chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pulmonary embolism
Clinical narrative: He has blood clots in his lungs; Cough; shortness of breath; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (01Sep2023), this case now contains all required information to be considered valid.   This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2 (BNT162B2), on 05Feb2021 as dose 1, single (Lot number: GL3248) at the age of 66 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "factor V Leiden mutation", start date: 11Jul2014 (ongoing), notes: Had a basket ball pole fall on his right foot in August. Clot found in December also found factor V Leiden mutation. Concomitant medication(s) included: AMLODIPINE (ongoing); LOSARTAN oral (ongoing); SIMVASTATIN oral (ongoing); VITAMIN D3 1000 (ongoing). The following information was reported: PULMONARY EMBOLISM (medically significant), outcome "recovering", described as "He has blood clots in his lungs"; COUGH (non-serious), outcome "unknown"; DYSPNOEA (non-serious), outcome "unknown", described as "shortness of breath". The event "he has blood clots in his lungs" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of pulmonary embolism: on blood thinner.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300272236 Same patient, reporter, same drug, different dose and event.;US-PFIZER INC-PV202300150289 Same patient, reporter, same drug, different dose and event.;
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Yes he had seizures after every booster shot; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 74 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 2, single, Lot Number: EN6205, Anatomical location: Arm), administration date: 26Feb2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "petit mal seizures"; BNT162b2 (DOSE 3 (BOOSTER), SINGLE , Lot Number: FH8028, Anatomical location: Arm), administration date: 11Nov2021, when the patient was 73-year-old, for COVID-19 immunization, reaction(s): "Yes he had seizures after every booster shot"; Bnt162b2 (Dose:1, single, Lot Number: EM9809, Anatomical location: arm left, Time the vaccination was given: Morning), for COVID-19 immunization, reaction(s): "Petite mal seizures starting sometime shortly after 1st COVID  Petit mal epilepsy"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 4 (BOOSTER), SINGLE, Lot: GL2092  , Anatomical location: Arm), administration date: 2023, when the patient was 74 years old, for COVID-19 immunization, reaction(s): "Yes he had seizures after every booster shot". The following information was reported: SEIZURE (medically significant) with onset 2023, outcome "unknown", described as "Yes he had seizures after every booster shot". She stated that her husband took the 1st dose, 2nd dose and three boosters. She also confirmed that the seizures started after the 1st dose and continued after at random times and then after the 1st booster dose he had one the next day. He had never had any seizures of any kind before the series of shots. The reason I believe it was the "Vaccine" is because each time he has gotten a booster, he would have at least 1 episode even though he has been taking XCOPRI 300's daily. Reporter stated- Yes he had seizures after every booster shot. They started with the initial shot. So the next day after each booster he would get a seizure- around 4 pm. Then the following morning- around 4am and he had another seizure. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300127998 same patient/drug/AE, different dose number;
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Seizure, Urinary tract infection
Clinical narrative: fever; uti; seizures; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 72-year-old female patient received BNT162b2 (BNT162B2), on 16Aug2021 as dose 3 (booster), single (Lot number: FC3180) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "Cancer", start date: Feb2021 (unspecified if ongoing). Concomitant medication(s) included: LIBTAYO [CEMIPLIMAB], start date: 17Nov2021. Past drug history included: Bactrim, reaction(s): "Allergies: Bactrim"; Ativan, reaction(s): "Allergies: Ativan". Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6199), administration date: 15Mar2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "skin cancer"; BNT162b2 (DOSE 2, SINGLE, Lot Number: EP7533), administration date: 05Apr2021, when the patient was 72-year-old, for COVID-19 immunization, reaction(s): "20May2021 graft at hospital and 22 lymph nodes removed", "22 lymph nodes removed". The following information was reported: SEIZURE (hospitalization, medically significant) with onset 25Dec2021, outcome "unknown", described as "seizures"; PYREXIA (hospitalization), outcome "unknown", described as "fever"; URINARY TRACT INFECTION (hospitalization), outcome "unknown", described as "uti". The patient was hospitalized for seizure, pyrexia, urinary tract infection (start date: 25Dec2021, discharge date: 28Dec2021, hospitalization duration: 4 day(s)). Therapeutic measures were taken as a result of seizure, pyrexia, urinary tract infection. Had seizures on 25Dec2021 from fever/UTI. She was sent home on 28Dec2021. She is now in much better shape. No Doctor said this was vaccine related but the reporter had no doubts.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293267 same patient/drug/reporter, different dose;US-PFIZER INC-202300293266 same patient/drug/reporter, different dose;US-PFIZER INC-PV202300139170 same patient/drug/reporter, different dose;
Age: 65.0
Sex: F
Vaccine: PNC20
Symptoms: Full blood count, Injection site erythema, Metabolic function test, Pyrexia
Clinical narrative: Acute fever and erythematous nonconfluent patches spreading from the injection site. No leukocytosis.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Myalgia, Pain
Clinical narrative: Muscle aches  Headache  Body ache  100 degree temperature
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Pain
Clinical narrative: Mild body ache started approximately 15 hours after vaccination. Took two Ibuprofen. Expect full recovery by morning.
