chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; 2nd on 4/2/2024 and 3rd on 4/19/2024.; first dose of GARDASIL 9 in July 2022, 2nd on 4/2/2024 and 3rd on 4/19/2024.; This spontaneous report was received from a physician and referred to a patient of unknown age and gender. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.    On an unknown date in July 2022, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided). On 02-APR-2024, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) (inappropriate schedule of product administration). On 10-APR-2024, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered for prophylaxis (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) (inappropriate schedule of product administration). The health care professional (HCP) was not aware that the patient already had received first dose in July 2022 at time of 02-APR-2024. No additional adverse event (AE).
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong product administered
Clinical narrative: No other AE; HBP calling to report a patient was inadvertently administered the PROQUAD Vaccine together with the VARIVAX Vaccine.  This patient was supposed to receive the MMR II and VARIVAX together.; HBP calling to report a patient was inadvertently administered the PROQUAD Vaccine together with the VARIVAX Vaccine.  This patient was supposed to receive the MMR II and VARIVAX together.; This spontaneous report was received from a health business professional (HBP), referring to a patient of unknow age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant therapies were not reported.   On 22-APR-2024, the patient was inadvertently vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHA) (PROQUAD) injection, lot #X007358 has been verified to be a valid lot number, expiration date was reported and validated as 09-AUG-2024, administered for prophylaxis (strength, dose, and route of administration were not provided) together with varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot #X021281 has been verified to be a valid lot number, expiration date was reported and validated as 20-AUG-2025, administered for prophylaxis (strength, dose and route of administration were not provided) (wrong product administered) (accidental overdose). The patient was supposed to receive the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection and varicella virus vaccine live (oka/merck) (VARIVAX) injection together for prophylaxis. No symptoms reported and no additional details provided. No other adverse event (AE) and no product quality concern (PQC) was reported (no adverse event).
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Caller reporting temperature excursion and a dose was administered. No additional AE, no PQC. No additional information.; Caller reporting temperature excursion and a dose was administered. No additional AE, no PQC. No additional information.; This spontaneous report was received from a medical assistant concerning to a patient of unspecified age and gender. The patient's medical history, historical drugs, known allergies, concurrent conditions, and concomitant therapies were not reported.  On an unknown date, the was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot #2014790, expiration date: 22-APR-2026, administered for prophylaxis (strength, exact dose, anatomical location, and route of administration were not provided) that underwent a temperature excursion of 10.76 degree Fahrenheit for 13 hours and 50 minutes and 10.69 degree Fahrenheit for 8 hours and 21 minutes (improper storage of product in use). It was stated that no previous excursions had occurred. No additional adverse events (AE), no product quality complaint (PQC). No additional information.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Vaccine excursion on 14-MAR-2024/vaccine adminsitred on 21-MAR-2024 after a supported temperature excursion.; This spontaneous report was received from a nurse and referred to a 15-year-old male patient.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 14-MAR-2024, the vaccine hepatitis a vaccine, inactivated (VAQTA) lot #X023975, (expiration date: 18-APR-2025), underwent a temperature excursion, temperature reported: 34.3-degree Fahrenheit (F) for 21 minutes. After the supported temperature excursion, on 21-MAR-2024, the patient was vaccinated in a private doctor's office/hospital with public funds by a health care professional with the improperly stored hepatitis a vaccine, inactivated (VAQTA), administered intramuscularly in the left deltoid for prophylaxis (strength and dose was not provided) (Product storage error) (it was reported that the medication error occurred during storage in clinical practice). Temperature excursion was discovered on 22-MAR-2024 and was reported to the manufacturer (after the vaccine excursion was reported, manufacturer was contacted). No previous temperature excursions. No additional adverse event (AE), no product quality complaint (PQC) (No adverse event). No additional information.   This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2403USA008020: US-009507513-2405USA002625: US-009507513-2405USA001628: US-009507513-2405USA001629: US-009507513-2405USA001626: US-009507513-2405USA001627: US-009507513-2405USA001625:
