chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAPIPV, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.   On 23-MAR-2020 at 15:50, the patient was vaccinated with improperly stored doses of PROQUAD rHA, lot# S030206, expiration date 24-MAR-2021 at a dose of 0.5 milliter, subcutaneously on the left thigh for prophylaxis and KINRIX lot# PP9L5 at a dose of 0.5 milliter, subcutaneously on the left thigh for prophylaxis (expiration date not reported). No adverse effects reported.  Administered doses of PROQUAD experienced the temperature excursion between -14 and -10 degrees Celsius (-11.2C) for 3 hours and 42 minutes. Digital data logger was involved. There were no previous temperature excursions reported.   This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008875: US-009507513-2008USA008884: US-009507513-2003USA002275: US-009507513-2008USA008889: US-009507513-2008USA008877: US-009507513-2008USA008880: US-009507513-2008USA008886: US-009507513-2008USA008876: US-009507513-2008USA008882: US-009507513-2008USA008890: US-009507513-2008USA008879: US-009507513-2008USA008881: US-009507513-2008USA008883: US-009507513-2008USA008885:
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported).  No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 17-MAR-2020 at 09:53 hours, the patinet was vaccinated with an improperly stored dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) with a valid lot # S023645 and expiration date on 03-MAR-2022 at a dose of 0.5 mL intramuscularly (IM) on the left tight (LT) and with an improperly stored dose of rotavirus G1 P1 vaccine live (89-12) (ROTARIX) oral route and lot # Y5CN5, diphtheria toxoid, and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was splitted and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008884: US-009507513-2008USA008882: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008879: US-009507513-2008USA008883: US-009507513-2008USA008885: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008876: US-009507513-2008USA008875: US-009507513-2008USA008877: US-009507513-2008USA008890: US-009507513-2008USA008906: US-009507513-2008USA008907: US-009507513-2008USA008909: US-009507513-2008USA008910: US-009507513-2008USA008911: US-009507513-2008USA008911: US-009507513-2008USA008913: US-009507513-2008USA008914: US-009507513-2008USA008915: US-009507513-2008USA008916: US-009507513-2008USA008917: US-009507513-2008USA008887: US-009507513-2008USA008919: US-009507513-2008USA008890: US-009507513-2008USA008890: US-009507513-2008USA008890: US-009507513-2008USA008922: US-009507513-2008USA008923:
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PPV, RV1
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; unspecified number of unspecified patients have been administered doses of improperly stored vaccines; This spontaneous report as received from a registered nurse, referring to a patient (gender and age not reported). No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-MAR-2020 at 09:56 hours, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB with a valid lot # S023645 and expiration date on 10-MAR-2022 ( at a dose of 0.5 mL intramuscularly (IM) on the right thigh (RT) and with an improperly stored dose of ROTARIX oral route and lot # Y5CN5, diphtheria toxoid, and an improperly stored dose of pneumococcal 13v conj vaccine (CRM197) dose of 0.5 mL intramuscularly (IM) on the left tight (LT) lot # AT8585; for prophylaxis, however no adverse effects reported.   Administered dose of LIQUID PEDVAXHIB experienced the temperature excursion above 9 degrees Celsius (15.5C) for 4 hour and 6 minutes. Digital data logger was involved. There were no previous temperature excursions reported.  This is one of the several reports received from the same reporter.   This case comes from a case previously considered non-valid, but per new information received (patient identifiers) the case was split and determined to be valid for a specific patient.; Sender's Comments:  US-009507513-2008USA008875: US-009507513-2008USA008885: US-009507513-2008USA008882: US-009507513-2008USA008884: US-009507513-2008USA008890: US-009507513-2008USA008889: US-009507513-2003USA002275: US-009507513-2008USA008877: US-009507513-2008USA008879: US-009507513-2008USA008883: US-009507513-2008USA008886: US-009507513-2008USA008880: US-009507513-2008USA008881: US-009507513-2008USA008876: US-009507513-2008USA008917: US-009507513-2008USA008904: US-009507513-2008USA008904: US-009507513-2008USA008932: US-009507513-2008USA008901: US-009507513-2008USA008930: US-009507513-2008USA008900: US-009507513-2008USA008899: US-009507513-2008USA008929: US-009507513-2008USA008928: US-009507513-2008USA008898: US-009507513-2008USA008927: US-009507513-2008USA008926: US-009507513-2008USA008925: US-009507513-2008USA008896: US-009507513-2008USA008923:
Age: 0.17
Sex: U
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 month old was administered PNEUMOVAX 23 by accident; This spontaneous report was received from a consumer concerning their 2-month-old patient of unknown gender. Information regarding concomitant medications, pertinent medical history and drug reactions/allergies was not reported.     On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis by accident (dose, dose number, route of administration, anatomical location, lot # and expiration date were not reported).