Age: 17.0
Sex: M
Vaccine: UNK
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17-year old patient was administered the pentacel vaccine with no reported adverse event; Initial information received on 01-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 17-year-old patient was administered the Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 12-Jul-2023, the patient received a dose of 0.5 ml of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine Suspension for injection of standard strength (lot: UJ841AA, Expiry date: 19-Feb-2024) via intramuscular route in the right arm for Immunization with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Nurse reported VAQTA was administered after improper storage; unknown of VAQTA was prefilled syringe or vial, however it is known that it was a pediatric dose administered. The operator of the device was a healthcare professional. Requested follow up; This spontaneous report was received from Other Health Professional and refers to an unknown age and gender patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 01-AUG-2023, the patient received hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, 1 dose, (lot #X003791, has been verified to be a valid lot number, expiration date was reported as 01-JUN-2024), administered for prophylaxis (product storage error) (strength, and route of administration were not provided). The vaccine experienced a temperature excursion of 51 Fahrenheit Degrees during one hour. The vaccine had no previous excursions.          This is one of several reports from the same reporter.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: estimated date of delivery: 23-Apr-2024 (with no reported adverse event); Initial information received on 29-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 23 years old female patient who was exposed to influenza quadrival A-B vaccine [Fluzone quadrivalent] in context of estimated date of delivery: 23-apr-2024 (with no reported adverse event). Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported event occurred at 7 weeks of pregnancy and the patient was exposed to influenza quadrival A-B vaccine, during first pregnancy trimester.  The date of last menstrual period was reported as 24-Jul-2023. The estimated due date is 23-Apr-2024. It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnanies.   On 29-Aug-2023, the patient received a dose 1  dose of suspect influenza quadrival A-B vaccine, Suspension for injection lot number not reported via intramuscular route in unknown administration site, estimated date of delivery: 23-apr-2024 (with no reported adverse event) (exposure during pregnancy) (latency same day). Information on the batch number was requested  It is unknown if there were lab data/results available  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event   Additionally, at time of reporting, the pregnancy is still ongoing.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: 50 year old female patient inadvertently treated with an expired Fluzone High Dose Quadrivalent vaccine with no reported adverse event; 50 year old female patient inadvertently treated with an expired Fluzone High Dose Quadrivalent vaccine with no reported adverse event; Initial information received on 05-Sep-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 50-year-old female patient who was inadvertently treated with an expired fluzone high dose quadrivalent vaccine with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, influenza quadrival A-B high dose HV vaccine via unknown route in unknown administration site for prophylactic vaccination (formulation, strength, dose, batch number and expiry date: unknown) was inadvertently administered to 50-year-old female that was expired with no reported adverse event (expired product administered and product administered to patient of inappropriate age) (same day latency).   Information on the batch number was requested  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both events.  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 the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: M
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: joint pain in left shoulder, no local redness or swelling, pain limiting ability to lift left shoulder above head
