chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQC details provided; temperature excursion that was intermittent beginning 28-JUL-2020, involving PROQUAD states that there has been administered doses/Administration of PROQUAD that was outside of recommended temperature storage range at the time of administration; This spontaneous report has been received from a registered nurse, regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  Since 28-JUL-2020, the temperature excursion of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) had been intermittent, and it was administered to the patient on 03-AUG-2020, at a dose of 0.5 milliliter, as prophylaxis, lot number S031882 has been verified to be valid, expiration date 07-APR-2021 (dose number, route of administration, and anatomical location of vaccination were not provided) (product storage error).  The temperature was reported to be between -14 degree Celsius (ºC) and -10 ºC (maximum -9.5 ºC) for 38 hours and 30 minutes. No previous temperature excursion was reported.  The call was placed because of a Digital Data logger report. No adverse effects were reported. ; Sender's Comments:  US-009507513-2008USA014709: US-009507513-2008USA014788:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC details provided.; RN that was calling to report temperature excursion that was intermittent beginning 7/28/2020, but not previously reported, involving PROQUAD states that there have been administered doses.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  It was reported that temperature excursion was intermittent beginning 28-AUG-2020, but not previously reported, involving Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD).   On 03-AUG-2020, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S031882 with expiration date of 07-APR-2021, 0.5 milliliter, for prophylaxis.   It was stated that the vaccines underwent a temperature excursion of -14 degrees Celsius (°C) to -10 °C (max -9.5°C) for a total of 38 hours and 30 minutes. No previous temperature excursion occurred. The call was because of a "data logger."   ; Sender's Comments:  US-009507513-2008USA014788:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Recurring Herpes Zoster/ occurs on the mandibular branch of his face, no other location/ His HZ was "never severe, just recurrent"; This spontaneous report was received from a physician via company representative concerning a 55-year-old male patient. The patient's medical history included natural varicella and it was reported that the patient presented herpes zoster every time he ran a marathon; the reporter confirmed that the patient had been on valacyclovir hydrochloride (VALTREX) prophylaxis for years and it was doing fine. The patient's concurrent conditions were not provided.  On an unknown date, approximately in 2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (Strength, dosage regimen, lot number and expiration date were not provided) due to his recurring herpes zoster episodes.   On an unknown date, approximately 3 years post-vaccination, the patient experienced Herpes Zoster on the mandibular branch of his face, no other location. Per the physician PCR testing was not performed; since it was assumed a wild type virus. The reporter did not considered the herpes zoster post vaccination to be an adverse event.   At the time of the report it was unknown if the patient had recovered from the herpes zoster reactivation. The causal relationship between zoster vaccine live(ZOSTAVAX) and the event was not reported.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered an improperly stored dose of VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was not provided.  On 31-AUG-2020, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis (concentration, number of administered dose, route and anatomical location of administration and vaccination scheme frequency were not reported; lot number T014835 and expiration date 17-JUL-2021). No adverse effects were reported for the patient.  According to the reporter, the temperature excursion was below 36 degrees Fahrenheit: 35 Fahrenheit for a time frame of four hours and 20 minutes on an unspecified date (product storage error), without any previous temperature excursion; which was detected by a digital data logger. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp; devicelotnumber: T014835; expirationdate: 17-JUL-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: 11 year old female had syncopal episode after 1st dose of GARDASIL 9 received in conjunction TDAP and Menactra.; This spontaneous report was received from an office manager via company representative referring to a 11-year-old female patient. Information about patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies was unknown by the reporter.     On 27-AUG-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) as routine immunization (prophylaxis) (concentration route and anatomical location of administration, dose, vaccination scheme frequency, lot number and expiration date were unknown by the reporter). Also, on the same day, the patient was vaccinated with diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid (reported as TDAP) and meningococcal acyw conj vaccine (dip toxoid)(MENACTRA) (concentration, indication, number of administered dose, route and anatomical location of administration, lot number and expiration date were not reported).    On 27-AUG-2020, the patient experienced syncope episode. The outcome of syncope was not reported. It was unknown by the reporter if the patient sought medical attention, if any laboratory diagnostic or if any treatment was given to the patient.  The causality assessment between all the suspect vaccines and the aforementioned event was not reported.  Upon internal review, syncope was determined to be medically significant event.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: she noted the MMR II expired 08/30/2020.; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 31-AUG-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) with expiration date of 30-AUG-2020, for prophylaxis (route of administration, frequency and lot/batch # were not reported).
