chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) 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 use was reported.   This case was linked to MOD-2021-435992.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of the Moderna COVID-19 vaccine/ The vial was punctured yesterday, 28DEC2021, and used for up to 17 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine/ The vial was punctured yesterday, 28DEC2021, and used for up to 17 hours post puncture) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine/ The vial was punctured yesterday, 28DEC2021, and used for up to 17 hours post puncture). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an expired dose of the Moderna COVID-19 vaccine/ The vial was punctured yesterday, 28DEC2021, and used for up to 17 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were reported.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Treatment information was not reported.  The vial was punctured on 28DEC2021 at 10 PM and administrated on 29DEC2021 at 10:30 AM - 2:55 PM, and used for up to 17 hours post puncture
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) 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 medications were reported.  The vial was punctured on 28-Dec-2021, and used for up to 17 hours post puncture. No patients have reported any side effects from this dose.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired vaccine given to patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.  On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patient) had resolved.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Pharmacist stated that, on 29-Dec-2021 at 10.30 am to 02.55 pm, patient received an expired dose of the Moderna COVID-19 vaccine. The vial was punctured on 28-Dec-2021 at 10 pm, and used for up to 17 hours post puncture. The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received an expired dose of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 vaccine). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (received an expired dose of the Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Number of doses/vials: 13 doses from 1 vial; date the vial was initially stored in the refrigerator: not sure, because the facility received the vaccine in thawed condition; date(s) and time(s) vial was first punctured: 28-Dec-2021 at 10 pm; date(s) of administration of vaccine: 29-Dec-2021 at 10:30 am - 2:55 pm; post puncture the vial was stored in RT; the vial did not undergo any temperature excursions; total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) was approximately 17 hours.  The patient did not report any side effects from this dose.  No treatment information was provided by the reporter.
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A 16 year old patient received the Moderna vaccine as Booster; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the Moderna vaccine as Booster) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013H21B, EW0182 and ER8736) for COVID-19 vaccination.     No Medical History information was reported.   On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Dec-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the Moderna vaccine as Booster). On 31-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 16 year old patient received the Moderna vaccine as Booster) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treat medications were given to patient.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash while eating in a restaurant; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash while eating in a restaurant) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third 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 and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (rash while eating in a restaurant). At the time of the report, RASH (rash while eating in a restaurant) outcome was unknown.            Concomitant medications were not provided.  It was reported that patient had no symptoms after first and second doses.  Treatment information was not provided.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Influenza like illness, Myalgia, Vaccination complication, Vaccination site erythema
Clinical narrative: Her arm is swollen since Thursday; This booster really kicked, her around; flu-like symptoms; The left shoulder where the shot was administered, she has a knot in her arm; The left shoulder where the shot was administered, she has a knot in her arm. It's really red.; She had body aches; She was really really sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (This booster really kicked, her around), INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (She was really really sick), VACCINATION SITE INDURATION (The left shoulder where the shot was administered, she has a knot in her arm) and VACCINATION SITE ERYTHEMA (The left shoulder where the shot was administered, she has a knot in her arm. It's really red.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer ((lot EN6207)) on 16-Mar-2021 and Pfizer ((lot EN0153)) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer; and Sickness with Pfizer.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (She was really really sick). On 29-Dec-2021, the patient experienced VACCINATION COMPLICATION (This booster really kicked, her around), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (The left shoulder where the shot was administered, she has a knot in her arm), VACCINATION SITE ERYTHEMA (The left shoulder where the shot was administered, she has a knot in her arm. It's really red.) and MYALGIA (She had body aches). On 30-Dec-2021, the patient experienced VACCINATION SITE SWELLING (Her arm is swollen since Thursday). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) from 29-Dec-2021 to 30-Dec-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (This booster really kicked, her around), INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (She was really really sick) and MYALGIA (She had body aches) outcome was unknown and VACCINATION SITE INDURATION (The left shoulder where the shot was administered, she has a knot in her arm), VACCINATION SITE ERYTHEMA (The left shoulder where the shot was administered, she has a knot in her arm. It's really red.) and VACCINATION SITE SWELLING (Her arm is swollen since Thursday) had not resolved.            She put alcohol with cotton swabs on her arm. Concomitant medication use was unknown
