chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Rash, Urticaria
Clinical narrative: Hot to touch; Extremely red; Large knots; Both arms broke out in hives; Swelling in both arms; My arms itched; Right and left arms developed a rash; Fever in both arms; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FEELING HOT (Hot to touch), ERYTHEMA (Extremely red), NODULE (Large knots), URTICARIA (Both arms broke out in hives) and PERIPHERAL SWELLING (Swelling in both arms) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Allergy to chemicals (Sulfur). Concomitant products included NAPROXEN SODIUM (ALEVE) for an unknown indication.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FEELING HOT (Hot to touch), ERYTHEMA (Extremely red), NODULE (Large knots), URTICARIA (Both arms broke out in hives), PERIPHERAL SWELLING (Swelling in both arms), PRURITUS (My arms itched), RASH (Right and left arms developed a rash) and PYREXIA (Fever in both arms). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itch, at an unspecified dose and frequency and CORTISONE for Rash, at an unspecified dose and frequency. At the time of the report, FEELING HOT (Hot to touch), ERYTHEMA (Extremely red), URTICARIA (Both arms broke out in hives), PERIPHERAL SWELLING (Swelling in both arms) and PYREXIA (Fever in both arms) had resolved and NODULE (Large knots), PRURITUS (My arms itched) and RASH (Right and left arms developed a rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient was instructed to put cold and hot on her arm along with treatment with Benadryl.   Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Significant follow up added, more events added
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: received the Moderna vaccine at 8 weeks pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (received the Moderna vaccine at 8 weeks pregnant) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (received the Moderna vaccine at 8 weeks pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (received the Moderna vaccine at 8 weeks pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No medical history reported No treatment was reported No last menstrual period date and due date was reported
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Headache, Myalgia, Pyrexia
Clinical narrative: arm was not as red as the 1st vaccine; fever; body aches; headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 30-Apr-2021 and was forwarded to Moderna on 11-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm was not as red as the 1st vaccine), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-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 ERYTHEMA (arm was not as red as the 1st vaccine), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache). At the time of the report, ERYTHEMA (arm was not as red as the 1st vaccine), PYREXIA (fever), MYALGIA (body aches) and HEADACHE (headache) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported. Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-034445 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 31-May-2021: Follow up document was attached on 31-May-2021 which contains non significant information.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Illness, Pyrexia
Clinical narrative: Sick; Blood pressure spikes; mild temperature; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD PRESSURE FLUCTUATION (Blood pressure spikes), ILLNESS (Sick) and PYREXIA (mild temperature) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19. Concurrent medical conditions included Multiple sclerosis. Concomitant products included FINGOLIMOD, DULOXETINE HYDROCHLORIDE (DELAXIN) and VITAMIN D NOS for an unknown indication.   On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BLOOD PRESSURE FLUCTUATION (Blood pressure spikes), ILLNESS (Sick) and PYREXIA (mild temperature). At the time of the report, BLOOD PRESSURE FLUCTUATION (Blood pressure spikes), ILLNESS (Sick) and PYREXIA (mild temperature) outcome was unknown.            Treatment information was not provided.  Company Comment  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.   This case was linked to MOD-2021-122205 (Patient Link).; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: developed ache in injection arm after receiving the first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (developed ache in injection arm after receiving the first dose) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Multiple sclerosis and COVID-19 virus test positive. Concomitant products included FINGOLIMOD for Multiple sclerosis, DULOXETINE HYDROCHLORIDE (DELAXIN) and VITAMIN D NOS for an unknown indication.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (developed ache in injection arm after receiving the first dose). At the time of the report, VACCINATION SITE PAIN (developed ache in injection arm after receiving the first dose) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-122180 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: not received her second dose in the recommended interval; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (not received her second dose in the recommended interval) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (not received her second dose in the recommended interval). At the time of the report, PRODUCT DOSE OMISSION ISSUE (not received her second dose in the recommended interval) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported by investigator   Patient has not received her second dose in the recommended interval. As of 11May2021, it has been 48 days since her first dose.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Deviation from the recommended interval between 2 doses; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Deviation from the recommended interval between 2 doses) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Deviation from the recommended interval between 2 doses). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Deviation from the recommended interval between 2 doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and treatment medication information was reported.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Chest pain, Headache, Myalgia, Paraesthesia
