chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Vaccination site pain
Clinical narrative: I had a sore injection site left arm and fatigue which lasted for 2 weeks; I had a sore injection site left arm and fatigue which lasted for 2 weeks; joint pain in my legs which lasted for 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I had a sore injection site left arm and fatigue which lasted for 2 weeks), FATIGUE (I had a sore injection site left arm and fatigue which lasted for 2 weeks) and ARTHRALGIA (joint pain in my legs which lasted for 2 weeks) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (I had a sore injection site left arm and fatigue which lasted for 2 weeks), FATIGUE (I had a sore injection site left arm and fatigue which lasted for 2 weeks) and ARTHRALGIA (joint pain in my legs which lasted for 2 weeks). At the time of the report, VACCINATION SITE PAIN (I had a sore injection site left arm and fatigue which lasted for 2 weeks), FATIGUE (I had a sore injection site left arm and fatigue which lasted for 2 weeks) and ARTHRALGIA (joint pain in my legs which lasted for 2 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.  Company Comment: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced, non-serious unlisted event of vaccination pain, fatigue, and arthralgia. The event occurred at an unspecified duration after first dose of Moderna COVID-19 Vaccine. The rechallenge was negative as these events did not recur after second dose of Moderna COVID-19 Vaccine.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-339331 (Patient Link).; Sender's Comments: This case concerns a 37-year-old, female patient with no relevant medical history, who experienced, non-serious unlisted event of vaccination pain, fatigue, and arthralgia. The event occurred at an unspecified duration after first dose of Moderna COVID-19 Vaccine. The rechallenge was negative as these events did not recur after second dose of Moderna COVID-19 Vaccine.  The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Illness, Interchange of vaccine products, Nasopharyngitis
Clinical narrative: Sleepy; Achy; Felt a little bit sick; Got a  J&J vaccine a couple of months ago and then got the Moderna first dose; Tired; Fever of 103°F/temperature dropped to 100°F; Felt they had a cold; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PAIN (Achy), ILLNESS (Felt a little bit sick), NASOPHARYNGITIS (Felt they had a cold) and INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD26 (J&J vaccine a couple of months ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced NASOPHARYNGITIS (Felt they had a cold) and PYREXIA (Fever of 103°F/temperature dropped to 100°F). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), PAIN (Achy), ILLNESS (Felt a little bit sick), INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) on 30-Sep-2021 at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy), PAIN (Achy) and FATIGUE (Tired) had not resolved, ILLNESS (Felt a little bit sick), NASOPHARYNGITIS (Felt they had a cold) and PYREXIA (Fever of 103°F/temperature dropped to 100°F) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 103 deg f 103 Degree F. On 30-Sep-2021, SARS-CoV-2 test: negative (Negative) negative. On 01-Oct-2021, Body temperature: 100 degree f 100 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned since Patient 1(Reporter) was not aware of any medication Patient 2 may be taking regularly. Patient's historical vaccine included J&J vaccine taken a couple of months ago with No indication mentioned.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test, Somnolence
Clinical narrative: Sleepy; Achy; Felt a little bit sick; Got a  J&J vaccine a couple of months ago and then got the Moderna first dose; Tired; Fever of 103°F/temperature dropped to 100°F; Felt they had a cold; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), PAIN (Achy), ILLNESS (Felt a little bit sick), NASOPHARYNGITIS (Felt they had a cold) and INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) in a 23-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD26 (J&J vaccine a couple of months ago).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced NASOPHARYNGITIS (Felt they had a cold) and PYREXIA (Fever of 103°F/temperature dropped to 100°F). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), PAIN (Achy), ILLNESS (Felt a little bit sick), INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) and FATIGUE (Tired). The patient was treated with PARACETAMOL (TYLENOL) on 30-Sep-2021 at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (Sleepy), PAIN (Achy) and FATIGUE (Tired) had not resolved, ILLNESS (Felt a little bit sick), NASOPHARYNGITIS (Felt they had a cold) and PYREXIA (Fever of 103°F/temperature dropped to 100°F) outcome was unknown and INTERCHANGE OF VACCINE PRODUCTS (Got a  J&J vaccine a couple of months ago and then got the Moderna first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 103 deg f 103 Degree F. On 30-Sep-2021, SARS-CoV-2 test: negative (Negative) negative. On 01-Oct-2021, Body temperature: 100 degree f 100 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were mentioned since Patient 1(Reporter) was not aware of any medication Patient 2 may be taking regularly. Patient's historical vaccine included J&J vaccine taken a couple of months ago with No indication mentioned.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: had a heart condition; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (had a heart condition) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CARDIAC DISORDER (had a heart condition) (seriousness criterion hospitalization prolonged). The patient was hospitalized on sometime in June 2021 due to CARDIAC DISORDER. At the time of the report, CARDIAC DISORDER (had a heart condition) outcome was unknown.            Concomitant product usage were not provided. Treatment details were not provided.  Caller stated that her father had a heart condition and was admitted to the hospital in June 2021.  