chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vertigo, Vision blurred
Clinical narrative: ELEVATED BLOOD PRESSURE; ELEVATED HEART RATE; CHEST TIGHTNESS; COATING OVER EYES; VERTIGO; BLURRY VISION; SEEING DOUBLE; HEADACHE; NAUSEA; SLEEPY; 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: 1802070, expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 to Right Deltoid for prophylactic vaccination. No concomitant medications were reported.  On MAR-2021, Laboratory data included: Blood pressure (NR: not provided) High Blood pressure. On 12-MAR-2021, the patient experienced elevated blood pressure. On the same day, the patient experienced coating over her eyes, vertigo, elevated blood pressure and heart rate 5 minutes within receiving the vaccine, headache, nausea, and sleepy. The patient felt heart racing fast. Ambulance was called and on the same day, the patient was hospitalized for 8-9 hours until blood pressure stabilized. Laboratory data included: Heart rate (NR: not provided) elevated Heart rate. It was not known if patient was discharged or not. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurry vision, and seeing double on MAR-2021, was recovering from coating over eyes, chest tightness, and elevated heart rate, and had not recovered from elevated blood pressure, vertigo, headache, nausea, and sleepy. The reporter and company causality considered between covid-19 vaccine ad26.cov2.s and blurry vision, seeing double, coating over eyes, chest tightness, elevated heart rate, blood pressure, vertigo, headache, nausea, and sleepy as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332091-Covid-19 vaccine ad26.cov2.s-Elevated blood pressure. 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: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Seizure
Clinical narrative: SEIZURE; DEHYDRATION; This spontaneous report received from a pharmacist concerned a 19 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included dehydrated, anxious, non alcohol user, non smoker, and penicillin allergy, and other pre-existing medical conditions included the patient did not had history of drug abuse or illicit drug use. the patient was not pregnant at the time of reporting. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 on right deltoid for prophylactic vaccination. No concomitant medications were reported. On 16-MAR-2021, the patient had an seizures with in 1 minute after vaccine administration which was lasted for 10 second. The patient did not had history of seizure. The patient was taken to hospital via ambulance and they found that she was dehydrated and was given fluids. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from seizure on 16-MAR-2021, and the outcome of dehydration was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210332197 -JANSSEN COVID-19 VACCINE Ad26.COV2.S-Seizure, Dehydration. 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: U
Vaccine: COVID19
Symptoms: Loss of consciousness
Clinical narrative: BLACKED OUT; This spontaneous report received from a pharmacist concerned a 49-year-old and unspecified sex. The patient's height, and weight were not reported.  The patient's concurrent conditions included anxiety about injection, nonsmoker, and abstains from alcohol, and other pre-existing medical conditions included the patient had not known allergy. The patient received covid-19 vaccine 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 to left deltoid for prophylactic vaccination.  On 13-MAR-2021, the patient experienced blacked out around 10 minutes after vaccination. EMS was called. They assessed patient and left, no other treatments received. The patient recovered from blacked out on 13-MAR-2021.  The action taken with covid-19 vaccine ad26.cov2. s was not applicable.  The outcome of the blacked out was recovered.  This report was serious (Other Medically Important Condition).  This case is associated with product quality complaint (PQC) number 90000173341. This record contains reports of adverse events that do not explicitly allege a potency issue. No product quality issues were reported. This complaint is approved for void.  Additional information was received from central complaint vigilance on 17-MAR-2021 following information was updated and incorporated into case narrative: Investigational results; Sender's Comments: 20210332620-Covid-19 vaccine ad26.cov2. s-Blacked out. 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: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product use issue
Clinical narrative: DRUG USE IN UNAPPROVED AGE GROUP; OFF LABEL USE; This spontaneous report received from a pharmacist concerned a 15 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, non alcohol user, and non smoker. The patient did not have any drug abuse/illicit drug use. The patient experienced drug allergy when treated with amoxicillin.  The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: not reported) dose was not reported, administered on 13-MAR-2021 to left deltoid as prophylactic vaccination. No concomitant medications were reported.  It was reported that the patient received vaccine on 13-MAR-2021 and he was too young to receive vaccine (coded as drug use in unapproved age group and off label use) and also patient denied having any adverse reactions. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug use in unapproved age group and off label use was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210333174-Covid-19 vaccine ad26.cov2.s-off label use and drug use in unapproved age group . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Hypoxia, Limb discomfort, Nausea