Clinical narrative: tingling in the left arm; burning in the skin of the face, arms, back and neck; skin is a little bit darker where it burns; small pain in the chest like pickets; very strong headaches/pulsations in a vein of the left part of the forehead; left arm it hurts; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the left arm), BURNING SENSATION (burning in the skin of the face, arms, back and neck), SKIN DISCOLOURATION (skin is a little bit darker where it burns), CHEST PAIN (small pain in the chest like pickets) and HEADACHE (very strong headaches/pulsations in a vein of the left part of the forehead) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in the left arm), BURNING SENSATION (burning in the skin of the face, arms, back and neck), SKIN DISCOLOURATION (skin is a little bit darker where it burns), CHEST PAIN (small pain in the chest like pickets), HEADACHE (very strong headaches/pulsations in a vein of the left part of the forehead) and MYALGIA (left arm it hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. At the time of the report, PARAESTHESIA (tingling in the left arm), BURNING SENSATION (burning in the skin of the face, arms, back and neck), SKIN DISCOLOURATION (skin is a little bit darker where it burns), CHEST PAIN (small pain in the chest like pickets), HEADACHE (very strong headaches/pulsations in a vein of the left part of the forehead) and MYALGIA (left arm it hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first dose of Moderna Covid-19 vaccine on 10May2021. It was administered on the right arm. Patient experienced three main symptoms: 1) Very strong headaches which caused pulsations in a vein of the left part of patient's forehead; 2) Tingling in the left arm and when patient pressing the left arm it hurts. Also mentioned perceiving problems with the circulation when touching left arm veins. 3) Burning in the skin of the face, arms, back and neck. There are no bumps or allergy but the skin is a little bit darker where it burns. Patient also mentioned a small pain in the chest like pickets. No fever. Patient took Tylenol 1000 mg every 8 hours (started taking before getting the vaccine) to treat symptoms. Patient does not take daily medication.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Skin discolouration
Clinical narrative: tingling in the left arm; burning in the skin of the face, arms, back and neck; skin is a little bit darker where it burns; small pain in the chest like pickets; very strong headaches/pulsations in a vein of the left part of the forehead; left arm it hurts; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the left arm), BURNING SENSATION (burning in the skin of the face, arms, back and neck), SKIN DISCOLOURATION (skin is a little bit darker where it burns), CHEST PAIN (small pain in the chest like pickets) and HEADACHE (very strong headaches/pulsations in a vein of the left part of the forehead) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in the left arm), BURNING SENSATION (burning in the skin of the face, arms, back and neck), SKIN DISCOLOURATION (skin is a little bit darker where it burns), CHEST PAIN (small pain in the chest like pickets), HEADACHE (very strong headaches/pulsations in a vein of the left part of the forehead) and MYALGIA (left arm it hurts). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1000 mg. At the time of the report, PARAESTHESIA (tingling in the left arm), BURNING SENSATION (burning in the skin of the face, arms, back and neck), SKIN DISCOLOURATION (skin is a little bit darker where it burns), CHEST PAIN (small pain in the chest like pickets), HEADACHE (very strong headaches/pulsations in a vein of the left part of the forehead) and MYALGIA (left arm it hurts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient received first dose of Moderna Covid-19 vaccine on 10May2021. It was administered on the right arm. Patient experienced three main symptoms: 1) Very strong headaches which caused pulsations in a vein of the left part of patient's forehead; 2) Tingling in the left arm and when patient pressing the left arm it hurts. Also mentioned perceiving problems with the circulation when touching left arm veins. 3) Burning in the skin of the face, arms, back and neck. There are no bumps or allergy but the skin is a little bit darker where it burns. Patient also mentioned a small pain in the chest like pickets. No fever. Patient took Tylenol 1000 mg every 8 hours (started taking before getting the vaccine) to treat symptoms. Patient does not take daily medication.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Missed 2nd dose in recommended Interval; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose in recommended Interval) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose in recommended Interval). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Missed 2nd dose in recommended Interval) outcome was unknown. not provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medication information was reported. Pharmacist reported on 12May2021 that patient was coming for 2nd dose of Moderna vaccine after 55 days of interval. She received her 1st dose of Moderna vaccine on 18Mar2021 and no symptoms after administration. No more information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: vial that was exposed to temperature excursion was administered to a patient; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (vial that was exposed to temperature excursion was administered to a patient) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017C21A) for COVID-19 vaccination.     No relevant past medical history was provided.     On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial that was exposed to temperature excursion was administered to a patient). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (vial that was exposed to temperature excursion was administered to a patient) 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.   .
