chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Developed a side effect, 8 days after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Developed a side effect, 8 days after receiving the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE REACTION (Developed a side effect, 8 days after receiving the vaccine). At the time of the report, VACCINATION SITE REACTION (Developed a side effect, 8 days after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bedridden, Headache, Injected limb mobility decreased, Nausea
Clinical narrative: stomach ache; pain in all body; can't get off the couch; Can't move her arm, looks like she was hit by a baseball bat; really bad headache; 103 F fever; nausea; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), PAIN (pain in all body), BEDRIDDEN (can't get off the couch), INJECTED LIMB MOBILITY DECREASED (Can't move her arm, looks like she was hit by a baseball bat) and HEADACHE (really bad headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (diabetes type 2 historical condition reported) and Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMINS + IRON and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 13-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), PAIN (pain in all body), BEDRIDDEN (can't get off the couch), INJECTED LIMB MOBILITY DECREASED (Can't move her arm, looks like she was hit by a baseball bat), HEADACHE (really bad headache), PYREXIA (103 F fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), PAIN (pain in all body), BEDRIDDEN (can't get off the couch), INJECTED LIMB MOBILITY DECREASED (Can't move her arm, looks like she was hit by a baseball bat), HEADACHE (really bad headache), PYREXIA (103 F fever) and NAUSEA (nausea) had not 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.   Concomitant medication also included diabetes type 2, blood pressure pills.; 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: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: stomach ache; pain in all body; can't get off the couch; Can't move her arm, looks like she was hit by a baseball bat; really bad headache; 103 F fever; nausea; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), PAIN (pain in all body), BEDRIDDEN (can't get off the couch), INJECTED LIMB MOBILITY DECREASED (Can't move her arm, looks like she was hit by a baseball bat) and HEADACHE (really bad headache) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041LZ0A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (diabetes type 2 historical condition reported) and Blood pressure. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), MULTIVITAMINS + IRON and SEMAGLUTIDE (OZEMPIC) for an unknown indication.    On 13-Jan-2021 at 12:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), PAIN (pain in all body), BEDRIDDEN (can't get off the couch), INJECTED LIMB MOBILITY DECREASED (Can't move her arm, looks like she was hit by a baseball bat), HEADACHE (really bad headache), PYREXIA (103 F fever) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN UPPER (stomach ache), PAIN (pain in all body), BEDRIDDEN (can't get off the couch), INJECTED LIMB MOBILITY DECREASED (Can't move her arm, looks like she was hit by a baseball bat), HEADACHE (really bad headache), PYREXIA (103 F fever) and NAUSEA (nausea) had not 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.   Concomitant medication also included diabetes type 2, blood pressure pills.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Red ring on arm; Arm soreness; Severe itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Red ring on arm), PAIN IN EXTREMITY (Arm soreness) and PRURITUS (Severe itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hay fever.    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 ERYTHEMA (Red ring on arm), PAIN IN EXTREMITY (Arm soreness) and PRURITUS (Severe itching). At the time of the report, ERYTHEMA (Red ring on arm), PAIN IN EXTREMITY (Arm soreness) and PRURITUS (Severe itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment information was not  provided. Laboratory details were not provided.  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.   Reporter did not allow further contact; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Heart beat increased; This spontaneous case was reported by a patient and describes the occurrence of HEART RATE INCREASED (Heart beat increased) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced HEART RATE INCREASED (Heart beat increased). At the time of the report, HEART RATE INCREASED (Heart beat increased) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment or concomitant medications reported.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Hyperhidrosis, Pollakiuria, Thirst
Clinical narrative: Excessive thirst; alternated feeling hot and cold throughout the night; excessive sweating through the night that soaked his bedding;excessive bathroom trips; This spontaneous case was reported by an other health care professional and describes the occurrence of THIRST (excessive thirst), POLLAKIURIA (excessive bathroom  trips), HYPERHIDROSIS (excessive sweating through the night that soaked his bedding) and FEELING OF BODY TEMPERATURE CHANGE (alternated feeling hot and cold throughout the night) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 11J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced THIRST (excessive thirst), POLLAKIURIA (excessive bathroom  trips), HYPERHIDROSIS (excessive sweating through the night that soaked his bedding) and FEELING OF BODY TEMPERATURE CHANGE (alternated feeling hot and cold throughout the night). At the time of the report, THIRST (excessive thirst), POLLAKIURIA (excessive bathroom  trips), HYPERHIDROSIS (excessive sweating through the night that soaked his bedding) and FEELING OF BODY TEMPERATURE CHANGE (alternated feeling hot and cold throughout the night) outcome was unknown.            No treatment or concomitant medications 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.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Dizziness, Headache, Limb discomfort
