporter did not allow further contact; Sender's Comments: Very limited information regarding this event has been provided at this time. However, 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. Further information can't be requested.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: Have ringing in my ears; side effect; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Have ringing in my ears) and VACCINATION COMPLICATION (side effect) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 088D21A, 016M20A and 032M20A) for COVID-19 vaccination.     Concurrent medical conditions included Multiple sclerosis. Concomitant products included GLATIRAMER ACETATE (COPAXONE) for Multiple sclerosis.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-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 TINNITUS (Have ringing in my ears) and VACCINATION COMPLICATION (side effect). At the time of the report, TINNITUS (Have ringing in my ears) had not resolved and VACCINATION COMPLICATION (side effect) outcome was unknown.            Copaxone was not taken during vaccination days. The treatment history was not reported.  It was reported that ringing in ears started after first dose.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Added Patient initials, added event - side effect. On 08-Sep-2021: Added Reporters information, Suspect drug first, second and third dose details, concomitant medication-Copaxone.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy skin, Blood test, Immunology test, Pemphigoid
Clinical narrative: The diagnosis of BP was confirmed; This literature-non-study case was reported in a literature article and describes the occurrence of PEMPHIGOID (The diagnosis of BP was confirmed) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   Concurrent medical conditions included Hand eczema.   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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PEMPHIGOID (The diagnosis of BP was confirmed) (seriousness criterion medically significant). At the time of the report, PEMPHIGOID (The diagnosis of BP was confirmed) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy skin: abnormal (abnormal) subepidermal separation and dermal infiltrates with eosinophils. On an unknown date, Blood test: >200/59 (Positive) Positive. On an unknown date, Immunology test: igg/c3/weak (Inconclusive) IgG/C3/ and weak granular IgM.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PEMPHIGOID (The diagnosis of BP was confirmed) to be possibly related.    Concomitant medications were not provided by the reporter.  The event was treated with intramuscular corticosteroid(IMCS), intravenous corticosteroid(IVCS), topical corticosteroid(TCS). The event was ongoing  at  day 23.   This case is related to patient 5 which show positive result of hematoxylin and eosin staining.  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, more information is required for further assessment. Clarification regarding the seriousness of the event is expected.   This case was linked to MOD-2021-309334, MOD-2021-309420, MOD-2021-309423, MOD-2021-309421 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow up received by safety 09-Sep-2021 included an Email received from a regulatory authority team and does not contain any new information.; 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, more information is required for further assessment. Clarification regarding the seriousness of the event is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Magnetic resonance imaging, Vaccination site pain
Clinical narrative: Swelling of the lymph nodes on her arm; Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of the lymph nodes on her arm) and VACCINATION SITE PAIN (Soreness at injection site) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy (Penicillin and penicillin derivatives allergy), Fruit allergy (kiwi), Fruit allergy (mango), Fragrance sensitivity, Soap allergy, Latex allergy, Allergy (furr), Detergent sensitivity, Hashimoto's disease and ANA increased (High ANA Levels , Patient is considered to be immunocompromised).    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling of the lymph nodes on her arm) and VACCINATION SITE PAIN (Soreness at injection site). On 15-Jan-2021, LYMPHADENOPATHY (Swelling of the lymph nodes on her arm) and VACCINATION SITE PAIN (Soreness at injection site) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) inflammation between her vertebrae (C1 to C7 and T2 to T3).     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.   Concomitant medication was not provided treatment information was not provided   This case was linked to MOD-2021-309590, MOD-2021-309638 (Patient Link).
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Magnetic resonance imaging, Myalgia
Clinical narrative: Swelling of the lymph nodes on her neck; Chills; Aches all over the body; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Sep-2021 and was forwarded to Moderna on 05-Sep-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling of the lymph nodes on her neck), CHILLS (Chills) and MYALGIA (Aches all over the body) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Food allergy, Perfume sensitivity, Soap allergy, Latex allergy, Hypersensitivity, Hashimoto's disease, ANA increased and Food allergy.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced LYMPHADENOPATHY (Swelling of the lymph nodes on her neck), CHILLS (Chills) and MYALGIA (Aches all over the body). On 12-Feb-2021, LYMPHADENOPATHY (Swelling of the lymph nodes on her neck), CHILLS (Chills) and MYALGIA (Aches all over the body) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: inconclusive (Inconclusive) Findings : inflammation between vertebrae (C1 to C7 and T2 to T3), stenosis, arthritis, flattening of the nerve.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment information provided   This case was linked to MOD-2021-309559, MOD-2021-309638 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I got Covid after being vaccinated; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got Covid after being vaccinated) 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 COVID-19 (I got Covid after being vaccinated). At the time of the report, COVID-19 (I got Covid after being vaccinated) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No Concomitant medication was reported.  No treatment medications were reported
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Nausea
Clinical narrative: funny feeling in the stomach; feeling tired; queasy tummy; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (funny feeling in the stomach), FATIGUE (feeling tired) and NAUSEA (queasy tummy) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016M20A and 025J20A) 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) (unknown route) 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 24-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (funny feeling in the stomach), FATIGUE (feeling tired) and NAUSEA (queasy tummy). On 25-Feb-2021, ABDOMINAL DISCOMFORT (funny feeling in the stomach), FATIGUE (feeling tired) and NAUSEA (queasy tummy) had resolved.            No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-309603 (Patient Link).   Reporter did not allow further contact
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: got a first dose of the Moderna vaccine and then got a Pfizer vaccine as a second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (got a first dose of the Moderna vaccine and then got a Pfizer vaccine as a second dose) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (got a first dose of the Moderna vaccine and then got a Pfizer vaccine as a second dose). On 28-Aug-2021, INTERCHANGE OF VACCINE PRODUCTS (got a first dose of the Moderna vaccine and then got a Pfizer vaccine as a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No Treatment medications were provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Inappropriate schedule of product administration, Mass, Myalgia, Pyrexia
