chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  Healthcare provider (HCP), an emergency medical technician, reported that they administered 2 lot numbers of the Moderna Covid-19 vaccine which had been stored in the refrigerator for more than 30 days to 18 patients. They said 2 lots - 039B21A, expiration date 02Oct2021 and 048B21A, expiration date 09Oct2021 - were placed in the refrigerator on 18Jun2021. HCP claimed that the vaccines did not experience temperature excursion while in the refrigerator. They wanted to seek guidance as to how to proceed in this situation e.g whether they should give an extra dose or not.  No treatment medications were provided.  Crosslinked with MOD21-122955, MOD21-122994, MOD21-122995, MOD21-122996, MOD21-122997, MOD21-122998, MOD21-122999, MOD21-123000, MOD21-123001, MOD21-123002, MOD21-123003, MOD21-123004, MOD21-123005, MOD21-123006, MOD21-123007, MOD21-123008 and MOD21-123009.   This case was linked to MOD-2021-265450 (Patient Link).
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin; Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) and RASH (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) and RASH (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin). At the time of the report, URTICARIA (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) and RASH (Spandex rash around his pelvic area and it burns like fire or like somebody taking a knife and sticking into his skin) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Device connection issue
Clinical narrative: The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.; After the injection a bit of liquid came off of the vaccination wound; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL UNDERDOSE (After the injection a bit of liquid came off of the vaccination wound) and DEVICE CONNECTION ISSUE (The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, CLONAZEPAM (CLONAZEPAM AUDEN) and BUPROPION HYDROCHLORIDE (WELLBUTRIN SR) for an unknown indication.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced ACCIDENTAL UNDERDOSE (After the injection a bit of liquid came off of the vaccination wound). On an unknown date, the patient experienced DEVICE CONNECTION ISSUE (The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.). At the time of the report, ACCIDENTAL UNDERDOSE (After the injection a bit of liquid came off of the vaccination wound) and DEVICE CONNECTION ISSUE (The first dose was applied to the upper left arm whit a long needle, after the injection a bit of liquid came off of the vaccination wound.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   This case was linked to MOD-2021-265748 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Jul-2021: no new information received. On 07-Oct-2021: Non-Significant followup  information included no new information
Sex: U
Vaccine: COVID19
Symptoms: Eye pain, Eye swelling
Clinical narrative: Left eye swelling above the right eyebrow area.; Left eye pain; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Left eye swelling above the right eyebrow area.) and EYE PAIN (Left eye pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-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 EYE SWELLING (Left eye swelling above the right eyebrow area.) and EYE PAIN (Left eye pain). At the time of the report, EYE SWELLING (Left eye swelling above the right eyebrow area.) and EYE PAIN (Left eye pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.   Reporter did not allow further contact
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (She intentionally missed her second dose appointment on  11MAY2021 because she was  skeptical about the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no medical history reported).    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). At the time of the report, PRODUCT STORAGE ERROR (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site nodule, Vaccination site swelling
Clinical narrative: swelling in the injection site; lump in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE NODULE (lump in the injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE NODULE (lump in the injection site). At the time of the report, VACCINATION SITE SWELLING (swelling in the injection site) and VACCINATION SITE NODULE (lump in the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant medications were not reported.  The treatment information was  not provided.    Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Product dose omission issue
Clinical narrative: Patient did not receive the second dose of the Moderna COVID-19 vaccine within 35 days (first dose on 22APR2021); Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine within 35 days (first dose on 22APR2021)) and MYALGIA (Sore arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     Concomitant products included PIROXICAM (FELDENE) and VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for an unknown indication.    On 22-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 PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine within 35 days (first dose on 22APR2021)) and MYALGIA (Sore arm). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient did not receive the second dose of the Moderna COVID-19 vaccine within 35 days (first dose on 22APR2021)) and MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On 21-Jul-2021, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment information was provided.   This case was linked to MOD-2021-265450 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site pain
