chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 expired doses administered). On 11-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 expired doses administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that on 06-Dec-2021, lot 012H21B vials were kept in refrigerator. Concomitant medication list was not provided. Treatment information was not provided.   This case was linked to MOD-2022-449524 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: bad reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (bad reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (bad reaction). At the time of the report, VACCINATION COMPLICATION (bad reaction) outcome was unknown. Not Provided      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 & Treatment drug reported.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Migraine, Myalgia, Nausea
Clinical narrative: Severe migraine; Freezing; Body aches; Chills; Nausous; This spontaneous case was reported by a nurse and describes the occurrence of MIGRAINE (Severe migraine), FEELING COLD (Freezing), MYALGIA (Body aches), CHILLS (Chills) and NAUSEA (Nausous) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.    In January 2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Severe migraine), FEELING COLD (Freezing), MYALGIA (Body aches), CHILLS (Chills) and NAUSEA (Nausous). At the time of the report, MIGRAINE (Severe migraine), FEELING COLD (Freezing), MYALGIA (Body aches), CHILLS (Chills) and NAUSEA (Nausous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not reported.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: feel the side effects/effects of the booster last; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (feel the side effects/effects of the booster last) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (feel the side effects/effects of the booster last). At the time of the report, VACCINATION COMPLICATION (feel the side effects/effects of the booster last) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal
Clinical narrative: not feeling good; some chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not feeling good) and CHILLS (some chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced FEELING ABNORMAL (not feeling good) and CHILLS (some chills). At the time of the report, FEELING ABNORMAL (not feeling good) and CHILLS (some chills) outcome was unknown.            The  concomitant medications on use were not provided. No treatment information was provided.   Reporter did not allow further contact
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 and a half received first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half received first dose) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half received first dose). On 03-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 and a half received first dose) 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.   No concomitant medications were reported. No treatment medications were reported.  It was reported that patient got first dose at the age of 17 and a half. The patient and her mother want the patient to get the second shot. Patient hasn't had any side effects, and she has not had any other COVID19 vaccinations.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (aching legs) and PYREXIA (Fever) 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 12-Jan-2022, the patient 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 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 12-Jan-2022, the patient experienced PAIN IN EXTREMITY (aching legs) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (aching legs) and PYREXIA (Fever) had not 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.
Sex: U
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis on my arms...started to clear up t is still 90% better; This spontaneous case was reported by an other health care professional and describes the occurrence of PSORIASIS (psoriasis on my arms...started to clear up t is still 90% better) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PSORIASIS (psoriasis on my arms...started to clear up t is still 90% better). At the time of the report, PSORIASIS (psoriasis on my arms..started to clear up t is still 90% better) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patient had the booster shot and a week or two later patient noticed psoriasis on arms, only area affected started to clear up. Now 4 or 5 weeks after it is still 90% better.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a sore right arm for a few days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore right arm for a few days) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PAIN IN EXTREMITY (Had a sore right arm for a few days). On 03-Apr-2021, PAIN IN EXTREMITY (Had a sore right arm for a few days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-450402, MOD-2022-450403 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: received her second Moderna COVID-19 vaccine in incorrect amount; received her second Moderna COVID-19 vaccine in incorrect amount and in double dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount) and EXTRA DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount and in double dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount) and EXTRA DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount and in double dose). At the time of the report, INCORRECT DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount) and EXTRA DOSE ADMINISTERED (received her second Moderna COVID-19 vaccine in incorrect amount and in double dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore left arm after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore left arm after 2nd dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014C21A and 031B21) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2021, the patient experienced PAIN IN EXTREMITY (Sore left arm after 2nd dose). On 30-Apr-2021, PAIN IN EXTREMITY (Sore left arm after 2nd dose) had resolved.            No Concomitant medication was reported.    No treatment medications were reported.   This case was linked to MOD-2022-450393, MOD-2022-450403 (Patient Link).