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site induration, Vaccination site swelling
Clinical narrative: Her arm is swollen since Thursday; This booster really kicked, her around; flu-like symptoms; The left shoulder where the shot was administered, she has a knot in her arm; The left shoulder where the shot was administered, she has a knot in her arm. It's really red.; She had body aches; She was really really sick; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (This booster really kicked, her around), INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (She was really really sick), VACCINATION SITE INDURATION (The left shoulder where the shot was administered, she has a knot in her arm) and VACCINATION SITE ERYTHEMA (The left shoulder where the shot was administered, she has a knot in her arm. It's really red.) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Pfizer ((lot EN6207)) on 16-Mar-2021 and Pfizer ((lot EN0153)) on 07-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer; and Sickness with Pfizer.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (She was really really sick). On 29-Dec-2021, the patient experienced VACCINATION COMPLICATION (This booster really kicked, her around), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE INDURATION (The left shoulder where the shot was administered, she has a knot in her arm), VACCINATION SITE ERYTHEMA (The left shoulder where the shot was administered, she has a knot in her arm. It's really red.) and MYALGIA (She had body aches). On 30-Dec-2021, the patient experienced VACCINATION SITE SWELLING (Her arm is swollen since Thursday). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) from 29-Dec-2021 to 30-Dec-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (This booster really kicked, her around), INFLUENZA LIKE ILLNESS (flu-like symptoms), ILLNESS (She was really really sick) and MYALGIA (She had body aches) outcome was unknown and VACCINATION SITE INDURATION (The left shoulder where the shot was administered, she has a knot in her arm), VACCINATION SITE ERYTHEMA (The left shoulder where the shot was administered, she has a knot in her arm. It's really red.) and VACCINATION SITE SWELLING (Her arm is swollen since Thursday) had not resolved.            She put alcohol with cotton swabs on her arm. Concomitant medication use was unknown
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) and HEADACHE (Headache) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K00A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Hospitalized for 20 days) in July 2020.    On 20-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Dec-2020, the patient experienced CHILLS (Chills) and HEADACHE (Headache). At the time of the report, CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were given. Patient tested positive for Covid-19 test on July2020 and was hospitalized for 20 days. Treatment for Covid 19 include Monoclonal antibodies, Plasma, Redemsivir, and Dexamethasone.  No treatment information were given.   This case was linked to MOD-2021-436130 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Facial paresis, Vaccination complication, Visual impairment
Clinical narrative: Vision kind of off on both eyes but more in the left eye; Facial muscle side effects, one side of his face's senses appear to be stronger that the other side; Side effects; This spontaneous case was reported by a consumer and describes the occurrence of VISUAL IMPAIRMENT (Vision kind of off on both eyes but more in the left eye), FACIAL PARESIS (Facial muscle side effects, one side of his face's senses appear to be stronger that the other side) and VACCINATION COMPLICATION (Side effects) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced VISUAL IMPAIRMENT (Vision kind of off on both eyes but more in the left eye), FACIAL PARESIS (Facial muscle side effects, one side of his face's senses appear to be stronger that the other side) and VACCINATION COMPLICATION (Side effects). At the time of the report, VISUAL IMPAIRMENT (Vision kind of off on both eyes but more in the left eye), FACIAL PARESIS (Facial muscle side effects, one side of his face's senses appear to be stronger that the other side) and VACCINATION COMPLICATION (Side effects) had not resolved.            Eight days later following vaccination on Monday the patient started to experience like side effects, facial muscle side effects, one side of his face's senses appear to be stronger that the other side, vision kind of off on both eyes but more in the left eye. The symptoms were ongoing. Concomitant medication included Colitis medication. Treatment medications were none.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Muscle injury, Pain in extremity, Vaccination complication, Vaccination site pain
