chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jul-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days). On 21-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Got the first dose of the Moderna vaccine on 12Jul2021 at their facility and then received a second dose after 9 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided by the reporter.  On 12-Jul-2021, the patient got the first dose of the Moderna vaccine at reporter's facility and then received a second dose after 9 days at another facility on 21-Jul-2021.  Patient now returned to get a third dose. HCP wanted some guidance on whether they should administer this second dose or not.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received contains no new information
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: Expired first dose; She has two doses done on the same date with different lot numbers; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has two doses done on the same date with different lot numbers) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has two doses done on the same date with different lot numbers). On 10-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired first dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She has two doses done on the same date with different lot numbers) had resolved.            The first lot number recorded is 030M20A; the second one added is 022C21A. The patient was not sure which dose she received. No concomitant medications were reported. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: Sinus infection; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection) 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.    In January 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (Sinus infection). At the time of the report, SINUSITIS (Sinus infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product information was not provided.  Patient visited doctor and patient was put on antibiotic.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle ache; Extreme fatigue; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Muscle ache) and FATIGUE (Extreme fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 MYALGIA (Muscle ache) and FATIGUE (Extreme fatigue). At the time of the report, MYALGIA (Muscle ache) and FATIGUE (Extreme fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication product use was not provided by the reporter. No treatment information was provided. The patient first shot was a week and a half ago.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Feels burning sensation in legs towards knees; Feel like all energy is being pulled out of me; Rash on top of feet; Exhaustion; aching all over Started on my legs; Felt lethargic; Can't even walk; Can't use arms or hands; Calves and veins hurt in back of legs; Felt very lightheaded, felt very dizzy; Shortness of breath after any exertion, lose breath if I am standing to long; Swelling in her hands; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs) and DIZZINESS (Felt very lightheaded, felt very dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs). At the time of the report, LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product were reported  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received. New events were added (Fatigue, Myalgia, Asthenia).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Lethargy, Limb discomfort, Myalgia, Pain in extremity
Clinical narrative: Feels burning sensation in legs towards knees; Feel like all energy is being pulled out of me; Rash on top of feet; Exhaustion; aching all over Started on my legs; Felt lethargic; Can't even walk; Can't use arms or hands; Calves and veins hurt in back of legs; Felt very lightheaded, felt very dizzy; Shortness of breath after any exertion, lose breath if I am standing to long; Swelling in her hands; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs) and DIZZINESS (Felt very lightheaded, felt very dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs). At the time of the report, LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product were reported  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received. New events were added (Fatigue, Myalgia, Asthenia).
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Feels burning sensation in legs towards knees; Feel like all energy is being pulled out of me; Rash on top of feet; Exhaustion; aching all over Started on my legs; Felt lethargic; Can't even walk; Can't use arms or hands; Calves and veins hurt in back of legs; Felt very lightheaded, felt very dizzy; Shortness of breath after any exertion, lose breath if I am standing to long; Swelling in her hands; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs) and DIZZINESS (Felt very lightheaded, felt very dizzy) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs). At the time of the report, LETHARGY (Felt lethargic), GAIT DISTURBANCE (Can't even walk), LIMB DISCOMFORT (Can't use arms or hands), PAIN IN EXTREMITY (Calves and veins hurt in back of legs), DIZZINESS (Felt very lightheaded, felt very dizzy), DYSPNOEA (Shortness of breath after any exertion, lose breath if I am standing to long), PERIPHERAL SWELLING (Swelling in her hands), BURNING SENSATION (Feels burning sensation in legs towards knees), ASTHENIA (Feel like all energy is being pulled out of me), RASH (Rash on top of feet), FATIGUE (Exhaustion) and MYALGIA (aching all over Started on my legs) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant product were reported  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 11-Aug-2021: Follow up received. New events were added (Fatigue, Myalgia, Asthenia).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Got the first dose of the vaccine and later was infected with COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got the first dose of the vaccine and later was infected with COVID) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got the first dose of the vaccine and later was infected with COVID). At the time of the report, COVID-19 (Got the first dose of the vaccine and later was infected with COVID) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Irritability, Vaccination site pain
Clinical narrative: Flu like symptoms; Irritability that he is having trouble controlling which has not stopped; Injection site pain; Headache; Tiredness; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritability that he is having trouble controlling which has not stopped), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache) and FATIGUE (Tiredness) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritability that he is having trouble controlling which has not stopped), VACCINATION SITE PAIN (Injection site pain), HEADACHE (Headache) and FATIGUE (Tiredness). On 07-Aug-2021, VACCINATION SITE PAIN (Injection site pain) and HEADACHE (Headache) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), IRRITABILITY (Irritability that he is having trouble controlling which has not stopped) and FATIGUE (Tiredness) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased, Oropharyngeal pain, Tonsillar hypertrophy
Clinical narrative: sore throat; swollen tonsils; elevated heart rate; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), TONSILLAR HYPERTROPHY (swollen tonsils) and HEART RATE INCREASED (elevated heart rate) 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 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat), TONSILLAR HYPERTROPHY (swollen tonsils) and HEART RATE INCREASED (elevated heart rate). At the time of the report, OROPHARYNGEAL PAIN (sore throat), TONSILLAR HYPERTROPHY (swollen tonsils) and HEART RATE INCREASED (elevated heart rate) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications and treatment medications were reported .
