chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain, Syncope
Clinical narrative: FELT INCOHERENT; SHINGLES RASH; COLLAPSED DUE TO DIZZINESS, COULDN'T STAY UP; BODY ACHE; SORE THROAT; MUSCLE ACHE; FATIGUE; HEADACHE; This spontaneous report received from a patient concerned an 86 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included steroid allergy, shellfish allergy, and allergic to x ray dyes. The patient received JNJ78436735 (Ad26.COV2.S) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 09:30 to left deltoid for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced fatigue and headache. On 14-MAR-2021, the patient experienced body ache, sore throat, muscle ache and collapsed due to dizziness as couldn't stay up. On 16-MAR-2021, the patient experienced shingles rash. On an unspecified date, the patient felt incoherent. The action taken with JNJ78436735 (Ad26.COV2.S) was not applicable. The patient had not recovered from fatigue, sore throat, headache, muscle ache, shingles rash, collapsed due to dizziness, couldn't stay up, and body ache whereas the outcome of felt incoherent was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210332591-Covid-19 Vaccine AD26.COV2.S-collapsed due to dizziness, couldn't stay up. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal
Clinical narrative: ABNORMAL HIGH BLOOD SUGAR / HIS BLOOD SUGAR WENT TO 469; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included covid-19, and concurrent conditions included diabetes, heart disease, and COPD (chronic obstructive pulmonary disease).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, administered on left arm on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the patient had abnormal high blood sugar, his blood sugar went to 469 (unit not specified).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abnormal high blood sugar / his blood sugar went to 469. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332893-COVID-19 VACCINE AD26.COV2.s-abnormal high blood sugar. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY, UNDERLYING DISEASE.
Sex: F
Vaccine: COVID19
Symptoms: Blindness, Cerebrovascular accident
Clinical narrative: BLIND; STROKE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose and therapy start date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date in MAR-2021 (reported as last week), the patient had a stroke and made her blind. There was no other information known about the patient or vaccine administration site. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blind and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333599- Covid-19 vaccine ad26.cov2.s-Blind, Stroke. 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).
Sex: F
Vaccine: COVID19
Symptoms: Culture urine, Escherichia urinary tract infection
Clinical narrative: E. COLI URINARY TRACT INFECTION; This spontaneous report received from a pharmacist concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included urinary tract infection with urinary urgency, and urinary burning.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown expiry: UNKNOWN) dose was not reported, administered on 14-MAR-2021 for prophylactic vaccination. Batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the subject experienced E. coli urinary tract infection with urinary urgency, and urinary burning. Patient prescribed Monurol to treat urinary tract infection, and her provider was concerned about interactions between Monurol and the vaccine. Per the pharmacist (reporter), the patient had been "fighting" this UTI for "awhile now" Laboratory data (dates unspecified) included: Urine culture (NR: not provided) Positive for E. Coli. Treatment medications (dates unspecified) included: fosfomycin trometamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from urinary tract infection. This report was serious (Other Medically Important Condition).       .; Sender's Comments: V0.20210333629-COVID-19 VACCINE AD26.COV2.S-E.Coli urinary tract infection. This event(s) is considered not related. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G decreased, Dizziness, Fatigue, Loss of consciousness
Clinical narrative: BLACKOUTS; DIZZINESS; FATIGUE; This spontaneous report received from a consumer concerned a 79 year old female. The patient's height, and weight were not reported. The patient's medical history included autoimmune disorder, and penicillin allergy. The patient experienced drug allergy when treated with azithromycin.  The patient received COVID-19 VACCINE AD26.COV2.S (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: UNKNOWN) dose was not reported, administered on 10-MAR-2021 14:30 hours for prophylactic vaccination.  No concomitant medications were reported.  On 15-MAR-2021, the subject experienced blackouts, dizziness and fatigue.  Laboratory data (dates unspecified) included: IgG decreased (NR: not provided) unknown. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient was recovering from blackouts, and had not recovered from dizziness, and fatigue. The reporter causality between COVID-19 VACCINE AD26.COV2.S and blackouts, Dizziness and Fatigue was related. The company causality between COVID-19 VACCINE AD26.COV2.S and blackouts, Dizziness and Fatigue was possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210333795-covid-19 vaccine ad26.cov2.s-Loss of consciousness. This event is considered unassessable. The event 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.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Oxygen saturation decreased, SARS-CoV-2 test
