chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Heavy menstrual bleeding, Menstruation irregular, Muscle spasms
Clinical narrative: Headache; Fatigue / Tiredness; nausea; feet cramp; no longer get periods since before 2021; The period lasted 09May2021 to 17May2021; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0173), via an unspecified route of administration in left arm on 29Apr2021 at 13:15 (age at vaccination 49-years-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history was none and not had any known allergies. Concomitant medication(s) included acetylsalicylic acid (ASPRIN) child asprin, cetirizine hydrochloride (ZYRTEC ALLERGY), caffeine, paracetamol (EXCEDRIN ASPIRIN FREE) and diphenhydramine hydrochloride, paracetamol (TYLENOL PM). Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 09May2021, patient had a period lasted from 09May2021 to 17May2021. It was reported that the patient did not have a period since December 2020 and was always two days, and no longer get periods since before 2021 and have had twice blood flow, and on 10May2021, patient experienced headache, fatigue or tiredness, nausea, and feet cramp. Nausea and tiredness have kept patient away from being able to do my usual workout or other activities. There was no redness/swelling, muscle pain/pain, chills/fever. Patient had a doctor or other healthcare professional office/clinic visit because of event period lasted from 09May2021 to 17May2021. The doctor scheduled an ultrasound but not until 21Jun2021. Patient had received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0187), via an unspecified route of administration, administered in left arm on 24May2021 at 13:15 as dose 2, single for COVID-19 immunization. Patient did not receive any treatment for the events headache, fatigue / tiredness, nausea and feet cramp and it was unknown if received treatment for event period lasted from 09May2021 to 17May2021. Since the vaccination, the patient had not been tested for Covid-19. The outcome of event period lasted from 09May2021 to 17May2021 was unknown, while all the other events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dizziness, Feeling abnormal, Hypoacusis, Magnetic resonance imaging
Clinical narrative: Dizziness, tinnitus, brain fog, speech diffiulty
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: Dizziness, tinnitus, brain fog, speech diffiulty
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling abnormal, Speech disorder, Tinnitus
Clinical narrative: Dizziness, tinnitus, brain fog, speech diffiulty
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Chest discomfort, Dyspnoea, Electrocardiogram, Electrocardiogram abnormal
Clinical narrative: Patient was triaged to ED room and evaluated by me. She arrives appearing uncomfortable and overtly hyperventilating, was offered Valium 2.5 mg given the cramping and overt anxiety.  EKG obtained and patient monitored closely. Had c/o increased itching without rash present on re-exam by me, given benadryl 25 and second dose of Valium 2.5 mg, lungs remain clear.  She had definite improvement, was falling asleep on re-exam.    She feels reluctant to consider the second vaccination and potential reaction so we talked extensively about the staff's experience here at the ER, real side effects but short lived. Advised that there are active covid cases including at this small hospital today and yesterday, risks of covid much higher than vaccination given her history.  Advised symptoms will resolve with time. Provided take home pack Valium, continue tylenol, rest
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperventilation, Muscle spasms, Muscular weakness, Myalgia, Paraesthesia
Clinical narrative: Patient was triaged to ED room and evaluated by me. She arrives appearing uncomfortable and overtly hyperventilating, was offered Valium 2.5 mg given the cramping and overt anxiety.  EKG obtained and patient monitored closely. Had c/o increased itching without rash present on re-exam by me, given benadryl 25 and second dose of Valium 2.5 mg, lungs remain clear.  She had definite improvement, was falling asleep on re-exam.    She feels reluctant to consider the second vaccination and potential reaction so we talked extensively about the staff's experience here at the ER, real side effects but short lived. Advised that there are active covid cases including at this small hospital today and yesterday, risks of covid much higher than vaccination given her history.  Advised symptoms will resolve with time. Provided take home pack Valium, continue tylenol, rest
