chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test, Eczema, Skin erosion, Skin fissures
Clinical narrative: Hands crack; hands became raw; Hands kept shedding skin/Like a bad case of eczema; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EROSION (hands became raw), ECZEMA (Hands kept shedding skin/Like a bad case of eczema) and SKIN FISSURES (Hands crack) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 013A21A and 046A21A) for COVID-19 vaccination.     Concomitant products included RAMIPRIL for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID], VITAMIN D NOS, PRAVASTATIN and CALCIUM for an unknown indication.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SKIN EROSION (hands became raw) and ECZEMA (Hands kept shedding skin/Like a bad case of eczema). On an unknown date, the patient experienced SKIN FISSURES (Hands crack). The patient was treated with PREDNISONE on 09-Dec-2021 for Adverse event, at a dose of 20mg prednisone for 7 days. At the time of the report, SKIN EROSION (hands became raw), ECZEMA (Hands kept shedding skin/Like a bad case of eczema) and SKIN FISSURES (Hands crack) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Allergy test: normal (normal) No allergies.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had stated that Due to Crack she couldn't go outside. Patient Had to wrap hands at night by using use steroids.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain in extremity
Clinical narrative: severe arm pain from the first dose and trouble sleeping due to pain; severe arm pain from the first dose and trouble sleeping due to pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (severe arm pain from the first dose and trouble sleeping due to pain) and INSOMNIA (severe arm pain from the first dose and trouble sleeping due to pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09AB21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, FENOFIBRATE, LISINOPRIL, LEVOTHYROXINE, TOPIRAMATE, OMEPRAZOLE and LIRAGLUTIDE (VICTOZA) for an unknown indication.    On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (severe arm pain from the first dose and trouble sleeping due to pain) and INSOMNIA (severe arm pain from the first dose and trouble sleeping due to pain). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (severe arm pain from the first dose and trouble sleeping due to pain) and INSOMNIA (severe arm pain from the first dose and trouble sleeping due to pain) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-407138 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient administered dose from a vial 12 hours post puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a vial 12 hours post puncture.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 002A21A and 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ROSUVASTATIN, ENALAPRIL and ASPIRIN [ACETYLSALICYLIC ACID] 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 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a vial 12 hours post puncture.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered dose from a vial 12 hours post puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment drug details was reported.  Vial taken out from freezer on 6-dec-2021 and first punctured on 6-dec-2021 and placed in refrigerator on 6-12-2021.   This case was linked to MOD-2021-407042, MOD-2021-407056, MOD-2021-407134 (Patient Link).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient 2: given booster >12hrs post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient 2: given booster >12hrs post puncture) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient 2: given booster >12hrs post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient 2: given booster >12hrs post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-407042, MOD-2021-407056, MOD-2021-407133 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Feeling cold, Headache
Clinical narrative: headache when bending down lower then waist that feels like pulsing in front of head by hairline; pressure feeling on top of teeth; coldness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (coldness), DISCOMFORT (pressure feeling on top of teeth) and HEADACHE (headache when bending down lower then waist that feels like pulsing in front of head by hairline) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034FZ1A, 031L20A and 011220A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (coldness). On 08-Dec-2021, the patient experienced DISCOMFORT (pressure feeling on top of teeth). On 08-Dec-2021 at 3:45 AM, the patient experienced HEADACHE (headache when bending down lower then waist that feels like pulsing in front of head by hairline). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 08-Dec-2021 at a dose of 1 dosage form twice a day. At the time of the report, FEELING COLD (coldness), DISCOMFORT (pressure feeling on top of teeth) and HEADACHE (headache when bending down lower then waist that feels like pulsing in front of head by hairline) outcome was unknown.            This case was linked to MOD-2021-407141 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 04AC21A and 09AB21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, GLIPIZIDE, FENOFIBRATE, LISINOPRIL, LEVOTHYROXINE, TOPIRAMATE, OMEPRAZOLE and LIRAGLUTIDE (VICTOZA) for an unknown indication.   On 09-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-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 VACCINATION SITE PAIN (Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own). The patient was treated with DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (DAYQUIL) for Adverse event, at an unspecified dose and frequency and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Second dose gave right arm pain but it resolved/The pain from the second dose resolved on its own) had resolved.            