Clinical narrative: CONFIRMED COVID-19 INFECTION; DECREASED OXYGENATION; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On MAR-2021, the patient experienced confirmed Covid-19 infection. On MAR-2021, the patient experienced decreased oxygenation. On 11-MAR-2021, Laboratory data included: COVID-19 virus test (NR: not provided) Positive. The patient started exhibiting Covid-19 symptoms decreased appetite, shivers, sweats and muscle aches. On Thursday 3/11/2021 father in law was taken to emergency room and was admitted, tested positive to Covid-19 on /March/2021. Since then father in law was discharged, but had to be readmitted some time later due to decreased oxygenation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed covid-19 infection and decreased oxygenation was not reported. This report was serious (Hospitalization Caused / Prolonged). The case is associated with a product quality complaint number: 90000173361 This case is a duplicate of 20210335533.; Sender's Comments: V0: 20210334839-Covid-19 vaccine ad26.cov2.s-Covid-19 infection. This event is considered not related. The event is deemed to be scientifically implausible, i.e., there is scientific evidence against a drug/event relationship; AND there is no known class effect. 20210334839-Covid-19 vaccine ad26.cov2.s-decreased oxygenation. This event is considered unassessable. The event 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.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: ANAPHYLAXIS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included no known 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: UNKNOWN expiry date: UNKNOWN) dose, 1 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had anaphylaxis post vaccination. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of anaphylaxis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210335633-Covid-19 vaccine ad26.cov2.s-Anaphylaxis. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s).
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Hallucination
Clinical narrative: POSSIBLE HALLUCINATION; This spontaneous report received from a consumer concerned an 87 year old male. The patient's weight, height, and medical history were not reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 19-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported. It was reported that the patient had his Janssen Covid-19 vaccination on 19-MAR-2021 and on 20-MAR-2021, the patient experienced possible hallucination and patient's son will be going to their house to investigate. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from possible hallucination. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210340686-COVID-19 VACCINE AD26.COV2.S-hallucination. This event is considered unassessable. The event 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.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea at rest, Fatigue, Feeling of body temperature change, Heart rate abnormal, Hyperhidrosis
Clinical narrative: SHORTNESS OF BREATH WHEN SITTING; HEART RACING; BLURRY VISION; DIFFICULTY SLEEPY; BODY ACHES; FELT LIKE FEVER BUT WASN'T; TIRED; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced heart racing, blurry vision, difficulty sleepy, body aches, felt like fever but was not, tired, sweating. Laboratory data included: Heart rate abnormal (NR: not provided) 130. On 18-MAR-2021, the patient experienced shortness of breath when sitting. It was reported that around 03:00 am heart racing, shortness of breath, body aches, tried to take blood pressure unable to obtain reading, reported that when able to take blood pressure, pulse around 130, being sweaty, thought had a fever but did not after checking her temperature felt like she was going into a-fib, reported blurry vision reports still having some of that but a little better. It was reported that her heart was not racing as much. At the time of reporting patient had slight shortness of breath and given herself a breathing treatment and doing breathing exercises felt better but when sitting or walking around and not doing treatments the shortness of breath returned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty sleepy, shortness of breath when sitting, tired, heart racing, body aches, felt like fever but was not, blurry vision and sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210340845-Covid-19 vaccine ad26.cov2.s-Shortness of breath. 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).
