chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: Feels miserable; Sore throat; Eyes real sore; Ache; Chills; A fever of 99°F; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feels miserable), OROPHARYNGEAL PAIN (Sore throat), EYE PAIN (Eyes real sore), PAIN (Ache) and CHILLS (Chills) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045j21a, 027a21a and 021b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Cholesterol.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced FEELING ABNORMAL (Feels miserable), OROPHARYNGEAL PAIN (Sore throat), EYE PAIN (Eyes real sore), PAIN (Ache), CHILLS (Chills) and PYREXIA (A fever of 99°F). At the time of the report, FEELING ABNORMAL (Feels miserable), OROPHARYNGEAL PAIN (Sore throat), EYE PAIN (Eyes real sore), PAIN (Ache), CHILLS (Chills) and PYREXIA (A fever of 99°F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Body temperature: 99 f (High) fever of 99°F.         Concomitant medication include cholesterol medication. Treatment information was not provided.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on back of neck/moving throughout my body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on back of neck/moving throughout my body) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 032L20A and 032B21A) for COVID-19 vaccination.     Concomitant products included LAMOTRIGINE (LAMICTAL) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.   On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Dec-2021, the patient experienced RASH (Rash on back of neck/moving throughout my body). At the time of the report, RASH (Rash on back of neck/moving throughout my body) outcome was unknown.            Treatment included  steroid cream, over the counter allergy medicine.   This case was linked to MOD-2021-406644 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Myalgia, Pain in extremity, Tremor
Clinical narrative: arm hurt,; whole body was hurting; couldn't stop shaking,; and had a temperature of 101°F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurt,), MYALGIA (whole body was hurting), TREMOR (couldn't stop shaking,) and BODY TEMPERATURE INCREASED (and had a temperature of 101°F) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ATORVASTATIN CALCIUM (ATORVASTIN) and THYRODEX T 150 for an unknown indication.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Dec-2021, the patient experienced PAIN IN EXTREMITY (arm hurt,), MYALGIA (whole body was hurting), TREMOR (couldn't stop shaking,) and BODY TEMPERATURE INCREASED (and had a temperature of 101°F). The patient was treated with IBUPROFEN for Body temperature increased, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (arm hurt,), MYALGIA (whole body was hurting) and TREMOR (couldn't stop shaking,) outcome was unknown and BODY TEMPERATURE INCREASED (and had a temperature of 101°F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Body temperature: 101 (High) 101°F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination complication
Clinical narrative: Lymph nodes in the right side of the neck are swollen; having side effects; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION (having side effects) and LYMPHADENOPATHY (Lymph nodes in the right side of the neck are swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (having side effects). On 06-Dec-2021, the patient experienced LYMPHADENOPATHY (Lymph nodes in the right side of the neck are swollen). At the time of the report, VACCINATION COMPLICATION (having side effects) and LYMPHADENOPATHY (Lymph nodes in the right side of the neck are swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided. Treatment information was not provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu like symptoms.; feel real ache; a fever of 105°F/super high fever; real bad chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms.), PAIN (feel real ache), PYREXIA (a fever of 105°F/super high fever) and CHILLS (real bad chills) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045j21a, 027a21a and 021b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms.), PAIN (feel real ache), PYREXIA (a fever of 105°F/super high fever) and CHILLS (real bad chills). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms.), PAIN (feel real ache), PYREXIA (a fever of 105°F/super high fever) and CHILLS (real bad chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Dec-2021, Body temperature: 105 (High) fever of 105°F.         No concomitant medication were provided. No treatment information were given.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears; Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears) and DIZZINESS (Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Dizziness (The patient had dizziness, started last year before the vaccination.) in 2020 and Vertigo (Had last year before the vaccination.).   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced VERTIGO (since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears) and DIZZINESS (Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness). At the time of the report, VERTIGO (since 2 weeks she has an episode of dizziness, vertigo,it's states from the ears) outcome was unknown and DIZZINESS (Since 2 weeks she has an episode of dizziness vertigo, states it's from the ears/It is horrible because you get dizzy and she still has it bad and still has her dizziness) had not resolved.            No concomitant medications reported. No treatment information was provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: Did not feel good after second shot; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Did not feel good after second shot) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 22-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 24-Feb-2021, the patient experienced FEELING ABNORMAL (Did not feel good after second shot). On 26-Feb-2021, FEELING ABNORMAL (Did not feel good after second shot) had resolved.            No concomitant medications were reported. No treatment medications were reported.        This case was linked to MOD-2021-406940 (Patient Link).
