chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: a little tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (a little tired) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 027B21A) for COVID-19 vaccination.     Concomitant products included PRAVASTATIN, VENLAFAXINE and LEVOTHYROXINE for an unknown indication.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced FATIGUE (a little tired). At the time of the report, FATIGUE (a little tired) outcome was unknown. Not Provided          Patient reports taking pain medicine and ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-071227 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071227:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Illness
Clinical narrative: felt sick; FATIGUE; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (felt sick) and FATIGUE (FATIGUE) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 007B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021, the patient experienced ILLNESS (felt sick) and FATIGUE (FATIGUE). At the time of the report, ILLNESS (felt sick) and FATIGUE (FATIGUE) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment information were reported by the reporter  Patient had covid in month of july and December 2020   This case was linked to US-MODERNATX, INC.-MOD-2021-071237 (E2B Linked Report). This case was linked to MOD-2021-071237 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071237:CROSS LINKED TO DOSE 2
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Chills; myalgia; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS, MYALGIA, NAUSEA, and HEADACHE in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEXAPRO and RISPERIDONE for an unknown indication.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced CHILLS, MYALGIA, NAUSEA, and HEADACHE. At the time of the report, CHILLS, MYALGIA, NAUSEA, and HEADACHE outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Apr-2021, Pyrexia: 101.7 (High).         Patient asked if she could take Tylenol for her symptoms, no other treatment medications were provided.
Sex: U
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Did not receive their 2nd dose (missed 2nd dose); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Did not receive their 2nd dose (missed 2nd dose)) 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 Exposure to COVID-19 (patient may have been exposed to their family member who tested positive).    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Did not receive their 2nd dose (missed 2nd dose)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Did not receive their 2nd dose (missed 2nd dose)) had resolved. 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 product use was not provided by the reporter.  Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Patient is having abdominal cramps; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Patient is having abdominal cramps) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Patient is having abdominal cramps). At the time of the report, ABDOMINAL PAIN (Patient is having abdominal cramps) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Fatigue, Lymphadenopathy, Vaccination complication, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (Axillary lump), VACCINATION COMPLICATION (She had a bad reaction with the first dose), VACCINATION SITE PAIN (Pain at injection left arm), FATIGUE (Fatigue) and LYMPHADENOPATHY (Swollen lymph node) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at injection left arm) and FATIGUE (Fatigue). On 31-Mar-2021, the patient experienced AXILLARY MASS (Axillary lump) and LYMPHADENOPATHY (Swollen lymph node). On an unknown date, the patient experienced VACCINATION COMPLICATION (She had a bad reaction with the first dose). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and Bed rest for Axillary mass. On 28-Mar-2021, VACCINATION SITE PAIN (Pain at injection left arm) had resolved. On 31-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, AXILLARY MASS (Axillary lump), VACCINATION COMPLICATION (She had a bad reaction with the first dose) and LYMPHADENOPATHY (Swollen lymph node) 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.  Treatment information also included heating pad.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Significant Follow up Appended - Reporter mail address updated and new event added and second dose information was updated.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications and treatment information was provided.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Covid-19 POSITIVE; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SARS-COV-2 TEST POSITIVE (Covid-19 POSITIVE) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included No adverse event (No Medical history or known allergies reported.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, the patient experienced SARS-COV-2 TEST POSITIVE (Covid-19 POSITIVE). At the time of the report, SARS-COV-2 TEST POSITIVE (Covid-19 POSITIVE) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Apr-2021, COVID-19: positive positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant or treatment medications listed. Patient reports after receiving Covid-19 vaccine he tested positive for Covid-19 on 03-APR-2021 and did not take any medication to treat the illness.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia, Tinnitus