Clinical narrative: bumps has gotten worst since yesterday; quarter sizes bumps and a rash all over his body; body aches; fever; got the first dose around June took two months between shots because he wasn't getting out; quarter sizes bumps and a rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of MASS (quarter sizes bumps and a rash all over his body), CONDITION AGGRAVATED (bumps has gotten worst since yesterday), RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062e21a and 027a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced MASS (quarter sizes bumps and a rash all over his body), RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches), PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose around June took two months between shots because he wasn't getting out). On 05-Sep-2021, the patient experienced CONDITION AGGRAVATED (bumps has gotten worst since yesterday). The patient was treated with NAPROXEN SODIUM (ALEVE) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 31-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose around June took two months between shots because he wasn't getting out) had resolved. At the time of the report, MASS (quarter sizes bumps and a rash all over his body) and CONDITION AGGRAVATED (bumps has gotten worst since yesterday) had not resolved and RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            No  Concomitant medications were provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: bumps has gotten worst since yesterday; quarter sizes bumps and a rash all over his body; body aches; fever; got the first dose around June took two months between shots because he wasn't getting out; quarter sizes bumps and a rash all over his body; This spontaneous case was reported by a consumer and describes the occurrence of MASS (quarter sizes bumps and a rash all over his body), CONDITION AGGRAVATED (bumps has gotten worst since yesterday), RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches) and PYREXIA (fever) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062e21a and 027a21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, the patient experienced MASS (quarter sizes bumps and a rash all over his body), RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches), PYREXIA (fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose around June took two months between shots because he wasn't getting out). On 05-Sep-2021, the patient experienced CONDITION AGGRAVATED (bumps has gotten worst since yesterday). The patient was treated with NAPROXEN SODIUM (ALEVE) on 04-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 31-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got the first dose around June took two months between shots because he wasn't getting out) had resolved. At the time of the report, MASS (quarter sizes bumps and a rash all over his body) and CONDITION AGGRAVATED (bumps has gotten worst since yesterday) had not resolved and RASH (quarter sizes bumps and a rash all over his body), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.            No  Concomitant medications were provided.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Myalgia, Product dose omission issue
Clinical narrative: Expose for tree hours to someone with covid19; Haven't taking the second dose yet; Experience a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of EXPOSURE TO SARS-COV-2 (Expose for tree hours to someone with covid19), PRODUCT DOSE OMISSION ISSUE (Haven't taking the second dose yet) and MYALGIA (Experience a sore arm) in a 52-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 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced MYALGIA (Experience a sore arm). On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (Expose for tree hours to someone with covid19) and PRODUCT DOSE OMISSION ISSUE (Haven't taking the second dose yet). At the time of the report, EXPOSURE TO SARS-COV-2 (Expose for tree hours to someone with covid19), PRODUCT DOSE OMISSION ISSUE (Haven't taking the second dose yet) and MYALGIA (Experience a sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication not reported by the reporter. Treatment details was not reported by the reporter. Patient that she had been expose for three hours to someone with covid19, and she wanted to know if she should take the vaccine know.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nervousness, Rash, Skin haemorrhage, Urticaria
Clinical narrative: so nervous about another vaccine; rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock; The buttock area was more like hives; like hives but it bled and scabbed up/ Hives bled/ Hives scabbed; This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (The buttock area was more like hives), SKIN HAEMORRHAGE (like hives but it bled and scabbed up/ Hives bled/ Hives scabbed), NERVOUSNESS (so nervous about another vaccine) and RASH (rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 015M20A) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitive skin (very hypersensitive to every everything), Myalgia and Autoimmune disorder NOS (autoimmune issue). Concomitant products included PREDNISONE for Myalgia and Autoimmune disorder NOS.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIA (The buttock area was more like hives), SKIN HAEMORRHAGE (like hives but it bled and scabbed up/ Hives bled/ Hives scabbed) and RASH (rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock). On an unknown date, the patient experienced NERVOUSNESS (so nervous about another vaccine). At the time of the report, URTICARIA (The buttock area was more like hives) and RASH (rash/hives started on the right arm (Second dose), moved to right side of leg, to the hip and then around to the hip to buttock) had not resolved, SKIN HAEMORRHAGE (like hives but it bled and scabbed up/ Hives bled/ Hives scabbed) had resolved and NERVOUSNESS (so nervous about another vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information included she went to the dermatologist, was prescribed cream, which did not work.   Patient stated she has Rheumatologist appointment for her Myalgia and autoimmune issue.   This case was linked to MOD-2021-309800 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Additional contact information-email ID updated, new event nervousness was added.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vaccination site pain
Clinical narrative: Had difficutly using it for functional activities; Very sore arm in the injection arm after injection; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Very sore arm in the injection arm after injection) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had difficutly using it for functional activities) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination.     Concurrent medical conditions included Cerebral palsy (with an atrophied non-dominant arm).    On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Aug-2021, the patient experienced VACCINATION SITE PAIN (Very sore arm in the injection arm after injection). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had difficutly using it for functional activities). At the time of the report, VACCINATION SITE PAIN (Very sore arm in the injection arm after injection) had resolved and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had difficutly using it for functional activities) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided by reporter. No treatment medications were provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Added Patient Ethnicity, Race information and outcome of event sore arm. Loss of personal independence in daily activities event added.