Age: 64.0
Sex: F
Vaccine: FLUR4, PNC20
Symptoms: Anger, Vaccination site cellulitis
Clinical narrative: Pt came to the pharmacy angry because she thought that we gave her the wrong vaccine. The pharmacist had followed all the correct process and given the correct vaccine to the patient on 08/30/2023. Per the pharmacy manager, Pt has cellulitis just under the location where the vaccine was administered. Pt had gotten both these vaccines in the same left arm and the pharmacist had separated two vaccines by 1 inch. Rx manager referred her to go see her provider.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: patient had not reported any symptoms; Pharmacist called and reported that one dose of PNEUMOVAX 23 had been administered after a temperature excursion.; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, drug allergies/reactions or concomitant medications was not provided.   On 09-AUG-2023, the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX), frequency reported as "1dose", as prophylaxis; lot number W021636 has been verified to be a valid number for Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX 23), expiration date was reported as 10-OCT-2023, but upon internal validation was established as 01-OCT-2023 (dose, route of administration, and anatomical location were not reported). The administered dose of the vaccine experienced a temperature excursion 56.4 degrees Fahrenheit for 12 hours. There was no previous temperature excursion reported. There was no other symptoms or adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No AE; she received late shipment on 8/7/2023 and should have been received on 8/6/2023 of VARIVAX and MMR II. Spoke with HCP who informed VARIVAX was given to 5patients; she received late shipment on 8/7/2023 and should have been received on 8/6/2023 of VARIVAX and MMR II. Spoke with HCP who informed VARIVAX was given to 5patients; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  Healthcare provided (HCP) stated she received late shipment on 07-AUG-2023 and should have been received on 06-AUG-2023 of varicella virus vaccine live (OKA/MERCK) (VARIVAX) (Product distribution issue). On 10-AUG-2023, the patient was vaccinated with an improperly storage varicella virus vaccine live (OKA/MERCK) (VARIVAX) subcutaneous injection, 0.5 milliliter/x1, lot #X010525, expiration date: 11-APR-2025, administered for prophylaxis (strength, and route of administration were not provided) (Product storage error). No additional adverse event was reported.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no additional AEs were reported; 20 year old patient missed third dose of GARDASIL 9; The patient received first and second GARDASIL 9 doses 4 years ago and came into the pharmacy today to receive the third dose; This spontaneous report was received from a pharmacist concerning a 20-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant medications were not provided.   On an unspecified date in 2019 (also reported as 4 years ago), the patient was vaccinated with the first and second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) injection, as prophylaxis (dosage regimen, route of administration, lot number and expiration date were not reported). On 17-AUG-2023 (also reported as today), the patient went to the pharmacy to receive the third dose, the pharmacist wanted to report a missed dose (Product dose omission issue), the patient had not had the third dose yet (Inappropriate schedule of product administration).  No additional adverse events were reported (No adverse event).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration
Clinical narrative: No side effects were reported/No addtiional AE/PQC; The patient received VARIVAX and MMRII one day apart; This spontaneous report was received from a medical assistant and referred to a 4-year-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 16-AUG-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) injection, then, on 17-AUG-2023, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (inappropriate schedule of product administration); both administered for prophylaxis (strength, lot number, expiry dates, vaccination scheme, anatomical locations and routes of administration were not provided).