This case was linked to MOD-2021-407132 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: hair falling out in droves; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair falling out in droves) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045A24) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included DILTIAZEM (CARDIZEM [DILTIAZEM]), CHLORTALIDONE (CHLORTHALIDONE), VITAMINS NOS, SERTRALINE HYDROCHLORIDE (ZOLOFT), POTASSIUM and FAMOTIDINE (PEPCID [FAMOTIDINE]) for an unknown indication.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced ALOPECIA (hair falling out in droves). At the time of the report, ALOPECIA (hair falling out in droves) outcome was unknown.            No Treatment information was provided
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Fatigue, Rash erythematous, Rash pruritic
Clinical narrative: weakness in left elbow and shoulder; Experienced a 5 inch rash/red circle on arm that itches; Experienced a 5 inch rash/red circle on arm that itches; Patient claims her kidneys felt tight and swollen; Elbow discomfort; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in left elbow and shoulder), RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen) and ARTHRALGIA (Elbow discomfort) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemic episode (borderline hypoglycemic), Pollen allergy and Allergy to chemicals (Fluoride allergy).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 ASTHENIA (weakness in left elbow and shoulder), RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen), ARTHRALGIA (Elbow discomfort) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness in left elbow and shoulder) and ARTHRALGIA (Elbow discomfort) had not resolved and RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient reported that they experienced a 5 inch rash/red circle on arm that itched as well as fatigue and weakness in left elbow and shoulder. The patient also claimed that their kidneys felt tight and swollen. It was reported that the symptoms were resolving over time, but elbow discomfort was still present.  No treatment information was provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Renal disorder
Clinical narrative: weakness in left elbow and shoulder; Experienced a 5 inch rash/red circle on arm that itches; Experienced a 5 inch rash/red circle on arm that itches; Patient claims her kidneys felt tight and swollen; Elbow discomfort; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness in left elbow and shoulder), RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen) and ARTHRALGIA (Elbow discomfort) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 018B21A and 043B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypoglycemic episode (borderline hypoglycemic), Pollen allergy and Allergy to chemicals (Fluoride allergy).   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-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 ASTHENIA (weakness in left elbow and shoulder), RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen), ARTHRALGIA (Elbow discomfort) and FATIGUE (fatigue). At the time of the report, ASTHENIA (weakness in left elbow and shoulder) and ARTHRALGIA (Elbow discomfort) had not resolved and RASH ERYTHEMATOUS (Experienced a 5 inch rash/red circle on arm that itches), RASH PRURITIC (Experienced a 5 inch rash/red circle on arm that itches), RENAL DISORDER (Patient claims her kidneys felt tight and swollen) and FATIGUE (fatigue) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The patient reported that they experienced a 5 inch rash/red circle on arm that itched as well as fatigue and weakness in left elbow and shoulder. The patient also claimed that their kidneys felt tight and swollen. It was reported that the symptoms were resolving over time, but elbow discomfort was still present.  No treatment information was provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Menstrual disorder, Pain in extremity, Vertigo
Clinical narrative: vertigo; arm soreness; really bad and pretty severe headaches/her head felt that was going to explode; started menstruating again; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started menstruating again), VERTIGO (vertigo), PAIN IN EXTREMITY (arm soreness) and HEADACHE (really bad and pretty severe headaches/her head felt that was going to explode) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037a21b) for COVID-19 vaccination.     The patient's past medical history included Vertigo. Concomitant products included VITAMINS NOS for an unknown indication.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, the patient experienced MENSTRUAL DISORDER (started menstruating again), PAIN IN EXTREMITY (arm soreness) and HEADACHE (really bad and pretty severe headaches/her head felt that was going to explode). On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, MENSTRUAL DISORDER (started menstruating again), VERTIGO (vertigo), PAIN IN EXTREMITY (arm soreness) and HEADACHE (really bad and pretty severe headaches/her head felt that was going to explode) outcome was unknown.            Patient was also taking supplements. It was reported that the patient had stopped having her period and the last time she had her period before receiving the vaccine and she didn't remember when was that. It was reported that the patient started to experience the events after 24hours later. No treatment medication was reported.   This case was linked to MOD-2021-407032, MOD-2021-407149 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lymph node pain, Menstrual disorder, Nipple disorder