Clinical narrative: HYPOXIC; LIGHT HEADED; HEAD FLOATING; ARMS AND LEGS FEEL LIKE CONCRETE; NAUSEA; 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, batch number: Unknown) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for the case. No concomitant medications were reported.  On 16-MAR-2021, the subject experienced hypoxic, light headed, head floating, arms and legs feel like concrete, and nausea. Patient told that he was light headed and nauseous all day. The feeling was like he was on boat and hypoxic at the same time. Arms and legs felt like concrete. No treatment was needed. The action taken with COVID-19 VACCINE AD26.COV2.S was not applicable. The outcome of the nausea, light headed, head floating, arms and legs feel like concrete and hypoxic was not reported.  This report was serious (Other Medically Important Condition).  Additional information was received on 25-MAR-2021. Following information was updated into the case: Due diligence updated, other identification numbers. Upon review, following corrections were performed in the case: Event onset date captured as 16-MAR-2021 for all the events. Vaccination date added in the tab and narrative. Reporter causality sentence removed from the narrative.; Sender's Comments: V1: Additional information  received in current version was regarding due diligence and other identification numbers. The following information was amended event onset date, vaccination date and narrative amended for reporter causality statement. This updated information received does not alter prior causality assessment of reported event. 20210333343-COVID-19 VACCINE AD26.COV2.S-hypoxic. 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: Feeling hot, Injection site pain, Nausea
Clinical narrative: DRY HEAT; NAUSEA; SORE ARM AT UPPER ARM AT SITE OF ADMINISTRATION; This spontaneous report received from a patient concerned a non 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: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 08-MAR-2021 for prophylactic vaccination on Left Deltoid .No concomitant medications were reported. On 08-MAR-2021, the patient experienced sore arm at upper arm at site of administration. On 10-MAR-2021 02:00, the patient experienced dry heat, and nausea. Patient visited emergency room for severe nausea and dry heat which went on for 8-10 hours and ended up going to ER. In the ER patient received anti nausea medication and IV fluids.  Patient stated that they had no fever. Patient went to hospital around noon time and it was resolved soon after receiving fluids and medication in hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient recovered from dry heat, and nausea on 10-MAR-2021, and sore arm at upper arm at site of administration on MAR-2021. The reporter causality with covid-19 vaccine  ad26.cov2.s was related.  This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210333680 - COVID-19 VACCINE Ad26.COV2.S -   Dry Heat . This event is considered un-assessable. The event has a compatible/suggestive temporal relationship, is un-labelled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. V0: 20210333680 - COVID-19 VACCINE Ad26.COV2.S -Nausea . This event is labelled and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose increased, Dizziness, Headache, Injection site pain
Clinical narrative: HIGH BLOOD SUGAR; DIZZINESS (LIGHTHEADED); INJECTION SITE PAIN; HEADACHE; This spontaneous report received from a consumer concerned a 30 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetic (28 years), hypothyroidism, and down's syndrome. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805018 expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 on right are for prophylactic vaccination. Concomitant medications included insulin glargine for high blood sugar, and insulin lispro for high blood sugar.  On 11-MAR-2021, the patient experienced injection site pain and headache. On 12-MAR-2021, he experience high blood sugar and dizziness (lightheaded). His blood  sugar kept on increasing (400). Therefore, his therapy dose of Humalog was increased, which was not seems to be working. At the time of reporter, the reporter mentioned that, the reporter has contacted the endocrinologist and his response was awaiting and his (the patient's) all blood sugar levels recorded on the Dexcom. Laboratory data (dates unspecified) included: Blood sugar increased (NR: not provided) 400. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from dizziness (lightheaded) on 12-MAR-2021, injection site pain on 13-MAR-2021, and headache, and had not recovered from high blood sugar. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210333817-COVID-19 VACCINE AD26.COV2. S- 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: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PARTIAL DOSE GIVEN; This spontaneous report received from a pharmacist concerned a male patient 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: 1805029, expiry: 25-MAY-2021) dose was not reported, administered to left deltoid on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-MAR-2021, partial dose administered to the patient. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of partial dose given was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and partial dose given as not related. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  20210333938-COVID-19 VACCINE AD26.COV2.S - Partial dose - 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: SPECIAL SITUATIONS.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site extravasation
