chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Fatigue, Swelling, Therapeutic response unexpected
Clinical narrative: FEELING LESS DEPRESSED; SWELLING; TIRED; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 72.7 kilograms, and height was not reported. The patient's concurrent conditions included depression, and primary pulmonary hypertension. The patient received macitentan (tablet, oral, batch number: ZM021B0101 expiry: 30/NOV/2023) 10 mg, every 1 day, frequency, and therapy dates were not reported for swelling, and tired. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included tadalafil, and treprostinil sodium. On an unspecified date, the subject experienced feeling less depressed, swelling, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and dose of macitentan was not changed. The patient recovered from swelling, and the outcome of feeling less depressed and tired was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: FEVER; This spontaneous report received from a health care professional concerned a 19 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: Unknown) 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 subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of fever was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Decreased activity, Illness, Vomiting
Clinical narrative: SICK; VOMITING A FEW TIMES; BEDRIDDEN FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 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 MAR-2021, the subject experienced sick. On MAR-2021, the subject experienced vomiting a few times. On MAR-2021, the subject experienced bedridden for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bedridden for 3 days on MAR-2021, and the outcome of sick and vomiting a few times was not reported. This report was non-serious.; Sender's Comments: V0: Medical Assessment Comment not required as per standard procedure as case assessed as non serious.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Injection site pain, Injection site warmth, Pain in extremity, Poor quality sleep
Clinical narrative: WARM AT SITE; WOKE HER UP; HURTS TO RAISE LEFT ARM; ACHY AT SITE; SPACY; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included exercise induced asthma, not treated, codeine allergy, alcohol use, and non smoker, and other pre-existing medical conditions included no drug abuse or illicit drug use. patient consumes 1-2 glasses of wine per week.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported,  batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccinatio on left arm.. Concomitant medications included ascorbic acid, and . On 08-MAR-2021, the subject experienced spacy. On 23-MAR-2021, the subject experienced achy at site. On 25-MAR-2021, the subject experienced hurts to raise left arm. On 26-MAR-2021, the subject experienced woke her up. On an unspecified date, the subject experienced warm at site. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spacy on 08-MAR-2021, had not recovered from achy at site, and warm at site, and the outcome of woke her up and hurts to raise left arm was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report was received from a consumer and concerned a female of an unspecified age and unknown race and unknown ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number and expiry date were Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Company is unable to perform follow-up to confirm batch/lot number. No concomitant medications were reported. It was also reported that the patient and her husband were vaccinated on same day apart from each other. The patient was received the JnJ vaccine and her husband received Moderna. The patient stated that, on an unknown date, they both had got their antibodies were tested and the patient test was negative (suspected immunological vaccination failure ) and her husband test was found positive.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20210358593-covid-19 vaccine ad26.cov2.s -Suspected Immunological failure. 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: SPECIAL SITUATIONS
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Death, Dysphagia, Hypotension, Peripheral embolism
Clinical narrative: ATRIAL FIBRILLATION; INABILITY TO SWALLOW; BLOOD CLOT IN RIGHT ARM; LOW BLOOD PRESSURE; DEATH 4 DAYS AFTER RECEIVING  VACCINE; This spontaneous report received from a vaccine facility via a company representative concerned a 95-year-old female. The patient's height, and weight were not reported. The patient's concurrent conditions included atrial fibrillation. 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 2021 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. It was reported that on an unspecified date in 2021 the patient received Janssen Covid-19 Vaccine and within 6hrs she had a major atrial fibrillation episode, then several the following day. The next day, she lost her ability to swallow. Two days later she was on oxygen. Three days later she developed a blood clot in her right arm, was still on oxygen and blood pressure was falling. On an unspecified date, the patient died 4 days after receiving vaccine. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The patient died 4 days after receiving vaccine on an unspecified date, and the outcome of atrial fibrillation, inability to swallow, blood clot in right arm and low blood pressure was not reported. This report was serious (Death, Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20210400509: This spontaneous report received from a vaccine facility via a company representative involved a 95-year-old female with the past medical history remarkable for atrial fibrillation who received the Janssen COVID-19 Vaccine for prevention of COVID-19 infection and within 6hrs had a major atrial fibrillation episode. No concomitant medications were reported. The next day, she lost her ability to swallow. Two days later she was on oxygen. Three days later she developed a blood clot in her right arm, was still on oxygen and blood pressure was falling. On an unspecified date, the patient died 4 days after receiving vaccine. No information was provided regarding the cause of death.  Considering the patient's past medical history of atrial fibrillation, the causality for the event of atrial fibrillation, as well the consequent events is assessed not related to the Janssen COVID-19 Vaccine.; Reported Cause(s) of Death: DEATH 4 DAYS AFTER RECEIVING VACCINE
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hepatic failure
Clinical narrative: LIVER FAILURE; HEADACHES; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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, 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 liver failure, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the liver failure and headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210403560-COVID-19 VACCINE AD26.COV2.S-Liver failure. 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.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Injection site warmth; Pain in other arm; Injection site pruritus; Injection site swelling; 2-3 eye blood capillaries exploded; A spontaneous report was received from a health care professional concerning a 33-years-old female patient who received Moderna's Covid-19 Vaccine (mRNA-1273) and experienced 2 or 3 eye blood capillaries had exploded, itchy in the site of injection, injection site swelling and felt pain in the other arm(not in the one were got the vaccine).  The patient's medical history includes hypothyroidism. Products known to have been used by patient, within two weeks prior to the event, included methimazole, proponalol, citalopram.  On 04-Jan-2021, approximately one day prior to the events the patient received their first of two planned doses of mRNA-1273 (Batch number: 026L20A) intramuscularly into the left arm for prophylaxis of COVID-19 infection.  On 05-Jan-2021, patient experienced 2 or 3 eye blood capillaries exploded, also experienced symptoms including itchy in the site of injection, swelling and warmth in the site of injection and pain in the other arm. Treatment for symptoms included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event 2 or 3 eye blood capillaries exploded was considered resolved on an unknown date. The outcome of an events itchy in the site of injection, swelling and warmth in the site of injection and felt pain in the other arm was 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.
Sex: M
Vaccine: COVID19
Symptoms: Cellulitis, Lymphadenopathy, Oedema, Swelling
Clinical narrative: cellulitis on the same arm; Swelling; Edema; Lymphadenopathy; A spontaneous report was received from a (Reporter like HCP or Consumer) concerning a  77 Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and ON 30 JAN 2021 he experienced cellulitis on the same arm, swelling, edema, lymphadenopathy. Patient has systemic luposistic inflammation.  The patient's medical history was not reported.   On 21 JAN 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (030L20A) intramuscularly on the right arm for prophylaxis of COVID-19 infection.  On 30 JAN 2021, the patient started experienced cellulitis on the same arm, swelling, edema, lymphadenopathy, patient has systemic luposistic inflammation. He thinks that the symptoms may not be related to the vaccine but he reports it. Event cellulitis on the same arm was considered medically significant.  No laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  Outcome of the events are progressing Not Recovered/Not Resolved; Reporter's Comments: Very limited information regarding the events has been provided at this time.  Further information has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose, Product colour issue, Pyrexia, Vaccination site warmth
Clinical narrative: Vaccine more of a brownish color/discoloration/Brownish yellow honey colored; Wasn't that much in the syringe; Injection site feels "warm to touch"; Got feverish like a normal shot would do; A spontaneous report was received from a consumer, who was also a 70-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and reported that the vaccine was not white or clear, more of a brownish yellow/honey colored /product color issue, she got feverish/pyrexia, there wasn't that much in the syringe/accidental underdose and injection site feels warm to touch/vaccination site warmth.  The patient's medical history was not provided. She had no allergies. No relevant concomitant medications were reported.  On 06 Feb 2021 at 8:30 am, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch number: 013M2014) intramuscularly in the right upper arm for prophylaxis of COVID-19 infection.    