Clinical narrative: Developed an itching condition, have been under a doctors care since early March/Never had any kind of itching condition before/ itching with major areas on abdomen and back, but also affected scalp, arms, legs and buttocks; Injection site soreness; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Developed an itching condition, have been under a doctors care since early March/Never had any kind of itching condition before/ itching with major areas on abdomen and back, but also affected scalp, arms, legs and buttocks), VACCINATION SITE PAIN (Injection site soreness) and RASH (Rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041M20A and 12M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-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 PRURITUS (Developed an itching condition, have been under a doctors care since early March/Never had any kind of itching condition before/ itching with major areas on abdomen and back, but also affected scalp, arms, legs and buttocks), VACCINATION SITE PAIN (Injection site soreness) and RASH (Rash). At the time of the report, PRURITUS (Developed an itching condition, have been under a doctors care since early March/Never had any kind of itching condition before/ itching with major areas on abdomen and back, but also affected scalp, arms, legs and buttocks) and RASH (Rash) had not resolved and VACCINATION SITE PAIN (Injection site soreness) had resolved.            The patient has been undergoing treatment for this condition since March of 2021.  No relevant concomitant medications were reported.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Peripheral swelling, Swelling
Clinical narrative: small bump reaction in my arm; small bump reaction around my eyes; small bump reaction in my head; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (small bump reaction in my arm), EYE SWELLING (small bump reaction around my eyes) and SWELLING (small bump reaction in my head) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043L20A and 013A21A) for COVID-19 vaccination.     Concomitant products included SALBUTAMOL SULFATE (PROAIR HFA), ROFLUMILAST (DALIRESP), LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D), PREDNISOLONE (PREDNERSONE), GABAPENTIN, CHIMAPHILA UMBELLATA, APAP;CODEINE, (6S)-5-METHYLTETRAHYDROFOLATE;BETAINE;PYRIDOXINE HYDROCHLORIDE;RIBOFLAVIN;VITAMIN B12 NOS;ZINC, ASCORBIC ACID (VITAMIIN C), CALCIUM, COLECALCIFEROL (CALCIUM +D3) and POTASSIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-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 PERIPHERAL SWELLING (small bump reaction in my arm), EYE SWELLING (small bump reaction around my eyes) and SWELLING (small bump reaction in my head). At the time of the report, PERIPHERAL SWELLING (small bump reaction in my arm), EYE SWELLING (small bump reaction around my eyes) and SWELLING (small bump reaction in my head) outcome was unknown.            Treatment information was not provided. Lab details were not provided.   This case was linked to MOD-2021-265823 (Patient Link).
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Moderna rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Moderna rash) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (Moderna rash). The patient was treated with FLUOCINONIDE (topical) at a dose of 5 percent; CLOBETASOL PROPIONATE for Rash pruritic, at a dose of 5 percent; HYDROXYZINE HCL for Sleep disorder, at a dose of 10 mg three times a day; CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency; CLOBETASOL for Itchy scalp, at a dose of 5 percent; TRIAMCINOLONE ACETONIDE at an unspecified dose and frequency and PREDNISONE at a dose of 20 mg. At the time of the report, VACCINATION SITE RASH (Moderna rash) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.   This case was linked to MOD-2021-265796 (Patient Link).   Reporter did not allow further contact
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Joint range of motion decreased, Pain in extremity, Pruritus
Clinical narrative: left upper arm pain; persistent itching in that arm; couldn't raise my arm above my shoulder; felt very weak; wanted to lay down all the time.; arm was sore that day at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak) and FATIGUE (wanted to lay down all the time.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore that day at the injection site). On 18-Apr-2021, the patient experienced PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak) and FATIGUE (wanted to lay down all the time.). At the time of the report, PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak), FATIGUE (wanted to lay down all the time.) and VACCINATION SITE PAIN (arm was sore that day at the injection site) outcome was unknown.            No Treatment was received by the patient.   No Concomitant medication was received by the patient   This case was linked to MOD-2021-265825, MOD-2021-265816 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: left upper arm pain; persistent itching in that arm; couldn't raise my arm above my shoulder; felt very weak; wanted to lay down all the time.; arm was sore that day at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak) and FATIGUE (wanted to lay down all the time.) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, the patient experienced VACCINATION SITE PAIN (arm was sore that day at the injection site). On 18-Apr-2021, the patient experienced PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak) and FATIGUE (wanted to lay down all the time.). At the time of the report, PAIN IN EXTREMITY (left upper arm pain), PRURITUS (persistent itching in that arm), JOINT RANGE OF MOTION DECREASED (couldn't raise my arm above my shoulder), ASTHENIA (felt very weak), FATIGUE (wanted to lay down all the time.) and VACCINATION SITE PAIN (arm was sore that day at the injection site) outcome was unknown.            No Treatment was received by the patient.   No Concomitant medication was received by the patient   This case was linked to MOD-2021-265825, MOD-2021-265816 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Somnolence