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: painful mass at injection site; swelling at injection site, swelling is extending outwards; chills; body aches; painful mass at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (painful mass at injection site), VACCINATION SITE SWELLING (swelling at injection site, swelling is extending outwards), CHILLS (chills), MYALGIA (body aches) and VACCINATION SITE PAIN (painful mass at injection site) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FJ8757 and 065F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, the patient experienced VACCINATION SITE MASS (painful mass at injection site), VACCINATION SITE SWELLING (swelling at injection site, swelling is extending outwards), CHILLS (chills), MYALGIA (body aches) and VACCINATION SITE PAIN (painful mass at injection site). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at a dose of 500 milligram twice a day. At the time of the report, VACCINATION SITE MASS (painful mass at injection site), VACCINATION SITE SWELLING (swelling at injection site, swelling is extending outwards), CHILLS (chills), MYALGIA (body aches) and VACCINATION SITE PAIN (painful mass at injection site) outcome was unknown.            Symptoms: It was reported that the patient had experienced adverse event post 48 hours of vaccination, and was seen on call with doctor. the swelling was extended outwards from mass, patient was going to visit her primary care doctor the next day if symptoms don't improve. Patient did not experienced any events after first dose of Moderna vaccine.  No concomitant medications were reported
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Headache, Pain, Pyrexia
Clinical narrative: puffiness of face and neck; Redness; pain; Puffinessof neck/swelling going through her body; Fever; Enormous headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (\whole household have acquired COVID-19 so that she was really scared and worried about it). Concurrent medical conditions included Drug allergy (Sulfur medication).    On 01-Apr-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 SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body), PYREXIA (Fever), HEADACHE (Enormous headache) and CHILLS (Chills). At the time of the report, SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body), PYREXIA (Fever), HEADACHE (Enormous headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. The patient experienced puffiness of face and neck, redness, pain and swelling al going through body after first dose of the vaccine. There's also fever, enormous headache and chills after. No treatment information was provided.   This case was linked to MOD-2021-406944 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: puffiness of face and neck; Redness; pain; Puffinessof neck/swelling going through her body; Fever; Enormous headache; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body) and PYREXIA (Fever) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (\whole household have acquired COVID-19 so that she was really scared and worried about it). Concurrent medical conditions included Drug allergy (Sulfur medication).    On 01-Apr-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 SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body), PYREXIA (Fever), HEADACHE (Enormous headache) and CHILLS (Chills). At the time of the report, SWELLING FACE (puffiness of face and neck), ERYTHEMA (Redness), PAIN (pain), SWELLING (Puffinessof neck/swelling going through her body), PYREXIA (Fever), HEADACHE (Enormous headache) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. The patient experienced puffiness of face and neck, redness, pain and swelling al going through body after first dose of the vaccine. There's also fever, enormous headache and chills after. No treatment information was provided.   This case was linked to MOD-2021-406944 (Patient Link).