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Patient was triaged to ED room and evaluated by me. She arrives appearing uncomfortable and overtly hyperventilating, was offered Valium 2.5 mg given the cramping and overt anxiety.  EKG obtained and patient monitored closely. Had c/o increased itching without rash present on re-exam by me, given benadryl 25 and second dose of Valium 2.5 mg, lungs remain clear.  She had definite improvement, was falling asleep on re-exam.    She feels reluctant to consider the second vaccination and potential reaction so we talked extensively about the staff's experience here at the ER, real side effects but short lived. Advised that there are active covid cases including at this small hospital today and yesterday, risks of covid much higher than vaccination given her history.  Advised symptoms will resolve with time. Provided take home pack Valium, continue tylenol, rest
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Discomfort, Electrocardiogram, Hyperventilation, Muscle spasms
Clinical narrative: Patient was triaged to ED room and evaluated by me. She arrives appearing uncomfortable and overtly hyperventilating, was offered Valium 2.5 mg given the cramping and overt anxiety.  EKG obtained and patient monitored closely. Had c/o increased itching without rash present on re-exam by me, given benadryl 25 and second dose of Valium 2.5 mg, lungs remain clear.  She had definite improvement, was falling asleep on re-exam.    She feels reluctant to consider the second vaccination and potential reaction so we talked extensively about the staff's experience here at the ER, real side effects but short lived. Advised that there are active covid cases including at this small hospital today and yesterday, risks of covid much higher than vaccination given her history.  Advised symptoms will resolve with time. Provided take home pack Valium, continue tylenol, rest
Age: 48.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Somnolence
Clinical narrative: Patient was triaged to ED room and evaluated by me. She arrives appearing uncomfortable and overtly hyperventilating, was offered Valium 2.5 mg given the cramping and overt anxiety.  EKG obtained and patient monitored closely. Had c/o increased itching without rash present on re-exam by me, given benadryl 25 and second dose of Valium 2.5 mg, lungs remain clear.  She had definite improvement, was falling asleep on re-exam.    She feels reluctant to consider the second vaccination and potential reaction so we talked extensively about the staff's experience here at the ER, real side effects but short lived. Advised that there are active covid cases including at this small hospital today and yesterday, risks of covid much higher than vaccination given her history.  Advised symptoms will resolve with time. Provided take home pack Valium, continue tylenol, rest
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature decreased, Chills, Decreased appetite, Fatigue, Headache
Clinical narrative: With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had severe tremors that lasted over 3 hours; Headache; Arm pain; Swelling; Muscle ache; Fatigue; Depressed appetite; Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533), via an unspecified route of administration on right arm on 21May2021 01:30 PM (age at vaccination: 49 years) as dose2, single for COVID-19 immunization at hospital. The patient medical history included Known allergies to Bandage adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Multi-Vitamin. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6704), via an unspecified route of administration on Right arm on 30Apr2021 01:15 PM (at the age of 49 years) as dose 1, single for COVID-19 immunization. On 22May2021 12:15 AM, the patient experienced chills symptom she had severe tremors that lasted over 3 hours. she also had headache, arm pain and swelling, muscle ache, fatigue, and depressed appetite. In addition she had a low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received. Since the vaccination, the patient has not been tested for COVID-19. The lab tests included test: Low body temperature, result: 97.7-97 (Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received) on 22May2021. It was reported that the awareness date 22May2021 is the same date that she began experiencing the symptoms. Due to the fatigue and feeling unwell she was not able to actually file the report until Sunday, 23May2021, but she did experienced the symptoms the previous day, Saturday, 22May2021. The patient did not receive any treatment for the events. The outcome of the events chills, tremors was recovered on 22May2021, while other events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Myalgia, Pain in extremity, Tremor
