chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) 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.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccination administered after storage guidelines; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccination administered after storage guidelines) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccination administered after storage guidelines). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccination administered after storage guidelines) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was mentioned No treatment medication was mentioned
Sex: U
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Cough; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) 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 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, COUGH (Cough) and OROPHARYNGEAL PAIN (Sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment was reported.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeding disorder, Feeling abnormal, General physical health deterioration, Illness
Clinical narrative: got so sick; felt exhausted; feeling horrible; health rapidly deteriorated; cannot eat; woke up every single day with her hands and muscles clenched; in excruciating pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling horrible), GENERAL PHYSICAL HEALTH DETERIORATION (health rapidly deteriorated), FEEDING DISORDER (cannot eat), MUSCLE TIGHTNESS (woke up every single day with her hands and muscles clenched) and PAIN (in excruciating pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (feeling horrible), GENERAL PHYSICAL HEALTH DETERIORATION (health rapidly deteriorated), FEEDING DISORDER (cannot eat), MUSCLE TIGHTNESS (woke up every single day with her hands and muscles clenched), PAIN (in excruciating pain) and FATIGUE (felt exhausted). On an unknown date, the patient experienced ILLNESS (got so sick). At the time of the report, FEELING ABNORMAL (feeling horrible), GENERAL PHYSICAL HEALTH DETERIORATION (health rapidly deteriorated), FEEDING DISORDER (cannot eat), MUSCLE TIGHTNESS (woke up every single day with her hands and muscles clenched), PAIN (in excruciating pain) and FATIGUE (felt exhausted) outcome was unknown.            Lab data included blood work and result was normal and also included weight decreased on Apr-2021 No relevant concomitant medications were reported. No treatment Information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up document received on 24-JUL-2021 and included event  illness was added.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle tightness, Pain
Clinical narrative: got so sick; felt exhausted; feeling horrible; health rapidly deteriorated; cannot eat; woke up every single day with her hands and muscles clenched; in excruciating pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 13-Jul-2021 and was forwarded to Moderna on 13-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (feeling horrible), GENERAL PHYSICAL HEALTH DETERIORATION (health rapidly deteriorated), FEEDING DISORDER (cannot eat), MUSCLE TIGHTNESS (woke up every single day with her hands and muscles clenched) and PAIN (in excruciating pain) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In April 2021, the patient experienced FEELING ABNORMAL (feeling horrible), GENERAL PHYSICAL HEALTH DETERIORATION (health rapidly deteriorated), FEEDING DISORDER (cannot eat), MUSCLE TIGHTNESS (woke up every single day with her hands and muscles clenched), PAIN (in excruciating pain) and FATIGUE (felt exhausted). On an unknown date, the patient experienced ILLNESS (got so sick). At the time of the report, FEELING ABNORMAL (feeling horrible), GENERAL PHYSICAL HEALTH DETERIORATION (health rapidly deteriorated), FEEDING DISORDER (cannot eat), MUSCLE TIGHTNESS (woke up every single day with her hands and muscles clenched), PAIN (in excruciating pain) and FATIGUE (felt exhausted) outcome was unknown.            Lab data included blood work and result was normal and also included weight decreased on Apr-2021 No relevant concomitant medications were reported. No treatment Information provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow up document received on 24-JUL-2021 and included event  illness was added.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Facial pain, Fatigue, Hypoaesthesia, Malaise, Movement disorder
Clinical narrative: couldn't really move for 3 days; feeling sick; One half of her face Sore and "Drippy"; High Fever; Fatigue; numb and droppy about 20; Prickling/Tingling; Decreased level of conciousness; This spontaneous case was reported by a pharmacist and describes the occurrence of FACIAL PAIN (One half of her face Sore and "Drippy"), HYPOAESTHESIA (numb and droppy about 20), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick) and PARAESTHESIA (Prickling/Tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia, Chronic pain, Rash, Throat swelling and Hives since an unknown date. Concurrent medical conditions included Type 2 diabetes mellitus (T2DM), Hypertension (HTN), GERD, Depression, Drug allergy (Cefoxitin - Hives, Rash) and Drug allergy (Lisinopril - Arrhythmia, swelling of throat). Concomitant products included INSULIN ASPART, INSULIN DETEMIR and GLIPIZIDE for Diabetes mellitus non-insulin-dependent, OMEPRAZOLE for GERD, ATENOLOL and LOSARTAN for Hypertension.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HYPOAESTHESIA (numb and droppy about 20), PARAESTHESIA (Prickling/Tingling) and STUPOR (Decreased level of conciousness). On an unknown date, the patient experienced FACIAL PAIN (One half of her face Sore and "Drippy"), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick), PYREXIA (High Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FACIAL PAIN (One half of her face Sore and "Drippy"), HYPOAESTHESIA (numb and droppy about 20), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick), PARAESTHESIA (Prickling/Tingling), STUPOR (Decreased level of conciousness), PYREXIA (High Fever) and FATIGUE (Fatigue) 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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and Patient demographic, Medical History, Concomitant medication, Adverse events updated.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Pyrexia, Stupor
