chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-May-2021 and was forwarded to Moderna on 31-May-2021.    Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds) 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 ILLNESS (if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds). At the time of the report, ILLNESS (if one gets sick after taking the Moderma vaccine it means you were carrying some of the viruds) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided  No Treatment medications were provided
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Body temperature, Chest X-ray, Dizziness, Fatigue, Hypokinesia
Clinical narrative: sick for 4 days; dizziness; she could not go to the bed and bathroom; achiness; nausea; fatigue; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness) and NAUSEA (nausea) in a 67-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.    Co-suspect product included non-company product DUPILUMAB injection for Eczema, Atopic dermatitis and Asthma.    The patient's past medical history included Depression from October 2020 to December 2020, COVID-19 ((latency: 1 year 3 months 6 days), the patient had fever (pyrexia), she did not have a cough and was sick for a month (illness).) on 12-Mar-2020, COVID-19 pneumonia on 13-Mar-2020, Dry eye and Cataract operation. Concurrent medical conditions included Pruritus (severe itching of the scalp and the shoulders) and Condition aggravated (history of lower back flaring in the previous years).   On 06-Dec-2020, the patient started DUPILUMAB (Subcutaneous) 600 mg. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever of 102). At the time of the report, ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2020, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 test-Positive. In March 2020, Chest X-ray: inconclusive (Inconclusive) no improvement on the Chest X-ray. In February 2021, Body temperature: 102 (High) fever of 102.         No Concomitant medications were reported No treatment information was provided The action taken for mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-004691.
Age: 67.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Illness, Myalgia, Nausea, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: sick for 4 days; dizziness; she could not go to the bed and bathroom; achiness; nausea; fatigue; fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness) and NAUSEA (nausea) in a 67-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.    Co-suspect product included non-company product DUPILUMAB injection for Eczema, Atopic dermatitis and Asthma.    The patient's past medical history included Depression from October 2020 to December 2020, COVID-19 ((latency: 1 year 3 months 6 days), the patient had fever (pyrexia), she did not have a cough and was sick for a month (illness).) on 12-Mar-2020, COVID-19 pneumonia on 13-Mar-2020, Dry eye and Cataract operation. Concurrent medical conditions included Pruritus (severe itching of the scalp and the shoulders) and Condition aggravated (history of lower back flaring in the previous years).   On 06-Dec-2020, the patient started DUPILUMAB (Subcutaneous) 600 mg. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever of 102). At the time of the report, ILLNESS (sick for 4 days), DIZZINESS (dizziness), HYPOKINESIA (she could not go to the bed and bathroom), MYALGIA (achiness), NAUSEA (nausea), FATIGUE (fatigue) and PYREXIA (fever of 102) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2020, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 test-Positive. In March 2020, Chest X-ray: inconclusive (Inconclusive) no improvement on the Chest X-ray. In February 2021, Body temperature: 102 (High) fever of 102.         No Concomitant medications were reported No treatment information was provided The action taken for mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-004691.
Sex: U
Vaccine: COVID19
Symptoms: Genital herpes
Clinical narrative: outbreak of genital herpes; 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 GENITAL HERPES (outbreak of genital herpes) 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 GENITAL HERPES (outbreak of genital herpes). At the time of the report, GENITAL HERPES (outbreak of genital herpes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  No treatment medication was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: 90 days post vaccine and almost to the day broke out in shingles on the same side of my face as the arm I was given the vaccine reported healthy and next day got shingles; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (90 days post vaccine and almost to the day broke out in shingles on the same side of my face as the arm I was given the vaccine reported healthy and next day got shingles) 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 HERPES ZOSTER (90 days post vaccine and almost to the day broke out in shingles on the same side of my face as the arm I was given the vaccine reported healthy and next day got shingles). At the time of the report, HERPES ZOSTER (90 days post vaccine and almost to the day broke out in shingles on the same side of my face as the arm I was given the vaccine reported healthy and next day got shingles) outcome was unknown.            Treatment medication not provided.  Concomitant medication not provided.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: my arms hurts; 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 arms hurts) 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) 1 dosage form. On an unknown date, the patient experienced MYALGIA (my arms hurts). At the time of the report, MYALGIA (my arms hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were provided No concomitant medications were provided