Clinical narrative: With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had severe tremors that lasted over 3 hours; Headache; Arm pain; Swelling; Muscle ache; Fatigue; Depressed appetite; Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533), via an unspecified route of administration on right arm on 21May2021 01:30 PM (age at vaccination: 49 years) as dose2, single for COVID-19 immunization at hospital. The patient medical history included Known allergies to Bandage adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Multi-Vitamin. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6704), via an unspecified route of administration on Right arm on 30Apr2021 01:15 PM (at the age of 49 years) as dose 1, single for COVID-19 immunization. On 22May2021 12:15 AM, the patient experienced chills symptom she had severe tremors that lasted over 3 hours. she also had headache, arm pain and swelling, muscle ache, fatigue, and depressed appetite. In addition she had a low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received. Since the vaccination, the patient has not been tested for COVID-19. The lab tests included test: Low body temperature, result: 97.7-97 (Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received) on 22May2021. It was reported that the awareness date 22May2021 is the same date that she began experiencing the symptoms. Due to the fatigue and feeling unwell she was not able to actually file the report until Sunday, 23May2021, but she did experienced the symptoms the previous day, Saturday, 22May2021. The patient did not receive any treatment for the events. The outcome of the events chills, tremors was recovered on 22May2021, while other events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Body temperature decreased, Chills, Decreased appetite, Fatigue
Clinical narrative: With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had severe tremors that lasted over 3 hours; Headache; Arm pain; Swelling; Muscle ache; Fatigue; Depressed appetite; Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533), via an unspecified route of administration on right arm on 21May2021 01:30 PM (age at vaccination: 49 years) as dose2, single for COVID-19 immunization at hospital. The patient medical history included Known allergies to Bandage adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Multi-Vitamin. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6704), via an unspecified route of administration on Right arm on 30Apr2021 01:15 PM (at the age of 49 years) as dose 1, single for COVID-19 immunization. On 22May2021 12:15 AM, the patient experienced chills symptom she had severe tremors that lasted over 3 hours. she also had headache, arm pain and swelling, muscle ache, fatigue, and depressed appetite. In addition she had a low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received. Since the vaccination, the patient has not been tested for COVID-19. The lab tests included test: Low body temperature, result: 97.7-97 (Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received) on 22May2021. It was reported that the awareness date 22May2021 is the same date that she began experiencing the symptoms. Due to the fatigue and feeling unwell she was not able to actually file the report until Sunday, 23May2021, but she did experienced the symptoms the previous day, Saturday, 22May2021. The patient did not receive any treatment for the events. The outcome of the events chills, tremors was recovered on 22May2021, while other events was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Myalgia, Pain in extremity, Swelling, Tremor
Clinical narrative: With the chills symptom I had severe tremors that lasted over 3 hours; With the chills symptom I had severe tremors that lasted over 3 hours; Headache; Arm pain; Swelling; Muscle ache; Fatigue; Depressed appetite; Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received.; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient (non-pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EP7533), via an unspecified route of administration on right arm on 21May2021 01:30 PM (age at vaccination: 49 years) as dose2, single for COVID-19 immunization at hospital. The patient medical history included Known allergies to Bandage adhesive. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient Concomitant medications within 2 weeks of vaccination included Multi-Vitamin. The patient previously received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6704), via an unspecified route of administration on Right arm on 30Apr2021 01:15 PM (at the age of 49 years) as dose 1, single for COVID-19 immunization. On 22May2021 12:15 AM, the patient experienced chills symptom she had severe tremors that lasted over 3 hours. she also had headache, arm pain and swelling, muscle ache, fatigue, and depressed appetite. In addition she had a low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received. Since the vaccination, the patient has not been tested for COVID-19. The lab tests included test: Low body temperature, result: 97.7-97 (Low body temperature ranging from 97.7 to the lowest at 97.0 within the 24 hours after the vaccine was received) on 22May2021. It was reported that the awareness date 22May2021 is the same date that she began experiencing the symptoms. Due to the fatigue and feeling unwell she was not able to actually file the report until Sunday, 23May2021, but she did experienced the symptoms the previous day, Saturday, 22May2021. The patient did not receive any treatment for the events. The outcome of the events chills, tremors was recovered on 22May2021, while other events was recovering.