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Tenderness
Clinical narrative: Sore and tender arm; Sore and tender arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore and tender arm) and TENDERNESS (Sore and tender arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Leukemia. Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included AMRUBICIN for an unknown indication.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore and tender arm) and TENDERNESS (Sore and tender arm). At the time of the report, PAIN IN EXTREMITY (Sore and tender arm) and TENDERNESS (Sore and tender arm) outcome was unknown.            The reporter's father who was a patient experienced a sore and tender arm after the second dose of the vaccine. It was also reported that the patient had a history of diabetes, blood pressure issues, and leukemia. Reportedly, the patient was regularly taking a blood pressure pill, medications for their diabetes, and amrubicin.  Other concomitant medications reported included a blood pressure pill and medications for diabetes. No treatment information was provided.   This case was linked to MOD-2021-406930, MOD-2021-406939 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Somnolence
Clinical narrative: arm and hand started tingling; with the feeling of it falling asleep; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (arm and hand started tingling) and SOMNOLENCE (with the feeling of it falling asleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Johnson and Johnson on 20-Mar-2021. Past adverse reactions to the above products included No adverse event with Johnson and Johnson.    On 06-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Dec-2021, the patient experienced PARAESTHESIA (arm and hand started tingling) and SOMNOLENCE (with the feeling of it falling asleep). At the time of the report, PARAESTHESIA (arm and hand started tingling) and SOMNOLENCE (with the feeling of it falling asleep) had not resolved.            No concomitant medication were reported.  Patient had the Johnson and Johnson vaccine on 20-Mar-2021 and had the Moderna booster on 06-Dec-2021. On 08-Dec-2021 patient arm and hand started tingling with the feeling of it falling asleep and it continues on 09-Dec-2021.  No treatment medication were reported.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: sore and tender arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore and tender arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Blood pressure abnormal and Leukemia. Concomitant products included AMRUBICIN for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore and tender arm). At the time of the report, VACCINATION SITE PAIN (sore and tender arm) outcome was unknown.  mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. The patient regularly took a blood pressure pill and medications for diabetes. Lot number or expiration date information were not available. No treatment information was provided by the reporter. This case was linked to MOD-2021-406930, MOD-2021-406936 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: Red injection site 2X2" after booster; Itchy Injection Site after booster; Red injection site 2X2" after booster; Very bad feeling after booster; Weak after booster; No appetite after booster; Muscle ache all over the body after booster; Chills after booster; A little Headache after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster) and CHILLS (Chills after booster) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 026L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-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 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster), CHILLS (Chills after booster) and HEADACHE (A little Headache after booster). On 08-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red injection site 2X2" after booster). On 09-Dec-2021, the patient experienced VACCINATION SITE PAIN (Red injection site 2X2" after booster) and VACCINATION SITE PRURITUS (Itchy Injection Site after booster). At the time of the report, FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster), CHILLS (Chills after booster) and HEADACHE (A little Headache after booster) was resolving and VACCINATION SITE ERYTHEMA (Red injection site 2X2" after booster), VACCINATION SITE PAIN (Red injection site 2X2" after booster) and VACCINATION SITE PRURITUS (Itchy Injection Site after booster) had not resolved.            No concomitant medications provided. On the 9-Dec-2021 the injection site was dark red with lighter red tong around it oval shape around 5. No treatment medications provided.   This case was linked to MOD-2021-406929 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Red injection site 2X2" after booster; Itchy Injection Site after booster; Red injection site 2X2" after booster; Very bad feeling after booster; Weak after booster; No appetite after booster; Muscle ache all over the body after booster; Chills after booster; A little Headache after booster; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster) and CHILLS (Chills after booster) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006B21A, 026L20A and 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-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 06-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster), CHILLS (Chills after booster) and HEADACHE (A little Headache after booster). On 08-Dec-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red injection site 2X2" after booster). On 09-Dec-2021, the patient experienced VACCINATION SITE PAIN (Red injection site 2X2" after booster) and VACCINATION SITE PRURITUS (Itchy Injection Site after booster). At the time of the report, FEELING ABNORMAL (Very bad feeling after booster), ASTHENIA (Weak after booster), DECREASED APPETITE (No appetite after booster), MYALGIA (Muscle ache all over the body after booster), CHILLS (Chills after booster) and HEADACHE (A little Headache after booster) was resolving and VACCINATION SITE ERYTHEMA (Red injection site 2X2" after booster), VACCINATION SITE PAIN (Red injection site 2X2" after booster) and VACCINATION SITE PRURITUS (Itchy Injection Site after booster) had not resolved.            No concomitant medications provided. On the 9-Dec-2021 the injection site was dark red with lighter red tong around it oval shape around 5. No treatment medications provided.   This case was linked to MOD-2021-406929 (Patient Link).