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Peripheral swelling, Skin lesion, Urticaria
Clinical narrative: Swollen feet; Feet burning on the bottom; Lesions; Welts; Red marks on right leg, right knee cap; 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 PERIPHERAL SWELLING (Swollen feet), BURNING SENSATION (Feet burning on the bottom), SKIN LESION (Lesions), URTICARIA (Welts) and ERYTHEMA (Red marks on right leg, right knee cap) 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 PERIPHERAL SWELLING (Swollen feet), BURNING SENSATION (Feet burning on the bottom), SKIN LESION (Lesions), URTICARIA (Welts) and ERYTHEMA (Red marks on right leg, right knee cap). At the time of the report, PERIPHERAL SWELLING (Swollen feet), BURNING SENSATION (Feet burning on the bottom), SKIN LESION (Lesions), URTICARIA (Welts) and ERYTHEMA (Red marks on right leg, right knee cap) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: injection site itching; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 18B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INJECTION SITE PRURITUS (injection site itching) and INJECTION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information included ointment.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching all over the body; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching all over the body) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced PRURITUS (Itching all over the body). At the time of the report, PRURITUS (Itching all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant drug was not reported. Treatment medication was not reported.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Feeling abnormal, Gait disturbance, Hypoaesthesia
Clinical narrative: Now, the weakness has gone to the other leg and both of her arms; The feeling in her left leg is unusual; she starts feeling tired and weak and she needs to sit down and rest; she could barely walk; On Sunday, her left leg started hurting really bad; the arm started hurting/2 days later, her left arm started hurting more; Felt numb; She had little temperature about 10-12 hours later.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb), BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.), PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad) and GAIT DISTURBANCE (she could barely walk) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included GABAPENTIN, LEVOTHYROXINE, MONTELUKAST SODIUM (SINGULAIR), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), HYDROCHLOROTHIAZIDE, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb) and BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad). On 12-Apr-2021, the patient experienced GAIT DISTURBANCE (she could barely walk). On 12-May-2021, the patient experienced ASTHENIA (Now, the weakness has gone to the other leg and both of her arms), FEELING ABNORMAL (The feeling in her left leg is unusual ) and FATIGUE (she starts feeling tired and weak and she needs to sit down and rest). The patient was treated with CYCLOBENZAPRINE at a dose of UNK dosage form; TIZANIDINE at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb), BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.), PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad), GAIT DISTURBANCE (she could barely walk), ASTHENIA (Now, the weakness has gone to the other leg and both of her arms), FEELING ABNORMAL (The feeling in her left leg is unusual ) and FATIGUE (she starts feeling tired and weak and she needs to sit down and rest) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Now, the weakness has gone to the other leg and both of her arms; The feeling in her left leg is unusual; she starts feeling tired and weak and she needs to sit down and rest; she could barely walk; On Sunday, her left leg started hurting really bad; the arm started hurting/2 days later, her left arm started hurting more; Felt numb; She had little temperature about 10-12 hours later.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb), BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.), PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad) and GAIT DISTURBANCE (she could barely walk) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history reported.  Concomitant products included GABAPENTIN, LEVOTHYROXINE, MONTELUKAST SODIUM (SINGULAIR), CLARITHROMYCIN (MACROBID [CLARITHROMYCIN]), HYDROCHLOROTHIAZIDE, LOSARTAN and ROSUVASTATIN for an unknown indication.    On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, the patient experienced PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb) and BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.). On 11-Apr-2021, the patient experienced PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad). On 12-Apr-2021, the patient experienced GAIT DISTURBANCE (she could barely walk). On 12-May-2021, the patient experienced ASTHENIA (Now, the weakness has gone to the other leg and both of her arms), FEELING ABNORMAL (The feeling in her left leg is unusual ) and FATIGUE (she starts feeling tired and weak and she needs to sit down and rest). The patient was treated with CYCLOBENZAPRINE at a dose of UNK dosage form; TIZANIDINE at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (the arm started hurting/2 days later, her left arm started hurting more), HYPOAESTHESIA (Felt numb), BODY TEMPERATURE INCREASED (She had little temperature about 10-12 hours later.), PAIN IN EXTREMITY (On Sunday, her left leg started hurting really bad), GAIT DISTURBANCE (she could barely walk), ASTHENIA (Now, the weakness has gone to the other leg and both of her arms), FEELING ABNORMAL (The feeling in her left leg is unusual ) and FATIGUE (she starts feeling tired and weak and she needs to sit down and rest) outcome was unknown.            Action taken with mRNA-1273 in response to the events were not applicable.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Feeling abnormal, Hypoaesthesia, Mobility decreased, Skin discolouration