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report has been received from a physician  concerning a 12 months- old patient of unknown gender. The patient's concomitant therapies, concurrent conditions, historical drugs and medical history were not reported.  On 09-AUG-2020,  the patient was vaccinated with one of the five doses of varicella virus vaccine live (oka/merck)(VARIVAX) subcutaneous injection 0.5 milliliter once for prophylaxis, that underwent temperature excursion.  Lot # reported as S026925 (Patient route of administration and expiration date was not reported).  The storage temperature was reported  to have been at -9.2° celsius degrees (C) and in between  -14° celsius degrees (C) to -10° celsius degrees (C) (-14.3) for 30 minutes.  There was digital data logger involved and  no previous temperature excursion was reported.  Lot #  S026925 is an invalid lot number for varicella virus vaccine live (oka/merck)  This is one of many reports received from the same reporter about related temperature excursion cases.; Sender's Comments:  US-009507513-2008USA011215: US-009507513-2008USA011215: US-009507513-2008USA011596: US-009507513-2008USA011473:
Age: 7.0
Sex: F
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse effects; The nurse stated that on 20-AUG-2020, a dose of expired but properly stored PROQUAD was administered to a female patient; This spontaneous report has been received from a registered nurse concerning a 7 years-old female patient. The patient's concomitant therapies included sterile diluent (MERCK STERILE DILUENT).The patient's concurrent conditions, historical drugs and medical history were not reported.        On 20-AUG-2020,  the patient was  inadvertently vaccinated with one dose of expired  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (rHA) subcutaneous injection, Lot # S005074, expiration date 18-AUG-2020 for prophylaxis(patient route of administration was not reported). The  measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) was reported to had been properly stored and it was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).No additional adverse effects were reported.
Sex: U
Vaccine: HPV9, HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no additional adverse effects reported; a 33-year-old patient started on GARDASIL 9; This spontaneous report was received from a pharmacist referring to a 33-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 18-FEB-2020, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1614898, expiration date 15-NOV-2021) (dose, frequency, route and anatomical location not reported) for prophylaxis (product administered to patient of inappropriate age).   It was reported that due to coronavirus disease 2019 (COVID-19) situation, the patient received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R028656, expiration date 27-JUL-2021) on 08-NOV-2020. The patient did not experience additional adverse effects. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1614898; expirationdate: 15-NOV-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; on 20-AUG-2020, the patient was administered improperly stored PROQUAD; This spontaneous report was received from a nurse, referring to a 4-years-old male patient. Information regarding the patient's pertinent medical history, concurrent conditions and previous drug reactions or allergies was not provided.   On 20-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), subcutaneously (strength, dose, vaccination scheme frequency and anatomical site of vaccination were not reported; lot number T001187 has been verified to be valid, expiration date reported and validated as 11-JUL-2021) as prophylaxis (product storage error). It was reported that the sterile diluent (MERCK STERILE DILUENT) used to reconstitute the vaccine was properly stored (lot number and expiration date was not provided).  The administered dose of the vaccine was stored in a temperature of 6 degrees Fahrenheit (F) to 14 degrees F (10.9 degrees F) for 2 hours and 30 minutes, as recorded by a data logger. There was no previous temperature excursion reported. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain in extremity