Clinical narrative: drowsy effects; all over body itch; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (all over body itch) and SOMNOLENCE (drowsy effects) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No medical history was reported.  Concomitant products included AZATHIOPRINE, HYDROCODONE BITARTRATE, PARACETAMOL (HYDROCODONE/ACETAMINOPHEN), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and GABAPENTIN for an unknown indication.    On 22-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jul-2021, the patient experienced PRURITUS (all over body itch). On an unknown date, the patient experienced SOMNOLENCE (drowsy effects). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (all over body itch) and SOMNOLENCE (drowsy effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The caller would like to know: if immunosuppressant meds will prevent body from making antibodies after the Moderna COVID-19 vaccine.   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow up received on 01-oct-2021 and contains mail address.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Dermatologist said he has seen patients who has similar side effects her her husband.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Dermatologist said he has seen patients who has similar side effects her her husband.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Dermatologist said he has seen patients who has similar side effects her her husband.). The patient was treated with FLUOCINONIDE (FLUOCINONIDE F) ongoing since an unknown date at an unspecified dose and frequency; CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE E) ongoing since an unknown date at an unspecified dose and frequency; HYDROXYZINE HCL ongoing since an unknown date at an unspecified dose and frequency; LORATADINE (CLARITINE) ongoing since an unknown date at an unspecified dose and frequency; CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE SHAMPOO) ongoing since an unknown date at an unspecified dose and frequency; CLOBETASOL PROPIONATE (CLOBETASOL [CLOBETASOL PROPIONATE]) ongoing since an unknown date at an unspecified dose and frequency; TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE (GLUCOCORTICOID)) ongoing since an unknown date at an unspecified dose and frequency and PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) at a dose of 5 days course. At the time of the report, VACCINATION COMPLICATION (Dermatologist said he has seen patients who has similar side effects her her husband.) 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.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow up Received on 21-Sep-2021, contains no new information. Patient identifiers added from initial versions document.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspepsia, Loss of personal independence in daily activities, Nausea, Pain in extremity
Clinical narrative: I can't carry anything with that left arm; Persistent itching in that injection site arm; Nausea; Arm was sore that day at the injection site; Left upper arm pain; felt very weak/ wanted to lay down all the time; heartburn/burning in my stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), DYSPEPSIA (heartburn/burning in my stomach), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm) and VACCINATION SITE PRURITUS (Persistent itching in that injection site arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), DYSPEPSIA (heartburn/burning in my stomach), VACCINATION SITE PRURITUS (Persistent itching in that injection site arm), NAUSEA (Nausea) and VACCINATION SITE PAIN (Arm was sore that day at the injection site). On 23-Jul-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm). On 22-May-2021, PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), VACCINATION SITE PRURITUS (Persistent itching in that injection site arm) and VACCINATION SITE PAIN (Arm was sore that day at the injection site) had resolved. At the time of the report, DYSPEPSIA (heartburn/burning in my stomach), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm) and NAUSEA (Nausea) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.    This case was linked to MOD-2021-265816 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: I can't carry anything with that left arm; Persistent itching in that injection site arm; Nausea; Arm was sore that day at the injection site; Left upper arm pain; felt very weak/ wanted to lay down all the time; heartburn/burning in my stomach; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), DYSPEPSIA (heartburn/burning in my stomach), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm) and VACCINATION SITE PRURITUS (Persistent itching in that injection site arm) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), DYSPEPSIA (heartburn/burning in my stomach), VACCINATION SITE PRURITUS (Persistent itching in that injection site arm), NAUSEA (Nausea) and VACCINATION SITE PAIN (Arm was sore that day at the injection site). On 23-Jul-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm). On 22-May-2021, PAIN IN EXTREMITY (Left upper arm pain), ASTHENIA (felt very weak/ wanted to lay down all the time), VACCINATION SITE PRURITUS (Persistent itching in that injection site arm) and VACCINATION SITE PAIN (Arm was sore that day at the injection site) had resolved. At the time of the report, DYSPEPSIA (heartburn/burning in my stomach), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't carry anything with that left arm) and NAUSEA (Nausea) had not resolved.            No concomitant medication details was reported. No treatment medication details was reported.    This case was linked to MOD-2021-265816 (Patient Link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lethargy, Pyrexia, SARS-CoV-2 test
