chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Accidental underdose
Clinical narrative: administrating less than 0,5 ml of the Shingrix vaccine to a patient due to leaking; This case was reported by a pharmacist via and described the occurrence of accidental underdose in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th May 2021, the patient received Shingrix. On 5th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The Health care provider reported that the patient administered less than 0.5 ml of the Shingrix vaccine to a patient due to leaking, which led to accidental underdose.  No adverse events details could be informed and no further events were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received first dose of Shingrix in October 2020 and failed to get the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient herself. The age at vaccination was not applicable for this report. The patient failed to receive the second dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow-up.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix B; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HBV (Engerix B) (batch number 4G2TT, expiry date 20th February 2021) for prophylaxis.   On 5th May 2021, the patient received the 1st dose of Engerix B. On 5th May 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: Nurse reported that the patient received a dose of Engerix B vaccine which was already expired on 20th February 2021. All patient identifiers were reported as well as batch number and expiration date. The reporter consented to follow up.
Age: 10.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Dose was given / to a 10 year old patient; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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 reporter requested information regarding the administration of a dose of Kinrix.  The 10 year old patient received dose of a kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up. This is 1 of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021097954:same reporter US-GLAXOSMITHKLINE-US2021AMR097825:same reporter
Age: 8.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix / to a 8 year old; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa-IPV (Kinrix) (batch number Z9MZ2, expiry date 3rd December 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th May 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 5th May 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was 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 Kinrix was adminsitered to 8 year old patient, which led to inappropriate age at vaccine administration. The reporter preferred follow-up by email and did not provide address. This is 1 of 3 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR097825:Same reporter US-GLAXOSMITHKLINE-US2021097952:same reporter
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: mistakenly mixed with sterile diluent rather than the provided additive; mistakenly mixed with sterile diluent rather than the provided additive / administered to a patient; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 79-year-old female patient who received Herpes zoster (Shingrix) (batch number NR55Z, expiry date 22nd October 2022) for prophylaxis.   On 28th April 2021, the patient received the 1st dose of Shingrix. On 28th April 2021, unknown after receiving Shingrix, 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 Shingrix was mistakenly mixed with sterile diluent rather than the provided additive, which led with wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter asked what steps should be taken from this point. The reporter confirmed that the dose was administered to a patient. The reporter consented to follow up via mail.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose of Shingrix on 30/Oct/2019 and has not received dose two; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 30th October 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report.  A pharmacist reported that a patient received the first dose of Shingrix and had not received dose two which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Blood iron decreased, Myalgia
Clinical narrative: LOW IRON; MUSCLE ACHES; This solicited report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included crohns disease, and other pre-existing medical conditions included unknown. The patient received combination product ustekinumab (solution for injection in pre-filled syringe, subcutaneous, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, 1 time every 4 weeks, from 22-MAR-2021 for crohns disease. Product constituent parts included . The patient initiated treatment with covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN expiry: UNKNOWN) dose was not reported, administered on MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced low iron. On MAR-2021, the patient experienced muscle aches. Treatment medications (dates unspecified) included: iron. The action taken with covid-19 vaccine ad26.cov2.s, and ustekinumab was not applicable. The outcome of the muscle aches and low iron was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and low iron, and muscle aches as possible; and between ustekinumab, and low iron, and muscle aches as possible.  This report was non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Headache, Injection site pain, Migraine, Myalgia