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A dose of Gardasil 9 was inadvertently administered to an 8 year old patient; This spontaneous report was received from a physician and refers to an 8-year-old of unknown gender patient. The patient's medical history, concurrent conditions and concomitant therpaies were not reported.   On 02-SEP-2020, the patient was inadvertently vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # 1637651 and expiration date: 09-JUN-2022) (dose and route of administration were not reported) for prophylaxis (product administered to patient of inappropriate age). combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; 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 suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient received an improperly stored dose of VARIVAX; This spontaneous report was received from a registered medical assistant and refers to patient of an unknown gender and age. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.    On 02-SEP-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) (dosage regimen and route of administration were not provided), lot number T002844; expiration date 23-JAN-2022, as prophylaxis. The vaccine was reconstituted using a properly stored sterile diluent (MERCK STERILE DILUENT) Lot # S035537 has been verified to be a valid lot# for sterile diluent, expiration date 25-JUN-2022.    The improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) experienced a temperature excursion of 5.5 Fahrenheit degree (F) for a period of 25 minutes. It was reported that the vaccine did not had a previous temperature excursion. The call was because a digital data logger.
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he gave a first dose of ROTATEQ to a 4 month old; This spontaneous report has been received from a physician via a company representative concerning to a 4-month-old patient of an unknown gender.   Information concerning patient's pertinent concurrent conditions, pertinent medical history, concomitant medications and drug reactions/allergies were not reported.   On 01-SEP-2020, the 4-month-old patient was administered with the first dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) taken orally (PO) (dose, frequency, lot number and expiration date were not reported) as prophylaxis. It was stated that the physician was unable to retrieve the product vial as it was disposed on that day after immunization.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Laboratory test normal, Lipase increased, Pancreatitis acute
Clinical narrative: A patient went to the emergency room and was diagnosed with acute pancreatitis one week after her second dose of GARDASIL 9; This spontaneous report was received from a physician via a company representative, referring to a 12-years-old female patient. The patient's pertinent medical history included dental surgery and seasonal allergic rhinitis. The patient's concomitant therapies included loratadine (CLARITIN) and multivitamins. Information regarding the patient's concurrent conditions and previous drug reactions was not provided.  In August 2019, 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) (dose, route of administration, vaccination scheme frequency, anatomical site of vaccination, lot number and expiration date were not reported) as human papillomavirus (HPV) prophylaxis. On 20-AUG-2020, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose 0.5 milliliter (ml), administered intramuscularly in the left deltoid (lot number and expiration date were unknown by the reporter).  On 27-AUG-2020, the patient went to the emergency room (ER) for medical attention and was admitted to the hospital due to acute pancreatitis. It was reported that the patient's lipase was 3445 (no amylase was drawn) and other laboratories were unremarkable. The patient was treated with intravenous (IV) fluids and was under observation.  The outcome of pancreatitis acute was reported as recovered on 29-AUG-2020 when she was discharged from the hospital. The causal relationship between the event and therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was considered unknown as there was no obvious cause for the pancreatitis acute.  Upon internal review, the event pancreatitis acute was considered to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: No adverse event
Clinical narrative: no additional adverse effects reported; MMR II expired 30-AUG-2020 that was administered to patient; This spontaneous report was received from a pharmacist, referring to a of unknown age or gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  The pharmacist reported that on 02-SEP-2020, the patient received as part of routine vaccination  a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) that had expired on 30-AUG-2020, lot # R024106 (strength, dose, vaccination scheme frequency, route of administration, and anatomical site of vaccination were not reported). No Additional adverse events reported.  Lot number R024106 is an invalid lot number for Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported.; VARIVAX underwent a temperature excursion and was administered.; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 31-AUG-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, 0.5 milliliter (ml) once (lot number S020159 which has been verified to be valid, expiration date reported as 31-JUN-2021, but upon internal validation established as 30-JUN-2021) (vaccination scheme, route of administration and anatomical site of injection were not reported), as prophylaxis (product storage error). The administered dose of the vaccine was stored at a temperature of -12.8 degrees Celsius, during a time frame of 1 hour, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Antinuclear antibody positive, Arthralgia, Blood test, Laboratory test
Clinical narrative: Sorting through autoimmune disorders; Having some joint pain; +ANA; This spontaneous report was received from an optometrist concerning her daughter, a 17 year old female patient. The patient did not have known drug reactions or allergies, concomitant medications or pertinent medical history.  On 08-JUL-2020, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), intramuscular for prophylaxis (dose, frequency, anatomical location, lot number and expiration date were not provided).  On an unspecified date in July 2020 (reported as "a couple of weeks later, sometime in the middle of July), the patient started having some joint pain (arthralgia). In approximately September 2020 (reported as "now"), they were sorting through autoimmune disorders to see what was wrong with her. On unspecified dates in 2020, they performed blood panels and tests on her, and the patient had an antinuclear antibody positive (+ANA) came back, but that was all, so far. No additional adverse events were reported.   The outcome of autoimmune disorder, antinuclear antibody positive and arthralgia was reported as not resolved. The reporter did not provide any causality assessment.  Upon internal review, autoimmune disorder was determined to be a medically significant event.
