chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 2.5-year-old patient received an adult dose of Havrix; 2.5-year-old patient received an adult dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of adult product administered to child in a 30-month-old female patient who received HAV (Havrix adult) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th April 2021, the patient received the 2nd dose of Havrix adult and Havrix Pre-Filled Syringe Device. On 28th April 2021, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced adult product administered to child and overdose. On an unknown date, the outcome of the adult product administered to child and overdose were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The nurse reported that an adult dose of Havrix was administered to a 2.5 year old patient, which led to adult product administered to child and overdose. The reporter consented to follow-up. The reported batch number J95HZ was not available in sales data sheet, hence updated to J95H7.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of  shingrix 3 years ago (elsewhere), 2nd shot on Nov 2020, about 2.5 years apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 85-year-old female patient who received Herpes zoster (Shingrix) (batch number 22LC7, expiry date 27th August 2022) for prophylaxis.   Previously administered products included shingrix (1st dose received 3 years ago from day of reporting).   In November 2020, the patient received the 2nd dose of Shingrix. In November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.  Additional details were reported as follows: The patient received the 2nd dose of Shingrix later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 2nd dose about 2.5 years apart from 1st dose. The reporter asked did the dose need to be repeated or not. The reporter did not consent to follow-up.
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue, Underdose
Clinical narrative: Accidental underdose; The liquid got in contact with the patient's arm; The liquid got in contact with the patient's arm; Needle leaked and less than the recommended dose was administered; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 33-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 9335X, expiry date 29th January 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Boostrix (1st dose received on an unknown date).   On 27th April 2021, the patient received the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 27th April 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and needle leak. On an unknown date, the outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and needle leak were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported but could be 32 or 33 years. The reporter stated that during the administration of vaccine the needle leaked and less than the recommended dose was administered which led to accidental underdose and needle leak. The reporter also reported that the vaccine leaked when the needle was removed from the patient's arm and the liquid got in contact with the patient's arm which led to exposure via skin contact and inadvertent exposure to vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Might have administered some / vaccines reconstituted with sterile water; Might have administered some / vaccines reconstituted with sterile water; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that they might have administered some Menveo vaccines reconstituted with sterile water instead that the approved diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case had been linked with case US2021094213, as reported by the same reporter The reporter had no data at time of call. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094213:Same reporter.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: EXPERIENCING SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned multiple patients. 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 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 experiencing side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of experiencing side effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210318906.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Gastrointestinal disorder, Pain, Pyrexia
Clinical narrative: SEVERE GASTROINTESTINAL SYMPTOMS; PAIN; DIARRHEA; FEVER; 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, The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose, start therapy date were not reported for prophylactic vaccination. Concomitant medications included ustekinumab for drug used for unknown indication. On an unspecified date, the subject experienced severe gastrointestinal symptoms, fever, pain, and diarrhea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe gastrointestinal symptoms, fever, pain and diarrhea was not reported. This report was non-serious.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye pain, Headache, Injection site pain, Pain