Clinical narrative: REDNESS AT INJECTION SITE; ARM PAIN; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experinced redness at injection site and arm pain for more than 7 days.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: developed hearing loss in right ear; This case was reported by a nurse via sales rep and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 2nd dose of Shingrix. On 13th August 2020, 3 days after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was not recovered/not resolved.   The reporter considered the hearing loss to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed hearing loss in right ear that was still ongoing at the time of reporting.  The patient thought it was related to Shingrix
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Pyrexia, Swelling
Clinical narrative: swelling; redness; pain; fever; This case was reported by a pharmacist via call center representative and described the occurrence of swelling in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th August 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced swelling, erythema, injection site pain and fever. On an unknown date, the outcome of the swelling, erythema, injection site pain and fever were recovering/resolving.   It was unknown if the reporter considered the swelling, erythema, injection site pain and fever to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. On 15th August 2020 the patient received Shingrix that patient had experienced swelling, redness, pain and fever.  The patient was wondering about the safety of a second shot given the adverse events of the first one.  The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fatigue; chills / extreme shivering; fever; This case was reported by a pharmacist via call center representative and described the occurrence of fatigue in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included alpha-gal allergy.   On 19th August 2020, the patient received the 1st dose of Shingrix. On 19th August 2020, less than a day after receiving Shingrix, the patient experienced fatigue, chills and fever. On an unknown date, the outcome of the fatigue, chills and fever were unknown.   It was unknown if the reporter considered the fatigue, chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her right arm and experience fever, chills, extreme shivering, and fatigue. The reporter consented to follow up.  This case linked with US2020167483 and US2020AMR167887, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR167887:same reporter US-GLAXOSMITHKLINE-US2020167483:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Immediate post-injection reaction, Muscular weakness, Myalgia
Clinical narrative: Fatigue; Muscle Weakness; Pain in calf muscles; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number L9F99, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on unknown date. please refer the case US2020AMR171009). Concurrent medical conditions included fibromyalgia.   On 7th July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 7th July 2020, immediately after receiving Shingrix, the patient experienced fatigue, muscle weakness and muscle pain. On 20th August 2020, the outcome of the fatigue, muscle weakness and muscle pain were recovered/resolved.   It was unknown if the reporter considered the fatigue, muscle weakness and muscle pain to be related to Shingrix.  Additional details were provided as follows: The patient experienced fatigue, muscle weakness and pain in her calf muscles. The patient still experiencing the above listed symptoms associated with receiving the 2nd vaccine. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR171009:same patient
Sex: U
Vaccine: FLUX
Symptoms: Disability, Guillain-Barre syndrome, Near death experience
Clinical narrative: got GBS; Near death experience; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria disability and GSK medically significant) and near death experience (serious criteria disability and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and near death experience were unknown.   It was unknown if the reporter considered the guillain barre syndrome and near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that 5 years ago from flu shot, the patient was permanently disabled as the patient also got guillain barre syndrome and nearly died. The patient had been having vaccine for many years as was in food industry and was the law.