He was later released (exact release date unknown).  The caller stated her father's heart condition had nothing to do with the Moderna vaccine in her opinion.  Company Comment: This case concerns a male subject of unknown age with no medical  history reported, who experienced the unexpected event of cardiac disorder. The event occurred on an unknown date and the patient's second dose of Moderna Covid-19 vaccine was also received on an unknown date. The rechallenge is not applicable since no information was provided of the first dose. The benefit-risk relationship of the vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a male subject of unknown age with no medical  history reported, who experienced the unexpected event of cardiac disorder. The event occurred on an unknown date and the patient's second dose of Moderna Covid-19 vaccine was also received on an unknown date. The rechallenge is not applicable since no information was provided of the first dose. The benefit-risk relationship of the vaccine is not affected by this report.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Muscle twitching, Vaccination site pain
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of feeling abnormal (fingers felt funny), muscle twitching (twitching in face) and vaccination site pain (arm pain wrist to elbow) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Aug 12, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Aug 12, 2021, patient experienced feeling abnormal (fingers felt funny), muscle twitching (twitching in face) and vaccination site pain (arm pain wrist to elbow). At the time of the report, feeling abnormal (fingers felt funny) resolved; muscle twitching (twitching in face) and vaccination site pain (arm pain wrist to elbow) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. After 5 to 10 minutes after the injection, her arm started aching from the elbow to her wrist. Then her two middle fingers started feeling funny and that lasted two days. The evening of Aug 12, 2021 she started having a twitch in her face. No concomitant medication or treatment information provided.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling hot, Vaccination site erythema, Vaccination site mass, Vaccination site pain
Clinical narrative: felt hot; swollen; rush on the injection site; felt sore; redness on the injection site; lump on the injection site/the lump is small.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump on the injection site/the lump is small.), FEELING HOT (felt hot), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (rush on the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014f21a) 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 LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, LORAZEPAM and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced VACCINATION SITE MASS (lump on the injection site/the lump is small.) and VACCINATION SITE ERYTHEMA (redness on the injection site). On 01-Oct-2021, the patient experienced FEELING HOT (felt hot), VACCINATION SITE SWELLING (swollen), VACCINATION SITE RASH (rush on the injection site) and VACCINATION SITE PAIN (felt sore). At the time of the report, VACCINATION SITE MASS (lump on the injection site/the lump is small.), FEELING HOT (felt hot), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE RASH (rush on the injection site) and VACCINATION SITE PAIN (felt sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 97.4 (High) 97.4 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was not received.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: felt hot; swollen; rush on the injection site; felt sore; redness on the injection site; lump on the injection site/the lump is small.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (lump on the injection site/the lump is small.), FEELING HOT (felt hot), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE RASH (rush on the injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014f21a) 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 LEVOTHYROXINE SODIUM (SYNTHROID), LOSARTAN, LORAZEPAM and PARACETAMOL (ACETAMINOPHEN) for an unknown indication.    On 21-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Sep-2021, the patient experienced VACCINATION SITE MASS (lump on the injection site/the lump is small.) and VACCINATION SITE ERYTHEMA (redness on the injection site). On 01-Oct-2021, the patient experienced FEELING HOT (felt hot), VACCINATION SITE SWELLING (swollen), VACCINATION SITE RASH (rush on the injection site) and VACCINATION SITE PAIN (felt sore). At the time of the report, VACCINATION SITE MASS (lump on the injection site/the lump is small.), FEELING HOT (felt hot), VACCINATION SITE ERYTHEMA (redness on the injection site), VACCINATION SITE SWELLING (swollen), VACCINATION SITE RASH (rush on the injection site) and VACCINATION SITE PAIN (felt sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, Body temperature: 97.4 (High) 97.4 degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment was not received.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Cough, Myalgia
Clinical narrative: Coughing; severe muscle pain; Severe Joint pain; This spontaneous case was reported by a patient and describes the occurrence of COUGH (Coughing), MYALGIA (severe muscle pain) and ARTHRALGIA (Severe Joint pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis and Parkinson's disease.   On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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 COUGH (Coughing), MYALGIA (severe muscle pain) and ARTHRALGIA (Severe Joint pain). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at a dose of 1 dosage form. At the time of the report, COUGH (Coughing), MYALGIA (severe muscle pain) and ARTHRALGIA (Severe Joint pain) outcome was unknown.            On 01-AUG-2021 patient received a negative result for lime disease also he had experienced two cerebral aneurisms and post traumatic stress disorder. No concomitant information were reported by the reporter