Age: 34.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient is a 36 year old male client who did not come back till today for his 2nd shot, 1st shot was a year in half ago.; Patient is a 36 year old male client who did not come back till today for his 2nd shot.; This spontaneous report was received from a pharmacist referring to a 36 year old male patient. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported.  In approximatedly march 2019 (reported as "a year in half ago", also reported as 01-JUL-2019 "), 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)(strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis.       The pharmacist reported that on 03-SEP2020 ( reported as "til today"), the patient came back for his second shot (inappropriate schedule of product administration and product administered to patient of inappropriate age).
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: administered vaccine after temp excursion NOT supported; This spontaneous report was received from a physician and a nurse referring to a 6 months old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.    On 22-JUN-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(lot # 1660704, expiration date 20-MAR-2021; exact dose and route of administration were not reported) for prophylaxis. No additional AE details are available.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA013130: US-009507513-2008USA013131: US-009507513-2009USA002370: US-009507513-2008USA011564:
Age: 0.33
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: administered vaccine after temp excursion NOT supported; This spontaneous report was received from a nurse referring to a 4 months old patient of unknown gender. There was no information about the patient's concurrent conditions, drug reactions, allergies, medical history, and concomitant therapies provided.     On 16-JUN-2020, the patient was administered an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ)(lot # 1660704, expiration date 20-MAR-2021; exact dose and route of administration were not reported) for prophylaxis. No additional AE details are available.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2008USA013130: US-009507513-2008USA013131: US-009507513-2008USA011564: US-009507513-2009USA002369:
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Received Second Dose 10 Days After the First Dose; Initial Report Received on 17-Aug-2020, 18-Aug-2020 and 19-Aug-2020  An Nurse reported that a 32 year-old (race and ethnicity not provided) patient received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization 10 days after the first dose.  No medical history was reported.   No concomitant medications were reported.  06-Jul-2020, the patient received the first dose of HEPLISAV-B (Lot 933623, expiration date 22-Aug-2021 and NDC # not reported).   On 16-Jul-2020, 10 days later, neither the nurse nor the scheduler had verified the dates of the patient's previous vaccines. The second dose of HEPLISAV-B (Lot 933623, expiration date 22-Aug-2021 and NDC # not reported) was administered intramuscularly in her right deltoid. The patient also received a varicella vaccine subcutaneously in her right upper arm on the same day.  At the time of the report, the patient did not have any adverse reactions to either of the HEPLISAV-B doses she received.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 32.0
Sex: U
Vaccine: HEP
Symptoms: Atrophy, Injection site indentation, Injection site pain, Injection site swelling
Clinical narrative: Dimpling at Injection Site; "Atrophy"; Swelling at Injection Site; Pain at Injection Site; Initial Report Received on 18-Aug-2020  An Employee Immunization Nurse reported to an Account Manager that a 32 year-old female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and the patient developed experienced pain, dimpling and swelling at the injection site and atrophy.    Medical history included pancreatic cancer at 21 years old.  No concomitant medications were reported.  On 03-Aug-2020, the patient received the first dose of HEPLISAV-B (Lot # 933624, expiration date 10-Aug-2021 and NDC # not reported) intramuscularly in the right deltoid with a 1-inch needle from a prefilled syringe at a clinic. No other vaccines were administered at that time. On the same day, the patient felt and saw dimpling at the injection site and swelling underneath.  On 18-Aug-2020, the patient was seen by a Nurse Practitioner at the clinic. The patient reported pain, dimpling and swelling to the Nurse Practitioner. She had felt pain and swelling under the injection site ever since the injection. The Nurse Practitioner noted dimpling at the injection site and swelling under the site and noted "I have never seen atrophy occur with a vaccine." An ultrasound of the area was ordered. The event was reported on the same day.  On an unspecified date, the patient stated that she was not surprised this happened to her, weird things happen to her all the time.  An ultrasound of the area was ordered.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: patient had fever when he got his 1st - dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of fever in a 71-year-old 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. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The case was reported by the wife of the patient. The age at vaccination was not reported. The patient had fever when he got his 1st of Shingrix in right arm. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2020176123, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176123:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever 99.8f; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as per the vaccine indication. The patient got Shingrix shot and experienced fever 99.8 degree F. The patient asked what should he/she take.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: come back with rashes; This case was reported by a pharmacist via call center representative and described the occurrence of rash in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable. Few patients came back with rashes after Shingrix.  The pharmacist provided general statement after transfer of call from first line specialist. Due to technical difficulties experienced with during the call, no further details were requested. This case has been linked with case US2020176166, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020176166:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Lymphoedema
Clinical narrative: lymphoedema  in both arms; This case was reported by a pharmacist via call center representative and described the occurrence of lymphedema in a 67-year-old female 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 lymphedema. On an unknown date, the outcome of the lymphedema was unknown.   It was unknown if the reporter considered the lymphedema to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter asked would the patient be able to receive Shingrix on the gluteus muscle, due to a lymphoedema in both arms not clarified if this was previous to dose one.  When asked heath care professional reported this would be 2nd dose of Shingrix, but not completely sure as reported.  The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster, Paralysis, Rash, Rash vesicular
Clinical narrative: It's zoster with ocular involvement; Shingles; blistering rash on her forehead; nerve-palsy; This case was reported by a physician via sales rep and described the occurrence of ophthalmic herpes zoster in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 20th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced palsy (serious criteria GSK medically significant). On 23rd August 2020, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and blistery rash. The patient was treated with antivirals nos. On an unknown date, the outcome of the ophthalmic herpes zoster, palsy, shingles and blistery rash were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, palsy, shingles and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was seronegative, had a history of rheumatoid arthritis but was not on immunosuppressive medication. After receiving Shingrix, the patient had blistering rash on her forehead. On 27th August 2020, the patient was diagnosed with shingles. It was zoster with ocular involvement. The patient was on oral and topical antivirals and had nerve-palsy presumed to be from the herpes zoster. The reporter consented to follow up. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178097:same reporter US-GLAXOSMITHKLINE-US2020178099:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Serology negative
Clinical narrative: It's zoster with ocular involvement; Shingles; blistering rash on her forehead; nerve-palsy; This case was reported by a physician via sales rep and described the occurrence of ophthalmic herpes zoster in a 89-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis.   On 20th August 2020, the patient received Shingrix. In August 2020, less than a week after receiving Shingrix, the patient experienced palsy (serious criteria GSK medically significant). On 23rd August 2020, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), shingles and blistery rash. The patient was treated with antivirals nos. On an unknown date, the outcome of the ophthalmic herpes zoster, palsy, shingles and blistery rash were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster, palsy, shingles and blistery rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was seronegative, had a history of rheumatoid arthritis but was not on immunosuppressive medication. After receiving Shingrix, the patient had blistering rash on her forehead. On 27th August 2020, the patient was diagnosed with shingles. It was zoster with ocular involvement. The patient was on oral and topical antivirals and had nerve-palsy presumed to be from the herpes zoster. The reporter consented to follow up. This was 1 of 3 linked cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020178097:same reporter US-GLAXOSMITHKLINE-US2020178099:same reporter
Sex: U
Vaccine: FLUR4
Symptoms: Headache, Injection site erythema, Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: headache; red, slight swelling and hot to touch at vaccination site; vaccination site red; slight swelling at vaccination site; hot to touch at vaccination site; Itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA241448 and 2020SA241537 (same reporter).  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Sex: U
Vaccine: FLUR4
Symptoms: Vaccination site warmth
Clinical narrative: headache; red, slight swelling and hot to touch at vaccination site; vaccination site red; slight swelling at vaccination site; hot to touch at vaccination site; Itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case is linked to cases 2020SA241448 and 2020SA241537 (same reporter).  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Sex: U
Vaccine: FLUR4