Age: 1.67
Sex: M
Vaccine: UNK
Symptoms: Rash, Swelling, Swelling face
Clinical narrative: rash all over body and swelling of body, including massive swelling to face and head.   I dont know the brand, lot or manufacturer of the vaccine.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Hyperaesthesia, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: Skin sensitivity and chills increasing the day of vaccination. Skin sensitivity and chills continuing overnight. Oral temperature of 100.7 around 6am the morning after vaccine. Nausea, brief loss of consciousness as fever broke.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site discolouration, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: discoloration at injection site,swollen,painful and a rash above and below injection site.Chills,fever (new -today).Pain when trying to lift arm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: discoloration at injection site,swollen,painful and a rash above and below injection site.Chills,fever (new -today).Pain when trying to lift arm.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Diplegia, Dizziness, Muscle twitching, Pallor, Seizure
Clinical narrative: AFTER GIVING THE GARDASIL VACCINE LIKE 15 SECONDS LATER PATIENT STARTED FEELING DIZZY. I CALLED FOR WATER FOR PATIENT WITHIN SECONDS PATIENT STARTED HAVING SEIZURES LIKE SYMPTOMS(SHAKING,LEGS AND ARMS PARALYZED). HE WAS VERY PALE AND NON RESPONSIVE. WE THEN LET PATIENT SMELL AMMONIA COUPLE OF SECONDS AFTER PATIENT BECAME ALERT STILL PALE WITH TWITCHING. TOOK OXYGEN LEVEL AND BLOOD PRESSURE VITALS WHERE FINE ,PATIENT WAITED IN THE OFFICE ADDITIONAL 20-30 MINUTES WITH DOCTOR AND NURSING STAFF THEN RELEASED TO GO HOME.
Age: 21.0
Sex: M
Vaccine: HPV9
Symptoms: Tremor, Unresponsive to stimuli
Clinical narrative: AFTER GIVING THE GARDASIL VACCINE LIKE 15 SECONDS LATER PATIENT STARTED FEELING DIZZY. I CALLED FOR WATER FOR PATIENT WITHIN SECONDS PATIENT STARTED HAVING SEIZURES LIKE SYMPTOMS(SHAKING,LEGS AND ARMS PARALYZED). HE WAS VERY PALE AND NON RESPONSIVE. WE THEN LET PATIENT SMELL AMMONIA COUPLE OF SECONDS AFTER PATIENT BECAME ALERT STILL PALE WITH TWITCHING. TOOK OXYGEN LEVEL AND BLOOD PRESSURE VITALS WHERE FINE ,PATIENT WAITED IN THE OFFICE ADDITIONAL 20-30 MINUTES WITH DOCTOR AND NURSING STAFF THEN RELEASED TO GO HOME.
Age: 0.42
Sex: M
Vaccine: IPV, PNC13
Symptoms: Urticaria
Clinical narrative: Hives for several hours following vaccination, treated with benadryl
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Acoustic stimulation tests, Deafness unilateral, Tympanometry
Clinical narrative: Patient called after receiving vaccine, stated he lost hearing in his left ear.  Prescribed predisone taper, referral made to ENT, and performed tympanic and hearing exam.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Treated for cellulitis
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: headache, fever, chills, body aches, neck pain starting one day following vaccination. Ongoing symptoms at time of re-evaluation 2 days after vaccination however improving, fever resolved.
Age: 57.0
Sex: F
Vaccine: HEPA, HEPAB, VARZOS
Symptoms: Wrong product administered
Clinical narrative: Ct. was due for her last Hep B. Given a Twinrix by mistake.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Major swelling of right bicep that moved down to elbow of patient, swollen and warm to the touch, symptoms since 8/25 and still continuing 2 days after injection
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Lip swelling, Swelling of eyelid
Clinical narrative: DIFFICULTY BREATHING SWELLING AROUND THE EYES AND LIPS
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient reported rash that spread down arm to elbow.  Mild itching.
