chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4, HPV9
Symptoms: Syncope
Clinical narrative: a patient fainted after receiving a dose of GARDASIL or GARDASIL 9; This spontaneous report was received from a pediatrician, via a company representative, regarding a female patient of unknown age. The patient did not have any concomitant medications, and her pertinent medical history, concurrent conditions and previous drug reactions/allergies were unknown by the reporter.  In approximately 2017 (reported as "about three years ago"), the patient was vaccinated with a dose of either quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration, anatomical site of vaccination, vaccination scheme, lot number, and expiration date were not reported) as prophylaxis.  In approximately 2017, after receiving the vaccination, the patient fainted (syncope). It was unknown by the reporter if any treatment was given or if laboratories or studies were performed due to the adverse event. The patient did not seek medical attention.  The patient recovered from the event on an unspecified date. The causality assessment between quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and syncope was not reported.  Upon internal review, the event syncope was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer referring to a female patient of unknown age. Information about concurrent condition, history condition and concomitant medication was not reported. On or around 23-DEC-2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a bad case of the shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event shingles was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the event shingles to be disability.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative, Incorrect route of product administration
Clinical narrative: the patient "had low titers and didn't know if she was ever vaccinated with MMR II; patient received a dose of MMR II (Lot#Unknown/Exp:Unknown) by the intramuscular route rather than the subcutaneous route; Information has been received from a pharmacist referring to a 58 years old female patient. The patient's medical history, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient received a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose detail, lot # and expiration date were unknown) by the intramuscular route rather than the subcutaneous route for low titers (incorrect route of product administration).        The patient had low titiers and did not know if she was ever vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II). The outcome of the event was unknown. The causality between the event and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) was not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer and consumers, referring to a patient of unknown age and gender. Information about concurrent condition, historical condition and concomitant medication was unknown.   In 2011, the patient was prescribed and administered with zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) for the long-term prevention of shingles and zoster-related conditions, by the pharmacist at a pharmacy.   On an unknown date, subsequently, the patient was treated by a health care provider in the medical office for shingles.   As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has and will 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 will continue to suffer such losses, and damages in the future. The outcome of event was considered as not recovered/not resolved. The event was considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional adverse effects were reported; a 23 year old patient was inadvertently given a dose of PROQUAD; This spontaneous report was received from a medical assistant referring to a 23 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.       On 03-MAR-2020, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), 1 dose, for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). No additional adverse effects were reported.
Age: 1.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse symptoms reported; patient was administered a dose of MMR II  (unknown lot/exp date) on 07/27/2016 and then was administered a dose of VARIVAX (unknown lot/exp date) on 08/10/2016; Information has been received from a registered nurse referring to a 12 months old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.     On 27-JUL-2016, the patient was administered a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis. On 10-AUG-2016, the patient was administered a dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis (inappropriate schedule of product administration). No adverse symptoms were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Soreness; Fatigue; Shivering; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain, fatigue and shivering. On an unknown date, the outcome of the pain, fatigue and shivering were not recovered/not resolved.   It was unknown if the reporter considered the pain, fatigue and shivering to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know how long did the mild side effects like soreness, fatigue and shivering tend to last after 2nd dose of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Feel achy; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 65-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received the 2nd dose of Shingrix. On 3rd March 2020, 1 days after receiving Shingrix, the patient experienced general body pain. On an unknown date, the outcome of the general body pain was unknown.   It was unknown if the reporter considered the general body pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, however the patient could be 64 or 65 years old. The patient received Shingrix and experienced feeling achy. The patient was enquiring that if it was okay to take Naproxen or Ibuprofen. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Injection site cellulitis, Injection site pain, Product complaint
Clinical narrative: Product Complaint; cellulitis at the site; last evening had pain and cellulitis at the site; This case was reported by a other health professional via call center representative and described the occurrence of injection site cellulitis in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA64AZ, expiry date 31st October 2021) for prophylaxis. This case was associated with a product complaint.   On 4th March 2020, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 4th March 2020, less than a day after receiving Bexsero, the patient experienced injection site cellulitis and injection site pain. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the injection site cellulitis and injection site pain were not recovered/not resolved and the outcome of the pharmaceutical product complaint was unknown.   It was unknown if the reporter considered the injection site cellulitis and injection site pain to be related to Bexsero.  Additional details were provided as follows: A day before reporting, the patient received a dose of Bexsero on left deltoid. At the evening, the patent experienced pain and cellulitis at the site. The patient returned to office this morning, with worsening of the events. The health care professional reviewed prescribing information of the events reported and the post marketing information. No product to return and no replacement at the time of reporting. The patient required to visit emergency room. The reporter consented to follow up. This case has been linked with case US2020040989, reported by the same reporter.
