chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: severe pain in her right arm after receiving PNEUMOVAX 23; Information has been received from a 67 year-old female consumer with no pertinent medical history and with allergy to aspirin reporting on herself. Her concomitant medications included ranitidine and pantoprazole 40 mg.  On approximately 13-JUN-2013 (reported as two weeks ago), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot number and expiration date were not provided).  It was reported that, on 13-JUN-2013 (two weeks ago), the patient experienced severe pain in her right arm after receiving pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). No treatment for the pain was reported. No lab test were performed. The patient sought a medical attention by a phone call to her doctor. At the time of the report, the patient was recovering from the pain in her arm.  The causality assessment between the event and the suspect vaccine was not provided.  Follow up information has been received from the female patient on 03-MAR-2014.  She stated that the pain in her right arm was so severe that she could not go to a hospital. It was the next morning that she called the doctor but she would not go to his office. The patient stated that it took days to raise her arm again. She stated that the doctor may not have anything much on record (if at all) to he of help. The reporter considered the event of pain in her right arm to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23); reported as "caused" from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23).  Follow-up information was received from the patient on 30-MAR-2021. It has been verified that the patient was 66-year-old at the time of the reaction. Her previous drug reactions included allergy to naproxen sodium (ALEVE). It was reported that the patient had no concomitant medications (previously reported as ranitidine and pantoprazole). The patient was vaccinated with 1 dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) on approximately 13-JUN-2013, around 9 AM (also reported as on an unspecified date in 2014 - conflicting information as initial report was received on 27-JUN-2013). On the same day, around 5 PM, the patient experienced severe pain in her right arm. The patient sought medical attention and spoke to the office, however she did not receive any treatment for the event. It was also reported that the patient was not hospitalized due to this event. On approximately 15-JUN-2020 (reported as 2 days after the vaccination), the patient recovered from the event.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no adverse event; Patient received first dose of GARDASIL 9 in July 2016. Diid not receive second and third dose; This spontaneous report was received from a physician assistant and refers to a 22-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drugs reactions or allergies were not provided.  On unspecified date in July 2016, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, strength, lot # and expiration date were not provided). The patient did not receive second and third dose ( inappropriate schedule of product administration). No other adverse event was reported.
Sex: M
Vaccine: FLUX, HPV9, VARCEL
Symptoms: Product storage error
Clinical narrative: no adverse effects; patient received improperly stored vaccine / Temperature: 37.9F; This spontaneous report as received from a medical assistant refers to a 10-year-old male patient. No information regarding the patient's pertinent medical history and drug reactions or allergies. The patient's concomitant therapies included hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and influenza virus split virion 3v vaccine inactivated (FLUVAX).     On an unknown date, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 12-FEB-2021, the patient was vaccinated with the second dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot # S021322, expiration date 09-JUL-2021, in the right arm for prophylaxis (lot # also reported as 1006345, expiration date 20-FEB-2022, lot# 1006345 has been verified to be not valid for varicella virus vaccine live (oka/merck)). The administered vaccine experienced a temperature excursion of 37.9 F for 7 hours 12 minutes. There was no previous temperature excursion. The data logger was involved. No adverse effects was reported.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: was given MMR-II on 8/11/2001 and then given VARlVAX 18 days after/VARIVAX that was administered too early; This spontaneous report as received from a physician assistant refers to a 12-month-old (currently 10-year-old) female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 11-AUG-2001, when she was 12-month-old, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On 29-AUG-2001, 18 days after, the patient was administered too early varicella virus vaccine live (oka/merck) (VARIVAX) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate schedule of product administration). The school noticed this and has brought it to their attention and was questioning the validity of the vaccines. No PQC reported. No other information reported.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: over 45years of age was administered a first Gardasil 9 dose; no additional AE; This spontaneous report was received from a pharmacist and a pharmacy intern and refers to a patient of unknown gender, who was over 45 years of age. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On an unspecified date, 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) (exact dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis (inappropriate age at vaccine administration). No adverse event (AE) was reported.  The pharmacist requested the vaccine medical information, however did not had supervisor's permission to be contacted regarding the event.
Age: 4.0
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: no additional AE; administration of liquid PEDVAXHIB  dose after expiration; This spontaneous report was received from a licensed practical nurse and refers to a 4-year-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not provided. On 26-MAR-2021, the patient was vaccinated with an expired single dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) 0.5 ml, lot # R013572 has been verified to be a valid lot number, expiration date reported as 21-MAR-2021 and confirmed, for prophylaxis. The patient had not reported any additional adverse experiences as result. There was no previous temperature excursions on the product.