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; HBP calling to report the administration of an expired dose of a PNEUMOVAX 23 SYRINGE to a patient on 08/31/2023.  No symptoms or further details reported.  No other AE and no PQC; This spontaneous report was received from a nurse refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 31-AUG-2023, the patient was vaccinated with the expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot #U032086, expiration date: 29-AUG-2023 (exact dose, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I gotten the Shingrix vaccine, but I've gotten shingles 5 times/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via other manufacturer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: I gotten the Shingrix vaccine, but I've gotten shingles 5 times/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles).  The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-SEP-2023 The patient got shingles 5 times even after administration of Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received a dose of Menveo reconstituted with sterile water; Patient received a dose of Menveo reconstituted with sterile water; This non-serious case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number SKBAMVAT21A) for prophylaxis.   On 03-AUG-2023, the patient received Menveo. On 03-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Patient received a dose of Menveo reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Patient received a dose of Menveo reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter reported that the patient received an incomplete dose of Menveo vaccine. The reporter reported that the patient received Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR121432:same reporter, drug and event US-GSK-US2023AMR121432:same reporter, drug and event
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient received a dose of Menveo reconstituted with sterile water; Patient received a dose of Menveo reconstituted with sterile water; This non-serious case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 15-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number SKBAMVA721A) for prophylaxis.   On 09-AUG-2023, the patient received Menveo. On 09-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Patient received a dose of Menveo reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Patient received a dose of Menveo reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter reported that the patient received an incomplete dose of Menveo vaccine. The reporter reported that the patient received Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR121420:same reporter, drug and event US-GSK-US2023AMR121420:same reporter, drug and event
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: he can still take his second dose of Shingrix was late dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in October 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: he can still take his second dose of Shingrix was late dose).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Aug-2023 The consumer called on the day of reporting to see if he an still take his second dose of Shingrix. The reporter consented to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she is 10 days overdue for her second Shingrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 0.5 ml intramuscularly in unknown arm in February 2023).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: she is 10 days overdue for her second Shingrix vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The patient self-reported this case. The reporter did not consent to follow-up. Till the time of reporting the patient did not receive the 2nd dose of Shingrix which led to incomplete course of vaccination.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 year old patient inadvertently received the Kinrix; 3 year old patient inadvertently received the Kinrix; This non-serious case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 7DY4, expiry date 22-AUG-2025) for prophylaxis.   On 28-JUL-2023, the patient received Kinrix (left thigh). On 28-JUL-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 3 year old patient inadvertently received the Kinrix) and inappropriate schedule of vaccine administered (Verbatim: 3 year old patient inadvertently received the Kinrix).  The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-AUG-2023 Medical physician called to inquired that the dose of Dtap and IPV count with the patient and asked how to proceed with series. The reporter declined to follow-up from safety. The case is linked with US2023117322, by same reporter. The patient inadvertently received the Kinrix (this is the patient's 5th dose of Dtap and IPV) due to the patient being mistaken for 4 years of age, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.; Sender's Comments:  US-GSK-US2023117322:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix - the 2 doses only 1 month apart; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: Shingrix - the 2 doses only 1 month apart).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter was a Pharmacist Clinical Service Manager. The reporter inquired that if the vaccine was viable with the 1-month interval or if they need to re-vaccinate. The reporter had a pharmacist administer Shingrix, the 2 doses only 1 month apart; the reporter know in the package insert it stated this could be done if they were immunosuppressed or would be immunosuppressed and need a shorter period of time, however this was just a standard non-immunocompromised patient, so the reporter just wanted to ensure this was ok and the patient was protected. Just a normal patient and was given 1 month apart. The reporter did not consent to follow-up. The patient received 2nd dose of Shingrix earlier than recommended interval, which led to shortening of vaccination schedule.