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Pain, Palpitations, Vision blurred
Clinical narrative: SHORTNESS OF BREATH WHEN SITTING; HEART RACING; BLURRY VISION; DIFFICULTY SLEEPY; BODY ACHES; FELT LIKE FEVER BUT WASN'T; TIRED; SWEATING; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802068, and batch number: 1802068 expiry: unknown) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, the patient experienced heart racing, blurry vision, difficulty sleepy, body aches, felt like fever but was not, tired, sweating. Laboratory data included: Heart rate abnormal (NR: not provided) 130. On 18-MAR-2021, the patient experienced shortness of breath when sitting. It was reported that around 03:00 am heart racing, shortness of breath, body aches, tried to take blood pressure unable to obtain reading, reported that when able to take blood pressure, pulse around 130, being sweaty, thought had a fever but did not after checking her temperature felt like she was going into a-fib, reported blurry vision reports still having some of that but a little better. It was reported that her heart was not racing as much. At the time of reporting patient had slight shortness of breath and given herself a breathing treatment and doing breathing exercises felt better but when sitting or walking around and not doing treatments the shortness of breath returned. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the difficulty sleepy, shortness of breath when sitting, tired, heart racing, body aches, felt like fever but was not, blurry vision and sweating was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210340845-Covid-19 vaccine ad26.cov2.s-Shortness of breath. 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: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Feeling abnormal, Hypotension, Syncope
Clinical narrative: FAINTED; LOW BLOOD PRESSURE; FEELING FUNNY; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 72.7 kilograms, and height was not reported.  The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. The patient received selexipag (form of admin and route of admin were not reported, batch number: 031491701) 800 ug, every 2 days, frequency, and therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included ambrisentan, and riociguat.  On 09-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) Low blood pressure. On 09-MAR-2021 13:00, the patient experienced low blood pressure, felt funny and she fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The outcome of the low blood pressure, fainted and feeling funny was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210342442-Covid-19 vaccine ad26.cov2.s-Fainted, Low blood pressure. These events are considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS  V0 20210342442-Selexipag-Fainted. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY AND UNDERLYING DISEASE  V0 20210342442-Selexipag-Low blood pressure. This event is labeled and is therefore considered potentially related
Age: 51.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypotension, Syncope
Clinical narrative: FAINTED; LOW BLOOD PRESSURE; FEELING FUNNY; This spontaneous report received from a patient concerned a 51 year old female. The patient's weight was 72.7 kilograms, and height was not reported.  The patient's concurrent conditions included primary pulmonary hypertension. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. The patient received selexipag (form of admin and route of admin were not reported, batch number: 031491701) 800 ug, every 2 days, frequency, and therapy dates were not reported for primary pulmonary hypertension. Concomitant medications included ambrisentan, and riociguat.  On 09-MAR-2021, Laboratory data included: Blood pressure (NR: not provided) Low blood pressure. On 09-MAR-2021 13:00, the patient experienced low blood pressure, felt funny and she fainted. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of selexipag was not changed. The outcome of the low blood pressure, fainted and feeling funny was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210342442-Covid-19 vaccine ad26.cov2.s-Fainted, Low blood pressure. These events are considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the events than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS  V0 20210342442-Selexipag-Fainted. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY AND UNDERLYING DISEASE  V0 20210342442-Selexipag-Low blood pressure. This event is labeled and is therefore considered potentially related
Sex: F
Vaccine: COVID19
Symptoms: Death, Pain in extremity
Clinical narrative: DIED; SORE ARM/ARM PAIN; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient had a sore arm/arm pain, and later on died. On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of sore arm/arm pain was not reported. This report was serious (Death). This case, from the same reporter is linked to 20210329044.; Sender's Comments: V0: 20210353764 - COVID-19 VACCINE AD26.COV2.S - Died. This event is considered Unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Feeling hot, Vaccination site erythema, Vaccination site swelling
