chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of rash and pruritus (itching on her arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 006C21A and 037C21A) for COVID-19 immunization. No medical history reported. On Apr 21, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 22, 2021, patient experienced rash and pruritus (itching on her arm). At the time of the report, rash and pruritus (itching on her arm) outcome: unknown. No concomitant and treatment medications provided.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products, Product administration error
Clinical narrative: Patient Received the Janssen COVID-19 Vaccine as the 2nd dose; Patient Received the Janssen COVID-19 Vaccine as the 2nd dose, after receiving Moderna for; 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 (Patient Received the Janssen COVID-19 Vaccine as the 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient Received the Janssen COVID-19 Vaccine as the 2nd dose, after receiving Moderna for) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product COVID-19 VACCINE for COVID-19 immunisation.    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 and second dose of COVID-19 VACCINE (unknown route) 1. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (Patient Received the Janssen COVID-19 Vaccine as the 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient Received the Janssen COVID-19 Vaccine as the 2nd dose, after receiving Moderna for). At the time of the report, PRODUCT ADMINISTRATION ERROR (Patient Received the Janssen COVID-19 Vaccine as the 2nd dose) and INTERCHANGE OF VACCINE PRODUCTS (Patient Received the Janssen COVID-19 Vaccine as the 2nd dose, after receiving Moderna for) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications reported No concomitant medications reported
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) in a 79-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 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 23-May-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant products and treatment medication were reported. The patient reported that she was home-bound . After getting the jab She could not get to her vaccination card to give the rest of the information. She had not taken medication but had eaten foods related to easing diarrhea. She had not seen her doctor.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-JUN-2021. Follow up contains no new information
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar high; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLOOD GLUCOSE INCREASED (blood sugar high) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BLOOD GLUCOSE INCREASED (blood sugar high). At the time of the report, BLOOD GLUCOSE INCREASED (blood sugar high) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: high (High) high.         No concomitant medications were reported.  No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Muscle pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Muscle pain). At the time of the report, MYALGIA (Muscle pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants included. No Treatment was included.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash; 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 RASH (Rash) in a patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced RASH (Rash). At the time of the report, RASH (Rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: Axillar pain after second dose; 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 AXILLARY PAIN (Axillar pain after second dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced AXILLARY PAIN (Axillar pain after second dose). At the time of the report, AXILLARY PAIN (Axillar pain after second dose) outcome was unknown.            No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site pain
Clinical narrative: Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine; Arm sore after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine) and VACCINATION SITE PAIN (Arm sore after vaccine) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030a21a and 019b21a) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy. Concurrent medical conditions included Arthritis since 2003 and Blood pressure abnormal (Under control with Meds). Concomitant products included QUINAPRIL HYDROCHLORIDE (ACCUPRIL), ALLOPURINOL, VITAMIN B12 NOS, COENZYME Q10 [UBIDECARENONE], VITAMIN D NOS and CELECOXIB (CELEBREX) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced SKIN DISCOLOURATION (Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine) and VACCINATION SITE PAIN (Arm sore after vaccine). The patient was treated with ARNICA MONTANA FLOWER, CERAMIDE, GLYCOLIC ACID, NICOTINAMIDE, PHYTOMENADIONE, RETINOL (DERMEND MOISTURIZING BRUISE FORMULA) for Adverse event, at an unspecified dose and frequency. In June 2021, SKIN DISCOLOURATION (Top of arm black and blue after vaccine/ Arm looks like it has broken blood vessel after vaccine) and VACCINATION SITE PAIN (Arm sore after vaccine) had resolved.            The patient post receiving their both doses of the Moderna COVID-19 vaccine has felt fine until the beginning of last week. The patient reported that their left arm where they received the vaccine was sore and looked like it had a broken blood vessel. The patient said the affected area was towards the top of their shoulder that was higher than the vaccine site and the top of their arm was now black and blue. The patient also reported that it has been almost 2 months since the patient received the 2nd dose.  On 30-Jun-2021, the patient informed that approximately, month to two months after the second dose, the patient noticed a large black and blue mark from top of their left shoulder to elbow and their arm was sore. The patient treated with dermend and it decreased and turned yellow and then vanished. The patient felt some soreness and that was all.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up was received on 30-Jun-2021. Updated the patient demographics. Added Medical history of the patient.  Added the concomitant medications and Treatment information. Updated the event outcome.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: received 1st moderna vaccine on 4/7/21.; 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 PRODUCT DOSE OMISSION ISSUE (received 1st moderna vaccine on 4/7/21.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (received 1st moderna vaccine on 4/7/21.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (received 1st moderna vaccine on 4/7/21.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Red rash about 3inches; Itching; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Red rash about 3inches) and PRURITUS (Itching) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 13L20A) for COVID-19 vaccination.     Concurrent medical conditions included Contrast media allergy.   On 16-Jan-2021 at 8:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021 at 8:00 AM, 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 RASH ERYTHEMATOUS (Red rash about 3inches) and PRURITUS (Itching). At the time of the report, RASH ERYTHEMATOUS (Red rash about 3inches) and PRURITUS (Itching) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications was provided by the reporter.  No Treatment medications was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Added allergy, patient height, weight and race information. Added 1st dose information, batch number and date of second dose
