chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injected limb mobility decreased, Muscular weakness, Myalgia, Palpitations
Clinical narrative: Can not raise the left arm after 2nd dose; Tingly Injection site after 2nd dose; Muscle Weakness after 2nd dose; Heart pounding; Itching bottom of feet, left ear; Red Injection site after 2nd dose; Pounding Head; Left arm injection site after 2nd shot; Muscle soreness after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose), PALPITATIONS (Heart pounding) and PRURITUS (Itching bottom of feet, left ear) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Tetanus (Reaction to Tetanus shot.). Past adverse reactions to the above products included Reaction to previous exposure to any vaccine with Tetanus.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose), PALPITATIONS (Heart pounding), PRURITUS (Itching bottom of feet, left ear), VACCINATION SITE ERYTHEMA (Red Injection site after 2nd dose), HEADACHE (Pounding Head), VACCINATION SITE PRURITUS (Left arm injection site after 2nd shot) and MYALGIA (Muscle soreness after 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 3 pills. At the time of the report, INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose) and VACCINATION SITE ERYTHEMA (Red Injection site after 2nd dose) had not resolved, PALPITATIONS (Heart pounding) and HEADACHE (Pounding Head) outcome was unknown and PRURITUS (Itching bottom of feet, left ear), VACCINATION SITE PRURITUS (Left arm injection site after 2nd shot) and MYALGIA (Muscle soreness after 2nd dose) was resolving.            No concomitant medications were provided.   This case was linked to MOD-2021-360548 (Patient Link).
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site erythema, Vaccination site paraesthesia, Vaccination site pruritus
Clinical narrative: Can not raise the left arm after 2nd dose; Tingly Injection site after 2nd dose; Muscle Weakness after 2nd dose; Heart pounding; Itching bottom of feet, left ear; Red Injection site after 2nd dose; Pounding Head; Left arm injection site after 2nd shot; Muscle soreness after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose), PALPITATIONS (Heart pounding) and PRURITUS (Itching bottom of feet, left ear) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011F21A and 058E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: Tetanus (Reaction to Tetanus shot.). Past adverse reactions to the above products included Reaction to previous exposure to any vaccine with Tetanus.   On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose), PALPITATIONS (Heart pounding), PRURITUS (Itching bottom of feet, left ear), VACCINATION SITE ERYTHEMA (Red Injection site after 2nd dose), HEADACHE (Pounding Head), VACCINATION SITE PRURITUS (Left arm injection site after 2nd shot) and MYALGIA (Muscle soreness after 2nd dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 3 pills. At the time of the report, INJECTED LIMB MOBILITY DECREASED (Can not raise the left arm after 2nd dose), VACCINATION SITE PARAESTHESIA (Tingly Injection site after 2nd dose), MUSCULAR WEAKNESS (Muscle Weakness after 2nd dose) and VACCINATION SITE ERYTHEMA (Red Injection site after 2nd dose) had not resolved, PALPITATIONS (Heart pounding) and HEADACHE (Pounding Head) outcome was unknown and PRURITUS (Itching bottom of feet, left ear), VACCINATION SITE PRURITUS (Left arm injection site after 2nd shot) and MYALGIA (Muscle soreness after 2nd dose) was resolving.            No concomitant medications were provided.   This case was linked to MOD-2021-360548 (Patient Link).