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching all over the body two weeks after booster; Hives move around on the body two weeks after booster; Rash all over body two weeks after booster; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062e21a, 031B21A and 014C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Dec-2021, the patient experienced PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching all over the body two weeks after booster), URTICARIA (Hives move around on the body two weeks after booster) and RASH (Rash all over body two weeks after booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitants medications was reported. The doctor ordered blood tests for patient to check if he was allergic to anything.   This case was linked to MOD-2022-450402, MOD-2022-450393 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little). At the time of the report, PAIN IN EXTREMITY (arm hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-450401, MOD-2022-450412 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling cold, Influenza like illness, Nausea, Pain
Clinical narrative: arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little). At the time of the report, PAIN IN EXTREMITY (arm hurt a little) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment medication was reported.   This case was linked to MOD-2022-450401, MOD-2022-450412 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little). At the time of the report, PAIN IN EXTREMITY (arm hurt a little) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  On 12-Jan-2022, the patient received booster dose.  Treatment information was not reported.   This case was linked to MOD-2022-450411, MOD-2022-450401 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling cold, Influenza like illness, Nausea, Pain
Clinical narrative: arm hurt a little; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt a little) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurt a little). At the time of the report, PAIN IN EXTREMITY (arm hurt a little) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported.  On 12-Jan-2022, the patient received booster dose.  Treatment information was not reported.   This case was linked to MOD-2022-450411, MOD-2022-450401 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: I feel like I've got the flu; hurting all over; Nauseated; At 1st I was really cold; I got the chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (At 1st I was really cold), INFLUENZA LIKE ILLNESS (I feel like I've got the flu), PAIN (hurting all over), CHILLS (I got the chills) and NAUSEA (Nauseated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 022M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, the patient experienced FEELING COLD (At 1st I was really cold) and CHILLS (I got the chills). On 13-Jan-2022, the patient experienced INFLUENZA LIKE ILLNESS (I feel like I've got the flu), PAIN (hurting all over) and NAUSEA (Nauseated). The patient was treated with PAPAIN (PAPAYA ENZYMES) for Nausea, at a dose of chewable pill. On 13-Jan-2022, NAUSEA (Nauseated) had resolved. At the time of the report, FEELING COLD (At 1st I was really cold), INFLUENZA LIKE ILLNESS (I feel like I've got the flu), PAIN (hurting all over) and CHILLS (I got the chills) outcome was unknown.            Patient got the Moderna Covid-19 booster at 12p. No concomitant medication  were reported.   This case was linked to MOD-2022-450411, MOD-2022-450412 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Feeling cold, Influenza like illness, Nausea, Pain
Clinical narrative: I feel like I've got the flu; hurting all over; Nauseated; At 1st I was really cold; I got the chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (At 1st I was really cold), INFLUENZA LIKE ILLNESS (I feel like I've got the flu), PAIN (hurting all over), CHILLS (I got the chills) and NAUSEA (Nauseated) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032H21A, 022M20A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jan-2022, the patient experienced FEELING COLD (At 1st I was really cold) and CHILLS (I got the chills). On 13-Jan-2022, the patient experienced INFLUENZA LIKE ILLNESS (I feel like I've got the flu), PAIN (hurting all over) and NAUSEA (Nauseated). The patient was treated with PAPAIN (PAPAYA ENZYMES) for Nausea, at a dose of chewable pill. On 13-Jan-2022, NAUSEA (Nauseated) had resolved. At the time of the report, FEELING COLD (At 1st I was really cold), INFLUENZA LIKE ILLNESS (I feel like I've got the flu), PAIN (hurting all over) and CHILLS (I got the chills) outcome was unknown.            Patient got the Moderna Covid-19 booster at 12p. No concomitant medication  were reported.   This case was linked to MOD-2022-450411, MOD-2022-450412 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours). On 13-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Patient received Moderna booster from an opened vial that was exposed to room temperature for over 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Date the vial was initially stored in the refrigerator:- 10-JAN-2022, The vial was opened on 11-JAN-2022, Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):- 48 hours. No concomitant products were reported. No treatment information was reported.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 ml. On 13-Jan-2022, the patient experienced ACCIDENTAL UNDERDOSE (given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose). On 13-Jan-2022, ACCIDENTAL UNDERDOSE (given a 0.25ml of the Moderna Covid-19 vaccine for his 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  No treatment information provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Rash, SARS-CoV-2 test, Vaccination site pruritus
