chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: My mom is a very healthy individual. She doesn't have any problems besides high triglycerides which she takes fenofibrate for the past 7-8 years. She exercise regularly and adopts a healthy vegan diet. She goes for her yearly eye exam and had cataract surgery done just in ONE eye in February 2021. In January and February 2021, she got 2 shots of Moderna vaccine. Few months later, she started noticing floaters which she ignored thinking it could be just from cataract. When she went for her yearly eye exam in June 2022, the eye doctor told her she has a retinal tear and to see an ophthalmologist as soon as possible. She got an appointment to see Ophthalmologist in July 12, 2022 and he told her she has "bilateral retinal detachment" and needs to get surgery as soon as possible. She got her emergency surgery done 2 days later. When I searched "bilateral retinal detachment" online, I came across few case studies of Healthy, young individuals getting bilateral retinal detachment few months after getting Moderna. They went to ER only when they started having blind spots. My mom, who's very healthy, no diabetes, no other problems besides high triglycerides all of a sudden got bilateral eye detachment, which is so rare. The only variable is that she received the Moderna vaccine months prior. We don't even have any family history of retinal problems. There have been cases of "mrna" technology causing microvascular damage which and our eyes consists of it. Emergency retinal attachment surgery done on 7/14/22
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Moderna use for COVID-19 under Emergency Use Authorization (EUA): Patient received injection in Right Delta on March 17, 2022. He is still complaining of pain at the injection site. He states it became swollen as typically seen but a know remains.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Autoimmune disorder, Biopsy skin abnormal, Vitiligo
Clinical narrative: I received the pfizer covid vaccine booster and developed vitiligo in the weeks/months following due to the vaccine causing an autoimmune response in my body. I now have a progressive expensive incurable disease. the pfizer covid booster i received in 2022 caused the progressive disease vitiligo to develop and I am now suffering great mental anguish and expensive dr visits and medications.
Age: 29.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site bruising, Myalgia
Clinical narrative: Bruise at injection site; Bilateral arm myalgias and bilateral lower extremity myalgias; This spontaneous case was retrieved on 04-Aug-2022 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 0882074-1), reported by other healthcare professional and concerned a 29-year-old, male patient.  The patient's medical history was not reported. The patient's concomitant medications included Zyrtec (cetirizine hydrochloride) for unreported indication.  On 02-Sep-2020, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; route of administration: intramuscular (IM), anatomical location: left arm (LA), dose and indication: not reported). The batch number reported was P100244639.  On 03-Sep-2020, one day after receiving Afluria Quadrivalent, the patient experienced bilateral arm myalgias, bilateral lower extremity myalgias and a bruise at injection site.   On the same date, the patient recovered from both events.  The reporter did not provide a causality assessment.  The case was assessed as non serious.  Company comment: A 29-year-old, male patient was vaccinated with the Afluria Quadrivalent vaccine. One day following vaccination, the patient developed myalgia and vaccination site bruising. Causality of the suspect vaccine is assessed as possibly related for both events due to biological and chronological plausibility.; Sender's Comments: A 29-year-old, male patient was vaccinated with the Afluria Quadrivalent vaccine. One day following vaccination, the patient developed myalgia and vaccination site bruising. Causality of the suspect vaccine is assessed as possibly related for both events due to biological and chronological plausibility.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Amnesia, Cognitive disorder, Feeling abnormal, Laboratory test, Respiratory rate
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was fine 2 weeks before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 29-MAY-2021, the patient experienced cognitive issues, looks like a brain fog, fade memory, and difficulty with words. On 13-MAY-2022, Laboratory data included: Laboratory test Normal. Laboratory data (dates unspecified) included: Respiratory rate Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cognitive issues, and the outcome of looks like a brain fog, fade memory, and difficulty with words was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Speech disorder
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was fine 2 weeks before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 29-MAY-2021, the patient experienced cognitive issues, looks like a brain fog, fade memory, and difficulty with words. On 13-MAY-2022, Laboratory data included: Laboratory test Normal. Laboratory data (dates unspecified) included: Respiratory rate Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cognitive issues, and the outcome of looks like a brain fog, fade memory, and difficulty with words was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Adverse event, Cognitive disorder, Mobility decreased
Clinical narrative: This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was fine 2 weeks before vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 27-MAY-2021 for covid-19 prophylaxis. No concomitant medications were reported. On 29-MAY-2021, the patient experienced cognitive issues, looks like a brain fog, fade memory, and difficulty with words. On 13-MAY-2022, Laboratory data included: Laboratory test Normal. Laboratory data (dates unspecified) included: Respiratory rate Normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cognitive issues, and the outcome of looks like a brain fog, fade memory, and difficulty with words was not reported. This report was non-serious.
