chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: A dose of Moderna was given today outside the 12 hour window after 1st puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose of Moderna was given today outside the 12 hour window after 1st puncture) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose of Moderna was given today outside the 12 hour window after 1st puncture). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (A dose of Moderna was given today outside the 12 hour window after 1st puncture) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow u received which contains no new significant information.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Gait disturbance, Hypoaesthesia, Product dose omission issue
Clinical narrative: Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area; Heart felt weak; Had pain in arteries and veins; A bit of numbness in fingers; Consumer did not get her 2nd dose, beyond 35 days; Felt super tired; Had trouble walking; This spontaneous case was reported by a patient and describes the occurrence of STRESS (Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area), ASTHENIA (Heart felt weak), VASCULAR PAIN (Had pain in arteries and veins), HYPOAESTHESIA (A bit of numbness in fingers) and GAIT DISTURBANCE (Had trouble walking) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Defibrillator/pacemaker insertion (Patient had heart condition and has pacemaker and defibrillator). Concomitant products included FUROSEMIDE, METOPROLOL and MELATONIN for an unknown indication.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced GAIT DISTURBANCE (Had trouble walking) and FATIGUE (Felt super tired). On an unknown date, the patient experienced STRESS (Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area). an unknown date, the patient experienced ASTHENIA (Heart felt weak), VASCULAR PAIN (Had pain in arteries and veins), HYPOAESTHESIA (A bit of numbness in fingers) and PRODUCT DOSE OMISSION ISSUE (Consumer did not get her 2nd dose, beyond 35 days). The patient was treated with FISH OIL for Product used for unknown indication, at a dose of 1 dosage form; PUNICA GRANATUM FRUIT (POMEGRANATE [PUNICA GRANATUM FRUIT]) at a dose of 1 UNK and UBIDECARENONE (COQ10 [UBIDECARENONE]) at a dose of 1 dosage form. At the time of the report, STRESS (Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area), ASTHENIA (Heart felt weak), VASCULAR PAIN (Had pain in arteries and veins), HYPOAESTHESIA (A bit of numbness in fingers), GAIT DISTURBANCE (Had trouble walking), PRODUCT DOSE OMISSION ISSUE (Consumer did not get her 2nd dose, beyond 35 days) and FATIGUE (Felt super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that some events started two weeks after vaccine administration, and a few started 24 hours later but she didn't felt it was due to the vaccine. Two weeks post vaccination she felt stress in body but thought it was because of things she was doing.  The patient experienced trouble while walking but when walked a little around it went away and took a nap. Treatment information also included use of immune aid and pomegranate juice.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Vascular pain
Clinical narrative: Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area; Heart felt weak; Had pain in arteries and veins; A bit of numbness in fingers; Consumer did not get her 2nd dose, beyond 35 days; Felt super tired; Had trouble walking; This spontaneous case was reported by a patient and describes the occurrence of STRESS (Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area), ASTHENIA (Heart felt weak), VASCULAR PAIN (Had pain in arteries and veins), HYPOAESTHESIA (A bit of numbness in fingers) and GAIT DISTURBANCE (Had trouble walking) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Defibrillator/pacemaker insertion (Patient had heart condition and has pacemaker and defibrillator). Concomitant products included FUROSEMIDE, METOPROLOL and MELATONIN for an unknown indication.    On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced GAIT DISTURBANCE (Had trouble walking) and FATIGUE (Felt super tired). On an unknown date, the patient experienced STRESS (Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area). an unknown date, the patient experienced ASTHENIA (Heart felt weak), VASCULAR PAIN (Had pain in arteries and veins), HYPOAESTHESIA (A bit of numbness in fingers) and PRODUCT DOSE OMISSION ISSUE (Consumer did not get her 2nd dose, beyond 35 days). The patient was treated with FISH OIL for Product used for unknown indication, at a dose of 1 dosage form; PUNICA GRANATUM FRUIT (POMEGRANATE [PUNICA GRANATUM FRUIT]) at a dose of 1 UNK and UBIDECARENONE (COQ10 [UBIDECARENONE]) at a dose of 1 dosage form. At the time of the report, STRESS (Felt a lot of stress in body/felt stress in glands under her neck, jaw,and ear area), ASTHENIA (Heart felt weak), VASCULAR PAIN (Had pain in arteries and veins), HYPOAESTHESIA (A bit of numbness in fingers), GAIT DISTURBANCE (Had trouble walking), PRODUCT DOSE OMISSION ISSUE (Consumer did not get her 2nd dose, beyond 35 days) and FATIGUE (Felt super tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient reported that some events started two weeks after vaccine administration, and a few started 24 hours later but she didn't felt it was due to the vaccine. Two weeks post vaccination she felt stress in body but thought it was because of things she was doing.  The patient experienced trouble while walking but when walked a little around it went away and took a nap. Treatment information also included use of immune aid and pomegranate juice.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives). At the time of the report, URTICARIA (Hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The concomitant medication used by the patient were not reported. The treatment medication were not reported.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided. The vaccine was administered to 4 patients today and it has been greater than 30 days in the refrigerator.Three out of the four patients received the vaccine today as their first dose. Caller states that they have not followed up with any of the patients because they want to hear from Moderna first; and none of the patients have called to report any adverse event.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site pain
