chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Influenza like illness, Pyrexia
Clinical narrative: Flu like symptoms; After the first dose he ran low grade temperature of 101 for 24 hours; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-May-2021 and was forwarded to Moderna on 26-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (After the first dose he ran low grade temperature of 101 for 24 hours) and HEADACHE (Headache) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 pneumonia on 03-Nov-2020. Concomitant products included FINASTERIDE for an unknown indication.    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (After the first dose he ran low grade temperature of 101 for 24 hours) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (After the first dose he ran low grade temperature of 101 for 24 hours) and HEADACHE (Headache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 101 (High) Increased.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was Hospitalized, was admitted in the  intensive Care Unit for 5 days, critical care unit for 1 day.  Other Procedures: Blood and fluid drainage from the brain, physical therapy, MRI, Scan.    Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: From TCR Report: Patient denied for the further follow-up
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Soreness; 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 (Soreness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (Soreness). At the time of the report, MYALGIA (Soreness) outcome was unknown.            No concomitant product use was provided by the reporter.  No treatment medication was provided.   The patient reported adverse event via chatbot.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Vaccination site pain
Clinical narrative: Soreness persist in the muscle almost a month; soreness moved down to the left forearm; soreness moved down to the elbow; soreness in the left arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness moved down to the left forearm), VACCINATION SITE PAIN (soreness in the left arm at the injection site), ARTHRALGIA (soreness moved down to the elbow) and MYALGIA (Soreness persist in the muscle almost a month) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 040B21A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN (ALVASTATIN) for Cholesterol, ALLOPURINOL for Gout.   On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (soreness in the left arm at the injection site). On 23-May-2021, the patient experienced ARTHRALGIA (soreness moved down to the elbow). On 26-May-2021, the patient experienced VACCINATION SITE PAIN (soreness moved down to the left forearm). On an unknown date, the patient experienced MYALGIA (Soreness persist in the muscle almost a month). The patient was treated with IBUPROFEN for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (soreness moved down to the left forearm), VACCINATION SITE PAIN (soreness in the left arm at the injection site), ARTHRALGIA (soreness moved down to the elbow) and MYALGIA (Soreness persist in the muscle almost a month) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR received on 9-Jun-2021 contains significant information. The outcome of events were reported as recovered.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort, Muscle spasms
Clinical narrative: right foot is dragging; muscle spasms; 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 LIMB DISCOMFORT (right foot is dragging) and MUSCLE SPASMS (muscle spasms) 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) 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (right foot is dragging) and MUSCLE SPASMS (muscle spasms). At the time of the report, LIMB DISCOMFORT (right foot is dragging) and MUSCLE SPASMS (muscle spasms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Lymphadenopathy, Mass
Clinical narrative: anxiety; shortness of breath; woke up with lump under her left arm; woke up with lump under her left arm It's like a lymph node; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (anxiety), DYSPNOEA (shortness of breath), MASS (woke up with lump under her left arm) and LYMPHADENOPATHY (woke up with lump under her left arm It's like a lymph node) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Cancer surgery (Patient had left breast cancer surgery done in 2010; only one of the duct. It was removed,treated, and now fine.). Concurrent medical conditions included Depression (got really bad depression during lockdown). Concomitant products included LOSARTAN for Hypertension, Syntroid, FOLIC ACID, VITAMIN D3, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced ANXIETY (anxiety), DYSPNOEA (shortness of breath), MASS (woke up with lump under her left arm) and LYMPHADENOPATHY (woke up with lump under her left arm It's like a lymph node). At the time of the report, ANXIETY (anxiety), DYSPNOEA (shortness of breath), MASS (woke up with lump under her left arm) and LYMPHADENOPATHY (woke up with lump under her left arm It's like a lymph node) outcome was unknown.            Patient reported that she had to go the ER. Her son is a pharmacist who took her. They did CT scans, draw blood every 2 hours, did a lot of tests. They didn't see anything. On 21-Apr-2021, she went to see oncologist for a regular appointment. He noticed the lump. He wanted to see her in 5 weeks.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: its been 7 weeks since patient got the first dose and still has not got the second dose; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (its been 7 weeks since patient got the first dose and still has not got the second dose) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) 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 26-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (its been 7 weeks since patient got the first dose and still has not got the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (its been 7 weeks since patient got the first dose and still has not got the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased
Clinical narrative: Temperature; 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 BODY TEMPERATURE INCREASED (Temperature) 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 BODY TEMPERATURE INCREASED (Temperature). At the time of the report, BODY TEMPERATURE INCREASED (Temperature) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant list is provided. No treatment is provided.  Company Comment: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.; Sender's Comments: This is an invalid case due to no identifiable patient. Also, very limited information regarding the event has been provided at this time.
