chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021; 3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) and PRODUCT STORAGE ERROR (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) and PRODUCT STORAGE ERROR (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021). On 22-Oct-2021, EXPIRED PRODUCT ADMINISTERED (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) and PRODUCT STORAGE ERROR (3rd Dose administered beyond 30-day use/Date taken out of freezer: 8Sep2021/Date of administration: 22Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported. No treatment information was provided.
Age: 70.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: We have some Moderna Covid-019 vaccine that was given after the expiration date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091D21A) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.). In October 2021, EXPIRED PRODUCT ADMINISTERED (We have some Moderna Covid-019 vaccine that was given after the expiration date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, SARS-CoV-2 test
Clinical narrative: Not feeling well several days after the first Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Not feeling well several days after the first Moderna Covid-19 vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Oct-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 MALAISE (Not feeling well several days after the first Moderna Covid-19 vaccine). At the time of the report, MALAISE (Not feeling well several days after the first Moderna Covid-19 vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.   The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported.  No treatment information was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Eczema, Weight decreased
Clinical narrative: Eczema; Lost 30 pounds; This spontaneous case was reported by a consumer and describes the occurrence of ECZEMA (Eczema) and WEIGHT DECREASED (Lost 30 pounds) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Stress.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ECZEMA (Eczema) and WEIGHT DECREASED (Lost 30 pounds). At the time of the report, ECZEMA (Eczema) had not resolved and WEIGHT DECREASED (Lost 30 pounds) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ECZEMA (Eczema) and WEIGHT DECREASED (Lost 30 pounds) to be not related.    Patient reported that he searched it and found out that the eczema that he has been experiencing after the vaccine is from stress and lost 30 pounds going through all the stress with his wife.  No relevant concomitant medications were reported.  Treatment information included unspecified Cream.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Dental caries, Toothache
Clinical narrative: only tooth ache/tooth sore; nowshe only has half of tooth; This spontaneous case was reported by a consumer and describes the occurrence of TOOTHACHE (only tooth ache/tooth sore) and DENTAL CARIES (nowshe only has half of tooth) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 007M21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced TOOTHACHE (only tooth ache/tooth sore) and DENTAL CARIES (nowshe only has half of tooth). At the time of the report, TOOTHACHE (only tooth ache/tooth sore) and DENTAL CARIES (nowshe only has half of tooth) had not resolved.            Caller stated she has scheduled her booster dose for tomorrow, but she has toothache. She saw her dentist yesterday and they recommend she should get a root canal, but they cannot do the procedure until the 19th, and caller wants to know if she can have her booster shot tomorrow. She has a slight toothache, doctor told her she should take a painkiller and warm water to keep it calm, and caller asks if she should postpone her booster shot or continue with her shot. The pain has been going on for a week, it is sore, and when she chewed, the filling fell out, and now she only has half of tooth. Caller stated she doesn't have fever, only tooth ache, tooth sore. Caller states they're going to do a root canal in two weeks.  No concomitant medication reported.    This case was linked to MOD-2021-374965 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: 2 people in another country had the same issues (vision issues); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (2 people in another country had the same issues (vision issues)) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (2 people in another country had the same issues (vision issues)). At the time of the report, VISUAL IMPAIRMENT (2 people in another country had the same issues (vision issues)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: very sore left injection site arm; patient was very tired after his second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (very sore left injection site arm) and FATIGUE (patient was very tired after his second shot) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-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 VACCINATION SITE PAIN (very sore left injection site arm) and FATIGUE (patient was very tired after his second shot). At the time of the report, VACCINATION SITE PAIN (very sore left injection site arm) and FATIGUE (patient was very tired after his second shot) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: sore left arm; experienced body aches; felt fatigued; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm), FATIGUE (felt fatigued) and MYALGIA (experienced body aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and MYALGIA (experienced body aches). In February 2021, the patient experienced FATIGUE (felt fatigued). At the time of the report, VACCINATION SITE PAIN (sore left arm), FATIGUE (felt fatigued) and MYALGIA (experienced body aches) outcome was unknown.            Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. Patient had a sore left arm, felt fatigued, and experienced body aches.   This case was linked to MOD-2021-375119 (Patient Link).
