chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes in both arms; Swollen lymph nodes on both breasts; Swollen lymph nodes on neck; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm), LYMPHADENOPATHY (Swollen lymph nodes in both arms), LYMPHADENOPATHY (Swollen lymph nodes on both breasts) and LYMPHADENOPATHY (Swollen lymph nodes on neck) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On an unknown date, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes in both arms), LYMPHADENOPATHY (Swollen lymph nodes on both breasts) and LYMPHADENOPATHY (Swollen lymph nodes on neck). On 21-Mar-2021, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes in both arms), LYMPHADENOPATHY (Swollen lymph nodes on both breasts) and LYMPHADENOPATHY (Swollen lymph nodes on neck) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Foot started hurting really badly; Regular aches; Foot almost feels swollen; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Foot started hurting really badly), PAIN (Regular aches), PERIPHERAL SWELLING (Foot almost feels swollen) and HEADACHE (headache) in a 67-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.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Foot started hurting really badly), PAIN (Regular aches), PERIPHERAL SWELLING (Foot almost feels swollen) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Foot started hurting really badly), PAIN (Regular aches), PERIPHERAL SWELLING (Foot almost feels swollen) and HEADACHE (headache) outcome was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Pain in extremity, Vaccination site pain
Clinical narrative: pain; blood pressure was elevated; soreness; headaches on and off; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (pain), HYPERTENSION (blood pressure was elevated), VACCINATION SITE PAIN (soreness) and HEADACHE (headaches on and off) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 003A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain), HYPERTENSION (blood pressure was elevated), VACCINATION SITE PAIN (soreness) and HEADACHE (headaches on and off). At the time of the report, PAIN IN EXTREMITY (pain), HYPERTENSION (blood pressure was elevated), VACCINATION SITE PAIN (soreness) and HEADACHE (headaches on and off) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 127 elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-068610 (E2B Linked Report).; Sender's Comments:  MOD-2021-068610:First dose of vaccine case.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nasopharyngitis, Pyrexia
Clinical narrative: COLD LIKE SYMPTOMS; FEVER; CHILLS; FATIGUE; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (COLD LIKE SYMPTOMS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (COLD LIKE SYMPTOMS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form and IBUPROFEN at a dose of UNK dosage form. At the time of the report, NASOPHARYNGITIS (COLD LIKE SYMPTOMS), PYREXIA (FEVER), CHILLS (CHILLS) and FATIGUE (FATIGUE) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       For mRNA-1273 (Moderna COVID-19 Vaccine) (UNKNOWN ROUTE), the reporter did not provide any causality assessments. Concomitant product is not provided. treatment is not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm after first dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm after first dose) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No medical history was provided by reporter.  Concurrent medical conditions included Blood pressure abnormal and Thyroid disorder NOS. Concomitant products included VITAMINS NOS for an unknown indication.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm after first dose). At the time of the report, PAIN IN EXTREMITY (sore arm after first dose) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is on concomitant medications of blood pressure, thyroid, and vitamins. No treatment medication information was provided.   This case was linked to MODERNATX, INC.-MOD-2021-068306 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: TCR on 20-May-2021 included no new information.; Sender's Comments: MODERNATX, INC.-MOD-2021-068306:2nd Dose
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Pain in extremity
Clinical narrative: a little bit of shortness of breath; extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), DYSPNOEA (a little bit of shortness of breath) and FATIGUE (extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Tiredness. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 31-Mar-2021, the patient experienced DYSPNOEA (a little bit of shortness of breath) and FATIGUE (extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved and DYSPNOEA (a little bit of shortness of breath) and FATIGUE (extremely tired/she already feel tired after taking her meds but it worsens after receiving the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included muscle relaxant due to arthritis.  Description: The patient had a sore arm that went well, but 3 or 4 days ago (31 Mar 2021) she noticed that she had a little bit of shortness of breath and she was extremely tired. The patient reported  that she already felt tired after taking her medications but it worsened after receiving the vaccine.  No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Nausea, Pain, Pain in extremity, Vaccination site erythema