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: Pain on left shoulder and on left side of neck and going down up to left elbo; Pain on left shoulder; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-May-2021 and was forwarded to Moderna on 31-May-2021.    This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Pain on left shoulder and on left side of neck and going down up to left elbo) and ARTHRALGIA (Pain on left shoulder) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history was reported.     On 03-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, the patient experienced ARTHRALGIA (Pain on left shoulder). On 26-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NECK PAIN (Pain on left shoulder and on left side of neck and going down up to left elbo). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) on 06-May-2021 for Neck pain, at a dose of 1 dosage form. At the time of the report, NECK PAIN (Pain on left shoulder and on left side of neck and going down up to left elbo) outcome was unknown and ARTHRALGIA (Pain on left shoulder) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.; 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. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site pain
Clinical narrative: Barely lift her arm; Pain in arm after 2nd dose; This spontaneous case was reported by an other caregiver and describes the occurrence of LIMB DISCOMFORT (Barely lift her arm) and VACCINATION SITE PAIN (Pain in arm after 2nd dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB DISCOMFORT (Barely lift her arm) and VACCINATION SITE PAIN (Pain in arm after 2nd dose). At the time of the report, LIMB DISCOMFORT (Barely lift her arm) and VACCINATION SITE PAIN (Pain in arm after 2nd dose) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. Treatment medication was not provided concomitant product was not provided   This case was linked to MOD-2021-169645, MOD-2021-169645 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore and tender arm around the injection site), tenderness (sore and tender arm), pyrexia (fever) and chills in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 026120A) for COVID-19 immunization. No medical history reported. On Jan 5, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; unspecified dose. On an unknown date, patient experienced pain in extremity (sore and tender arm around the injection site), tenderness (sore and tender arm), pyrexia (fever) and chills. At the time of the report, pain in extremity (sore and tender arm around the injection site), tenderness (sore and tender arm), pyrexia (fever) and chills outcome: unknown. mRNA-1273 (Moderna COVID-19 vaccine), intramuscular and mRNA-1273 (Moderna COVID-19 vaccine), unknown route; dosing remained unchanged. Action taken with mRNA-1273 in response to the drug: no change. No concomitant medication or treatment information provided. This case linked to MOD-2021-039052 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: 3 days after first dose I have rashes on several areas; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of RASH (3 days after first dose I have rashes on several areas) 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 RASH (3 days after first dose I have rashes on several areas). At the time of the report, RASH (3 days after first dose I have rashes on several areas) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications were not provided
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Feeling sick; 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 MALAISE (Feeling sick) 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) UNK dosage form. On an unknown date, the patient experienced MALAISE (Feeling sick). At the time of the report, MALAISE (Feeling sick) outcome was unknown.            No treatment medication were reported.  Patient submitted via social media what happens if you get the vaccine while feeling sick.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: 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 HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medications were not reported. The treatment information was not provided.   Reporter did not allow further contact
Age: 62.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Arm Soreness; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Tiredness) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for an unknown indication.    No Medical History information was reported.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DUPILUMAB (DUPIXENT) (unknown route) 150 mg. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Tiredness). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) and FATIGUE (Tiredness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Additional information reported included that the co-suspect dupilumab was administered via wrong route using dupixent single dose pre-filled pen.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received contains NNI
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: caught coven; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (caught coven/What percentage of fully vaccinated individuals get covid) 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 COVID-19 (caught coven/What percentage of fully vaccinated individuals get covid).        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Below the shot in my arm it became red; Below the shot in my arm it became a litle swollen; 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 ERYTHEMA (Below the shot in my arm it became red) and PERIPHERAL SWELLING (Below the shot in my arm it became a litle swollen) 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 ERYTHEMA (Below the shot in my arm it became red) and PERIPHERAL SWELLING (Below the shot in my arm it became a litle swollen). At the time of the report, ERYTHEMA (Below the shot in my arm it became red) and PERIPHERAL SWELLING (Below the shot in my arm it became a litle swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications was provided  No treatment medications was provided
Sex: M
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Pyrexia, Rash erythematous, Vaccination complication
Clinical narrative: bad reaction to the shot; bright red rash all over his chest and back; sweat; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction to the shot), RASH ERYTHEMATOUS (bright red rash all over his chest and back), HYPERHIDROSIS (sweat), CHILLS (chills) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction to the shot), RASH ERYTHEMATOUS (bright red rash all over his chest and back), HYPERHIDROSIS (sweat), CHILLS (chills) and PYREXIA (Fever). At the time of the report, VACCINATION COMPLICATION (bad reaction to the shot), RASH ERYTHEMATOUS (bright red rash all over his chest and back), HYPERHIDROSIS (sweat), CHILLS (chills) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  Treatment medications were unknown.