Age: 4.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: When patient came to our clinic today for COVID 19 vaccine was noted to have had his first Pfizer dose (5-11yo dose) at age 4 from a different facility (out patient pharmacy).  The patient parent stated that the error was noted when they returned to this pharmacy 21 days later for dose 2 and were turned away given the patient did not yet qualify for the COVID vaccine (at this time 5 and up were eligible).  At today's clinic the patient received dose 2 and is deemed primary series complete, eligible for future booster dose.  Parent asked about how the patient tolerated dose 1 (5-11 year old dose received while age 4.5y) to which parent stated that he had no issues.
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: pt with glioblastoma multiforme and seizures; placed in hospice facility (Hospice); pt had a positive COVID test on 2/7/22; pt passed away in the hospice facility
Age: 83.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Death, Glioblastoma multiforme, SARS-CoV-2 test positive, Seizure
Clinical narrative: pt with glioblastoma multiforme and seizures; placed in hospice facility (Hospice); pt had a positive COVID test on 2/7/22; pt passed away in the hospice facility
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site pain
Clinical narrative: Injection was given to high up on left arm.  It was given into the shoulder joint.  The person giving the  injection was pushing hard on the sryinge and stated after completing the injection that he had to push very hard to get the plunger pushed in.  It was very painful during the procedure and within a few days my entire shoulder joint became extremly painful to the point where any movement of the joint was painful.  Over the following 2 weeks my shoulder joint became more and more painful.  I was using ice and pain medicine with little relief.  After 2 weeks it gradually has gotten better, but is still painful to movement at this time.  I believe the injection was actually given into my shoulder joint and not IM as it was given high up on my shoulder and the person doing it was pushing on the plunger very hard.  It was obviously not going into muscle, but rather into the joint connective tissue or cartilage.  I know pharmacy techs are not trained, nor authorized to give injections into joints.  At this time I don't know if my shoulder will recover fully.
Age: 75.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Arthralgia, Injection site pain, Pain, Product administered at inappropriate site, Wrong technique in product usage process
Clinical narrative: Injection was given to high up on left arm.  It was given into the shoulder joint.  The person giving the  injection was pushing hard on the sryinge and stated after completing the injection that he had to push very hard to get the plunger pushed in.  It was very painful during the procedure and within a few days my entire shoulder joint became extremly painful to the point where any movement of the joint was painful.  Over the following 2 weeks my shoulder joint became more and more painful.  I was using ice and pain medicine with little relief.  After 2 weeks it gradually has gotten better, but is still painful to movement at this time.  I believe the injection was actually given into my shoulder joint and not IM as it was given high up on my shoulder and the person doing it was pushing on the plunger very hard.  It was obviously not going into muscle, but rather into the joint connective tissue or cartilage.  I know pharmacy techs are not trained, nor authorized to give injections into joints.  At this time I don't know if my shoulder will recover fully.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aneurysm, Cerebrovascular accident, Hypertension, Subarachnoid haemorrhage
Clinical narrative: In December of 2021 I had a stroke (SAH)with no history of strokes.  Currently now have issues with high blood pressure which I never had a issue or history of.  Plus I still have 2 anyerisums.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Vaccination site pain
Clinical narrative: pain in his arm after the shot; Inappropriate schedule of vaccine administered; This spontaneous report was received from a patient mother on behalf of her son who was a 16-year-old male patient. Pertinent medical history, concomitant medications and drug reactions/allergies were reported as none.  The patient was on a three-dose regimen of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9). On 25-MAR-2022, the patient was vaccined with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in his arm for the benefits (prophylaxis) (strength, dose, lot # and expiry date were not provided, unknown if intramuscular). On 21-JUN-2022 later than two months (inappropriate schedule of product administration), the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in his arm for the benefits (prophylaxis) (strength, dose, lot # and expiry date were not provided, unknown if intramuscular). The patient also received the vaccine with meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) in his arm (strength, formulation, dose, lot #, expiry date, indication and route of administration were not provided). The patient experienced pain in his arm after the second shot on 21-JUN-2022. The patient had not sought medical attention, received the treatment or performed any lab diagnostics/studies. The outcome of vaccination site pain was reported as recovered (recovery date was an unknown date in 2022).   The reporter did not know if the pain was from hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) or meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO) (causality with vaccine site pain was considered as unknown).