Clinical narrative: immobile half body; right arm feels bloodless/feels blood less; right arm seems darker than the left; metallic feeling in mouth; numb hands; Soreness/Pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (immobile half body), FEELING ABNORMAL (right arm feels bloodless/feels blood less), SKIN DISCOLOURATION (right arm seems darker than the left), DYSGEUSIA (metallic feeling in mouth) and HYPOAESTHESIA (numb hands) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Stomach Surgery). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MOBILITY DECREASED (immobile half body), FEELING ABNORMAL (right arm feels bloodless/feels blood less), SKIN DISCOLOURATION (right arm seems darker than the left), DYSGEUSIA (metallic feeling in mouth), HYPOAESTHESIA (numb hands) and VACCINATION SITE PAIN (Soreness/Pain). At the time of the report, MOBILITY DECREASED (immobile half body), FEELING ABNORMAL (right arm feels bloodless/feels blood less), SKIN DISCOLOURATION (right arm seems darker than the left), DYSGEUSIA (metallic feeling in mouth), HYPOAESTHESIA (numb hands) and VACCINATION SITE PAIN (Soreness/Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: immobile half body; right arm feels bloodless/feels blood less; right arm seems darker than the left; metallic feeling in mouth; numb hands; Soreness/Pain; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (immobile half body), FEELING ABNORMAL (right arm feels bloodless/feels blood less), SKIN DISCOLOURATION (right arm seems darker than the left), DYSGEUSIA (metallic feeling in mouth) and HYPOAESTHESIA (numb hands) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Surgery (Stomach Surgery). Concomitant products included ETHINYLESTRADIOL, FERROUS FUMARATE, NORETHISTERONE ACETATE (LO LOESTRIN FE) for Birth control.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced MOBILITY DECREASED (immobile half body), FEELING ABNORMAL (right arm feels bloodless/feels blood less), SKIN DISCOLOURATION (right arm seems darker than the left), DYSGEUSIA (metallic feeling in mouth), HYPOAESTHESIA (numb hands) and VACCINATION SITE PAIN (Soreness/Pain). At the time of the report, MOBILITY DECREASED (immobile half body), FEELING ABNORMAL (right arm feels bloodless/feels blood less), SKIN DISCOLOURATION (right arm seems darker than the left), DYSGEUSIA (metallic feeling in mouth), HYPOAESTHESIA (numb hands) and VACCINATION SITE PAIN (Soreness/Pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications provided by the reporter.
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema; he developed rash on his left ankle which kept growing inside out; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema) and RASH (he developed rash on his left ankle which kept growing inside out) 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 03-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 27-Feb-2021, the patient experienced RASH (he developed rash on his left ankle which kept growing inside out). On an unknown date, the patient experienced RASH PRURITIC (experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema). The patient was treated with HYDROCORTISONE for Rash, at a dose of on hydrocortisone for 5 days. At the time of the report, RASH PRURITIC (experiencing itching red bump rash on his body which comes and go. His PCP told him they will treat that as eczema) and RASH (he developed rash on his left ankle which kept growing inside out) outcome was unknown. PCP told him they will treat that as eczema
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Nausea, Pyrexia
Clinical narrative: Feeling nauseous; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Feeling nauseous) and PYREXIA (Fever) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-May-2021, the patient experienced NAUSEA (Feeling nauseous) and PYREXIA (Fever). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, NAUSEA (Feeling nauseous) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-May-2021, Body temperature: 102 (Inconclusive) Fever of 102 degrees.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia
Clinical narrative: General fatigue; Joint Pain; Muscle pain; Headaches; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (General fatigue), ARTHRALGIA (Joint Pain), MYALGIA (Muscle pain) and HEADACHE (Headaches) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) and AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL) for an unknown indication.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced FATIGUE (General fatigue), ARTHRALGIA (Joint Pain), MYALGIA (Muscle pain) and HEADACHE (Headaches). At the time of the report, FATIGUE (General fatigue), ARTHRALGIA (Joint Pain), MYALGIA (Muscle pain) and HEADACHE (Headaches) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.  The patient provided consent to follow-up, but does not have an HCP (health care provider).