Clinical narrative: HALF DOSE LEAKED/PARTIAL DOSE; HALF DOSE LEAKED/OOZED OUT FROM ARM; This spontaneous report received from a pharmacist 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, and batch number were not reported) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 17-MAR-2021, the patient's half dose just leaked/partial dose and it oozed out from arm. She would like to know if it was okay to re-administer the whole dose. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the half dose leaked/partial dose and half dose leaked/oozed out from arm was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: 20210336532-covid-19 vaccine ad26.cov2.s -Half dose leaked/Partial dose . This event(s) is considered not related. The event(s) 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(s) than the drug. Specifically: SPECIAL SITUATIONS
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: STROKE; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021,13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke  was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210340063-Covid-19 vaccine ad26.cov2.s-Stroke. 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
Age: 84.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Abstains from alcohol, Cerebrovascular accident, Drug hypersensitivity, Haemorrhage, Tobacco user
Clinical narrative: STROKE; This spontaneous report received from a patient concerned an 84 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, non alcoholic, and cigarette smoker (one pack per day).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry date: unknown) dose was not reported, administered on 03-MAR-2021,13:36 right arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 04-MAR-2021, Patient experienced a stroke. Patient was sent to the ER. The patient was treated per stroke treatment guidelines, The patient was hospitalized for two days. The patient returned to hospital a week later. Professionals at the hospital found reason for blood loss, but could not find reason for the stroke. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stroke on 06-MAR-2021. The reporter causality assessment for stroke  was not related. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0:20210340063-Covid-19 vaccine ad26.cov2.s-Stroke. 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
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Blood pressure measurement, Diarrhoea
Clinical narrative: INCREASED BLOOD PRESSURE; ANXIETY; LOOSE BOWEL MOVEMENTS; This spontaneous report received from a patient concerned a 76 year old female. The patient's height, and weight were not reported. The patient's past medical history included thyroidectomy, and concurrent conditions included milk allergy, and the patient was not pregnant at the time of reporting. The patient experienced drug allergy when treated with cephalosporin nos. 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, 1 total, administered on 22-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-MAR-2021, the subject experienced anxiety, loose bowel movements, increased blood pressure. She said that her normal blood pressure was 120-130/ 68 mm of Hg. On the day of report, her blood pressure after receiving the vaccine was 161/84, although this was after eating.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from anxiety, loose bowel movements, and increased blood pressure. The reporter considered the causality between covid-19 vaccine ad26.cov2.s and anxiety, loose bowel movements, and increased blood pressure as possible. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20210343165-Covid-19 vaccine ad26.cov2.s -Increased blood pressure. 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: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: RIGHT ARM SORENESS; This spontaneous report received from a patient concerned a 69 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included type 1 diabetes, and heart disease. 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 24-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-MAR-2021, the patient experienced right arm soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right arm soreness. This report was non-serious.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Urticaria