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: information about a 12 year-old patient that received Infanrix instead of Boostrix; information about a 12 year-old patient that received Infanrix instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa (Infanrix) (batch number 9HP9Z, expiry date 21-APR-2024) for prophylaxis.   On 25-AUG-2023, the patient received Infanrix. On 25-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: information about a 12 year-old patient that received Infanrix instead of Boostrix) and inappropriate age at vaccine administration (Verbatim: information about a 12 year-old patient that received Infanrix instead of Boostrix).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-AUG-2023 The reported stated 12 year old patient received Infanrix instead of Boostrix which led to wrong vaccine administration and Inappropriate age at vaccine administration. The Healthcare profession wanted to know how to proceed with the patient. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received Shingrix (left deltoid). On 02-AUG-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site).  The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 29-AUG-2023 and 30-AUG-2023 The patient self-reported this case. The reporter called for the medical advice as she had pain at the injection site one day of Shingrix vaccine administration. She received Shingrix in left deltoid and had pain in her left upper arm which was not resolved. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first Shingrix vaccine on 8-4-2020, in an unknown arm and her second Shingrix vaccine on 8-31-2020, in an unknown arm; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 31-AUG-2020, the patient received the 2nd dose of Shingrix (intramuscular, unknown arm) .5 ml. On 31-AUG-2020, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: first Shingrix vaccine on 8-4-2020, in an unknown arm and her second Shingrix vaccine on 8-31-2020, in an unknown arm).  The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 29-AUG-2023 The pharmacist reported one of her customer administered 1st dose of Shingrix on 04 August 2020 and 2nd dose of Shingrix on 31 August 2020 which led to which led to shortening of vaccination schedule. Patients doctor wanted to known if she can have third shingrix vaccine. The caller was calling to see if that was recommended. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Hypersomnia, Injection site erythema, Injection site warmth
Clinical narrative: slept for two days due to fatigue; reddness at injection site that seems to be spreading down to her mid-arm; fatigue; warm to the touch; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-AUG-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm) .5 ml. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced sleepiness (Verbatim: slept for two days due to fatigue). On 26-AUG-2023, the patient experienced erythema of extremities (Verbatim: reddness at injection site that seems to be spreading down to her mid-arm), fatigue (Verbatim: fatigue) and skin warm (Verbatim: warm to the touch).  In AUG-2023, the outcome of the sleepiness was resolved.  On 28-AUG-2023, the outcome of the fatigue was resolved (duration 2 days). The outcome of the erythema of extremities was not resolved and the outcome of the skin warm was not reported.   It was unknown if the reporter considered the erythema of extremities, fatigue, skin warm and sleepiness to be related to Shingrix.     It was unknown if the company considered the erythema of extremities, fatigue, skin warm and sleepiness to be related to Shingrix.   Additional Information: GSK Receipt date: 30-AUG-2023 The patient reported that she received her first Shingrix vaccine on 25 Aug 2023 and the next day she noticed a redness around at the injection site that seems to be spreading down to her mid-arm.  The patient reports the redness was warm to the touch but does not itch and on 26 Aug 2023 she slept for two days due to fatigue.  The patient states that the fatigue resolved after two days and she will contact the doctor if the redness, on her left arm, did not resolve or improve by Friday. The reporter did not consent to follow-up.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Pediarix by mistake; received Pediarix by mistake; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a adult patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On an unknown date, the patient received Pediarix. On an unknown date, an unknown time after receiving Pediarix, the patient experienced wrong vaccine administered (Verbatim: received Pediarix by mistake) and inappropriate age at vaccine administration (Verbatim: received Pediarix by mistake).  The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 30 Aug 2023:: The reporter was a nurse supervisor who stated an adult patient (18+ Years old) received Pediarix by mistake, which led to wrong vaccine administered and inappropriate age at vaccine administration. No other information provided. The reporter consented to follow up.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient received only the liquid CWY component of Menveo; patient received only the liquid CWY component of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA957A, expiry date 30-SEP-2024) for prophylaxis.   On 29-AUG-2023, the patient received Menveo. On 29-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: patient received only the liquid CWY component of Menveo) and inappropriate dose of vaccine administered (Verbatim: patient received only the liquid CWY component of Menveo).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 30-AUG-2023 Nurse reported that a patient received only the liquid CWY component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up via email. This case was 1 of 3 cases, reported by same reporter.; Sender's Comments:  US-GSK-US2023118668:same reporter US-GSK-US2023118682:Same reporter US-GSK-US2023118684:Same reporter