Clinical narrative: Ringing in his ear / fluttery feeling and sounds in his ear; Still not feeling great; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in his ear / fluttery feeling and sounds in his ear), MALAISE (Still not feeling great) and MYALGIA (Body aches) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for an unreported indication: TETANUS VACCINE (Got a tetanus shot two weeks after the first dose).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced TINNITUS (Ringing in his ear / fluttery feeling and sounds in his ear), MALAISE (Still not feeling great) and MYALGIA (Body aches). At the time of the report, TINNITUS (Ringing in his ear / fluttery feeling and sounds in his ear), MALAISE (Still not feeling great) and MYALGIA (Body aches) outcome was unknown.            No concomitant medications were reported. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Oropharyngeal pain, Pain in extremity, Pyrexia
Clinical narrative: Sore throat at night after injection; achy right arm at night after injection; Fever at night after injection; achy muscles at night after injection; headache at night after injection; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat at night after injection), PAIN IN EXTREMITY (achy right arm at night after injection), PYREXIA (Fever at night after injection), MYALGIA (achy muscles at night after injection) and HEADACHE (headache at night after injection) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A and 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat at night after injection), PAIN IN EXTREMITY (achy right arm at night after injection), PYREXIA (Fever at night after injection), MYALGIA (achy muscles at night after injection) and HEADACHE (headache at night after injection). At the time of the report, OROPHARYNGEAL PAIN (Sore throat at night after injection), PAIN IN EXTREMITY (achy right arm at night after injection), PYREXIA (Fever at night after injection), MYALGIA (achy muscles at night after injection) and HEADACHE (headache at night after injection) had not resolved. Not Provided          No concomitant and treatment medications were not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Hypokinesia, Inappropriate schedule of product administration, Malaise, Pain
Clinical narrative: a fever 99.6; severe lower back pain; she can hardly move/she can hardly sit; very hard to get comfortable; a very intense pain; caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)), PYREXIA (a fever 99.6), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit) and MALAISE (very hard to get comfortable) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)). On 05-Apr-2021, the patient experienced PYREXIA (a fever 99.6), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit), MALAISE (very hard to get comfortable) and PAIN (a very intense pain). On 06-Apr-2021, PYREXIA (a fever 99.6) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit), MALAISE (very hard to get comfortable) and PAIN (a very intense pain) outcome was unknown.            Concomitants: Levothyroxine 88 mcg, Venlafaxine, Pravastatin 20 mg Treatment Pain medicine. Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-071215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071215:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: a fever 99.6; severe lower back pain; she can hardly move/she can hardly sit; very hard to get comfortable; a very intense pain; caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021); This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)), PYREXIA (a fever 99.6), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit) and MALAISE (very hard to get comfortable) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)). On 05-Apr-2021, the patient experienced PYREXIA (a fever 99.6), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit), MALAISE (very hard to get comfortable) and PAIN (a very intense pain). On 06-Apr-2021, PYREXIA (a fever 99.6) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (caller received 2nd dose on 03Apr2021 (1st dose was on 30Jan2021)), BACK PAIN (severe lower back pain), HYPOKINESIA (she can hardly move/she can hardly sit), MALAISE (very hard to get comfortable) and PAIN (a very intense pain) outcome was unknown.            Concomitants: Levothyroxine 88 mcg, Venlafaxine, Pravastatin 20 mg Treatment Pain medicine. Ibuprofen.   This case was linked to US-MODERNATX, INC.-MOD-2021-071215 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071215:
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache for 3 days) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma (Patient uses Asthma Inhalers (Not Steroid).).    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 HEADACHE (Headache for 3 days). On 21-Mar-2021, HEADACHE (Headache for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided No treatment medications were provided   This case was linked to US-MODERNATX, INC.-MOD-2021-071187 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071187:mother case
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Pain in arm; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and HEADACHE (slight headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination.     Concomitant products included FAMOTIDINE for Heartburn, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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 PAIN IN EXTREMITY (Pain in arm) and HEADACHE (slight headache). At the time of the report, PAIN IN EXTREMITY (Pain in arm) and HEADACHE (slight headache) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-071238 (Patient Link).
