chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: No additional AE reported; expired GARDASIL 9 that was administered; Product also experienced temperature excursion; This spontaneous report was received from Pharmacist and refers to a 14-year-old male.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 30-NOV-2022, the patient was vaccinated with an improperly stored first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #T025367, expiration date: 18-NOV-2022, administered intramuscularly in the right deltoid for prophylaxis (strength was not provided) (Improper storage of product in use) (Expired vaccine used). The vaccine underwent a temperature excursion of 24.5 degree Celsius (C) for a period of 15 hours and 38 minutes. The vaccine did not undergo previous temperature excursions. The pharmacist reported that the patient did not experience any adverse event.  The medical assistant confused the date format, only saw the month and year of expiration and thought that the vaccine was good until the end of the month and the caller wanted to verify vaccine viability. The vaccine underwent a temperature excursion of 24.5 degree Celsius (C) for a period of 15 hours and 38 minutes. The vaccine did not undergo previous temperature excursions. The pharmacist reported that the patient did not experience any adverse event.  The nurse considered the event of Expired vaccine used as resolved.
Sex: U
Vaccine: VARZOS
Symptoms: Cerebrovascular accident
Clinical narrative: massive stroke; This spontaneous report was received from a patient of unknown gender and age and referred to herself/himself.  The patient's medical history, concurrent condition and concomitant therapy were not reported.  On an unknown date in 2018, the patient was ordered to get a dose of zoster vaccine live (ZOSTAVAX) (strength, lot #, expiry date, and route of administration were not provided) for prophylaxis, which was to qualify for life-saving surgery. And on an unknown date (reported as 10 days later), the patient had a massive stroke. The outcome of event was unknown. The action taken was not applicable.  The patient considered the event was undeniably caused by zoster vaccine live (ZOSTAVAX).  Upon internal review, the event stroke was considered to be medical significant event.  This is one of two cases sent by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Suffered multiple outbreaks of herpes zoster; Information has been received from a lawyer regarding a case in litigation and referred to a patient (pt) of unknown age and gender. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, strength, route, lot number and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). After receiving zoster vaccine live (ZOSTAVAX) vaccine, the pt suffered multiple outbreaks of herpes zoster. As a result of these symptoms, the pt was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The pt also experience mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the event was considered as not recovered. The causality assessment between the event and suspect vaccine was related. Herpes zoster was considered as disability by the reporter.
Sex: U
Vaccine: HEPA, HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; Caller reported 2nd dose of VAQTA was administered too early.; This spontaneous report was received from a nurse and refers to an 18-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 23-JUN-2022, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). On 05-DEC-2022, the patient was vaccinated too early with the second dose of hepatitis a vaccine, inactivated (VAQTA) (Inappropriate schedule of product administration) intramuscular injection, 0.5 milliliter, valid lot #W002894, expiration date: 06-MAR-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: FLUN4
Symptoms: Cough, Influenza, Influenza A virus test positive, Influenza B virus test positive, Pyrexia
Clinical narrative: PATIENT WAS VACCINATED WITH FLUMIST QUADRIVALENT AND REPORTED 4 DAYS LATER WITH A FEVER AND COUGH. PATIENT WAS TESTED AND IT CAME BACK POSITIVE FOR BOTH INFLUENZA A; Patient was vaccinated with FluMist Quadrivalent and reported 4 days later with a fever and cough.  Patient was tested and it came back positive for both influenza A & B; POSITIVE FOR INFLUENZA B; Patient was vaccinated with FluMist Quadrivalent and reported 4 days later with a fever and cough.  Patient was tested and it came back positive for both influenza A & B; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender (age not provided) of Unknown ethnic origin.    No medical history was reported. The following demography was reported for the patient's parent:   Sex: Unknown    No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) once/single administration, via nasal route, on an unknown date.     A Health Professional administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On an unknown date, the patient experienced patient was vaccinated with flumist quadrivalent and reported 4 days later with a fever and cough. patient was tested and it came back positive for both influenza a (preferred term: Influenza A virus test positive). On an unknown date, the patient experienced positive for influenza b (preferred term: Influenza B virus test positive).     The outcome of the event(s) of patient was vaccinated with flumist quadrivalent and reported 4 days later with a fever and cough. patient was tested and it came back positive for both influenza a and positive for influenza b was unknown.     The events were considered non-serious.     Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray   Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome
Clinical narrative: guillian barre syndrome; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Shingrix.     Additional Information: GSK Receipt Date: 10-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that one Shingrix vaccine gave him/her Guillain Barre syndrome. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 0.5
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 6 month old received Bexsero; This case was reported by a consumer and described the occurrence of inappropriate age at vaccine administration in a 6-month-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd December 2022, unknown after receiving Bexsero and Bexsero 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 Information: GSK Receipt Date: 04-DEC-2022 Reporter's comment: The reporter stated that 6 month old baby was mistakenly administered one dose of bexsero in her thigh. The reporter stated the patient did not had any visible adverse reactions, but were hoping to speak to someone about the incident as physician's office was not been very helpful. Additional Supportive Information: The six month old patient received a dose of Bexsero which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Chest discomfort
Clinical narrative: Tightness in chest; This case was reported by a consumer via interactive digital media and described the occurrence of chest tightness in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 5th December 2022, the patient received Shingles vaccine. On 5th December 2022, less than a day after receiving Shingles vaccine, the patient experienced chest tightness. On an unknown date, the outcome of the chest tightness was not recovered/not resolved.   It was unknown if the reporter considered the chest tightness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05 DEC 2022 Reporter's comment: This case was reported by the patient's wife interactive digital media. The patient's wife stated that the patient got a shingles shot about 3 hours ago The patient was feeling a tightness in chest.
Sex: M
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: immobilized  left arm.; This case was reported by a consumer via interactive digital media and described the occurrence of mobility decreased in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced mobility decreased. On an unknown date, the outcome of the mobility decreased was unknown.   The reporter considered the mobility decreased to be possibly related to Shingrix.  Additional Information: GSK Receipt Date: 04-DEC-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient had Shingrix vaccine and immobilized his left arm. The reporter thought that, the event might had been related to the drug. Additional Supportive Information: The follow up would not possible, as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose a year go, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received  a year ago .).   On an unknown date, the patient did not 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 Information: GSK receipt date:  05-DEC-2022 Reporters comment: The reporter was the patient brother and he reported that the his brother got first shingrix shot a year ago and has not received the second shingrix shot. No further information reported to the agent by the patient. The reporter declined to give any further contact information and ended call promptly The reporter did not consent to follow-up. Additional Supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only adjuvant used; Only adjuvant administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th December 2022, the patient received Shingrix. On 5th December 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-DEC-2022 Reporter's Comments: The pharmacist reported that the patient accidentally received only the adjuvant of the Shingrix. The health care professional did not have any information about the patient or the vaccine (lot number or expiration date) since the call was done on behalf of the HCP that administered it. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional supportive information: The patient accidentally received only the adjuvant of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 20.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 20-year-old male patient who received HBV (Engerix B) (batch number 4F472, expiry date 6th November 2022) for prophylaxis.   On 4th December 2022, the patient received the 3rd dose of Engerix B. On 4th December 2022, 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 Information: GSK Receipt Date: 06-DEC-2022 Reporter's comment: The reporter stated that on 4th December 2022 a patient had been administered a dose of Engerix-B that had expired on 6th November 2022. Additional Supportive Information: The patient received expire dose of Engerix B which leads to expire vaccine used. The reporter gave consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose received before 2 months; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's comment: The registered nurse reported that the patient received second dose of Shingrix greater than 28 days after first dose but less than two months after the first dose of Shingrix. As per reporter patient was immunocompetent and it indicated age range for Shingrix administration. At the time of reporting, the reporter did not have any additional details about adverse event (that was patient demographics, dates of Shingrix administration, lot and expiration dates of Shingrix vaccines) The reporter did not consent to follow up. Additional supportive information: The patient received the second dose of Shingrix earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Optic nerve injury, Vaccination failure