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Fatigue, Headache, Myalgia
Clinical narrative: CHEST PAIN; FEVER; LETHARGIC; ARM SORENESS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to weeds, allergic to grass, allergic to dust, allergic to pollen, allergic to dairy products, asthma, high blood pressure, type 2 diabetes, and alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included olmesartan medoxomil. On 21-MAY-2021, the patient experienced lethargic and arm soreness. On 22-MAY-2021, the patient experienced fever. On 14-JUN-2021, the patient experienced chest pain, and was hospitalized for 1 day. Patient experienced some side effects. He did some medical tests and it all came back negative. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 23-MAY-2021, and had not recovered from arm soreness, lethargic, and chest pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210748476-Covid-19 vaccine ad26.cov2.s - CHEST PAIN . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: CHEST PAIN; FEVER; LETHARGIC; ARM SORENESS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to weeds, allergic to grass, allergic to dust, allergic to pollen, allergic to dairy products, asthma, high blood pressure, type 2 diabetes, and alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included olmesartan medoxomil. On 21-MAY-2021, the patient experienced lethargic and arm soreness. On 22-MAY-2021, the patient experienced fever. On 14-JUN-2021, the patient experienced chest pain, and was hospitalized for 1 day. Patient experienced some side effects. He did some medical tests and it all came back negative. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 23-MAY-2021, and had not recovered from arm soreness, lethargic, and chest pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210748476-Covid-19 vaccine ad26.cov2.s - CHEST PAIN . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 55.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Laboratory test, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: CHEST PAIN; FEVER; LETHARGIC; ARM SORENESS; This spontaneous report received from a patient concerned a 55 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included allergic to weeds, allergic to grass, allergic to dust, allergic to pollen, allergic to dairy products, asthma, high blood pressure, type 2 diabetes, and alcoholic, and other pre-existing medical conditions included no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, expiry: UNKNOWN) dose was not reported, 1 total administered at left arm on 21-MAY-2021 for prophylactic vaccination. Concomitant medications included olmesartan medoxomil. On 21-MAY-2021, the patient experienced lethargic and arm soreness. On 22-MAY-2021, the patient experienced fever. On 14-JUN-2021, the patient experienced chest pain, and was hospitalized for 1 day. Patient experienced some side effects. He did some medical tests and it all came back negative. Laboratory data (dates unspecified) included: Lab test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 23-MAY-2021, and had not recovered from arm soreness, lethargic, and chest pain. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0-20210748476-Covid-19 vaccine ad26.cov2.s - CHEST PAIN . This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Electrocardiogram, Myocarditis
Clinical narrative: Myopercardis; heavy tightness in chest; maybe difficulty breathing; weak; chest pain; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Myopercardis) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired). On an unknown date, the patient experienced PERICARDITIS (Myopercardis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Myopercardis), CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Electrocardiogram: inconclusive (abnormal) inconclusive.         No treatment information was reported. No concomitant medications were reported.  On 24 May 2021, the reporter stated the patient's father noticed the patient had chest tightness and maybe a difficulty breathing, was weak and tired. The patient's father took the patient to the hospital. The patient was diagnosed with myopericarditis and was being followed by a cardiologist.  Company Comment: This is a  21-year-old male patient with pericarditis and myocarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 26-JUL-2021 contains significant information new event  Myopercardis is updated.; Sender's Comments: This is a  21-year-old male patient with pericarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Electrocardiogram ST segment elevation, Myocarditis, Troponin
Clinical narrative: Myopercardis; heavy tightness in chest; maybe difficulty breathing; weak; chest pain; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Myopercardis) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired). On an unknown date, the patient experienced PERICARDITIS (Myopercardis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Myopercardis), CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Electrocardiogram: inconclusive (abnormal) inconclusive.         No treatment information was reported. No concomitant medications were reported.  On 24 May 2021, the reporter stated the patient's father noticed the patient had chest tightness and maybe a difficulty breathing, was weak and tired. The patient's father took the patient to the hospital. The patient was diagnosed with myopericarditis and was being followed by a cardiologist.  Company Comment: This is a  21-year-old male patient with pericarditis and myocarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 26-JUL-2021 contains significant information new event  Myopercardis is updated.; Sender's Comments: This is a  21-year-old male patient with pericarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Chest pain, Dyspnoea, Electrocardiogram