Clinical narrative: Injection site soreness; Muscle ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Injection site soreness), MYALGIA (Muscle ache) and FATIGUE (Fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031A21A and 024MZ0A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension since 15-Jan-2019. Concomitant products included LOSARTAN from 15-Jan-2019 to an unknown date for Blood pressure, MULTIVITAMIN [VITAMINS NOS], WITHANIA SOMNIFERA (ASHWAGANDHA [WITHANIA SOMNIFERA]), VITAMIN D3 and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021 at 11:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE PAIN (Injection site soreness). March 2021, the patient experienced MYALGIA (Muscle ache) and FATIGUE (Fatigue). At the time of the report, VACCINATION SITE PAIN (Injection site soreness), MYALGIA (Muscle ache) and FATIGUE (Fatigue) outcome was unknown.            Treatment information provided.     This case was linked to MOD-2021-025267 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Neck pain
Clinical narrative: Neck where also sore; Left shoulder where also sore; Tired; Headache; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Neck where also sore), MYALGIA (Sore arm), ARTHRALGIA (Left shoulder where also sore), FATIGUE (Tired) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034A21A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced MYALGIA (Sore arm). On 27-Mar-2021, the patient experienced NECK PAIN (Neck where also sore) and ARTHRALGIA (Left shoulder where also sore). 27-Mar-2021, the patient experienced FATIGUE (Tired) and HEADACHE (Headache). On 30-Mar-2021, NECK PAIN (Neck where also sore), MYALGIA (Sore arm), ARTHRALGIA (Left shoulder where also sore), FATIGUE (Tired) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported   This case was linked to MOD-2021-255679 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy to vaccine, Arthralgia, Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: an allergic reaction/broke out on jawline/ face breakout; Hives; stress body was under; terrible joint pain; itching spread through out the body; big read rash on the arm; top arm tender; top arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (top arm swollen), PRURITUS (itching spread through out the body), TENDERNESS (top arm tender), ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout) and URTICARIA (Hives) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034A21A and 034A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (top arm swollen) and TENDERNESS (top arm tender). On 24-Apr-2021, the patient experienced PRURITUS (itching spread through out the body) and RASH ERYTHEMATOUS (big read rash on the arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout), URTICARIA (Hives), STRESS (stress body was under) and ARTHRALGIA (terrible joint pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of 1 UNK. At the time of the report, PERIPHERAL SWELLING (top arm swollen), PRURITUS (itching spread through out the body), TENDERNESS (top arm tender), ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout), URTICARIA (Hives), STRESS (stress body was under), RASH ERYTHEMATOUS (big read rash on the arm) and ARTHRALGIA (terrible joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-255663 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Stress, Tenderness, Urticaria
Clinical narrative: an allergic reaction/broke out on jawline/ face breakout; Hives; stress body was under; terrible joint pain; itching spread through out the body; big read rash on the arm; top arm tender; top arm swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (top arm swollen), PRURITUS (itching spread through out the body), TENDERNESS (top arm tender), ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout) and URTICARIA (Hives) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034A21A and 034A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORATADINE (CLARITIN [LORATADINE]) for Seasonal allergy, ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PERIPHERAL SWELLING (top arm swollen) and TENDERNESS (top arm tender). On 24-Apr-2021, the patient experienced PRURITUS (itching spread through out the body) and RASH ERYTHEMATOUS (big read rash on the arm). On an unknown date, the patient experienced ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout), URTICARIA (Hives), STRESS (stress body was under) and ARTHRALGIA (terrible joint pain). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Allergic reaction, at a dose of 1 UNK. At the time of the report, PERIPHERAL SWELLING (top arm swollen), PRURITUS (itching spread through out the body), TENDERNESS (top arm tender), ALLERGY TO VACCINE (an allergic reaction/broke out on jawline/ face breakout), URTICARIA (Hives), STRESS (stress body was under), RASH ERYTHEMATOUS (big read rash on the arm) and ARTHRALGIA (terrible joint pain) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-255663 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: Heart condition; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart condition) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (Heart condition). At the time of the report, CARDIAC DISORDER (Heart condition) outcome was unknown.            Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable. No relevant concomitant medications were reported. No treatment information was provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Four patients were administered doses of the Moderna COVID-19 vaccine from an expired vial.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients were administered doses of the Moderna COVID-19 vaccine from an expired vial.) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients were administered doses of the Moderna COVID-19 vaccine from an expired vial.). On 12-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Four patients were administered doses of the Moderna COVID-19 vaccine from an expired vial.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned.  No treatment details were reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Jul-2021: Follow up received contains updated patient-1  demographics: Patient initials, age, gender, race and ethinicity; Updated anatomical site of vaccination; On 28-Jul-2021: Follow up received contains updated patient -2 demographics: Patient initials, age, gender, race and ethinicity; Updated anatomical site of vaccination; On 28-Jul-2021: Follow up received contains no new information (NNI) On 28-Jul-2021: Follow up received contains no new information (NNI)
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Fatigue
Clinical narrative: she doesn't remember anything that happened that day, until next day; felt fatigue; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (she doesn't remember anything that happened that day, until next day) and FATIGUE (felt fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced AMNESIA (she doesn't remember anything that happened that day, until next day) and FATIGUE (felt fatigue). At the time of the report, AMNESIA (she doesn't remember anything that happened that day, until next day) and FATIGUE (felt fatigue) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient took 2nd dose of Moderna COVID-19 Vaccine on 24-Feb-2021 and has no side effects. No concomitant medications information was reported. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Allergy to animal, Urticaria
Clinical narrative: hives; cat allergy; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) and ALLERGY TO ANIMAL (cat allergy) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives) and ALLERGY TO ANIMAL (cat allergy). At the time of the report, URTICARIA (hives) and ALLERGY TO ANIMAL (cat allergy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was reported. No treatment drug details was reported.
Sex: U
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: patch of red/patches on the back of my knees; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (patch of red/patches on the back of my knees) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ERYTHEMA (patch of red/patches on the back of my knees). At the time of the report, ERYTHEMA (patch of red/patches on the back of my knees) outcome was unknown.            Patient stated taking concomitant medications(unspecified) for 8 to 10 years. No treatment medications were provided.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02CB21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included Hysterectomy. Concurrent medical conditions included Pulmonary hypertension since 01-Jan-2017, Runny nose, Heart rate high and Ocular rosacea. Concomitant products included METOPROLOL for Heart rate, ESTROGENS CONJUGATED (PREMARIN) from 15-Mar-2001 to an unknown date for Hysterectomy, DOXYCYCLINE from 01-Jan-2020 to an unknown date for Ocular rosacea, IPRATROPIUM BROMIDE (IPRATROPIUM [IPRATROPIUM BROMIDE]) from 01-Jan-2020 to an unknown date for Runny nose, SIMVASTATIN for an unknown indication.   On 16-Mar-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021 at 3:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021, the patient experienced PYREXIA (Fever). 21-Apr-2021, the patient experienced CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-076297 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Gait disturbance, Limb discomfort, Mobility decreased, Pain
Clinical narrative: pain in the feet, going from one to the other and also moving to their back and arm; Pain in feet, painful going from one to the other and also moving to their back and arm; pain in the feet, going from one to the other and also moving to their back and arm; feel their limbs are asleep; difficult for them to go down or up the stairs because they cannot bend their feet; a limp on the right foot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in the feet, going from one to the other and also moving to their back and arm), PAIN IN EXTREMITY (Pain in feet, painful going from one to the other and also moving to their back and arm), PAIN (pain in the feet, going from one to the other and also moving to their back and arm), LIMB DISCOMFORT (feel their limbs are asleep) and MOBILITY DECREASED (difficult for them to go down or up the stairs because they cannot bend their feet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-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 BACK PAIN (pain in the feet, going from one to the other and also moving to their back and arm), PAIN IN EXTREMITY (Pain in feet, painful going from one to the other and also moving to their back and arm), PAIN (pain in the feet, going from one to the other