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Intermittent chest pain/Chest pain every 20 to 30 minutes; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Intermittent chest pain/Chest pain every 20 to 30 minutes) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 012M20A and 025J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Nov-2021, the patient experienced CHEST PAIN (Intermittent chest pain/Chest pain every 20 to 30 minutes). At the time of the report, CHEST PAIN (Intermittent chest pain/Chest pain every 20 to 30 minutes) outcome was unknown.            No concomitant medications were provided by the reporter.  No treatment medications were provided.   This case was linked to MOD-2021-375118, MOD-2021-375044 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Vaccination complication, Vaccination site pain
Clinical narrative: Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine; Mild flu; Mild pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine), INFLUENZA (Mild flu) and VACCINATION SITE PAIN (Mild pain in the injection site) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030l20a) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced INFLUENZA (Mild flu) and VACCINATION SITE PAIN (Mild pain in the injection site). On an unknown date, the patient experienced VACCINATION COMPLICATION (Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Vaccination site pain, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (Having a reaction to the blood thinner takes after getting vaccinated with the Moderna covid19 vaccine) and VACCINATION SITE PAIN (Mild pain in the injection site) outcome was unknown and INFLUENZA (Mild flu) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No Concomitant medication information was proviided   This case was linked to MOD-2021-375208 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 46 patients received an expired dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (46 patients received an expired 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.    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 EXPIRED PRODUCT ADMINISTERED (46 patients received an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (46 patients received an expired dose) 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.  Date the vial was initially stored in the refrigerator was 23Sep2021 Date(s) of administration of vaccine are  24Oct2021, 25Oct2021, 26Oct2021, 27Oct2021, 28Oct2021.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: An adverse effect of the Moderna COVID-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (An adverse effect of the Moderna COVID-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (An adverse effect of the Moderna COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (An adverse effect of the Moderna COVID-19 vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus, Vaccination complication
Clinical narrative: Had ringing in his ears very laud/major ringing in his ears, got worst; On blood thinner at the time, and had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Had ringing in his ears very laud/major ringing in his ears, got worst) and VACCINATION COMPLICATION (On blood thinner at the time, and had a reaction) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023m20a and 030l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-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 TINNITUS (Had ringing in his ears very laud/major ringing in his ears, got worst) and VACCINATION COMPLICATION (On blood thinner at the time, and had a reaction). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, TINNITUS (Had ringing in his ears very laud/major ringing in his ears, got worst) and VACCINATION COMPLICATION (On blood thinner at the time, and had a reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient didn't want to provide concomitant medication  Treatment information was not provided  Patient had ringing in ears very laud until 20-MAR-2021, major ringing in his ears, got worst.   This case was linked to MOD-2021-375190 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Ringing in my ear; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Ringing in my ear) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included LOSARTAN for Blood pressure high, VITAMIN B [VITAMIN B NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and CALCIUM for an unknown indication.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced TINNITUS (Ringing in my ear). At the time of the report, TINNITUS (Ringing in my ear) had not resolved.             She went to the doctor and they don't know if it was correlated to the vaccination or not. It has been consistent. She has not taken any treatment medications for it.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Inappropriate schedule of product administration, Injection site erythema, Injection site induration
Clinical narrative: Been up all night with dizziness; A sore arm; The injection site is red and harden; The injection site is red and harden; The area is very sore; A headache; Nauseas; Both had their second dose probably two months later; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden) and INJECTION SITE PAIN (The area is very sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Both had their second dose probably two months later). On 03-Nov-2021, the patient experienced DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden), INJECTION SITE PAIN (The area is very sore), HEADACHE (A headache) and NAUSEA (Nauseas). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Both had their second dose probably two months later) had resolved. At the time of the report, DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden), INJECTION SITE PAIN (The area is very sore), HEADACHE (A headache) and NAUSEA (Nauseas) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported.  The reporter was calling on behalf of their husband who after getting their booster dose on the 03-Nov-2021 experienced side effects. After vaccination, the patient was up all night with dizziness and developed a headache, nauseas and the injection site were red and harden. Reportedly the area was very sore, and the patient experienced a sore arm.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Pain in extremity
Clinical narrative: Been up all night with dizziness; A sore arm; The injection site is red and harden; The injection site is red and harden; The area is very sore; A headache; Nauseas; Both had their second dose probably two months later; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden) and INJECTION SITE PAIN (The area is very sore) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Both had their second dose probably two months later). On 03-Nov-2021, the patient experienced DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden), INJECTION SITE PAIN (The area is very sore), HEADACHE (A headache) and NAUSEA (Nauseas). In April 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Both had their second dose probably two months later) had resolved. At the time of the report, DIZZINESS (Been up all night with dizziness), PAIN IN EXTREMITY (A sore arm), INJECTION SITE INDURATION (The injection site is red and harden), INJECTION SITE ERYTHEMA (The injection site is red and harden), INJECTION SITE PAIN (The area is very sore), HEADACHE (A headache) and NAUSEA (Nauseas) outcome was unknown.            No Concomitant medication was reported.    No treatment medications were reported.  The reporter was calling on behalf of their husband who after getting their booster dose on the 03-Nov-2021 experienced side effects. After vaccination, the patient was up all night with dizziness and developed a headache, nauseas and the injection site were red and harden. Reportedly the area was very sore, and the patient experienced a sore arm.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Temperature 101.5; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature 101.5) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In October 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced PYREXIA (Temperature 101.5). At the time of the report, PYREXIA (Temperature 101.5) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.5 (abnormal) 101.5.         No concomitant medications were provided. No treatment medications were provided.  Patient had taken 2 Tylenol . The second night he experienced temperature 101.5.   This case was linked to MOD-2021-375351 (Patient Link).