Clinical narrative: BOTH EYES HAVING PRESSURE-TYPE PAIN, NOW LOCALIZED TO LEFT EYE; HEADACHE; INJECTION SITE PAIN SPREAD IN LEFT ARM; BODY ACHES; CHILLS; This spontaneous report received from a consumer concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included diabetes ii, insomnia, neuropathy, tinnitus, vertigo, acne, chronic back pain (bulging discs), seasonal nut allergies, anxiety, smoker, non alcohol user, depression, hearing loss, and cholesterol.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: not reported) dose was not reported, administered on 08-APR-2021 12:00 for prophylactic vaccination. Concomitant medications included atorvastatin for cholesterol, bupropion, lamotrigine, metformin hydrochloride, montelukast, and sertraline. On 08-APR-2021, the subject experienced body aches. On 08-APR-2021, the subject experienced chills. On 08-APR-2021 12:00, the subject experienced injection site pain spread in left arm. On 08-APR-2021 15:00, the subject experienced headache. On 09-APR-2021, the subject experienced both eyes having pressure-type pain, now localized to left eye. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from injection site pain spread in left arm, body aches, chills, headache, and both eyes having pressure-type pain, now localized to left eye. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Heart rate, Heart rate decreased, Heart rate increased
Clinical narrative: PASSED OUT (FAINTED); HEART RATE OF 43; HEART RATE AS HIGH AS 149; TIREDNESS; HOT FLASHES; CHILLS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and penicillin allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 11-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced hot flashes and chills which would come and come. She did not had temperature, but she took paracetamol (Tylenol) for her side effects. On 12-APR-2021 (within 24 hours of getting the vaccine), she passed out (fainted), which occurred once. While passed out her heart rate was 43 which she said lasted for minutes. Her heart rate was as high as 149 since she has received the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from passed out (fainted), had not recovered from hot flashes, chills, and tiredness, and the outcome of heart rate of 43 and heart rate as high as 149 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210424060-covid-19 vaccine ad26.cov2.s -Passed out (fainted). This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Loss of consciousness
Clinical narrative: PASSED OUT (FAINTED); HEART RATE OF 43; HEART RATE AS HIGH AS 149; TIREDNESS; HOT FLASHES; CHILLS; This spontaneous report received from a patient concerned a 59 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included seasonal allergies, and penicillin allergy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total dose administered on 11-APR-2021 on left deltoid for prophylactic vaccination. No concomitant medications were reported.  On 11-APR-2021, the patient experienced hot flashes and chills which would come and come. She did not had temperature, but she took paracetamol (Tylenol) for her side effects. On 12-APR-2021 (within 24 hours of getting the vaccine), she passed out (fainted), which occurred once. While passed out her heart rate was 43 which she said lasted for minutes. Her heart rate was as high as 149 since she has received the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from passed out (fainted), had not recovered from hot flashes, chills, and tiredness, and the outcome of heart rate of 43 and heart rate as high as 149 was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0. 20210424060-covid-19 vaccine ad26.cov2.s -Passed out (fainted). 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: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Auditory disorder, Cough, Diarrhoea, Discomfort
Clinical narrative: LOUD HEARING; BARELY GET OUT OF BED; SENSATION OF PRESSURE IN EAR; TIREDNESS; HEADACHE; SKIN HURTS TO TOUCH; PAIN IN SPINE; EAR RINGING; ITCHING TOE AND LEFT EAR; DISCOMFORT; DIARRHEA; IRRITABLE; COUGH; JOINT PAIN; EXHAUSTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included experienced rare side effects for past medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin hurts to touch. On APR-2021, the subject experienced pain in spine. On APR-2021, the subject experienced ear ringing. On APR-2021, the subject experienced itching toe and left ear. On APR-2021, the subject experienced discomfort. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced irritable. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced exhaustion. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced sensation of pressure in ear. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced barely get out of bed. On 10-APR-2021, the subject experienced loud hearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sensation of pressure in ear, tiredness, skin hurts to touch, pain in spine, discomfort, ear ringing, irritable, headache, cough, joint pain, diarrhea, itching toe and left ear, exhaustion, barely get out of bed and loud hearing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Fatigue, Headache, Irritability, Mobility decreased
Clinical narrative: LOUD HEARING; BARELY GET OUT OF BED; SENSATION OF PRESSURE IN EAR; TIREDNESS; HEADACHE; SKIN HURTS TO TOUCH; PAIN IN SPINE; EAR RINGING; ITCHING TOE AND LEFT EAR; DISCOMFORT; DIARRHEA; IRRITABLE; COUGH; JOINT PAIN; EXHAUSTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included experienced rare side effects for past medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin hurts to touch. On APR-2021, the subject experienced pain in spine. On APR-2021, the subject experienced ear ringing. On APR-2021, the subject experienced itching toe and left ear. On APR-2021, the subject experienced discomfort. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced irritable. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced exhaustion. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced sensation of pressure in ear. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced barely get out of bed. On 10-APR-2021, the subject experienced loud hearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sensation of pressure in ear, tiredness, skin hurts to touch, pain in spine, discomfort, ear ringing, irritable, headache, cough, joint pain, diarrhea, itching toe and left ear, exhaustion, barely get out of bed and loud hearing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus, Spinal pain, Tinnitus