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Fatigue) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017c21a and 007c21a) for COVID-19 vaccination.     Concurrent medical conditions included Panic attacks (in treatment), Anxiety (in treatment) and Blood pressure high (occasionally take high blood pressure medication). Concomitant products included CITALOPRAM for Anxiety, METOPROLOL for Blood pressure management.   On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-May-2021, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Feel like got the flu; 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 INFLUENZA (Feel like got the flu) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Feel like got the flu). At the time of the report, INFLUENZA (Feel like got the flu) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in the injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (soreness in the injection site) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness in the injection site). On 12-Feb-2021, VACCINATION SITE PAIN (soreness in the injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided by the reporter and no concomitant medication reported.   This case was linked to MOD-2021-163394 (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 event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Illness, Muscle spasms, Myalgia, Pain in extremity
Clinical narrative: Several leg cramps; Pain in my right leg; Was so ill; Fever; Chills; Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Several leg cramps), PAIN IN EXTREMITY (Pain in my right leg), ILLNESS (Was so ill), PYREXIA (Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 MUSCLE SPASMS (Several leg cramps), PAIN IN EXTREMITY (Pain in my right leg), ILLNESS (Was so ill), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, MUSCLE SPASMS (Several leg cramps) outcome was unknown, PAIN IN EXTREMITY (Pain in my right leg) had not resolved and ILLNESS (Was so ill), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) was resolving.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. On an unspecified date, an ultrasound was done.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Several leg cramps; Pain in my right leg; Was so ill; Fever; Chills; Body aches; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE SPASMS (Several leg cramps), PAIN IN EXTREMITY (Pain in my right leg), ILLNESS (Was so ill), PYREXIA (Fever) and CHILLS (Chills) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 MUSCLE SPASMS (Several leg cramps), PAIN IN EXTREMITY (Pain in my right leg), ILLNESS (Was so ill), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, MUSCLE SPASMS (Several leg cramps) outcome was unknown, PAIN IN EXTREMITY (Pain in my right leg) had not resolved and ILLNESS (Was so ill), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) was resolving.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable. On an unspecified date, an ultrasound was done.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination site erythema, Vaccination site reaction
Clinical narrative: COVID Arm; redness; fever mid day of 101; 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 SITE REACTION (COVID Arm), PYREXIA (fever mid day of 101) and VACCINATION SITE ERYTHEMA (redness) in a 52-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 20-May-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 21-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PYREXIA (fever mid day of 101). On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID Arm) and VACCINATION SITE ERYTHEMA (redness). At the time of the report, VACCINATION SITE REACTION (COVID Arm) and VACCINATION SITE ERYTHEMA (redness) had not resolved and PYREXIA (fever mid day of 101) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Body temperature: 101 (High) 101.         No concomitant medications were reported. No treatment details were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm after first shot) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced MYALGIA (Sore arm after first shot). At the time of the report, MYALGIA (Sore arm after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment medication was not  provided. Concomitant product use was not provided by the reporter. This case was linked to MOD-2021-163385 (Patient Link).   This case was linked to MOD-2021-163385 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Quite sick from the first vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Quite sick from the first vaccine) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Quite sick from the first vaccine). At the time of the report, VACCINATION COMPLICATION (Quite sick from the first vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications and treatment medications were not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: aching arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (aching arm) in a patient of an unknown age and gender 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) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (aching arm). At the time of the report, PAIN IN EXTREMITY (aching arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information was provided. No treatment medication information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got 2nd shot after 3 weeks; 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd shot after 3 weeks) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd shot after 3 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got 2nd shot after 3 weeks) had resolved.            No concomitant medications were reported.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Heart rate, Pain in extremity, Pyrexia
Clinical narrative: I was catching my breath; Fever; Chills; after second shot, sore arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (I was catching my breath), PAIN IN EXTREMITY (after second shot, sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032b21A and 038A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in April 2020.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced PAIN IN EXTREMITY (after second shot, sore arm). On 10-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 12-Apr-2021, the patient experienced DYSPNOEA (I was catching my breath). On 17-Apr-2021, DYSPNOEA (I was catching my breath) had resolved. At the time of the report, PAIN IN EXTREMITY (after second shot, sore arm), PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Heart rate: 95-45 (abnormal) Heart rate was fluctuating as monitored by watch..         Concomitant product use was not provided.   Treatment information was not provided.   This case was linked to MOD-2021-163379 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up received and included updated event terms and lab data. On 25-Jul-2021: Follow up received and contains No new information.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: neck to toe joint pain; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (neck to toe joint pain) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (neck to toe joint pain). At the time of the report, ARTHRALGIA (neck to toe joint pain) outcome was unknown.            Concomitant product details was not reported.  Treatment details was not reported .