Clinical narrative: Nerve damage in the eye; Shingles of the trigeminal nerve; Got shingles after two Shingrix doses/Suspected vaccination failure; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7FY22, expiry date 25th April 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 9XC39, expiry date 30th January 2020) for prophylaxis.   On 15th May 2018, the patient received the 2nd dose of Shingrix. On 31st January 2018, the patient received the 1st dose of Shingrix. On 25th September 2022, 1594 days after receiving Shingrix and 1698 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced optic nerve damage (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the optic nerve damage and shingles were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, optic nerve damage and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 07-DEC-2022 Reporter's Comment: The retired pharmacist reported that the patient received first and second dose of Shingrix at a local in 2018 and diagnosed with shingles of the trigeminal nerve and the patient was still struggling with some nerve damage in the eye, unfortunately. The reporter reported that the patient was her husband also a pharmacist. The reporter asked if a person got shingles even after having the two Shingrix doses, should he get another Shingrix vaccination after he recovers.  The reporter consented to follow up by postal.  Additional Supportive Information: This case was considered as suspected vaccination failure as details regarding, laboratory test confirming shingles were unknown at the time of reporting.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months old received Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number PX27D, expiry date 17th January 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st December 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st December 2022, 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 Information: GSK receipt date: 07-DEC-2022 Reporter's comment: The reporter reported that Kinrix was administered to the 5 patients under the age of 4 years old. The reporter was consented to follow up. Additional supportive information: The patient received Kinrix at 4 months of age, which led to Inappropriate age at vaccine administration. This is one of 5 link cases reported by same reporter.; Sender's Comments:  US-GSK-US2022183609:Same reporter US-GSK-US2022183610:Same reporter US-GSK-US2022183612:Same reporter US-GSK-US2022183615:Same reporter
Sex: M
Vaccine: COVID19
Symptoms: CSF protein, Demyelinating polyneuropathy
Clinical narrative: DEMYELINATING NEUROPATHY; This spontaneous report was received from literature. This report concerned a male of unspecified age, race and ethnicity. The objective of this study was to report on demyelinating neuropathies following COVID-19 Vaccination.  The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not had other co-morbidities or histories suggesting an alternate diagnosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. 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 four cases of acute and chronic demyelinating neuropathies following COVID-19 vaccination were seen. All were males, ages 2683 years old. Two received the Pfizer-BioNTech vaccine, one received Moderna and one received Johnson and Johnson. Post vaccination ranged from 221 days after the final dose of vaccination, the time from symptom onset to neurological evaluation ranged from 3 weeks to 4 months, during which symptoms progressed. Patient presented with progressive numbness, weakness, areflexia in all limbs and had difficulty walking. Severe facial diplegia was seen and other bulbar symptoms one other case. Three patient had electrophysiologic studies confirming demyelination while one case had subacute polyradiculopathies. Cerebrospinal fluid protein was elevated and also normal. The diagnosis was acute inflammatory demyelinating polyneuropathy (AIDP) in one case, chronic demyelinating polyradiculoneuropathy (CIDP) in two, and subacute polyradiculopathies in one. The cases with AIDP and CIDP received treatment with intravenous immunoglobulin due to significant motor disability, while the case with subacute polyradiculopathies had spontaneous recovery within 8 weeks. Of the treated cases, two had significant improvement by outpatient follow-up at 24 weeks post-treatment and one has yet to follow up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of demyelinating neuropathy was not reported. The authors emphasized that continued identification and reporting of demyelinating neuropathies following COVID-19 vaccination was essential to determining whether a causal association was present. Prompt evaluation for alternative etiologies was vital, and early treatment was recommended. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221216773-demyelinating neuropathy. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Serology test