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, SARS-CoV-2 test negative
Clinical narrative: lost all sense of taste and still can't taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (lost all sense of taste and still can't taste) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013M20A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included LOSARTAN, AMLODIPINE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (lost all sense of taste and still can't taste). At the time of the report, AGEUSIA (lost all sense of taste and still can't taste) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, SARS-CoV-2 test negative: negative negative.         No treatment medications were not provided.   This case was linked to MOD-2021-071678 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INJECTED LIMB MOBILITY DECREASED (can not lift up) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported.  On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021 at 8:00 PM, the patient experienced PAIN IN EXTREMITY (sore arm) and INJECTED LIMB MOBILITY DECREASED (can not lift up). At the time of the report, PAIN IN EXTREMITY (sore arm) and INJECTED LIMB MOBILITY DECREASED (can not lift up) had resolved. Not Provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: TCR  information received on 08JUL2021 contains significant information outcome recovered.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Administration of a third dose of an mRNA vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Administration of a third dose of an mRNA vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Administration of a third dose of an mRNA vaccine). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Administration of a third dose of an mRNA vaccine) outcome was unknown. Not Provided      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 not provided. No treatment medications were not provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Itching; Red rash in her chest, arms, and shoulders; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in her chest, arms, and shoulders) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in her chest, arms, and shoulders). At the time of the report, PRURITUS (Itching) and RASH ERYTHEMATOUS (Red rash in her chest, arms, and shoulders) had not resolved. Not Provided          No concomitant medications were reported. No treatment information was provided.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: rash at injection site; puffy injection site; itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (puffy injection site) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (itching at the injection site). On 08-Apr-2021, the patient experienced VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (puffy injection site). At the time of the report, VACCINATION SITE PRURITUS (itching at the injection site), VACCINATION SITE RASH (rash at injection site) and VACCINATION SITE SWELLING (puffy injection site) 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. No treatment information was provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia eye, Paraesthesia, Paraesthesia oral, Periorbital swelling
Clinical narrative: lips started tingling and that feeling went into cheeks and progressed under her eyes; tingling in her cheeks lips and seemed to be more on her right side; Eyes were slightly numb; Eyes were slightly puffy; This spontaneous case was reported by a physician assistant (subsequently medically confirmed) and describes the occurrence of PARAESTHESIA ORAL (lips started tingling and that feeling went into cheeks and progressed under her eyes), PARAESTHESIA (tingling in her cheeks lips and seemed to be more on her right side), HYPOAESTHESIA EYE (Eyes were slightly numb) and PERIORBITAL SWELLING (Eyes were slightly puffy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Headache ("The patient had a headache 3 days before the shot.") on 23-Mar-2021. Concomitant products included ESTRADIOL, FAMOTIDINE (PEPCID AC) and ALPRAZOLAM (XANAX).   On 26-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced PARAESTHESIA ORAL (lips started tingling and that feeling went into cheeks and progressed under her eyes), PARAESTHESIA (tingling in her cheeks lips and seemed to be more on her right side), HYPOAESTHESIA EYE (Eyes were slightly numb) and PERIORBITAL SWELLING (Eyes were slightly puffy). On 05-Apr-2021, PARAESTHESIA ORAL (lips started tingling and that feeling went into cheeks and progressed under her eyes), PARAESTHESIA (tingling in her cheeks lips and seemed to be more on her right side), HYPOAESTHESIA EYE (Eyes were slightly numb) and PERIORBITAL SWELLING (Eyes were slightly puffy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.; 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: Product administration error
Clinical narrative: Possible incorrect administration of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 023M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in July 2020 and COVID-19 in December 2020.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 07-Apr-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose). At the time of the report, PRODUCT ADMINISTRATION ERROR (Possible incorrect administration of the second dose) had resolved. Not Provided          Concomitant medications were not reported.    This case was linked to US-MODERNATX, INC.-MOD-2021-071216 (E2B Linked Report). This case was linked to MOD-2021-071216 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071216:CROSS LINKED TO DOSE 2