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Gave expired vaccine. No reaction
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Low grade fever, aches, sore throat, fatigue
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored administered vaccines; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 03-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) lot # S020160, expiration date: 30-JUN-2021 (dose, route of administration were not reported) and improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # S038175, expiration date: 26-NOV-2021 (dose, route of administration were not reported) both for prophylaxis.  It was reported that the doses of vaccines administered to the patient were not stored properly for the time frame 1 hour and 15 minutes in the temperature between 6 degrees Fahrenheit (F) to 14 F (10F), for 1 hour and 30 minutes in the temperature between 15 F to 46 F (44.8 F) and for 2 hours and 30 minutes in the temperature between 47 F to 77 F (50 F). There was no previous temperature excursion reported. Digital Data Logger was involved.  The outcome of medication error was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or about 25-SEP-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided), as prescribed and/or administered by a pharmacist at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, on an unknown date, the patient was treated by a physician for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was considered to be not recovered. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC; five doses of the VARIVAX that underwent the temperature excursion were administered; This spontaneous report was received from a physician and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 14-MAY-2020, the varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot # S008695 has been verified to be a valid lot number for varicella virus vaccine live (Oka/Merck), expiration date not reported, but upon internal validation established as 21-MAR-2021,0.5 ml once, for prophylaxis; route was not reported) that underwent the temperature excursion was administered. According to the reporter, the temperature excursions were below 9.2 degrees Celsius (°C) for 30 minutes; below 14 °C to below 10 °C (below 14.3) for 30 minutes, without any previous temperature excursion. No additional adverse effect was reported. The call was because of digital data logger. No product quality complaint reported.  This is one of the several reports from the same reporter.; Sender's Comments:  US-009507513-2008USA011114: US-009507513-2008USA011215: US-009507513-2008USA011596:
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; the patient was administered improperly stored PROQUAD; This spontaneous report was received from a nurse and refers to a 4-year-old male patient. No information regarding the patient's medical history, concurrent conditions, concomitant medications and previous drug reactions or allergies was reported.  On 18-AUG-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live rHA (recombinant human albumin) (PROQUAD) subcutaneously, lot # T001187 was verified to be valid, expiration date reported and established as 11-JUL-2021 (dose and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with a properly stored sterile diluent.  The administered dose of vaccine experienced a temperature excursion of 6 to 14 Fahrenheit degrees (10.9 Fahrenheit degrees) for 2 hours and 30 minutes. There was no previous temperature excursion. Digital Data Logger was involved.  The patient did not experience any additional adverse events.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chromaturia, Hepatic failure, Liver function test increased, Ocular icterus, Pruritus
Clinical narrative: concerns of liver failure; Severe rash; dark urine; yellow eyes; Severe itching; This case was reported by a nurse via sales rep and described the occurrence of liver failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix and an unknown time after starting triamcinolone, the patient experienced pruritus. On an unknown date, the patient experienced liver failure (serious criteria GSK medically significant), rash, urine discoloration and yellow ocular coloring. The patient was treated with triamcinolone and methylprednisolone. On an unknown date, the outcome of the liver failure, pruritus, rash, urine discoloration and yellow ocular coloring were unknown.   It was unknown if the reporter considered the liver failure, pruritus, rash, urine discoloration and yellow ocular coloring to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received Shingri and on 27th July 2020 returned to office due to severe itching. The physician prescribed triamcinolone On 3rd August 2020, the patient returned to office again due to ongoing itching, the physician prescribed methylprednisolone. On 13th August 2020, the patient returned to office again due to rash and itching, the physician prescribed methylprednisolone again (to continue using triamcinolone). On 18th August 2020, the patient returned with itching but no rash, labs were checked and patient had LFTs more than 10 time upper normal limit. The patient also had dark urine and yellow eyes (concerns of liver failure).  