chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Chills, Hypersomnia, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a patient and describes the occurrence of HYPERSOMNIA (Slept for 17 hours and felt fine), BACK PAIN (Lower body ache in his lower back.), VACCINATION SITE PAIN (Sore left arm) and CHILLS (Within 24 hours patient felt severe chills) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HYPERSOMNIA (Slept for 17 hours and felt fine), BACK PAIN (Lower body ache in his lower back.) and CHILLS (Within 24 hours patient felt severe chills). In February 2021, the patient experienced VACCINATION SITE PAIN (Sore left arm). In February 2021, HYPERSOMNIA (Slept for 17 hours and felt fine), BACK PAIN (Lower body ache in his lower back.) and CHILLS (Within 24 hours patient felt severe chills) had resolved. At the time of the report, VACCINATION SITE PAIN (Sore left arm) outcome was unknown. No concomitant medications reported by reporter. No treatment medications provided by the reporter. Company comment: This case concerns a 61-year-old male patient with no medical history provided who experienced non-serious unexpected events of Hypersomnia and Back pain and non-serious expected events of Chills and Vaccination site pain. The events Hypersomnia, Back pain and Chills occurred on the same day after the second dose of mRNA-1273. The precise temporal relationship for the event Vaccination site pain cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, outcome of the event Vaccination site pain was unknown whereas all the other events resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2022-455204 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Jan-2022: Non significant Follow-up received. Sender's Comments: This case concerns a 61-year-old male patient with no medical history provided who experienced non-serious unexpected events of Hypersomnia and Back pain and non-serious expected events of Chills and Vaccination site pain. The events Hypersomnia, Back pain and Chills occurred on the same day after the second dose of mRNA-1273. The precise temporal relationship for the event Vaccination site pain cannot be determined, having in mind that the exact start date of the reported event was not provided. At the time of the report, outcome of the event Vaccination site pain was unknown whereas all the other events resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 077C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.). On 15-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna product expired on 14-Jan-2022 was administered on 15-Jan-2022 to 3 patientsas a booster dose.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Patient is in her 40 s.It was reported that the vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to MOD-2022-455209, MOD-2022-455269, MOD-2022-455277 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of SARS-COV-2 TEST POSITIVE (Positive for COVID after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (Positive for COVID after vaccination). At the time of the report, SARS-COV-2 TEST POSITIVE (Positive for COVID after vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive for COVID. 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 medications were mentioned. No treatment details were reported. Company comment: This case concerns a patient of unknown age and gender, with no medical history reported in this case, who experienced the non-serious AESI of SARS-CoV-2 test positive. The event occurred on an unknown date after the administration of an unknown dose of the mRNA-1273 vaccine, in a patient with an unknown schedule of vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a patient of unknown age and gender, with no medical history reported in this case, who experienced the non-serious AESI of SARS-CoV-2 test positive. The event occurred on an unknown date after the administration of an unknown dose of the mRNA-1273 vaccine, in a patient with an unknown schedule of vaccination. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive for covid; first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (tested positive for covid) and DRUG INEFFECTIVE (first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 03-Jan-2022, the patient experienced COVID-19 (tested positive for covid) and DRUG INEFFECTIVE (first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid). On 13-Jan-2022, COVID-19 (tested positive for covid) had resolved. At the time of the report, DRUG INEFFECTIVE (first dose of the Moderna COVID-19 vaccine on 25Mar2021 (Lot # 044A21A) and the second dose on 23Apr2021 (Lot # 001C21A). On 03Jan2022 she tested positive for covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive. On 13-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative.         Company comment: This is a spontaneous case concerning a 54-year-old female patient with no reported medical history, who experienced the non-serious AESI COVID-19, more than 8 months after receiving  the second dose of mRNA-1273.  Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   No concomitant medications reported. No treatment reported.; Sender's Comments: Company comment: This is a spontaneous case concerning a 54-year-old female patient with no reported medical history, who experienced the non-serious AESI COVID-19, more than 8 months after receiving  the second dose of mRNA-1273.  Drug ineffective was also captured as an event. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Muscle stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscle stiffness) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscle stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscle stiffness) 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 medications were reported. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.). At the time of the report, COVID-19 (Caller reports that his Therapist received a Covid-19 vaccine series and booster and caught Covid-19 anyway.) outcome was unknown.            Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, after receiving the booster dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.  No concomitant medication reported No treatment medication reported The reporter was not sure which Covid-19 vaccine that the patient received.; Sender's Comments: Company comment: This is a spontaneous case concerning a patient of an unknown age and gender with no reported medical history, who experienced the non-serious AESI COVID-19, after receiving the booster dose of mRNA-1273.  The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: tired after first vaccine; nauseous after vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired after first vaccine) and NAUSEA (nauseous after vaccine) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    In April 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 FATIGUE (tired after first vaccine) and NAUSEA (nauseous after vaccine). At the time of the report, FATIGUE (tired after first vaccine) and NAUSEA (nauseous after vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication information provided by the reporter. No treatment information provided.   This case was linked to MOD-2022-455736, MOD-2022-455739 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Significant Follow-Up Appended. Reporter's Demographics updated.Dosage information updated for 1st Dose.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the left arm injection site.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the left arm injection site.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043120A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain at the left arm injection site.). At the time of the report, VACCINATION SITE PAIN (pain at the left arm injection site.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported by the reporter.  No treatment medication was reported by the reporter.   This case was linked to MOD-2022-455784 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Jan-2022: Follow up received contain no significant information.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Inflammation
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INFLAMMATION (inflammation in her body) and COVID-19 (still got covid twice) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (inflammation in her body) and COVID-19 (still got covid twice). At the time of the report, INFLAMMATION (inflammation in her body) and COVID-19 (still got covid twice) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by the reporter. No treatment was reported by the reporter. Company comment.  This spontaneous case concerns a patient, with no reported relevant medical history, who experienced the unexpected AESI event of COVID - 19. The date of onset of the event was not reported neither vaccination date. No information about vaccination schedule was provided. At the time of the report the outcome of the event was unknown. No medical assessment or treatment has been informed. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient, with no reported relevant medical history, who experienced the unexpected AESI event of COVID - 19. The date of onset of the event was not reported neither vaccination date. No information about vaccination schedule was provided. At the time of the report the outcome of the event was unknown. No medical assessment or treatment has been informed. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) in a 38-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator). On 18-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) and PRODUCT STORAGE ERROR (Two patients received a booster dose of Moderna Covid-19 vaccine on day 32 of being in the refrigerator) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-456292 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Gait disturbance, Myalgia
Clinical narrative: Could hardly walk.; Again she experienced chilling, shivering and used 7 blankets and was still freezing; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Could hardly walk.), CHILLS (Again she experienced chilling, shivering and used 7 blankets and was still freezing) and MYALGIA (Body aches) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025J202A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced GAIT DISTURBANCE (Could hardly walk.), CHILLS (Again she experienced chilling, shivering and used 7 blankets and was still freezing) and MYALGIA (Body aches). At the time of the report, GAIT DISTURBANCE (Could hardly walk.), CHILLS (Again she experienced chilling, shivering and used 7 blankets and was still freezing) and MYALGIA (Body aches) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2022-456330, MOD-2022-456359 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Muscle spasms, Uterine polyp
Clinical narrative: Heavy menstrual bleeding/Bleeding non stop; Cramps in the thigh; Pulp in uterus; This spontaneous case was reported by a consumer and describes the occurrence of HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding/Bleeding non stop), MUSCLE SPASMS (Cramps in the thigh) and UTERINE POLYP (Pulp in uterus) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes.    On 24-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 HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding/Bleeding non stop), MUSCLE SPASMS (Cramps in the thigh) and UTERINE POLYP (Pulp in uterus). At the time of the report, HEAVY MENSTRUAL BLEEDING (Heavy menstrual bleeding/Bleeding non stop), MUSCLE SPASMS (Cramps in the thigh) and UTERINE POLYP (Pulp in uterus) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Other concurrent medical conditions included Blood Pressure.  Concomitant medications includes Blood pressure and Diabetes medications. No treatment information was provided.  Patient stated that she took 2nd dose on 24-Apr-2021, Lot number 009C21A.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Daughter had arthritis in her hands. Got the first shot. And it went away; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Daughter had arthritis in her hands. Got the first shot. And it went away) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Arthritis (Arthritis in her hands).   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 THERAPEUTIC RESPONSE UNEXPECTED (Daughter had arthritis in her hands. Got the first shot. And it went away). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Daughter had arthritis in her hands. Got the first shot. And it went away) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medications were reported   No treatment information was provided