Sex: U
Vaccine: COVID19
Symptoms: Facial pain
Clinical narrative: Face feels sore; 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 FACIAL PAIN (Face feels sore) 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) dosage form. On an unknown date, the patient experienced FACIAL PAIN (Face feels sore). At the time of the report, FACIAL PAIN (Face feels sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Wrist 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 (Wrist pain) 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 ARTHRALGIA (Wrist pain). At the time of the report, ARTHRALGIA (Wrist pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Severe hives about a week after his vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Severe hives about a week after his 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 was provided.     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 URTICARIA (Severe hives about a week after his vaccination). At the time of the report, URTICARIA (Severe hives about a week after his vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Side effects; 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 (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. Unknown and 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 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) had not resolved.            Concomitant medications was not provided.  Treatment medications was not provided.  Action taken with mRNA-1273 in response to events was not applicable.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: My heart rate is racing; 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 HEART RATE INCREASED (My heart rate is racing) 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 HEART RATE INCREASED (My heart rate is racing). At the time of the report, HEART RATE INCREASED (My heart rate is racing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant treatment medications were reported.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Blepharospasm
Clinical narrative: Eye spasms/eye twitching; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a non-health professional and describes the occurrence of BLEPHAROSPASM (Eye spasms/eye twitching) 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 BLEPHAROSPASM (Eye spasms/eye twitching). At the time of the report, BLEPHAROSPASM (Eye spasms/eye twitching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Urticaria, Vaccination complication
Clinical narrative: hives; received moderna COVID-19 vaccine and had side effects; 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 URTICARIA (hives) and VACCINATION COMPLICATION (received moderna COVID-19 vaccine and had side effects) 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 URTICARIA (hives) and VACCINATION COMPLICATION (received moderna COVID-19 vaccine and had side effects). At the time of the report, URTICARIA (hives) and VACCINATION COMPLICATION (received moderna COVID-19 vaccine and had side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No details provided.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, Bone pain, Chills, Headache
Clinical narrative: Extremely weak; Bone pain; Stomach pain; Severe reaction to second moderna vaccine; Throwing up; Head pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine) and VOMITING (Throwing up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine), VOMITING (Throwing up), HEADACHE (Head pain) and CHILLS (Chills). At the time of the report, ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine), VOMITING (Throwing up), HEADACHE (Head pain) and CHILLS (Chills) outcome was unknown.            No concomitant medication was reported.  The treatment information was not given.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication, Vomiting
Clinical narrative: Extremely weak; Bone pain; Stomach pain; Severe reaction to second moderna vaccine; Throwing up; Head pain; Chills; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine) and VOMITING (Throwing up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) 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 ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine), VOMITING (Throwing up), HEADACHE (Head pain) and CHILLS (Chills). At the time of the report, ASTHENIA (Extremely weak), BONE PAIN (Bone pain), ABDOMINAL PAIN UPPER (Stomach pain), VACCINATION COMPLICATION (Severe reaction to second moderna vaccine), VOMITING (Throwing up), HEADACHE (Head pain) and CHILLS (Chills) outcome was unknown.            No concomitant medication was reported.  The treatment information was not given.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Eye pain, Fatigue, Feeling cold, Headache
Clinical narrative: very cold; eyes hurt; don't feel well; chills; head hurts; feel very tired; 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 FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills) and HEADACHE (head hurts) 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 30-May-2021 at 1:00 AM, the patient experienced FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills), HEADACHE (head hurts), FATIGUE (feel very tired) and PYREXIA (fever). At the time of the report, FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills), HEADACHE (head hurts), FATIGUE (feel very tired) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: very cold; eyes hurt; don't feel well; chills; head hurts; feel very tired; 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 FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills) and HEADACHE (head hurts) 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 30-May-2021 at 1:00 AM, the patient experienced FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills), HEADACHE (head hurts), FATIGUE (feel very tired) and PYREXIA (fever). At the time of the report, FEELING COLD (very cold), EYE PAIN (eyes hurt), MALAISE (don't feel well), CHILLS (chills), HEADACHE (head hurts), FATIGUE (feel very tired) and PYREXIA (fever) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications were reported. Treatment information was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Myalgia, Pain in extremity