Clinical narrative: BRUISE IN LEFT GROIN; BUMP IN LEFT GROIN; MIGRAINE; HAMSTRING AND QUADRICEP PAIN; MAJOR ARM PAIN; INTERMITTENT HEADACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included norethisterone.  On APR-2021, treatment medications included: acetylsalicylic acid, ibuprofen, and paracetamol. On 09-APR-2021, the subject experienced intermittent headaches. On 09-APR-2021, the subject experienced sore arm at injection site. On 14-APR-2021, the subject experienced major arm pain. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced hamstring and quadricep pain. On 24-APR-2021, the subject experienced bruise in left groin. On 24-APR-2021, the subject experienced bump in left groin. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 20-APR-2021, major arm pain on 17-APR-2021, and sore arm at injection site on 16-APR-2021, was recovering from hamstring and quadricep pain, bruise in left groin, and bump in left groin, and had not recovered from intermittent headaches. This report was non-serious. This case, from the same reporter is linked to 20210458898.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Swelling, Ultrasound scan
Clinical narrative: BRUISE IN LEFT GROIN; BUMP IN LEFT GROIN; MIGRAINE; HAMSTRING AND QUADRICEP PAIN; MAJOR ARM PAIN; INTERMITTENT HEADACHES; SORE ARM AT INJECTION SITE; This spontaneous report received from a patient concerned a 54 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included migraine, and allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031,expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. Concomitant medications included norethisterone.  On APR-2021, treatment medications included: acetylsalicylic acid, ibuprofen, and paracetamol. On 09-APR-2021, the subject experienced intermittent headaches. On 09-APR-2021, the subject experienced sore arm at injection site. On 14-APR-2021, the subject experienced major arm pain. On 19-APR-2021, the subject experienced migraine. On 19-APR-2021, the subject experienced hamstring and quadricep pain. On 24-APR-2021, the subject experienced bruise in left groin. On 24-APR-2021, the subject experienced bump in left groin. Laboratory data (dates unspecified) included: Diagnostic ultrasound (NR: not provided) unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from migraine on 20-APR-2021, major arm pain on 17-APR-2021, and sore arm at injection site on 16-APR-2021, was recovering from hamstring and quadricep pain, bruise in left groin, and bump in left groin, and had not recovered from intermittent headaches. This report was non-serious. This case, from the same reporter is linked to 20210458898.; Sender's Comments: V0: Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Hospitalisation
Clinical narrative: HOSPITALIZATION; This spontaneous report received from a patient via a company representative concerned five adult female 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, batch number: Unknown) dose, 1 total, start therapy date were not reported on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Non-company co-suspect medications included unspecified birth control pills (pills, oral) dose, start therapy date were not reported for contraception. No concomitant medications were reported.  On an unspecified date, the patients were hospitalized for heart transplant to be performed. As per their physician, this could be due to Janssen Covid-19 vaccine and unspecified birth control pills. Number of hospitalization days were not specified. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hospitalization was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:  20210458940 -COVID-19 VACCINE AD26.COV2.S- Hospitalization. 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: Dizziness
Clinical narrative: LIGHT HEADED; This spontaneous report received from a patient via a company representative concerned a 96 year old female. 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 MAR-2021 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 MAR-2021, the subject experienced light headed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light headed on MAR-2021. This report was non-serious.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Computerised tomogram head, Echocardiogram, Magnetic resonance imaging head, Ophthalmological examination
Clinical narrative: TRANSIENT ISCHAEMIC ATTACK; BLINDNESS UNILATERAL; VISION BLURRED; COMPUTERISED TOMOGRAM HEAD; ECHOCARDIOGRAM; MAGNETIC RESONANCE IMAGING HEAD; ULTRASOUND DOPPLER; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1231357) concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included congestive heart failure, and atrial fibrillation, and concurrent conditions included diabetes, and other pre-existing medical conditions included patient has no allergy or illness. 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, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, magnesium, and mecobalamin. On 06-APR-2021, the patient woke up with lost of vision in left eye for 4 to 5 hours. Patient went to her ophthalmologist; the sight came back but very blurry. Retina specialist had seen patient on 13-APR-2021 and diagnosed transient ischaemic attack of left eye. The patient was guided to go to ER on 13-APR-2021. On 06-APR-2021, the patient experienced blindness unilateral, vision blurred. The patient was admitted in the hospital on 13-APR-2021 and was hospitalized for 3 days. Laboratory data included: Computerized tomogram head (NR: not provided) UNKNOWN, Echocardiogram (NR: not provided) UNKNOWN, Magnetic resonance imaging head (NR: not provided) UNKNOWN, and Ultrasound Doppler (NR: not provided) UNKNOWN. Laboratory data (dates unspecified) included: Eye exam (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210500771 - Covid-19 vaccine ad26.cov2.s- blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. 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: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Transient ischaemic attack, Ultrasound Doppler, Vision blurred