Clinical narrative: her nipples very sensitive and erected 3rd dose; vertigo; on and off headaches; dizziness; lymph nodes in the arm of the injection were very sore booster; started to menstruate again 2 days later and it continued; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started to menstruate again 2 days later and it continued), NIPPLE DISORDER (her nipples very sensitive and erected 3rd dose), VERTIGO (vertigo), DIZZINESS (dizziness) and HEADACHE (on and off headaches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030h21b, 031a21a and 037a21b) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vertigo. Concomitant products included VITAMINS NOS for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced MENSTRUAL DISORDER (started to menstruate again 2 days later and it continued) and LYMPH NODE PAIN (lymph nodes in the arm of the injection were very sore booster). On 08-Dec-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced NIPPLE DISORDER (her nipples very sensitive and erected 3rd dose), VERTIGO (vertigo) and HEADACHE (on and off headaches). At the time of the report, MENSTRUAL DISORDER (started to menstruate again 2 days later and it continued) and HEADACHE (on and off headaches) had not resolved and NIPPLE DISORDER (her nipples very sensitive and erected 3rd dose), VERTIGO (vertigo), DIZZINESS (dizziness) and LYMPH NODE PAIN (lymph nodes in the arm of the injection were very sore booster) outcome was unknown.            Other concomitant medications included supplements.  Treatment information was not provided.   This case was linked to MOD-2021-407147, MOD-2021-407032 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: her nipples very sensitive and erected 3rd dose; vertigo; on and off headaches; dizziness; lymph nodes in the arm of the injection were very sore booster; started to menstruate again 2 days later and it continued; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (started to menstruate again 2 days later and it continued), NIPPLE DISORDER (her nipples very sensitive and erected 3rd dose), VERTIGO (vertigo), DIZZINESS (dizziness) and HEADACHE (on and off headaches) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030h21b, 031a21a and 037a21b) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Vertigo. Concomitant products included VITAMINS NOS for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Dec-2021, the patient experienced MENSTRUAL DISORDER (started to menstruate again 2 days later and it continued) and LYMPH NODE PAIN (lymph nodes in the arm of the injection were very sore booster). On 08-Dec-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced NIPPLE DISORDER (her nipples very sensitive and erected 3rd dose), VERTIGO (vertigo) and HEADACHE (on and off headaches). At the time of the report, MENSTRUAL DISORDER (started to menstruate again 2 days later and it continued) and HEADACHE (on and off headaches) had not resolved and NIPPLE DISORDER (her nipples very sensitive and erected 3rd dose), VERTIGO (vertigo), DIZZINESS (dizziness) and LYMPH NODE PAIN (lymph nodes in the arm of the injection were very sore booster) outcome was unknown.            Other concomitant medications included supplements.  Treatment information was not provided.   This case was linked to MOD-2021-407147, MOD-2021-407032 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021) 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 03-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021). On 03-Dec-2021, EXPIRED PRODUCT ADMINISTERED (We have some patients who were given your vaccine after the published expiration date. These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the vaccines were moved from the freezer to room temperature on the date of administration for all vaccines given.  No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-407154, MOD-2021-407155 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after expiration date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after expiration date) 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 06-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after expiration date). On 06-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered after expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient received expired vaccine, and the vaccines were moved from the freezer to room temperature on the day it was administered.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-407151, MOD-2021-407155 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered after expiration date,vaccines were administered on 7DEC2021; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered after expiration date,vaccines were administered on 7DEC2021) 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 07-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered after expiration date,vaccines were administered on 7DEC2021). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Administered after expiration date,vaccines were administered on 7DEC2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   These vaccines were administered on 3DEC2021, 6DEC2021, and 7DEC2021. The vaccines were moved from the freezer to room temperature on the date of administration for all vaccines given.  Date(s) of administration for the vial(s) moved to refrigerator on October 5 , 2021. Date(s)of administration for the vial(s) moved to refrigerator on November 4, 2021.  No Concomitants and Treatment medication were reported.   This case was linked to MOD-2021-407151 (Patient Link).