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: experienced vertigo; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VERTIGO (experienced vertigo) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (experienced vertigo). At the time of the report, VERTIGO (experienced vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No Treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: rapid heart beat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heart beat) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEART RATE INCREASED (rapid heart beat). At the time of the report, HEART RATE INCREASED (rapid heart beat) outcome was unknown.            No concomitant medication were reported. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-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 FATIGUE (tired). At the time of the report, FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.   This case was linked to MOD-2021-310341 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Fatigue, Feeling abnormal, Loss of consciousness
Clinical narrative: Went in to try and wake her up and could not so; Suddenly she felt like she had to sit down; Does not remember anything/  memory seems worse/ forget what she is saying in the middle of a sentence; 2 millimeter cyst on her ovary; Lack of energy; And then threw up; So exhausted that she has to lay down after; Had a 102 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Went in to try and wake her up and could not so) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Had a 102 degree fever). On 25-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Went in to try and wake her up and could not so) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Suddenly she felt like she had to sit down), MEMORY IMPAIRMENT (Does not remember anything/  memory seems worse/ forget what she is saying in the middle of a sentence), OVARIAN CYST (2 millimeter cyst on her ovary), ASTHENIA (Lack of energy), VOMITING (And then threw up) and FATIGUE (So exhausted that she has to lay down after). At the time of the report, LOSS OF CONSCIOUSNESS (Went in to try and wake her up and could not so), FEELING ABNORMAL (Suddenly she felt like she had to sit down), MEMORY IMPAIRMENT (Does not remember anything/  memory seems worse/ forget what she is saying in the middle of a sentence), OVARIAN CYST (2 millimeter cyst on her ovary), ASTHENIA (Lack of energy), VOMITING (And then threw up), PYREXIA (Had a 102 degree fever) and FATIGUE (So exhausted that she has to lay down after) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 102f (High) 102F.         No concomitant medications were provided by the reporter.   Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.   This case was linked to MOD-2021-310293 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Ovarian cyst, Pyrexia, Vomiting
Clinical narrative: Went in to try and wake her up and could not so; Suddenly she felt like she had to sit down; Does not remember anything/  memory seems worse/ forget what she is saying in the middle of a sentence; 2 millimeter cyst on her ovary; Lack of energy; And then threw up; So exhausted that she has to lay down after; Had a 102 degree fever; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Went in to try and wake her up and could not so) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PYREXIA (Had a 102 degree fever). On 25-Jun-2021, the patient experienced LOSS OF CONSCIOUSNESS (Went in to try and wake her up and could not so) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Suddenly she felt like she had to sit down), MEMORY IMPAIRMENT (Does not remember anything/  memory seems worse/ forget what she is saying in the middle of a sentence), OVARIAN CYST (2 millimeter cyst on her ovary), ASTHENIA (Lack of energy), VOMITING (And then threw up) and FATIGUE (So exhausted that she has to lay down after). At the time of the report, LOSS OF CONSCIOUSNESS (Went in to try and wake her up and could not so), FEELING ABNORMAL (Suddenly she felt like she had to sit down), MEMORY IMPAIRMENT (Does not remember anything/  memory seems worse/ forget what she is saying in the middle of a sentence), OVARIAN CYST (2 millimeter cyst on her ovary), ASTHENIA (Lack of energy), VOMITING (And then threw up), PYREXIA (Had a 102 degree fever) and FATIGUE (So exhausted that she has to lay down after) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Apr-2021, Body temperature: 102f (High) 102F.         No concomitant medications were provided by the reporter.   Treatment information was not provided.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.   This case was linked to MOD-2021-310293 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.  More information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Unidentified Adverse event/a side effect that he saw in social media; 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 (Unidentified Adverse event/a side effect that he saw in social media) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Unidentified Adverse event/a side effect that he saw in social media). At the time of the report, VACCINATION COMPLICATION (Unidentified Adverse event/a side effect that he saw in social media) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.