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Weird metal taste; 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 DYSGEUSIA (Weird metal taste) 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 DYSGEUSIA (Weird metal taste). At the time of the report, DYSGEUSIA (Weird metal taste) 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: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Myalgia, Nausea
Clinical narrative: flu like symptoms; joint pains; extreme tiredness; muscle aches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pains), FATIGUE (extreme tiredness), MYALGIA (muscle aches) and NAUSEA (nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pains), FATIGUE (extreme tiredness), MYALGIA (muscle aches) and NAUSEA (nausea). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), ARTHRALGIA (joint pains), FATIGUE (extreme tiredness), MYALGIA (muscle aches) and NAUSEA (nausea) outcome was unknown.            The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicable. No Relevant concomitant medications were reported. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; 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 AGEUSIA (loss of taste) 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 20-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste). At the time of the report, AGEUSIA (loss of taste) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information and concomitant medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Why does the body feel strange or weird after having the first vaccination; 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 FEELING ABNORMAL (Why does the body feel strange or weird after having the first vaccination) in a patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Why does the body feel strange or weird after having the first vaccination). At the time of the report, FEELING ABNORMAL (Why does the body feel strange or weird after having the first vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The treatment medicines relevant to events were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sickness; 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 ILLNESS (sickness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sickness). At the time of the report, ILLNESS (sickness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Pyrexia, Urticaria, Vaccination site swelling
Clinical narrative: Allergy, with red dots around the hole body; Swelling of the arm where the injection was given; Experience fever; Hives; Pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives), PAIN IN EXTREMITY (Pain in the arm), HYPERSENSITIVITY (Allergy, with red dots around the hole body), VACCINATION SITE SWELLING (Swelling of the arm where the injection was given) and PYREXIA (Experience fever) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, the patient experienced URTICARIA (Hives), PAIN IN EXTREMITY (Pain in the arm) and PYREXIA (Experience fever). On 23-May-2021, the patient experienced HYPERSENSITIVITY (Allergy, with red dots around the hole body) and VACCINATION SITE SWELLING (Swelling of the arm where the injection was given). On 23-May-2021, URTICARIA (Hives), PAIN IN EXTREMITY (Pain in the arm) and PYREXIA (Experience fever) had resolved. At the time of the report, HYPERSENSITIVITY (Allergy, with red dots around the hole body) and VACCINATION SITE SWELLING (Swelling of the arm where the injection was given) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported. No treatment was reported.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue
Clinical narrative: Sometime trouble breathing; Suffering from fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Sometime trouble breathing) and FATIGUE (Suffering from fatigue) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Sometime trouble breathing) and FATIGUE (Suffering from fatigue). At the time of the report, DYSPNOEA (Sometime trouble breathing) and FATIGUE (Suffering from fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Cough, Fatigue, Pyrexia
Clinical narrative: severe chronic cough; pain in the stomach; fatigue; slight fever; pain in the joints; pain in the injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of COUGH (severe chronic cough), ABDOMINAL PAIN UPPER (pain in the stomach), FATIGUE (fatigue), PYREXIA (slight fever) and ARTHRALGIA (pain in the joints) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (pain in the stomach), FATIGUE (fatigue), PYREXIA (slight fever), ARTHRALGIA (pain in the joints) and VACCINATION SITE PAIN (pain in the injection site). On 17-Mar-2021, the patient experienced COUGH (severe chronic cough). On 11-Mar-2021, ABDOMINAL PAIN UPPER (pain in the stomach), FATIGUE (fatigue), PYREXIA (slight fever), ARTHRALGIA (pain in the joints) and VACCINATION SITE PAIN (pain in the injection site) had resolved. At the time of the report, COUGH (severe chronic cough) had not resolved.            Concomitant medication was not reported.  Treatment information was not reported.   This case was linked to MOD-2021-163376 (Patient Link).