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine, SARS-CoV-2 test
Clinical narrative: I got a allergic reaction; This spontaneous case was reported by a patient and describes the occurrence of ALLERGY TO VACCINE (I got a allergic reaction) 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 ALLERGY TO VACCINE (I got a allergic reaction). At the time of the report, ALLERGY TO VACCINE (I got a allergic reaction) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID Diagnosis.         No treatment information provided by the reporter. No  concomitant medical  provided by the reporter.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu-like symptoms; pain and achiness all over; incredible fatigue/extreme fatigue for at least 2-3 days every week/felt so tired all the time; fever of 101.5 degrees Fahrenheit; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (pain and achiness all over), FATIGUE (incredible fatigue/extreme fatigue for at least 2-3 days every week/felt so tired all the time) and PYREXIA (fever of 101.5 degrees Fahrenheit) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 27A21A and 012M20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR), MULTIVITAMINS [VITAMINS NOS] and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (pain and achiness all over), FATIGUE (incredible fatigue/extreme fatigue for at least 2-3 days every week/felt so tired all the time) and PYREXIA (fever of 101.5 degrees Fahrenheit). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), MYALGIA (pain and achiness all over), FATIGUE (incredible fatigue/extreme fatigue for at least 2-3 days every week/felt so tired all the time) and PYREXIA (fever of 101.5 degrees Fahrenheit) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Body temperature: 101.5f (High) fever of 101.5 degrees Fahrenheit.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (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) (Intramuscular) dosage form. On an unknown date, the patient experienced PYREXIA (fever). At the time of the report, PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm, months later; 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 PAIN IN EXTREMITY (sore arm, months later) 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 PAIN IN EXTREMITY (sore arm, months later). At the time of the report, PAIN IN EXTREMITY (sore arm, months later) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no treatment concomitant medication reported.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Induration, Influenza like illness, Pain in extremity, Ultrasound scan
Clinical narrative: Second dose experienced pain in the feet and went to ER; Red 2 inch round spot which felt hard to touch; Red 2 inch round spot which felt hard to touch; Bad flu like symptoms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Bad flu like symptoms), PAIN IN EXTREMITY (Second dose experienced pain in the feet and went to ER), ERYTHEMA (Red 2 inch round spot which felt hard to touch) and INDURATION (Red 2 inch round spot which felt hard to touch) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 043B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METOPROLOL for Blood pressure, POTASSIUM for an unknown indication.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced INFLUENZA LIKE ILLNESS (Bad flu like symptoms). On 15-May-2021, the patient experienced ERYTHEMA (Red 2 inch round spot which felt hard to touch) and INDURATION (Red 2 inch round spot which felt hard to touch). On 17-May-2021, the patient experienced PAIN IN EXTREMITY (Second dose experienced pain in the feet and went to ER). At the time of the report, INFLUENZA LIKE ILLNESS (Bad flu like symptoms), PAIN IN EXTREMITY (Second dose experienced pain in the feet and went to ER), ERYTHEMA (Red 2 inch round spot which felt hard to touch) and INDURATION (Red 2 inch round spot which felt hard to touch) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Ultrasound scan: normal (normal) No blood clots were detected.         Treatment information included paracetamol given by doctor but the patient did not take it. Action taken with mRNA-1273 in response to the events was not applicable. The patient was also tested for electrolytes and the result was normal   This case was linked to MOD-2021-177506 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had a reaction after the second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a reaction after the second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a reaction after the second shot). At the time of the report, VACCINATION COMPLICATION (Had a reaction after the second shot) outcome was unknown.            No concomitant medications provided No treatment medications provided