Clinical narrative: skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both); itchy (where shot was done); soreness/soreness in the back of the neck area.; itchy neck, back, feet and hands; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy neck, back, feet and hands), RASH (skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both)), VACCINATION SITE PRURITUS (itchy (where shot was done)) and MYALGIA (soreness/soreness in the back of the neck area.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H21A) for COVID-19 vaccination.     Concomitant products included MULTIVITAMINS [VITAMINS NOS] and FISH OIL for an unknown indication.    On 27-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jan-2022, the patient experienced PRURITUS (itchy neck, back, feet and hands). On an unknown date, the patient experienced RASH (skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both)), VACCINATION SITE PRURITUS (itchy (where shot was done)) and MYALGIA (soreness/soreness in the back of the neck area.). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PRURITUS (itchy neck, back, feet and hands) and VACCINATION SITE PRURITUS (itchy (where shot was done)) had not resolved, RASH (skin rashes/rash neck /rash shoulder area/rash back/rash foot (both)/rash wrists (both)/rash hands (both)) was resolving and MYALGIA (soreness/soreness in the back of the neck area.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.         Patient is also taking allergy medicine.   This case was linked to MOD-2022-450491 (Patient Link).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm initially; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm initially) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Nov-2020.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm initially). At the time of the report, PAIN IN EXTREMITY (sore arm initially) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported. Patient at work started exp symptoms flu like sx fever, congestion,sore throat, headache, slight fever 17nov2020, dec2020 still positive.   This case was linked to MOD-2022-450431 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation delayed, Vaccination complication
Clinical narrative: spotting, pink colored, as if her period was going to start but it stopped; she had some spotting, pink colored, as if her period was going to start but it stopped; usual side effects; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (spotting, pink colored, as if her period was going to start but it stopped), VACCINATION COMPLICATION (usual side effects) and MENSTRUAL DISORDER (she had some spotting, pink colored, as if her period was going to start but it stopped) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jan-2022, the patient experienced VACCINATION COMPLICATION (usual side effects). On 11-Jan-2022, the patient experienced MENSTRUATION DELAYED (spotting, pink colored, as if her period was going to start but it stopped) and MENSTRUAL DISORDER (she had some spotting, pink colored, as if her period was going to start but it stopped). On 10-Jan-2022, VACCINATION COMPLICATION (usual side effects) had resolved. On 12-Jan-2022, MENSTRUAL DISORDER (she had some spotting, pink colored, as if her period was going to start but it stopped) had resolved. At the time of the report, MENSTRUATION DELAYED (spotting, pink colored, as if her period was going to start but it stopped) had not resolved.            Concomitant medication was not reported. Treatment information was not reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine) in a 37-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 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 INFLUENZA LIKE ILLNESS (feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine). At the time of the report, INFLUENZA LIKE ILLNESS (feeling like she was coming down with the flu after her second Moderna Covid-19 vaccine) outcome was unknown.            No Concomitant medications were reported. No treatment medications were reported.  The patient slept for a day and she was fine.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose) 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.   In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 50 microgram. On 13-Jan-2022, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced ACCIDENTAL UNDERDOSE (Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose). In December 2021, ACCIDENTAL UNDERDOSE (Someone received the booster dose (50mcg) as their 1st dose, then a month later got the full dose for the 2nd dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Bone pain, Headache, Myalgia, Nausea
Clinical narrative: Severe bone and muscle pain; Sore Arm; Fever of 102 Degrees; Nausea; Headache; Severe bone and muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Severe bone and muscle pain). At the time of the report, BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Severe bone and muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever 102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history information was reported.  No treatment information was reported.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Severe bone and muscle pain; Sore Arm; Fever of 102 Degrees; Nausea; Headache; Severe bone and muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea) and HEADACHE (Headache) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included OCRELIZUMAB (OCREVUS) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Severe bone and muscle pain). At the time of the report, BONE PAIN (Severe bone and muscle pain), PAIN IN EXTREMITY (Sore Arm), PYREXIA (Fever of 102 Degrees), NAUSEA (Nausea), HEADACHE (Headache) and MYALGIA (Severe bone and muscle pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever 102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history information was reported.  No treatment information was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.  None of the patients have reported side effects, so far.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication were reported.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received an expired 2nd dose of Moderna COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd dose of Moderna COVID-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd dose of Moderna COVID-19). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received an expired 2nd dose of Moderna COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported. No treatment information was reported.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        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 reported.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported. None of the patients have reported side effects, so far
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Patient had not reported side effects so far.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (All patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. No treatment information was reported.  None of the patients have reported side effects, so far.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients received Expired Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine). On 30-Dec-2021, EXPIRED PRODUCT ADMINISTERED (patients received Expired Moderna COVID-19 vaccine) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.   Patients received Expired Moderna COVID-19 vaccine from a vial that was stored in the refrigerator beyond 30 days.