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Crying, Disorientation, Emotional disorder
Clinical narrative: felt like her body was disoriented and tried to walk to the right and my body went to the left; crying; emotional; This spontaneous case was reported by a consumer and describes the occurrence of DISORIENTATION (felt like her body was disoriented and tried to walk to the right and my body went to the left), CRYING (crying) and EMOTIONAL DISORDER (emotional) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included BUSPIRONE for Antidepressant therapy, FLUOXETINE for an unknown indication.   In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 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 DISORIENTATION (felt like her body was disoriented and tried to walk to the right and my body went to the left), CRYING (crying) and EMOTIONAL DISORDER (emotional). At the time of the report, DISORIENTATION (felt like her body was disoriented and tried to walk to the right and my body went to the left), CRYING (crying) and EMOTIONAL DISORDER (emotional) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The Patient received the 2nd Moderna Covid-19 vaccine in left arm shoulder deltoid muscle and no adverse reactions or side effects reported for 2nd dose. Patient felt reactions were due to her antidepressant Buspirone. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 20-Jan-2022: Follow up contains no new information.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes all over the body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes all over the body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes all over the body). At the time of the report, RASH (Rashes all over the body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were reported.   This case was linked to MOD-2022-456445 (Patient Link).
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nasopharyngitis, Vaccination site pain
Clinical narrative: Cold; Vaccination site pain/Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect products included non-company products COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination and ADALIMUMAB for an unknown indication.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form, first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (Intramuscular) 1 dosage form and ADALIMUMAB (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt). At the time of the report, NASOPHARYNGITIS (Cold) and VACCINATION SITE PAIN (Vaccination site pain/Arm hurt) outcome was unknown.            No concomitant medication provided. No treatment medication provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) and HYPERSENSITIVITY (it was an allergic reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017F21A, 031M20A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes, Anxiety and Blood pressure high. Concomitant products included DULOXETINE for Anxiety, AMLODIPINE for Blood pressure high, METFORMIN for Diabetes, MINERALS NOS, VITAMINS NOS (CENTRUM BALANCE) for Vitamin supplementation. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Dec-2021, the patient experienced PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) and HYPERSENSITIVITY (it was an allergic reaction). The patient was treated with CORTISONE ongoing since an unknown date for Allergic reaction, at an unspecified dose and frequency. At the time of the report, PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) and HYPERSENSITIVITY (it was an allergic reaction) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PRURITUS (experienced itches crazy, so bad that the patient wants to take out her skin, every time in different parts of body, like arms, legs, back, hands) to be related. No further causality assessment was provided for HYPERSENSITIVITY (it was an allergic reaction). The patient did not experience any symptom after the second dose. The itchiness happened several times during the day for the patient, and then it stopped for no apparent reason. The patient thought that it might be due to booster dose, because the patient did not make any change of the patient's diet or skin products, and went to see the physician, but the physician told the patient that it was an allergic reaction, and the physician did not prescribe any treatment. This case was linked to MOD-2022-456565 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Abscess limb, Antibody test, Burning sensation, Erythema, Glossitis