Clinical narrative: hardness at the injection site; the injection site was really red; the injection site was really raised; vomiting; nausea; I was achy; arm became sore; slept for 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE ERYTHEMA (the injection site was really red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vaccination adverse reaction (Had reactions, similar to current vaccination ADR, after having a shingles vaccine a few months prior.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 26-Mar-2021, the patient experienced PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VOMITING (vomiting) and NAUSEA (nausea). On 27-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (the injection site was really red) and VACCINATION SITE SWELLING (the injection site was really raised). On 27-Mar-2021, VOMITING (vomiting) and NAUSEA (nausea) had resolved. On 28-Mar-2021, PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (the injection site was really red) and VACCINATION SITE SWELLING (the injection site was really raised) had resolved.            Treatment was taken for the events with Tylenol. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling, Vomiting
Clinical narrative: hardness at the injection site; the injection site was really red; the injection site was really raised; vomiting; nausea; I was achy; arm became sore; slept for 18 hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE ERYTHEMA (the injection site was really red) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 032L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vaccination adverse reaction (Had reactions, similar to current vaccination ADR, after having a shingles vaccine a few months prior.).   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to dosage form. On 26-Mar-2021, the patient experienced PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VOMITING (vomiting) and NAUSEA (nausea). On 27-Mar-2021, the patient experienced VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (the injection site was really red) and VACCINATION SITE SWELLING (the injection site was really raised). On 27-Mar-2021, VOMITING (vomiting) and NAUSEA (nausea) had resolved. On 28-Mar-2021, PAIN (I was achy), PAIN IN EXTREMITY (arm became sore), HYPERSOMNIA (slept for 18 hours), VACCINATION SITE INDURATION (hardness at the injection site), VACCINATION SITE ERYTHEMA (the injection site was really red) and VACCINATION SITE SWELLING (the injection site was really raised) had resolved.            Treatment was taken for the events with Tylenol. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: tenderness at the injection site; a little bit of fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (a little bit of fatigue) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 03814211A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy. Concomitant products included IBUPROFEN, GABAPENTIN, DULOXETINE HYDROCHLORIDE (CYMBALTA), CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (tenderness at the injection site) and FATIGUE (a little bit of fatigue). On 13-Mar-2021, VACCINATION SITE PAIN (tenderness at the injection site) had resolved. On 14-Mar-2021, FATIGUE (a little bit of fatigue) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concomitant medications included Vitamins.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; headaches; muscle pain; chills; chest pain; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (headaches), MYALGIA (muscle pain), CHILLS (chills) and CHEST PAIN (chest pain) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (headaches), MYALGIA (muscle pain), CHILLS (chills) and CHEST PAIN (chest pain). At the time of the report, FATIGUE (Fatigue), HEADACHE (headaches), MYALGIA (muscle pain), CHILLS (chills) and CHEST PAIN (chest pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dyspnoea, Fatigue, Pain, Pain in extremity
Clinical narrative: Fatigue; sore arm; Body ache; Stomach ache; Shortness of breath; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), ABDOMINAL PAIN UPPER (Stomach ache) and DYSPNOEA (Shortness of breath) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 03-Apr-2021, the patient experienced FATIGUE (Fatigue), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 102F). At the time of the report, FATIGUE (Fatigue), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 102F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 (High) 102 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue; sore arm; Body ache; Stomach ache; Shortness of breath; Fever of 102F; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), ABDOMINAL PAIN UPPER (Stomach ache) and DYSPNOEA (Shortness of breath) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 03-Apr-2021, the patient experienced FATIGUE (Fatigue), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 102F). At the time of the report, FATIGUE (Fatigue), PAIN IN EXTREMITY (sore arm), PAIN (Body ache), ABDOMINAL PAIN UPPER (Stomach ache), DYSPNOEA (Shortness of breath) and PYREXIA (Fever of 102F) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102 (High) 102 degree Fahrenheit.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose was administered to a patient after the punctured vial has been out for more than 12hrs; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient after the punctured vial has been out for more than 12hrs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient after the punctured vial has been out for more than 12hrs). On 03-Apr-2021, EXPIRED PRODUCT ADMINISTERED (A dose was administered to a patient after the punctured vial has been out for more than 12hrs) 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.   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Initial Additional-1