Sex: U
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines that were stored out of range for 3 months at a temperature of 33°F, administered to three patients/no AE; Based on additional information received on 02-MAR-2020, this case initially considered as non-valid was upgraded to valid.   Initial information received on 28-Feb-2020 regarding an unsolicited non-valid non-serious case received from a non-health care professional.  This case is link to 2020SA063065 (same reporter).  This case involves three patients (demography not reported) who received vaccine IPV (VERO) [IPOL] that was stored out of range for 3 months at a temperature of 33°f, administered to three patients/no ae, while he/she received vaccine IPV (VERO) [IPOL] (Product storage error).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, three patients received a dose of IPV (VERO) lot number: P1E701M, Expiry date: 09-Nov-2020, via unknown route and site of administration for prophylactic vaccination.  It was a case of actual medication error due to Product storage error temperature too low.  Case details: Office manager called to check the stability of their ActHIB, Tenivac, Menactra, Fluzone Quad (0.50mL) and Ipol MDV (punctured) vaccines that were stored out of range for 3 months at a temperature of 33°F. Caller stated the vaccines were stored out of range for so long due to the refrigerator being set too cold. Caller also stated the Ipol was not administered during the time the 3 month excursion but it was administered to 3 patients after being placed back into recommended temperature range.  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Follow-up information received on 02-MAR-2020 regarding an unsolicited valid non-serious case received from a non-health care professional (office staff.  Case validity changed from non-valid to valid. Number of patient added.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17.5 yr old patient was given FluBlok Quadrivalent/ no AE; Initial information received on 04-Mar-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves 17 year 4 month 22 days (17.5 years) old female patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 16-Nov-2019, the patient received a dose of suspect 0.5 ml INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1924 and expiry date: 30-Jun-2020 via intramuscular route in right arm for prophylactic vaccination.  It was a case of actual medication error due to inappropriate age at vaccine administration (Product administered to patient of inappropriate age).  At the time of reporting, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: HIBV
Symptoms: Inappropriate schedule of product administration, No adverse event, Product storage error
Clinical narrative: His daycare  is saying he should have gotten one dose after he turned 12 months old/no AE; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves a 32 months old male patient who should have gotten one dose of HIB (PRP/T) VACCINE [ACT-HIB] after he turned 12 months old (drug dose administration interval too long, PT: Inappropriate schedule of product administration).  Medical history, medical treatment, vaccination and family history were not provided.    On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  This is a case of actual medication error due to inappropriate schedule of product administration.  At the time of this report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: the Acthib she received last year was expired/no AE; Initial information received on 03-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 2 years old female patient who was administered expired HIB (PRP/T) VACCINE [ActHIB] last year (expired product administered).  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; HIB VACCINE CONJ (TET TOX) (HIBERIX) for Immunisation; VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation.  On 19-Feb-2019, the patient received a fourth 0.5mL dose of suspect HIB (PRP/T) VACCINE lot UI895AAB via intramuscular route in the left thigh for prophylactic vaccination.  This is a case of actual medication error due to expired product administered.  At the time of this report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: On 07 Jan 2020, the patient was inadvertently administered two doses of the liquid component of the Pentacel vaccine (DTaP-IPV), and none of the Hib component/No AE; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from the other health care professional.  This case involves a four months old male patient who was inadvertently administered 0.5ml two doses of the liquid component of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] and none of the HIB component on 07-Jan-2020 lot number and expiry date not reported via intramuscular route in the right thigh for prophylactic vaccination.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Insomnia, Myalgia