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS LIMB (pus pocket down the side of toe), BURNING SENSATION (hands and feet are big red, burn like fire), ERYTHEMA (Hands and feet are big red, burn like fire/ her big toe on left  foot swell up, got all red), GLOSSITIS (Leftside of the tongue is raw) and MOUTH ULCERATION (Ulcers inside the mouth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0114214/ 011A21A and 012M00A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included CLONAZEPAM for Anxiety.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced BURNING SENSATION (hands and feet are big red, burn like fire) and ERYTHEMA (Hands and feet are big red, burn like fire/ her big toe on left  foot swell up, got all red). In November 2021, the patient experienced GLOSSITIS (Leftside of the tongue is raw), MOUTH ULCERATION (Ulcers inside the mouth) and TONGUE DISCOLOURATION (Underside of tongue is black). On an unknown date, the patient experienced ABSCESS LIMB (pus pocket down the side of toe), PAIN (Sore pain around the heart), PERIPHERAL SWELLING (Big toe on left foot swell up and red) and WEIGHT DECREASED (Almost lost 20 pounds). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABSCESS LIMB (pus pocket down the side of toe), BURNING SENSATION (hands and feet are big red, burn like fire), ERYTHEMA (Hands and feet are big red, burn like fire/ her big toe on left  foot swell up, got all red), GLOSSITIS (Leftside of the tongue is raw), MOUTH ULCERATION (Ulcers inside the mouth), PAIN (Sore pain around the heart), PERIPHERAL SWELLING (Big toe on left foot swell up and red), TONGUE DISCOLOURATION (Underside of tongue is black) and WEIGHT DECREASED (Almost lost 20 pounds) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, Antibody test: not provided Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got Blood work  done but could not find anything wrong. She cannot sleep due to the side effects. Patient asked if there is a local specialist that Moderna refers patients to and if the side effects will go away if the antibodies disappear.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Mouth ulceration, Pain, Peripheral swelling, Tongue discolouration, Weight decreased
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ABSCESS LIMB (pus pocket down the side of toe), BURNING SENSATION (hands and feet are big red, burn like fire), ERYTHEMA (Hands and feet are big red, burn like fire/ her big toe on left  foot swell up, got all red), GLOSSITIS (Leftside of the tongue is raw) and MOUTH ULCERATION (Ulcers inside the mouth) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0114214/ 011A21A and 012M00A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anxiety. Concomitant products included CLONAZEPAM for Anxiety.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced BURNING SENSATION (hands and feet are big red, burn like fire) and ERYTHEMA (Hands and feet are big red, burn like fire/ her big toe on left  foot swell up, got all red). In November 2021, the patient experienced GLOSSITIS (Leftside of the tongue is raw), MOUTH ULCERATION (Ulcers inside the mouth) and TONGUE DISCOLOURATION (Underside of tongue is black). On an unknown date, the patient experienced ABSCESS LIMB (pus pocket down the side of toe), PAIN (Sore pain around the heart), PERIPHERAL SWELLING (Big toe on left foot swell up and red) and WEIGHT DECREASED (Almost lost 20 pounds). The patient was treated with GABAPENTIN for Adverse event, at an unspecified dose and frequency. At the time of the report, ABSCESS LIMB (pus pocket down the side of toe), BURNING SENSATION (hands and feet are big red, burn like fire), ERYTHEMA (Hands and feet are big red, burn like fire/ her big toe on left  foot swell up, got all red), GLOSSITIS (Leftside of the tongue is raw), MOUTH ULCERATION (Ulcers inside the mouth), PAIN (Sore pain around the heart), PERIPHERAL SWELLING (Big toe on left foot swell up and red), TONGUE DISCOLOURATION (Underside of tongue is black) and WEIGHT DECREASED (Almost lost 20 pounds) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Dec-2021, Antibody test: not provided Not provided.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient got Blood work  done but could not find anything wrong. She cannot sleep due to the side effects. Patient asked if there is a local specialist that Moderna refers patients to and if the side effects will go away if the antibodies disappear.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired moderna booster dose administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose administered) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 026C21A and 008C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose administered). On 13-Jan-2021, EXPIRED PRODUCT ADMINISTERED (Expired moderna booster dose administered) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The booster dose was administered out of a vial which was punctured more than 12 hours.  No concomitant medication were reported.  No treatment medication were reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Illness, Malaise
Clinical narrative: Has covid; Not feeling well; Sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Has covid), MALAISE (Not feeling well) and ILLNESS (Sick) 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.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, 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 (Has covid), MALAISE (Not feeling well) and ILLNESS (Sick). At the time of the report, COVID-19 (Has covid), MALAISE (Not feeling well) and ILLNESS (Sick) had not resolved.            No Concomitant product use was reported.  The patient reported that they had Covid, was not feeling well, and was sick. The patient also reported that they completed their Moderna Covid-19 vaccination series in 2021. It was mentioned that the patient was looking for monoclonal antibodies.  No treatment information was provided.  Company Comment - This case concerns a female patient of unknown age with no relevant medical history, who experienced the non-serious unexpected events of COVID-19, malaise and illness. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the non-serious unexpected events of COVID-19, malaise and illness. The events occurred on an unknown date after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing infection. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Oropharyngeal pain, SARS-CoV-2 test