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood cholesterol, Dizziness, Feeling abnormal, Heart rate
Clinical narrative: She said she experienced rapid heartbeat; Anxiety problems; She felt like she almost had a heart attack; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (She said she experienced rapid heartbeat), ANXIETY (Anxiety problems), FEELING ABNORMAL (She felt like she almost had a heart attack) and DIZZINESS (Dizziness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Her whole household have acquired COVID-19 so that she was really scared and worried about it) in March 2020. Concurrent medical conditions included Sulfonamide allergy (She had an allergic reaction to sulfur medication).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 TACHYCARDIA (She said she experienced rapid heartbeat), ANXIETY (Anxiety problems), FEELING ABNORMAL (She felt like she almost had a heart attack) and DIZZINESS (Dizziness). At the time of the report, TACHYCARDIA (She said she experienced rapid heartbeat), ANXIETY (Anxiety problems), FEELING ABNORMAL (She felt like she almost had a heart attack) and DIZZINESS (Dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: hightened (High) She also experienced heightened level of cholesterol. On an unknown date, Heart rate: rapid (High) She experienced rapid heart beat. On an unknown date, Oxygen consumption: low (Low) Low blood oxygen.         No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-406934 (Patient Link).
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Oxygen consumption, Tachycardia
Clinical narrative: She said she experienced rapid heartbeat; Anxiety problems; She felt like she almost had a heart attack; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (She said she experienced rapid heartbeat), ANXIETY (Anxiety problems), FEELING ABNORMAL (She felt like she almost had a heart attack) and DIZZINESS (Dizziness) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 020B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Her whole household have acquired COVID-19 so that she was really scared and worried about it) in March 2020. Concurrent medical conditions included Sulfonamide allergy (She had an allergic reaction to sulfur medication).   On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-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 TACHYCARDIA (She said she experienced rapid heartbeat), ANXIETY (Anxiety problems), FEELING ABNORMAL (She felt like she almost had a heart attack) and DIZZINESS (Dizziness). At the time of the report, TACHYCARDIA (She said she experienced rapid heartbeat), ANXIETY (Anxiety problems), FEELING ABNORMAL (She felt like she almost had a heart attack) and DIZZINESS (Dizziness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood cholesterol: hightened (High) She also experienced heightened level of cholesterol. On an unknown date, Heart rate: rapid (High) She experienced rapid heart beat. On an unknown date, Oxygen consumption: low (Low) Low blood oxygen.         No concomitant medications were reported. No treatment details were reported.   This case was linked to MOD-2021-406934 (Patient Link).
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Vial had been punctured for 18 hours. The vial was stored in the refrigerator after the first puncture. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.
Age: 61.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 61-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved.        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.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Bad headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Bad headache) in a 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 08-Dec-2021, 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 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. In 2021, the patient experienced HEADACHE (Bad headache). At the time of the report, HEADACHE (Bad headache) outcome was unknown.      No Concomitants and Treatment medications were reported.   Reporter did not allow further contact
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vertigo
Clinical narrative: Migraines since about 6 months ago; vertigo since about 6 months ago/ vertigo since before the booster; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraines since about 6 months ago) and VERTIGO (vertigo since about 6 months ago/ vertigo since before the booster) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B214) for COVID-19 vaccination.     Concurrent medical conditions included Migraine.    On 19-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced MIGRAINE (Migraines since about 6 months ago) and VERTIGO (vertigo since about 6 months ago/ vertigo since before the booster). At the time of the report, MIGRAINE (Migraines since about 6 months ago) and VERTIGO (vertigo since about 6 months ago/ vertigo since before the booster) outcome was unknown.            NO Concomitant drug reported. NO Treatment drug reported.   This case was linked to MOD-2021-404999 (Patient Link).
Age: 20.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered to patients 18 hours after first vial puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) in a 20-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 071F21A) 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 EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered to patients 18 hours after first vial puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.  The vial was stored in the refrigerator after the first puncture.