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039d21a and 039d21a) for COVID-19 vaccination.     No medical history information were reported.  Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), HYDROXYZINE, TAMSULOSIN HYDROCHLORIDE (FLOMAX [TAMSULOSIN HYDROCHLORIDE]), FERROUS SULFATE, PARACETAMOL (TYLENOL) and SUCRALFATE (CARAFATE) for an unknown indication.   On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (received too soon the 2nd dose by mistake/Second dose administered at <21 days after the first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medication use was reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Cough
Clinical narrative: Had experienced coughing like when she did when she had covid; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Had experienced coughing like when she did when she had covid) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In September 2021, the patient experienced COUGH (Had experienced coughing like when she did when she had covid). In September 2021, COUGH (Had experienced coughing like when she did when she had covid) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported. No treatment information was provided.  Patient had COVID back in December 2020 , did cold and flu medications for days and also had lingering effects from it including chest pain which happens randomly. She had an Electrocardiography (ECG), chest X ray (CXR), Computed tomography (CT) scans, and an Echo which was all normal prior to receiving the vaccine.   This case was linked to MOD-2021-339278 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discolouration, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Left arm with slight pinkness; Left arm has been painful at the injection site and continues to be painful even after 9 days; Left arm is itchy; Redness at the injection site; Left arm was swollen at Injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLOURATION (Left arm with slight pinkness), VACCINATION SITE PAIN (Left arm has been painful at the injection site and continues to be painful even after 9 days), VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Left arm was swollen at Injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Sep-2021, the patient experienced VACCINATION SITE DISCOLOURATION (Left arm with slight pinkness), VACCINATION SITE PAIN (Left arm has been painful at the injection site and continues to be painful even after 9 days), VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Left arm was swollen at Injection site). At the time of the report, VACCINATION SITE DISCOLOURATION (Left arm with slight pinkness), VACCINATION SITE PRURITUS (Left arm is itchy), VACCINATION SITE ERYTHEMA (Redness at the injection site) and VACCINATION SITE SWELLING (Left arm was swollen at Injection site) outcome was unknown and VACCINATION SITE PAIN (Left arm has been painful at the injection site and continues to be painful even after 9 days) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling of body temperature change, Headache, Tremor, Vaccination site anaesthesia, Vaccination site lymphadenopathy
Clinical narrative: Upon using left arm, left hand starts shaking; Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers; Hands and feet get hot and cold; Headaches that will not stop; Swollen lymph node under the left arm; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0US1B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm). At the time of the report, TREMOR (Upon using left arm, left hand starts shaking), VACCINATION SITE ANAESTHESIA (Constant numbness in the left arm & 2 fingers/ Degree of numbness goes up and down in the left arm & 2 fingers), FEELING OF BODY TEMPERATURE CHANGE (Hands and feet get hot and cold), HEADACHE (Headaches that will not stop) and VACCINATION SITE LYMPHADENOPATHY (Swollen lymph node under the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided. No treatment information was provided.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site reaction, Vaccination site urticaria
Clinical narrative: Rash where she had injection; Raised hives where she had injection; Rash; This spontaneous case was reported by a physician and describes the occurrence of RASH (Rash), VACCINATION SITE REACTION (Rash where she had injection) and VACCINATION SITE URTICARIA (Raised hives where she had injection) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced RASH (Rash). On 04-Feb-2021, the patient experienced VACCINATION SITE REACTION (Rash where she had injection) and VACCINATION SITE URTICARIA (Raised hives where she had injection). The patient was treated with CORTISONE for Rash, at an unspecified dose and frequency. On 05-Feb-2021, RASH (Rash) and VACCINATION SITE REACTION (Rash where she had injection) had resolved. At the time of the report, VACCINATION SITE URTICARIA (Raised hives where she had injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient reported that, about 3 weeks to 1 month after the first injection she broke out a rash with raised hives where she had the injection. This rash lasted about a day after using cortisone lotion.   This case was linked to MOD-2021-339269 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Events start date, new events and outcome was updated. On 01-Oct-2021: Suspect drug start date was updated.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots; This spontaneous case was reported by a health care professional and describes the occurrence of THROMBOSIS (blood clots) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (blood clots) (seriousness criteria medically significant and life threatening). At the time of the report, THROMBOSIS (blood clots) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient who got their first dose back in April No concomitant medication was reported.  No treatment medication use was reported.  