chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Exposure during pregnancy, Premature delivery
Clinical narrative: preterm birth; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2729869-1 (VAERS ID).  A 34-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 21Dec2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal exposure timing unspecified. The patient's relevant medical history included: "OSA" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; VITAMIN D NOS; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]. The patient also took other concomitant therapy. Past drug history included: Sudaphed, reaction(s): "Allergies: Sudaphed"; Ibuprofen, reaction(s): "Allergies: ibuprofen". The following information was reported: PREMATURE DELIVERY (hospitalization), outcome "recovered", described as "preterm birth". The patient was hospitalized for premature delivery (hospitalization duration: 4 day(s)). The baby was delivered premature.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event Maternal exposure during pregnancy was removed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400034329 mother-baby cases;
Sex: F
Vaccine: RSV, RSV, RSV
Symptoms: Blood glucose abnormal, Disease recurrence, Exposure during pregnancy, Gestational diabetes, Premature delivery
Clinical narrative: preterm birth; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2729869-1 (VAERS ID).  A 34-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 21Dec2023 as dose 1, single (Batch/Lot number: unknown) intramuscular, in right arm for maternal exposure timing unspecified. The patient's relevant medical history included: "OSA" (unspecified if ongoing); "anxiety" (unspecified if ongoing); "acid reflux" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT; VITAMIN D NOS; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; PEPCID [FAMOTIDINE]. The patient also took other concomitant therapy. Past drug history included: Sudaphed, reaction(s): "Allergies: Sudaphed"; Ibuprofen, reaction(s): "Allergies: ibuprofen". The following information was reported: PREMATURE DELIVERY (hospitalization), outcome "recovered", described as "preterm birth". The patient was hospitalized for premature delivery (hospitalization duration: 4 day(s)). The baby was delivered premature.  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: Event Maternal exposure during pregnancy was removed.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400034329 mother-baby cases;
Sex: F
Vaccine: RSV, RSV
Symptoms: Exposure during pregnancy, Premature delivery, Premature separation of placenta
Clinical narrative: premature delivery; placental abruption/ 32 weeks gestation; This is a spontaneous report received from a Consumer or other non HCP from Regulatory Authority. Regulatory number: 2740240-1 (VAERS ID).  A 29-year-old female patient (pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 04Jan2024 as dose number unknown, single (Batch/Lot number: unknown) intramuscular, in right arm for immunisation. Also reported Dose: 1, Route: SYR. The patient's relevant medical history included: "Penicilin allergy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). Current illness: none. The patient was 32 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 25Feb2024. Concomitant medication(s) included: SLOW FE; PRENATAL [FOLIC ACID;IRON]; OMEGA 3 [FISH OIL]. Past drug history included: Cefzil, reaction(s): "Drug allergy: cefzil". The following information was reported: PREMATURE SEPARATION OF PLACENTA (hospitalization, medically significant) with onset 04Jan2024, outcome "recovered", described as "placental abruption/ 32 weeks gestation"; PREMATURE DELIVERY (hospitalization) outcome "recovered". The patient was hospitalized for premature delivery, premature separation of placenta (hospitalization duration: 4 day(s)). Reported events of exposure during pregnancy, premature delivery, premature separation of placenta. Placental abruption; healthy pregnancy. The baby was delivered premature. The baby weighed 1785.656 grams (delivered 3 lbs 15 oz at 32 weeks gestation).  No follow-up attempts are possible. Batch/lot number is not provided, and it cannot be obtained.  Amendment: This follow-up report is being submitted to amend previous information: event "exposure during pregnancy" was deleted.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400034308 baby case;
Sex: F
Vaccine: RVX, UNK
Symptoms: Exposure during pregnancy, Product use issue, Wrong product administered