Clinical narrative: A spontaneous report was received from a Consumer concerning a 22 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cellulitis, skin felt hot/feeling hot, arm was red/redness generalized, arm was swollen/peripheral swelling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 15 Jan 2021, the patient experienced the events as cellulitis, skin felt hot, arm was red, arm was swollen. Treatment information was provided as patient has taken antibiotic Cephalexin 1 capsule four times a day for a week. Action taken with mRNA-1273 in response to the events was unknown. The seriousness criteria of event cellulitis was assessed as serious as per EMA list. The outcome of the event swollen arm was resolved. The outcome of the events cellulitis, skin felt hot, arm was red was unknown.; Reporter's Comments: 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood pressure measurement, Body temperature increased, Cough
Clinical narrative: Congested in chest; Heat sensation in the stomach; like a fire in stomach; Allergy type cough here and there; Heat sensation in knees; Fever, aches and pains all over - muscle, joint, back, knees, arms; Fever, aches and pains all over - muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Fever; Aches and pains all over-muscle, joint, back, knees, arms; Headache; A spontaneous report  was received from a Consumer concerning a 73 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pyrexia, arthralgia, pain in extremity, myalgia, headache, dyspepsia, pulmonary congestion, cough, feeling hot and back pain .   The patient's medical history was not provided. Relevant concomitant medications included Valsartan and Levothyroxine.   On Date 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) for prophylaxis of COVID-19 infection.   On date 20-Jan-2021, The patient experienced the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache, heat sensation in the stomach- Like fire in stomach, congested in chest, allergy type cough and heat sensation in knees.   Laboratory details if provided.   Treatment details include Tylenol for the event increased body temperature.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache and heat sensation in the stomach- Like fire in stomach was recovering; outcome of the events congested in chest, allergy type cough and heat sensation in knees was unknown.; Reporter's Comments: This case concerns a 73-year-old female who had a serious unexpected event of pulmonary congestion along with nonserious unexpected dyspepsia, feeling hot, back pain, pain in extremity and expected pyrexia, headache, myalgia, arthralgia. Event onset on day 2 after first dose mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Feeling hot, Headache, Myalgia, Oxygen saturation
Clinical narrative: Congested in chest; Heat sensation in the stomach; like a fire in stomach; Allergy type cough here and there; Heat sensation in knees; Fever, aches and pains all over - muscle, joint, back, knees, arms; Fever, aches and pains all over - muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Fever; Aches and pains all over-muscle, joint, back, knees, arms; Headache; A spontaneous report  was received from a Consumer concerning a 73 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pyrexia, arthralgia, pain in extremity, myalgia, headache, dyspepsia, pulmonary congestion, cough, feeling hot and back pain .   The patient's medical history was not provided. Relevant concomitant medications included Valsartan and Levothyroxine.   On Date 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) for prophylaxis of COVID-19 infection.   On date 20-Jan-2021, The patient experienced the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache, heat sensation in the stomach- Like fire in stomach, congested in chest, allergy type cough and heat sensation in knees.   Laboratory details if provided.   Treatment details include Tylenol for the event increased body temperature.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache and heat sensation in the stomach- Like fire in stomach was recovering; outcome of the events congested in chest, allergy type cough and heat sensation in knees was unknown.; Reporter's Comments: This case concerns a 73-year-old female who had a serious unexpected event of pulmonary congestion along with nonserious unexpected dyspepsia, feeling hot, back pain, pain in extremity and expected pyrexia, headache, myalgia, arthralgia. Event onset on day 2 after first dose mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pulmonary congestion, Pyrexia