Clinical narrative: LOUD HEARING; BARELY GET OUT OF BED; SENSATION OF PRESSURE IN EAR; TIREDNESS; HEADACHE; SKIN HURTS TO TOUCH; PAIN IN SPINE; EAR RINGING; ITCHING TOE AND LEFT EAR; DISCOMFORT; DIARRHEA; IRRITABLE; COUGH; JOINT PAIN; EXHAUSTION; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included experienced rare side effects for past medications. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced skin hurts to touch. On APR-2021, the subject experienced pain in spine. On APR-2021, the subject experienced ear ringing. On APR-2021, the subject experienced itching toe and left ear. On APR-2021, the subject experienced discomfort. On APR-2021, the subject experienced diarrhea. On APR-2021, the subject experienced irritable. On APR-2021, the subject experienced cough. On APR-2021, the subject experienced joint pain. On APR-2021, the subject experienced exhaustion. On APR-2021, the subject experienced headache. On 09-APR-2021, the subject experienced sensation of pressure in ear. On 09-APR-2021, the subject experienced tiredness. On 10-APR-2021, the subject experienced barely get out of bed. On 10-APR-2021, the subject experienced loud hearing. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sensation of pressure in ear, tiredness, skin hurts to touch, pain in spine, discomfort, ear ringing, irritable, headache, cough, joint pain, diarrhea, itching toe and left ear, exhaustion, barely get out of bed and loud hearing was not reported. This report was non-serious.; Sender's Comments: V0 Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: MASSIVE STROKE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, 1 total, administered in APR-2021 (about eight days prior to this report) for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported.  It was reported that, in APR-2021, the patient had a massive stroke and died. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: - Covid-19 Vaccine Ad26.Cov2.S - Massive Stroke. This event is considered Unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.; Reported Cause(s) of Death: MASSIVE STROKE
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Swelling
Clinical narrative: SHORTNESS OF BREATH; SWELLING; HEADACHES; 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: Unk) dose was not reported, administered on 13-MAR-2021 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 shortness of breath, swelling, and headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from shortness of breath, swelling, and headaches. This report was non-serious. This case, from the same reporter is linked to 20210435804.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain
Clinical narrative: BODY ACHES; HEADACHE; NAUSEA; 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced body aches, headache, and nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea, and had not recovered from body aches, and headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Thrombosis
Clinical narrative: BLOOD CLOTS; SEVERE PAIN; This spontaneous report received from a consumer concerned a patient of unspecified sex and age. 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the patient experienced blood clots and severe pain, and was hospitalized (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and severe pain was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: This is a report of a patient, unspecified age, unspecified gender, unknown ethnicity, who was hospitalized for pain and blood clots on an unspecified number of days after receiving the covid-19 vaccine ad26.cov.2.s. The information provided precludes a meaningful medical assessment. Additional information requested.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Ventricular extrasystoles, Vertigo
Clinical narrative: LOSS OF BALANCE, POSSIBLE VERTIGO; POSSIBLE PREMATURE VENTRICULAR CONTRACTIONS, FLUTTERING IN CHEST; This spontaneous report received from a consumer (company representative) concerned a 56 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 was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 2021, the subject experienced possible premature ventricular contractions, fluttering in chest. On MAR-2021, the subject experienced loss of balance, possible vertigo. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the possible premature ventricular contractions, fluttering in chest and loss of balance, possible vertigo was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Haemorrhoids thrombosed
Clinical narrative: LARGE EXTERNAL THROMBOSED HEMORRHOID (BLOOD CLOT); This spontaneous report received from a consumer concerned a 32 year old male of unknown race and ethnic origin. 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 11-MAR-2021 for prophylactic vaccination. The batch number was not reported and it has been requested. No concomitant medications were reported.  On 15-MAR-2021, the patient underwent surgery for a large external thrombosed hemorrhoid (blood clot). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of large external thrombosed hemorrhoid (blood clot), surgery was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:-covid-19 vaccine ad26.cov2.s-large external thrombosed hemorrhoid (blood clot) . 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: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Dysarthria, Echocardiogram, Magnetic resonance imaging