Clinical narrative: HIVES UNDER SHOULDER BLADE, LOWER BACK AND NECK; SHORTNESS OF BREATH; FELT TIRED; This spontaneous report received from a patient concerned a 73 year old of unspecified 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: 1805018, and expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 10:30 for prophylactic vaccination on left arm.. No concomitant medications were reported. On 17-MAR-2021, the subject experienced felt tired. On 19-MAR-2021, the subject experienced shortness of breath. On 22-MAR-2021 20:00, the subject experienced hives under shoulder blade, lower back and neck. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, and the outcome of felt tired and hives under shoulder blade, lower back and neck was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Fatigue, Headache, Nausea, Oropharyngeal pain
Clinical narrative: NAUSEA; SORE THROAT; SWALLOWING DIFFICULTY; FATIGUE; BODY ACHES; FEVER; RECURRENT HEADACHE; 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: 1805122, and batch number: 1805122 expiry: unknown) dose was not reported, administered on 13-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced sore throat. On 20-MAR-2021, the subject experienced swallowing difficulty. On 20-MAR-2021, the subject experienced headaches. On 23-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 14-MAR-2021, and fatigue on 15-MAR-2021, and had not recovered from fever, headaches, sore throat, nausea, and swallowing difficulty. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: NAUSEA; SORE THROAT; SWALLOWING DIFFICULTY; FATIGUE; BODY ACHES; FEVER; RECURRENT HEADACHE; 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: 1805122, and batch number: 1805122 expiry: unknown) dose was not reported, administered on 13-MAR-2021 (vaccinated at left arm) for prophylactic vaccination. No concomitant medications were reported. On 14-MAR-2021, the subject experienced body aches. On 14-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced fatigue. On 20-MAR-2021, the subject experienced sore throat. On 20-MAR-2021, the subject experienced swallowing difficulty. On 20-MAR-2021, the subject experienced headaches. On 23-MAR-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches on 14-MAR-2021, and fatigue on 15-MAR-2021, and had not recovered from fever, headaches, sore throat, nausea, and swallowing difficulty. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Blood glucose, Blood glucose increased, Fatigue, Hypoacusis
Clinical narrative: Blurred vision; Complete loss vision; Hearing impairment Whoosh; spike in blood sugar; Fatigue; A spontaneous report was received from a consumer who was a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete loss of vision (blindness), fatigue, blurred vision, spike in blood sugar (blood sugar increased), and hearing impairment "whoosh" (hearing impaired).  The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications were insulin glargine and insulin lispro.  The patient said he was compliant with his insulin injections.  On 29 Dec 2020 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced a spike in blood sugar.  He tested his blood sugar immediately following the vaccination and it was in the 280-380 range.  Prior to the vaccine, it was 100 to 150.  On an unspecified date, his hemoglobin A1C was below 7.  On 05 Jan 2021, he experienced hearing impairment "whoosh".  On 09 Jan 2021, the patient experienced complete vision loss.    On 11 Jan 2021, he experienced blurred vision.     Action taken with mRNA-1273 in response to the events was not reported.   The event of complete vision loss resolved on 11 Jan 2021.  The outcomes of the events of fatigue, blurred vision, hearing impairment "whoosh", and blood sugar spike 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.  The patient's medical history of diabetes remains a confounding factor. Further information has been requested.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Blurred vision; Complete loss vision; Hearing impairment Whoosh; spike in blood sugar; Fatigue; A spontaneous report was received from a consumer who was a 41-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced complete loss of vision (blindness), fatigue, blurred vision, spike in blood sugar (blood sugar increased), and hearing impairment "whoosh" (hearing impaired).  The patient's medical history, as provided by the reporter, included diabetes. Concomitant medications were insulin glargine and insulin lispro.  The patient said he was compliant with his insulin injections.  On 29 Dec 2020 , prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 29 Dec 2020, the patient experienced a spike in blood sugar.  He tested his blood sugar immediately following the vaccination and it was in the 280-380 range.  Prior to the vaccine, it was 100 to 150.  On an unspecified date, his hemoglobin A1C was below 7.  On 05 Jan 2021, he experienced hearing impairment "whoosh".  On 09 Jan 2021, the patient experienced complete vision loss.    On 11 Jan 2021, he experienced blurred vision.     Action taken with mRNA-1273 in response to the events was not reported.   The event of complete vision loss resolved on 11 Jan 2021.  The outcomes of the events of fatigue, blurred vision, hearing impairment "whoosh", and blood sugar spike 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.  The patient's medical history of diabetes remains a confounding factor. Further information has been requested.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Pneumonia, SARS-CoV-2 test