Age: 45.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a 45-year-old male patient referring to himself. Pertinent medical history, concomitant medications and drug reactions/allergies were not reported. The patient received his first dose of GARDASIL 9 in January 2022, and second dose in March 2022, but when he went to get his third dose on 25-JUL-2022, Pharmacy told him they were unable to do it due to his age and turned him away. The caller turned 46 on 10-APR-2022, which was the reason Pharmacy told him they were unable to provide him with his last dose of the third dose schedule (inappropriate schedule of product administration). The patient would have a visit with his healthcare provider on 29-JUL-2022 and the patient would speak to him regarding the third dose. No additional adverse event was reported (no adverse event).
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; an expired dose of ROTATEQ was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 29-JUL-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter, once, lot #1821811 with expiration date: 27-JUL-2022, orally for prophylaxis (strength was not provided) (expired product administered). The rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had no history of temperature excursions. The patient had no adverse effects or symptoms from this dose (no adverse event).
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; Nurse calling in TE case 02215786 reports 1 dose of VARIVAX stored outside of recommended range administered to 1 patient.; This spontaneous report was received from a nurse and refers to an 1-year-old female patient. The patient's medical history, current conditions and concomitant medications were not reported.  On 30-JUL-2022, the patient was vaccinated with 1 dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot #U030162, expiration date: 28-SEP-2023 (anatomical location and route of administration were not provided) for prophylaxis, after the temperature excursion happened (Improper storage of product in use). Administrated vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was stored at 35 Fahrenheit (F) for 1 hour and 59 minutes. There was no previous temperature excursion.  There were no adverse events reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No symptoms or adverse effects from administration of these vaccines; 4-year-old patient received PROQUAD and VARIVAX concomitantly; This spontaneous report has been received from a medical assistant referring a 4-years-old patient of unknown gender.  The patient's pertinent medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medication were not reported.  On 03-AUG-2022, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) subcutaneous injection, at the dose of 0.5 milliliters (ml), once for prophylaxis, (lot number U031561 had been verified to be a valid number, expiration date was reported and established as 06-APR-2023) (strength, route of administration and anatomical location were not provided). And with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, at the dose of 0.5 ml for prophylaxis, (lot number U015687 had been verified to be a valid number, expiration date was reported and establised as 18-MAY-2023) (strength, route of administration and anatomical location were not provided) (drug use for unapproved schedule). Both reconstituted with sterile diluent solution for injection, at a dose of 0.7 ml (lot number T020662 had been verified to be a valid number, expiration date was reported and established as 30-DEC-2022). Patient had no symptoms or adverse effects from administration of these vaccines.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; A nurse reported that an improperly stored dose of ROTATEQ was administered to a patient; This spontaneous report was received from a registered nurse and refers to a 4-month-old patient of unknown gender. The patient's concurrent conditions, medical history, allergies and concomitant therapies were not reported.  On 01-AUG-2022, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (1 dose [DS] x 10 tubes) oral liquid, lot #U037812, expiration date: 29-MAR-2023, administered for prophylaxis (product storage error). No adverse event was reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Overdose
Clinical narrative: No additional AE information provided; HCP states that a pediatric patient received a dose of PROQUAD and a dose of VARIVAX on the same date: 01AUG2022; This spontaneous report was received from a physician referring to a pediatric patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapies were not reported.   On 01-AUG-2022, the patient received a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 mL and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 mL (strength and route for both vaccines were not provided) for prophylaxis (Overdose). Lot numbers and expiration dates were unknown by the physician at time of call. No additional adverse event (AE) information provided.
Age: 11.0
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional adverse events reported; an "extra dose" of PROQUAD; This spontaneous report has been received from a medical assistant, concerning a 11 year old patient of unknown gender. The patient had no history of previous Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) or varicella virus vaccine live (Oka/Merck) (VARIVAX) administered. The patient's medical history, concurrent conditions, and concomitant therapies were not provided.   On 15-OCT-2021, the patient was vaccinated with first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) injection, as prophylaxis (dose, route of administration, anatomical location, site of injection, lot number and expiration date were not provided).   On 09-AUG-2022, the patient was accidentally administered an extra dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (rHA) (PROQUAD) injection, lot number W010523 had been verified to be a valid number, expiration date reported and validated as 25-SEP-2023 (dose, route of administration and anatomical site of injection were not provided) as prophylaxis (extra dose administered). No additional adverse events were reported in the patient.