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Covid infection after vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid infection after vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid infection after vaccine.). At the time of the report, COVID-19 (Covid infection after vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant drugs were reported. no treatment medication were reported,   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure decreased
Clinical narrative: Reduced blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE DECREASED (Reduced blood pressure) 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 BLOOD PRESSURE DECREASED (Reduced blood pressure). At the time of the report, BLOOD PRESSURE DECREASED (Reduced blood pressure) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Patient reported "I am 50 hours post thejab and am at mid 90's".  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Rash on the injected arm after second dose and  later traveled to the right arm; Fever after second dose; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever after second dose) and RASH (Rash on the injected arm after second dose and  later traveled to the right arm) 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 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced PYREXIA (Fever after second dose). On an unknown date, the patient experienced RASH (Rash on the injected arm after second dose and  later traveled to the right arm). At the time of the report, PYREXIA (Fever after second dose) and RASH (Rash on the injected arm after second dose and  later traveled to the right arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Aug-2021, SARS-CoV-2 test: negative (Negative) COVID test negative.         No concomitant medication reported. No treatment medication reported. Expiration  Date of both dose  was unknown . Patient took second dose on  AUG  2021 .
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Erythema, Influenza like illness, Injection site atrophy
Clinical narrative: loosing muscle were vaccine was injected; Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected; Itching; heat, injection site was hot to touch; Injection site puffy and swollen; Bump in the injection site; Redness; Dizziness; Like having a severe flu; Sick to stomach; Quarter size lump; Quarter size knot were had injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach) and PRURITUS (Itching) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen), INJECTION SITE MASS (Bump in the injection site), VACCINATION SITE MASS (Quarter size lump) and INJECTION SITE NODULE (Quarter size knot were had injection). In July 2021, the patient experienced PRURITUS (Itching) and INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected). On an unknown date, the patient experienced INJECTION SITE ATROPHY (loosing muscle were vaccine was injected). On 23-Jun-2021, ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen) and INJECTION SITE MASS (Bump in the injection site) had resolved. At the time of the report, PRURITUS (Itching), INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected) and INJECTION SITE ATROPHY (loosing muscle were vaccine was injected) outcome was unknown, VACCINATION SITE MASS (Quarter size lump) had resolved with sequelae and INJECTION SITE NODULE (Quarter size knot were had injection) had resolved.            No concomitant medication information was provided.  Patient took a headache pill to treat symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site indentation, Injection site mass, Injection site nodule, Injection site oedema, Injection site warmth
Clinical narrative: loosing muscle were vaccine was injected; Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected; Itching; heat, injection site was hot to touch; Injection site puffy and swollen; Bump in the injection site; Redness; Dizziness; Like having a severe flu; Sick to stomach; Quarter size lump; Quarter size knot were had injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach) and PRURITUS (Itching) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen), INJECTION SITE MASS (Bump in the injection site), VACCINATION SITE MASS (Quarter size lump) and INJECTION SITE NODULE (Quarter size knot were had injection). In July 2021, the patient experienced PRURITUS (Itching) and INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected). On an unknown date, the patient experienced INJECTION SITE ATROPHY (loosing muscle were vaccine was injected). On 23-Jun-2021, ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen) and INJECTION SITE MASS (Bump in the injection site) had resolved. At the time of the report, PRURITUS (Itching), INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected) and INJECTION SITE ATROPHY (loosing muscle were vaccine was injected) outcome was unknown, VACCINATION SITE MASS (Quarter size lump) had resolved with sequelae and INJECTION SITE NODULE (Quarter size knot were had injection) had resolved.            