Clinical narrative: Drug Exposure During Pregnancy; This non-serious prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included Pertussis vaccine for prophylaxis.   On an unknown date, the patient received RSV vaccine and Pertussis vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced vaccine exposure during pregnancy (Verbatim: Drug Exposure During Pregnancy). The outcome of the vaccine exposure during pregnancy was unknown.   Pregnancy exposure: Gestation time at first exposure (RSV vaccine): 36 Weeks Pregnancy Exposure (RSV vaccine): To mother in third trimester Gestation time at first exposure (Pertussis vaccine): 36 Weeks Pregnancy Exposure (Pertussis vaccine): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 07-MAR-2024 Medical information specialist (MIS) received a call from a doctor regarding Arexvy. The reporter stated they were giving RSV vaccination at 36 weeks to pregnant women with whooping cough vaccine in order to protect newborns. Doctor then hung up before more information could be obtained regarding the potential adverse event.  RA conservatively reported as GSK had a RSV vaccine (Arexvy) that was also marketed reported for use of RSV vaccine in pregnant patients. However, doctor did not specifically state that the RSV vaccine administered to the pregnant patients was Arexvy. The reporter asked whether Arexvy was the same vaccine for women late in pregnancy to protect their newborn children. The reporter wanted to know whether it was this vaccine or it was another specific one, because he knew this was how they treated people in the winter overseas. After information was provided, he asked if Arexvy was supplied and if it was the case, then GSK should know what they were using over there, because this was where it had been treated over there. MIS asked if he wanted to know what was the RSV vaccine recommended for pregnant women, he said that was right. Before MIS could offer to escalate the question, he then said it was alright and he could ring them himself. The case is linked with CA2024030239, same reporter.; Sender's Comments:  AU-GSK-CA2024030239:Same reeporter
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Paraesthesia, Pruritus, Vaccination failure
Clinical narrative: Patient had vaccine still got milder shingles/Suspected vaccination failure; Shingles; Red marks of shingles; itching; tingle; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had vaccine still got milder shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), skin red (Verbatim: Red marks of shingles), pruritus (Verbatim: itching) and tingling (Verbatim: tingle). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the skin red, pruritus and tingling were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, skin red, pruritus and tingling to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, skin red, pruritus and tingling to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 11-MAR-2024 This case was reported by a patient's spouse via interactive digital media. The patient stated that they each had the shots but the husband still got a milder version of shingles in January. In March he still had red marks of shingles that itched or tingle. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Hypertension, Oral herpes zoster, Pain, Pyrexia, Rash
Clinical narrative: Patient had shingles after vaccination/Suspected vaccination failure; have them inside of my lips; rash on upper chest; mouth sores; pain; low fever; high blood pressure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: have them inside of my lips), rash (Verbatim: rash on upper chest), sores mouth (Verbatim: mouth sores), pain (Verbatim: pain), fever (Verbatim: low fever) and blood pressure high (Verbatim: high blood pressure). The patient was treated with magic mouthwash. The outcome of the vaccination failure was unknown and the outcome of the herpes zoster, rash, sores mouth and pain were not reported and the outcome of the fever and blood pressure high were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster, rash, sores mouth, pain, fever and blood pressure high to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster, rash, sores mouth, pain, fever and blood pressure high to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she thought he/she had them covered by getting the shingles 2 shots. Wrong. The patient had them (shingles) inside of the lips and had a rash on upper chest. The mouth sores were the worst. The patient stated that the pain would bring you to your knees. The patient got 4 prescriptions and magic mouthwash. Also, the patient had a low fever and made patient's blood pressure higher. The patient stated 4 days in, and the medications had not kicked in at that time. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Stomatitis, Vaccination failure
Clinical narrative: Patient had shingles after vaccination/Suspected vaccination failure; have them inside of my lips; rash on upper chest; mouth sores; pain; low fever; high blood pressure; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles after vaccination/Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: have them inside of my lips), rash (Verbatim: rash on upper chest), sores mouth (Verbatim: mouth sores), pain (Verbatim: pain), fever (Verbatim: low fever) and blood pressure high (Verbatim: high blood pressure). The patient was treated with magic mouthwash. The outcome of the vaccination failure was unknown and the outcome of the herpes zoster, rash, sores mouth and pain were not reported and the outcome of the fever and blood pressure high were not resolved.   