Sex: F
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient recently had titers which showed she was not immune.; Caller also thinks the patient may have received dose 1 too early; This spontaneous report was received from registered nurse and refers to a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On an unknown date, as child, the patient was vaccinated with 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (dose, lot #, expiry date, route of administration, and anatomical location were not provided) for prophylaxis. On an unknown date (reported as recently), the patient had titers which showed she was not immune to varicella (antibody test negative). The reporter thought that the patient might have received dose 1 too early, but did not have any more specific information on timing of that dose (inappropriate schedule of product administration). The outcome of the event was unknown. Action taken was not applicable.  The causal relationship between the event and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Papilloma viral infection
Clinical narrative: contracted HPV infection.; This spontaneous report was received from a pharmacist via company representative concerning a female patient of unknown age.   The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On unknown dates, the patient received 3 doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection; or quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided) (Company unidentified HPV vaccine administered).   On an unspecified date, the patient contracted Human papillomavirus (HPV) infection. The outcome of the HPV infection was not reported.   The causal relationship between the Company unidentified HPV vaccine administered and the HPV infection was not reported.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient did not experience any side effects. No additional AE/No PQC.; a patient accidentally received a 4th dose of PEDVAXHIB; This spontaneous report as received from a registered nurse referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.      On 12-AUG-2022, the patient accidentally received a 4th dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (0.5 mL/once, lot # U029144, expiration date 31-MAR-2024; strength, route of administration and anatomical location were not reported) for prophylaxis (extra dose administered).  The patient's 3rd dose was not documented in charts and it was not realized until after the patient had received a 4th dose. The patient did not experience any side effects. No additional adverse event (AE) or product quality complaint (PQC) was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AEs; Caller reporting temperature excursion for VARIVAX.; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 26-MAY-2022, varicella virus vaccine live (oka/merck) (VARIVAX) experienced a temperature excursion of 9 to 25 degree Celsius (14.5 degree Celsius) for 2 hours and -14 up to -10 degree Celsius (-11.49 degree Celsius) for 2 hours. On 01-JUN-2022, improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #T027305 was confirmed to be valid, expiration date was reported as 31-AUG-2022 but upon internal validation established as 12-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis (product storage error). No additional reports was reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA006061:
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No adverse effects reported; A HCP called to report that a improperly stored dose of VARIVAX was administered to a patient; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history and drug reactions/allergies were not reported. Concomitant medication included sterile diluent (manufacturer unknown).  On 12-AUG-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml/once, lot #W003820, expiration date: 02-FEB-2024, (strength, and route of administration were not provided) administered for prophylaxis (product storage error). No adverse effects reported.   The administered dose of the vaccine experienced a temperature excursion in 6 degrees Fahrenheit (F) up to 14 F for 14 hours 10 minutes, and in 14 F up to 46 F (16.7F) for 5 hours 40 minutes. There was no previous temperature excursion.   This is one of four cases received from the same reporter.; Sender's Comments:  US-009507513-2208USA006030: US-009507513-2208USA006265: US-009507513-2208USA006344:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; improperly stored dose of ROTATEQ was administered to the patient; This spontaneous report was received from other non-health professional reporter and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies details were not reported.  On 24-MAY-2022, the patient was vaccinated improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #U026666, expiration date: 08-MAR-2023, administered for prophylaxis (strength, and route of administration were not provided) (product storage error). Administered dose of vaccine experienced the temperature excursion of 54.5 degrees Fahrenheit for 11 hours. There was no adverse event or product quality complaint reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; An improperly stored dose of VAQTA was administered to the patient on 26MAY2022 after experiencing a temperautre excursion.; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-MAY-2022, the patient was vaccinated with an improperly stored of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (lot # U033212 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported as 28-OCT-2022 and establish as 07-NOV-2022) (strength, dose, route of administration and anatomical location were not provided). The temperature of storage and time frame of the excursion were 54.4° Fahrenheit (F) for 11 hours respectively.  If a digital data logger was involved was not reported.  The vaccines did not experience a previous temperature excursion.  No adverse event reported.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test
Clinical narrative: contract the virus / COVID-19; passed away; This serious spontaneous report was reported to Amgen on 10/AUG/2022 by a consumer from a commercial program and involves a female patient (sister) who passed away [PT: death], contracted the virus/COVID-19 [PT: COVID-19] while receiving Enbrel. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 Vaccine. The patient began Enbrel on an unknown date. On an unknown date, the patient contracted the Coronavirus disease 2019 (COVID-19) after receiving the vaccine while concurrently taking Enbrel. Shortly after on an unknown date in OCT/2021, the patient had passed away. The cause of death was unknown. It was unknown if an autopsy was done. No treatment information was received. The outcome of the event COVID-19 was reported as unknown. Action taken with Enbrel was reported as unknown for the event COVID-19. The causal relationship between the events death, COVID-19 and Enbrel was not provided by the consumer. Follow up has been requested.  Amgen comment: This safety report does not necessarily reflect a conclusion by Amgen that etanercept, caused or contributed to the adverse event reported; however, consistent with regulatory reporting requirements, this case is being reported because it contains one or more suspected adverse reactions. This individual case report does not change the safety profile of the product.  ENBREL is under agreement with Amgen.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Nervousness, Pruritus, Vaccination failure