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Ear pain, Eye pain, Feeling abnormal
Clinical narrative: leg pain; he has symptoms of Covid 19; Eyes are runny; pain throughout his body; eyes and ears bother him the most; eyes and ears bother him the most; Brain fog couple of times; chills; diziness; head itches; Stayed home; got hot, but not a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body) and EAR PAIN (eyes and ears bother him the most) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse drug reaction NOS with Flu shot. Concurrent medical conditions included Dyspepsia, Allergic reaction to antibiotics (Tetracycline) and Allergy to chemicals (sulfur). Concomitant products included FAMOTIDINE for Heartburn, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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 FEELING HOT (got hot, but not a fever) and IMPAIRED WORK ABILITY (Stayed home). On 07-Apr-2021, the patient experienced DIZZINESS (diziness) and PRURITUS (head itches). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING ABNORMAL (Brain fog couple of times) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING HOT (got hot, but not a fever), DIZZINESS (diziness), FEELING ABNORMAL (Brain fog couple of times), PRURITUS (head itches), IMPAIRED WORK ABILITY (Stayed home) and CHILLS (chills) outcome was unknown. Not Provided          No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-071229 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Impaired work ability, Lacrimation increased, Pain, Pain in extremity
Clinical narrative: leg pain; he has symptoms of Covid 19; Eyes are runny; pain throughout his body; eyes and ears bother him the most; eyes and ears bother him the most; Brain fog couple of times; chills; diziness; head itches; Stayed home; got hot, but not a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body) and EAR PAIN (eyes and ears bother him the most) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse drug reaction NOS with Flu shot. Concurrent medical conditions included Dyspepsia, Allergic reaction to antibiotics (Tetracycline) and Allergy to chemicals (sulfur). Concomitant products included FAMOTIDINE for Heartburn, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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 FEELING HOT (got hot, but not a fever) and IMPAIRED WORK ABILITY (Stayed home). On 07-Apr-2021, the patient experienced DIZZINESS (diziness) and PRURITUS (head itches). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING ABNORMAL (Brain fog couple of times) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING HOT (got hot, but not a fever), DIZZINESS (diziness), FEELING ABNORMAL (Brain fog couple of times), PRURITUS (head itches), IMPAIRED WORK ABILITY (Stayed home) and CHILLS (chills) outcome was unknown. Not Provided          No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-071229 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Suspected COVID-19
Clinical narrative: leg pain; he has symptoms of Covid 19; Eyes are runny; pain throughout his body; eyes and ears bother him the most; eyes and ears bother him the most; Brain fog couple of times; chills; diziness; head itches; Stayed home; got hot, but not a fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body) and EAR PAIN (eyes and ears bother him the most) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Adverse drug reaction NOS with Flu shot. Concurrent medical conditions included Dyspepsia, Allergic reaction to antibiotics (Tetracycline) and Allergy to chemicals (sulfur). Concomitant products included FAMOTIDINE for Heartburn, VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Apr-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 FEELING HOT (got hot, but not a fever) and IMPAIRED WORK ABILITY (Stayed home). On 07-Apr-2021, the patient experienced DIZZINESS (diziness) and PRURITUS (head itches). On an unknown date, the patient experienced PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING ABNORMAL (Brain fog couple of times) and CHILLS (chills). At the time of the report, PAIN IN EXTREMITY (leg pain), SUSPECTED COVID-19 (he has symptoms of Covid 19), LACRIMATION INCREASED (Eyes are runny), PAIN (pain throughout his body), EAR PAIN (eyes and ears bother him the most), EYE PAIN (eyes and ears bother him the most), FEELING HOT (got hot, but not a fever), DIZZINESS (diziness), FEELING ABNORMAL (Brain fog couple of times), PRURITUS (head itches), IMPAIRED WORK ABILITY (Stayed home) and CHILLS (chills) outcome was unknown. Not Provided          No treatment medications were reported.  Action taken with mRNA-1273 in response to the events was not Applicable.   This case was linked to MOD-2021-071229 (Patient Link).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Fatigue, Ocular discomfort, Tachycardia