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: doctor recommend a male patient get the Gardasil 9 vaccine who is out of the age range; no other issues or AE; This spontaneous report was received from an office manager and refers to a male patient of unknown age. The patient concurrent condition included immune compromised and break of warts in mouth and on tongue. His medical history, drug reactions, allergies and concomitant medication were not provided.   The physician recommended to the patient who was out of age range to get hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot #, expiration date, strength, exact dose, dose #, route of administration and anatomical location were not reported) for prophylaxis. No other issues or adverse events were reported.
Age: 1.33
Sex: F
Vaccine: PPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: no AE; PNEUMOVAX 23 administered to a 16 month old instead of PREVENAR 13; PNEUMOVAX 23 administered to a 16 month old instead of PREVENAR 13; This spontaneous report was received from a medical assistant and refers to a 16-month-old female patient. The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 02-APR-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23), 0.5 milliliter, once (lot # T024557, expiry date 15-MAR-2022) for prophylaxis, instead of pneumococcal 13v conj vaccine (crm197)(PREVNAR 13). The reporter stated there was no confusion between the two products. No additional adverse event was reported.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: No signs or symptoms reported; temperature excursion on PNEUMOVAX 23/ PNEUMOVAX 23 was given on 4/2/2021/ Temperature: 0.8C; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 02-APR-2021, the patient was vaccinated with incorrectly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) lot # T035379 with expiration date on 31-MAY-2022, 0.5 milliliter (route of administration was unknown) for prophylaxis. The vaccine underwent temperature excursion of 0.8 degrees Celsius for 54 minutes. No adverse event was reported. Digital data logger was involved. No previous excursions occurred. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: HEP
Symptoms: Emotional distress, Hypersensitivity, Illness, Pain, Pyrexia
Clinical narrative: severely ill.; fever; pain; received 2 Engerix-B vaccines and experience allergic reaction to binders.; suffered greatly; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced sickness (serious criteria hospitalization), fever (serious criteria hospitalization), pain (serious criteria hospitalization), allergic reaction and emotional suffering. On an unknown date, the outcome of the sickness, fever, pain, allergic reaction and emotional suffering were recovered/resolved.   It was unknown if the reporter considered the sickness, fever, pain, allergic reaction and emotional suffering to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist was looking for binders in Engerix B vaccine because the patient was allergic to binders from the vaccine. The 5 years prior to the report, the patient received the 1st dose of Engerix B vaccine and experienced allergic reaction to binders. The patient was severely ill, had fever and pain that went about 2 to 3 months. The patient was hospitalized and went to the Emergency room (ER) and suffered greatly. The physician fount out that the patient might be allergic to ingredients in the Engerix B. They were trying to find out what in the Engerix B and the patient might be allergic to and they were guessing aluminum hydroxide. The reporter did not have the details about lot numbers, dates or patient information at the moment of the call. The reporter consented to follow up via fax. For further tolerance of 2nd odse, refer case US2021073794, reporter for same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021073794:same reporter, same patient, same vaccine, different dose-2nd dose
Sex: M
Vaccine: TDAP
Symptoms: Autism spectrum disorder, Foetal exposure during pregnancy, Tourette's disorder, Vaccination complication
Clinical narrative: This case was reported by another health professional via interactive digital media and described the occurrence of Asperger's disorder in a male patient exposed to DTPa (Reduced antigen) (Tdap Vaccine) in utero. The parent received the product for prophylaxis.   On an unknown date, the mother received Tdap Vaccine. The mother's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient was exposed at an unknown time during the pregnancy. The patient was diagnosed with Asperger's disorder (serious criteria GSK medically significant) and Tourette's syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the Asperger's disorder and Tourette's syndrome were unknown.   It was unknown if the reporter considered the Asperger's disorder and Tourette's syndrome to be related to Tdap Vaccine.  Additional details were reported as follows: The age at vaccination was not reported. Twenty-six years before the date of reporting, the patient had a reaction to TDap then diagnosed with Asperger's and Tourette's syndrome (TS). The reporter push vaccines unless high risk patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074518: same reporter Deleted case
Sex: U
Vaccine: MEN
Symptoms: Fatigue, Local reaction, Pain in extremity
Clinical narrative: had a sore arm; huge local reaction; and just tired about 24 hours; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a child patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced pain in arm, local reaction and tiredness. On an unknown date, the outcome of the pain in arm and local reaction were unknown and the outcome of the tiredness was recovered/resolved.   It was unknown if the reporter considered the pain in arm, local reaction and tiredness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The reporter was patient's parent. Age at vaccination was not reported. The patient had a sore arm, huge local reaction and just tired for about 24 hours. The reporter commented that, his/her brother almost dies from meningococcal disease and that's why they chose to vaccinate their kids. The case had been linked with US2021AMR074584 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074584:same reporter