Clinical narrative: tested positive for COVID-19; feeling bad; pneumonia; A spontaneous report was received from a consumer concerning a 71-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced feeling bad (feeling abnormal), tested positive for COVID-19 (COVID-19), and pneumonia.  The patient's medical history, as provided by the reporter, included a heart operation and pulmonary problems and respiratory insufficiency since then.  Concomitant medications included salbutamol sulfate.  On 14 Jan 2021  prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.   The patient reported that after receiving the vaccine, he travelled outside the country.  He was feeling really bad and thought it could be due to the vaccination.    On 18 Jan 2021, he tested positive for COVID-19.  The patient consulted a healthcare professional while abroad, who detected pneumonia.  The patient was "feeling well" at the time of this report.  Treatment for the events included cortisone, an antihistamine, and isolation.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events of feeling bad, tested positive for COVID-19 (COVID-19), and pneumonia were considered resolving.; Reporter's Comments: The patient's COVID-19 is unlikely to be due to Moderna's mRNA vaccine. 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; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-053411:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Vaccination site erythema, Vaccination site mass
Clinical narrative: Red round rump below the deltoid muscle; Red round rump below the deltoid muscle; Injection was wrongly administered at the wrong muscle site; A spontaneous report  was received from a nurse, concerning a 19-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and developed red round lump below the deltoid muscle/ vaccination site mass and vaccination site erythema, injection was wrongly administered at the wrong muscle site/ incorrect route of product administration.  The patient's medical history was not reported. No relevant concomitant medications were reported.  On 06 Jan 2021, prior to onset of event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025L20A) on right arm for prophylaxis of COVID-19 infection.   On an unknown date, after vaccination, the patient developed red round lump below the deltoid muscle and the patient's mother believed that the injection was wrongly administered at the wrong muscle site.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event red round lump below the deltoid muscle was unknown. The outcome of event injection was wrongly administered at the wrong muscle site was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of  Product administration error for mRNA-1273, lot # 025L20A  with  associated AEs. 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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Pain, Pyrexia
Clinical narrative: my entire body started screaming in pain, every bone, every nerve, on a scale of 1-10, it was way out of 10; My shoulder started hurting; chills; temperature was 101F; A spontaneous report  was received from a (Physician ) concerning a  85 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  my shoulder started hurting/Arthralgia, my entire body started screaming in pain, every bone, every nerve, On a scale of 1-10, it was way out of 10/Pain, Chills and temperature was 101F/Pyrexia  The patient's medical history included as she had the virus but was asymptomatic. Her test came positive. No relevant concomitant medications were reported.    On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced my shoulder started hurting, my entire body started screaming in pain, every bone-every nerve, On a scale of 1-10, it was way out of 10/Pain, was serious event, Chills and temperature was 101F.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events were Not Resolved/Not Recovered.; Reporter's Comments: This case concerns an 85-year-old female, with PMH of COVID-19, who experienced a serious unexpected event of severe pain along with nonserious expected fever, chills, arthralgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. 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: 85.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: my entire body started screaming in pain, every bone, every nerve, on a scale of 1-10, it was way out of 10; My shoulder started hurting; chills; temperature was 101F; A spontaneous report  was received from a (Physician ) concerning a  85 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced  my shoulder started hurting/Arthralgia, my entire body started screaming in pain, every bone, every nerve, On a scale of 1-10, it was way out of 10/Pain, Chills and temperature was 101F/Pyrexia  The patient's medical history included as she had the virus but was asymptomatic. Her test came positive. No relevant concomitant medications were reported.    On 15 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 16 Jan 2021, the patient experienced my shoulder started hurting, my entire body started screaming in pain, every bone-every nerve, On a scale of 1-10, it was way out of 10/Pain, was serious event, Chills and temperature was 101F.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events were Not Resolved/Not Recovered.; Reporter's Comments: This case concerns an 85-year-old female, with PMH of COVID-19, who experienced a serious unexpected event of severe pain along with nonserious expected fever, chills, arthralgia.  Event onset occurred on Day 2 after the first dose of mRNA-1273. Treatment not reported. Events ongoing. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bronchitis, Dizziness, Dyspnoea