Symptoms: Headache, Injection site erythema, Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: headache; red, slight swelling and hot to touch at vaccination site; vaccination site red; slight swelling at vaccination site; hot to touch at vaccination site; itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (Office Staff).  This case is linked to cases 2020SA231242 and 2020SA241537 (same reporter).  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Sex: U
Vaccine: FLUR4
Symptoms: Vaccination site warmth
Clinical narrative: headache; red, slight swelling and hot to touch at vaccination site; vaccination site red; slight swelling at vaccination site; hot to touch at vaccination site; itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (Office Staff).  This case is linked to cases 2020SA231242 and 2020SA241537 (same reporter).  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Sex: U
Vaccine: FLUR4
Symptoms: Headache, Injection site erythema, Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: headache; red, slight swelling and hot to touch at vaccination site; red at vaccination site; slight swelling at vaccination site; hot to touch at vaccination site; itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (office staff).   This case is linked to cases 2020SA231242 and 2020SA241448 (same reporter)  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Sex: U
Vaccine: FLUR4
Symptoms: Vaccination site warmth
Clinical narrative: headache; red, slight swelling and hot to touch at vaccination site; red at vaccination site; slight swelling at vaccination site; hot to touch at vaccination site; itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (office staff).   This case is linked to cases 2020SA231242 and 2020SA241448 (same reporter)  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Age: 17.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK QUADRIVALENT was administered to a 17 year old male/no AE; Initial information received on 03-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old male patient who was vaccinated with 0.5 mL INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (batch number and expiry date not reported) via unknown route in unknown administration site on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to inappropriate age at vaccine administration.  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 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.  There will be no information available on batch number for this case.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Arthritis reactive, Blood creatine phosphokinase normal, C-reactive protein normal, Full blood count normal, Gait disturbance
Clinical narrative: Seen in office 9/2/20 - complaints of bilateral leg pain - "Patient is a 10-year-old girl here with father for evaluation of leg pain that has been going on for last couple of days . On Monday child went to park and did way more walking than she is used to. She started complaining of leg pain Monday night.  She had trouble bearing weight and walking on Tuesday morning.  She called the office and was advised to take ibuprofen for pain and if it does not get better they should call for further evaluation.  She comes today on crutches.  She was not able to bear weight.  She complains of bilateral leg pain from thighs to her ankles.  She has been drinking okay and her urine color is normal without any red tinges.  She is eating and drinking well.  Does not complain of belly pain or nausea or vomiting.  She is otherwise a healthy girl." - sent to ER for further work-up - diagnosed with Myalgia 1. Myalgia - "No specific identifiable etiology for bilateral leg pain on visit to the emergency department today.  All labs and x-rays normal.  Continue with increased oral hydration with clear, non-sugary fluids throughout the day.  Children's Motrin every 6-8 hours as needed for discomfort.  Rest while remaining active.  Follow-up with your PCP this week for continued symptoms.  Return the emergency department immediately for any worsening symptoms or additional concerns." -  Follow-up on 9/4/20 - "Patient is a 10-year-old girl with bilateral lower leg myalgia.  She has been evaluated extensively including creatinine kinase, CBC, S CRP, ESR, renal function test and x-ray of the hips.  All the labs have been normal.  Her pain is not getting any significant better.  But the pain is also not getting any worse.  I added prednisone 50 mg twice a day for 5 days in addition to ibuprofen.  I have advised her to take with food to prevent gastric irritation.  I also advised her to drink plenty of fluid.  Per parents concerns, we have reported vaccine adverse reaction form and send it to CDC.  She had gotten her HPV 11 days before." - Seen at orthopedics on 9/8/20 - "Knee pain, bilateral - I ordered and reviewed bilateral knee x-rays as well as reviewed the prior x-rays and labs, all which appeared normal.  I discussed with the mother she is likely having reactive arthritis that should improve in the coming weeks.  I recommended continuing NSAIDs, modifying activities to tolerance, resting, warm soaks, icing as needed, and have written a note keep around gym class for the next 3 weeks.  I will have her follow-up at that point to her monitor her progress.  I discussed the possibility of rheumatoid or other autoimmune disorder, but the general recommendation is against ordering labs for such issues at this point in the presentation of pediatric patients give most will improve without it and the labs will be negative."