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Confusional state, Dizziness, Dyspnoea, Fatigue
Clinical narrative: inflammation; dizziness; was tired for a couple of days/exhaustion; pain in chest/mild activity it gets worse; hard time breathing like they wanted to faint; confusion; regular symptoms/symptoms were off and on; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (regular symptoms/symptoms were off and on), CHEST PAIN (pain in chest/mild activity it gets worse), DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion) and INFLAMMATION (inflammation) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 30-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (regular symptoms/symptoms were off and on) and VACCINATION SITE PAIN (arm was sore). On 04-Dec-2021, the patient experienced CHEST PAIN (pain in chest/mild activity it gets worse), DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion), DIZZINESS (dizziness) and FATIGUE (was tired for a couple of days/exhaustion). On an unknown date, the patient experienced INFLAMMATION (inflammation). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Inflammation, at a dose of 500 mg for past 3 days. In 2021, VACCINATION COMPLICATION (regular symptoms/symptoms were off and on) and VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, CHEST PAIN (pain in chest/mild activity it gets worse) and FATIGUE (was tired for a couple of days/exhaustion) had not resolved and DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion), INFLAMMATION (inflammation) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient had been taking Tylenol for the past 3 days with hopes that it help with inflammation but had not been working. Patient had never tested positive for covid19 but did note that near the beginning Covid19. The patient had gone to (city name) and came back with a supposedly infection in chest which lasted for 3 months where had constant fever, chest congested, completely wiped out and the only thing that had helped her get better was a steroid. Patient did not have a past medical history of any other heart conditions.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammation, Vaccination complication, Vaccination site pain
Clinical narrative: inflammation; dizziness; was tired for a couple of days/exhaustion; pain in chest/mild activity it gets worse; hard time breathing like they wanted to faint; confusion; regular symptoms/symptoms were off and on; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (regular symptoms/symptoms were off and on), CHEST PAIN (pain in chest/mild activity it gets worse), DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion) and INFLAMMATION (inflammation) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 08-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE.    On 30-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (regular symptoms/symptoms were off and on) and VACCINATION SITE PAIN (arm was sore). On 04-Dec-2021, the patient experienced CHEST PAIN (pain in chest/mild activity it gets worse), DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion), DIZZINESS (dizziness) and FATIGUE (was tired for a couple of days/exhaustion). On an unknown date, the patient experienced INFLAMMATION (inflammation). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Inflammation, at a dose of 500 mg for past 3 days. In 2021, VACCINATION COMPLICATION (regular symptoms/symptoms were off and on) and VACCINATION SITE PAIN (arm was sore) had resolved. At the time of the report, CHEST PAIN (pain in chest/mild activity it gets worse) and FATIGUE (was tired for a couple of days/exhaustion) had not resolved and DYSPNOEA (hard time breathing like they wanted to faint), CONFUSIONAL STATE (confusion), INFLAMMATION (inflammation) and DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Patient had been taking Tylenol for the past 3 days with hopes that it help with inflammation but had not been working. Patient had never tested positive for covid19 but did note that near the beginning Covid19. The patient had gone to (city name) and came back with a supposedly infection in chest which lasted for 3 months where had constant fever, chest congested, completely wiped out and the only thing that had helped her get better was a steroid. Patient did not have a past medical history of any other heart conditions.
Sex: F
Vaccine: COVID19
Symptoms: Limb mass
Clinical narrative: Experienced a lump on their arm; This spontaneous case was reported by an other health care professional and describes the occurrence of LIMB MASS (Experienced a lump on their arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Migraine. Concomitant products included SUMATRIPTAN (IMITREX [SUMATRIPTAN]) for Migraine.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LIMB MASS (Experienced a lump on their arm). At the time of the report, LIMB MASS (Experienced a lump on their arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was on one additional medication other than Imitrex. Treatment information was not provided. After receiving the booster dose had experienced a lump on their arm that had persisted up until today. That information was collected from the patient today by a colleague of the individual reporting. They currently take 3 concomitant medications including Imitrex, a medication for migraines, and one additional medication.
Sex: U
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: exposed to COVID; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPOSURE TO SARS-COV-2 (exposed to COVID) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXPOSURE TO SARS-COV-2 (exposed to COVID). At the time of the report, EXPOSURE TO SARS-COV-2 (exposed to COVID) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was reported. Patient was fully vaccinated and was exposed to COVID with no symptoms.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain Meds for Vaccination Symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PAIN (Pain Meds for Vaccination Symptoms) 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 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Pain Meds for Vaccination Symptoms). At the time of the report, VACCINATION SITE PAIN (Pain Meds for Vaccination Symptoms) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants and treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: An immunocompromised patient only received a booster (50mcg) dose of the Moderna COVID-19 vaccine instead of full dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (An immunocompromised patient only received a booster (50mcg) dose of the Moderna COVID-19 vaccine instead of full dose) in a 12-week-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (An immunocompromised patient only received a booster (50mcg) dose of the Moderna COVID-19 vaccine instead of full dose). On 22-Oct-2021, ACCIDENTAL UNDERDOSE (An immunocompromised patient only received a booster (50mcg) dose of the Moderna COVID-19 vaccine instead of full dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site inflammation, Vaccination site pain
