chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Influenza like illness
Clinical narrative: Flu like symptoms,Influenza like illness; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sickness) and INFLUENZA LIKE ILLNESS (Flu like symptoms,Influenza like illness) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product TREPROSTINIL SODIUM (TYVASO) inhalation gas for Primary pulmonary hypertension.    Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included AMBRISENTAN (LETAIRIS) and TADALAFIL (ADCIRCA) for an unknown indication.   On 26-Jan-2021, the patient started TREPROSTINIL SODIUM (TYVASO) (unknown route) at an unspecified dose. In 2021, TREPROSTINIL SODIUM (TYVASO) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (Sickness). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms,Influenza like illness). At the time of the report, ILLNESS (Sickness) and INFLUENZA LIKE ILLNESS (Flu like symptoms,Influenza like illness) outcome was unknown. Not Provided          Tyvaso delivered by Tyvaso Inhalation Device (TD-300/A),  The current dose was reported as 18-54 µg (3-9 breaths), four times a day (QID) via inhalation (IH) route.  The events of coughing (cough), headaches (headache), and flushing (flushing). The patient was on IH Tyvaso and coughing during sessions. Coughing was a problem. He also had headaches and flushing for 1-1.5 hours after IH Tyvaso sessions. Side effects were not that bad. Action taken with IH Tyvaso was not reported for the events of cough, headache, and flushing. At the time of reporting, the outcome of cough, headache, and flushing was unknown.  The patient received a booster COVID shot. The booster made the patient sick (flu like symptoms) for an estimation of about 3.5 days.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Joint stiffness
Clinical narrative: top of right knee cap stiffening when going from a sitting to a standing position; When stands up, it takes a while to walk off; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (top of right knee cap stiffening when going from a sitting to a standing position) and GAIT DISTURBANCE (When stands up, it takes a while to walk off) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient had no medical history.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 JOINT STIFFNESS (top of right knee cap stiffening when going from a sitting to a standing position) and GAIT DISTURBANCE (When stands up, it takes a while to walk off). At the time of the report, JOINT STIFFNESS (top of right knee cap stiffening when going from a sitting to a standing position) and GAIT DISTURBANCE (When stands up, it takes a while to walk off) outcome was unknown.            No concomitant medications were reported. No treatments were reported.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Greater than 35 days between Moderna Covid-19 vaccinations.; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Greater than 35 days between Moderna Covid-19 vaccinations.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided.  No treatment  medication were provided
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Light sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Light sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     The patient's past medical history included Liver transplant in February 2021. Concomitant products included MYCOPHENOLATE MOFETIL (MYCOPHENOLATE) and TACROLIMUS for an unknown indication.    On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, the patient experienced PAIN IN EXTREMITY (Light sore arm). At the time of the report, PAIN IN EXTREMITY (Light sore arm) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Patient also takes many other antirejection medications.  No treatment medications were reported.  Patient had a light sore arm, the following day it was a little bit more and patient did not take any medications.   This case was linked to MOD-2021-320754 (Patient Link).
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica
Clinical narrative: Diagnosed with PMR  Poly myalgia Rheunatica; This spontaneous case was reported by a consumer and describes the occurrence of POLYMYALGIA RHEUMATICA (Diagnosed with PMR  Poly myalgia Rheunatica) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-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 POLYMYALGIA RHEUMATICA (Diagnosed with PMR  Poly myalgia Rheunatica) (seriousness criterion medically significant). The patient was treated with NAPROXEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (ACETAMINOPHEN) for Adverse event, at an unspecified dose and frequency. At the time of the report, POLYMYALGIA RHEUMATICA (Diagnosed with PMR  Poly myalgia Rheunatica) outcome was unknown.            Patient experienced pain from her neck to her knees, any movement hurts. Patient stated that she had been diagnosed with PMR Poly myalgia Rheumatic by her neurologist.  Company Comment : This case concerns a 46-year-old, female patient with no medical history reported, who experienced the unexpected event of Polymyalgia rheumatica. The event occurred after the second dose of Spikevax. The rechallenge was negative since after the first dose the patient reported no adverse events. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 46-year-old, female patient with no medical history reported, who experienced the unexpected event of Polymyalgia rheumatica. The event occurred after the second dose of Spikevax. The rechallenge was negative since after the first dose the patient reported no adverse events. The benefit-risk relationship of Spikevax is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus, Urticaria