Clinical narrative: Unable to sleep  Injection site pain  Muscle pain Tiredness  Headache
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site joint pain, Injection site swelling
Clinical narrative: Severe chills and fatigue.  Large red raised patch at injection site and sore shoulder joint.  This was the second injection.  There were absolutely no/zero adverse reactions to the first injection 2 months earlier.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Abdominal pain upper, Altered state of consciousness, Asthenia, Chills
Clinical narrative: High fever beginning at midnight after a late afternoon shot.  Shivering and overall body cramping. Headache, panting, stomach ache, muscle pain, weakness, upset stomach, constipation - no diarhhea or vomiting.  Continue for 30  hours nearly unconscious, complete zombie, no thoughts, clenched in shivering position despite blankets.  36 hours later (now) just achey all over, finally had a b.m., no fever, all other symptoms gone.  Although I was given the normal warnings, I never expected the knock-down all-out severity of my reaction., which is why I am reporting.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Constipation, Headache, Muscle spasms, Myalgia, Pain
Clinical narrative: High fever beginning at midnight after a late afternoon shot.  Shivering and overall body cramping. Headache, panting, stomach ache, muscle pain, weakness, upset stomach, constipation - no diarhhea or vomiting.  Continue for 30  hours nearly unconscious, complete zombie, no thoughts, clenched in shivering position despite blankets.  36 hours later (now) just achey all over, finally had a b.m., no fever, all other symptoms gone.  Although I was given the normal warnings, I never expected the knock-down all-out severity of my reaction., which is why I am reporting.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Posture abnormal, Pyrexia
Clinical narrative: High fever beginning at midnight after a late afternoon shot.  Shivering and overall body cramping. Headache, panting, stomach ache, muscle pain, weakness, upset stomach, constipation - no diarhhea or vomiting.  Continue for 30  hours nearly unconscious, complete zombie, no thoughts, clenched in shivering position despite blankets.  36 hours later (now) just achey all over, finally had a b.m., no fever, all other symptoms gone.  Although I was given the normal warnings, I never expected the knock-down all-out severity of my reaction., which is why I am reporting.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Induration, Pruritus, Swelling
Clinical narrative: Area is swollen, hard, softball size area after vaccine.  Itchy, no pain.
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Flu vaccine was inadvertently administered to a one month old in place of Hep B vaccine.  Patient is doing well with no adverse effects at this time. Parent was informed.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Amnesia, Confusional state, Dizziness, Fatigue, Generalised tonic-clonic seizure
Clinical narrative: Administered patient vaccines as MCV4, TDaP, and then HPV last. After administering the HPV vaccine pt. immediately said "Oh wow, I feel dizzy" and proceeded to lose consciousness. Seconds after losing consciousness he appeared to have Tonic-Clonic seizure-like activity and his pupils fully dilated. This episode lasted around 60 seconds. Minutes after the seizure-like activity, pt. had BP of 118/78 R arm and 8 mins post-ictal BP 110/72 R arm P:78 Patient's mother stated that this patient has no history of seizures.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Loss of consciousness, Mydriasis, Postictal state
Clinical narrative: Administered patient vaccines as MCV4, TDaP, and then HPV last. After administering the HPV vaccine pt. immediately said "Oh wow, I feel dizzy" and proceeded to lose consciousness. Seconds after losing consciousness he appeared to have Tonic-Clonic seizure-like activity and his pupils fully dilated. This episode lasted around 60 seconds. Minutes after the seizure-like activity, pt. had BP of 118/78 R arm and 8 mins post-ictal BP 110/72 R arm P:78 Patient's mother stated that this patient has no history of seizures.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication.   In 2012, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route, lot# and expiration date were unknown) for the long-term prevention of shingles and/or zoster-related conditions(for prophylaxis). Subsequent to patient's zoster vaccine live(ZOSTAVAX) inoculation, patient was treated for shingles.  As a direct and proximate result of patient's use of the zoster vaccine live(ZOSTAVAX) vaccine, patient has and will 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 will continue to suffer such losses, and damages in the future.