Clinical narrative: Arm soreness; Light headed; Nausea; Fever; Chills; Vomiting; Headache; Neck pain; Lower back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting), HEADACHE (Headache), NECK PAIN (Neck pain) and BACK PAIN (Lower back pain). On 13-Jan-2021, LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), CHILLS (Chills) and VOMITING (Vomiting) had resolved, HEADACHE (Headache) was resolving. At the time of the report, NAUSEA (Nausea) had resolved and PYREXIA (Fever), NECK PAIN (Neck pain) and BACK PAIN (Lower back pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was unknown.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pyrexia, Vomiting
Clinical narrative: Arm soreness; Light headed; Nausea; Fever; Chills; Vomiting; Headache; Neck pain; Lower back pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), NAUSEA (Nausea), PYREXIA (Fever) and CHILLS (Chills) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), NAUSEA (Nausea), PYREXIA (Fever), CHILLS (Chills), VOMITING (Vomiting), HEADACHE (Headache), NECK PAIN (Neck pain) and BACK PAIN (Lower back pain). On 13-Jan-2021, LIMB DISCOMFORT (Arm soreness), DIZZINESS (Light headed), CHILLS (Chills) and VOMITING (Vomiting) had resolved, HEADACHE (Headache) was resolving. At the time of the report, NAUSEA (Nausea) had resolved and PYREXIA (Fever), NECK PAIN (Neck pain) and BACK PAIN (Lower back pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was unknown.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Adverse event, Urticaria
Clinical narrative: Customer care reported AE , no further details provided; Hives on both his hands and face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives on both his hands and face) and ADVERSE EVENT (Customer care reported AE , no further details provided) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced URTICARIA (Hives on both his hands and face). On an unknown date, the patient experienced ADVERSE EVENT (Customer care reported AE , no further details provided). At the time of the report, URTICARIA (Hives on both his hands and face) was resolving and ADVERSE EVENT (Customer care reported AE , no further details provided) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2021: No specific follow-up information recorded.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: itchy left arm, around the injection site; Big red rash around the injection site; swollen left arm, around the injection site; sore mild symptoms on left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore mild symptoms on left arm), VACCINATION SITE RASH (Big red rash around the injection site), VACCINATION SITE PRURITUS (itchy left arm, around the injection site) and VACCINATION SITE SWELLING (swollen left arm, around the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore mild symptoms on left arm). On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (Big red rash around the injection site), VACCINATION SITE PRURITUS (itchy left arm, around the injection site) and VACCINATION SITE SWELLING (swollen left arm, around the injection site). In January 2021, VACCINATION SITE PAIN (sore mild symptoms on left arm) had resolved. At the time of the report, VACCINATION SITE RASH (Big red rash around the injection site), VACCINATION SITE PRURITUS (itchy left arm, around the injection site) and VACCINATION SITE SWELLING (swollen left arm, around the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment medication was not used by the patient. The sore mild symptoms on her left arm went away with the days ( don´t know the exact date).   This case was linked to MOD21-05339 (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: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Huge bump in the injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Huge bump in the injection site left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE MASS (Huge bump in the injection site left arm). At the time of the report, VACCINATION SITE MASS (Huge bump in the injection site left arm) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Vaccination site erythema, Vaccination site induration, Vaccination site rash
Clinical narrative: hardness in the injection site; rash in the injection site; redness in the injection site; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (hardness in the injection site), VACCINATION SITE RASH (rash in the injection site), VACCINATION SITE ERYTHEMA (redness in the injection site) and HEADACHE (headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. (77/11)20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2021, the patient experienced VACCINATION SITE INDURATION (hardness in the injection site), VACCINATION SITE RASH (rash in the injection site), VACCINATION SITE ERYTHEMA (redness in the injection site) and HEADACHE (headache). At the time of the report, VACCINATION SITE INDURATION (hardness in the injection site), VACCINATION SITE RASH (rash in the injection site), VACCINATION SITE ERYTHEMA (redness in the injection site) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment for the event included Tylenol, Ibuprofen and icing the injection site.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Myalgia, Nausea
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (right arm was inarticulate really bad), headache (severe headache), myalgia (body aches) and nausea in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced feeling abnormal (right arm was inarticulate really bad), headache (severe headache), myalgia (body aches) and nausea. At the time of the report, feeling abnormal (right arm was inarticulate really bad), headache (severe headache), myalgia (body aches) and nausea outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant product use and treatment information not provided. Reporter did not allow further contact.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Hypoaesthesia, Nausea
Clinical narrative: Really bad vertigo; Lightheaded; foggy brain; Fatigue; Vomiting; Nausea; Numbness; tingling in her arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), VERTIGO (Really bad vertigo), DIZZINESS (Lightheaded) and FEELING ABNORMAL (foggy brain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), FATIGUE (Fatigue), VOMITING (Vomiting) and NAUSEA (Nausea). On 16-Jan-2021, the patient experienced VERTIGO (Really bad vertigo), DIZZINESS (Lightheaded) and FEELING ABNORMAL (foggy brain). On 16-Jan-2021, VERTIGO (Really bad vertigo) had resolved. At the time of the report, HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), DIZZINESS (Lightheaded), FEELING ABNORMAL (foggy brain), FATIGUE (Fatigue), VOMITING (Vomiting) and NAUSEA (Nausea) was resolving.        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.   Treatment for the events included OTC meclizine and paracetamol.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vertigo, Vomiting