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of fatigue (patient felt fatigued since Tuesday) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 017F21A) for COVID-19 immunization. No medical history reported. On  Nov 2, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Nov 2, 2021, patient experienced fatigue (patient felt fatigued since Tuesday). At the time of the report, fatigue (patient felt fatigued since Tuesday) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided. Reporter did not allow further contact.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: wanted to sleep; joints hurt; muscles hurt; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (wanted to sleep), ARTHRALGIA (joints hurt), MYALGIA (muscles hurt) and PYREXIA (Fever) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 007B21A and 012A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 29-Dec-2020.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-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 SOMNOLENCE (wanted to sleep), ARTHRALGIA (joints hurt), MYALGIA (muscles hurt) and PYREXIA (Fever). At the time of the report, SOMNOLENCE (wanted to sleep), ARTHRALGIA (joints hurt), MYALGIA (muscles hurt) and PYREXIA (Fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, SARS-CoV-2 test: positive (Positive) COVID-19 Positive..         No concomitant medications reported.  The patient didn't had nausea and chest congestion which she experienced during covid.  No treatment information was provided.  This case concerns a 86 year old female with  reported medical history Covid 19 last 2020 ,  who experienced Non-serious  unexpected event of  Somnolence  and expected event of Arthralgia , fever and myalgia which occurred on an unknown time after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine) . The re- challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) is not affected by this report.; Sender's Comments: This case concerns a 86 year old female with  reported medical history Covid 19 last 2020 ,  who experienced Non-serious  unexpected event of  Somnolence  and expected event of Arthralgia , fever and myalgia which occurred on an unknown time after vaccination with the 3rd dose ( booster dose ) of mRNA-1273 vaccine ( Moderna Covid 19 Vaccine) . The re- challenge for this case is not applicable. The benefit -risk relationship of mRNA-1273 vaccine ( Moderna Covid 19 vaccine ) is not affected by this report.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of injection site pain (sore arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 011M20A) for COVID-19 immunization. No medical history reported. On Feb 11, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced injection site pain (sore arm). At the time of the report, injection site pain (sore arm) resolved. Concomitant information and treatment information not provided. This case linked to MOD-2021-375328, MOD-2021-375329 (patient link).
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: Hands hurt/arm was sore; Feet hurt; Legs hurt; Fever of 99.1; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Hands hurt/arm was sore), PAIN IN EXTREMITY (Feet hurt), PAIN IN EXTREMITY (Legs hurt), PYREXIA (Fever of 99.1) and HEADACHE (Headache) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 011L20A and 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PAIN IN EXTREMITY (Hands hurt/arm was sore), PAIN IN EXTREMITY (Feet hurt), PAIN IN EXTREMITY (Legs hurt), PYREXIA (Fever of 99.1) and HEADACHE (Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Hands hurt/arm was sore), PAIN IN EXTREMITY (Feet hurt), PAIN IN EXTREMITY (Legs hurt), PYREXIA (Fever of 99.1) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Nov-2021, Body temperature: high (High) fever of 99.1.         No Concomitant product use was reported.  The patient after receiving the booster dose of the vaccine started to have a headache and their hands, feet and legs were hurting. The patient's arm was sore, and they had a fever of 99.1. The patient was scheduled to get a CT with PO and IV contrast soon.  The patient stated that it all started at 04-Nov-2021 morning at 1:00 AM and they took an Advil for their symptoms. Reportedly, the patient had not discussed this with their HCP.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of vaccination complication ("normal side effects" to the first two Moderna COVID-19 vaccinations) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination complication ("normal side effects" to the first two Moderna COVID-19 vaccinations). At the time of the report, vaccination complication ("normal side effects" to the first two Moderna COVID-19 vaccinations) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Concomitant medication and treatment information not provided. This case was linked to MOD-2021-375294, MOD-2021-375331 (patient link). Reporter did not allow further contact.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: was administered a vaccine punctured more than 24 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (was administered a vaccine punctured more than 24 hours) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (was administered a vaccine punctured more than 24 hours). On 04-Nov-2021, EXPIRED PRODUCT ADMINISTERED (was administered a vaccine punctured more than 24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were given.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 68-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication was  reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hot flush, Nausea