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient got a booster dose from an expired vial; No Adverse Event; This spontaneous retrospective pregnancy case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from an expired vial) and NO ADVERSE EVENT (No Adverse Event) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Oct-2021, the patient received third 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 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from an expired vial) and NO ADVERSE EVENT (No Adverse Event). The delivery occurred  on 28-May-2021, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient got a booster dose from an expired vial) and NO ADVERSE EVENT (No Adverse Event) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   There were 3 patients in total. This case pertained to patient 1.  Patient mentioned that they (patient 1,2 and 3) got all the doses on the left arm, and did not take any medication regularly. Patient 1 was pregnant at the time of first and second inoculation and the delivery date was 28-May-2021.  1 vial, carried 10 doses, originally, only 3 doses were administered from it. The vial was left to thaw straight from the freezer right before being used.  No concomitant and treatment medication were provided COMPANY COMMENT: This is a case of expired vaccine used for this 34-year-old female patient who was approximately 5 months post-partum with no reported associated adverse event. The vaccine dose was a booster third dose administered approximately 10 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2021-360752 (Patient Link).; Sender's Comments: This is a case of expired vaccine used for this 34-year-old female patient who was approximately 5 months post-partum with no reported associated adverse event. The vaccine dose was a booster third dose administered approximately 10 months after the second dose of mRNA-1273 vaccine. The rechallenge was not applicable, as no additional dosing will be administered. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient got a booster dose from an expired vial; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003C21A, 011J20A and 028L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a booster dose from an expired vial) had resolved.        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. Patient mentioned they got all doses on the left arm, does not take any medication regularly. Patient was pregnant at the time of first and second inoculation and delivery date was 28May2021. Patient  would like to participate in the pregnancy registry.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient received dose from expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A and 062E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine). On 21-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient received dose from expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment information was not provided. The vial did not undergo any temperature excursions as per the reporter.   This case was linked to MOD-2021-360687 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizziness; Vertigo/everything would start to spin (upon sitting or lying down); This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness) and VERTIGO (Vertigo/everything would start to spin (upon sitting or lying down)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A(Or4)21A and 041L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced DIZZINESS (Dizziness) and VERTIGO (Vertigo/everything would start to spin (upon sitting or lying down)). The patient was treated with MECLIZINE [MECLOZINE] for Vertigo, at a dose of 12.5 milligram twice a day. At the time of the report, DIZZINESS (Dizziness) and VERTIGO (Vertigo/everything would start to spin (upon sitting or lying down)) outcome was unknown.            The  concomitant medications on use were not provided.    This case was linked to MOD-2021-361049 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Feeling abnormal, Illness, Peripheral swelling
Clinical narrative: arm was red; felt like crap like she had been run over by a truck; arm was swollen; felt sick; cancer was gone/cancer had disappeared; fever of 103; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (arm was red), FEELING ABNORMAL (felt like crap like she had been run over by a truck), PERIPHERAL SWELLING (arm was swollen), ILLNESS (felt sick) and THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/cancer had disappeared) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholangiocarcinoma and Chemotherapy on 20-Apr-2021. Concomitant products included IVOSIDENIB (TIBSOVO) for Cancer.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced ERYTHEMA (arm was red), FEELING ABNORMAL (felt like crap like she had been run over by a truck), PERIPHERAL SWELLING (arm was swollen), ILLNESS (felt sick), THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/cancer had disappeared) and PYREXIA (fever of 103). At the time of the report, ERYTHEMA (arm was red), FEELING ABNORMAL (felt like crap like she had been run over by a truck), PERIPHERAL SWELLING (arm was swollen) and PYREXIA (fever of 103) outcome was unknown and ILLNESS (felt sick) and THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/cancer had disappeared) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was reported.  The patient had a history of Cholangiocarcinoma that had spread to her liver, and settled on her blood vessels. This also at some point had spread to her lungs. She had about 1 year of chemotherapy and was going through the chemotherapy when she had the first 2 shots. She had her chemotherapy appointments on either the same day or the day before or after receiving the first 2 doses of the Moderna vaccine. Her chemotherapy ended around 20-Apr-2021 and she received follow up PET and CT scans which showed her cancer was gone. She then was sent to a radiation oncologist to radiate her lung tumors, but he also stated her lung cancer had disappeared. She continues to take an oral cancer medication Tibsovo at night. Her doctor believes that the Moderna vaccine had some influence in helping her cancer's remission.   This case was linked to MOD-2021-360858 (Patient Link).