Clinical narrative: Difficulty breathing; Ear was hurting inside for several hours; Back pain; Lip was itching; Bottom lip swelled; 1-2 hives on her lips; Dizzy spells; Vertigo; Migraines/ low grade headache; Coughing up dark mucus; Not feeling well; Itchy, 2 inches in diameter of a red circle at vaccination site; Respiratory infection; Bronchitis; Side of her neck was hurting; Itchy, 2 inches in diameter of a red circle at injection site; Congestion; Shoulder pain; A spontaneous report  was received from a  consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled, 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well.  The patient's medical history, as provided by the reporter, included chronic fatigue syndrome, respiratory infection. Concomitant medications were not reported.   On 10 Feb 2021, approximately same day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, prior to receiving mRNA-1273, the patient felt covid arm around 7 days later where it was itchy, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection. The event respiratory infection was considered medically significant.  Treatment for the events included antibiotics and steroids.  Action taken with mRNA-1273 in response to the events was not reported.   The events, itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well, 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 event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Lip pruritus, Lip swelling, Malaise, Migraine
Clinical narrative: Difficulty breathing; Ear was hurting inside for several hours; Back pain; Lip was itching; Bottom lip swelled; 1-2 hives on her lips; Dizzy spells; Vertigo; Migraines/ low grade headache; Coughing up dark mucus; Not feeling well; Itchy, 2 inches in diameter of a red circle at vaccination site; Respiratory infection; Bronchitis; Side of her neck was hurting; Itchy, 2 inches in diameter of a red circle at injection site; Congestion; Shoulder pain; A spontaneous report  was received from a  consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled, 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well.  The patient's medical history, as provided by the reporter, included chronic fatigue syndrome, respiratory infection. Concomitant medications were not reported.   On 10 Feb 2021, approximately same day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, prior to receiving mRNA-1273, the patient felt covid arm around 7 days later where it was itchy, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection. The event respiratory infection was considered medically significant.  Treatment for the events included antibiotics and steroids.  Action taken with mRNA-1273 in response to the events was not reported.   The events, itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well, 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 event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Productive cough, Respiratory tract infection, Upper respiratory tract congestion, Urticaria
Clinical narrative: Difficulty breathing; Ear was hurting inside for several hours; Back pain; Lip was itching; Bottom lip swelled; 1-2 hives on her lips; Dizzy spells; Vertigo; Migraines/ low grade headache; Coughing up dark mucus; Not feeling well; Itchy, 2 inches in diameter of a red circle at vaccination site; Respiratory infection; Bronchitis; Side of her neck was hurting; Itchy, 2 inches in diameter of a red circle at injection site; Congestion; Shoulder pain; A spontaneous report  was received from a  consumer concerning a 73-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled, 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well.  The patient's medical history, as provided by the reporter, included chronic fatigue syndrome, respiratory infection. Concomitant medications were not reported.   On 10 Feb 2021, approximately same day prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On an unspecified date in Feb 2021, prior to receiving mRNA-1273, the patient felt covid arm around 7 days later where it was itchy, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection. The event respiratory infection was considered medically significant.  Treatment for the events included antibiotics and steroids.  Action taken with mRNA-1273 in response to the events was not reported.   The events, itchy arm, 2 inches in diameter of a red circle at the injection site, pain going up her shoulder, congestion, bronchitis, difficulty breathing, side of her neck was hurting, ear was also hurting inside for several hours, back pain, lip was itching, bottom lip swelled and had 1-2 hives on her lips, dizzy spells, like vertigo, migraines, low grade headache, coughing up dark mucus, respiratory infection, and not feeling well, 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 event, a causal relationship cannot be excluded.