Clinical narrative: TRANSIENT ISCHAEMIC ATTACK; BLINDNESS UNILATERAL; VISION BLURRED; COMPUTERISED TOMOGRAM HEAD; ECHOCARDIOGRAM; MAGNETIC RESONANCE IMAGING HEAD; ULTRASOUND DOPPLER; This spontaneous report received from a patient via a Regulatory Authority Vaccine Adverse Event Reporting System (VAERS) (VAER reference number 1231357) concerned a 79 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included congestive heart failure, and atrial fibrillation, and concurrent conditions included diabetes, and other pre-existing medical conditions included patient has no allergy or illness. 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, 1 total, administered on left arm on 08-MAR-2021 for prophylactic vaccination. Concomitant medications included ergocalciferol, magnesium, and mecobalamin. On 06-APR-2021, the patient woke up with lost of vision in left eye for 4 to 5 hours. Patient went to her ophthalmologist; the sight came back but very blurry. Retina specialist had seen patient on 13-APR-2021 and diagnosed transient ischaemic attack of left eye. The patient was guided to go to ER on 13-APR-2021. On 06-APR-2021, the patient experienced blindness unilateral, vision blurred. The patient was admitted in the hospital on 13-APR-2021 and was hospitalized for 3 days. Laboratory data included: Computerized tomogram head (NR: not provided) UNKNOWN, Echocardiogram (NR: not provided) UNKNOWN, Magnetic resonance imaging head (NR: not provided) UNKNOWN, and Ultrasound Doppler (NR: not provided) UNKNOWN. Laboratory data (dates unspecified) included: Eye exam (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210500771 - Covid-19 vaccine ad26.cov2.s- blindness unilateral, transient ischaemic attack, vision blurred, computerised tomogram head, echocardiogram, magnetic resonance imaging head, and ultrasound doppler. 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: 66.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Coronavirus test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 66 year old female. The patient's height, and weight were not reported. The patient's height, and weight were not reported. The patient's concurrent conditions included high-blood pressure, non smoker, no alcohol use, pain, and allergy-sneezing, and other pre-existing medical conditions included no drug abuse/illicit drug use. 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 01-APR-2021 on right arm for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included diphenhydramine hydrochloride for allergies-sneezing, ascorbic acid/thiamine hydrochloride for drug used for unknown indication, amlodipine for high blood pressure, and ibuprofen for pain. The patient had no adverse events after the vaccine. On 30-APR-2021, the patient underwent a swab test for COVID-19 which was positive. At the time of the report, patient was not feeling well with runny nose, light cough, light body aches and no appetite. She further reported that she felt warm and cold occasionally. Laboratory data included: Coronavirus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from confirmed covid-19 infection, and confirmed clinical vaccination failure. This report was serious (Other Medically Important Condition).; Sender's Comments: 2021501889-Covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. 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: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling drunk, Gait disturbance, Heart rate increased
Clinical narrative: FAST HEARTBEAT; FEELING FAINT; TWITCHING IN INJECTION SITE ARM; FELT LIKE GETTING DRUNK; ARM FELT NUMB; FEELING LIKE FLUID IS GOING INTO  ARM RANDOMLY; PHANTOM INJECTION SITE ARM PAIN; STUMBLED A BIT; LEGS BUCKLED; This spontaneous report received from a patient concerned a 28 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 MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced feeling faint. On MAR-2021, the subject experienced twitching in injection site arm. On MAR-2021, the subject experienced felt like getting drunk. On MAR-2021, the subject experienced arm felt numb. On MAR-2021, the subject experienced feeling like fluid is going into arm randomly. On MAR-2021, the subject experienced phantom injection site arm pain. On MAR-2021, the subject experienced stumbled a bit. On MAR-2021, the subject experienced legs buckled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like getting drunk on MAR-2021, had not recovered from phantom injection site arm pain, twitching in injection site arm, fast heartbeat, legs buckled, feeling faint, and feeling like fluid is going into arm randomly, and the outcome of arm felt numb and stumbled a bit was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Injection site reaction, Muscular weakness