Clinical narrative: Congested in chest; Heat sensation in the stomach; like a fire in stomach; Allergy type cough here and there; Heat sensation in knees; Fever, aches and pains all over - muscle, joint, back, knees, arms; Fever, aches and pains all over - muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Aches and pains all over-muscle, joint, back, knees, arms; Fever; Aches and pains all over-muscle, joint, back, knees, arms; Headache; A spontaneous report  was received from a Consumer concerning a 73 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events pyrexia, arthralgia, pain in extremity, myalgia, headache, dyspepsia, pulmonary congestion, cough, feeling hot and back pain .   The patient's medical history was not provided. Relevant concomitant medications included Valsartan and Levothyroxine.   On Date 19-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 012L20A) for prophylaxis of COVID-19 infection.   On date 20-Jan-2021, The patient experienced the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache, heat sensation in the stomach- Like fire in stomach, congested in chest, allergy type cough and heat sensation in knees.   Laboratory details if provided.   Treatment details include Tylenol for the event increased body temperature.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events fever, aches and pains all over - muscle, joint, back, knees, arms, bad headache and heat sensation in the stomach- Like fire in stomach was recovering; outcome of the events congested in chest, allergy type cough and heat sensation in knees was unknown.; Reporter's Comments: This case concerns a 73-year-old female who had a serious unexpected event of pulmonary congestion along with nonserious unexpected dyspepsia, feeling hot, back pain, pain in extremity and expected pyrexia, headache, myalgia, arthralgia. Event onset on day 2 after first dose mRNA-1273. Treated with Tylenol. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Headache, Multiple fractures, Pain in extremity
Clinical narrative: broken bones; Warm body; arm pain; headache; A spontaneous report  was received from a consumer, concerning himself, a male patient, born in 1947 who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced warm body, broken bones, arm pain and headache.  The patient's medical history was not provided. Concomitant medications were not provided.  On 20 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (lot number: 020L270A) for the prophylaxis of COVID-19 infection.  On Sunday (24 Jan 2021), the patient experienced warm body, broken bones, arm pain and headache.  The events of warm body, broken bones, arm pain and headache were considered to be serious with criteria of Other.  Therapeutic measures included were unknown.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.  The outcome of the events warm body, broken bones, arm pain and headache was unknown.; Reporter's Comments: 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.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gait disturbance, Loss of consciousness, Muscle strain, Vomiting
Clinical narrative: Passed out; Diarrhea; pulled leg muscles; She could hardly walk; vomiting; A spontaneous report was received on,28-JAN-2021 concerning a female patient of age 75 years old, who experienced Diarrhea, vomiting, passed out and hit the floor, she might have passed out for maybe 5 minutes, when she fell her right leg bent severely and pulled some muscles, she could hardly walk., with the use of mRNA-1273 as prophylaxis for COVID-19 infection.   The patient's history was not reported.   Concomitant medications such as sertraline ,Synthroid, hctz rosuvastatin trazodone, pantoprazole sodium, vitamins, fiber, aspirin, fish oil included.   On 26 Jan 2021, the patient started taking first dose of Moderna COVID-19 Vaccine for COVID-19 infection.  On the same day at 09:30 PM, patient experienced Diarrhea, vomiting, passed out and hit the floor, she might have passed out for maybe 5 minutes, when she fell her right leg bent severely and pulled some muscles, she could hardly walk.  The action taken for the adverse events were not provided.  The outcome of all events were resolved.; Reporter's Comments: 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: arthritis flared up; rash; headache; muscle pain; tired; cold; warm; ringing in her left ear; dizzy; Lethargic; A spontaneous report (United States) was received from a Consumer who is a 69-years-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cold symptoms, feeling warm, ringing in her left ear, rash, headache, arthritis flare-up, muscle pain, dizziness, lethargy, and tiredness.  The patient's medical history was not provided. Concomitant medications reported were Synthroid, singular, losartan, escitalopram, Vitamin D, Xopenex, Alvesco for unknown indication.  On 27-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 27-JAN-2021, the patient experienced cold symptoms, feeling warm, and ringing in her left ear. On 28-JAN-2021, the patient experienced rash, headache, arthritis flare-up, muscle pain, dizziness, lethargy, and tiredness.  Treatment was reported to include Advil.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, cold symptoms, feeling warm , ringing in her left ear, headache and arthritis flared, was resolved on 28-JAN-2021. The outcome of event muscle pain was resolved on 30-JAN-2021. The outcome of event rash was resolved on 01-FEB-2021. The outcome of events dizziness, lethargy, tiredness was not reported.; Reporter's Comments: 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: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Nasopharyngitis, Rash, Tinnitus