Sex: F
Vaccine: MEN
Symptoms: Illness, Meningococcal infection, Vaccination failure
Clinical narrative: Was vaccinated and still got and has never been the same; Was vaccinated and still got and has never been the same; Very sick to this day; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), meningococcal infection (serious criteria GSK medically significant) and sickness. On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown and the outcome of the sickness was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, meningococcal infection and sickness to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter mentioned that, the patient was vaccinated and still got the disease and had never been the same. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for target disease and laboratory confirmation of meningococcal infection (specific serogroup) were unknown at the time of reporting. The reporter stated that, the patient was 18 years old and graduating and got bit by a mosquito and almost died. Till the time of reporting, the patient was very sick. No further information was available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: COVID-19, Herpes zoster, SARS-CoV-2 test positive, Vaccination failure
Clinical narrative: She broke out in shingles / suspected vaccination failure; She broke out in shingles; covid; quarantined for 2 weeks; This case was reported by a consumer via other manufacturer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included covid-19 (experienced in 2019).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, covid-19 and quarantine. On an unknown date, the outcome of the vaccination failure, shingles, covid-19 and quarantine were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and covid-19 to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient reported for herself. The age at vaccination was not reported. The patient had Covid twice, the 1st time was in 2019 and the 2nd time was in 2020.  The 2nd time she had the virus, she quarantined for 2 weeks with her daughter.  On 5th April 2021, the patient received the 2nd dose of Covid-19 vaccine. However, after her 1st dose, she said she experienced soreness at the injection site, and felt as if a truck ran over her. The patient already had 2 shingle shots last year and broke out in shingles so she was confused as to why the vaccine would cause her to get it again. This case was considered as suspected vaccination failure as time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore vaccine arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm 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 selected as adult as per the vaccine indication. The patient received a dose of Shingrix and experienced sore vaccine arm. No further details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had 1st injection 12/19 Didn't get 2nd due to Covid shutdown; This case was reported by a consumer and described the occurrence of social problem in an elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the 1st dose and never get the 2nd dose due to COVID-19 shut down. The reporter asked did he or she need to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose was given on 11Nov2019 / second dose had not been given yet at time of call; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th November 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable.  The age group was selected as an adult as per vaccine indication. Till the time of reporting, the patient had not received 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First Shingrix shot two years ago. Can I still get my second shot; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The case was reported by patient himself/herself. The age group was not reported but was selected as adult as per vaccine indication. The age at vaccination was not applicable to this report. The patient received his/her 1st dose of Shingrix two years ago and till the time of reporting, The patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient enquired if the 2nd shot could be administered or if he/she had to repeat 1st shot. The follow-up would not possible as no contact details were available.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4months female baby who received Kinrix; This vaccines is her s econd dose of Dtap and IPV too; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 5th April 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 5th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The healthcare professional stated that the 4 months old patient received Kinrix, which led to inappropriate age at vaccine administration and it was her 2nd dose of Dtap and IPV too, which led to inappropriate schedule of vaccine administered. The reporter consented to follow up.
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: A nurse / gave Boostrix to a baby; This case was reported by a physician via sales rep and described the occurrence of inappropriate age at vaccine administration in a infant patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: Age at vaccination was not reported. The reporter reported that the nurse in the office gave Boostrix to the patient, which led to inappropriate age at vaccine administered. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Swelling face