Clinical narrative: Sore throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 05-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Dec-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). 26-Dec-2021, the patient experienced HEADACHE (Headache). At the time of the report, OROPHARYNGEAL PAIN (Sore throat) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Dec-2021, SARS-CoV-2 test: negative (Negative) negative.         No concomitant medication information provided. No treatment information provided
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, COVID-19, Interchange of vaccine products
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of ASYMPTOMATIC COVID-19 (tested positive for COVID-19 but no symptoms) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for Prophylactic vaccination. Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination. No Medical History information was reported. In March 2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. In October 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 20-Dec-2021, the patient experienced ASYMPTOMATIC COVID-19 (tested positive for COVID-19 but no symptoms). In October 2021, INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved. At the time of the report, ASYMPTOMATIC COVID-19 (tested positive for COVID-19 but no symptoms) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, COVID-19: sars-cov-2 negative (Negative) SARS-CoV-2 Negative and sars-cov-2 positive (Positive) SARS-CoV-2 positive. No concomitant and treatment information was provided by the reporter. Company comment: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history and Interchange of vaccine products (the patient received one dose of the JANSSEN COVID-19 VACCINE, 7 months prior), who experienced the non-serious unexpected, AESI of Asymptomatic COVID-19. The event occurred approximately 2 months after the booster dose of mRNA-1273 vaccine (second dose in the series since the first dose was JANSSEN COVID-19 VACCINE). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a male patient of unknown age, with no reported medical history and Interchange of vaccine products (the patient received one dose of the JANSSEN COVID-19 VACCINE 7, months prior), who experienced the non-serious unexpected, AESI of Asymptomatic COVID-19. The event occurred approximately 2 months after the booster dose of mRNA-1273 vaccine (second dose in the series since the first dose was JANSSEN COVID-19 VACCINE). The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Expired Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine). On 21-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Administered Expired Vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received expired vaccine from the lot that had beyond use date of 01/20/22. No side effect had been reported by patient during the 15 minute observation time. No concomitant medication were given. No treatment information were given.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Moderna vaccine administered to a patient 10 years of age; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to a patient 10 years of age) in a 10-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to a patient 10 years of age). On 12-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Moderna vaccine administered to a patient 10 years of age) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter stated that it was 39 days since the administration of the first Moderna Covid-19 vaccine.   No concomitant medications were reported. No treatment medications were reported.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Migraine, Vertigo
Clinical narrative: Migraine Headache; Vertigo; could not walk or drive for 1.5 months; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine Headache), VERTIGO (Vertigo), GAIT DISTURBANCE (could not walk or drive for 1.5 months) and DIZZINESS (Dizziness) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024C21A and 001C21A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy.   On 18-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced MIGRAINE (Migraine Headache), VERTIGO (Vertigo), GAIT DISTURBANCE (could not walk or drive for 1.5 months) and DIZZINESS (Dizziness). On 30-Jun-2021, MIGRAINE (Migraine Headache), VERTIGO (Vertigo), GAIT DISTURBANCE (could not walk or drive for 1.5 months) and DIZZINESS (Dizziness) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.  it was reported that patient had no side effects with Dose 1.   This case was linked to MOD-2022-457586 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: greater than 35 days between Moderna Covid-19 vaccinations; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations) 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 15-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations). On 17-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between Moderna Covid-19 vaccinations) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. No other Adverse Reactions or side effects are reported.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Sinus headache
Clinical narrative: sinus headache; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (sinus headache) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received 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 18-Jan-2022, the patient experienced SINUS HEADACHE (sinus headache). The patient was treated with ACETAMINOPHEN for Sinus headache, at an unspecified dose and frequency. At the time of the report, SINUS HEADACHE (sinus headache) outcome was unknown.            No concomitant medication was provided. On 19-Jan-2022, the patient received the booster dose. The night prior, the patient had taken 2 pills of Acetaminophen for a sinus headache. After booster dose the patient took Tylenol.