Clinical narrative: Had dual shot, got Shingles/suspected vaccination failure; I got Shingles on my back; very itchy; nervous; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st Shingles vaccine years ago from reporting, when it was costly and 50 percent effected).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and nervous. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and nervous were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and nervous to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 02-Aug-2022 Reporters comment: This case was reported by the patient via interactive digital media. The patient stated that when the more effective, dual shot came out, his/her doctor said he/she should get it. The patient had 2nd and 3rd Shingles vaccine was the current new vaccine in 2021 and the patient experienced shingles on back in spring 2022, which was very itchy and nervous, not pleasant for sure The patient also stated that he/she hate to think what it would had been without the vaccine.  Additional Supportive information: This case was considered as suspected vaccination failure as detail regarding laboratory confirmation regarding shingles was unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and continue to get shingles/Suspected vaccination failure; continue to get shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had both shots and the patient continued to get shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/both vaccinations and I'm on my 3rd episode of shingles; my 3rd episode of shingles since; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated that it was the same for him/her. The patient had both vaccinations and was on his/her 3rd episode of shingles since. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Vaccination failure
Clinical narrative: Worst head pain I have ever had; Suspected vaccination failure/I have them now and had the double dose vaccine; I have them now too!; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In August 2022, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and headache were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient have had them now too. The patient had the double dose vaccine that was 90 percent effective. The patient stated that the worst head pain he/she have ever had and for over 2 weeks. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: COVID19, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/had the vaccine and have had them twice this year; have had them twice this year/got them again; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID-19 BOOSTER) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 BOOSTER. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated yes him/her, even had the shingles vaccine and have had them twice already this year (2022).  The patient got them 30 days after his/her Covid booster and then 30 days after that got them again. The patient had to report them to health department as it could be a reaction. Additional supportive information: It was unknown if the reporter considered the shingles to be related to COVID-19 BOOSTER.   This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles after the shot/Suspected vaccination failure; I got shingles after the shot; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included pain (horrible pain).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient stated horrible pain. The patient got shingles after the shot. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. As it was not clear that horrible pain was occurred before or after the shot so, in worst approach it was considered as current condition not as event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure/My sister got the shingles vax and got shingles; My sister got the shingles vax and got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (Family History) (unvaccinated brother-in-law had shingles ).   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient's sister via interactive digital media. The patient got the shingles vaccine and both she and reporter's unvaccinated husband (patient's brother-in-law) got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I now have another mild case/Suspected vaccination failure; I now have another mild case; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included Shingles vaccine (received Shingles vaccine (original) on an unknown date that was wearing off after 7 years ) and Antiviral (took antiviral to kept shingles to a mild case).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In August 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 5-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the shingles even after getting original vaccine that was wearing off after 7 years. The patient took antiviral.to kept them to a mild case.  The patient stated that fast forward to 3 years after getting 2 doses of Shingrix and  now have had another mild case.  The patient began antiviral tonite.  The patient convinced if he/she had not had vaccines they would be much worse. The patient stated that get the shots if you had no allergy to it. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got 2 shots, still came down shingles/Suspected vaccination failure; shingles/Got 2 shots, still came down shingles/suffering through it now; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 4-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient got his/her 2 shots and still came down shingles. The patient stated that he/she was suffering through them now. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: HEP, RVX
Symptoms: Product storage error
Clinical narrative: vaccine excursion, unknown if administered to any patient; This case was reported by a consumer via other manufacturer and described the occurrence of incorrect storage of drug in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included Rotavirus vaccine for prophylaxis.   On an unknown date, the patient received Engerix B and Rotavirus vaccine. On an unknown date, unknown after receiving Engerix B and Rotavirus vaccine, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 09-AUG- 2022 Reporters comment: The reporter reported that had an excursion last week from reporting, the vaccines. Reporter stated that he/she worked on the doctor's office and had Engerix b and rotavirus vaccine. Reporter requested to call the manufacturer to know the viability of Engerix. The reporter did not consent to follow up. Additional Supportive information: Had an excursion last week, the vaccines, which led to incorrect storage of drug.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: More than two years since first vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st dose received more than 2 years ago.).   On an unknown date, the patient did not received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, 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: 08-AUG-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter stated that the more than two years ago patient received Shingles vaccine. The reporter asked patient need to restart the series. Follow-up would not possible as no contact details were available. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.