Age: 79.0
Sex: F
Vaccine: PPV, UNK
Symptoms: Chills, Peripheral swelling, Rash
Clinical narrative: chills; swelling of the arm in which the dose was administered; a rash/It is unknown where on the patient's body the rash was located.; This initial spontaneous report was received from a physician via a company representative referring to a 79 years old female patient. Information about concomitant medications, pertinent medical history, drug reactions or allergies was unknown by the reporter.      On an unknown date, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # S021740, expiration date 25-MAR-2021; dosage detail, strength and route were not reported) for prophylaxis.    On an unknown date, the patient experienced chills, swelling of the arm in which the dose was administered and a rash. It was unknown where on the patient's body the rash was located. The patient was hospitalized in an unspecified hospital on an unspecified date after administration of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23). The patient had sought medical attention and had treatment given for the events. It was unknown if any laboratory tests were performed for the events. The outcome of the events was unknown. Causality assessment was not provided. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: S021740; expirationdate: 25-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: No information about the availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent; Sender's Comments:  US-009507513-2003USA003005:
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia; shingles; Information has been received regarding a case in litigation from a lawyer and consumers, referring to a female patient of unknown age. Information about concurrent condition, historical condition and concomitant medication was unknown.   On 02-DEC-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX), (dose, frequency and route unknown) in a pharmacy for the routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster).   In approximately December 2016 (reported as within approximately 1 month), the patient experienced a severe outbreak of shingles. Since this initial outbreak, the patient had additional outbreaks of painful and debilitating shingles, all caused by the zoster vaccine live (ZOSTAVAX). As a result of the zoster vaccine live (ZOSTAVAX), the patient was formally diagnosed with postherpetic neuralgia (PHN). These injuries resulted in extensive medical care and treatment.   As a result of zoster vaccine live (ZOSTAVAX), the patient's husband suffered loss of services and society and asserts a loss of consortium claim. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient suffered severe injuries and disfigurement not present prior to using the product, which were directly caused by the zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and disfiguring personal injuries, including emotional injuries and loss of consortium. The patient suffered serious, progressive, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of post herpetic neuralgia and herpes zoster was unknown. The events were considered to be related to zoster vaccine live (ZOSTAVAX).     Both events herpes zoster and post herpetic neuralgia were considered to be disabling.
Age: 75.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever - 100.7; Aches; This case was reported by a consumer via call center representative and described the occurrence of fever in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th February 2020, the patient received the 2nd dose of Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced fever and pain. On an unknown date, the outcome of the fever and pain were unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows: The patient receivde dose of Shingrix vaccine and had fever and aches.
Sex: F
Vaccine: VARZOS
Symptoms: Hepatic enzyme increased, Liver function test increased
Clinical narrative: elevated Liver Function; This case was reported by a physician via call center representative and described the occurrence of elevated liver enzymes in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown.   It was unknown if the reporter considered the elevated liver enzymes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The physician reported an elevated Liver Function Test after a patient received Shingrix. The follow up consent was not granted.      Lab Comments: Lab test performed on an unknown date
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; arm became sore later that day, and the soreness; This case was reported by a consumer via call center representative and described the occurrence of headache in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number Z4359, expiry date 19th September 2021) for prophylaxis.   Concomitant products included medication unknown (Unspecified Treatment).   On 16th January 2020, the patient received the 1st dose of Shingrix (intramuscular). In January 2020, 1 week after receiving Shingrix, the patient experienced headache. On 16th January 2020, the patient experienced pain in arm. The patient was treated with PARACETAMOL (TYLENOL). Shingrix was discontinued. On an unknown date, the outcome of the headache was recovering/resolving and the outcome of the pain in arm was resolved with sequelae.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix at a cancer center institute where was being treated as a patient and had her arm sore later that day, and lasted approximately 2 to 3 days.  Approximately 1 week after vaccination, the patient developed a headache that reoccurs in different area of her head. The reporter initially thought headaches were sinus related but determined they were not. The day before reporting on the left side of her forehead she developed a headache and it extended downwards. The patient taken Tylenol to help with headache pain.  The patient did not received her 2nd of Shingrix due to headaches. The follow up consent was granted.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast cancer female, Circumstance or information capable of leading to medication error, Lymphadenectomy, Product administered at inappropriate site
Clinical narrative: Breast cancer; Shingrix could be administered in an IM site other than the deltoid; Shingrix could be administered in an IM site other than the deltoid; This case was reported by a other health professional via call center representative and described the occurrence of breast cancer in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 9227H, expiry date 28th February 2020) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In October 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, between 5 and 6 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant), circumstance or information capable of leading to medication error and vaccine administered at inappropriate site. On an unknown date, the outcome of the breast cancer, circumstance or information capable of leading to medication error and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional details were provided as follows: The patient could not say if this was before or after dose one of Shingrix, the patient was diagnosed with breast cancer and had surgery with lymph node removal.  The reporter inquired if Shingrix could be administered in an intramuscular site other than the deltoid which led to circumstance or information capable of leading to medication error and vaccine administered at inappropriate site The follow up consent was granted.