Clinical narrative: Myopercardis; heavy tightness in chest; maybe difficulty breathing; weak; chest pain; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Myopercardis) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired). On an unknown date, the patient experienced PERICARDITIS (Myopercardis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Myopercardis), CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Electrocardiogram: inconclusive (abnormal) inconclusive.         No treatment information was reported. No concomitant medications were reported.  On 24 May 2021, the reporter stated the patient's father noticed the patient had chest tightness and maybe a difficulty breathing, was weak and tired. The patient's father took the patient to the hospital. The patient was diagnosed with myopericarditis and was being followed by a cardiologist.  Company Comment: This is a  21-year-old male patient with pericarditis and myocarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 26-JUL-2021 contains significant information new event  Myopercardis is updated.; Sender's Comments: This is a  21-year-old male patient with pericarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 21.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pericarditis
Clinical narrative: Myopercardis; heavy tightness in chest; maybe difficulty breathing; weak; chest pain; tired; This spontaneous case was reported by a consumer and describes the occurrence of PERICARDITIS (Myopercardis) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 22-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired). On an unknown date, the patient experienced PERICARDITIS (Myopercardis) (seriousness criterion medically significant). At the time of the report, PERICARDITIS (Myopercardis), CHEST DISCOMFORT (heavy tightness in chest), DYSPNOEA (maybe difficulty breathing), ASTHENIA (weak), CHEST PAIN (chest pain) and FATIGUE (tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-May-2021, Electrocardiogram: inconclusive (abnormal) inconclusive.         No treatment information was reported. No concomitant medications were reported.  On 24 May 2021, the reporter stated the patient's father noticed the patient had chest tightness and maybe a difficulty breathing, was weak and tired. The patient's father took the patient to the hospital. The patient was diagnosed with myopericarditis and was being followed by a cardiologist.  Company Comment: This is a  21-year-old male patient with pericarditis and myocarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2021: Follow-up information received on 26-JUL-2021 contains significant information new event  Myopercardis is updated.; Sender's Comments: This is a  21-year-old male patient with pericarditis among other events after receiving mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abulia, Asthenia, Blood test, Dysstasia, Electrocardiogram
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fall, Hypoaesthesia, Joint adhesion, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Slow response to stimuli, Speech disorder, Visual impairment
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Angiocardiogram, Blood creatine phosphokinase, Blood test, Cerebrovascular accident, Computerised tomogram thorax
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Fatigue, Fine motor skill dysfunction, Headache, Hemiplegia
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Impaired driving ability, Impaired work ability, Magnetic resonance imaging head, Magnetic resonance imaging neck, Muscular weakness
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Perfusion brain scan, Scan with contrast, Thrombosis, Troponin I, Unemployment
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Visual impairment
Clinical narrative: Patient suffered 1st stroke the very next day (4/11/2021) with left body paralysis. 2nd stroke occurred after a month on 5/11/2021 due to blood clot.  Patient still suffer with vision, fine motor skills, Left hand weakness ,headaches and fatigue. Patient is not able to work ,currently unemployed and has been advised by doctors to not drive.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Intermenstrual bleeding, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Last normal period was August 2018, so assumed at 56 (nearly 57) I was post-menopausal after having no period for over 2, nearly 3 years.; Discovered (pseudo-period) blood spot.Continued spotting, with heavier spotting Monday afternoon/afternoon evening.; Fever; Nausea; Achiness; Sore arm; This is a spontaneous report from a contactable consumer (patient).A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0172) via an unspecified route of administration in left arm on 28May2021 at 15:45 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included high-blood pressure and multiple sclerosis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination included metoprolol succinate (Toprol XL 50 MG), amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (Juice Plus) and cholecalciferol (D-3 5000 IU), Flax See. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to honeydew. Patient previously took Tylenol, penicillin, sulfa-based medications and experienced allergy.On 30May2021, patient experienced fever, nausea, achiness and sore arm on Saturday and Sunday. On 30May2021 (Sunday), in the evening patient discovered (pseudo-period) blood spot, continued spotting, with heavier spotting on Monday afternoon/afternoon evening. Last normal period was Aug2018, so assumed at 56 (nearly 57) patient was post-menopausal after having no period for over 2, nearly 3 years. Patient did not receive any treatment in response to the events. The patient was recovering from all events.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Pain, Pain in extremity, Postmenopausal haemorrhage, Pyrexia