Clinical narrative: FAST HEARTBEAT; FEELING FAINT; TWITCHING IN INJECTION SITE ARM; FELT LIKE GETTING DRUNK; ARM FELT NUMB; FEELING LIKE FLUID IS GOING INTO  ARM RANDOMLY; PHANTOM INJECTION SITE ARM PAIN; STUMBLED A BIT; LEGS BUCKLED; This spontaneous report received from a patient concerned a 28 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 MAR-2021, the subject experienced fast heartbeat. On MAR-2021, the subject experienced feeling faint. On MAR-2021, the subject experienced twitching in injection site arm. On MAR-2021, the subject experienced felt like getting drunk. On MAR-2021, the subject experienced arm felt numb. On MAR-2021, the subject experienced feeling like fluid is going into arm randomly. On MAR-2021, the subject experienced phantom injection site arm pain. On MAR-2021, the subject experienced stumbled a bit. On MAR-2021, the subject experienced legs buckled. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt like getting drunk on MAR-2021, had not recovered from phantom injection site arm pain, twitching in injection site arm, fast heartbeat, legs buckled, feeling faint, and feeling like fluid is going into arm randomly, and the outcome of arm felt numb and stumbled a bit was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 POSITIVE; This spontaneous report received from a patient concerned a 54 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: 1808609 and expiry: 09-JUN-2021) dose was not reported, administered on 31-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported.  The patient received the Janssen covid vaccine on 31-MAR-2021 then travelled on 17-APR-2021. On 18-APR-2021, the patient went to get tested, Laboratory data included: COVID-19 virus test (NR: not provided) Negative. On 01-MAY-2021, patient was tested again using a Polymerase chain reaction (PCR) test and it was found out that the patient was positive (confirmed covid-19 positive and confirmed clinical vaccination failure). It was reported that the patient was asymptomatic and did not exhibited any signs of a Covid 19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the confirmed clinical vaccination failure and confirmed covid-19 positive was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000178236.; Sender's Comments: V0:20210502752- COVID-19 VACCINE AD26.COV2.S-CONFIRMED CLINICAL VACCINATION FAILURE. 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: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Feeling abnormal
Clinical narrative: GO INTO A FIB MUCH MORE THAN I DID; THOUGHT WAS GONNA DIE FOR 10 DAYS; This spontaneous report received from a  patient via social media concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included autoimmune disease, and atrial fibrillation. 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 was gonna die for 10 days. It had been a Montblanc doing better except she went into atrial fibrillation much more than she did. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the thought was gonna die for 10 days and go into a fib much more than I did was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210503103-covid-19 vaccine ad26.cov2.s -Go into a fib much more than i did. This event(s) is considered unassessable. The event(s) has an unknown/unclear 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: Body temperature, Cardiac arrest, Diarrhoea, Feeling abnormal, Headache
Clinical narrative: CARDIAC ARREST; HYPOTHERMIA; HER BG WAS LOW; DIARRHEA; NAUSEA; FELT SOMETHING WAS GOING THROUGH HER BODY; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bypass, and concurrent conditions included type 1 diabetes mellitus (T1DM), and heart disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021 after receiving the vaccine, the patient felt something was going through her body for 45 minutes. She experienced nausea and a slight headache. On 18-MAR-2021, she felt fine. On 29-MAR-2021, she woke up middle on the night and felt he blood glucose (BG) was low (T1DM). Later she woke up again and experienced nausea and drank juice. She developed diarrhea and sever chest pain. The ambulance arrived, her body temperature was 93.7 degrees F, her BG was 54 mg/dL. She developed cardiac arrest and admitted to the hospital for 3 day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest, hypothermia, diarrhea, nausea, and felt something was going through her body, and slight headache on 18-MAR-2021, and the outcome of her BG was low was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210503747-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST, HYPOTHERMIA, HER BG WAS LOW. 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, UNDERLYING DISEASE 20210503747-COVID-19 VACCINE AD26.COV2.S-DIARRHEA. 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). 20210503747-COVID-19 VACCINE AD26.COV2.S-NAUSEA. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Hypoglycaemia, Hypothermia, Nausea