Clinical narrative: TIP VARIANT OF FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS); This spontaneous report was received from literature. This report concerned a 45 year old male. The objective of this study was to describe tip variant of focal segmental glomerulosclerosis post COVID-19 vaccination with one case report. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no past medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. Age at time of vaccination 5 decade old. 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, 1 week after receiving vaccine, the patient presented with progressive worsening lower extremity edema. He was not taking any prescribed or over the counter medications. His physical exam showed BP (blood pressure) of 160/90 mmHg and plus 2 lower extremity edema. Laboratory studies revealed that, BUN (blood urea nitrogen) 97 mg/dL, serum creatinine 6.7 mg/dL (baseline 0.8 mg/ dL), serum albumin 1.8 g/dL and 24-hour urine protein of 6.5 g. Serological workup was negative. A kidney biopsy showed focal areas of segmental glomerulosclerosis (FSGS), associated with endocapillary foam cells and epithelial cell capping, predominantly involving the takeoff point of the proximal tubule. The areas of segmental sclerosis herniated into the proximal tubule. Immunofluorescence was negative and electron microscopy revealed diffuse epithelial foot process effacement. The patient was diagnosed with tip variant of FSGS (focal segmental glomerulosclerosis) and started on oral prednisone 80 mg daily. He required initiation of dialysis and has no evidence of renal recovery to date. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from tip variant of focal segmental glomerulosclerosis (FSGS). The authors emphasized on new cases and relapses of GN's (glomerulonephritis) can present shortly after mRNA COVID-19 vaccination. IgA nephropathy, FSGS and minimal change disease have been reported. The tip variant of FSGS usually presents as a primary podocytopathy and had the best prognosis among the various forms of FSGS due to its high response to steroid therapy and low risk of progression. This report was serious (Other Medically Important Condition). This case, from the Others is linked to 20221220276.; Sender's Comments: V0- 20221218638- A tip variant of focal segmental glomerulosclerosis-The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the Agency Causality is considered indeterminate. The company causality is considered related.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: CSF test, Central nervous system inflammation, Facial paresis, Magnetic resonance imaging
Clinical narrative: PERSISTENT CENTRAL NERVOUS SYSTEM INFLAMMATION; BILATERAL PERIPHERAL FACIAL WEAKNESS; This spontaneous report was received from literature. This report concerned a 39 year old male of an unspecified race and ethnicity. The objective of this study was to report a case series of 3 patients who developed neuro-inflammation following administration of the J and J vaccine. Spinal cord was involved in all 3 patients, brain in 2, and peripheral nervous system involvement (facial nerve enhancement, radiculitis) in 2 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, and batch number and expiry were not reported) dose not reported, 1 total administered on an unspecified date for covid-19 prophylaxis. Age at time of vaccination 4 decade old. 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, after ten days of vaccination, the patient experienced persistent central and peripheral nervous system inflammation, bilateral ascending numbness, gait instability, urinary hesitancy/urgency, and bilateral peripheral facial weakness. Laboratory data (dates unspecified) included: CSF (Cerebrospinal fluid) test results showed lymphocytic pleocytosis and elevated protein, with no oligoclonal bands Extensive serum, and Magnetic resonance imaging (MRI) bilateral facial nerve enhancement, patchy cervical and thoracic cord and cauda equina enhancement. Patient developed recurrent symptoms during steroid taper 3 months later; MRIs (Magnetic resonance imaging) showed persistent enhancement and enlarging lesions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the persistent central nervous system inflammation and bilateral peripheral facial weakness was not reported. The authors concluded that central and peripheral nervous system inflammatory involvement without clear alternative explanation can rarely be seen in close temporal relationship to administration of the J&J COVID-19 vaccine. Unusual feature of case was clinical/radiographic worsening and persistent enhancement several months after initial presentation. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20221218576 and 20221219559.; Sender's Comments: V0: 20221219487-Persistent central nervous system inflammation and Bilateral peripheral facial weakness. The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: CSF test, Central nervous system inflammation, Lumbar radiculopathy, Magnetic resonance imaging
Clinical narrative: PERSISTENT CENTRAL AND PERIPHERAL NERVOUS SYSTEM INFLAMMATION; LUMBAR NERVE ROOT ENHANCEMENT/RADICULITIS; This spontaneous report was received from literature. This report concerned a 34 year old female of an unspecified race and ethnicity. The objective of this case series was to report a case of a patient who developed neuro-inflammation following administration of the J and J vaccine (Ad26.COV2.S). The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 administered for covid-19 prophylaxis. 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 2 weeks after J&J covid-19 vaccination, the patient experienced persistent central and peripheral nervous system inflammation, and on an unspecified date experienced lumbar nerve root enhancement/radiculitis. It was reported that the patient developed blurred vision, body aches, paresthesias and urinary retention 2 weeks after J&J covid-19 vaccination, and 3 months later patient developed new enhancing brain lesions with persistent enhancement in the spine. Laboratory data (dates unspecified) included: Magnetic resonance imaging revealed large, mostly enhancing fluffy occipital/parietal lesions, cervical lesion, longitudinally extensive thoracic lesion and lumbar nerve root enhancement, and CSF (cerebrospinal fluid) test revealed neutrophilic pleocytosis and elevated protein. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the persistent central and peripheral nervous system inflammation and lumbar nerve root enhancement/radiculitis was not reported. The authors of this case series highlighted that central and peripheral nervous system inflammatory involvement without clear alternative explanation can rarely be seen in close temporal relationship to administration of the J&J COVID-19 vaccine. Unusual feature of this cases was clinical/radiographic worsening and persistent enhancement several months after initial presentation. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20221218576 and 20221219487.; Sender's Comments: V0: 20221219559- persistent central nervous system inflammation, lumbar nerve root enhancement/ radiculitis.   The event has a compatible/suggestive temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, this event is considered consistent with vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: HAD A BLOOD CLOT; This spontaneous report received from a patient through social media (J&J Corporate) and via a company representative concerned a female of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total, dose 1 administered for covid-19 prophylaxis. 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 patient developed a blood clot, and had stents in legs. It was reported that "Took the j & j now have stents in my legs, had a blood clot, hubby had Sepsis and passed away. I trusted J because they had been around forever and should know what they are doing". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had a blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221222577.; Sender's Comments: V0: 20221222579- had a blood clot. The event has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 57.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Asthma, Rash, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; EXACERBATED ASTHMA; RASH BROKE OUT ON BODY AFTER COVID INFECTION; This spontaneous report received from a patient concerned a 58 year old. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, underlying conditions Shellfish allergy, and overweight. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin not reported, batch number: 1805022, expiry: UNKNOWN) dose was not reported, 1 total administered on 18-MAR-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 57 years old. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, route of admin not reported, batch number: 211091A expiry: UNKNOWN) dose was not reported, 1 total administered on 01-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 57 years old. No concomitant medications were reported. The patient also received Non-company suspect vaccine included: influenza vaccine (form of admin, route of admin, and batch number and expiry date were not reported) dose was not reported, administered on 01-DEC-2021 for prophylactic vaccination. On unspecified date around beginning to middle of SEP-2022, the patient experienced suspected covid-19 infection (Omicron variant) (along with symptoms of breathing issues and extreme fatigue) (Dose number in series 2). On an unspecified date in 2022, the patient experienced exacerbated asthma (breathing from - exacerbated asthma) and rash broke out on body after infection (Dose number in series 2). The patient still had breathing issues from exacerbated asthma, some long term covid effects of breathing issues, rash that broke out on body (after infection), and extreme fatigue. The action taken with covid-19 vaccine ad26.cov2.s, and influenza vaccine was not applicable. The patient had not recovered from exacerbated asthma, rash broke out on body after covid infection, and suspected covid-19 infection. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction, Pain
Clinical narrative: REACTION; SEVER PAIN; This spontaneous report received from a consumer via a company representative  concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received booster of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 01 total administered for covid-19 prophylaxis. 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 patient experienced reaction after the booster and severe pain (Dose number in series 2). As per the reporter, "Johnson and Johnson it was not just Johnson and Johnson my friend had her reaction after the booster getting some better after all the sever pain etc". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from reaction, and sever pain. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Angina pectoris, Herpes zoster, Lichen planus
Clinical narrative: HEART PAINS; SHINGLES; LICHEN PLANUS BECAME MORE SEVERE; This spontaneous report received from a consumer via a company representative via media concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose, 1 total start therapy date were not reported for covid-19 prophylaxis. On an unspecified date, the patient experienced lichen planus/blisters with every meal (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced heart pains, shingles, and lichen planus became more severe (dose number in series 2). It was reported that, "Her booster brought heart pains and shingles a day later. And the lichen plantus became more severe. Get a few more shots. That'll show me. Idiot." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lichen planus became more severe, and the outcome of heart pains and shingles was not reported. This report was serious (Other Medically Important Condition). This case, involving the same patient is linked to 20220614567.; Sender's Comments: V0: 20221226022- heart pains. The event 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. Therefore, the Agency Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Nephrolithiasis, Thrombosis