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on chest after 1st dose; Rash all over back after 2nd dose; Itchy rash on legs and chest after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on chest after 1st dose), RASH (Rash all over back after 2nd dose) and RASH (Itchy rash on legs and chest after 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006m20 and 007b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Rash on chest after 1st dose), RASH (Rash all over back after 2nd dose) and RASH (Itchy rash on legs and chest after 2nd dose). The patient was treated with TRIAMCINOLONE ACETONIDE for Itch, at an unspecified dose and frequency and HYDROXYZINE HYDROCHLORIDE (HYDROXIZINE) for Itch, at an unspecified dose and frequency. At the time of the report, RASH (Rash on chest after 1st dose), RASH (Rash all over back after 2nd dose) and RASH (Itchy rash on legs and chest after 2nd dose) outcome was unknown. Not Provided
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oropharyngeal pain, Peripheral swelling, Pyrexia, Vaccination site erythema, Vaccination site mass
Clinical narrative: lump at injection site; Both hands swollen; sore throat; Fever; Swollen Arm at Injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever) and VACCINATION SITE SWELLING (Swollen Arm at Injection site) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). On 09-Mar-2021, VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071028:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site swelling
Clinical narrative: lump at injection site; Both hands swollen; sore throat; Fever; Swollen Arm at Injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever) and VACCINATION SITE SWELLING (Swollen Arm at Injection site) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). On 09-Mar-2021, VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071028:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Chills, Pain, Pyrexia, Vomiting
Clinical narrative: lump at injection site; Both hands swollen; sore throat; Fever; Swollen Arm at Injection site; redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever) and VACCINATION SITE SWELLING (Swollen Arm at Injection site) in a 22-year-old female patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 05-Mar-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) 1 dosage form. On 05-Mar-2021, the patient experienced VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site). On 09-Mar-2021, VACCINATION SITE MASS (lump at injection site), PERIPHERAL SWELLING (Both hands swollen), OROPHARYNGEAL PAIN (sore throat), PYREXIA (Fever), VACCINATION SITE SWELLING (Swollen Arm at Injection site) and VACCINATION SITE ERYTHEMA (redness at injection site) had resolved.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) was unknown.       no concomitant medications reported. no treatment details reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-071028 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071028:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gingival bleeding, Headache, Laryngeal papilloma, Oropharyngeal pain
Clinical narrative: Tingling of pins and needles of leg; Achiness of feet; Sore throat; continous sore throat; severe sore throat from a procedure; Mild bleeding gums once a week; Growth to back of throat next to uvula; papilloma removed from the; Irritation in her throat since having the papilloma removed; pharyngeal mass; Headache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week) and LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the) in a 48-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.     The patient's past medical history included Papilloma excision on 18-Mar-2021. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT), SILDENAFIL CITRATE and WARFARIN for an unknown indication.    On 19-Mar-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 PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass) and HEADACHE (Headache) outcome was unknown and CHILLS (Chills) and PYREXIA (Low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pain assessment: 6.00 (Inconclusive) Rated 6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Pain in extremity, Paraesthesia, Pharyngeal mass, Pyrexia
Clinical narrative: Tingling of pins and needles of leg; Achiness of feet; Sore throat; continous sore throat; severe sore throat from a procedure; Mild bleeding gums once a week; Growth to back of throat next to uvula; papilloma removed from the; Irritation in her throat since having the papilloma removed; pharyngeal mass; Headache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week) and LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the) in a 48-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.     The patient's past medical history included Papilloma excision on 18-Mar-2021. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT), SILDENAFIL CITRATE and WARFARIN for an unknown indication.    On 19-Mar-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 PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass) and HEADACHE (Headache) outcome was unknown and CHILLS (Chills) and PYREXIA (Low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pain assessment: 6.00 (Inconclusive) Rated 6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Tingling of pins and needles of leg; Achiness of feet; Sore throat; continous sore throat; severe sore throat from a procedure; Mild bleeding gums once a week; Growth to back of throat next to uvula; papilloma removed from the; Irritation in her throat since having the papilloma removed; pharyngeal mass; Headache; Chills; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week) and LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the) in a 48-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.     