Clinical narrative: arthritis flared up; rash; headache; muscle pain; tired; cold; warm; ringing in her left ear; dizzy; Lethargic; A spontaneous report (United States) was received from a Consumer who is a 69-years-old female patient that received Moderna's COVID-19 vaccine (mRNA-1273) and experienced cold symptoms, feeling warm, ringing in her left ear, rash, headache, arthritis flare-up, muscle pain, dizziness, lethargy, and tiredness.  The patient's medical history was not provided. Concomitant medications reported were Synthroid, singular, losartan, escitalopram, Vitamin D, Xopenex, Alvesco for unknown indication.  On 27-JAN-2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot batch: 029L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 27-JAN-2021, the patient experienced cold symptoms, feeling warm, and ringing in her left ear. On 28-JAN-2021, the patient experienced rash, headache, arthritis flare-up, muscle pain, dizziness, lethargy, and tiredness.  Treatment was reported to include Advil.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of events, cold symptoms, feeling warm , ringing in her left ear, headache and arthritis flared, was resolved on 28-JAN-2021. The outcome of event muscle pain was resolved on 30-JAN-2021. The outcome of event rash was resolved on 01-FEB-2021. The outcome of events dizziness, lethargy, tiredness was not reported.; Reporter's Comments: 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: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Vaccination site pain
Clinical narrative: Sore arm; Transient ischemic attack, symptoms of tia; A spontaneous report was received from a consumer concerning a 76-year-old, female patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced symptoms of transient ischaemic attack (TIA), transient ischemic attack/transient ischaemic attack and sore arm/pain in extremity.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 13 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number 028L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date patient had sore arm like from a flu vaccine. On 24 Jan 2021, the patient went to emergency room thinking patient had a TIA (transient ischemic attack). TIA was not detected at that time but found one later which is considered as medically significant event. Patient had all the symptoms of TIA to the point where patient could not talk, right leg was numb, and eyes went grey. It is unknown whether the patient had history of TIA.   The patient had a brain scan, heart tests, and an MRI whose results were not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time. Further information has been requested.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy
Clinical narrative: Face was drooping; Loss of taste; A spontaneous report was received from a physician concerning, a 58-year-old, male  patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of taste/ageusia and face drooping/facial paralysis.   The patient's medical history included COVID-19 approximately six months prior to this event. Concomitant product use was not provided by the reporter.  On 09 Jan 2021, approximately 3 days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 11 Jan 2021, after receiving mRNA-1273, the patient experienced loss of taste buds. On 20 Jan 2021 patient noticed that his face "felt funny" while drinking water and went to the mirror where he saw the right side of his face was drooping. Patient was seen by PCP on 25 Jan 2021.  Treatment for the events included high dose steroid therapy and valacyclovir 1 gm by mouth twice daily for ten days.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, ageusia and face dropping, were considered unknown.; Reporter's Comments: 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. Further information has been requested.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bradycardia, Chest pain, Dizziness, Dysgeusia
Clinical narrative: A spontaneous report (United States) was received from a consumer concerning a 39-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced metallic taste, eyes burning, dizzy spells, heart rate dropped, sharp stabbing pain abdomen, sharp stabbing pain chest, vaccination site swelling, and vaccination site tenderness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27-JAN-2021, the patient received first of two planned dose of Moderna vaccine and after one minute of dose he experienced the event(s) metallic taste, eyes burning, he waited in the nursing area for one hour. While he was driving home, he experienced a dizzy spell for a couple of minutes and then his heart rate dropped to 40 beats per minute coming back to normal after. On 28-JAN-2021, for a period of three to four hours, the patient experienced localized sharp stabbing pain at upper left abdominal and lower chest areas and then it stopped. All side effects have stopped except for swelling and tenderness at vaccine location. No treatment information was provided. No laboratory tests were reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, metallic taste, eyes burning, dizzy spells, heart rate dropped, sharp stabbing pain abdomen, and sharp stabbing pain chest, was resolved on 28-JAN-2021. The outcome of events, vaccination site swelling and vaccination site tenderness, was unknown.; Reporter's Comments: 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: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Eye irritation, Vaccination site pain, Vaccination site swelling