No concomitant medication information was provided.  Patient took a headache pill to treat symptoms.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site mass
Clinical narrative: loosing muscle were vaccine was injected; Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected; Itching; heat, injection site was hot to touch; Injection site puffy and swollen; Bump in the injection site; Redness; Dizziness; Like having a severe flu; Sick to stomach; Quarter size lump; Quarter size knot were had injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach) and PRURITUS (Itching) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017C21A and 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen), INJECTION SITE MASS (Bump in the injection site), VACCINATION SITE MASS (Quarter size lump) and INJECTION SITE NODULE (Quarter size knot were had injection). In July 2021, the patient experienced PRURITUS (Itching) and INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected). On an unknown date, the patient experienced INJECTION SITE ATROPHY (loosing muscle were vaccine was injected). On 23-Jun-2021, ERYTHEMA (Redness), DIZZINESS (Dizziness), INFLUENZA LIKE ILLNESS (Like having a severe flu), ABDOMINAL DISCOMFORT (Sick to stomach), INJECTION SITE WARMTH (heat, injection site was hot to touch), INJECTION SITE OEDEMA (Injection site puffy and swollen) and INJECTION SITE MASS (Bump in the injection site) had resolved. At the time of the report, PRURITUS (Itching), INJECTION SITE INDENTATION (Indentation,huge indentation in upper arm, indentation is two fingers wide across the arm and loosing muscle were vaccine was injected) and INJECTION SITE ATROPHY (loosing muscle were vaccine was injected) outcome was unknown, VACCINATION SITE MASS (Quarter size lump) had resolved with sequelae and INJECTION SITE NODULE (Quarter size knot were had injection) had resolved.            No concomitant medication information was provided.  Patient took a headache pill to treat symptoms.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Gait disturbance, General physical health deterioration, Mental impairment, Mobility decreased
Clinical narrative: Drag himself even after using a walker which makes it harder for him to walk.; Become physically weak; has to walk very slow and drag himself even after using a walker which makes it harder for him to walk; Lost his physical ability; Wet himself; Lost his  mental ability; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Lost his mental ability) and MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MENTAL IMPAIRMENT (Lost his  mental ability) (seriousness criterion medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (Lost his physical ability) and URINARY INCONTINENCE (Wet himself). On an unknown date, the patient experienced ASTHENIA (Become physically weak), MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) (seriousness criterion medically significant) and GAIT DISTURBANCE (has to walk very slow and drag himself even after using a walker which makes it harder for him to walk). The patient was treated with Physical therapy for Mental impairment; Physical therapy for General physical health deterioration; Physical therapy for Mobility decreased and Physical therapy for Gait disturbance. At the time of the report, MENTAL IMPAIRMENT (Lost his  mental ability) and GENERAL PHYSICAL HEALTH DETERIORATION (Lost his physical ability) had not resolved and URINARY INCONTINENCE (Wet himself), ASTHENIA (Become physically weak), MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) and GAIT DISTURBANCE (has to walk very slow and drag himself even after using a walker which makes it harder for him to walk) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  was provided.  Treatment information include that the patient had seen by a physical therapist but stated that there was no any improvements.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.