Age: 39.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 39 year old male patient was administered a pediatric dose of Engerix-B; 39 year old male patient was administered a pediatric dose of Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 39-year-old male patient who received HBV (Engerix B pediatric) (batch number EP724, expiry date 14-MAR-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (RECOMBIVAX).   On 30-AUG-2023, the patient received the 2nd dose of Engerix B pediatric. On 30-AUG-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: 39 year old male patient was administered a pediatric dose of Engerix-B) and adult use of a child product (Verbatim: 39 year old male patient was administered a pediatric dose of Engerix-B).  The outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 30-Aug-2023 Pharmacist reported that the patient was administered a pediatric dose of Engerix-B and this was the patient's second dose in the series.   In looking at the record, the reporter stated that it appeared that the patient also received a pediatric dose for their first dose on 26th July 2023, and that the first dose was Recombivax. However, the lot number for that dose he provided (E42X5) pulls up in batch master as 20 mcg dose of Engerix-B.   At the time of reporting, no additional doses had been administered. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. An adult patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient; Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA932A, expiry date 30-JUN-2024) for prophylaxis.   On 25-AUG-2023, the patient received Menveo. On 25-AUG-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient) and inappropriate dose of vaccine administered (Verbatim: Medical Assistant, inadvertently administered Menveo liquid portion alone without mixing with the powder to an 18 year old female patient).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 31-AUG-2023 The reporter stated her medical assistant colleagues inadvertently administered Menveo liquid portion alone without mixing with the powder which led Inappropriate dose of vaccine administered and Inappropriate preparation of medication. The reporter consented to follow up.
Age: 72.0
Sex: M
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: Pain at the injection site/today the pain is heavy; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   In AUG-2023, the patient received Arexvy. In AUG-2023, 5 days after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at the injection site/today the pain is heavy).  The outcome of the injection site pain was not resolved.   It was unknown if the reporter considered the injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient stated 10 days ago from reporting he received Arexvy vaccine. 5 days later he developed pain in the injection site that was getting worst day by day, today (31 August 2023) the pain was heavy. No further information was provided. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Cough
Clinical narrative: dry cough; This non-serious case was reported by a consumer via call center representative and described the occurrence of dry cough in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In AUG-2023, the patient received the 1st dose of Shingrix. In AUG-2023, an unknown time after receiving Shingrix, the patient experienced dry cough (Verbatim: dry cough).  The outcome of the dry cough was unknown.   It was unknown if the reporter considered the dry cough to be related to Shingrix.     It was unknown if the company considered the dry cough to be related to Shingrix.   Additional Information: GSK Receipt Date: 31-AUG-2023 The patient reported that she had the first shingrix vaccination over 24 hours ago and had experienced almost every common side effect. Additionally she had developed a dry cough. The reporter enquired can that be associated with the vaccine. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received the 2nd dose yet.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received the 2nd dose yet.).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-SEP-2023 The pharmacist called to inform that a patient that received the 1st dose of Shingrix in 2021 had not received the 2nd dose yet. The vaccine administration facility was the same as primary reporter. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Vertigo
Clinical narrative: Vertigos; Shingrix first dose received in 2019, and the second dose on 8/5/2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of vertigo in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2019).   On 05-AUG-2023, the patient received the 2nd dose of Shingrix. On 05-AUG-2023, 5 min after receiving Shingrix, the patient experienced vertigo (Verbatim: Vertigos) and drug dose administration interval too long (Verbatim: Shingrix first dose received in 2019, and the second dose on 8/5/2023).  On 05-AUG-2023, the outcome of the vertigo was resolved (duration 1 hr). The outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the vertigo to be related to Shingrix.     It was unknown if the company considered the vertigo to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-SEP-2023 The patient was self-reported this case. The patient reported that he received Shingrix vaccine he received Shingrix vaccine and experienced vertigos for 1 hour. The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The reporter did not consent to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: expired dose of Engerix-B was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 29-year-old female patient who received HBV (Engerix B) (batch number 4345R, expiry date 11-AUG-2023) for prophylaxis.   On 30-AUG-2023, the patient received Engerix B. On 30-AUG-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: expired dose of Engerix-B was administered to a patient).The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 05-SEP-2023 The reporter called to report that an expired dose of Engerix-B was administered to a patient, which led to expired vaccine used. The patient´s initials were asked to reporter but information was declined. The reporter consented to follow up via email.