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Tdap given instead on Dtap staff at Health Dept notified
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Myalgia
Clinical narrative: Patient reported increased muscle aches from what patient normally experiences.  The 2nd dose of shingrix was administered on 02/16/20.  First dose was administered 01/20/20.  This was less than 2 month minimum between 1st and 2nd dose.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Localised oedema, Pain, Skin warm
Clinical narrative: 5 inch erythmematous and edematous LLT, warm to touch and pain to palpation but without drainage.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash & RASH
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Magnetic resonance imaging, Pain, Quality of life decreased
Clinical narrative: Pain, reduced range of motion, loss of quality of life
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, SMALL, TYP, TYP, ANTH, JEV1, SMALL, TYP
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin increased, Human chorionic gonadotropin negative
Clinical narrative: Patient was schedule for vaccines on 2/27/20 and was briefed/screen and sent for urine HCG testing which came back negative and so patient was given 4 vaccines - Anthrax, Typhoid, Japanese Encephalitis and Smallpox. Few days after the vaccines were given the patient performed a home pregnancy test which was positive and so the patient went to medical center  on 3/11/20 for follow-up appointment where she was sent for a HCG Quant blood test which result as 1007.86 mIU/ml (H). Pt was seen in Health Clinic at 0900am 3/12/20 and was schedule to see the OB intake nurse at Health Clinic at 10am 3/12/20 where she will be referred and given an appointment to be evaluated and tracked at the OB health Clinic.
Age: 23.0
Sex: F
Vaccine: ANTH, ANTH, JEV1, JEV1, SMALL, SMALL, TYP, TYP, ANTH, JEV1, SMALL, TYP
Symptoms: Delivery, Pregnancy
Clinical narrative: Patient was schedule for vaccines on 2/27/20 and was briefed/screen and sent for urine HCG testing which came back negative and so patient was given 4 vaccines - Anthrax, Typhoid, Japanese Encephalitis and Smallpox. Few days after the vaccines were given the patient performed a home pregnancy test which was positive and so the patient went to medical center  on 3/11/20 for follow-up appointment where she was sent for a HCG Quant blood test which result as 1007.86 mIU/ml (H). Pt was seen in Health Clinic at 0900am 3/12/20 and was schedule to see the OB intake nurse at Health Clinic at 10am 3/12/20 where she will be referred and given an appointment to be evaluated and tracked at the OB health Clinic.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Peripheral swelling
Clinical narrative: Pt had swelling in the arm for several days due to Prevnar 13
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Acute coronary syndrome, Acute myocardial infarction, Chest pain, Herpes zoster, Musculoskeletal pain
Clinical narrative: acute coronary syndrome and acute myocardial infarction; acute coronary syndrome and acute myocardial infarction; a painful shingles rash on his chest; Information has been received regarding a case in litigation from a lawyer and consumer, referring to a 61-year-old patient of unknown gender. Information about concurrent condition, historical condition and concomitant medication was unknown.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-FEB-2015, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) at a medical group by a facility administrator.   The patient suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live (ZOSTAVAX): the patient experienced a painful shingles rash on his chest, which was diagnosed on 24-DEC-2015. A few weeks later, the patient experienced intermittent pain in his left chest radiating to his left shoulder and arm. The patient was hospitalized and diagnosed with acute coronary syndrome and acute myocardial infarction, which were diagnosed on 15-JAN-2016. The outcome of the events was unknown. All the events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events acute coronary syndrome and acute myocardial infarction were considered to be medically significant.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: acute coronary syndrome and acute myocardial infarction; acute coronary syndrome and acute myocardial infarction; a painful shingles rash on his chest; Information has been received regarding a case in litigation from a lawyer and consumer, referring to a 61-year-old patient of unknown gender. Information about concurrent condition, historical condition and concomitant medication was unknown.  The patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions. On or about 05-FEB-2015, the patient was administered the zoster vaccine live (ZOSTAVAX) (dose, frequency and route unknown) at a medical group by a facility administrator.   