It was unknown if it was started prior to Shingrix The patient cannot clearly identify when symptoms of itching started (pre or post Shingrix dose). The reporter consented to followup.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: concerns of liver failure; Severe rash; dark urine; yellow eyes; Severe itching; This case was reported by a nurse via sales rep and described the occurrence of liver failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix and an unknown time after starting triamcinolone, the patient experienced pruritus. On an unknown date, the patient experienced liver failure (serious criteria GSK medically significant), rash, urine discoloration and yellow ocular coloring. The patient was treated with triamcinolone and methylprednisolone. On an unknown date, the outcome of the liver failure, pruritus, rash, urine discoloration and yellow ocular coloring were unknown.   It was unknown if the reporter considered the liver failure, pruritus, rash, urine discoloration and yellow ocular coloring to be related to Shingrix.  Additional details were provided as follows: It was reported that the patient received Shingri and on 27th July 2020 returned to office due to severe itching. The physician prescribed triamcinolone On 3rd August 2020, the patient returned to office again due to ongoing itching, the physician prescribed methylprednisolone. On 13th August 2020, the patient returned to office again due to rash and itching, the physician prescribed methylprednisolone again (to continue using triamcinolone). On 18th August 2020, the patient returned with itching but no rash, labs were checked and patient had LFTs more than 10 time upper normal limit. The patient also had dark urine and yellow eyes (concerns of liver failure).  It was unknown if it was started prior to Shingrix The patient cannot clearly identify when symptoms of itching started (pre or post Shingrix dose). The reporter consented to followup.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Condition aggravated, Coordination abnormal, Deafness neurosensory
Clinical narrative: Vertigo/Spinning head; tinnitus; imbalance; giddiness; Benign paroxysmal positional vertigo of left ear; Acute sinusitis; Labyrinthis; Fatigue; head pressure; Sensorineural hearing loss; Puking; Flu like ilness; fever; chills; Nausea; This case was reported by a lawyer and described the occurrence of sensorineural hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced sensorineural hearing loss (serious criteria GSK medically significant), vertigo and tinnitus. On an unknown date, the outcome of the sensorineural hearing loss, vertigo and tinnitus were unknown.   It was unknown if the reporter considered the sensorineural hearing loss, vertigo and tinnitus to be related to Shingrix.  The initial information received on 17 August 2020 via medical records (The case is medically confirmed). As per the pharmacy records on 16 September 2019, the female patient was prescribed with Shingrix 50 mcg Injection. As per record dated 11 November 2019, she reported a history of episodic vertigo and imbalance following vaccinations. Patient reports a history of MS (Multiple sclerosis). Today's results suggestive of a mild to moderately severe SNHL (Sensorineural hearing loss) bilaterally. As per records dated 12 November 2019, she had chief complaint of dizziness since getting vaccines for the flu, pneumonia, hepatitis, and shingles. She reports feeling as if she had the flu the next morning with fever, chills, and nausea. On the morning of the 18 September 2019, she felt like she was spinning when she woke up. As per the auditory complaint she had Right tinnitus since age 10, high pitch in left ear since symptoms started, decreases with steroids. On 28 December 2019, she started with head pressure, and fatigue the night before. She reports feeling over-stimulated with sensitivity to any motion. On 27 January 2020, she reported vertigo. The motion sensation described as a rotation sensation. The vertigo began 3 months ago and has since been intermittent, occurring frequently with episodes lasting 4 days. As per records dated 01 February 2020, she stated that the day after shingles vaccine on 16 September 2019, she developed dizziness and spins In October 2019, she followed with ear nose and throat specialist and was clinically diagnosed with labyrinthitis. She had two flare-ups, one started on 01 February 2020, she stated that she had past flare up but were less severe. She endorses spinning sensation with movements. She also stated she was not able to walk due to spins. She also had light headaches and poor balance and coordination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Gait inability, Head discomfort, Influenza like illness