Clinical narrative: allergic reaction; face grossly swelling, more on the right side; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced allergic reaction and facial swelling. On an unknown date, the outcome of the allergic reaction and facial swelling were unknown.   It was unknown if the reporter considered the allergic reaction and facial swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that, the patient received Shingrix and experienced allergic reaction and facial swelling which was more on the right side. The reporter consented to follow up.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: not reconstituted with the supplied diluent / possibly reconstituted with sterile water; patient received a dose of Hiberix that was not reconstituted with the supplied diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Hib (Hiberix) (batch number 4925E, expiry date 24th October 2021) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that the patient received a dose of Hiberix that was not reconstituted with the supplied diluent which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered. The reporter stated that the incorrect dose was possibly reconstituted with sterile water. No further information was provided. The reporter consented to follow up. This is1 of 4 cases linked cases reported by same reporter. Notes: All the linked cases were conservatively considered as valid as the reporter was unsure which patient received the incorrectly reconstituted dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR073596:same reporter US-GLAXOSMITHKLINE-US2021AMR073598:same reporter US-GLAXOSMITHKLINE-US2021AMR073597:same reporter
Sex: U
Vaccine: HEP, HEPA, TDAP, VARZOS
Symptoms: Intercepted product storage error
Clinical narrative: above/below temp excursion / Might have administered to pt during the excur period; This case was reported by a nurse via call center representative and described the occurrence of intercepted product storage error in a unspecified number of patients who received HAV (Havrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis and HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Havrix, Shingrix, Boostrix and Engerix B. On an unknown date, unknown after receiving Havrix, Shingrix, Boostrix and Engerix B, the patient experienced intercepted product storage error. On an unknown date, the outcome of the intercepted product storage error was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The nurse was unaware of above or below temperature excursions that happened since January 2021. Temperature excursion information was reviewed and the cumulative time of exposure was 30 hours, which led to intercepted product storage error. The vaccines that were administered were still viable. The consent to follow-up was granted.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Injection site erythema, Neck pain, Neuropathy peripheral
Clinical narrative: hand neuropathy; upset stomach; redness at injection site; neck pain; arm soreness / arm pain; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy.   On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, 10 hrs after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), upset stomach, injection site erythema, neck pain, pain in arm, chills and fever. On an unknown date, the outcome of the peripheral neuropathy, upset stomach, injection site erythema, neck pain, pain in arm, chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy, upset stomach, injection site erythema, neck pain, pain in arm, chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on 1st April 2021 at 4 PM and about 10 hours later, the patient reports arm soreness, arm pain, redness at injection site, fever, chills, upset stomach, hand neuropathy, and neck pain.   The formulation was unknown. At time of report the events are unresolved. The reporter did not consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: hand neuropathy; upset stomach; redness at injection site; neck pain; arm soreness / arm pain; chills; fever; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sulfonamide allergy.   On 1st April 2021, the patient received the 1st dose of Shingrix (intramuscular). In April 2021, 10 hrs after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), upset stomach, injection site erythema, neck pain, pain in arm, chills and fever. On an unknown date, the outcome of the peripheral neuropathy, upset stomach, injection site erythema, neck pain, pain in arm, chills and fever were not recovered/not resolved.   It was unknown if the reporter considered the peripheral neuropathy, upset stomach, injection site erythema, neck pain, pain in arm, chills and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix on 1st April 2021 at 4 PM and about 10 hours later, the patient reports arm soreness, arm pain, redness at injection site, fever, chills, upset stomach, hand neuropathy, and neck pain.   The formulation was unknown. At time of report the events are unresolved. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose in December of 2019 / She still has not received the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of shingrix vaccine on December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the second dose of the Shingrix, which led to incomplete course of vaccination. The patient did not report any other information. The patient did not consent to follow up.
Age: 57.0
Sex: M
Vaccine: TDAP
Symptoms: Erectile dysfunction, Injection site bruising, Pruritus
Clinical narrative: Erectile Dysfunction; Bruising at the injection site; Itching of bilateral palms of his hands; This case was reported by a consumer via call center representative and described the occurrence of erectile dysfunction in a 57-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 24th March 2021, the patient received Boostrix (intramuscular). On an unknown date, less than 2 weeks after receiving Boostrix, the patient experienced erectile dysfunction (serious criteria GSK medically significant), injection site bruising and itching both hands. On an unknown date, the outcome of the erectile dysfunction, injection site bruising and itching both hands were unknown.   It was unknown if the reporter considered the erectile dysfunction, injection site bruising and itching both hands to be related to Boostrix.  Additional details were provided as follows: The case was reported by the patient's spouse. The patient experienced bruising at the injection site, itching of bilateral palms of his hands, and erectile dysfunction.  The patient went to the doctor regarding the bruising and was told it might last one to one half weeks longer. The reporter did not consent to follow up.  All the information was not available.