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itching; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itching). At the time of the report, PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-177909 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: magnet stick to her arm, placed the magnet on her arm and wiggles it around and the magnet sticks, magnetic forces having an affect on her heart and other body parts; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (magnet stick to her arm, placed the magnet on her arm and wiggles it around and the magnet sticks, magnetic forces having an affect on her heart and other body parts) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION COMPLICATION (magnet stick to her arm, placed the magnet on her arm and wiggles it around and the magnet sticks, magnetic forces having an affect on her heart and other body parts). At the time of the report, VACCINATION COMPLICATION (magnet stick to her arm, placed the magnet on her arm and wiggles it around and the magnet sticks, magnetic forces having an affect on her heart and other body parts) outcome was unknown.            Concomitant information use was not reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: Follow up source document contains No New Information
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Can you take for pain from the shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Can you take for pain from the shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Can you take for pain from the shot). At the time of the report, VACCINATION SITE PAIN (Can you take for pain from the shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication included.  No treatment medication included.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Feeling hot, Insomnia, Myalgia
Clinical narrative: weakness but going inch by inch down her arm; Area warm to the touch; Woke up in middle of the nigh; Swelling at injection site; Pain at injection site; Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm; pain moving down her arm/elbow area; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema, Accident in 1979, Wrist injury (Broke left wrist near the palm) and Hip injury. Concurrent medical conditions included Polycystic ovarian syndrome, Thyroid disorder, Sjogren's syndrome, Lupus syndrome and Asthma. Concomitant products included LEVOTHYROXINE and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm) and ARTHRALGIA (pain moving down her arm/elbow area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm) and ARTHRALGIA (pain moving down her arm/elbow area) 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.   Patient was born with DES (diethylstilbestrol) exposure. Patient had issues when she was born. Patient never got period when teenager and also never able to get pregnant.   This case was linked to MOD-2021-177941 (Patient Link).
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: weakness but going inch by inch down her arm; Area warm to the touch; Woke up in middle of the nigh; Swelling at injection site; Pain at injection site; Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm; pain moving down her arm/elbow area; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site) and VACCINATION SITE PAIN (Pain at injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Eczema, Accident in 1979, Wrist injury (Broke left wrist near the palm) and Hip injury. Concurrent medical conditions included Polycystic ovarian syndrome, Thyroid disorder, Sjogren's syndrome, Lupus syndrome and Asthma. Concomitant products included LEVOTHYROXINE and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm) and ARTHRALGIA (pain moving down her arm/elbow area). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness but going inch by inch down her arm), FEELING HOT (Area warm to the touch), INSOMNIA (Woke up in middle of the nigh), VACCINATION SITE SWELLING (Swelling at injection site), VACCINATION SITE PAIN (Pain at injection site), MYALGIA (Arm hurts/ proceeded to get worse/ throbbing started/ muscle pain/ but going inch by inch down her arm) and ARTHRALGIA (pain moving down her arm/elbow area) 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.   