Clinical narrative: lethargic feeling for about 24 hours; first dose in JAN 2021 and second dose in MAY 2021; I had my second shot with a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (lethargic feeling for about 24 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose in JAN 2021 and second dose in MAY 2021) and PYREXIA (I had my second shot with a low grade fever) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Medical history was not provided.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-May-2021, the patient experienced LETHARGY (lethargic feeling for about 24 hours), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose in JAN 2021 and second dose in MAY 2021) and PYREXIA (I had my second shot with a low grade fever). On 08-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose in JAN 2021 and second dose in MAY 2021) had resolved. At the time of the report, LETHARGY (lethargic feeling for about 24 hours) and PYREXIA (I had my second shot with a low grade fever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive.         No Concomitant drug reported No Treatment drug reported..   This case was linked to MOD-2021-081493 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: stored in the refrigerator for more than 30 days; administered with the vaccine which has been stored in the refrigerator for more than 30 days; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered with the vaccine which has been stored in the refrigerator for more than 30 days) and PRODUCT STORAGE ERROR (stored in the refrigerator for more than 30 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medications were not reported. Treatment information was not provided
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast pain
Clinical narrative: Breast pain; underarm pain; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Breast pain) and AXILLARY PAIN (underarm pain) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid nodule (Graves with thyroid Nodules) since 1999, Graves' disease (Graves with thyroid Nodules) since 1999 and Varicose veins since 2019. Concomitant products included VIT D [VITAMIN D NOS], MULTIVITAMINS [VITAMINS NOS], FEXOFENADINE HYDROCHLORIDE (ALLEGRA) and ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication.   On 04-Feb-2021 at 3:40 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 10:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Mar-2021, the patient experienced BREAST PAIN (Breast pain). 05-Mar-2021, the patient experienced AXILLARY PAIN (underarm pain). In 2021, BREAST PAIN (Breast pain) and AXILLARY PAIN (underarm pain) had resolved.            No treatment medications were reported.   This case was linked to MOD-2021-039741 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Blood immunoglobulin G decreased, SARS-CoV-2 antibody test
Clinical narrative: spike antibody test, cov2 AB Ig G was a 1.8. (considered not good); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jul-2021 and was forwarded to Moderna on 23-Jul-2021.    This spontaneous case was reported by a consumer and describes the occurrence of BLOOD IMMUNOGLOBULIN G DECREASED (spike antibody test, cov2 AB Ig G was a 1.8. (considered not good)) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 031L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high (A touch of high blood pressure) and Blood cholesterol abnormal (statin for cholesterol).   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-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 BLOOD IMMUNOGLOBULIN G DECREASED (spike antibody test, cov2 AB Ig G was a 1.8. (considered not good)). At the time of the report, BLOOD IMMUNOGLOBULIN G DECREASED (spike antibody test, cov2 AB Ig G was a 1.8. (considered not good)) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: 1.8 (Low) Considered not good.         Concomitant medication iinclude statin for cholesterol.  No treatment information were provided.  Patient received both Moderna vaccines and after receiving the vaccines, went to MD and had spike antibody test, Cov2 AB Ig G and the score was a 1.8. (considered not good) hence wanted to know if there was any data available on these tests and would booster be recommended for lower numbers on antibody tests (to spike numbers up).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Gout, Hypersensitivity, Pain