Sex: F
Vaccine: HEP
Symptoms: Emotional distress, Hypersensitivity, Illness, Irritability, Pain
Clinical narrative: was severely ill.; fever; pain; received 2 Engerix-B vaccines and experience allergic reaction to binders.; suffered greatly; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B with an associated reaction of pyrexia (1st dose received on an unknown date  and also experienced sickness, pain etc, refer case US2021AMR074309).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced sickness (serious criteria hospitalization), fever (serious criteria hospitalization), pain (serious criteria hospitalization), allergic reaction and emotional suffering. Rechallenge with Engerix B was positive. On an unknown date, the outcome of the sickness, fever, pain, allergic reaction and emotional suffering were unknown.   It was unknown if the reporter considered the sickness, fever, pain, allergic reaction and emotional suffering to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist was looking for binders in Engerix B vaccine because the patient was allergic to binders from the vaccine. The 5 years prior to the report, the patient received the 2nd dose of Engerix B vaccine and experienced allergic reaction to binders. The patient was severely ill, had fever and pain that went about 2 to 3 months. The patient was hospitalized and went to the Emergency room (ER) and suffered greatly. The physician fount out that the patient might be allergic to ingredients in the Engerix B. They were trying to find out what in the Engerix B and the patient might be allergic to and they were guessing aluminum hydroxide. The reporter did not have the details about lot numbers, dates or patient information at the moment of the call. The reporter consented to follow up via fax.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074309:same reporter, same patient, same vaccine, different dose-1st dose
Sex: F
Vaccine: HEP
Symptoms: Pyrexia, Vaccine positive rechallenge
Clinical narrative: was severely ill.; fever; pain; received 2 Engerix-B vaccines and experience allergic reaction to binders.; suffered greatly; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B with an associated reaction of pyrexia (1st dose received on an unknown date  and also experienced sickness, pain etc, refer case US2021AMR074309).   On an unknown date, the patient received the 2nd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced sickness (serious criteria hospitalization), fever (serious criteria hospitalization), pain (serious criteria hospitalization), allergic reaction and emotional suffering. Rechallenge with Engerix B was positive. On an unknown date, the outcome of the sickness, fever, pain, allergic reaction and emotional suffering were unknown.   It was unknown if the reporter considered the sickness, fever, pain, allergic reaction and emotional suffering to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist was looking for binders in Engerix B vaccine because the patient was allergic to binders from the vaccine. The 5 years prior to the report, the patient received the 2nd dose of Engerix B vaccine and experienced allergic reaction to binders. The patient was severely ill, had fever and pain that went about 2 to 3 months. The patient was hospitalized and went to the Emergency room (ER) and suffered greatly. The physician fount out that the patient might be allergic to ingredients in the Engerix B. They were trying to find out what in the Engerix B and the patient might be allergic to and they were guessing aluminum hydroxide. The reporter did not have the details about lot numbers, dates or patient information at the moment of the call. The reporter consented to follow up via fax.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR074309:same reporter, same patient, same vaccine, different dose-1st dose
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Patient who received an expired dose of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA268A, expiry date 31st March 2021) for prophylaxis.   On 2nd April 2021, the patient received Menveo. On 2nd April 2021, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were provided as follows: The reporter was a medical assistant. Reporter informed patient was administered with the expired Menveo vaccine on 02nd April 2021. Vaccine was expired on 31st March 2021. Reporter consented to follow up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Vomiting
Clinical narrative: Pt received rotarix and vomited after dose 2 / vomiting less than 15 min; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 3594G, expiry date 2nd May 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 2nd April 2021, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 2nd April 2021, less than an hour after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The office manager reported the case. After Rotarix administration and breastfeeding, the patient vomited in less than 15 minutes.  The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: second dose has not been received yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 24th June 2020 with batch number C7EX2 and expiry date 26th January 2022).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.  The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administration of only the liquid portion of the Shingrix vaccine; administration of only the liquid portion of the Shingrix vaccine; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Herpes zoster (Shingrix) (batch number EJ4MB, expiry date unknown) for prophylaxis.   On 2nd April 2021, the patient received Shingrix. On 2nd April 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at the vaccination was unknown. The reporter stated that the patient was administered only the liquid portion of the Shingrix vaccine and not the active component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: head to toe body rash; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th March 2021, 7 days after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was not recovered/not resolved.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient reported head to toe body rash following 1st dose of Shingrix in left arm. Till the time of reporting, the adverse event was unresolved. The reporter did not consent to follow-up and also not consent to follow up with physician.
Age: 38.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 38 years old female patient received a pediatric (0.5 mL) dose; 38 years old female patient received a pediatric (0.5 mL) dose; This case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 38-year-old female patient who received HAV (Havrix pediatric) (batch number B23EA, expiry date 15th May 2022) for prophylaxis.   On 2nd April 2021, the patient received the 1st dose of Havrix pediatric .5 ml. On 2nd April 2021, unknown after receiving Havrix pediatric, the patient experienced adult use of a child product and underdose. On an unknown date, the outcome of the adult use of a child product and underdose were unknown.  Additional details were provided as follows: All patient identifiers were reported as well as batch number and expiration date. It was reported that the patient received a pediatric dose instead of Adult dose, which led to adult use of a child product and underdose. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient is late for the second dose / first dose was administrated on 2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix with an associated reaction of no adverse event (1st dose received in 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by Office manager  The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter did not consented to follow up. No further information was reported.