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Therapeutic response unexpected
Clinical narrative: arm was red; felt like crap like she had been run over by a truck; arm was swollen; felt sick; cancer was gone/cancer had disappeared; fever of 103; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (arm was red), FEELING ABNORMAL (felt like crap like she had been run over by a truck), PERIPHERAL SWELLING (arm was swollen), ILLNESS (felt sick) and THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/cancer had disappeared) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Cholangiocarcinoma and Chemotherapy on 20-Apr-2021. Concomitant products included IVOSIDENIB (TIBSOVO) for Cancer.    On 08-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced ERYTHEMA (arm was red), FEELING ABNORMAL (felt like crap like she had been run over by a truck), PERIPHERAL SWELLING (arm was swollen), ILLNESS (felt sick), THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/cancer had disappeared) and PYREXIA (fever of 103). At the time of the report, ERYTHEMA (arm was red), FEELING ABNORMAL (felt like crap like she had been run over by a truck), PERIPHERAL SWELLING (arm was swollen) and PYREXIA (fever of 103) outcome was unknown and ILLNESS (felt sick) and THERAPEUTIC RESPONSE UNEXPECTED (cancer was gone/cancer had disappeared) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103 (High) 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment drug details was reported.  The patient had a history of Cholangiocarcinoma that had spread to her liver, and settled on her blood vessels. This also at some point had spread to her lungs. She had about 1 year of chemotherapy and was going through the chemotherapy when she had the first 2 shots. She had her chemotherapy appointments on either the same day or the day before or after receiving the first 2 doses of the Moderna vaccine. Her chemotherapy ended around 20-Apr-2021 and she received follow up PET and CT scans which showed her cancer was gone. She then was sent to a radiation oncologist to radiate her lung tumors, but he also stated her lung cancer had disappeared. She continues to take an oral cancer medication Tibsovo at night. Her doctor believes that the Moderna vaccine had some influence in helping her cancer's remission.   This case was linked to MOD-2021-360858 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling, Vaccination complication, Vaccination site reaction
Clinical narrative: Swelling; Covid arm; Had a rash; Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling), VACCINATION SITE REACTION (Covid arm), VACCINATION COMPLICATION (Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.) and RASH (Had a rash) 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 March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Oct-2021, the patient experienced VACCINATION COMPLICATION (Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.). On an unknown date, the patient experienced SWELLING (Swelling), VACCINATION SITE REACTION (Covid arm) and RASH (Had a rash). At the time of the report, SWELLING (Swelling), VACCINATION SITE REACTION (Covid arm), VACCINATION COMPLICATION (Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.) and RASH (Had a rash) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  I did get both shots of Moderna in March 2021.  Can I please have the AE document sent to me in paper form mailed to me? They sent it to me in email, but I'm not technologically savvy, & I had a hard time trying to complete it.  Crosslinked with MOD21-041140 (AE case)
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Blood sodium, Decreased appetite, Feeling abnormal
Clinical narrative: felt kind of crummy; lost appetite; not my energized self; stomach kind a thing; achy; nausea, nauseated; headache; a little fever; passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt kind of crummy), DECREASED APPETITE (lost appetite), ASTHENIA (not my energized self), ABDOMINAL DISCOMFORT (stomach kind a thing), PAIN (achy), NAUSEA (nausea, nauseated), HEADACHE (headache) and PYREXIA (a little fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 12-Feb-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. At the time of the report, FEELING ABNORMAL (felt kind of crummy), DECREASED APPETITE (lost appetite), ASTHENIA (not my energized self), ABDOMINAL DISCOMFORT (stomach kind a thing), PAIN (achy), NAUSEA (nausea, nauseated), HEADACHE (headache) and PYREXIA (a little fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood sodium: low (Low) sodium level was down.         No treatment medication details were provided.  No concomitant medication details were provided.  Vaccine was administered on the left nondominant arm. Reporter reported an ambulance took patient to the hospital were "they run all kind of tests" and everything was fine.  Company comment: This case concerns a  53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day (few hours) after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day (few hours) after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Loss of consciousness, Nausea, Pain, Pyrexia
Clinical narrative: felt kind of crummy; lost appetite; not my energized self; stomach kind a thing; achy; nausea, nauseated; headache; a little fever; passed out; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Feb-2021, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (felt kind of crummy), DECREASED APPETITE (lost appetite), ASTHENIA (not my energized self), ABDOMINAL DISCOMFORT (stomach kind a thing), PAIN (achy), NAUSEA (nausea, nauseated), HEADACHE (headache) and PYREXIA (a little fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 12-Feb-2021, LOSS OF CONSCIOUSNESS (passed out) had resolved. At the time of the report, FEELING ABNORMAL (felt kind of crummy), DECREASED APPETITE (lost appetite), ASTHENIA (not my energized self), ABDOMINAL DISCOMFORT (stomach kind a thing), PAIN (achy), NAUSEA (nausea, nauseated), HEADACHE (headache) and PYREXIA (a little fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood sodium: low (Low) sodium level was down.         No treatment medication details were provided.  No concomitant medication details were provided.  Vaccine was administered on the left nondominant arm. Reporter reported an ambulance took patient to the hospital were "they run all kind of tests" and everything was fine.  Company comment: This case concerns a  53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day (few hours) after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  53-year-old, female patient with no relevant medical history, who experienced the unexpected event of Loss of consciousness. The event occurred approximately 1 day (few hours) after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable since event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia, Platelet count