The patient's past medical history included Papilloma excision on 18-Mar-2021. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included MACITENTAN (OPSUMIT), SILDENAFIL CITRATE and WARFARIN for an unknown indication.    On 19-Mar-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 PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Tingling of pins and needles of leg), PAIN IN EXTREMITY (Achiness of feet), OROPHARYNGEAL PAIN (Sore throat; continous sore throat; severe sore throat from a procedure), GINGIVAL BLEEDING (Mild bleeding gums once a week), LARYNGEAL PAPILLOMA (Growth to back of throat next to uvula; papilloma removed from the), THROAT IRRITATION (Irritation in her throat since having the papilloma removed), PHARYNGEAL MASS (pharyngeal mass) and HEADACHE (Headache) outcome was unknown and CHILLS (Chills) and PYREXIA (Low grade fever) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Pain assessment: 6.00 (Inconclusive) Rated 6.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Lymphadenopathy, Throat irritation
Clinical narrative: annoyance in the throat/throat is itchy; annoyance in lymph nodes; Cough; tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), THROAT IRRITATION (annoyance in the throat/throat is itchy), LYMPHADENOPATHY (annoyance in lymph nodes) and COUGH (Cough) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for an unknown indication.    On 14-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 14-Mar-2021, the patient experienced FATIGUE (tired). On 17-Mar-2021, the patient experienced THROAT IRRITATION (annoyance in the throat/throat is itchy), LYMPHADENOPATHY (annoyance in lymph nodes) and COUGH (Cough). At the time of the report, FATIGUE (tired), THROAT IRRITATION (annoyance in the throat/throat is itchy), LYMPHADENOPATHY (annoyance in lymph nodes) and COUGH (Cough) outcome was unknown.            no treatment details reported.   This case was linked to MOD21-037471, MOD21-030926 (E2B Linked Report). This case was linked to MOD-2021-014998 (Patient Link).; Sender's Comments:  MOD21-037471: MOD21-030926:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Vaccination site rash
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of bone pain (bone/joint pain), vaccination site rash (rash at injection site) and arthralgia (bone/joint pain) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 00137959) for COVID-19 immunization. No medical history reported. On Mar 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 6, 2021, patient experienced bone pain (bone/joint pain), vaccination site rash (rash at injection site) and arthralgia (bone/joint pain). At the time of the report, bone pain (bone/joint pain), vaccination site rash (rash at injection site) and arthralgia (bone/joint pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Pain in extremity
Clinical narrative: Arm Soreness; Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm Soreness) and MENSTRUAL DISORDER (Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 004C21A) for COVID-19 vaccination.     Concurrent medical conditions included Polycystic ovarian syndrome.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm Soreness) and MENSTRUAL DISORDER (Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days). At the time of the report, PAIN IN EXTREMITY (Arm Soreness) outcome was unknown and MENSTRUAL DISORDER (Menstrual period started early/Menstrual blood looks different,bleed on and off for 10 days) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was unknown by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Followup received on 26-may-2021 , reported contact details, AE details and and second dose start date were updated.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Pain in extremity
Clinical narrative: pain woke her up at 3am and she could not sleep; Pain in arm.Could not move her arm out from her body; shoulder was "killing" her.cannot move her shoulder as it hurts; This spontaneous case was reported by an other and describes the occurrence of ARTHRALGIA (shoulder was "killing" her.cannot move her shoulder as it hurts), INSOMNIA (pain woke her up at 3am and she could not sleep) and PAIN IN EXTREMITY (Pain in arm.Could not move her arm out from her body) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     The patient's past medical history included no adverse event.    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-2021, the patient experienced ARTHRALGIA (shoulder was "killing" her.cannot move her shoulder as it hurts). On 06-Apr-2021, the patient experienced INSOMNIA (pain woke her up at 3am and she could not sleep) and PAIN IN EXTREMITY (Pain in arm.Could not move her arm out from her body). The patient was treated with IBUPROFEN on 05-Apr-2021 for Pain, at a dose of 600 mg once a day. At the time of the report, ARTHRALGIA (shoulder was "killing" her.cannot move her shoulder as it hurts), INSOMNIA (pain woke her up at 3am and she could not sleep) and PAIN IN EXTREMITY (Pain in arm.Could not move her arm out from her body) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications reported.