The patient reported that the vaccine administered was not white or clear, but more of a brownish yellow (also reported as honey colored).  There was a discoloration but had already been administered.  When the patient looked at the syringe on television, it was clear.  She stated that the website said it should be white, but this was more of a yellowish brown.  The patient also reported that there wasn't much in the syringe but knew it was supposed to be the 0.5 ml.  The patient also reported that she didn't even feel the shot being given when it was administered.    As the day went on, the patient got feverish like a normal shot would do, which she said lasted a couple of days and through this week.  She did not contact her primary care physician about her concerns because she doesn't really go to the doctor.  The patient felt comfortable that the vaccine was administered the right way, intramuscularly.  She was not sure if the vaccine was spoiled at that color.  In addition, the patient reported that the injection site felt warm to touch. No treatment was provided for the events.  Action taken with mRNA-1273 in response to the events was not reported.   The events, vaccine was not white or clear, more of a brownish yellow/honey colored and wasn't that much in the syringe were considered resolved on 06 Feb 2021.  The event, got feverish, was considered resolved on an unknown day in February 2021. At the time of this report, the outcome of the event, injection site feels warm to touch, was unknown.  Follow-up Follow-up received on 24 Mar 2021 included vaccination date details and events.; Sender's Comments: This report refers to a case of (Product discoloration issue and accidental underdose  for mRNA-1273, lot # 013M2014  with associated AEs vaccination site warmth and pyrexia. 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. US-MODERNATX, INC.-MOD-2021-012063:
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination
Clinical narrative: Unable to provide me a second dose of vaccine due to a mismanagement of doses; This spontaneous case was reported by a consumer and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Unable to provide me a second dose of vaccine due to a mismanagement of doses) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Unable to provide me a second dose of vaccine due to a mismanagement of doses). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Unable to provide me a second dose of vaccine due to a mismanagement of doses) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # unknown  with no associated AEs
Sex: F
Vaccine: COVID19
Symptoms: Epistaxis, Pain in extremity, Tenderness
Clinical narrative: Bleeding nose; sore arm  ,tenderness on the left arm , bleeding on the nose; tenderness on the left arm; A spontaneous report was received from a consumer, concerning a female patient of 55 years of age, who received Moderna's COVID-19 vaccine and experienced Pain in extremity, Tenderness, Epistaxis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 07-Jan-2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number 037K20A) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On an unspecified date, after First dose of vaccine, the patient experienced Pain in extremity, Tenderness, Epistaxis. No treatment medication was reported.  Action taken with mRNA-1273 in response to the event was not applicable.  The outcome of the events were considered to be unknown at the time of this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Headache, Myalgia
Clinical narrative: Arthritis worsen; Body ache; Headache; A spontaneous report was received from a consumer, concerning a   70 years-old, female patient, who received Moderna's COVID-19 vaccine and experienced body ache/Myalgia, headache,her arthritis worsen/arthritis.  The patient's medical history include arthritis. Concomitant product use was not provided by the reporter.  On 21-feb-2021, prior to the onset of events, the patient received their planned dose of mRNA-1273 (lot number unknown) via unknown route for COVID-19 infection prophylaxis.  On 21-feb-2021, the patient experienced body ache, headache,her arthritis worsen. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, body ache, headache, worsened arthritis, were 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: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Chills, Fall, Headache, Hypertrophic cardiomyopathy
Clinical narrative: hypertrophic cardiomyopathy; he just suddenly fell; lost his sense of taste; excruciating pains all over his body; General body aches like he got ran over by a truck/excruciating pains all over his body; Headache; Chills; Fever; Nausea; Pain; Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies, causal relationship cannot be excluded..This spontaneous case was reported by a consumer and describes the occurrence of hypertrophic cardiomyopathy in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination.   The patient's past medical history included Angiogram (Was told they had an excellent heart and no surgery was needed)   Concomitant products included acetylsalicylic (E.C.) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 23-Feb-2021, the patient experienced pain, headache, chills, fever and nausea.   