Clinical narrative: Really bad vertigo; Lightheaded; foggy brain; Fatigue; Vomiting; Nausea; Numbness; tingling in her arms and legs; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), VERTIGO (Really bad vertigo), DIZZINESS (Lightheaded) and FEELING ABNORMAL (foggy brain) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), FATIGUE (Fatigue), VOMITING (Vomiting) and NAUSEA (Nausea). On 16-Jan-2021, the patient experienced VERTIGO (Really bad vertigo), DIZZINESS (Lightheaded) and FEELING ABNORMAL (foggy brain). On 16-Jan-2021, VERTIGO (Really bad vertigo) had resolved. At the time of the report, HYPOAESTHESIA (Numbness), PARAESTHESIA (tingling in her arms and legs), DIZZINESS (Lightheaded), FEELING ABNORMAL (foggy brain), FATIGUE (Fatigue), VOMITING (Vomiting) and NAUSEA (Nausea) was resolving.        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.   Treatment for the events included OTC meclizine and paracetamol.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, Nausea, Vaccination site pain
Clinical narrative: Flu like symptoms; Sore thigh; Fatigue / Hang over; Nausea; This spontaneous case was reported by a medical assistant and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (Sore thigh), FATIGUE (Fatigue / Hang over) and NAUSEA (Nausea) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026-L020A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (Sore thigh), FATIGUE (Fatigue / Hang over) and NAUSEA (Nausea). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), VACCINATION SITE PAIN (Sore thigh), FATIGUE (Fatigue / Hang over) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment related information has been reported.
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Vaccination site swelling
Clinical narrative: discomfort; little swollen arm; 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 DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (little swollen arm) 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 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (little swollen arm). At the time of the report, DISCOMFORT (discomfort) and VACCINATION SITE SWELLING (little swollen arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The treatment history was not provided  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.   Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: injection site was swollen, red and itching; injection site was swollen, red and itching; injection site was swollen, red and itching; This spontaneous case was reported by a pharmacist and describes the occurrence of VACCINATION SITE SWELLING (injection site was swollen, red and itching), VACCINATION SITE ERYTHEMA (injection site was swollen, red and itching) and VACCINATION SITE PRURITUS (injection site was swollen, red and itching) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (injection site was swollen, red and itching), VACCINATION SITE ERYTHEMA (injection site was swollen, red and itching) and VACCINATION SITE PRURITUS (injection site was swollen, red and itching). At the time of the report, VACCINATION SITE SWELLING (injection site was swollen, red and itching), VACCINATION SITE ERYTHEMA (injection site was swollen, red and itching) and VACCINATION SITE PRURITUS (injection site was swollen, red and itching) had not 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.   Concomitant medication was not reported. Treatment medication was not 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.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) 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 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment for the events were not reported.  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: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (became a little tired) and vaccination site pain (it was a little painful in her arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 041L20A) for COVID-19 immunization. The patient's past medical history included COVID-19 August 2020. On Jan 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Jan 11, 2021, patient experienced fatigue (became a little tired) and vaccination site pain (it was a little painful in her arm). On Jan 13, 2021, fatigue (became a little tired) and vaccination site pain (it was a little painful in her arm) resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment provided: Tylenol. Sender's comments: Very limited information regarding these events have been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN (Body aches). On 18-Jan-2021, PAIN (Body aches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment related information has been 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 event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: Discomfort; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Discomfort) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced DISCOMFORT (Discomfort). At the time of the report, DISCOMFORT (Discomfort) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided  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-2021-008450 (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: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Fatigue
Clinical narrative: Felt so weak; Didn't feel like eating; Felt a lot of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Felt so weak), DECREASED APPETITE (Didn't feel like eating) and FATIGUE (Felt a lot of fatigue) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced FATIGUE (Felt a lot of fatigue). On 13-Jan-2021, the patient experienced ASTHENIA (Felt so weak) and DECREASED APPETITE (Didn't feel like eating). On 11-Jan-2021, FATIGUE (Felt a lot of fatigue) had resolved. On 14-Jan-2021, ASTHENIA (Felt so weak) and DECREASED APPETITE (Didn't feel like eating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Treatment information mentions a nutrition drink. Lab tests were not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pain, Pyrexia