Clinical narrative: SLURRED SPEECH; TINGLING FEELING IN ALL FOUR LIMBS; STROKE; VISION DECREASED; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System;)  a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included history of CABG (Coronary artery bypass grafting), and concurrent conditions included diabetes mellitus, congestive heart failure, and diabetic retinopathy, and other pre-existing medical conditions included the patient had no known allergies to medications, food, or other products and did not had other illnesses at the time of vaccination and up to one month prior. The patient did not have an adverse event following any previous vaccination. The patient, at age of 57 years, received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included insulin and insulin lispro for drug used for unknown indication.  On 20-APR-2021, the patient began experiencing tingling feeling in all four limbs at different times. On 28-MAR-2021, patient experienced slurred speech. The patient experienced what he described as near blindness. The patient was driving down road and all of the sudden most of visual field went black and could only see the white lines of the road. The patient was close to hospital and was able to see enough to get himself to the hospital and was diagnosed as having a stroke. The patient had CT, MRI, and ultrasound of heart (results unspecified).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling feeling in all four limbs, slurred speech, vision decreased and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210440193-covid-19 vaccine ad26.cov2.s-Stroke, Vision decreased, Tingling sensation in all four limbs, Slurred speech. 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: MEDICAL HISTORY: history of CABG, UNDERLYING DISEASE: congestive heart failure, and diabetic retinopathy
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Visual impairment
Clinical narrative: SLURRED SPEECH; TINGLING FEELING IN ALL FOUR LIMBS; STROKE; VISION DECREASED; This spontaneous report received from a patient via the VAERS (Vaccine Adverse Event Reporting System;)  a 57 year old male. The patient's height, and weight were not reported. The patient's past medical history included history of CABG (Coronary artery bypass grafting), and concurrent conditions included diabetes mellitus, congestive heart failure, and diabetic retinopathy, and other pre-existing medical conditions included the patient had no known allergies to medications, food, or other products and did not had other illnesses at the time of vaccination and up to one month prior. The patient did not have an adverse event following any previous vaccination. The patient, at age of 57 years, received Covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 18-MAR-2021 to left arm for prophylactic vaccination. Concomitant medications included insulin and insulin lispro for drug used for unknown indication.  On 20-APR-2021, the patient began experiencing tingling feeling in all four limbs at different times. On 28-MAR-2021, patient experienced slurred speech. The patient experienced what he described as near blindness. The patient was driving down road and all of the sudden most of visual field went black and could only see the white lines of the road. The patient was close to hospital and was able to see enough to get himself to the hospital and was diagnosed as having a stroke. The patient had CT, MRI, and ultrasound of heart (results unspecified).  The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tingling feeling in all four limbs, slurred speech, vision decreased and stroke was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: 20210440193-covid-19 vaccine ad26.cov2.s-Stroke, Vision decreased, Tingling sensation in all four limbs, Slurred speech. 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: MEDICAL HISTORY: history of CABG, UNDERLYING DISEASE: congestive heart failure, and diabetic retinopathy
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, SARS-CoV-2 test positive, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; BRAIN FOG; This spontaneous report received from a patient concerned a 49 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sharp pain in ear, and covid-19 infection. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A expiry: 23-JUN-2021) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination.  No concomitant medications were reported. On 10-APR-2021, the subject experienced brain fog. On 12-APR-2021, the subject experienced suspected covid-19 infection. Laboratory data included: COVID-19 rapid POC test positive (NR: not provided) Positive. Treatment medications (dates unspecified) included: vitamins nos, and paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from brain fog, and suspected covid-19 infection. This report was non-serious. This case, involving the same patient is linked to 20210449934.       .; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case was assessed as non serious
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Dizziness, Dry mouth, Electrocardiogram, Fatigue