On 24-Feb-2021, the patient experienced lost his sense of taste, excruciating pains all over his body and myalgia (general body aches like he got ran over by a truck/excruciating pains all over his body).   On 06-Mar-2021, the patient experienced hypertrophic cardiomyopathy (seriousness criterion death) and he just suddenly fell.. An autopsy was performed.    Consumer reported on behalf of spouse. Ambulance was called and patient was pronounced dead. Awaiting toxicology report.  Most recent FOLLOW-UP information incorporated above includes:  On 26-Mar-2021: Major narrative update - outcome of events, additional events reported; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of pain, headache, chills, fever , nausea, loss of sense of taste, excruciating pains all over his body and myalgia and excluding other etiologies, causal relationship cannot be excluded. There is not enough details to assess the fatal event of hypertrophic cardiomyopathy and the administration of the product. Additional information has been requested.; Reported Cause(s) of Death: hypertrophic cardiomyopathy
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: hypertrophic cardiomyopathy; he just suddenly fell; lost his sense of taste; excruciating pains all over his body; General body aches like he got ran over by a truck/excruciating pains all over his body; Headache; Chills; Fever; Nausea; Pain; Based on the current available information which includes a strong temporal association between the use of the product and onset of the events, and excluding other etiologies, causal relationship cannot be excluded..This spontaneous case was reported by a consumer and describes the occurrence of hypertrophic cardiomyopathy in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 007M20A) for COVID-19 vaccination.   The patient's past medical history included Angiogram (Was told they had an excellent heart and no surgery was needed)   Concomitant products included acetylsalicylic (E.C.) for an unknown indication.   On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form.  On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form.   On 23-Feb-2021, the patient experienced pain, headache, chills, fever and nausea.   On 24-Feb-2021, the patient experienced lost his sense of taste, excruciating pains all over his body and myalgia (general body aches like he got ran over by a truck/excruciating pains all over his body).   On 06-Mar-2021, the patient experienced hypertrophic cardiomyopathy (seriousness criterion death) and he just suddenly fell.. An autopsy was performed.    Consumer reported on behalf of spouse. Ambulance was called and patient was pronounced dead. Awaiting toxicology report.  Most recent FOLLOW-UP information incorporated above includes:  On 26-Mar-2021: Major narrative update - outcome of events, additional events reported; Sender's Comments: Based on the current available information which includes a strong temporal association between the use of the product and onset of pain, headache, chills, fever , nausea, loss of sense of taste, excruciating pains all over his body and myalgia and excluding other etiologies, causal relationship cannot be excluded. There is not enough details to assess the fatal event of hypertrophic cardiomyopathy and the administration of the product. Additional information has been requested.; Reported Cause(s) of Death: hypertrophic cardiomyopathy
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Discomfort, Haemorrhage, Myalgia
Clinical narrative: Woke up in the middle of the night; Pain in the legs; Blood on toilet paper when wiped; Fever; Joint pain; Muscle pain; Uncomfortable; Chills/Shivering; Pain on the Injection Site; A spontaneous report was received from a consumer concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, discomfort, injection site pain, fever/pyrexia, sleep disturbance/sleep disorder ,bleeding/haemorrhage, joint pain/arthralgia, myalgia/muscle pain, pain in extremity/pain in leg.   The patient's medical history was  as cloudy urine prior to vaccination .No  Concomitant medications were reported.   On 04 Feb 2021,the patient  received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in an unknown location  for prophylaxis of COVID-19 infection.   On 04 Feb 2021 ,night after receiving the vaccine the patient developed chills, was uncomfortable and had little pain in the injection site. On 06 Feb 2021 in the middle of night the patient started shivering, chills and fever to a temperature of 101.4.The patient also noticed bleeding when she went to bathroom. But there was no pain or burning sensation on urination. The patient also experienced muscle  pain, joint pain and leg pain as well. Event Blood on toilet paper when wiped was considered medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The events, chill, uncomfortable and little pain on injection site were considered recovered on the days 05 Feb 2021.And the events fever bleeding ,muscle pain, joint pain and leg pain were considered unknown; Reporter's Comments: This case concerns a 45 Y/O F with a serious unexpected hemorrhage and nonserious unexpected discomfort, sleep disorder, pain in extremity, and expected vaccination site pain, pyrexia, chills, arthralgia, myalgia.  Event onset the same days as first dose mRNA-1273. Based on 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.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Sleep disorder, Vaccination site pain