Clinical narrative: Arm welted up; Arm turned to blisters; Arm  itched; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Arm welted up), BLISTER (Arm turned to blisters) and PRURITUS (Arm  itched) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Arm welted up), BLISTER (Arm turned to blisters) and PRURITUS (Arm  itched). At the time of the report, URTICARIA (Arm welted up), BLISTER (Arm turned to blisters) and PRURITUS (Arm  itched) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: some of the vaccine oozed out; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (some of the vaccine oozed out) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, the patient experienced ACCIDENTAL UNDERDOSE (some of the vaccine oozed out). At the time of the report, ACCIDENTAL UNDERDOSE (some of the vaccine oozed out) 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.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd Dose not taken; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd Dose not taken) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A   or 052C4A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd Dose not taken). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd Dose not taken) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Caller called and need to know about  ability to take 2nd dose.   Reporter reported that 1st Moderna dose was on 30July2021 to left non dominant arm via IM injection. Due to work and weather, I was not able to take 2nd dose at appropriate time which was 27Aug2021. Patient eligible to receive 2nd dose still? what was proper procedure. Pharmacy said since patient did not receive in 42 days, so patient to wait for booster. Caller confirmed no side effects with 1st dose and is on no other medications.  Concomitant and treatment medications were not provided.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Myalgia
Clinical narrative: hair started falling out in clumps; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair started falling out in clumps) and MYALGIA (sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A or 0U5A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), TELMISARTAN (MICARDIS), POTASSIUM CHLORIDE (K-DUR), ASCORBIC ACID, BIOFLAVONOIDS NOS (VITAMIN C [ASCORBIC ACID;BIOFLAVONOIDS NOS]) and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for an unknown indication.    On 17-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 ALOPECIA (hair started falling out in clumps) and MYALGIA (sore arm). The patient was treated with CLOBETASOL for Inflammation, at an unspecified dose and frequency. At the time of the report, ALOPECIA (hair started falling out in clumps) had resolved and MYALGIA (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient was given two vaccination cards with different lot. Patient reported that within 2 weeks her hair started falling out in clumps and she was told by her dermatologist to not get another shot. Patient reports she had a plasma treatment that had her hair grow back.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Product dose omission issue, Pyrexia
Clinical narrative: sick; fever; received one shot in February and did not receive the second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick), PYREXIA (fever) and PRODUCT DOSE OMISSION ISSUE (received one shot in February and did not receive the second dose yet) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In February 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 ILLNESS (sick), PYREXIA (fever) and PRODUCT DOSE OMISSION ISSUE (received one shot in February and did not receive the second dose yet). At the time of the report, ILLNESS (sick), PYREXIA (fever) and PRODUCT DOSE OMISSION ISSUE (received one shot in February and did not receive the second dose yet) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: She found out that she was pregnant after the shot; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (She found out that she was pregnant after the shot) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. In 2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (She found out that she was pregnant after the shot) (seriousness criterion hospitalization). In 2021, MATERNAL EXPOSURE DURING PREGNANCY (She found out that she was pregnant after the shot) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was withdrawn on an unknown date.       No concomitant medications were provided. No treatment information was provided. Reporter stated that his 18-year-old granddaughter had the Moderna COVID-19 vaccine and she found out that she was pregnant after the shot.  Patient stated that she will not be getting the shot.  This case concerns an 18-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy. The patient received the first dose of vaccine at unknown weeks of gestation. The event was considered not applicable to the product; however, the reporter's assessment was not provided. The benefit-risk relationship of Spikevax in not affected by this report.; Sender's Comments: This case concerns an 18-year-old, female patient with no relevant medical history, who experienced the unexpected events of vaccine exposure during pregnancy. The patient received the first dose of vaccine at unknown weeks of gestation. The event was considered not applicable to the product; however, the reporter's assessment was not provided. The benefit-risk relationship of Spikevax in not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke 2-3 weeks after second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (Stroke 2-3 weeks after second vaccine) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced CEREBROVASCULAR ACCIDENT (Stroke 2-3 weeks after second vaccine) (seriousness criterion medically significant). In 2021, CEREBROVASCULAR ACCIDENT (Stroke 2-3 weeks after second vaccine) outcome was unknown.            No treatment information was provided. Lab details were not provided. No relevant concomitant medications were reported.  Company Comment: This case concerns an 85 year-old female patient, who experienced the unexpected event of Cerebrovascular accident. The event occurred 2-3 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns an 85 year-old female patient, who experienced the unexpected  event of Cerebrovascular accident. The event occurred 2-3 weeks after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Inappropriate schedule of product administration, Joint stiffness