It was unknown if the reporter considered the vaccination failure, herpes zoster, rash, sores mouth, pain, fever and blood pressure high to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster, rash, sores mouth, pain, fever and blood pressure high to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she thought he/she had them covered by getting the shingles 2 shots. Wrong. The patient had them (shingles) inside of the lips and had a rash on upper chest. The mouth sores were the worst. The patient stated that the pain would bring you to your knees. The patient got 4 prescriptions and magic mouthwash. Also, the patient had a low fever and made patient's blood pressure higher. The patient stated 4 days in, and the medications had not kicked in at that time. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient had shingles after vaccination/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 75-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JAN-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had shingles after vaccination/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 Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 09-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she never had any side effects from the shingles vaccine. The patient was 70 years of age then. At the time of reporting patient was 75 and had the shingles since January of this year. The doctor said the patient had a milder case because he/she got the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I've had it/ suspected vaccination failure; I've had it; lot of pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included open heart surgery. Concurrent medical conditions included arthritis (painful Arthritis).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I've had it/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I've had it) and pain (Verbatim: lot of pain). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved and the outcome of the pain was not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 09-MAR-2024 This case was reported by consumer via interactive digital media. The reporter was a patient. The patient had the shingles and it was going on 9 weeks. Patient had the Shingles vaccine about 6 years ago from reporting date, if patient ever get over this, patient would took the shot again. Patient said that who knows might be it would work this time. Patient thought that god was angry with patient for some reason. Patient reported that anyone who had open heart surgery, several other surgery's and painful arthritis feels shingles was worse than any of these things must be in a lot of pain and that was patient. The reporter requested to consent to follow-up. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory details were unknown at a time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: still it happened again/ Suspected vaccination failure; still it happened again; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: still it happened again/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still it happened again). 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 and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK received date: 11-Mar-2024 This case was reported by a patient via interactive digital media. Patient took both doses of Shingrix and it still happened again. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient got the shingle shot and got them/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient got the shingle shot and got them/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the shingle shot had them. Two times This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: PNC20, TDAP, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore Arm; This non-serious case was reported by a other health professional and described the occurrence of pain in arm in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 2BR9G) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Tdap Vaccine) (batch number DH3A2, expiry date 29-SEP-2023) for prophylaxis and PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) (batch number GN1897, expiry date 29-SEP-2023) for prophylaxis.   On 06-JUN-2023, the patient received Shingrix (right deltoid), Tdap Vaccine and PREVNAR 20 (left deltoid). On 06-JUN-2023, less than a day after receiving Shingrix and Tdap Vaccine and an unknown time after receiving PREVNAR 20, the patient experienced pain in arm (Verbatim: Sore Arm). The outcome of the pain in arm was not resolved.   The reporter considered the pain in arm to be related to Shingrix and Tdap Vaccine.     The company considered the pain in arm to be related to Shingrix and Tdap Vaccine.   Additional Information: GSK receipt date: 07-MAR-2024 The patient received first dose and sore arm on vaccination date and still sore till the day of reporting. Patient told healthcare professional that she will not receive the 2nd dose of Shingrix because of sore arm. The reporter considered the pain in arm to be related to Prevenar 20.