The patient did not experience any other known symptoms, and they are not sure about any treatments given. For their second dose of the vaccine now the provider gave this patient an anticoagulant to take 30 minutes prior to receiving the vaccine to try and prevent further clotting.  This case concerns a female patient (Unknown age) with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred on an unspecified date after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.; Sender's Comments: This case concerns a female patient (Unknown age) with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred on an unspecified date after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. Limited information provided precludes a complete medical and causal assessment of this case. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received an invalid dose of vaccine. Vaccine past it's beyond use date.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that vial of COVID-19 vaccine was punctured on 01 Oct 2021 at 12 Noon. A dose of the vaccine was administered to a patient at 12:25 on 02 Oct 2021. It was reported that the vial was initially stored in the refrigerator on 27 Sep 2021.Date and time vial was first punctured at 12:00 on 01 Oct 2021.Date of administration of vaccine 12:25 on 20 Oct 2021. The vial was stored post puncture under refrigeration. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F) about 2 minutes.  No concomitant medications were reported.  No treatment medications were reported.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction, Chest pain, Cough, Eye swelling, Hypersensitivity
Clinical narrative: Eye swelling; Itching in throat; Adverse drug reaction; Rare allergic reaction; Nausea; Coughing; Severe chest pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), CHEST PAIN (Severe chest pain), EYE SWELLING (Eye swelling), THROAT IRRITATION (Itching in throat) and ADVERSE DRUG REACTION (Adverse drug reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Mid December; Patient had lingering effects from it including chest pain which happened randomly. Patient took cold and flu medications for 6 days.) in December 2020.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced COUGH (Coughing), CHEST PAIN (Severe chest pain), HYPERSENSITIVITY (Rare allergic reaction) and NAUSEA (Nausea). On an unknown date, the patient experienced EYE SWELLING (Eye swelling), THROAT IRRITATION (Itching in throat) and ADVERSE DRUG REACTION (Adverse drug reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Coughing) was resolving, CHEST PAIN (Severe chest pain), ADVERSE DRUG REACTION (Adverse drug reaction), HYPERSENSITIVITY (Rare allergic reaction) and NAUSEA (Nausea) outcome was unknown and EYE SWELLING (Eye swelling) and THROAT IRRITATION (Itching in throat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications also included steroid.  Patient was presented to emergency room and they put in the notes that the cause of her symptoms was an adverse drug reaction.  She had an ECG,CXR, CT scans, and an Echo which was all normal prior to receiving the vaccine and also undergone a stress test before having vaccine. Patient stated that her valves looked perfect.  Mother passed away at 60 from a heart attack.   This case was linked to MOD-2021-339242 (Patient Link).
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test, Throat irritation
Clinical narrative: Eye swelling; Itching in throat; Adverse drug reaction; Rare allergic reaction; Nausea; Coughing; Severe chest pain; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), CHEST PAIN (Severe chest pain), EYE SWELLING (Eye swelling), THROAT IRRITATION (Itching in throat) and ADVERSE DRUG REACTION (Adverse drug reaction) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (Mid December; Patient had lingering effects from it including chest pain which happened randomly. Patient took cold and flu medications for 6 days.) in December 2020.   On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced COUGH (Coughing), CHEST PAIN (Severe chest pain), HYPERSENSITIVITY (Rare allergic reaction) and NAUSEA (Nausea). On an unknown date, the patient experienced EYE SWELLING (Eye swelling), THROAT IRRITATION (Itching in throat) and ADVERSE DRUG REACTION (Adverse drug reaction). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency and PREDNISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Coughing) was resolving, CHEST PAIN (Severe chest pain), ADVERSE DRUG REACTION (Adverse drug reaction), HYPERSENSITIVITY (Rare allergic reaction) and NAUSEA (Nausea) outcome was unknown and EYE SWELLING (Eye swelling) and THROAT IRRITATION (Itching in throat) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, SARS-CoV-2 test: positive (Positive) Positive COVID-19 test.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Treatment medications also included steroid.  Patient was presented to emergency room and they put in the notes that the cause of her symptoms was an adverse drug reaction.  She had an ECG,CXR, CT scans, and an Echo which was all normal prior to receiving the vaccine and also undergone a stress test before having vaccine. Patient stated that her valves looked perfect.  Mother passed away at 60 from a heart attack.   This case was linked to MOD-2021-339242 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: felt a little achy; tired; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (felt a little achy) and FATIGUE (tired) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (felt a little achy) and FATIGUE (tired). The patient was treated with PARACETAMOL (TYLENOL) for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, MYALGIA (felt a little achy) and FATIGUE (tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. Patient stated that after receiving the first 2 doses of the vaccine she felt a little achy and tired but that was about it.    This case was linked to MOD-2021-339316, MOD-2021-339317 (Patient Link).