Clinical narrative: BLOOD CLOTS; KIDNEY STONES; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy dates were not reported for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced blood clots, and kidney stones (Dose number in series 2). It was reported that, "I got blood clots and kidney stones after shots". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the blood clots and kidney stones was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221226118-blood clots and kidney stones. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: VACCINE INJURIES; This spontaneous report received from a consumer 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. 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 patient experienced vaccine injuries. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine injuries was not reported. This report was non-serious.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, COVID-19 immunisation
Clinical narrative: REBOUND COVID-19 INFECTION; REVACCINATION WITH DIFFERENT COVID-19 VACCINE; This spontaneous report received from a patient via other manufacturer (Pfizer) concerned a 43 year old male. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 01 total administered at left arm on 13-APR-2021 at 12:00 PM for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 41 years old. Concomitant medications included diazepam, and sertraline.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1) The patient additionally received non-company suspect vaccine included: (Pfizer) tozinameran (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered at right arm on 01-JUN-2022 at 12:00 PM for covid-19 prophylaxis which was revaccination with different covid-19 vaccine (dose number in series 2). On unspecified date, patient experienced covid-19 infection and was treated with non-company suspect Paxlovid (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered from 22-NOV-2022 to 26-NOV-2022 for Covid-19 treatment (Dose number in series 2). On 28-NOV-2022, the patient experienced rebound covid-19 infection (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s, and tozinameran was not applicable, and with Paxlovid was drug discontinued. The outcome of the rebound covid-19 infection and revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Off label use
Clinical narrative: IRREGULAR HEARTBEAT; OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient concerned a 74 year old female. The patient's height, and weight were not reported. The patient's past medical history included: sudden cardiac death (in 2011), and concurrent conditions included: tachycardia (heart issues), premature ventricular contractions (Pre-ventricular compression (PVCs)), sulpha allergy (Sulfonamide allergy), drug allergy (Steroids (unspecified)), no alcohol use, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient had previously received elasomeran (Moderna covid-19 vaccine) (Dose number in series 1) (form of admin, route of admin and batch number were not reported, expiry: Unknown) dose was not reported, dose 1 administered on 27-JAN-2021 for covid-19 prophylaxis. On an unspecified date following vaccination with elasomeran (Moderna covid-19 vaccine), the patient experienced allergic reaction (Dose number in series 1). The outcome of allergic reaction was not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 207A21A and expiry: Unknown) dose was not reported, 1 total, dose 2 (first booster) administered in left arm on 13-SEP-2021 for covid-19 prophylaxis which was an off label dosing frequency associated with Off label use and revaccination with different covid-19 vaccine (Dose number in series 2). The outcome of the off label dosing frequency and revaccination with different covid-19 vaccine was not reported. The patient had previously received covid-19 vaccine ad26.cov2.s (Dose number in series 3) (suspension for injection, route of admin not reported, batch number: 1822809 and expiry: Unknown) dose was not reported, 1 total, dose 3 (second booster) administered in left arm on 19-NOV-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination with second booster of covid-19 vaccine ad26.cov2.s (Dose number in series 3). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 4) (suspension for injection, route of admin not reported, batch number: 211D21A and expiry: Unknown) dose was not reported, 1 total, dose 4 (third booster) administered in left arm on 09-APR-2022 for covid-19 prophylaxis which was an off label dosing frequency (Off label use) (Dose number in series 4). Age at time of vaccination 74 years old. No concomitant medications were reported. On an unspecified date following vaccination with third booster dose of covid-19 vaccine ad26.cov2.s, the patient experienced irregular heartbeat (Dose number in series 4). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from irregular heartbeat, and the outcome of off label dosing frequency was not reported. This report was non-serious. This case, involving the same patient is linked to 20221225921.