Age: 93.0
Sex: M
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Drag himself even after using a walker which makes it harder for him to walk.; Become physically weak; has to walk very slow and drag himself even after using a walker which makes it harder for him to walk; Lost his physical ability; Wet himself; Lost his  mental ability; This spontaneous case was reported by a consumer and describes the occurrence of MENTAL IMPAIRMENT (Lost his mental ability) and MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MENTAL IMPAIRMENT (Lost his  mental ability) (seriousness criterion medically significant), GENERAL PHYSICAL HEALTH DETERIORATION (Lost his physical ability) and URINARY INCONTINENCE (Wet himself). On an unknown date, the patient experienced ASTHENIA (Become physically weak), MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) (seriousness criterion medically significant) and GAIT DISTURBANCE (has to walk very slow and drag himself even after using a walker which makes it harder for him to walk). The patient was treated with Physical therapy for Mental impairment; Physical therapy for General physical health deterioration; Physical therapy for Mobility decreased and Physical therapy for Gait disturbance. At the time of the report, MENTAL IMPAIRMENT (Lost his  mental ability) and GENERAL PHYSICAL HEALTH DETERIORATION (Lost his physical ability) had not resolved and URINARY INCONTINENCE (Wet himself), ASTHENIA (Become physically weak), MOBILITY DECREASED (Drag himself even after using a walker which makes it harder for him to walk.) and GAIT DISTURBANCE (has to walk very slow and drag himself even after using a walker which makes it harder for him to walk) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication  was provided.  Treatment information include that the patient had seen by a physical therapist but stated that there was no any improvements.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; 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.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Rash, Rash erythematous, Swelling
Clinical narrative: (rash)red; a little swollen; looks like a Covid arm; super super tired/tired; Rash was growing again/Rash was growing again/her whole upper arm has a rash; Woke up and had a Rash; Arm was really really sore; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was really really sore), RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm) and RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Patient states that the only other time she had a reaction to a medication was to an antibiotic.). Concomitant products included METOPROLOL for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was really really sore). On 08-Aug-2021, the patient experienced RASH (Woke up and had a Rash). On 09-Aug-2021, the patient experienced RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash). On an unknown date, the patient experienced RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm) and FATIGUE (super super tired/tired). At the time of the report, PAIN IN EXTREMITY (Arm was really really sore), RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm), RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash), RASH (Woke up and had a Rash) and FATIGUE (super super tired/tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included Antihistamines for the adverse events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: (rash)red; a little swollen; looks like a Covid arm; super super tired/tired; Rash was growing again/Rash was growing again/her whole upper arm has a rash; Woke up and had a Rash; Arm was really really sore; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Arm was really really sore), RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm) and RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to antibiotic (Patient states that the only other time she had a reaction to a medication was to an antibiotic.). Concomitant products included METOPROLOL for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Arm was really really sore). On 08-Aug-2021, the patient experienced RASH (Woke up and had a Rash). On 09-Aug-2021, the patient experienced RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash). On an unknown date, the patient experienced RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm) and FATIGUE (super super tired/tired). At the time of the report, PAIN IN EXTREMITY (Arm was really really sore), RASH ERYTHEMATOUS ((rash)red), SWELLING (a little swollen), VACCINATION COMPLICATION (looks like a Covid arm), RASH (Rash was growing again/Rash was growing again/her whole upper arm has a rash), RASH (Woke up and had a Rash) and FATIGUE (super super tired/tired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included Antihistamines for the adverse events.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Has not received the second dose > 4 months after the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Has not received the second dose > 4 months after the first dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Patient decided not to get the second shot. On 11 Aug 2021, she walked in to this pharmacy and presented her vaccination card and she is requesting to get the second shot.  No treatment information was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Diarrhea; Threw up; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and VOMITING (Threw up) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medication history information was provided.  Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication.   On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VOMITING (Threw up). On 07-Aug-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, DIARRHOEA (Diarrhea) had not resolved and VOMITING (Threw up) outcome was unknown.            No treatment medications were provided.   This case was linked to MOD-2021-283815 (Parent-Child Link).   See case MOD-2021-283815 for details regarding the child case.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Headache, Tremor
Clinical narrative: Felt miserable, felt all over terrible; Laid in bed shaking from the chills; Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), CHILLS (Chills) and HEADACHE (Headaches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (resulted in losing her right eye.) and Headache.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states she took lots of medications and declines in sharing this information as it is not relevant.She states that she does not have a stroke history and heart problems. No concomitant medication provided. No treatment information mentioned.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-283822 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Rectal haemorrhage
Clinical narrative: bleeding from the rectum; pain in her stomach area; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of RECTAL HAEMORRHAGE (bleeding from the rectum) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Intestinal cyst.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Mar-2021, the patient experienced RECTAL HAEMORRHAGE (bleeding from the rectum) (seriousness criterion medically significant), ABDOMINAL PAIN UPPER (pain in her stomach area) and DIARRHOEA (diarrhea). At the time of the report, RECTAL HAEMORRHAGE (bleeding from the rectum), ABDOMINAL PAIN UPPER (pain in her stomach area) and DIARRHOEA (diarrhea) outcome was unknown.            Patient was treated with antibiotics No concomitant medications were reported. Patient stated a colonoscopy has been ordered.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events which was greater than one month and the patient's pre-existing intestinal condition the Company believes a causal relationship is unlikely.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Myalgia
Clinical narrative: dizzy; muscle pain/elt like she was beat up; bad headache; This spontaneous case was reported by a physician and describes the occurrence of   in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 001B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment information was reported.   This case was linked to MOD-2021-283990 (Patient Link).