Clinical narrative: Diarrhea; very sore and painful arm; Body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (very sore and painful arm), MYALGIA (Body aches) and CHILLS (chills) 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 DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (very sore and painful arm), MYALGIA (Body aches) and CHILLS (chills). At the time of the report, DIARRHOEA (Diarrhea), PAIN IN EXTREMITY (very sore and painful arm), MYALGIA (Body aches) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Side effects; 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 (Side effects) 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 REACTION (Side effects). At the time of the report, VACCINATION SITE REACTION (Side effects) 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.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Inappropriate schedule of product administration
Clinical narrative: Got second dose more than 36 days after first dose; As of the moment she only felt burning sensation on her leg; felt whole body was burning; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (felt whole body was burning), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 36 days after first dose) and BURNING SENSATION (As of the moment she only felt burning sensation on her leg) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037121A and 096821A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-May-2021, the patient experienced BURNING SENSATION (felt whole body was burning) and BURNING SENSATION (As of the moment she only felt burning sensation on her leg). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 36 days after first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, BURNING SENSATION (felt whole body was burning), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got second dose more than 36 days after first dose) and BURNING SENSATION (As of the moment she only felt burning sensation on her leg) had resolved.            Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: Event outcome updated.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Eye pain, Feeling abnormal, Headache
Clinical narrative: I was almost dead; Stomach pains; Left eye was painful; Headaches; 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 (I was almost dead), ABDOMINAL PAIN UPPER (Stomach pains), EYE PAIN (Left eye was painful) and HEADACHE (Headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant medical history was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (I was almost dead), ABDOMINAL PAIN UPPER (Stomach pains), EYE PAIN (Left eye was painful) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (I was almost dead), ABDOMINAL PAIN UPPER (Stomach pains), EYE PAIN (Left eye was painful) and HEADACHE (Headaches) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Report a side effect; 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 (Report a side effect) 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 VACCINATION COMPLICATION (Report a side effect). At the time of the report, VACCINATION COMPLICATION (Report a side effect) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: Dizziness; Headaches; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches). At the time of the report, DIZZINESS (Dizziness), HEADACHE (Headaches) and MYALGIA (Body aches) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.   This case was linked to MOD-2021-190455.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: decided not to get the second dose.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (decided not to get the 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (decided not to get the second dose.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient decided not to get the second dose.
Sex: U
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Vaccination site erythema
Clinical narrative: A lot of itching; The spot is hot; The spot is 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 PRURITUS (A lot of itching), FEELING HOT (The spot is hot) and VACCINATION SITE ERYTHEMA (The spot is red) 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 PRURITUS (A lot of itching), FEELING HOT (The spot is hot) and VACCINATION SITE ERYTHEMA (The spot is red). At the time of the report, PRURITUS (A lot of itching), FEELING HOT (The spot is hot) and VACCINATION SITE ERYTHEMA (The spot is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment and concomitant medication reported.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Pain below the sternum that comes and goes; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHEST PAIN (Pain below the sternum that comes and goes) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Pain below the sternum that comes and goes). At the time of the report, CHEST PAIN (Pain below the sternum that comes and goes) outcome was unknown.            Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; 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 DIARRHEA (Diarrhea) 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 DIARRHEA (Diarrhea). At the time of the report, DIARRHEA (Diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided Concomitant medication were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: Redness all around the injected area; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness all around the injected area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Redness all around the injected area). At the time of the report, VACCINATION SITE ERYTHEMA (Redness all around the injected area) outcome was unknown.            No concomitant medication reported. No treatment information reported. patient having redness all round the injected area
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: had a 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 HEADACHE (had a 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 HEADACHE (had a headache). At the time of the report, HEADACHE (had a headache) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.  Patient had a headache since his  2nd vaccination 15 days ago at the time of report.  Concomitant and treatment medication were not provided.