and also moving to their back and arm), LIMB DISCOMFORT (feel their limbs are asleep), MOBILITY DECREASED (difficult for them to go down or up the stairs because they cannot bend their feet) and GAIT DISTURBANCE (a limp on the right foot). At the time of the report, BACK PAIN (pain in the feet, going from one to the other and also moving to their back and arm), PAIN IN EXTREMITY (Pain in feet, painful going from one to the other and also moving to their back and arm), PAIN (pain in the feet, going from one to the other and also moving to their back and arm), LIMB DISCOMFORT (feel their limbs are asleep), MOBILITY DECREASED (difficult for them to go down or up the stairs because they cannot bend their feet) and GAIT DISTURBANCE (a limp on the right foot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in the feet, going from one to the other and also moving to their back and arm; Pain in feet, painful going from one to the other and also moving to their back and arm; pain in the feet, going from one to the other and also moving to their back and arm; feel their limbs are asleep; difficult for them to go down or up the stairs because they cannot bend their feet; a limp on the right foot; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in the feet, going from one to the other and also moving to their back and arm), PAIN IN EXTREMITY (Pain in feet, painful going from one to the other and also moving to their back and arm), PAIN (pain in the feet, going from one to the other and also moving to their back and arm), LIMB DISCOMFORT (feel their limbs are asleep) and MOBILITY DECREASED (difficult for them to go down or up the stairs because they cannot bend their feet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-May-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 BACK PAIN (pain in the feet, going from one to the other and also moving to their back and arm), PAIN IN EXTREMITY (Pain in feet, painful going from one to the other and also moving to their back and arm), PAIN (pain in the feet, going from one to the other and also moving to their back and arm), LIMB DISCOMFORT (feel their limbs are asleep), MOBILITY DECREASED (difficult for them to go down or up the stairs because they cannot bend their feet) and GAIT DISTURBANCE (a limp on the right foot). At the time of the report, BACK PAIN (pain in the feet, going from one to the other and also moving to their back and arm), PAIN IN EXTREMITY (Pain in feet, painful going from one to the other and also moving to their back and arm), PAIN (pain in the feet, going from one to the other and also moving to their back and arm), LIMB DISCOMFORT (feel their limbs are asleep), MOBILITY DECREASED (difficult for them to go down or up the stairs because they cannot bend their feet) and GAIT DISTURBANCE (a limp on the right foot) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The pharmacist reported that his pharmacy used a vial of the Moderna COVID-19 vaccine that had been refrigerated for 31 days  On the 31st day (12JUL2021) administered doses of the Moderna COVID-19 vaccine from the vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The pharmacist reported that his pharmacy used a vial of the Moderna COVID-19 vaccine that had been refrigerated for 31 days  On the 31st day (12JUL2021) administered doses of the Moderna COVID-19 vaccine from the vial) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The pharmacist reported that his pharmacy used a vial of the Moderna COVID-19 vaccine that had been refrigerated for 31 days  On the 31st day (12JUL2021) administered doses of the Moderna COVID-19 vaccine from the vial). On 12-Jul-2021, EXPIRED PRODUCT ADMINISTERED (The pharmacist reported that his pharmacy used a vial of the Moderna COVID-19 vaccine that had been refrigerated for 31 days  On the 31st day (12JUL2021) administered doses of the Moderna COVID-19 vaccine from the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid). At the time of the report, COVID-19 (Caller reported that his son had the two doses of the Moderna covid19 vaccine and had covid) outcome was unknown.            No concomitant medications information was reported. No treatment medications were provided.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypersomnia
Clinical narrative: Slept most of the day; March 3 second dose only reaction was tiredness on March 4; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (March 3 second dose only reaction was tiredness on March 4) and HYPERSOMNIA (Slept most of the day) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Flutter atrial (02/2019 Pacemaker, 09/2019 Av node ablation) in 2017. Concurrent medical conditions included Allergy to antibiotic (Early 1970s -1980s, red rash (reaction to Declostatin,swollen thumb with warm red rash)), Hypersensitivity reaction (hypersensitivity reaction to Flecainide and had Extreme dizziness and irregular heartbeat) in 2019, Hypersensitivity reaction (hypersensitivity reaction to Ilosone) in 1970, Hypersensitivity reaction (hypersensitivity reaction to Vytorin and had legs ached) in 2013 and Type 2 diabetes mellitus since 2018.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 2 dosage form. On 04-Mar-2021, the patient experienced FATIGUE (March 3 second dose only reaction was tiredness on March 4). On an unknown date, the patient experienced HYPERSOMNIA (Slept most of the day). At the time of the report, FATIGUE (March 3 second dose only reaction was tiredness on March 4) and HYPERSOMNIA (Slept most of the day) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No treatment medication was provided by the reporter.   This case was linked to MOD-2021-018614 (Patient Link).