Sex: U
Vaccine: COVID19
Symptoms: Accidental underdose, Product administration error
Clinical narrative: A small droplet came out during administration; A small droplet came out during administration; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (A small droplet came out during administration) and PRODUCT ADMINISTRATION ERROR (A small droplet came out during administration) 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 ACCIDENTAL UNDERDOSE (A small droplet came out during administration) and PRODUCT ADMINISTRATION ERROR (A small droplet came out during administration). At the time of the report, ACCIDENTAL UNDERDOSE (A small droplet came out during administration) and PRODUCT ADMINISTRATION ERROR (A small droplet came out during administration) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter who was a pharmacist stated that when a provider was administering 0.25ml booster dose of the Moderna COVID-19 vaccine to the patient, a small droplet came out but the majority of it was administered.  No Concomitant product use was reported. No treatment information was provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Vomiting
Clinical narrative: night diarrhea; vomiting; This spontaneous case was reported by a pharmacist and describes the occurrence of DIARRHOEA (night diarrhea) and VOMITING (vomiting) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced DIARRHOEA (night diarrhea) and VOMITING (vomiting). At the time of the report, DIARRHOEA (night diarrhea) and VOMITING (vomiting) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient receive a booster dose when he should have gotten a third dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (Patient receive a booster dose when he should have gotten a third dose) in a male 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Patient receive a booster dose when he should have gotten a third dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Patient receive a booster dose when he should have gotten a third dose) 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: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient 4:  given dose >12hrs post vial puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient 4:  given dose >12hrs post vial puncture.) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OMEPRAZOLE, DILTIAZEM HYDROCHLORIDE (DILTIAZEM XR), ATORVASTATIN, LEVETIRACETAM (KEPPRA [LEVETIRACETAM]), GABAPENTIN, CYCLOBENZAPRINE, VITAMIN D3, TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA), FAMOTIDINE, ALBUTEROL [SALBUTAMOL], CHLORTHALIDONE, KCL, ONDANSETRON (ZOFRAN [ONDANSETRON]) and LISINOPRIL for an unknown indication.    On 30-Nov-2021 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient 4:  given dose >12hrs post vial puncture.). On 30-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Patient 4:  given dose >12hrs post vial puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications were not provided.  It was reported that vial was opened on 19-Nov-2021 at 11:29 AM and storage condition from 19-Nov-2021 to 30-Nov-2021 was unknown.   This case was linked to MOD-2021-407133, MOD-2021-407134, MOD-2021-407056, MOD-2021-406232 (Patient Link).
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient 3: dose given >12hrs post vial puncture.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient 3: dose given >12hrs post vial puncture.) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 038K20A and 002A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021 at 1:11 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient 3: dose given >12hrs post vial puncture.). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient 3: dose given >12hrs post vial puncture.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment reported  Patient took Vaccine on 07 Dec 2021 and Vial opened on 06 Dec 2021.   This case was linked to MOD-2021-407042, MOD-2021-407134, MOD-2021-407133 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: feel terrible today; This spontaneous case was reported by a pharmacist and describes the occurrence of MALAISE (feel terrible today) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced MALAISE (feel terrible today). At the time of the report, MALAISE (feel terrible today) outcome 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   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Sore arm) 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, 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 MYALGIA (Sore arm). At the time of the report, MYALGIA (Sore arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant and Treatment medication were reported.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011220A) for COVID-19 vaccination.     No Medical History information was reported.  Concomitant products included VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Treatment information was not provided.   This case was linked to MOD-2021-407136 (Patient Link).
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of the Moderna COVID-19 vaccine more than 12 hours after it was punctured; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine more than 12 hours after it was punctured) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A and 071F21A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included HYDROCHLOROTHIAZIDE, METFORMIN, SIMVASTATIN and LISINOPRIL for an unknown indication.   On 10-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine more than 12 hours after it was punctured). On 09-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of the Moderna COVID-19 vaccine more than 12 hours after it was punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F). .4 hours at room temperature No treatment medications were reported.