Age: 1.0
Sex: U
Vaccine: FLU3, MMR, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Medical Assistant confirmed the patient did not experience any medical concerns or reactions after being administered the improperly reconstituted VARIVAX or MMR II vaccines.; Medical Assistant stated that a 12 month old was administered their first dose of MMR II and VARIVAX on 5/9/2024 after each of the vaccines were reconstitued improperly with the non-live virus influenza vaccine, FLUZONE; This spontaneous report has been received from a medical assistant, regarding a 12-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 09-MAY-2024, the patient was vaccinated with the first dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection (lot number: X008385, which was determined to be valid, with an expiration date on 21-MAR-2025. Therapy type: rHa) and the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: X026325, which was determined to be valid, with an expiration date on 07-NOV-2025), both at a dose of 0.5 milliliters as prophylaxis (strengths, routes and anatomical locations of administration were not reported).  Both vaccines were reportedly reconstituted with influenza vaccine (FLUZONE) (Product preparation error).  Medical Assistant confirmed the patient did not experience any medical concerns or reactions after being administered the improperly reconstituted varicella virus vaccine live (Oka/Merck) (VARIVAX) or Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) vaccines.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; Caller reported AE on behalf of a patient who received an expired dose of MMR-II on 5/13/2024 (w/ no TEs)-- SUPPORTED via post-expiry memo. No symptoms reported. Obtained consent to contact HCP. MIR Filed. No additional AE/PQC.; This spontaneous report was received from registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 13-MAY-2024, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter, lot #W034592, expiration date: 10-MAY-2024, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). No additional adverse event was reported.
Age: 1.33
Sex: F
Vaccine: MMR
Symptoms: Device connection issue, Needle issue, Poor quality product administered
Clinical narrative: poor quality device used; "patient is fine"/No additional AE/PQC reported.; The "round piece on syringe where needle attaches broke" during administration causing needle to come off syringe. the luer lock fell to the floor in one piece/ Caller stated it was as if the luer lock "just detached" from the syringe and needle; The luer lock fell to the floor in one piece/ Caller stated it was as if the luer lock "just detached" from the syringe and needle; the needle felt slightly loose when they attached it but they were able to administer the product without issue/ the luer lock fell to the floor in one piece while the needle stayed in the patient.; after administration the syringe came off and the luer lock fell to the floor in one piece while the needle stayed in the patient; This spontaneous report has been received from a medical assistant, regarding a 16-month-old female patient. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On 10-MAY-2024, the patient was vaccinated with a dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) injection, which was diluted with sterile diluent (BAXTER STERILE DILUENT) solution for injection/infusion (lot number: 1973250, which was determined to be valid as syringe formulation, with an expiration date on 11-FEB-2026), both as prophylaxis (strengths, doses, schemes, routes and anatomical locations of administration were not reported).  Caller stated the needle felt slightly loose when they attached it but they were able to administer the product without issue. When they went to remove the needle after administration the syringe came off and the luer lock fell to the floor in one piece while the needle stayed in the patient (Poor quality product administered, Needle issue). Caller stated they removed the needle from the patient and that it was as if the luer lock "just detached" from the syringe and needle (Syringe issue, Device connection issue).  No patient symptoms have been reported.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Immediate post-injection reaction, Infantile vomiting
Clinical narrative: Nurse reports that a 2 month old was given ROTATEQ and then immediately vomited after getting the ROTATEQ dose; This spontaneous report has been received from a nurse, regarding a 2-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies were not reported.  On an unspecified date, the patient was vaccinated with a dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) oral liquid, as prophylaxis (strength, dose, scheme, route of administration, lot number and expiration date were not reported).  Immediately after the vaccination, the patient vomited (Vomiting). By the time of the report, the outcome of the event was unknown.  The causal relationship between vomiting and Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) was not provided.   