Clinical narrative: severe inflammatoryreaction that was greater than 10cm with redness and pain; severe inflammatoryreaction that was greater than 10cm with redness and pain; severe inflammatoryreaction that was greater than 10cm with redness and pain; had a little fever; This spontaneous case was reported by a physician and describes the occurrence of INFLAMMATION (severe inflammatoryreaction that was greater than 10cm with redness and pain), ERYTHEMA (severe inflammatoryreaction that was greater than 10cm with redness and pain), PAIN (severe inflammatoryreaction that was greater than 10cm with redness and pain) and PYREXIA (had a little fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (severe inflammatoryreaction that was greater than 10cm with redness and pain), ERYTHEMA (severe inflammatoryreaction that was greater than 10cm with redness and pain), PAIN (severe inflammatoryreaction that was greater than 10cm with redness and pain) and PYREXIA (had a little fever). At the time of the report, INFLAMMATION (severe inflammatoryreaction that was greater than 10cm with redness and pain), ERYTHEMA (severe inflammatoryreaction that was greater than 10cm with redness and pain), PAIN (severe inflammatoryreaction that was greater than 10cm with redness and pain) and PYREXIA (had a little fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment related information has been reported.   Reporter did not allow further contact
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Facial swelling; This spontaneous case was reported by a health care professional and describes the occurrence of SWELLING FACE (Facial swelling) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A20A) for COVID-19 vaccination.     Concurrent medical conditions included Dermal filler injection.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced SWELLING FACE (Facial swelling). At the time of the report, SWELLING FACE (Facial swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment for the event is not provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS NOS for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No laboratory data was provided. No treatment information was given.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Palpitations
Clinical narrative: Heart palpitation; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of PALPITATIONS (Heart palpitation) and DYSPNOEA (Shortness of breath) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced PALPITATIONS (Heart palpitation) and DYSPNOEA (Shortness of breath). On 09-Jan-2021, PALPITATIONS (Heart palpitation) and DYSPNOEA (Shortness of breath) 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.   Patient took no medications for treatment nor called any health care provider. No laboratory test was reported.  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; 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: Vaccination site induration, Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Injection site a little warm; injection site was hard; Injection site itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injection site a little warm), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE PRURITUS (Injection site itchy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Injection site a little warm), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE PRURITUS (Injection site itchy). At the time of the report, VACCINATION SITE WARMTH (Injection site a little warm), VACCINATION SITE INDURATION (injection site was hard) and VACCINATION SITE PRURITUS (Injection site itchy) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Laboratory details was not provided. No treatment information was provided.   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 event,s a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Itching on the night; Hot to the touch; Swollen; It get red; Arm was sore for one day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was sore for one day), PRURITUS (Itching on the night), SKIN WARM (Hot to the touch), PERIPHERAL SWELLING (Swollen) and ERYTHEMA (It get red) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.).    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore for one day). On 13-Jan-2021, the patient experienced PRURITUS (Itching on the night), SKIN WARM (Hot to the touch), PERIPHERAL SWELLING (Swollen) and ERYTHEMA (It get red). On 06-Jan-2021, PAIN IN EXTREMITY (Arm was sore for one day) had resolved. At the time of the report, PRURITUS (Itching on the night), SKIN WARM (Hot to the touch), PERIPHERAL SWELLING (Swollen) and ERYTHEMA (It get red) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Lymph nodes seam swollen under the right arm; At the injection site it is red; At the injection site it is warm; At the injection site it is swollen; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Jan-2021 and was forwarded to Moderna on 15-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph nodes seam swollen under the right arm), VACCINATION SITE ERYTHEMA (At the injection site it is red), VACCINATION SITE WARMTH (At the injection site it is warm) and VACCINATION SITE SWELLING (At the injection site it is swollen) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 14-Jan-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes seam swollen under the right arm), VACCINATION SITE ERYTHEMA (At the injection site it is red), VACCINATION SITE WARMTH (At the injection site it is warm) and VACCINATION SITE SWELLING (At the injection site it is swollen). At the time of the report, LYMPHADENOPATHY (Lymph nodes seam swollen under the right arm), VACCINATION SITE ERYTHEMA (At the injection site it is red), VACCINATION SITE WARMTH (At the injection site it is warm) and VACCINATION SITE SWELLING (At the injection site it is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment information was not provided. Concomitant medication was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Mild fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Mild fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (Mild fever). At the time of the report, PYREXIA (Mild fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported.  Treatment medication was not reported.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: Event outcome and AE for husband reported. On 12-Apr-2021: Outgoing call to obtain email address, voice message left.