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis, Hypersensitivity
Clinical narrative: 16 nose bleeds since vaccination; allergies were acting up; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (16 nose bleeds since vaccination) and HYPERSENSITIVITY (allergies were acting up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypersensitivity (Not specified). Concomitant products included LORATADINE for Allergy.    In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced EPISTAXIS (16 nose bleeds since vaccination) and HYPERSENSITIVITY (allergies were acting up). At the time of the report, EPISTAXIS (16 nose bleeds since vaccination) and HYPERSENSITIVITY (allergies were acting up) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient stated that due to unspecified allergies outburst, he was taking Loratadine three times a day instead of once. The patient also noted that after he stopped taking the Loratadine the nose bleeds stopped as well. No treatment information was provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-Jun-2021: Event added and concomitant medication was added.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Itchy rash on legs and chest after 2nd dose; Rash all over back after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on legs and chest after 2nd dose) and RASH (Rash all over back after 2nd dose) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007b21a) for COVID-19 vaccination.     The patient's past medical history included No adverse event (not reported).    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, the patient experienced RASH PRURITIC (Itchy rash on legs and chest after 2nd dose) and RASH (Rash all over back after 2nd dose). The patient was treated with TRIAMCINOLONE for Itch, at an unspecified dose and frequency and HYDROXYZINE for Itch, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on legs and chest after 2nd dose) and RASH (Rash all over back after 2nd dose) had not resolved.            no concomitant medications reported.   This case was linked to MOD21-070169 (E2B Linked Report).; Sender's Comments:  MOD21-070169:MOD-2021-068630  1st dose case
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: active shingles rash; This spontaneous case was reported by a pharmacist and describes the occurrence of HERPES ZOSTER (active shingles rash) in an 87-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.    On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (active shingles rash). At the time of the report, HERPES ZOSTER (active shingles rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   no concomitant medications reported. no treatment details reported.
Age: 98.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye pruritus, Pruritus
Clinical narrative: she experienced redness around her neck; got itchy; itchy eyes; itching on the head; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA, PRURITUS, EYE PRURITUS, and PRURITUS in a 98-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. Concomitant products included TOPROL, LOSARTAN, LEVOTHYROXINE SODIUM, and LEXAPRO for an unknown indication.    On 16-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced ERYTHEMA, PRURITUS, EYE PRURITUS, and PRURITUS. On 16-Mar-2021, ERYTHEMA had resolved. On 17-Mar-2021, PRURITUS, EYE PRURITUS, and PRURITUS had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no treatment details reported.   This case was linked to MOD21-070112, MOD21-055367, US-MODERNATX, INC MOD-2021-068792.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: F/u received on 12 may 2021, reporter contact information updated. Sender's Comments:  MOD21-070112: MOD21-055367: US-MODERNATX, INC MOD-2021-068792.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Caller reports that people she knows got sick from moderna 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 ILLNESS (Caller reports that people she knows got sick from moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.  The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced ILLNESS (Caller reports that people she knows got sick from moderna vaccine). At the time of the report, ILLNESS (Caller reports that people she knows got sick from moderna vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported.  Treatment information not provided.     This case was linked to MOD21-070412, US-MODERNATX, INC.-MOD-2021-068360, US-MODERNATX, INC.-MOD-2021-068394 (Linked Report).; Sender's Comments:  MOD21-070412: US-MODERNATX, INC.-MOD-2021-068360: US-MODERNATX, INC.-MOD-2021-068394:
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIARRHOEA (diarrhea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       no concomitant medications reported. no treatment details reported.