Clinical narrative: Stiff knees; Inappropriate schedule of vaccine administered; Headache; This spontaneous case was reported by a consumer and describes the occurrence of JOINT STIFFNESS (Stiff knees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and HEADACHE (Headache) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062620A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-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 JOINT STIFFNESS (Stiff knees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and HEADACHE (Headache). At the time of the report, JOINT STIFFNESS (Stiff knees), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and HEADACHE (Headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood pressure measurement: high (High) blood pressure is also a little more than it usually.         Concomitant medication information not provided.  Treatment information not provided.  Patient stated that when he sits down for a period of time and gets up, the top of his left knee cap is stiffening. He experienced a slight headache at night. His blood pressure is also a little more than it usually. He thought he might have COVID-19 but was not tested yet.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness, SARS-CoV-2 test, Somnolence
Clinical narrative: doesn't want to get up; fatigue; like a normal flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like a normal flu), SOMNOLENCE (doesn't want to get up) and FATIGUE (fatigue) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (like a normal flu). On an unknown date, the patient experienced SOMNOLENCE (doesn't want to get up) and FATIGUE (fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (like a normal flu), SOMNOLENCE (doesn't want to get up) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided.  Treatment information include Antihistaminic and regular flu medicine.   Reporter did not allow further contact
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, SARS-CoV-2 test, Skin mass, Sleep disorder
Clinical narrative: not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours; back ache from neck down area; knot in the arm; feeling of no energy,did not get her cycle for 5 weeks; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back ache from neck down area), SKIN MASS (knot in the arm), SLEEP DISORDER (not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours) and FATIGUE (feeling of no energy,did not get her cycle for 5 weeks) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, the patient experienced BACK PAIN (back ache from neck down area), SKIN MASS (knot in the arm), SLEEP DISORDER (not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours) and FATIGUE (feeling of no energy,did not get her cycle for 5 weeks). At the time of the report, BACK PAIN (back ache from neck down area), SLEEP DISORDER (not sleeping well /can hardly sleep for 5 to 10 minutes/cannot go back to sleep for few hours) and FATIGUE (feeling of no energy,did not get her cycle for 5 weeks) outcome was unknown and SKIN MASS (knot in the arm) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided by the reporter.  Treatment information was not provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: other people had experienced a reaction; 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 VACCINATION COMPLICATION (other people had experienced a reaction) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (other people had experienced a reaction). At the time of the report, VACCINATION COMPLICATION (other people had experienced a reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications provided.  No treatment medications provided.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Experienced much worse arm pain/hurts to put pants on because arm; a slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Experienced much worse arm pain/hurts to put pants on because arm) and HEADACHE (a slight headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jul-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 PAIN IN EXTREMITY (Experienced much worse arm pain/hurts to put pants on because arm) and HEADACHE (a slight headache). At the time of the report, PAIN IN EXTREMITY (Experienced much worse arm pain/hurts to put pants on because arm) and HEADACHE (a slight headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported, No treatment information was provided by the reporter.   This case was linked to MOD-2021-320520 (Patient Link).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiomyopathy, Electrocardiogram
Clinical narrative: she has a weak heart muscle; This spontaneous case was reported by a consumer and describes the occurrence of CARDIOMYOPATHY (she has a weak heart muscle) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 001A21A) for COVID-19 vaccination.     The patient's past medical history included Head injury in February 2021.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced CARDIOMYOPATHY (she has a weak heart muscle) (seriousness criterion medically significant). At the time of the report, CARDIOMYOPATHY (she has a weak heart muscle) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2021, Electrocardiogram: abnormal (abnormal) Abnormal. On an unknown date, Electrocardiogram: normal (normal) Normal.         No treatment information was provided. No relevant concomitant medications were reported.  Husband (retired is calling to report that his 55-year-old wife fell and bumped her head the first week of FEB2021 about 2 weeks before she received the first vaccine. While she was in the Hospital, they did an EKG and it was normal. Her heart was healthy prior to vaccination. He reports that his 55-year-old wife received the first dose of Moderna COVID-19 vaccine on 25FEB2021 (Lot# 001A21A & Exp. Date:  Unknown) and received the second Moderna COVID-19 vaccine on 25MAR2021  (Lot# 003A21A  &   Exp. Date: 14AUG2021). Sometime at the end of AUG2021 she went for routine check up and they did an EKG.  The EKG was abnormal. Wife was told that she has a weak heart muscle.  Company Comment: This case concerns 65 year old female who experienced cardiomyopathy after approximately 5 months after the second dose of the vaccine. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report.; Sender's Comments: This case concerns 65 year old female who experienced cardiomyopathy after approximately 5 months after the second dose of the vaccine. Dechallenge is unknown and rechallenge is not applicable. The benefit-risk relationship is not affected by this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Application site vesicles, Intracardiac thrombus