Clinical narrative: Vertigo/Spinning head; tinnitus; imbalance; giddiness; Benign paroxysmal positional vertigo of left ear; Acute sinusitis; Labyrinthis; Fatigue; head pressure; Sensorineural hearing loss; Puking; Flu like ilness; fever; chills; Nausea; This case was reported by a lawyer and described the occurrence of sensorineural hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced sensorineural hearing loss (serious criteria GSK medically significant), vertigo and tinnitus. On an unknown date, the outcome of the sensorineural hearing loss, vertigo and tinnitus were unknown.   It was unknown if the reporter considered the sensorineural hearing loss, vertigo and tinnitus to be related to Shingrix.  The initial information received on 17 August 2020 via medical records (The case is medically confirmed). As per the pharmacy records on 16 September 2019, the female patient was prescribed with Shingrix 50 mcg Injection. As per record dated 11 November 2019, she reported a history of episodic vertigo and imbalance following vaccinations. Patient reports a history of MS (Multiple sclerosis). Today's results suggestive of a mild to moderately severe SNHL (Sensorineural hearing loss) bilaterally. As per records dated 12 November 2019, she had chief complaint of dizziness since getting vaccines for the flu, pneumonia, hepatitis, and shingles. She reports feeling as if she had the flu the next morning with fever, chills, and nausea. On the morning of the 18 September 2019, she felt like she was spinning when she woke up. As per the auditory complaint she had Right tinnitus since age 10, high pitch in left ear since symptoms started, decreases with steroids. On 28 December 2019, she started with head pressure, and fatigue the night before. She reports feeling over-stimulated with sensitivity to any motion. On 27 January 2020, she reported vertigo. The motion sensation described as a rotation sensation. The vertigo began 3 months ago and has since been intermittent, occurring frequently with episodes lasting 4 days. As per records dated 01 February 2020, she stated that the day after shingles vaccine on 16 September 2019, she developed dizziness and spins In October 2019, she followed with ear nose and throat specialist and was clinically diagnosed with labyrinthitis. She had two flare-ups, one started on 01 February 2020, she stated that she had past flare up but were less severe. She endorses spinning sensation with movements. She also stated she was not able to walk due to spins. She also had light headaches and poor balance and coordination.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Labyrinthitis, Nausea, Pyrexia, Tinnitus, Vertigo
Clinical narrative: Vertigo/Spinning head; tinnitus; imbalance; giddiness; Benign paroxysmal positional vertigo of left ear; Acute sinusitis; Labyrinthis; Fatigue; head pressure; Sensorineural hearing loss; Puking; Flu like ilness; fever; chills; Nausea; This case was reported by a lawyer and described the occurrence of sensorineural hearing loss in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular). On an unknown date, unknown after receiving Shingrix, the patient experienced sensorineural hearing loss (serious criteria GSK medically significant), vertigo and tinnitus. On an unknown date, the outcome of the sensorineural hearing loss, vertigo and tinnitus were unknown.   It was unknown if the reporter considered the sensorineural hearing loss, vertigo and tinnitus to be related to Shingrix.  The initial information received on 17 August 2020 via medical records (The case is medically confirmed). As per the pharmacy records on 16 September 2019, the female patient was prescribed with Shingrix 50 mcg Injection. As per record dated 11 November 2019, she reported a history of episodic vertigo and imbalance following vaccinations. Patient reports a history of MS (Multiple sclerosis). Today's results suggestive of a mild to moderately severe SNHL (Sensorineural hearing loss) bilaterally. As per records dated 12 November 2019, she had chief complaint of dizziness since getting vaccines for the flu, pneumonia, hepatitis, and shingles. She reports feeling as if she had the flu the next morning with fever, chills, and nausea. On the morning of the 18 September 2019, she felt like she was spinning when she woke up. As per the auditory complaint she had Right tinnitus since age 10, high pitch in left ear since symptoms started, decreases with steroids. On 28 December 2019, she started with head pressure, and fatigue the night before. She reports feeling over-stimulated with sensitivity to any motion. On 27 January 2020, she reported vertigo. The motion sensation described as a rotation sensation. The vertigo began 3 months ago and has since been intermittent, occurring frequently with episodes lasting 4 days. As per records dated 01 February 2020, she stated that the day after shingles vaccine on 16 September 2019, she developed dizziness and spins In October 2019, she followed with ear nose and throat specialist and was clinically diagnosed with labyrinthitis. She had two flare-ups, one started on 01 February 2020, she stated that she had past flare up but were less severe. She endorses spinning sensation with movements. She also stated she was not able to walk due to spins. She also had light headaches and poor balance and coordination.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Occupational exposure to product, Product complaint, Skin laceration