Clinical narrative: Woke up in the middle of the night; Pain in the legs; Blood on toilet paper when wiped; Fever; Joint pain; Muscle pain; Uncomfortable; Chills/Shivering; Pain on the Injection Site; A spontaneous report was received from a consumer concerning a 68-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, discomfort, injection site pain, fever/pyrexia, sleep disturbance/sleep disorder ,bleeding/haemorrhage, joint pain/arthralgia, myalgia/muscle pain, pain in extremity/pain in leg.   The patient's medical history was  as cloudy urine prior to vaccination .No  Concomitant medications were reported.   On 04 Feb 2021,the patient  received their first of two planned doses of mRNA-1273 (Lot number: 013L20A) intramuscularly in an unknown location  for prophylaxis of COVID-19 infection.   On 04 Feb 2021 ,night after receiving the vaccine the patient developed chills, was uncomfortable and had little pain in the injection site. On 06 Feb 2021 in the middle of night the patient started shivering, chills and fever to a temperature of 101.4.The patient also noticed bleeding when she went to bathroom. But there was no pain or burning sensation on urination. The patient also experienced muscle  pain, joint pain and leg pain as well. Event Blood on toilet paper when wiped was considered medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   The events, chill, uncomfortable and little pain on injection site were considered recovered on the days 05 Feb 2021.And the events fever bleeding ,muscle pain, joint pain and leg pain were considered unknown; Reporter's Comments: This case concerns a 45 Y/O F with a serious unexpected hemorrhage and nonserious unexpected discomfort, sleep disorder, pain in extremity, and expected vaccination site pain, pyrexia, chills, arthralgia, myalgia.  Event onset the same days as first dose mRNA-1273. Based on 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.
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Ultrasound Doppler, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Arm is tender when moving sometimes; Cellulitis in left arm; Red bump on the injection site; Red bump on the injection site that started to grow; A spontaneous report was received from a consumer, who was also a 62-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced cellulitis in left arm / cellulitis, swollen left arm / peripheral swelling, arm is tender when moving sometimes / tenderness, red bump on the injection site / injection site erythema, and red bump on the injection site that started to grow / injection site swelling.    The patient's medical history was not provided. Concomitant medications reported included cholesterol medication (not specified) and blood pressure medication (not specified).  On 23 Dec 2020, approximately one day prior to the onset of events, the patient received their first of two planned dose of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    On 24 Dec 2020, a red bump appeared at the injection site that started to grow and grow. Her left arm became swollen.  On 28 Dec 2020, the patient's left arm didn't look fine and she went to the emergency room. She was treated with two different oral antibiotics (not specified) to be taken for one week.  On 29 Jan 2021, the patient's left arm was still swollen, above and below the elbow, and considerably larger than her right arm. Her left arm was tender with movement but she was still able to move her arm.   On unknown date, the patient underwent a vascular ultrasound that showed her vascularity was fine. The left arm was noted to be 5 cm bigger (larger) and 3 cm bigger above the elbow.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events, cellulitis in left arm, swollen left arm, arm is tender when moving sometimes, red bump on the injection site, and red bump on the injection site that started to grow, were not provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Headache, Heart rate increased
Clinical narrative: feeling shaky, dizzy and not right; Blood pressure was 172/101 at 6am, now is improving at 159/94, but heir normal blood pressure; body aches; feeling shaky; fever; headaches; oxygen was not as good as usual, at 95% (usually between 97-99%); elevated heart rate of 110ppm and climbing, for 3 days; A spontaneous report was received from a Healthcare Professional and a consumer concerning a 76 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Heart rate increased, Hypoxia, Dizziness, Blood pressure increased, Pyrexia, Pain and Headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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 for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced elevated heart rate of 110ppm and climbing for 3 days, felt they were having a heart attack, oxygen was not as good as usual, at 95 percent (usually between 97 to 99).   On 4 Feb 2021, the patient experienced the events feeling shaky, dizzy and not right, blood pressure was 172,101, now was improving at 159, 94, headache, fever and body aches. The Hypoxia was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 2 Feb 2021 the outcome of elevated heart rate was resolved and for blood pressure was recovering.  On an unknown date the outcome of other event was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with PMH of COVID-19 who had a serious unexpected event of hypoxia and nonserious unexpected blood pressure increased, heart rate increased, dizziness, nervousness, and expected pyrexia, headache.  Event onset on Day 4 after first dose mRNA-1273. Main event outcome unknown. Based on 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.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoxia, Nervousness, Pain, Pyrexia