Clinical narrative: couldn't really move for 3 days; feeling sick; One half of her face Sore and "Drippy"; High Fever; Fatigue; numb and droppy about 20; Prickling/Tingling; Decreased level of conciousness; This spontaneous case was reported by a pharmacist and describes the occurrence of FACIAL PAIN (One half of her face Sore and "Drippy"), HYPOAESTHESIA (numb and droppy about 20), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick) and PARAESTHESIA (Prickling/Tingling) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Arrhythmia, Chronic pain, Rash, Throat swelling and Hives since an unknown date. Concurrent medical conditions included Type 2 diabetes mellitus (T2DM), Hypertension (HTN), GERD, Depression, Drug allergy (Cefoxitin - Hives, Rash) and Drug allergy (Lisinopril - Arrhythmia, swelling of throat). Concomitant products included INSULIN ASPART, INSULIN DETEMIR and GLIPIZIDE for Diabetes mellitus non-insulin-dependent, OMEPRAZOLE for GERD, ATENOLOL and LOSARTAN for Hypertension.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced HYPOAESTHESIA (numb and droppy about 20), PARAESTHESIA (Prickling/Tingling) and STUPOR (Decreased level of conciousness). On an unknown date, the patient experienced FACIAL PAIN (One half of her face Sore and "Drippy"), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick), PYREXIA (High Fever) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, FACIAL PAIN (One half of her face Sore and "Drippy"), HYPOAESTHESIA (numb and droppy about 20), MOVEMENT DISORDER (couldn't really move for 3 days), MALAISE (feeling sick), PARAESTHESIA (Prickling/Tingling), STUPOR (Decreased level of conciousness), PYREXIA (High Fever) and FATIGUE (Fatigue) 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.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received and Patient demographic, Medical History, Concomitant medication, Adverse events updated.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Injection site rash, Myalgia, Pruritus, Pyrexia
Clinical narrative: itching; Rash at the injection site; rash at the injection site which started from the elbow spread to the shoulder, back of the neck; arm hurts; fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), INJECTION SITE RASH (Rash at the injection site), RASH (rash at the injection site which started from the elbow spread to the shoulder, back of the neck), PYREXIA (fever) and MYALGIA (arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) 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 PRURITUS (itching), INJECTION SITE RASH (Rash at the injection site), RASH (rash at the injection site which started from the elbow spread to the shoulder, back of the neck), PYREXIA (fever) and MYALGIA (arm hurts). At the time of the report, PRURITUS (itching), INJECTION SITE RASH (Rash at the injection site), RASH (rash at the injection site which started from the elbow spread to the shoulder, back of the neck) and MYALGIA (arm hurts) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103.         Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: itching; Rash at the injection site; rash at the injection site which started from the elbow spread to the shoulder, back of the neck; arm hurts; fever; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), INJECTION SITE RASH (Rash at the injection site), RASH (rash at the injection site which started from the elbow spread to the shoulder, back of the neck), PYREXIA (fever) and MYALGIA (arm hurts) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) 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 PRURITUS (itching), INJECTION SITE RASH (Rash at the injection site), RASH (rash at the injection site which started from the elbow spread to the shoulder, back of the neck), PYREXIA (fever) and MYALGIA (arm hurts). At the time of the report, PRURITUS (itching), INJECTION SITE RASH (Rash at the injection site), RASH (rash at the injection site which started from the elbow spread to the shoulder, back of the neck) and MYALGIA (arm hurts) outcome was unknown and PYREXIA (fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103.         Concomitant medications were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Muscle weakness; she experienced redness/ covid arm; itching/ covid arm; vaccination site swelling/ covid arm; covid arm/muscle soreness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), VACCINATION SITE ERYTHEMA (she experienced redness/ covid arm), VACCINATION SITE PRURITUS (itching/ covid arm), VACCINATION SITE SWELLING (vaccination site swelling/ covid arm) and MYALGIA (covid arm/muscle soreness) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), VACCINATION SITE ERYTHEMA (she experienced redness/ covid arm), VACCINATION SITE PRURITUS (itching/ covid arm), VACCINATION SITE SWELLING (vaccination site swelling/ covid arm) and MYALGIA (covid arm/muscle soreness). The patient was treated with CORTISONE (topical) at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness), VACCINATION SITE ERYTHEMA (she experienced redness/ covid arm), VACCINATION SITE PRURITUS (itching/ covid arm), VACCINATION SITE SWELLING (vaccination site swelling/ covid arm) and MYALGIA (covid arm/muscle soreness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   This case was linked to MOD-2021-255394.