Clinical narrative: Clot in his Heart due to the Vaccine; A small Bubble in the Injection site; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (Clot in his Heart due to the Vaccine) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 092D21A and 059E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced APPLICATION SITE VESICLES (A small Bubble in the Injection site). On 06-Sep-2021, the patient experienced INTRACARDIAC THROMBUS (Clot in his Heart due to the Vaccine) (seriousness criteria death and medically significant). The patient died on 06-Sep-2021. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. At the time of death, APPLICATION SITE VESICLES (A small Bubble in the Injection site) outcome was unknown.            Concomitant product use was not provided by the reporter.  The patient died in his sleep after 24 hours of getting his second dose of the Moderna Covid-19 vaccine. The patient did not have any existing medical condition and the cause of death indicated on death certificate was a clot in his heart due to the vaccine. Patient only had a small bubble in the injection site.  No treatment information was provided.  Company comment: This fatal case concerns a 74-year-old male patient with no medical history reported, who experienced the serious unexpected event Intracardiac thrombosis .The event occurred approximately 28 days after the first dose and one day after the second and most recent dose of mRNA-1273 Moderna vaccine. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Sender's Comments: This fatal case concerns a 74-year-old male patient with no medical history reported, who experienced the serious unexpected event Intracardiac thrombosis .The event occurred approximately 28 days after the first dose and one day after the second and most recent dose of mRNA-1273 Moderna vaccine. The reported cause of death was clot in his heart due to the vaccine. It is unknown if an autopsy was performed. Further information has been requested. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.; Reported Cause(s) of Death: Clot in his Heart due to the Vaccine
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness, Product dose omission issue, Rash
Clinical narrative: It moved bad through her body, and it lasted one week until it was gone.; had an allergic reaction, she had a serious reaction, I'm allergic to it; was really sick; More than 35 days after the first dose without receiving the second dose; her full body had a total rash, had a full body rash from her neck to her ankles.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (her full body had a total rash, had a full body rash from her neck to her ankles.), RASH (It moved bad through her body, and it lasted one week until it was gone.), HYPERSENSITIVITY (had an allergic reaction, she had a serious reaction, I'm allergic to it), ILLNESS (was really sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (her full body had a total rash, had a full body rash from her neck to her ankles.). On an unknown date, the patient experienced RASH (It moved bad through her body, and it lasted one week until it was gone.), HYPERSENSITIVITY (had an allergic reaction, she had a serious reaction, I'm allergic to it), ILLNESS (was really sick) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH (her full body had a total rash, had a full body rash from her neck to her ankles.), RASH (It moved bad through her body, and it lasted one week until it was gone.) and PRODUCT DOSE OMISSION ISSUE (More than 35 days after the first dose without receiving the second dose) had resolved and HYPERSENSITIVITY (had an allergic reaction, she had a serious reaction, I'm allergic to it) and ILLNESS (was really sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient took Over the counter vitamins supplement concomitantly.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Feeling abnormal, Headache, Inappropriate schedule of product administration
Clinical narrative: 2nd dose given more than 35 days after 1st dose; back of my head is swollen; 3 hours after vaccination, she felt like the liquid was going up to her head; feel weak/weakness; I have temp (fever); Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 037F81A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN POTASSIUM for an unknown indication.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)), CHILLS (Chills), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 35 days after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 35 days after 1st dose) had resolved. At the time of the report, SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling
Clinical narrative: 2nd dose given more than 35 days after 1st dose; back of my head is swollen; 3 hours after vaccination, she felt like the liquid was going up to her head; feel weak/weakness; I have temp (fever); Chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)) and CHILLS (Chills) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 037F81A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.  Concomitant products included LOSARTAN POTASSIUM for an unknown indication.   On 11-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Sep-2021, the patient experienced SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)), CHILLS (Chills), HEADACHE (headache) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 35 days after 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose given more than 35 days after 1st dose) had resolved. At the time of the report, SWELLING (back of my head is swollen), FEELING ABNORMAL (3 hours after vaccination, she felt like the liquid was going up to her head), ASTHENIA (feel weak/weakness), PYREXIA (I have temp (fever)), CHILLS (Chills) and HEADACHE (headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal, Head discomfort
Clinical narrative: hard to move my head in any direction; feel like I'm gonna pass out; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (hard to move my head in any direction) and FEELING ABNORMAL (feel like I'm gonna pass out) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEAD DISCOMFORT (hard to move my head in any direction) and FEELING ABNORMAL (feel like I'm gonna pass out). At the time of the report, HEAD DISCOMFORT (hard to move my head in any direction) and FEELING ABNORMAL (feel like I'm gonna pass out) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.   Reporter did not allow further contact
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Pain in extremity, Product dose omission issue
Clinical narrative: twitching  every minute throughout their body, in different places all day long; has not gotten the second dose yet; heavy pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (heavy pain in the arm), MUSCLE TWITCHING (twitching  every minute throughout their body, in different places all day long) and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced PAIN IN EXTREMITY (heavy pain in the arm). On an unknown date, the patient experienced MUSCLE TWITCHING (twitching  every minute throughout their body, in different places all day long) and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet). At the time of the report, PAIN IN EXTREMITY (heavy pain in the arm) and MUSCLE TWITCHING (twitching  every minute throughout their body, in different places all day long) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided.  Treatment information was not provided.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity, Paraesthesia
Clinical narrative: Sore arm; Lower back pain; Jaw nerve sensation; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BACK PAIN (Lower back pain) and PARAESTHESIA (Jaw nerve sensation) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Latex allergy.    On 14-Sep-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 PAIN IN EXTREMITY (Sore arm), BACK PAIN (Lower back pain) and PARAESTHESIA (Jaw nerve sensation). At the time of the report, PAIN IN EXTREMITY (Sore arm) and BACK PAIN (Lower back pain) had resolved and PARAESTHESIA (Jaw nerve sensation) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: have both dosages of the Moderna vaccine, had minimum side effects; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (have both dosages of the Moderna vaccine, had minimum side effects) 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. In 2021, the patient experienced VACCINATION COMPLICATION (have both dosages of the Moderna vaccine, had minimum side effects). At the time of the report, VACCINATION COMPLICATION (have both dosages of the Moderna vaccine, had minimum side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose administered greater than 35 days after 1st dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered greater than 35 days after 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered greater than 35 days after 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose administered greater than 35 days after 1st dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications were not provided by the reporter.    Reporter did not allow further contact
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Hot to the touch entire upper left arm  after first shot; Blotchy entire upper left arm  after first shot; Itching entire upper left arm  after first shot; Swollen entire upper left arm  after first shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch entire upper left arm  after first shot), RASH MACULAR (Blotchy entire upper left arm  after first shot), VACCINATION SITE PRURITUS (Itching entire upper left arm  after first shot) and VACCINATION SITE SWELLING (Swollen entire upper left arm  after first shot) in a 58-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 18-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Aug-2021, the patient experienced VACCINATION SITE WARMTH (Hot to the touch entire upper left arm  after first shot), RASH MACULAR (Blotchy entire upper left arm  after first shot), VACCINATION SITE PRURITUS (Itching entire upper left arm  after first shot) and VACCINATION SITE SWELLING (Swollen entire upper left arm  after first shot). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Injection site reaction, at a dose of 1 dosage form and PARACETAMOL (TYLENOL) for Injection site reaction, at a dose of 1 dosage form. On 29-Aug-2021, VACCINATION SITE WARMTH (Hot to the touch entire upper left arm  after first shot), RASH MACULAR (Blotchy entire upper left arm  after first shot), VACCINATION SITE PRURITUS (Itching entire upper left arm  after first shot) and VACCINATION SITE SWELLING (Swollen entire upper left arm  after first shot) had resolved.            Concomitant medication was not provided. Treatment medication  was not provided .
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach pain; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (diarrhea) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023621A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Aug-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 ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach pain) and DIARRHOEA (diarrhea) had resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-320724 (Patient Link).