Clinical narrative: feeling shaky, dizzy and not right; Blood pressure was 172/101 at 6am, now is improving at 159/94, but heir normal blood pressure; body aches; feeling shaky; fever; headaches; oxygen was not as good as usual, at 95% (usually between 97-99%); elevated heart rate of 110ppm and climbing, for 3 days; A spontaneous report was received from a Healthcare Professional and a consumer concerning a 76 years old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Heart rate increased, Hypoxia, Dizziness, Blood pressure increased, Pyrexia, Pain and Headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.  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 for prophylaxis of COVID-19 infection.  On 30 Jan 2021, the patient experienced elevated heart rate of 110ppm and climbing for 3 days, felt they were having a heart attack, oxygen was not as good as usual, at 95 percent (usually between 97 to 99).   On 4 Feb 2021, the patient experienced the events feeling shaky, dizzy and not right, blood pressure was 172,101, now was improving at 159, 94, headache, fever and body aches. The Hypoxia was considered medically significant.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   On 2 Feb 2021 the outcome of elevated heart rate was resolved and for blood pressure was recovering.  On an unknown date the outcome of other event was unknown.; Reporter's Comments: This case concerns a 76 Y/O F with PMH of COVID-19 who had a serious unexpected event of hypoxia and nonserious unexpected blood pressure increased, heart rate increased, dizziness, nervousness, and expected pyrexia, headache.  Event onset on Day 4 after first dose mRNA-1273. Main event outcome unknown. Based on 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.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Patient hasn't received 2nd dose; Shingles; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INCOMPLETE COURSE OF VACCINATION (Patient hasn't received 2nd dose) and HERPES ZOSTER (Shingles) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no relevant medical history reported.). Concomitant products included AMLODIPINE, OMEPRAZOLE and PYRIDOXINE HYDROCHLORIDE (VITAMINE) for an unknown indication.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 07-Feb-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (Patient hasn't received 2nd dose). At the time of the report, INCOMPLETE COURSE OF VACCINATION (Patient hasn't received 2nd dose) had resolved and HERPES ZOSTER (Shingles) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: No specific follow-up information recorded.; Sender's Comments: This report refers to a case of incomplete course of vaccination for mRNA-1273, lot # 013L20A  with no associated AE shingles. 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.
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chromaturia, Diarrhoea, Hepatic cirrhosis, Ultrasound scan
Clinical narrative: Liver Cirrhosis; Urined turned very yellow/ yellowish bright almost orange-ish; Soft/ loose stools; A spontaneous report, was received from a consumer concerning a 82 year old male patient (race unknown, ethnic group unknown) who received Moderna's COVID-19 Vaccine (mRNA-1273), and experienced his urine colour changing to yellow and then to orange-ish (chromaturia), his stools were loose and soft (diarrhoea) and later he was diagnosed with liver cirrhosis (hepatic cirrhosis).  The patient had no medical history. Concomitant medications reported included are metformin, atorvastatin and multivitamins.  On 11 Jan 2021, prior to the onset of events, the patient received his first of two planned doses of mRNA-1273 (Batch number: 013L20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 07 Feb 2021, after administering the vaccine, the consumer experienced his stools turned very yellow and his stools were soft.  On 08 Feb 2021, the patient received second of his two planned doses of mRNA-1273 (Batch number: 013M20A), intramuscularly in the left arm for prophylaxis of COVID-19 infection.  Approximately after two days of the second dose, the consumer again experienced his stools turned bright yellow to almost orange-ish and loose stools. His primary physician got him bloodwork done and the laboratory results showed signs of liver cirrhosis.   On 26 Feb 2021, he got ultrasound scan and few more blood tests done and the results showed possible liver cirrhosis. The patient was booked for another CT scan for 27 Feb 2021. No treatment information was provided.   The outcome of the events, chromaturia and diarrhea was unknown. The outcome of the event hepatic cirrhosis was considered not recovered.; Reporter's Comments: 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.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose decreased, Loss of consciousness