The patient suffered the following injuries and was diagnosed on the following dates as a result of the zoster vaccine live (ZOSTAVAX): the patient experienced a painful shingles rash on his chest, which was diagnosed on 24-DEC-2015. A few weeks later, the patient experienced intermittent pain in his left chest radiating to his left shoulder and arm. The patient was hospitalized and diagnosed with acute coronary syndrome and acute myocardial infarction, which were diagnosed on 15-JAN-2016. The outcome of the events was unknown. All the events were considered to be related to zoster vaccine live (ZOSTAVAX).   Upon internal review, the events acute coronary syndrome and acute myocardial infarction were considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: After you get a shingles vaccine shot, does the site get itchy?; This case was reported by a consumer and described the occurrence of injection site itching in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching was not recovered/not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient wanted to know did the shingles vaccine site get itchy after shot.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: severe pain at the site of injection; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced severe pain at the site of injection for five days.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: Cold sores; This case was reported by a pharmacist via call center representative and described the occurrence of cold sores in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date 8th March 2022) for prophylaxis.   On 22nd November 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 4 months after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a cold sore and but it was not aware whether the patient is taking a medication for this infection or not, and she did not know when the patient developed the cold sore. The pharmacist was enquiring whether to administer 2nd dose since the patient had cold sore. The reporter consented to follow up.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Cystitis
Clinical narrative: Bladder Infection; This case was reported by a pharmacist via call center representative and described the occurrence of bladder infection in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 5TH3L, expiry date 19th November 2021) for prophylaxis.   On 12th October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 5 months after receiving Shingrix, the patient experienced bladder infection. The patient was treated with antibiotics nos. On an unknown date, the outcome of the bladder infection was unknown.   It was unknown if the reporter considered the bladder infection to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix and couple of weeks ago from the date of reporting, developed bladder infection. The reported consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; sore arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult 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 fever and pain in arm. On an unknown date, the outcome of the fever and pain in arm were unknown.   It was unknown if the reporter considered the fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after vaccination, the patient experienced fever and sore arm. No other details or specifics were available. The reporter stated that, ended the call before collection of answers to questions. The reporter did not consent to follow up.
Age: 4.0
Sex: M
Vaccine: FLU4, MMR
Symptoms: Crying, Feeling abnormal, Injection site pain, Musculoskeletal stiffness
Clinical narrative: 5:45p: patient made a noise and got stiff for about 60 seconds (no longer than 2 minutes). Arms, legs, and hands stiff. No shaking. Mother rolled him on his side and he started crying when stiffness ended. No postictal period. Told mom he felt like he got "hit in the head" and his legs hurt. Mother took him to urgent care - no fever noted.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Erythema, Injection site erythema, Injection site swelling, Muscle spasms
Clinical narrative: Pt phones provider's office reporting redness to left arm. Pt states redness is "a couple inches diameter around injection site and a spot below it", a bump on injection site and a line under his arm. He reports temp of 99.2 F starting last night, "went down since then", stiff fingers and cramping in the arm. Pt denies adverse reaction/allergy to vaccine in the past. Per Dr., pt having an immune response to the vaccine as it has been within 24-48 hours from when the vaccine has been received, have pt ice area, draw a line around the reddened area and monitor it for increasing redness outside the marked line, pt can take ibuprofen as well. RN phones pt with Dr. further direction, pt verbalizes understanding and is agreeable to plan. RN advises pt to call provider if redness increases outside of line drawn, temperature increases, arm becomes warm to the touch, symptoms do not improve. Pt verbalizes agreement to do so if needed. Pt denies further questions/concerns/needs at this time.