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were provided. No treatment information was provided.   This case was linked to MOD-2021-339324 (Patient Link).
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD since July 1968. Concomitant products included TIMOLOL for Glaucoma.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site). At the time of the report, VACCINATION SITE PAIN (After 2nd shot left shoulder started aching again and it's still aching/Chronic pain injection site) had not resolved.            No relevant concomitant medications were reported. No treatment information was provided.   This case was linked to MOD-2021-339287 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up information received on 05-OCT-2021 included patient's medical history, concomitant medication and updated patient details.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Haematopoietic neoplasm
Clinical narrative: Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer; This spontaneous case was reported by a consumer and describes the occurrence of HAEMATOPOIETIC NEOPLASM (Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 028A20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (The patient stated that she has been cancer free for last 10 years). Concurrent medical conditions included Ear feels clogged, Allergy, Blood pressure abnormal and Hearing impaired.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HAEMATOPOIETIC NEOPLASM (Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer) (seriousness criteria medically significant and life threatening). At the time of the report, HAEMATOPOIETIC NEOPLASM (Diagnosis for bone marrow cancer/ Cancer came back/ Bone marrow cancer) outcome was unknown.            Concomitant medications include blood pressure medications.   Treatment medication include bone marrow medication.  The caller was a patient who stated that she was calling in reference to the 3rd shot that was coming out but decided to mention in the call that she had clogging in the ears due to allergy and had problems hearing due to the allergy. The patient stated that she had been cancer free for last 10 years but did had a latest diagnosis for bone marrow cancer in the summer when she went for her yearly checkup. The patient stated that when the cancer came back and the doctor started treatment immediately. The bone marrow cancer was negative during the last ten years, but the doctor saw cells and the patient went into treatment so that the cancer did not go further. The patient stated that she had one treatment and had 4 more treatments to go.  Company comment: This case concerns a 79-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of hematopoietic neoplasm. The event occurred after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since limited information is provided. Elderly age of patient remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 79-year-old, female patient with no previous relevant medical history, who experienced the unexpected event of hematopoietic neoplasm. The event occurred after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since limited information is provided. Elderly age of patient remains a confounder.  The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Inflammation, Pruritus, Rash, Rash macular
Clinical narrative: Entire torso was inflamed; Still has rash; Entire torso turned bright red; Entire torso blotchy; Had itching but no rash/entire torso itchy/still has a lot of itching; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Entire torso turned bright red), RASH MACULAR (Entire torso blotchy), INFLAMMATION (Entire torso was inflamed), PRURITUS (Had itching but no rash/entire torso itchy/still has a lot of itching) and RASH (Still has rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRURITUS (Had itching but no rash/entire torso itchy/still has a lot of itching). On 26-Sep-2021, the patient experienced ERYTHEMA (Entire torso turned bright red) and RASH MACULAR (Entire torso blotchy). On an unknown date, the patient experienced INFLAMMATION (Entire torso was inflamed) and RASH (Still has rash). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency; METHYLPREDNISOLONE SODIUM SUCCINATE (SOLUMEDROL) for Adverse event, at a dose of 125 mg and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, ERYTHEMA (Entire torso turned bright red), RASH MACULAR (Entire torso blotchy) and INFLAMMATION (Entire torso was inflamed) was resolving and PRURITUS (Had itching but no rash/entire torso itchy/still has a lot of itching) and RASH (Still has rash) had not resolved.            No concomitant medication was reported by the reporter.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Myalgia, Nausea
Clinical narrative: Regular aches and pains; Nausea; Stomach issues; Diarrhea and stuff like that; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea and stuff like that), MYALGIA (Regular aches and pains) and NAUSEA (Nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea and stuff like that) and NAUSEA (Nausea). On an unknown date, the patient experienced MYALGIA (Regular aches and pains). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (Stomach issues), DIARRHOEA (Diarrhea and stuff like that), MYALGIA (Regular aches and pains) and NAUSEA (Nausea) had not resolved.            No concomitant medication was mentioned.   This case was linked to MOD-2021-339316, MOD-2021-339288 (Patient Link).