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: All of his joints ached, they hurts so bad.; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (All of his joints ached, they hurts so bad.) 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 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced ARTHRALGIA (All of his joints ached, they hurts so bad.). At the time of the report, ARTHRALGIA (All of his joints ached, they hurts so bad.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use was not provided.  Treatment information was not provided.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Felt light headed; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2021. Concurrent medical conditions included Vertigo (before the COVID the patient was diagnosed with vertigo).    On 10-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 DIZZINESS (Felt light headed). At the time of the report, DIZZINESS (Felt light headed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications included Diabetic medication.   This case was linked to MOD-2021-255400 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Muscular weakness
Clinical narrative: muscle weakness to that left arm; itched really badly; It was red; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (muscle weakness to that left arm), INJECTION SITE PRURITUS (itched really badly) and INJECTION SITE ERYTHEMA (It was red) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, the patient experienced MUSCULAR WEAKNESS (muscle weakness to that left arm), INJECTION SITE PRURITUS (itched really badly) and INJECTION SITE ERYTHEMA (It was red). The patient was treated with HYDROCORTISONE (CORTISONE [HYDROCORTISONE]) for Itching and Swelling, at an unspecified dose and frequency. At the time of the report, MUSCULAR WEAKNESS (muscle weakness to that left arm), INJECTION SITE PRURITUS (itched really badly) and INJECTION SITE ERYTHEMA (It was red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported No treatment information were provided   This case was linked to MOD-2021-255382 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: cough; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough) and OROPHARYNGEAL PAIN (sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Jul-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 COUGH (cough) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, COUGH (cough) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of tinnitus in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot#  unknown) for COVID-19  immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jul 13, 2021, patient experienced tinnitus. At the time of the report, tinnitus outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information reported.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Decreased activity, Decreased appetite, Dizziness, Dysstasia
Clinical narrative: Felt light headed; Vertigo got worse; Couldn't stand up; Couldn't do normal job/ attempting to get short term disability from his job; Couldn't walk; Couldn't eat food; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job) and GAIT DISTURBANCE (Couldn't walk) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021. Concurrent medical conditions included Diabetes.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-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 DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Couldn't eat food) and CHEST PAIN (chest pain). At the time of the report, DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Couldn't eat food) and CHEST PAIN (chest pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for diabetic. Treatment included motion sickness pills for dizziness and Brea inhaler for his chest.   This case was linked to MOD-2021-255387 (Patient Link).
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Vertigo
Clinical narrative: Felt light headed; Vertigo got worse; Couldn't stand up; Couldn't do normal job/ attempting to get short term disability from his job; Couldn't walk; Couldn't eat food; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job) and GAIT DISTURBANCE (Couldn't walk) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in April 2021. Concurrent medical conditions included Diabetes.   On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jun-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 DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Couldn't eat food) and CHEST PAIN (chest pain). At the time of the report, DIZZINESS (Felt light headed), VERTIGO (Vertigo got worse), DYSSTASIA (Couldn't stand up), DECREASED ACTIVITY (Couldn't do normal job/ attempting to get short term disability from his job), GAIT DISTURBANCE (Couldn't walk), DECREASED APPETITE (Couldn't eat food) and CHEST PAIN (chest pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included medication for diabetic. Treatment included motion sickness pills for dizziness and Brea inhaler for his chest.   This case was linked to MOD-2021-255387 (Patient Link).