Patient was born with DES (diethylstilbestrol) exposure. Patient had issues when she was born. Patient never got period when teenager and also never able to get pregnant.   This case was linked to MOD-2021-177941 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Tenderness on the injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Tenderness on the injection Site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE PAIN (Tenderness on the injection Site). On 29-Apr-2021, VACCINATION SITE PAIN (Tenderness on the injection Site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medications were reported.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: itching on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching on the left arm) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (itching on the left arm). The patient was treated with ISOPROPANOL (RUBBING ALCOHOL) (topical) on 26-May-2021 for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PRURITUS (itching on the left arm) had resolved.      No concomitant medications were reported.   This case was linked to MOD-2021-177827 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Follow-up information received contains Significant information-Updated event outcome: Recovered and lower level term for the event was updated.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: I had my first Moderna shot at the end of February and have not gotten my second shot yet; 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 (I had my first Moderna shot at the end of February and have not gotten my second shot yet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I had my first Moderna shot at the end of February and have not gotten my second shot yet). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I had my first Moderna shot at the end of February and have not gotten my second shot yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitants are included. No Treatment included.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain
Clinical narrative: Ribs feel like they are hurting; Could not bend my arm fully/ cannot move elbow well and cannot straighten it out without pain; Having a hard time breathing; Palm looks red; areas that were injured back then are now hurting her after the vaccine; severe throbbing muscle aching/ Pain moving my arm/elbow area; Pain is moving down to where wrist was broken/ Felt like the same pain when wrist was broken/ Pain also in knee; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (Ribs feel like they are hurting), HYPOKINESIA (Could not bend my arm fully/ cannot move elbow well and cannot straighten it out without pain), DYSPNOEA (Having a hard time breathing), ERYTHEMA (Palm looks red) and PAIN (areas that were injured back then are now hurting her after the vaccine) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Eczema, Thyroid disorder, Polycystic ovarian syndrome (never got period when teenager polycystic ovarian syndrome, never able to get pregnant,), Sjogren's syndrome, Lupus syndrome and Asthma. Concomitant products included LEVOTHYROXINE and SPIRONOLACTONE (ALDACTONE [SPIRONOLACTONE]) for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL CHEST PAIN (Ribs feel like they are hurting), HYPOKINESIA (Could not bend my arm fully/ cannot move elbow well and cannot straighten it out without pain), DYSPNOEA (Having a hard time breathing), ERYTHEMA (Palm looks red), PAIN (areas that were injured back then are now hurting her after the vaccine), MYALGIA (severe throbbing muscle aching/ Pain moving my arm/elbow area) and ARTHRALGIA (Pain is moving down to where wrist was broken/ Felt like the same pain when wrist was broken/ Pain also in knee). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL CHEST PAIN (Ribs feel like they are hurting), HYPOKINESIA (Could not bend my arm fully/ cannot move elbow well and cannot straighten it out without pain), DYSPNOEA (Having a hard time breathing), ERYTHEMA (Palm looks red), PAIN (areas that were injured back then are now hurting her after the vaccine), MYALGIA (severe throbbing muscle aching/ Pain moving my arm/elbow area) and ARTHRALGIA (Pain is moving down to where wrist was broken/ Felt like the same pain when wrist was broken/ Pain also in knee) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-177877 (Patient Link).