Clinical narrative: Fatigue; Hot flashes; intense nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of HOT FLUSH (Hot flashes), NAUSEA (intense nausea) and FATIGUE (Fatigue) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     Concurrent medical conditions included Migraine since 2008, Nausea and Allergy to antibiotic (maculopapular rash).   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-Nov-2021, the patient experienced HOT FLUSH (Hot flashes) and NAUSEA (intense nausea). On 04-Nov-2021, the patient experienced FATIGUE (Fatigue). The patient was treated with ONDANSETRON (oral) ongoing since an unknown date for Migraine, at a dose of 8 milligram as necessary. On 03-Nov-2021, HOT FLUSH (Hot flashes) and NAUSEA (intense nausea) had resolved. On 04-Nov-2021, FATIGUE (Fatigue) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered HOT FLUSH (Hot flashes), NAUSEA (intense nausea) and FATIGUE (Fatigue) to be related.    Three hours after the vaccine administration had intense nausea and hot flashes not associated with migraine. The patient took 8 mg ODT of Ondansetron  and symptoms resolved after 45 minutes. No other adverse experience were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Nov-2021: Follow up received on 07-Nov-2021. Updated patient demographics, medical history, dose 1 and dose 2 details, and event fatigue updated.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 51-year-old male 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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was provided.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 39-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 an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment medications provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test
Clinical narrative: Feeling Sick; COVID-19 diagnosis/received the positive result of the test; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19 diagnosis/received the positive result of the test) and MALAISE (Feeling Sick) in a 29-year-old male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced COVID-19 (COVID-19 diagnosis/received the positive result of the test). On an unknown date, the patient experienced MALAISE (Feeling Sick). At the time of the report, COVID-19 (COVID-19 diagnosis/received the positive result of the test) and MALAISE (Feeling Sick) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2021, SARS-CoV-2 test: positive (Positive) Positive.         The patient went to get moderna booster dose and also received the positive result of the COVID 19 test.  No concomitant medications were reported.  No treatment information was provided This case concerns a 29 year-old male patient with no reported medical history who experienced the unexpected adverse event of special interest of COVID-19. The event occurred approximately on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 29 year-old male patient with no reported medical history who experienced the unexpected adverse event of special interest of COVID-19. The event occurred approximately on an unknown date relative to vaccination with the third dose of Moderna COVID-19 Vaccine. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore arm eight hours after the booster and is still on going) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 20, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. April 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 3, 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 3, 2021, after the mRNA-1273 (Moderna COVID-19 vaccine), patient had pain in extremity (sore arm eight hours after the booster and is still on going). At the time of the report, pain in extremity (sore arm eight hours after the booster and is still on going): not resolved. No concomitant medication or treatment information provided. This case linked to MOD-2021-375348 (patient link).
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA and CHILLS 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 PYREXIA and CHILLS. At the time of the report, PYREXIA and CHILLS outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Expired product administered, Extra dose administered, Product storage error
Clinical narrative: Anxiety; Patient was already revaccinated with another booster dose of 0.25mL.; Expired dose given was booster dose on 3Nov2021; Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):26 hours; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (Anxiety), EXPIRED PRODUCT ADMINISTERED (Expired dose given was booster dose on 3Nov2021), PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):26 hours) and EXTRA DOSE ADMINISTERED (Patient was already revaccinated with another booster dose of 0.25mL.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Nov-2021 at 3:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 02-Nov-2021, the patient experienced PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):26 hours). On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given was booster dose on 3Nov2021). On an unknown date, the patient experienced ANXIETY (Anxiety) and EXTRA DOSE ADMINISTERED (Patient was already revaccinated with another booster dose of 0.25mL.). On 03-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given was booster dose on 3Nov2021) and PRODUCT STORAGE ERROR (Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F):26 hours) had resolved. At the time of the report, ANXIETY (Anxiety) outcome was unknown and EXTRA DOSE ADMINISTERED (Patient was already revaccinated with another booster dose of 0.25mL.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Dose was administered >12(US)/24(CA) hours post puncture. Vial was first punctured on 2nd Nov2021 at 12:45 pm. Patient was revaccinated with another booster dose of 0.25mL on an unknown date. No concomitant medication were given. No treatment information were provided.