Sex: U
Vaccine: VARZOS
Symptoms: Local reaction
Clinical narrative: Increased Local reaction t 1st dose of vaccine; This non-serious case was reported by a nurse via sales rep and described the occurrence of local reaction in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immunocompromised.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced local reaction (Verbatim: Increased Local reaction t 1st dose of vaccine). The outcome of the local reaction was not reported.   It was unknown if the reporter considered the local reaction to be related to Shingrix.     It was unknown if the company considered the local reaction to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-MAR-2024 The nurse reported that the patient aged 60 plus received Shingrix. The patient had increased local reaction to the 1st dose of the vaccine. The patient was immunocompromised and was receiving immunosuppressive medication at the time of reporting. The reporter agrees to follow up from GlaxoSmithKline. This case has been linked to the case US2024AMR031181 reported by the same reporter.  ; Sender's Comments:  US-GSK-US2024AMR031181:
Sex: F
Vaccine: COVID19, VARZOS
Symptoms: Contusion, Illness, Malaise
Clinical narrative: Contusion/Bruising of arm; really sick for 2 days/feeling sick; really sick for 2 days/feeling sick; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of contusion in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ELASOMERAN (SPIKEVAX) for prophylaxis.   On an unknown date, the patient received Shingrix and SPIKEVAX. On an unknown date, an unknown time after receiving Shingrix, the patient experienced contusion (Verbatim: Contusion/Bruising of arm), malaise (Verbatim: really sick for 2 days/feeling sick) and sickness (Verbatim: really sick for 2 days/feeling sick). The outcome of the contusion was not reported and the outcome of the malaise and sickness were resolved.   It was unknown if the reporter considered the contusion, malaise and sickness to be related to Shingrix.     It was unknown if the company considered the contusion, malaise and sickness to be related to Shingrix.   Additional Information: RA receipt date: 07-MAR-2024 On an unknown date, the patient experienced contusion (severe reaction with bruising on her arm) and malaise (was really sick for 2 days). The reporter did not provide any causality assessments. The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter. The reporter was reporting for her neighbor who had the Spikevax Covid-19 vaccine along with a Shingrix shot and had a severe reaction with bruising on her arm. The reporter attributed it to having two vaccines at the same time. The neighbor was really sick for two days. It was unknown if the reporter considered the contusion, malaise and sickness to be related to Spikevax.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation issue
Clinical narrative: inadvertently received the diluent of Menveo without it being reconstituted with the lyophilized component; received the diluent of Menveo without it being reconstituted with the lyophilized component; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA956A, expiry date 31-JUL-2024) for prophylaxis.   On 05-MAR-2024, the patient received Menveo. On 05-MAR-2024, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently received the diluent of Menveo without it being reconstituted with the lyophilized component) and inappropriate dose of vaccine administered (Verbatim: received the diluent of Menveo without it being reconstituted with the lyophilized component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 05-MAR-2024 The nurse called in to request recommendations about how to proceed after a patient inadvertently received the diluent of Menveo without it being reconstituted with the lyophilized component, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered.  The vaccine administration facility was the same as primary reporter.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree celius; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old male patient who received HAV (Havrix) for prophylaxis.   On 08-FEB-2024, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree celius). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt date: 05-MAR-2024 Front desk worker reported that Havrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree Celsius and after this temperature excursion vaccine was administered to a patient which led to incorrect storage of drug.
Age: 20.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Product storage error
Clinical narrative: temperature excursion vaccine was administered to a patient; Pediarix vaccine was administered to a 20-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 20-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 11-JAN-2024, the patient received Pediarix. On 11-JAN-2024, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: Pediarix vaccine was administered to a 20-year-old patient). On an unknown date, the patient experienced incorrect storage of drug (Verbatim: Pediarix vaccine was stored outside of recommended storage conditions exposed to -0.8°C  and after this temperature excursion vaccine was administered to a patient). The outcome of the inappropriate age at vaccine administration and incorrect storage of drug 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: 05-MAR-2024 The front desk worker called and reported that the Pediarix vaccine was stored outside of recommended storage conditions and exposed to minus 0.8 degree C and after this temperature excursion vaccine was administered to a patient. The reporter consented to follow up via email.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Boostrix administration after storage error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 11-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 11-JAN-2024, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced incorrect storage of drug (Verbatim: Boostrix administration after storage error). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 05-MAR-2024 The front desk worker called to report Boostrix vaccine was stored outside of recommended storage conditions, exposed to minus 0.8 degree C and after this temperature excursion vaccine was administered to a patient, which led to an incorrect storage of drug.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Kinrix to a 7 year old patient; administration of Kinrix instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 29-FEB-2024, the patient received Kinrix. On 29-FEB-2024, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: administration of Kinrix to a 7 year old patient) and wrong vaccine administered (Verbatim: administration of Kinrix instead of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong 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: 06-MAR-2024 The healthcare professional reported that administration of Kinrix to a 7-year-old patient instead of Boostrix which led to an inappropriate age at vaccine administration and wrong vaccine administered. The healthcare professional did not need data, had already consulted with the CDC (Centers for Disease Control and Prevention) for guidance. No medical information data needed, just wanted to report adverse events as per healthcare professional adverse events reported to VAERS as well. The reporter consented to follow up. This case had been linked with US2024029878, reported by same reporter.; Sender's Comments:  US-GSK-US2024029878:SAME PRODUCT/ DIFFERENT PATIENT
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: drew up the solution, never mixed it with the powder; adjuvant only administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number X5J23) for prophylaxis.   On 05-MAR-2024, the patient received Shingrix. On 05-MAR-2024, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: drew up the solution, never mixed it with the powder) and inappropriate dose of vaccine administered (Verbatim: adjuvant only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-MAR-2024 The nurse reported that he/she yesterday (day before reporting) accidentally drew up the Shingrix solution, never mixed it with the powder and administered. So, the patient never got the reconstituted vaccine, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix late second dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27-OCT-2021).   On 09-DEC-2023, the patient received the 2nd dose of Shingrix. On 09-DEC-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Shingrix late second dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2024 Nurse called to report a patient received the second dose of Shingrix late, which led to lengthening of the vaccination scheduled. No lot number reported. The reporter consented to the follow up.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: A medical assistant called to report the administration of an extra dose of Engerix-B to a 15 year-old patient. Both doses were given today.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 15-year-old female patient who received HBV (Engerix B) (batch number 95D74, expiry date 28-MAR-2025) for prophylaxis.   Concomitant products included Hepatitis b vaccine rHBsAg (yeast) (Engerix b).   On 06-MAR-2024, the patient received Engerix B. On 06-MAR-2024, an unknown time after receiving Engerix B, the patient experienced overdose (Verbatim: A medical assistant called to report the administration of an extra dose of Engerix-B to a 15 year-old patient. Both doses were given today.). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 06-MAR-2024 The reporter was a medical assistant. The reporter called to report that the administration of an extra dose of Engerix-B to patient and both doses were given at the time of reporting, which led to overdose. The healthcare professional asked for expected side effects. It was not confirmed if both doses had the same lot number. The reporter consented to follow up.
Age: 65.0
Sex: U
Vaccine: RSV
Symptoms: Muscle spasms, Pain, Paraesthesia, Pyrexia
Clinical narrative: whole left side tingling when touches it down to the knee cap; sore and it still aches; Spasms in Left shoulder; fever; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of spasms in a 65-year-old patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX3T4, expiry date 20-AUG-2025) for prophylaxis.   On 29-FEB-2024, the patient received Arexvy (left arm). On 02-MAR-2024, 2 days after receiving Arexvy, the patient experienced tingling (Verbatim: whole left side tingling when touches it down to the knee cap). In MAR-2024, the patient experienced spasms (Verbatim: Spasms in Left shoulder), fever (Verbatim: fever) and pain (Verbatim: sore and it still aches). The outcome of the spasms, fever, tingling and pain were not resolved.   It was unknown if the reporter considered the spasms, fever, tingling and pain to be related to Arexvy.     It was unknown if the company considered the spasms, fever, tingling and pain to be related to Arexvy.   Additional Information: GSK receipt date: 07-MAR-2024 The pharmacist reported a patient received the Arexvy dose and stated that stating, on Saturday 2nd March 2024 patient noticed, whole left side tingling when touches it down to the knee cap. If you push hard enough it's sore and it still aches. It has been going on for 1 week since the Arexvy injection and there's tingling in skin under Left arm pit, fever, and spasms in left shoulder. Healthcare professional mentioned, patient received Arexvy injection in left arm and asked the patient was there any redness or warmth to touch and patient stated no.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: 2nd dose on 07Mar/2024.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 75-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 7X24T, expiry date 21-AUG-2025) for prophylaxis.   Previously administered products included Arexvy (on 16th October 2023 received a dose of Arexvy.).   On 07-MAR-2024, the patient received the 2nd dose of Arexvy. On 07-MAR-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: 2nd dose on 07Mar/2024.). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 07-MAR-2024 The pharmacist called to inform that he needed information about a patient getting two Arexvy in 5 months, which led to extra dose administered. The Vaccine Administration Facility was the same as Primary Reporter The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Blood pressure increased