Age: 35.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given mishandled dose / punctured vial in the refrigerator for 22 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given mishandled dose / punctured vial in the refrigerator for 22 hours.) in a 35-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given mishandled dose / punctured vial in the refrigerator for 22 hours.). On 13-Jul-2021, EXPIRED PRODUCT ADMINISTERED (patient given mishandled dose / punctured vial in the refrigerator for 22 hours.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication not provided.  Treatment information not provided.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Genital herpes, Herpes simplex, Oral herpes
Clinical narrative: her outbreaks have been a lot worse; she gets genital herpes once a month; cold sore in her nose every 2-3 weeks; This spontaneous case was reported by a consumer and describes the occurrence of HERPES SIMPLEX (her outbreaks have been a lot worse), GENITAL HERPES (she gets genital herpes once a month) and ORAL HERPES (cold sore in her nose every 2-3 weeks) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 030L20A) for COVID-19 vaccination.     The patient's past medical history included Cold sores and Genital herpes. Concurrent medical conditions included Herpes infection. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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 HERPES SIMPLEX (her outbreaks have been a lot worse), GENITAL HERPES (she gets genital herpes once a month) and ORAL HERPES (cold sore in her nose every 2-3 weeks). The patient was treated with ACYCLOVIR [ACICLOVIR] for Herpes infection, at a dose of 500 mg once a day. At the time of the report, HERPES SIMPLEX (her outbreaks have been a lot worse), GENITAL HERPES (she gets genital herpes once a month) and ORAL HERPES (cold sore in her nose every 2-3 weeks) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up received on 27-JUL-2021 and included non-significant information.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Pain
Clinical narrative: pain; Every morning every day I wake up stiff as a lock; started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (pain), MUSCULOSKELETAL STIFFNESS (Every morning every day I wake up stiff as a lock) and MUSCLE SPASMS (started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     Medical history was not provided by the reporter.  Concomitant products included DULOXETINE for Depression, GABAPENTIN for Sleep problem.    On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (pain), MUSCULOSKELETAL STIFFNESS (Every morning every day I wake up stiff as a lock) and MUSCLE SPASMS (started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back). At the time of the report, PAIN (pain), MUSCULOSKELETAL STIFFNESS (Every morning every day I wake up stiff as a lock) and MUSCLE SPASMS (started having muscle spasms, and it has continued ever since the first dose / muscle spams in his back, upper shoulders, whole muscles, whole back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient Stated that he has been going to all kind of doctors and physical therapists. No treatment was taken by the patient.   This case was linked to MOD-2021-253995 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Fatigue, Malaise, Vaccination site pain, Vomiting
Clinical narrative: Throwing up; Stomach burn; Didn't feel good; tired; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of DYSPEPSIA (Stomach burn), MALAISE (Didn't feel good), VOMITING (Throwing up), FATIGUE (tired) and VACCINATION SITE PAIN (Sore left arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 002A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included CURCUMA LONGA (TURMERIC CURCUMIN [CURCUMA LONGA]) for Nutritional supplement, VITAMIN C [ASCORBIC ACID] and MESO ZEAXANTHIN, XANTOFYL, ZEAXANTHIN (MACUHEALTH WITH LMZ3) for Supplementation therapy, MULTIVITAMIN [VITAMINS NOS] for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (tired) and VACCINATION SITE PAIN (Sore left arm). On 30-Apr-2021, the patient experienced DYSPEPSIA (Stomach burn) and MALAISE (Didn't feel good). On 30-Apr-2021 at 8:45 PM, the patient experienced VOMITING (Throwing up). At the time of the report, DYSPEPSIA (Stomach burn), MALAISE (Didn't feel good), VOMITING (Throwing up), FATIGUE (tired) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment information was provided.   This case was linked to MOD-2021-059462 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Decreased appetite, Fatigue, Insomnia, Myalgia