Clinical narrative: On her way to the emergency room with ITP,in extreme danger.; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNE THROMBOCYTOPENIA (On her way to the emergency room with ITP,in extreme danger.) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 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 IMMUNE THROMBOCYTOPENIA (On her way to the emergency room with ITP,in extreme danger.) (seriousness criterion medically significant). At the time of the report, IMMUNE THROMBOCYTOPENIA (On her way to the emergency room with ITP,in extreme danger.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: zero (abnormal) Zero.         Concomitant medications were not provided.  Treatment information was not provided.  Patient received the vaccination in June, and she is on her way to the emergency room with ITP. Her platelet count is zero, she is basically in extreme danger. The doctor told her not to hit her head on the way to the emergency room because she is going to hemorrhage. She received her 1st dose at the end of June and her 2nd dose 28 days later.  Company Comment: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected event of Immune Thrombocytopenia. The event occurred on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a  24-year-old, female patient with no relevant medical history, who experienced the unexpected event of Immune Thrombocytopenia. The event occurred on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable as event occurred after second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This spontaneous case was reported by a consumer and describes the occurrence of PNEUMONIA (Pneumonia) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013U20A and 027L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PNEUMONIA (Pneumonia) (seriousness criteria hospitalization and medically significant). At the time of the report, PNEUMONIA (Pneumonia) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment: This case concerns a 61-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.; Sender's Comments: This case concerns a 61-year-old, female patient with no previous relevant medical history reported, who experienced the unexpected event of pneumonia. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 is not affected by this report. Further information was requested.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Slight side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Slight side effects) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A, D1DF21A and 044A21A) for COVID-19 vaccination.     Concurrent medical conditions included Muscle disorder NOS (Immunocompromised due to Underlying Muscle disease) and Immunocompromised.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, 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 experienced VACCINATION COMPLICATION (Slight side effects). At the time of the report, VACCINATION COMPLICATION (Slight side effects) outcome was unknown.            No concomitant medications were mentioned since patient declined. No treatment details were reported since patient declined.  Patient reported that he is considered immunocompromised as per his doctor due to underlying muscle disease.   This case was linked to MOD-2021-361341, MOD-2021-361352 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: Afib; 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 ATRIAL FIBRILLATION (Afib) 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 ATRIAL FIBRILLATION (Afib) (seriousness criterion medically significant). At the time of the report, ATRIAL FIBRILLATION (Afib) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication details provided. No treatment medication details provided. It was reported that two people that work for reporter had the vaxx had to quite shortly after they got the vax because they developed AFIB. Their lives have changed.  Company Comment: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of atrial fibrillation. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report.   This case was linked to MODERNATX, INC.-MOD-2021-361453 (E2B Linked Report).; Sender's Comments: This case concerns an unknown age and unknown gender patient with no relevant medical history, who experienced the unexpected event of atrial fibrillation. The event occurred unknown number of days after a dose of mRNA-1273 vaccine.  It is not clear from the source document whether this was a first or second dose. The rechallenge was unknown since there's not enough information to assess this in the source document. The benefit-risk relationship of the vaccine not affected by this report. MODERNATX, INC.-MOD-2021-361453:Crosslinked case (same reporter)
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: got a weird thing on their hand after the second dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (got a weird thing on their hand after the second dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-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 VACCINATION COMPLICATION (got a weird thing on their hand after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (got a weird thing on their hand after the second dose) outcome was unknown.            Concomitant medications were not reported by the reporter. Patient 1 reported that patient 3 may be 65-57 years of age.   This case was linked to MOD-2021-361534 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: for doses 1 and 2 she had a sore muscle, a little touchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (for doses 1 and 2 she had a sore muscle, a little touchy) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 038K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (for doses 1 and 2 she had a sore muscle, a little touchy). At the time of the report, VACCINATION SITE PAIN (for doses 1 and 2 she had a sore muscle, a little touchy) outcome was unknown.            Concomitant medication: "a lot of medication".  No treatment medications were reported   This case was linked to MOD-2021-361527, MOD-2021-361528 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac discomfort
Clinical narrative: had something similar after the second dose and was told it was a cardiac thing, related to the heart; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISCOMFORT (had something similar after the second dose and was told it was a cardiac thing, related to the heart) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-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 CARDIAC DISCOMFORT (had something similar after the second dose and was told it was a cardiac thing, related to the heart). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, CARDIAC DISCOMFORT (had something similar after the second dose and was told it was a cardiac thing, related to the heart) outcome was unknown.            No concomitant medications were provided.  Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-362400, MOD-2021-362429, MOD-2021-361503 (Patient Link).