Clinical narrative: cut her hand during the process of removing the vial from the packaging; her hand during the process of removing the vial; Occupational exposure via skin contact with product; the glass broke at the bottom of the vial; This case was reported by a pharmacist via call center representative and described the occurrence of laceration of hand in a female patient who received Herpes zoster (Shingrix) (batch number 47D2Z, expiry date 24th April 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced laceration of hand, exposure via skin contact, occupational exposure via skin contact with product and pharmaceutical product complaint. On an unknown date, the outcome of the laceration of hand, exposure via skin contact, occupational exposure via skin contact with product and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the laceration of hand to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The first eight doses and the tenth dose in the package were intact. When the patient removed the ninth antigen vial from the package, the glass broke at the bottom of the vial. The product was clearly not damaged due to shipping. There was no antigen seen inside or outside the vial. Two areas of the vial were chipped, and a hole was seen inside the vial. The patient cut her hand during the process of removing the vial from the packaging, which led to exposure via skin contact and occupational exposure via skin contact. The reporter consented to follow up. All information was not available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Social problem
Clinical narrative: she had received the Shingrix vaccine (first dose) in January 2020. Due to covid 19, she had not yet received the second vaccine.; 3 worst bouts of shingles/getting 40 blisters of shingles; blisters; This case was reported by a consumer via call center representative and described the occurrence of shingles in a female 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 (had 3 worst bouts of shingles that had in 5 years).   In January 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. In July 2020, between 6 and 7 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and blister. On an unknown date, the patient experienced social problem. On an unknown date, the outcome of the shingles, blister and social problem were unknown.   It was unknown if the reporter considered the shingles and blister to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and had 3 worst bouts of shingles. Due to covid 19, she had not yet received the second vaccine.  The reporter felt as if susceptibility was higher than it's been in 5 years and it did not make sense that getting 40 blisters of shingles at the time of reporting when had not anything in 5 years. The reporter consented to follow up.
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Malaise, Nerve compression, Pain
Clinical narrative: possible/suspected pinched nerve, pain may be some sort of compressed nerve; lot of chronic pain; felt lousy; Initial information received on 19-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer (patient).  This case involves an unknown age female patient who experienced lot of chronic pain (pain), possible/suspected pinched nerve, pain may be some sort of compressed nerve(nerve compression) and felt lousy (malaise), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (formulation: Injection, batch number and expiry date: not reported) via an unknown route in the left arm for prophylactic vaccination.  On an unknown date, the patient developed a non-serious lot of chronic pain (pain) possible/suspected pinched nerve, pain may be some sort of compressed nerve (nerve compression) and felt lousy (malaise), two weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of events pain, nerve compression and malaise was not reported.  There will be no information available on the batch number for this case.
Age: 0.58
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a pt came in for imms and they received a vaccine that was meant for a 4 year old instead of the vaccines being given separately
Age: 0.67
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pt received wrong vaccine pt needed to receive dtap and ipv alone but received kinrix and wrong for pt age at time of vaccine
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Client received immunizations.  DTaP was noted to be expired after administration.  VFC, CDC, MD, supervisor notified of event, pending CDC return instructions for re-vaccination.  CDC recommendations received one month later, follow up being completed currently.  Child to be scheduled for re-vaccination, with parent notification.  No adverse event reported back to clinic r/t child receiving expired vaccine.  Reporting as per VFC guidelines for administration of expired vaccine.
Age: 61.0
Sex: F
Vaccine: UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was immunized with 3 doses of shingrix, where it should be only 2 doses. Patient did not report any adverse reaction to it.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Lethargy
Clinical narrative: Pt initially started feeling lethargic with muscle aches. The next day, a red rash developed from the site of injection. Per pt, the rash was similar to a "sunburn but it's about 7in long down the arm, and 4in wide." Pt was concerned because she didn't have a reaction at all the first time she had it. Pt states she has no issues with ROM and does not have any severe pain or swelling. The rash itself is warm and tender to touch.