Clinical narrative: Swelling arm/swollen  upper arm; I experienced  a mild out break of gout; pain is very severe for the first few days; It was a little warm; itchy; Redness; Hypersensitivity reactions; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reactions), PERIPHERAL SWELLING (Swelling arm/swollen  upper arm), GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days) and FEELING HOT (It was a little warm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingles ( Shingrix on 12-Sep-2020; for an unreported indication: FLU. Past adverse reactions to the above products included Gout with Shingles ( Shingrix. Concurrent medical conditions included Hypersensitivity reaction, Diabetes since 01-Sep-2008, Chronic kidney disease stage 3 since 26-Feb-2009 and Blood pressure high since 20-Sep-2002. Concomitant products included ATENOLOL, CLONIDINE and LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, INSULIN GLARGINE (TOUJEO) for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN) and COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) for an unknown indication.   On 04-Mar-2012, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reactions). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm/swollen  upper arm), GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days), FEELING HOT (It was a little warm), PRURITUS (itchy) and ERYTHEMA (Redness). The patient was treated with COLCHICINE for Gout, at a dose of .6 mg twice a day. On 13-Feb-2021, HYPERSENSITIVITY (Hypersensitivity reactions) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling arm/swollen  upper arm) had resolved and GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days), FEELING HOT (It was a little warm), PRURITUS (itchy) and ERYTHEMA (Redness) outcome was unknown.            The patient had history of much stronger side effects to some described reaction as more intense side effects generally experienced. The patient historical medications include Blood pressure lowering. The patient historical vaccines condition include flu or pneumonia.   This case was linked to MOD-2021-031242 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Swelling arm/swollen  upper arm; I experienced  a mild out break of gout; pain is very severe for the first few days; It was a little warm; itchy; Redness; Hypersensitivity reactions; This spontaneous case was reported by a patient and describes the occurrence of HYPERSENSITIVITY (Hypersensitivity reactions), PERIPHERAL SWELLING (Swelling arm/swollen  upper arm), GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days) and FEELING HOT (It was a little warm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Shingles ( Shingrix on 12-Sep-2020; for an unreported indication: FLU. Past adverse reactions to the above products included Gout with Shingles ( Shingrix. Concurrent medical conditions included Hypersensitivity reaction, Diabetes since 01-Sep-2008, Chronic kidney disease stage 3 since 26-Feb-2009 and Blood pressure high since 20-Sep-2002. Concomitant products included ATENOLOL, CLONIDINE and LOSARTAN for Blood pressure, ATORVASTATIN for Cholesterol, INSULIN GLARGINE (TOUJEO) for Diabetes, ACETYLSALICYLIC ACID (BABY ASPIRIN) and COD-LIVER OIL (FISH OIL [COD-LIVER OIL]) for an unknown indication.   On 04-Mar-2012, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HYPERSENSITIVITY (Hypersensitivity reactions). On an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling arm/swollen  upper arm), GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days), FEELING HOT (It was a little warm), PRURITUS (itchy) and ERYTHEMA (Redness). The patient was treated with COLCHICINE for Gout, at a dose of .6 mg twice a day. On 13-Feb-2021, HYPERSENSITIVITY (Hypersensitivity reactions) had resolved. At the time of the report, PERIPHERAL SWELLING (Swelling arm/swollen  upper arm) had resolved and GOUT (I experienced  a mild out break of gout), PAIN (pain is very severe for the first few days), FEELING HOT (It was a little warm), PRURITUS (itchy) and ERYTHEMA (Redness) outcome was unknown.            The patient had history of much stronger side effects to some described reaction as more intense side effects generally experienced. The patient historical medications include Blood pressure lowering. The patient historical vaccines condition include flu or pneumonia.   This case was linked to MOD-2021-031242 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Much delayed second moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Much delayed second moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Much delayed second moderna vaccine). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Much delayed second moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 026A21A) 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 05-May-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 MYALGIA (Sore arm). On 08-Apr-2021, MYALGIA (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       The concomitant medications were not reported  The treatment information was not provided.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: 20 spots on my back/new one on my wrist/and one on my leg; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (20 spots on my back/new one on my wrist/and one on my leg) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Covid in March and was hospitalized). Concurrent medical conditions included Heart rate irregular. Concomitant products included METOPROLOL and LISINOPRIL for Heart rate irregular.    On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced RASH MACULAR (20 spots on my back/new one on my wrist/and one on my leg). At the time of the report, RASH MACULAR (20 spots on my back/new one on my wrist/and one on my leg) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Prior to receiving vaccine patient had some spots on back, like insect bites, which continued to spread and patient thought of having bitten by a spider and now had a new one on wrist tonight which was just a bump right now, and one on leg.  Patient has not taken any treatment for the events.