Clinical narrative: passed out; Blood sugar was 60; A spontaneous report was received from a consumer concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced passed out and blood sugar was 60.  The patient's medical history included diabetes and high blood pressure. Concomitant medications included human insulin(Novolin 70/30).    On 19Feb2021, the day before the onset of the events, the patient received first of two planned doses of mRNA-1273 (Lot: not reported) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 20Feb2021 at approximately 1 am, the patient experienced a blood sugar of 60. He drank orange juice and ate half an orange but passed out in the kitchen. He got up but passed out again.  He states that he took his insulin  and passed out due to his insulin and not the vaccine. and  his health care provider switched him to dulaglutide.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, passed out and blood sugar was 60 were 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. However, since the patient is known diabetic and is on  insulin may remain a contributing factor to this event. Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Blood test, Electrocardiogram, Hyperhidrosis, Hypotension
Clinical narrative: Taken to ER where had EKG, blood tests and low blood pressure; Vaccine Poisoning; Fainted 2 times; Sweating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted 2 times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 13-Feb-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced SYNCOPE (Fainted 2 times) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced HYPOTENSION (Taken to ER where had EKG, blood tests and low blood pressure) and TOXICITY TO VARIOUS AGENTS (Vaccine Poisoning). At the time of the report, SYNCOPE (Fainted 2 times), HYPERHIDROSIS (Sweating), HYPOTENSION (Taken to ER where had EKG, blood tests and low blood pressure) and TOXICITY TO VARIOUS AGENTS (Vaccine Poisoning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) low. On an unknown date, Blood test: unknoiwn unknown. On an unknown date, Electrocardiogram: unknoiwn unknown.         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.   This case was linked to (patient link). Sender'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: M
Vaccine: COVID19
Symptoms: Syncope, Toxicity to various agents
Clinical narrative: Taken to ER where had EKG, blood tests and low blood pressure; Vaccine Poisoning; Fainted 2 times; Sweating; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 03-Mar-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of SYNCOPE (Fainted 2 times) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On 13-Feb-2021 at 10:00 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced SYNCOPE (Fainted 2 times) (seriousness criterion medically significant) and HYPERHIDROSIS (Sweating). On an unknown date, the patient experienced HYPOTENSION (Taken to ER where had EKG, blood tests and low blood pressure) and TOXICITY TO VARIOUS AGENTS (Vaccine Poisoning). At the time of the report, SYNCOPE (Fainted 2 times), HYPERHIDROSIS (Sweating), HYPOTENSION (Taken to ER where had EKG, blood tests and low blood pressure) and TOXICITY TO VARIOUS AGENTS (Vaccine Poisoning) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) low. On an unknown date, Blood test: unknoiwn unknown. On an unknown date, Electrocardiogram: unknoiwn unknown.         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.   This case was linked to (patient link). Sender'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: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Loss of consciousness, Pain in extremity, Vaccination site pruritus
Clinical narrative: Passed out; Dehydrated; kept vomiting; Chills; her arm was swollen, itching and caused pain; arm was swollen; caused pain; A spontaneous report was received from a consumer,  concerning a 69-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm was swollen (peripheral swelling), itching (pruritus), and caused pain (pain in extremity), passed out (loss of consciousness), kept vomiting (vomiting), chills and was dehydrated (dehydration).  The patient's medical history was not provided.  Concomitant medications reported included ascorbic acid/biotin/dl-alpha tocopheryl acetate, nadolol, acetylsalicylic acid, sertraline, levothyroxine sodium and spironolactone.   On 13 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 030M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 13 Feb 2021, the patient's arm was swollen, itching and caused pain for about 2 days. On 14 Feb 2021, the passed out. The patient stated that she did not know how long she was out and that the event did not happen again. Since 14 Feb 2021, the patient kept vomiting where she couldn't eat or drink at all and she could eat on 20 Feb 2021. On 14 Feb 2021, the patient had the chills and was dehydrated which lasted for 7 days. The patients' doctor told her not to get the second Moderna COVID-19 vaccination.  Treatment information was not provided.    The patient was advised by her doctor to avoid getting the second dose of mRNA-1273.  The outcome of the events, arm was swollen, itching and caused pain, were considered resolved on 15 Feb 2021. The event, passed out, was considered resolved on 14 Feb 2021. The outcome of the  events, kept vomiting and could not eat or drink at all, were considered resolved on 20 Feb 2021. The events, chills and was dehydrated, were considered resolved on 21 Feb 2021.; 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.