Clinical narrative: Side effects; Feeling of a strained hamstring; Pain in legs; Pain in knees; General soreness where the shot was given; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects), MUSCLE INJURY (Feeling of a strained hamstring), PAIN IN EXTREMITY (Pain in legs), ARTHRALGIA (Pain in knees) and VACCINATION SITE PAIN (General soreness where the shot was given) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 070H21A, 036B21A and 07A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021 at 2:30 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced MUSCLE INJURY (Feeling of a strained hamstring), PAIN IN EXTREMITY (Pain in legs), ARTHRALGIA (Pain in knees) and VACCINATION SITE PAIN (General soreness where the shot was given). On 31-Dec-2021 at 10:00 AM, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) had not resolved and MUSCLE INJURY (Feeling of a strained hamstring), PAIN IN EXTREMITY (Pain in legs), ARTHRALGIA (Pain in knees) and VACCINATION SITE PAIN (General soreness where the shot was given) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient was on some concomitant medication.  Treatment information was not provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Morphoea, Sleep disorder
Clinical narrative: patient has trouble sleeping because of the skin condition.; skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SLEEP DISORDER (patient has trouble sleeping because of the skin condition.), MORPHOEA (skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048A21A and 015M20A) for COVID-19 vaccination.     Concomitant products included TACROLIMUS and BETAMETHASONE for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Mar-2021, the patient experienced CHILLS (Chills) and HEADACHE (Headache). In April 2021, the patient experienced SLEEP DISORDER (patient has trouble sleeping because of the skin condition.) and MORPHOEA (skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea). At the time of the report, SLEEP DISORDER (patient has trouble sleeping because of the skin condition.), MORPHOEA (skin in her chest is getting hard and it was changing color/became brownish and in some places red/spread to her back,belly button,groin/ skin hardness has spread all over /Morphea), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was reported. No medical history was provided by the reporter.  Patient went to see a Dermatologist in the spring of 2021 and thought she had a heat rash, Dermatologist diagnosed her condition as Morphea. Patient is seeing a Dermatologist and a Rheumatologist, Rheumatologist ordered an MRI for the patient's chest. MRI has not yet been taken
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 5 years old was given the booster dose of the Moderna COVID 19 vaccine (0.25 mL); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 years old was given the booster dose of the Moderna COVID 19 vaccine (0.25 mL)) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 31-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 years old was given the booster dose of the Moderna COVID 19 vaccine (0.25 mL)). On 31-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (5 years old was given the booster dose of the Moderna COVID 19 vaccine (0.25 mL)) had resolved.            Concomitant medications was not provided by the reporter. Treatment information was not provided.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: spontaneous hives,extremely painful and extremely extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (spontaneous hives,extremely painful and extremely extremely itchy) 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 19-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (spontaneous hives,extremely painful and extremely extremely itchy). At the time of the report, URTICARIA (spontaneous hives,extremely painful and extremely extremely itchy) outcome was unknown.            No concomitant medication reported.  The patient had spontaneous hives for the past 5 weeks, said that it was severe on its first 2 weeks and it's extremely painful and extremely extremely itchy.  For the treatment of hives the patient had taken primarily ordinary antihistamines and then stronger antihistamines.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Vaccination Symptoms; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Vaccination Symptoms) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 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 (Vaccination Symptoms). At the time of the report, VACCINATION COMPLICATION (Vaccination Symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported. No treatment information was provided.  The patient reported pain Meds for Vaccination Symptoms.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: sore left arm shoulder deltoid muscle; was tired; had a headache; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left arm shoulder deltoid muscle), FATIGUE (was tired) and HEADACHE (had a headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Pfizer vaccine for her primary series.). Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    On 08-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced MYALGIA (sore left arm shoulder deltoid muscle), FATIGUE (was tired) and HEADACHE (had a headache). At the time of the report, MYALGIA (sore left arm shoulder deltoid muscle), FATIGUE (was tired) and HEADACHE (had a headache) outcome was unknown.            Patient received  Moderna Booster dose on 08-Dec-2021  NO Concomitant and  Treatment drug reported.   This case was linked to MOD-2021-436175 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-Dec-2021: Follow up document received contains non significant information
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity
Clinical narrative: Had a very sore right arm; Patient received the Moderna booster shot after the Pfizer primary series; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a very sore right arm) and INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna booster shot after the Pfizer primary series) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer and Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 14-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Dec-2021, the patient experienced PAIN IN EXTREMITY (Had a very sore right arm) and INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna booster shot after the Pfizer primary series). On 14-Dec-2021, INTERCHANGE OF VACCINE PRODUCTS (Patient received the Moderna booster shot after the Pfizer primary series) had resolved. At the time of the report, PAIN IN EXTREMITY (Had a very sore right arm) outcome was unknown.            No concomitant medications were provided. No treatment medications were reported.  The patient received the Moderna booster shot after the Pfizer primary series.   This case was linked to MOD-2021-436174, MOD-2021-437043 (Patient Link).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Arm started getting very sore around where the shot was injected; Fever; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm started getting very sore around where the shot was injected), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031H21A, 045B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, the patient experienced VACCINATION SITE PAIN (Arm started getting very sore around where the shot was injected). 10-Dec-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache). On 13-Dec-2021, VACCINATION SITE PAIN (Arm started getting very sore around where the shot was injected), PYREXIA (Fever), CHILLS (Chills) and HEADACHE (Headache) had resolved.            No concomitant medications were provided. No treatment medications were taken by the patient.  The patient's symptoms were 80% resolved within 2 days, and were completely resolved within 3.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good) and PAIN IN EXTREMITY (left arm pain that occurred with certain movements) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced FEELING ABNORMAL (didn't feel good) and PAIN IN EXTREMITY (left arm pain that occurred with certain movements). At the time of the report, FEELING ABNORMAL (didn't feel good) and PAIN IN EXTREMITY (left arm pain that occurred with certain movements) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2021-436403 (Patient Link).
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Eye discharge
Clinical narrative: left eye began leaking profusely; This spontaneous case was reported by a consumer and describes the occurrence of EYE DISCHARGE (left eye began leaking profusely) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047B21A and 017B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EYE DISCHARGE (left eye began leaking profusely). At the time of the report, EYE DISCHARGE (left eye began leaking profusely) had not resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       The concomitant medications were not reported. Treatment medications were reported as some unknown eyedrops and eye medications.   This case was linked to MOD-2021-436213, MOD-2021-436265 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Peripheral swelling, Pruritus
Clinical narrative: itching; swelling on arm; red spots; chills; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (itching), PERIPHERAL SWELLING (swelling on arm), ERYTHEMA (red spots) and CHILLS (chills) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Blood pressure high.    On 26-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PRURITUS (itching), PERIPHERAL SWELLING (swelling on arm), ERYTHEMA (red spots) and CHILLS (chills). At the time of the report, PRURITUS (itching), PERIPHERAL SWELLING (swelling on arm), ERYTHEMA (red spots) and CHILLS (chills) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications of the patient included diabetes medication and high blood pressure medication.  No treatment information was provided by the reporter.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: flu-like symptoms; fever; chills; body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication of the patient was not reported.   The patient reported those events as normal side effects, and all the events were resolved within 3-4 days.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-436372, MOD-2021-436373 (E2B Linked Report).; Sender's Comments:  MOD-2021-436372:Dose-2 MOD-2021-436373:Dose 3
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Pruritus, Urticaria
Clinical narrative: hives/urticaria; itchy neck that migrated to body in patches; Hot; not pleasant; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/urticaria), PRURITUS (itchy neck that migrated to body in patches), FEELING HOT (Hot) and FEELING ABNORMAL (not pleasant) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F22A) for COVID-19 vaccination.     Concomitant products included ETHINYLESTRADIOL, NORGESTIMATE (SPRINTEC) for an unknown indication.   In May 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2021, the patient experienced URTICARIA (hives/urticaria), PRURITUS (itchy neck that migrated to body in patches), FEELING HOT (Hot) and FEELING ABNORMAL (not pleasant). The patient was treated with PREDNISONE at an unspecified dose and frequency and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) at an unspecified dose and frequency. At the time of the report, URTICARIA (hives/urticaria), PRURITUS (itchy neck that migrated to body in patches), FEELING HOT (Hot) and FEELING ABNORMAL (not pleasant) outcome was unknown.            It was reported that 11 days after the booster, patient experienced hives, urticaria, itchy neck that migrated to all her body in patches, hot, not pleasant. Patient's doctor prescribed prednisone and Claritin for about a week which has helped and patient has tried over the counter lotions.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypotension
Clinical narrative: Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021; Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021; This spontaneous case was reported by a physician and describes the occurrence of HYPOTENSION (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) and HEADACHE (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LISINOPRIL for an unknown indication.   On 25-Jun-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, the patient experienced HYPOTENSION (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) and HEADACHE (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021). The patient was treated with SALINE [SODIUM CHLORIDE] (intravenous) at an unspecified dose and frequency. At the time of the report, HYPOTENSION (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) and HEADACHE (Patient had episode of low blood pressure, severe headache, taken to ER in AUG2021) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Blood pressure measurement: low (Low) low blood pressure.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was provided by the reporter. Patient was taken to Emergency Room in August 2021.   Reporter did not allow further contact
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: Flu-like symptoms; Fever; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 006B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (Body aches) had resolved.            No concomitant medications were reported.  Treatment information was not provided.   This case was linked to MOD-2021-436309, MOD-2021-436373, MOD-2021-436047 (Patient Link).
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of URTICARIA (hives after 2nd dose) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02LM20A and 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy, Fruit allergy (she can only eat berries and citrus fruits) and Allergy to chemicals. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 URTICARIA (hives after 2nd dose). At the time of the report, URTICARIA (hives after 2nd 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 use was reported.  This case was linked to MOD-2021-436363 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Palpitations
Clinical narrative: Racing heart; Nausea; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (Racing heart) and NAUSEA (Nausea) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PALPITATIONS (Racing heart) and NAUSEA (Nausea). At the time of the report, PALPITATIONS (Racing heart) and NAUSEA (Nausea) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.     This case was linked to MOD-2021-436217 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; headaches; This spontaneous case was reported by an other health care professional and describes the occurrence of FATIGUE (fatigue) and HEADACHE (headaches) 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 FATIGUE (fatigue) and HEADACHE (headaches). At the time of the report, FATIGUE (fatigue) and HEADACHE (headaches) 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 was not reported. Treatment information was not reported.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Vaccination site pain
Clinical narrative: didn't feel good; left arm pain that occurred with certain movements; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (didn't feel good) and VACCINATION SITE PAIN (left arm pain that occurred with certain movements) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In June 2021, the patient experienced FEELING ABNORMAL (didn't feel good) and VACCINATION SITE PAIN (left arm pain that occurred with certain movements). At the time of the report, FEELING ABNORMAL (didn't feel good) outcome was unknown and VACCINATION SITE PAIN (left arm pain that occurred with certain movements) had not resolved.            No concomitant medications were reported. No treatment medications were reported for dose 2.   This case was linked to MOD-2021-436255, MOD-2021-436405 (Patient Link).
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Lethargy, Pain in extremity
Clinical narrative: She has also felt lethargic; right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs; she couldn't even touch her arm, and it is red; had a dull headache; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (She has also felt lethargic), PAIN IN EXTREMITY (right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs), ERYTHEMA (she couldn't even touch her arm, and it is red) and HEADACHE (had a dull headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A, 038C21A and 039B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In December 2021, the patient experienced LETHARGY (She has also felt lethargic), PAIN IN EXTREMITY (right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs), ERYTHEMA (she couldn't even touch her arm, and it is red) and HEADACHE (had a dull headache). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, LETHARGY (She has also felt lethargic), PAIN IN EXTREMITY (right arm pain/couldn't even touch my arm/She has also had shooting pains in her legs), ERYTHEMA (she couldn't even touch her arm, and it is red) and HEADACHE (had a dull headache) outcome was unknown.            Treatment also included Drinking as much as she can. No concomitant medications reported Patient believes that the reactions could be covid arm.   This case was linked to MOD-2021-436255, MOD-2021-436403 (Patient Link).