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: severe chronic cough; pain in the stomach; fatigue; slight fever; pain in the joints; pain in the injection site; This spontaneous case was reported by an other caregiver and describes the occurrence of COUGH (severe chronic cough), ABDOMINAL PAIN UPPER (pain in the stomach), FATIGUE (fatigue), PYREXIA (slight fever) and ARTHRALGIA (pain in the joints) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (pain in the stomach), FATIGUE (fatigue), PYREXIA (slight fever), ARTHRALGIA (pain in the joints) and VACCINATION SITE PAIN (pain in the injection site). On 17-Mar-2021, the patient experienced COUGH (severe chronic cough). On 11-Mar-2021, ABDOMINAL PAIN UPPER (pain in the stomach), FATIGUE (fatigue), PYREXIA (slight fever), ARTHRALGIA (pain in the joints) and VACCINATION SITE PAIN (pain in the injection site) had resolved. At the time of the report, COUGH (severe chronic cough) had not resolved.            Concomitant medication was not reported.  Treatment information was not reported.   This case was linked to MOD-2021-163376 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Headache, Influenza like illness
Clinical narrative: flu like symptoms that are off and on; hell my headache; 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 INFLUENZA LIKE ILLNESS (flu like symptoms that are off and on) and HEADACHE (hell my headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 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 INFLUENZA LIKE ILLNESS (flu like symptoms that are off and on) and HEADACHE (hell my headache). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms that are off and on) and HEADACHE (hell my headache) outcome was unknown.            No concomitant medications were reported. No treatment details were reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Missed second dose (11 weeks since first dose); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed second dose (11 weeks since first dose)) 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 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed second dose (11 weeks since first dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose (11 weeks since first dose)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient couldn't take second dose of vaccine due to Bypass surgery. No concomitant medications and treatment information were reported.
Sex: U
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: itchy; rashes; 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 PRURITUS (itchy) and RASH (rashes) 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 PRURITUS (itchy) and RASH (rashes). At the time of the report, PRURITUS (itchy) and RASH (rashes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Gave 3 individuals expired vaccination; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a hospital service technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave 3 individuals expired vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C2A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave 3 individuals expired vaccination). On 23-May-2021, EXPIRED PRODUCT ADMINISTERED (Gave 3 individuals expired vaccination) 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 were reported. No treatment information was provided. pharmacist accidently gave and expired vaccine to 3 individuals and the  Pharmacist asked about the stability of the one day expired dose and if a thrid vaccination is required.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient got both dose of vaccine; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got both dose of vaccine) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033C21A and 033C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got both dose of vaccine). On 22-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 year old patient got both dose of 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 medications were provided. Treatment medications were unknown.  Patient has not reported any symptoms.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: Dose 2 details recieved
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got both Moderna vaccine shots but recently tested for Covid positive again; 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 COVID-19 (Got both Moderna vaccine shots but recently tested for Covid positive again) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   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 COVID-19 (Got both Moderna vaccine shots but recently tested for Covid positive again). At the time of the report, COVID-19 (Got both Moderna vaccine shots but recently tested for Covid positive again) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive.         Patient received both the Moderna vaccine shots but recently tested for COVID positive. It was reported that patient did not felt ill and was told to quarantine. No concomitant medications were reported. No treatment details were reported.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: my body aches in joint pain all over; joint pain all over; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (my body aches in joint pain all over) and ARTHRALGIA (joint pain all over) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On an unknown date, the patient experienced MYALGIA (my body aches in joint pain all over) and ARTHRALGIA (joint pain all over). At the time of the report, MYALGIA (my body aches in joint pain all over) and ARTHRALGIA (joint pain all over) outcome was unknown.            Concomitant medications were not provided.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: got covid on april 7; sick till April 26; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (got covid on april 7) and ILLNESS (sick till April 26) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history provided.     On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced COVID-19 (got covid on april 7) and ILLNESS (sick till April 26). On 26-Apr-2021, COVID-19 (got covid on april 7) and ILLNESS (sick till April 26) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Treatment information was not provided.