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: During administration some of the vaccine leaked out from the syringe; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (During administration some of the vaccine leaked out from the syringe) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced UNDERDOSE (During administration some of the vaccine leaked out from the syringe). On 26-May-2021, UNDERDOSE (During administration some of the vaccine leaked out from the syringe) 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 was reported.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (body aches) and PYREXIA (fever) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (body aches) and PYREXIA (fever). The patient was treated with IBUPROFEN for Fever and Myalgia, at an unspecified dose and frequency. At the time of the report, MYALGIA (body aches) and PYREXIA (fever) had resolved.            No concomitant medications were reported.   This case was linked to MOD-2021-020094 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Have been feeling short of breath; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Have been feeling short of breath) 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 DYSPNOEA (Have been feeling short of breath). At the time of the report, DYSPNOEA (Have been feeling short of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported.  The patient had received vaccine 3 weeks ago and felt shortness of breath since vaccine.  The treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Swelling around where the Moderna vaccine was given; Red; 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 SWELLING (Swelling around where the Moderna vaccine was given) and VACCINATION SITE ERYTHEMA (Red) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     there is no historical conditions reported by the reporter.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling around where the Moderna vaccine was given) and VACCINATION SITE ERYTHEMA (Red). At the time of the report, VACCINATION SITE SWELLING (Swelling around where the Moderna vaccine was given) and VACCINATION SITE ERYTHEMA (Red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant information use was not reported.  Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: developed a rash on my face - 1 week after my second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed a rash on my face - 1 week after my second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 RASH (developed a rash on my face - 1 week after my second shot). At the time of the report, RASH (developed a rash on my face - 1 week after my second shot) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received Expired Dose of Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 25-May-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) (Intramuscular) 1 dosage form. On 25-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine). On 25-May-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose of Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.  The vials were placed in the refrigerator on 21Apr2021 and stayed in the same location until their administration date on 25May2021
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue, Underdose
Clinical narrative: Vaccine leaked out of syringe; Vaccine leaked out of syringe; Patient did not get any of the dose; 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 DEVICE CONNECTION ISSUE (Vaccine leaked out of syringe), UNDERDOSE (Vaccine leaked out of syringe) and ACCIDENTAL UNDERDOSE (Patient did not get any of the 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 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced DEVICE CONNECTION ISSUE (Vaccine leaked out of syringe), UNDERDOSE (Vaccine leaked out of syringe) and ACCIDENTAL UNDERDOSE (Patient did not get any of the dose). On 25-May-2021, DEVICE CONNECTION ISSUE (Vaccine leaked out of syringe), UNDERDOSE (Vaccine leaked out of syringe) and ACCIDENTAL UNDERDOSE (Patient did not get any of the dose) 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.   Concomitant Medications were not provided by the reporter. Treatment Medications were not provided by the reporter
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Insomnia, Pain in extremity
Clinical narrative: Pain in arm; Trouble in sleeping at nights; Very very foggy; Headache/Headache type of symptoms; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), INSOMNIA (Trouble in sleeping at nights), FEELING ABNORMAL (Very very foggy) and HEADACHE (Headache/Headache type of symptoms) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2021, the patient experienced INSOMNIA (Trouble in sleeping at nights), FEELING ABNORMAL (Very very foggy) and HEADACHE (Headache/Headache type of symptoms). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm), INSOMNIA (Trouble in sleeping at nights), FEELING ABNORMAL (Very very foggy) and HEADACHE (Headache/Headache type of symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  After the first dose of vaccination patient just had pain in her arm which lasted for couple of days and no other side effects. On 24 May 2021 patient experienced headache, trouble in sleeping at nights, headache type of symptoms, very very foggy which was effecting her work.   Treatment activities for event was done with over the counter sleeping pill.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Only 9 doses could be drawn from 9 Vials approximately 54 people receive the dosages; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Only 9 doses could be drawn from 9 Vials approximately 54 people receive the dosages) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-May-2021, the patient experienced UNDERDOSE (Only 9 doses could be drawn from 9 Vials approximately 54 people receive the dosages). On 26-May-2021, UNDERDOSE (Only 9 doses could be drawn from 9 Vials approximately 54 people receive the dosages) 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.   Pharmacist states only 9 doses each of Moderna Vaccine could be drawn from 9 vials in a box of 10. She states multiple people draw vaccine from the vials. Individuals were given the vaccine -approximately 54 from the 9 vial total.   No Treatment medications were provided  No  Concomitant medications were provided
Sex: U
Vaccine: COVID19
Symptoms: Muscle swelling
Clinical narrative: right oblique is swollen like a lymph node; 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 MUSCLE SWELLING (right oblique is swollen like a lymph node) 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 MUSCLE SWELLING (right oblique is swollen like a lymph node). At the time of the report, MUSCLE SWELLING (right oblique is swollen like a lymph node) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided. treatment medication was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: has high blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of HYPERTENSION (has high blood pressure) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 HYPERTENSION (has high blood pressure). At the time of the report, HYPERTENSION (has high blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.