Clinical narrative: swollen lymph nodes under arm/The lymph nodes are still swollen; inflammation in shot area; feels pain from time to time where shot was/presses against it, it hurt; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph nodes under arm/The lymph nodes are still swollen), VACCINATION SITE INFLAMMATION (inflammation in shot area) and VACCINATION SITE PAIN (feels pain from time to time where shot was/presses against it, it hurt) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 021B21A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included AMLODIPINE BESILATE (NORVASC) for Blood pressure high, ACETYLSALICYLIC ACID (BABY ASPIRIN) and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes under arm/The lymph nodes are still swollen), VACCINATION SITE INFLAMMATION (inflammation in shot area) and VACCINATION SITE PAIN (feels pain from time to time where shot was/presses against it, it hurt). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, LYMPHADENOPATHY (swollen lymph nodes under arm/The lymph nodes are still swollen) and VACCINATION SITE INFLAMMATION (inflammation in shot area) had not resolved and VACCINATION SITE PAIN (feels pain from time to time where shot was/presses against it, it hurt) outcome was unknown.            Treatment medications were included hot and cold compresses. She also had a mammogram and ultrasound shortly after, which threw off everything. She mentioned she goes to the gym, does weight training, walks 5-6 miles, was active.   This case was linked to MOD-2021-407328, MOD-2021-407326 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, Vaccination complication
Clinical narrative: Symptoms were much worse after the first two doses; 104 fever for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Symptoms were much worse after the first two doses) and PYREXIA (104 fever for 6 hours) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Symptoms were much worse after the first two doses) and PYREXIA (104 fever for 6 hours). The patient was treated with IBUPROFEN for Adverse event, at a dose of 2 cycles 40mg. At the time of the report, VACCINATION COMPLICATION (Symptoms were much worse after the first two doses) outcome was unknown and PYREXIA (104 fever for 6 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 fever (High) Had a 104 fever.   Patient mentioned that his symptoms were much worse after the first two doses. Patient had Flu vaccine at the same as the booster. No concomitant medications were mentioned.   This case was linked to MOD-2021-407187, MOD-2021-407170 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Condition aggravated, Pyrexia, Vaccination complication
Clinical narrative: symptoms were much worse after the first two doses; symptoms were much worse after the first two dose; 104 fever for 6 hours; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (symptoms were much worse after the first two doses), CONDITION AGGRAVATED (symptoms were much worse after the first two dose) and PYREXIA (104 fever for 6 hours) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (symptoms were much worse after the first two doses), CONDITION AGGRAVATED (symptoms were much worse after the first two dose) and PYREXIA (104 fever for 6 hours). The patient was treated with IBUPROFEN for Adverse reaction, at a dose of 2 cycles. At the time of the report, VACCINATION COMPLICATION (symptoms were much worse after the first two doses), CONDITION AGGRAVATED (symptoms were much worse after the first two dose) and PYREXIA (104 fever for 6 hours) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 fever (High) Had a 104 fever.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported.   This case was linked to MOD-2021-407184, MOD-2021-407170 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: covid rash on right arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (covid rash on right arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (covid rash on right arm). At the time of the report, RASH (covid rash on right arm) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: A little arm discomfort after first dose/A little out of it after first dose; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (A little arm discomfort after first dose/A little out of it after first dose) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Previously administered products included for Arthritis: Humira. Past adverse reactions to the above products included Adverse event with Humira. Concurrent medical conditions included Arthritis.    On 07-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced LIMB DISCOMFORT (A little arm discomfort after first dose/A little out of it after first dose). At the time of the report, LIMB DISCOMFORT (A little arm discomfort after first dose/A little out of it after first dose) was resolving.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant Medications reported were  Cimzia Injection, Enbrel Injection No treatment reported   This case was linked to MOD-2021-407412, MOD-2021-407413 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Hyperhidrosis, Illness, Pyrexia
Clinical narrative: sweating like you couldn't believe; Had a 104 fever; on bed all day and night; After first dose patient was 5 days sick; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating like you couldn't believe), ILLNESS (After first dose patient was 5 days sick), PYREXIA (Had a 104 fever) and FATIGUE (on bed all day and night) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (before getting the vaccine and naturally recovered.).    On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating like you couldn't believe), ILLNESS (After first dose patient was 5 days sick), PYREXIA (Had a 104 fever) and FATIGUE (on bed all day and night). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, HYPERHIDROSIS (sweating like you couldn't believe), PYREXIA (Had a 104 fever) and FATIGUE (on bed all day and night) outcome was unknown and ILLNESS (After first dose patient was 5 days sick) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 104 (High) 104 fever.     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 reported. Treatment medication included Gabapentin which did not help much.   This case was linked to MOD-2021-407247 (Patient Link).