Clinical narrative: TACHYCARDIA; DRY MOUTH; DIZZINESS WITH STANDING AND INTERMITTENTLY WITH SITTING; PULMONARY EMBOLISM; FEELING OF DOOM/ FEELING OF PASSED OUT; FATIGUE; This spontaneous report received from a patient via a company representative via the VAERS (Vaccine Adverse Event Reporting System) concerned a 50 year old female unknown ethnicity . The patient's height, and weight were not reported. The patient's concurrent conditions included osteoarthritis, gluten intolarance, and diflucan allergy. The patient was previously treated with fluconazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) with unspecified dose on left arm, on 27-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included amino acids NOS, biotin, cannabidiol, collagen, ethinylestradiol/norethisterone acetate, and hyaluronic acid.  On 07-APR-2021, the patient experienced dizziness with standing and intermittently with sitting, tachycardia, dry mouth, chest pressure, shortness of breath, and feeling of extreme doom. On an unspecified date, the patient was transported to the clinic. In the clinic the patient had heart rate of about 140 with irregular beats. The patient had undergone Electrocardiography test which showed ST Depression. The patient's symptoms were improved by taking nitroglycerin. As the clinic did not have the technology to provide care so the patient was emergently transported to the hospital. In the hospital the patient's D-dimer level was positive. Later the patient undergone Computerized Angiogram for lungs which showed pulmonary embolism. The patient undergone Dopplers studies of both legs which showed as negative. The patient had received Heparin treatment for several hours and then later switched to Eliquis. After 6 hours being on Eliquis treatment the patient had same original symptoms and for that again nitroglycerin was administered. The patient was placed back on heparin for a longer period of time. Later on the patient got switched to Eliquis 10 mg twice daily for 7 days and further to 5 mg twice daily for 6 to 9 months. The patient had undergone Angiogram of head and neck which was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, feeling of doom/ feeling of passed out and dry mouth on APR-2021, had not recovered from fatigue, dizziness with standing and intermittently with sitting and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Pulmonary embolism , Feeling doom, Tachycardia, Dry mouth, Dizziness with standing, Fatigue 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer increased, Heart rate increased, Loss of consciousness, Pulmonary embolism, Tachycardia
Clinical narrative: TACHYCARDIA; DRY MOUTH; DIZZINESS WITH STANDING AND INTERMITTENTLY WITH SITTING; PULMONARY EMBOLISM; FEELING OF DOOM/ FEELING OF PASSED OUT; FATIGUE; This spontaneous report received from a patient via a company representative via the VAERS (Vaccine Adverse Event Reporting System) concerned a 50 year old female unknown ethnicity . The patient's height, and weight were not reported. The patient's concurrent conditions included osteoarthritis, gluten intolarance, and diflucan allergy. The patient was previously treated with fluconazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) with unspecified dose on left arm, on 27-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included amino acids NOS, biotin, cannabidiol, collagen, ethinylestradiol/norethisterone acetate, and hyaluronic acid.  On 07-APR-2021, the patient experienced dizziness with standing and intermittently with sitting, tachycardia, dry mouth, chest pressure, shortness of breath, and feeling of extreme doom. On an unspecified date, the patient was transported to the clinic. In the clinic the patient had heart rate of about 140 with irregular beats. The patient had undergone Electrocardiography test which showed ST Depression. The patient's symptoms were improved by taking nitroglycerin. As the clinic did not have the technology to provide care so the patient was emergently transported to the hospital. In the hospital the patient's D-dimer level was positive. Later the patient undergone Computerized Angiogram for lungs which showed pulmonary embolism. The patient undergone Dopplers studies of both legs which showed as negative. The patient had received Heparin treatment for several hours and then later switched to Eliquis. After 6 hours being on Eliquis treatment the patient had same original symptoms and for that again nitroglycerin was administered. The patient was placed back on heparin for a longer period of time. Later on the patient got switched to Eliquis 10 mg twice daily for 7 days and further to 5 mg twice daily for 6 to 9 months. The patient had undergone Angiogram of head and neck which was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, feeling of doom/ feeling of passed out and dry mouth on APR-2021, had not recovered from fatigue, dizziness with standing and intermittently with sitting and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Pulmonary embolism , Feeling doom, Tachycardia, Dry mouth, Dizziness with standing, Fatigue 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: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound Doppler, Ultrasound pelvis
Clinical narrative: TACHYCARDIA; DRY MOUTH; DIZZINESS WITH STANDING AND INTERMITTENTLY WITH SITTING; PULMONARY EMBOLISM; FEELING OF DOOM/ FEELING OF PASSED OUT; FATIGUE; This spontaneous report received from a patient via a company representative via the VAERS (Vaccine Adverse Event Reporting System) concerned a 50 year old female unknown ethnicity . The patient's height, and weight were not reported. The patient's concurrent conditions included osteoarthritis, gluten intolarance, and diflucan allergy. The patient was previously treated with fluconazole.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805029, expiry: UNKNOWN) with unspecified dose on left arm, on 27-MAR-2021 11:00 for prophylactic vaccination. Concomitant medications included amino acids NOS, biotin, cannabidiol, collagen, ethinylestradiol/norethisterone acetate, and hyaluronic acid.  