Clinical narrative: Last normal period was August 2018, so assumed at 56 (nearly 57) I was post-menopausal after having no period for over 2, nearly 3 years.; Discovered (pseudo-period) blood spot.Continued spotting, with heavier spotting Monday afternoon/afternoon evening.; Fever; Nausea; Achiness; Sore arm; This is a spontaneous report from a contactable consumer (patient).A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0172) via an unspecified route of administration in left arm on 28May2021 at 15:45 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included high-blood pressure and multiple sclerosis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination included metoprolol succinate (Toprol XL 50 MG), amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (Juice Plus) and cholecalciferol (D-3 5000 IU), Flax See. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to honeydew. Patient previously took Tylenol, penicillin, sulfa-based medications and experienced allergy.On 30May2021, patient experienced fever, nausea, achiness and sore arm on Saturday and Sunday. On 30May2021 (Sunday), in the evening patient discovered (pseudo-period) blood spot, continued spotting, with heavier spotting on Monday afternoon/afternoon evening. Last normal period was Aug2018, so assumed at 56 (nearly 57) patient was post-menopausal after having no period for over 2, nearly 3 years. Patient did not receive any treatment in response to the events. The patient was recovering from all events.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: Last normal period was August 2018, so assumed at 56 (nearly 57) I was post-menopausal after having no period for over 2, nearly 3 years.; Discovered (pseudo-period) blood spot.Continued spotting, with heavier spotting Monday afternoon/afternoon evening.; Fever; Nausea; Achiness; Sore arm; This is a spontaneous report from a contactable consumer (patient).A 56-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection; Batch/lot number: EW0172) via an unspecified route of administration in left arm on 28May2021 at 15:45 (at the age of 56-year-old) as dose 1, single for COVID-19 immunization at Pharmacy or Drug Store. Medical history of the patient included high-blood pressure and multiple sclerosis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications that the patient received within 2 weeks of vaccination included metoprolol succinate (Toprol XL 50 MG), amylase, ascorbic acid, cellulase, folic acid, lipase, protease nos (Juice Plus) and cholecalciferol (D-3 5000 IU), Flax See. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient was allergic to honeydew. Patient previously took Tylenol, penicillin, sulfa-based medications and experienced allergy.On 30May2021, patient experienced fever, nausea, achiness and sore arm on Saturday and Sunday. On 30May2021 (Sunday), in the evening patient discovered (pseudo-period) blood spot, continued spotting, with heavier spotting on Monday afternoon/afternoon evening. Last normal period was Aug2018, so assumed at 56 (nearly 57) patient was post-menopausal after having no period for over 2, nearly 3 years. Patient did not receive any treatment in response to the events. The patient was recovering from all events.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: UNK, UNK, COVID19
Symptoms: Blood test, Muscle spasms, Pain in extremity, Sleep disorder
Clinical narrative: felt leg pain then disappeared day after/feel leg soreness; woke up 2-3 times per night; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021 afternoon, after the first dose, the patient felt leg pain then disappeared day after. Couple days after, the patient started to feel leg soreness during nights and woke up 2-3 times per night. The patient went to check with doctor. The patient underwent lab tests and procedures which included all blood test: normal (everything was great) on an unspecified date in 2021. The leg pain continues. On 13Jul2021, the patient watched nightly news and noticed new side effects which was exactly same as the patient feeling. The outcome for the event leg pain was not recovered while it was unknown for woke up 2-3 times per night.  Information about batch/lot number has been requested.
Sex: U
Vaccine: UNK, UNK, COVID19
Symptoms: Blood test, Middle insomnia, Pain in extremity
Clinical narrative: felt leg pain then disappeared day after/feel leg soreness; woke up 2-3 times per night; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported), via an unspecified route of administration on 09Apr2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 09Apr2021 afternoon, after the first dose, the patient felt leg pain then disappeared day after. Couple days after, the patient started to feel leg soreness during nights and woke up 2-3 times per night. The patient went to check with doctor. The patient underwent lab tests and procedures which included all blood test: normal (everything was great) on an unspecified date in 2021. The leg pain continues. On 13Jul2021, the patient watched nightly news and noticed new side effects which was exactly same as the patient feeling. The outcome for the event leg pain was not recovered while it was unknown for woke up 2-3 times per night.  Information about batch/lot number has been requested.