Clinical narrative: blood pressure went up since then; This non-serious case was reported by a consumer via call center representative and described the occurrence of increased blood pressure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   In DEC-2023, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced increased blood pressure (Verbatim: blood pressure went up since then). The outcome of the increased blood pressure was unknown.   It was unknown if the reporter considered the increased blood pressure to be related to Shingrix.     It was unknown if the company considered the increased blood pressure to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2024 The reporter reported that the patient received Shingrix vaccine first dose in October 2023, then second dose in December 2023 and his blood pressure went up since then. No other information provided. The reporter did not consent to follow up.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Prostatic specific antigen increased
Clinical narrative: noted an elevated PSA level; This non-serious case was reported by a consumer via call center representative and described the occurrence of prostate specific antigen increased in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2023, the patient received the 1st dose of Shingrix. In DEC-2023, 1 month after receiving Shingrix, the patient experienced prostate specific antigen increased (Verbatim: noted an elevated PSA level). The outcome of the prostate specific antigen increased was unknown.   It was unknown if the reporter considered the prostate specific antigen increased to be related to Shingrix.     It was unknown if the company considered the prostate specific antigen increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-MAR-2024 The patient reported that he received the Shingrix vaccine first dose in November of 2023.  In December, he saw his physician and noted an elevated Prostate specific antigen level. In November before the vaccine his PSA was 3.2 and in December it was 7.4. It has not been checked since then. He received his 2nd Shingrix dose today on 8 March 2024. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt lousy for about a day; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of feeling bad in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   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 feeling bad (Verbatim: Felt lousy for about a day). The outcome of the feeling bad was resolved (duration 1 day).   It was unknown if the reporter considered the feeling bad to be related to Shingrix.     It was unknown if the company considered the feeling bad to be related to Shingrix.   Additional Information: GSK Receipt date: 08-MAR-2024 A pharmacist was self-reported. She stated that after the application of the second dose, she felt lousy for about a day and then she was fine. The reporter did not consent to follow up.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: dose of Menveo was accidentally given after the lyophilized component had expired; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In FEB-2024, the patient received Menveo. In FEB-2024, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: dose of Menveo was accidentally given after the lyophilized component had expired). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 12-MAR-2024 A licensed practical nurse (LPN) called and reported that about two weeks ago from reporting, a dose of Menveo was accidentally given after the lyophilized component had expired, which led to expired vaccine used. They provided partial information about the vaccine, patient and event. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOTS; This spontaneous report received from a consumer (family member) via other manufacture (Pfizer Inc.) and concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's past medical history included: blood clots, and concurrent conditions included: diabetes, and thyroid disease. The patient experienced blood clots when treated with estradiol for product use for unknown indication. It was reported that the patient took a birth control pill they don't know what it was but induced blood clots in other body then went through the whole thing they put a tube in your neck and get rid of them.  The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date the patient got covid shot and got the blood clots within a month (Dose series 1) within a month. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Thrombosis: The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Post herpetic neuralgia, Vaccination failure
Clinical narrative: shingles/ suspected vaccination failure; shingles; nerve pain/ hurts so bad; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 67-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On 09-MAR-2024, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles) and post herpetic neuralgia (Verbatim: nerve pain/ hurts so bad). The outcome of the vaccination failure was unknown and the outcome of the shingles and post herpetic neuralgia were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine.   Additional Information: GSK received date: 09-Mar-2024 This case was reported by a patient via interactive digital media. Patient got the shot last year in 2023 and at the time of reporting patient had shingles, had nerve pain and it hurt so bad. Patient was going to get the shots again and see what happens. Patient stated, this pain was the worst as patient had a lot of nerve pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation regarding shingles were unknown at the time of reporting.