On 07-APR-2021, the patient experienced dizziness with standing and intermittently with sitting, tachycardia, dry mouth, chest pressure, shortness of breath, and feeling of extreme doom. On an unspecified date, the patient was transported to the clinic. In the clinic the patient had heart rate of about 140 with irregular beats. The patient had undergone Electrocardiography test which showed ST Depression. The patient's symptoms were improved by taking nitroglycerin. As the clinic did not have the technology to provide care so the patient was emergently transported to the hospital. In the hospital the patient's D-dimer level was positive. Later the patient undergone Computerized Angiogram for lungs which showed pulmonary embolism. The patient undergone Dopplers studies of both legs which showed as negative. The patient had received Heparin treatment for several hours and then later switched to Eliquis. After 6 hours being on Eliquis treatment the patient had same original symptoms and for that again nitroglycerin was administered. The patient was placed back on heparin for a longer period of time. Later on the patient got switched to Eliquis 10 mg twice daily for 7 days and further to 5 mg twice daily for 6 to 9 months. The patient had undergone Angiogram of head and neck which was normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tachycardia, feeling of doom/ feeling of passed out and dry mouth on APR-2021, had not recovered from fatigue, dizziness with standing and intermittently with sitting and pulmonary embolism. This report was serious (Hospitalization Caused / Prolonged, Other Medically Important Condition, and Life Threatening). Sender's Comments: V0 -covid-19 vaccine ad26.cov2.s-Pulmonary embolism , Feeling doom, Tachycardia, Dry mouth, Dizziness with standing, Fatigue 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: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Back pain, Haemorrhage, Headache
Clinical narrative: LOSS OF BLOOD; VOMITING; BACK PAIN; ABDOMINAL PAIN; FEELING WEAK; HEADACHE; BLOOD CLOTTING; COULD NOT MOVE; ONLY COULD DO 5 MINUTES OF WORK; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070CCHD,expiry: UNKNOWN) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 22-MAR-2021, the patient experienced blood clotting which lasted for three weeks and resolved as per physician on same day the patient experienced headache which got resolved on 22-Apr-2021. On 18-APR-2021, the patient experienced loss of blood, vomiting, back pain, abdominal pain and patient felt weak. On an unspecified date in 2021, the patient went to hospital, it was also reported that patient was not able to move and could do only 5 minutes of work. Patient got confused between clotting with menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clotting on 12-APR-2021, and headache on 22-MAR-2021, was recovering from loss of blood, feeling weak, vomiting, back pain, and abdominal pain, and the outcome of could not move and only could do 5 minutes of work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: In narrative of source document vaccination date is 20-Mar-2021 and in the structured field of source document vaccination date is 20-Apr-2021. So as per conservative approach, date given in narrative 20-Mar-2021 is taken as vaccination date. V0 20210440392-COVID-19 VACCINE AD26.COV2.S-Blood clotting and loss of blood. 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: MEDICAL HISTORY.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokinesia, Loss of personal independence in daily activities, Thrombosis, Vomiting
Clinical narrative: LOSS OF BLOOD; VOMITING; BACK PAIN; ABDOMINAL PAIN; FEELING WEAK; HEADACHE; BLOOD CLOTTING; COULD NOT MOVE; ONLY COULD DO 5 MINUTES OF WORK; This spontaneous report received from a patient concerned a 45 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included fibroids. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802070CCHD,expiry: UNKNOWN) dose was not reported,1 total administered on 20-MAR-2021 for prophylactic vaccination to left arm. No concomitant medications were reported.  On 22-MAR-2021, the patient experienced blood clotting which lasted for three weeks and resolved as per physician on same day the patient experienced headache which got resolved on 22-Apr-2021. On 18-APR-2021, the patient experienced loss of blood, vomiting, back pain, abdominal pain and patient felt weak. On an unspecified date in 2021, the patient went to hospital, it was also reported that patient was not able to move and could do only 5 minutes of work. Patient got confused between clotting with menstruation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blood clotting on 12-APR-2021, and headache on 22-MAR-2021, was recovering from loss of blood, feeling weak, vomiting, back pain, and abdominal pain, and the outcome of could not move and only could do 5 minutes of work was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: In narrative of source document vaccination date is 20-Mar-2021 and in the structured field of source document vaccination date is 20-Apr-2021. So as per conservative approach, date given in narrative 20-Mar-2021 is taken as vaccination date. V0 20210440392-COVID-19 VACCINE AD26.COV2.S-Blood clotting and loss of blood. 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: MEDICAL HISTORY.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia
Clinical narrative: TERRIBLE BODY ACHES; HEADACHE; FEVER; This spontaneous report received from a patient via a company representative concerned a 22 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced terrible body aches, headache, and fever. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102 (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from terrible body aches, headache, and fever. This report was non-serious. This case, from the same reporter is linked to 20210439367, 20210439312 and 20210440603.