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: developed pain at the injection site; swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (developed pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, the patient experienced VACCINATION SITE PAIN (developed pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site). At the time of the report, VACCINATION SITE PAIN (developed pain at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Fatigue, Headache
Clinical narrative: dizziness; Fatigue; Chills; Joint pains; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: dizziness; Fatigue; Chills; Joint pains; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains) and NAUSEA (nausea) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains), NAUSEA (nausea) and HEADACHE (headache). At the time of the report, DIZZINESS (dizziness), FATIGUE (Fatigue), CHILLS (Chills), ARTHRALGIA (Joint pains), NAUSEA (nausea) and HEADACHE (headache) outcome was unknown.            Concomitant product use was not provided by the reporter. Treatment information was not provided. Action taken with mRNA-1273 in response to the events were not applicable.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pityriasis rosea, Product dose omission issue, Pruritus, Urticaria
Clinical narrative: she stated that they were just itchy; Pityriasis rosea; She stated she did not get the second dose of vaccine because she was worried the events would be worse.; hives - big one on her back and a couple of little ones on her chest; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives - big one on her back and a couple of little ones on her chest), PRURITUS (she stated that they were just itchy), PITYRIASIS ROSEA (Pityriasis rosea) and PRODUCT DOSE OMISSION ISSUE (She stated she did not get the second dose of vaccine because she was worried the events would be worse.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Apr-2021, the patient experienced URTICARIA (hives - big one on her back and a couple of little ones on her chest). On an unknown date, the patient experienced PRURITUS (she stated that they were just itchy), PITYRIASIS ROSEA (Pityriasis rosea) and PRODUCT DOSE OMISSION ISSUE (She stated she did not get the second dose of vaccine because she was worried the events would be worse.). The patient was treated with STEROIDS (topical) for Pityriasis rosea, at an unspecified dose and frequency. At the time of the report, URTICARIA (hives - big one on her back and a couple of little ones on her chest) and PRODUCT DOSE OMISSION ISSUE (She stated she did not get the second dose of vaccine because she was worried the events would be worse.) had resolved, PRURITUS (she stated that they were just itchy) had not resolved and PITYRIASIS ROSEA (Pityriasis rosea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 and contain significant information. The event "Pityriasis rosea" and missing dose and treatment has been updated.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Sneezing
Clinical narrative: felt really cold and chilly; Sneezing; felt really cold and chilly; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt really cold and chilly), SNEEZING (Sneezing) and CHILLS (felt really cold and chilly) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 025821A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included VITAMIN D NOS for an unknown indication.   On 10-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-May-2021, the patient experienced FEELING COLD (felt really cold and chilly), SNEEZING (Sneezing) and CHILLS (felt really cold and chilly). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK UNK, bid. At the time of the report, FEELING COLD (felt really cold and chilly), SNEEZING (Sneezing) and CHILLS (felt really cold and chilly) had resolved.            Other concomitant medications included depression medications.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Outcome of the events were provided.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash
Clinical narrative: Itching below the injection site; Red rash below the injection site; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE RASH (Red rash below the injection site) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.    On 10-May-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 10-May-2021, the patient experienced VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE RASH (Red rash below the injection site). At the time of the report, VACCINATION SITE PRURITUS (Itching below the injection site) and VACCINATION SITE RASH (Red rash below the injection site) outcome was unknown.            The concomitant medications were reported as unknown medications for blood pressure, cholesterol and muscle spasms. The treatment information was not provided.  The medical history of the patient is given as blood pressure, cholesterol and muscle spasms.  The action taken with mRNA 1273 with the events was considered as not applicable.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Injection site muscle weakness, Interchange of vaccine products
Clinical narrative: lost a significant amount of strength in my arms my left arm; Arms are numb; second dose was from Pfizer; This spontaneous case was reported by a consumer and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (second dose was from Pfizer), INJECTION SITE MUSCLE WEAKNESS (lost a significant amount of strength in my arms my left arm) and HYPOAESTHESIA (Arms are numb) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    The patient's past medical history included Carpal tunnel syndrome and Surgery (Surgery on both hands in January for carpal tunnel syndrome) in January 2021. Concurrent medical conditions included Diabetes.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (second dose was from Pfizer). On an unknown date, the patient experienced INJECTION SITE MUSCLE WEAKNESS (lost a significant amount of strength in my arms my left arm) and HYPOAESTHESIA (Arms are numb). On 19-Apr-2021, INTERCHANGE OF VACCINE PRODUCTS (second dose was from Pfizer) had resolved. At the time of the report, INJECTION SITE MUSCLE WEAKNESS (lost a significant amount of strength in my arms my left arm) and HYPOAESTHESIA (Arms are numb) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: The additional events, patient's medical history and vaccination site were provided.