Clinical narrative: A spontaneous report (United States) was received from a consumer concerning a 39-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced metallic taste, eyes burning, dizzy spells, heart rate dropped, sharp stabbing pain abdomen, sharp stabbing pain chest, vaccination site swelling, and vaccination site tenderness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27-JAN-2021, the patient received first of two planned dose of Moderna vaccine and after one minute of dose he experienced the event(s) metallic taste, eyes burning, he waited in the nursing area for one hour. While he was driving home, he experienced a dizzy spell for a couple of minutes and then his heart rate dropped to 40 beats per minute coming back to normal after. On 28-JAN-2021, for a period of three to four hours, the patient experienced localized sharp stabbing pain at upper left abdominal and lower chest areas and then it stopped. All side effects have stopped except for swelling and tenderness at vaccine location. No treatment information was provided. No laboratory tests were reported. Action taken with mRNA-1273 in response to the events was not reported. The outcome for the events, metallic taste, eyes burning, dizzy spells, heart rate dropped, sharp stabbing pain abdomen, and sharp stabbing pain chest, was resolved on 28-JAN-2021. The outcome of events, vaccination site swelling and vaccination site tenderness, was unknown.; Reporter's Comments: 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Delirium, Dizziness, Headache, Pyrexia
Clinical narrative: delirious/uncontrolled laughing; loss of memory; 102 F fever; pied on self; dizzy; headache; A spontaneous report was received from a Consumer, concerning herself of 73 years old female, who received Modena's COVID-19 vaccine, and experienced headache, delirious/uncontrolled laughing, 102F fever, lost memory, peed on self, dizziness.  The patient's medical history was not provided.   Concomitant medication included Gabapentin for pain 80 mg 3 times a day, Amlodipine, Esomeprazole twice a day 40 mg, Furosemide 40 mg 2 in the morning, Citalopram 20 mg, Pentosan polysulfate 100 mg 3 times a day, Renoxin 1000 mg twice a day, potassium 20 mq twice a day, Atorvastatin twice a day, Trazodone 150 mg once a day, Linaclotide once in a while 290 mcg, vitamin D once a week, Clonazepam twice a day, Diphenhydramine, Alirocumab injection.   On 03 FEB 2021, the patient received their first of two planed doses of mRNA-1273 (Batch number 012M20A) on right non-dominant arm for prophylaxis of COVID-19 infection.   On 05 Feb 2021, 2 days after vaccination, the patient had headache and a day after had memory loss and fever ranging from 102 to 103, pied on self, dizzy, uncontrolled laughing and delirious, all of which lasted for 3 days but treated only for headache.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: delirious/uncontrolled laughing; loss of memory; 102 F fever; pied on self; dizzy; headache; A spontaneous report was received from a Consumer, concerning herself of 73 years old female, who received Modena's COVID-19 vaccine, and experienced headache, delirious/uncontrolled laughing, 102F fever, lost memory, peed on self, dizziness.  The patient's medical history was not provided.   Concomitant medication included Gabapentin for pain 80 mg 3 times a day, Amlodipine, Esomeprazole twice a day 40 mg, Furosemide 40 mg 2 in the morning, Citalopram 20 mg, Pentosan polysulfate 100 mg 3 times a day, Renoxin 1000 mg twice a day, potassium 20 mq twice a day, Atorvastatin twice a day, Trazodone 150 mg once a day, Linaclotide once in a while 290 mcg, vitamin D once a week, Clonazepam twice a day, Diphenhydramine, Alirocumab injection.   On 03 FEB 2021, the patient received their first of two planed doses of mRNA-1273 (Batch number 012M20A) on right non-dominant arm for prophylaxis of COVID-19 infection.   On 05 Feb 2021, 2 days after vaccination, the patient had headache and a day after had memory loss and fever ranging from 102 to 103, pied on self, dizzy, uncontrolled laughing and delirious, all of which lasted for 3 days but treated only for headache.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events were reported as resolved.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.