Clinical narrative: CARDIAC ARREST; HYPOTHERMIA; HER BG WAS LOW; DIARRHEA; NAUSEA; FELT SOMETHING WAS GOING THROUGH HER BODY; SLIGHT HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included bypass, and concurrent conditions included type 1 diabetes mellitus (T1DM), and heart disease. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, 1 total dose administered on 17-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 17-MAR-2021 after receiving the vaccine, the patient felt something was going through her body for 45 minutes. She experienced nausea and a slight headache. On 18-MAR-2021, she felt fine. On 29-MAR-2021, she woke up middle on the night and felt he blood glucose (BG) was low (T1DM). Later she woke up again and experienced nausea and drank juice. She developed diarrhea and sever chest pain. The ambulance arrived, her body temperature was 93.7 degrees F, her BG was 54 mg/dL. She developed cardiac arrest and admitted to the hospital for 3 day. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cardiac arrest, hypothermia, diarrhea, nausea, and felt something was going through her body, and slight headache on 18-MAR-2021, and the outcome of her BG was low was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20210503747-COVID-19 VACCINE AD26.COV2.S-CARDIAC ARREST, HYPOTHERMIA, HER BG WAS LOW. 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, UNDERLYING DISEASE 20210503747-COVID-19 VACCINE AD26.COV2.S-DIARRHEA. 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). 20210503747-COVID-19 VACCINE AD26.COV2.S-NAUSEA. This event(s) is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: POTENTIALLY EXPIRED DOSE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 50 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, expiry: 21-JUN-2021) dose was not reported, administered on 30-APR-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 30-APR-2021, the subject experienced expired dose administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired dose administered was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthenia, COVID-19, Paraesthesia
Clinical narrative: ELECTRIC SHOCK SENSATIONS; STOMACH PAIN; HEADACHE, NAUSEA, MUSCLE SORENESS; LACK OF ENERGY AND TIREDNESS; This spontaneous report received from a patient concerned a 52 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient was non alcoholic, non smoker and had no known drug allergies. the patient did not have any drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 29-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 01-MAY-2021, the subject experienced lack of energy and tiredness. On 02-MAY-2021, the subject experienced electric shock sensations, stomach pain, headache, nausea, muscle soreness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stomach pain on 02-MAY-2021, and headache, nausea, muscle soreness, and had not recovered from electric shock sensations, and lack of energy and tiredness. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Malaise, Pyrexia, Vomiting
Clinical narrative: VOMITTING/CANNOT KEEP ANYTHING DOWN, IT KEEPS COMING BACK UP; CHILLS; MALAISE; FEVER 102; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and batch number: 203A21A expiry: UNKNOWN) dose was not reported, administered on 03-MAY-2021 10:30 for prophylactic vaccination. No concomitant medications were reported. On 03-MAY-2021, the subject experienced vomiting /cannot keep anything down, it keeps coming back up. On 03-MAY-2021, the subject experienced chills. On 03-MAY-2021, the subject experienced malaise. On 03-MAY-2021, the subject experienced fever 102. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever 102, malaise, vomiting/cannot keep anything down, it keeps coming back up, and chills. This report was non-serious.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest discomfort, Headache, Hypoaesthesia, Hypoaesthesia eye, Magnetic resonance imaging
Clinical narrative: LEFT ARM NUMBNESS; LEG CRAMPING; NUMBNESS UNDER LEFT EYE; NAUSEA; CHEST PRESSURE; SEVERE HEADACHES; This spontaneous report received from a parent concerned a 43 year old female. 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) frequency 1 total, dose not reported, on approximately 08-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.The patient was not pregnant at the time of report. Patient had the Janssen Covid-19 vaccine on approximately 08-APR-2021 and started experiencing side effects on 14-APR-2021 (six days later) which included severe headaches, nausea, left arm numbness, cramping in one leg, and chest pressure. Patient went to Emergency room several times for these symptoms and was discharged each time. Patient also had numbness under left eye and was admitted to hospital on or about 16-APR-2021 or 17-APR-2021 to rule out blood clot on MRI and was diagnosed with arachnoid granulation and released on 20-APR-2021. Patient was hospitalized for approximately 3-4 days. Patient then started with chest pressure, slight headache and leg cramping and went to Emergency room on evening of 02-MAY-2021.On an unspecified date in  APR-2021, Laboratory data included: MRI(Magnetic resonance imaging) (NR: not provided) arachnoid granulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure, severe headaches, left arm numbness, leg cramping, numbness under left eye and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210504059- Covid-19 vaccine ad26.cov2.s- left arm numbness, leg cramping, numbness under left eye. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210504059-covid-19 vaccine ad26.cov2.s nausea. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle spasms, Nausea