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chest pain, Ear discomfort, Fatigue
Clinical narrative: Arm pain; Stomach Ache; Chest pain; Fever (102°F); Nausea; Headache; Felt tired; Intense heart bit like tachycardia/Heart pounding; Ears pounding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PALPITATIONS (Intense heart bit like tachycardia/Heart pounding) and EAR DISCOMFORT (Ears pounding) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for Anxiolytic therapy.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PALPITATIONS (Intense heart bit like tachycardia/Heart pounding) and EAR DISCOMFORT (Ears pounding). On 23-Oct-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PYREXIA (Fever (102°F)), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Felt tired). On 24-Oct-2021 at 10:00 AM, PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PALPITATIONS (Intense heart bit like tachycardia/Heart pounding), EAR DISCOMFORT (Ears pounding), PYREXIA (Fever (102°F)), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 102 (High) 102°F.         No treatment drug details was reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Arm pain; Stomach Ache; Chest pain; Fever (102°F); Nausea; Headache; Felt tired; Intense heart bit like tachycardia/Heart pounding; Ears pounding; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PALPITATIONS (Intense heart bit like tachycardia/Heart pounding) and EAR DISCOMFORT (Ears pounding) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included LORAZEPAM for Anxiolytic therapy.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Oct-2021, the patient experienced PALPITATIONS (Intense heart bit like tachycardia/Heart pounding) and EAR DISCOMFORT (Ears pounding). On 23-Oct-2021 at 10:00 AM, the patient experienced PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PYREXIA (Fever (102°F)), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Felt tired). On 24-Oct-2021 at 10:00 AM, PAIN IN EXTREMITY (Arm pain), ABDOMINAL PAIN UPPER (Stomach Ache), CHEST PAIN (Chest pain), PALPITATIONS (Intense heart bit like tachycardia/Heart pounding), EAR DISCOMFORT (Ears pounding), PYREXIA (Fever (102°F)), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Felt tired) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Oct-2021, Body temperature: 102 (High) 102°F.         No treatment drug details was reported.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Body ache; Headache; Tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (Tired) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN LOW), ABIRATERONE ACETATE, PREDNISONE, FINASTERIDE, TAMSULOSIN and ROSUVASTATIN CALCIUM (CRESTOR) for an unknown indication.   In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (Tired). At the time of the report, MYALGIA (Body ache), HEADACHE (Headache) and FATIGUE (Tired) outcome was unknown.            Patient did not take any medication for treatment.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Had a reaction for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Had a reaction for 3 days) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a reaction for 3 days). At the time of the report, VACCINATION COMPLICATION (Had a reaction for 3 days) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  Treatment information was unknown.   Reporter did not allow further contact
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-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 VACCINATION SITE REACTION (felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.). At the time of the report, VACCINATION SITE REACTION (felt like he got wallaped in the left injection site arm with both Moderna Covid-19 vaccines.) outcome was unknown.            Concomitant medications details were not reported. Treatment details was not reported.   This case was linked to MOD-2021-361603 (Patient Link).
Age: 63.0
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose, Inappropriate schedule of product administration
Clinical narrative: Got a full dose for his third shot and is not immunocompromised; inappropriate schedule of vaccine admiinistration; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE (Got a full dose for his third shot and is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine admiinistration) in a 63-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.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (Got a full dose for his third shot and is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine admiinistration). On 23-Oct-2021, ACCIDENTAL OVERDOSE (Got a full dose for his third shot and is not immunocompromised) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine admiinistration) had resolved.            No concomitant medication was mentioned.  No treatment medication was mentioned.  First dose was in March for her Honey.