Clinical narrative: Physical exhaustion; No appetite; Body aches; Fever of 104.1/Fever of 102 throughout the day; No sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (No sleep), DECREASED APPETITE (No appetite), MYALGIA (Body aches), PYREXIA (Fever of 104.1/Fever of 102 throughout the day) and FATIGUE (Physical exhaustion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Type of test: PCR) on 30-Nov-2020. Concurrent medical conditions included Seasonal allergy and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 05-Jan-2013 to an unknown date for Anxiety, DROSPIRENONE, ETHINYLESTRADIOL (SYEDA) from 05-Jan-2012 to an unknown date for Birth control, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 05-Jan-2020 to an unknown date for Seasonal allergy.   On 24-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (No sleep). On 21-Apr-2021 at 3:00 PM, the patient experienced PYREXIA (Fever of 104.1/Fever of 102 throughout the day). On 22-Apr-2021, the patient experienced DECREASED APPETITE (No appetite) and MYALGIA (Body aches). On 23-Apr-2021, the patient experienced FATIGUE (Physical exhaustion). The patient was treated with ACETAMINOPHEN for Fever, at an unspecified dose and frequency. On 22-Apr-2021 at 12:00 PM, PYREXIA (Fever of 104.1/Fever of 102 throughout the day) had resolved. At the time of the report, INSOMNIA (No sleep), DECREASED APPETITE (No appetite), MYALGIA (Body aches) and FATIGUE (Physical exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (Positive) positive. On 21-Apr-2021, Body temperature: 104.1 (High) 104.1. On 22-Apr-2021, Body temperature: 102 (High) 102.         No treatment information was provided by the reporter for rest of the events.   This case was linked to MOD-2021-146059 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Physical exhaustion; No appetite; Body aches; Fever of 104.1/Fever of 102 throughout the day; No sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (No sleep), DECREASED APPETITE (No appetite), MYALGIA (Body aches), PYREXIA (Fever of 104.1/Fever of 102 throughout the day) and FATIGUE (Physical exhaustion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Type of test: PCR) on 30-Nov-2020. Concurrent medical conditions included Seasonal allergy and Anxiety. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 05-Jan-2013 to an unknown date for Anxiety, DROSPIRENONE, ETHINYLESTRADIOL (SYEDA) from 05-Jan-2012 to an unknown date for Birth control, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 05-Jan-2020 to an unknown date for Seasonal allergy.   On 24-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (No sleep). On 21-Apr-2021 at 3:00 PM, the patient experienced PYREXIA (Fever of 104.1/Fever of 102 throughout the day). On 22-Apr-2021, the patient experienced DECREASED APPETITE (No appetite) and MYALGIA (Body aches). On 23-Apr-2021, the patient experienced FATIGUE (Physical exhaustion). The patient was treated with ACETAMINOPHEN for Fever, at an unspecified dose and frequency. On 22-Apr-2021 at 12:00 PM, PYREXIA (Fever of 104.1/Fever of 102 throughout the day) had resolved. At the time of the report, INSOMNIA (No sleep), DECREASED APPETITE (No appetite), MYALGIA (Body aches) and FATIGUE (Physical exhaustion) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Nov-2020, SARS-CoV-2 test: positive (Positive) positive. On 21-Apr-2021, Body temperature: 104.1 (High) 104.1. On 22-Apr-2021, Body temperature: 102 (High) 102.         No treatment information was provided by the reporter for rest of the events.   This case was linked to MOD-2021-146059 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: She had a high fever; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (She had a high fever) 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 24-Feb-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) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PYREXIA (She had a high fever). At the time of the report, PYREXIA (She had a high fever) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.