Clinical narrative: Heaviness in the eyes; Dizziness; Chest pain; Rapid heart rate; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), TACHYCARDIA (Rapid heart rate), OCULAR DISCOMFORT (Heaviness in the eyes), DIZZINESS (Dizziness) and FATIGUE (fatigue) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2020,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (fatigue). On 24-Mar-2021, the patient experienced CHEST PAIN (Chest pain) and TACHYCARDIA (Rapid heart rate). On 25-Mar-2021, the patient experienced OCULAR DISCOMFORT (Heaviness in the eyes) and DIZZINESS (Dizziness). At the time of the report, CHEST PAIN (Chest pain), TACHYCARDIA (Rapid heart rate), OCULAR DISCOMFORT (Heaviness in the eyes), DIZZINESS (Dizziness) and FATIGUE (fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.   Treatment included unspecified anxiety medication.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Vaccination site paraesthesia
Clinical narrative: hand tingling; Face tingling on the right side; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PARAESTHESIA (hand tingling) and PARAESTHESIA (Face tingling on the right side) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     Concomitant products included ROSUVASTATIN, BUPROPION HYDROCHLORIDE (BUPROPION HCL XL), CINITAPRIDE and PIOGLITAZONE for an unknown indication.    On 02-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 VACCINATION SITE PARAESTHESIA (hand tingling) and PARAESTHESIA (Face tingling on the right side). At the time of the report, VACCINATION SITE PARAESTHESIA (hand tingling) and PARAESTHESIA (Face tingling on the right side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Night sweats, Pyrexia
Clinical narrative: Night sweats; Bad sweating; Bad itching in hand; Severe Chills; Fever; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VACCINATION SITE PRURITUS (Bad itching in hand), CHILLS (Severe Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VACCINATION SITE PRURITUS (Bad itching in hand), CHILLS (Severe Chills), PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 08-Apr-2021, HYPERHIDROSIS (Bad sweating) was resolving. At the time of the report, NIGHT SWEATS (Night sweats), CHILLS (Severe Chills), PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache) was resolving and VACCINATION SITE PRURITUS (Bad itching in hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-071399 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071399:Husband case
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vomiting
Clinical narrative: Night sweats; Bad sweating; Bad itching in hand; Severe Chills; Fever; Vomiting; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VACCINATION SITE PRURITUS (Bad itching in hand), CHILLS (Severe Chills) and PYREXIA (Fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.    On 06-Apr-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced NIGHT SWEATS (Night sweats), HYPERHIDROSIS (Bad sweating), VACCINATION SITE PRURITUS (Bad itching in hand), CHILLS (Severe Chills), PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache). The patient was treated with ONDANSETRON HYDROCHLORIDE (ZOFRAN [ONDANSETRON HYDROCHLORIDE]) for Nausea, at an unspecified dose and frequency and NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency. On 08-Apr-2021, HYPERHIDROSIS (Bad sweating) was resolving. At the time of the report, NIGHT SWEATS (Night sweats), CHILLS (Severe Chills), PYREXIA (Fever), VOMITING (Vomiting) and HEADACHE (Headache) was resolving and VACCINATION SITE PRURITUS (Bad itching in hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant product use was not provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2021-071399 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-071399:Husband case
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Fatigue, Headache, Hypokinesia, Malaise
Clinical narrative: she cannot move; waking up in the middle of the night due to pain; hives popped up on the injection site; fatigue; headache; fever; 3 inches wheal on arm of injection site- allergic and inflamed; feeling unwell; mild transient side effects; scratchy throat; This spontaneous case was reported by a physician and describes the occurrence of ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), HYPOKINESIA (she cannot move), MALAISE (feeling unwell) and PAIN (waking up in the middle of the night due to pain) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), MALAISE (feeling unwell), VACCINATION SITE REACTION (3 inches wheal on arm of injection site- allergic and inflamed), PYREXIA (fever) and HEADACHE (headache). On 07-Apr-2021, the patient experienced VACCINATION SITE URTICARIA (hives popped up on the injection site) and FATIGUE (fatigue). On an unknown date, the patient experienced HYPOKINESIA (she cannot move) and PAIN (waking up in the middle of the night due to pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and CIMETIDINE (TAGAMET [CIMETIDINE]) at an unspecified dose and frequency. At the time of the report, ADVERSE EVENT (mild transient side effects), OROPHARYNGEAL DISCOMFORT (scratchy throat), HYPOKINESIA (she cannot move), MALAISE (feeling unwell), PAIN (waking up in the middle of the night due to pain), VACCINATION SITE REACTION (3 inches wheal on arm of injection site- allergic and inflamed), VACCINATION SITE URTICARIA (hives popped up on the injection site), PYREXIA (fever), FATIGUE (fatigue) and HEADACHE (headache) outcome was unknown. Not Provided      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 product  use was reported.