Clinical narrative: LEFT ARM NUMBNESS; LEG CRAMPING; NUMBNESS UNDER LEFT EYE; NAUSEA; CHEST PRESSURE; SEVERE HEADACHES; This spontaneous report received from a parent concerned a 43 year old female. 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) frequency 1 total, dose not reported, on approximately 08-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.The patient was not pregnant at the time of report. Patient had the Janssen Covid-19 vaccine on approximately 08-APR-2021 and started experiencing side effects on 14-APR-2021 (six days later) which included severe headaches, nausea, left arm numbness, cramping in one leg, and chest pressure. Patient went to Emergency room several times for these symptoms and was discharged each time. Patient also had numbness under left eye and was admitted to hospital on or about 16-APR-2021 or 17-APR-2021 to rule out blood clot on MRI and was diagnosed with arachnoid granulation and released on 20-APR-2021. Patient was hospitalized for approximately 3-4 days. Patient then started with chest pressure, slight headache and leg cramping and went to Emergency room on evening of 02-MAY-2021.On an unspecified date in  APR-2021, Laboratory data included: MRI(Magnetic resonance imaging) (NR: not provided) arachnoid granulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure, severe headaches, left arm numbness, leg cramping, numbness under left eye and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210504059- Covid-19 vaccine ad26.cov2.s- left arm numbness, leg cramping, numbness under left eye. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210504059-covid-19 vaccine ad26.cov2.s nausea. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest discomfort, Chest pain, Echocardiogram
Clinical narrative: LEFT ARM NUMBNESS; LEG CRAMPING; NUMBNESS UNDER LEFT EYE; NAUSEA; CHEST PRESSURE; SEVERE HEADACHES; This spontaneous report received from a parent concerned a 43 year old female. 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) frequency 1 total, dose not reported, on approximately 08-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.The patient was not pregnant at the time of report. Patient had the Janssen Covid-19 vaccine on approximately 08-APR-2021 and started experiencing side effects on 14-APR-2021 (six days later) which included severe headaches, nausea, left arm numbness, cramping in one leg, and chest pressure. Patient went to Emergency room several times for these symptoms and was discharged each time. Patient also had numbness under left eye and was admitted to hospital on or about 16-APR-2021 or 17-APR-2021 to rule out blood clot on MRI and was diagnosed with arachnoid granulation and released on 20-APR-2021. Patient was hospitalized for approximately 3-4 days. Patient then started with chest pressure, slight headache and leg cramping and went to Emergency room on evening of 02-MAY-2021.On an unspecified date in  APR-2021, Laboratory data included: MRI(Magnetic resonance imaging) (NR: not provided) arachnoid granulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure, severe headaches, left arm numbness, leg cramping, numbness under left eye and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210504059- Covid-19 vaccine ad26.cov2.s- left arm numbness, leg cramping, numbness under left eye. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210504059-covid-19 vaccine ad26.cov2.s nausea. This event is labeled per RSI and is therefore considered potentially related.
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram, Hypoaesthesia, Magnetic resonance imaging, Migraine, Nausea
Clinical narrative: LEFT ARM NUMBNESS; LEG CRAMPING; NUMBNESS UNDER LEFT EYE; NAUSEA; CHEST PRESSURE; SEVERE HEADACHES; This spontaneous report received from a parent concerned a 43 year old female. 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) frequency 1 total, dose not reported, on approximately 08-APR-2021 for prophylactic vaccination.The batch number was not reported and has been requested. No concomitant medications were reported.The patient was not pregnant at the time of report. Patient had the Janssen Covid-19 vaccine on approximately 08-APR-2021 and started experiencing side effects on 14-APR-2021 (six days later) which included severe headaches, nausea, left arm numbness, cramping in one leg, and chest pressure. Patient went to Emergency room several times for these symptoms and was discharged each time. Patient also had numbness under left eye and was admitted to hospital on or about 16-APR-2021 or 17-APR-2021 to rule out blood clot on MRI and was diagnosed with arachnoid granulation and released on 20-APR-2021. Patient was hospitalized for approximately 3-4 days. Patient then started with chest pressure, slight headache and leg cramping and went to Emergency room on evening of 02-MAY-2021.On an unspecified date in  APR-2021, Laboratory data included: MRI(Magnetic resonance imaging) (NR: not provided) arachnoid granulation. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chest pressure, severe headaches, left arm numbness, leg cramping, numbness under left eye and nausea was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- 20210504059- Covid-19 vaccine ad26.cov2.s- left arm numbness, leg cramping, numbness under left eye. These events are considered unassessable. The events have a compatible/suggestive temporal relationship, are unlabeled, and have unknown scientific plausibility. There is no information on any other factors potentially associated with the event. 20210504059-covid-19 vaccine ad26.cov2.s nausea. This event is labeled per RSI and is therefore considered potentially related.