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Dizziness, Feeling hot, Vaccination site pain
Clinical narrative: Pain when he stands up; Dizzy; Pain where his bones join; Pain in his back; Pain in his arm; Feels hot inside; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), BONE PAIN (Pain where his bones join), BACK PAIN (Pain in his back), VACCINATION SITE PAIN (Pain in his arm) and FEELING HOT (Feels hot inside) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A and 008D2VA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 12-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jul-2021, the patient experienced DIZZINESS (Dizzy), BONE PAIN (Pain where his bones join), BACK PAIN (Pain in his back), VACCINATION SITE PAIN (Pain in his arm) and FEELING HOT (Feels hot inside). On an unknown date, the patient experienced BONE PAIN (Pain when he stands up). At the time of the report, DIZZINESS (Dizzy), BONE PAIN (Pain where his bones join), BACK PAIN (Pain in his back), VACCINATION SITE PAIN (Pain in his arm), FEELING HOT (Feels hot inside) and BONE PAIN (Pain when he stands up) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: three months later feels exactly same symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (three months later feels exactly same symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-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 16-Mar-2021, the patient experienced VACCINATION COMPLICATION (three months later feels exactly same symptoms). At the time of the report, VACCINATION COMPLICATION (three months later feels exactly same symptoms) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Product dose omission issue, Vaccination site pain
Clinical narrative: Local soreness/tenderness around injection site; Brief fatigue; Unable to get our second dose;  First dose was 23 April; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Unable to get our second dose;  First dose was 23 April), VACCINATION SITE PAIN (Local soreness/tenderness around injection site) and FATIGUE (Brief fatigue) 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 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Unable to get our second dose;  First dose was 23 April). On an unknown date, the patient experienced VACCINATION SITE PAIN (Local soreness/tenderness around injection site) and FATIGUE (Brief fatigue). On 13-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Unable to get our second dose;  First dose was 23 April) had resolved. At the time of the report, VACCINATION SITE PAIN (Local soreness/tenderness around injection site) and FATIGUE (Brief fatigue) outcome was unknown.            Patient has stated that they were received their first dose on 23 April and unable to got their second dose and  they have got opportunity to get their second dose on 14 may and also stated that should they plan for third dose. The only reactions that can be noted after dose 1 were Local soreness or tenderness around injection site and Brief fatigue less than 24 hours. No concomitant and treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Additional information was received on 29-JUL-2021, New events were added
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Never got his 2nd shot; Tested positive for Covid; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Never got his 2nd shot) and COVID-19 (Tested positive for Covid) 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 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 (Never got his 2nd shot) and COVID-19 (Tested positive for Covid). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Never got his 2nd shot) had resolved and COVID-19 (Tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive positive (Positive) Tested positive for COVID..     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 and treatment medications were reported.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired Vaccine Administered to a Patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to a Patient) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to a Patient). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine Administered to a Patient) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Mild Flu like symptoms; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (Mild Flu like symptoms) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Mild Flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (Mild Flu like symptoms) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant product reported by reporter. No treatment medication reported by reporter.   This case was linked to MOD-2021-023022 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Moderna Vaccine administered after Pfizer vaccine administered; This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Moderna Vaccine administered after Pfizer vaccine administered) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     Previously administered products included for an unreported indication: PFIZER BIONTECH COVID-19 VACCINE in February 2021.    On 02-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Moderna Vaccine administered after Pfizer vaccine administered). On 02-Jul-2021, INTERCHANGE OF VACCINE PRODUCTS (Moderna Vaccine administered after Pfizer vaccine administered) had resolved.        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 medications and no treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up Information received contains no new information
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Confusional state, Fatigue, Feeling abnormal, Feeling hot
Clinical narrative: hives; weird nightmares; feeling hot; confused; itchiness; a lot of pain; weak; extreme headaches; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused) and PRURITUS (itchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused), PRURITUS (itchiness), PAIN (a lot of pain), ASTHENIA (weak), HEADACHE (extreme headaches), MYALGIA (body aches) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused), PRURITUS (itchiness), PAIN (a lot of pain), ASTHENIA (weak), HEADACHE (extreme headaches), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Pruritus, Urticaria
Clinical narrative: hives; weird nightmares; feeling hot; confused; itchiness; a lot of pain; weak; extreme headaches; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused) and PRURITUS (itchiness) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused), PRURITUS (itchiness), PAIN (a lot of pain), ASTHENIA (weak), HEADACHE (extreme headaches), MYALGIA (body aches) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives), FEELING ABNORMAL (weird nightmares), FEELING HOT (feeling hot), CONFUSIONAL STATE (confused), PRURITUS (itchiness), PAIN (a lot of pain), ASTHENIA (weak), HEADACHE (extreme headaches), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for Covid) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy NOS (Severe allergies).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jul-2021, the patient experienced COVID-19 (tested positive for Covid). At the time of the report, COVID-19 (tested positive for Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jul-2021, SARS-CoV-2 test: positive (Positive) Positive.         No concomitant medications were reported. No treatment medications were reported.  Action taken with mRNA-1273 in response to the event was not applicable.   Reporter did not allow further contact
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. RA6059) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (With the first one had a ripping sensation on my bicep" then clarified "is not on the shot site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided.  Treatment information was Healing peptides and BPC 157   This case was linked to MOD-2021-255606 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline; Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It) and UNDERDOSE (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1.8 ml. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jul-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It). On an unknown date, the patient experienced UNDERDOSE (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline). At the time of the report, PRODUCT ADMINISTRATION ERROR (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline. It) and UNDERDOSE (Diluted the Moderna COVID 19 vaccine that was given to a patient with 1.8 mL of normal saline) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided Treatment information was not provided
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: covid-19; sick; This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (covid-19) and ILLNESS (sick) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     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 COVID-19 (covid-19) and ILLNESS (sick). At the time of the report, COVID-19 (covid-19) and ILLNESS (sick) 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 medications reported. Treatment included- Antibody treatment, Z-pack