Nurse declined permission to contact, no additional information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: hospitalization post receiving first dose of Shingrix; This serious case was reported by pharmacist via market research programs. This female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis was enrolled in study and experienced the occurrence of hospitalization.   The patient received the 1st dose of Hz/su + AS01B on an unknown date, for prophylaxis. On an unknown date, an unknown time after receiving Hz/su + AS01B, the patient experienced hospitalization (Verbatim: hospitalization post receiving first dose of Shingrix) (serious criteria hospitalization). The outcome of the hospitalization was unknown.   The reporter considered the hospitalization to be possibly related to Hz/su + AS01B.   The company considered the hospitalization to be possibly related to Hz/su + AS01B.   Additional Information: GSK Receipt Date: 10-MAY-2024  Patient received Hz/su + AS01B was Shingrix. The pharmacist reported that two years ago one of the respondent patients received first dose of Shingrix and post receiving faced hospitalization.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Me & my brother both have been dealing with the shingles/suspected vaccination faiuer; Me & my brother both have been dealing with the 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. In APR-2024, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Me & my brother both have been dealing with the shingles/suspected vaccination faiuer) (serious criteria GSK medically significant) and shingles (Verbatim: Me & my brother both have been dealing with the shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   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: 10-MAY-2024 This case was reported by a consumer via interactive digital media. The reporter stated that the patient had been dealing with the shingles. The patient got it from the center of his/her back to center of his/her chest 3 weeks ago.  The reporter stated that his/her was not as bad because he/she had the shingles vaccine shot a while back. The reporter asked people to get the Shingles vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2024AMR060438, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024AMR060438:Same reporter different patient
Sex: U
Vaccine: TDAP
Symptoms: Anaphylactic shock
Clinical narrative: End up going to the hospital for Anaphylactic shock; This serious case was reported by a pharmacist via other manufacturer and described the occurrence of anaphylactic shock in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, an unknown time after receiving Boostrix, the patient experienced anaphylactic shock (Verbatim: End up going to the hospital for Anaphylactic shock) (serious criteria hospitalization and GSK medically significant). The outcome of the anaphylactic shock was unknown.   It was unknown if the reporter considered the anaphylactic shock to be related to Boostrix.     It was unknown if the company considered the anaphylactic shock to be related to Boostrix.   Additional Information: GSK Receipt Date: 09-May-2024. The reporter reported that the patient received Prevnar 20 a Pfizer product. Medical information inquiry only was the Boostrix Vaccine a Pfizer product, No Boostrix vaccine manufacturer was GlaxoSmithKline.  The call was transferred from Pfizer customer service by transferring agent stated, he or she had a customer on hold who needs assistances was a pharmacist and gave one of patient's shot with the Prevnar 20 today and they had some side effects later clarified that patient had no side effects with the Prevnar 20. The patient end up going to the hospital for Anaphylactic shock, and was calling to get more information any type of certain type of ingredients or anything, and getting more information on that.  When paraphrased the concern, Pharmacist stated, After taking the Tdap vaccine later clarified as Boostrix vaccine. So, he or she calling, wanted to get the Prevnar 20 and he or she called to see if there was anything similar in the Prevnar 20 to the Tdap later clarified as Boostrix vaccine. So we should, if there was any issue. The reporter clarified if the patient got side effects after taking Prevnar 20, Pharmacist stated, No. wants to get the Prevnar 20. But was concerned because had issues, its Boostrix. Pharmacist was informed about the Pfizer Medical Information Department and provided with the number as and department works from 09:00 AM to 05:00 PM from Monday to Friday. In response for further probing, Pharmacist stated, he or she actually had somebody waiting to talk to me. So I cannot, So further probing could not be done. Hence, Product details and other patient details were unknown.
Sex: F
Vaccine: HIBV
Symptoms: Device connection issue, Injury associated with device, Product complaint
Clinical narrative: Needle fell of the syringe; Product complaint; Needle stick; This non-serious case was reported by a nurse via sales rep and described the occurrence of needle stick/puncture in a adult female patient who received Hib (Hiberix) for prophylaxis. This case was associated with a product complaint.   On 02-MAY-2024, the patient received Hiberix. On 02-MAY-2024, less than a day after receiving Hiberix, the patient experienced needle stick/puncture (Verbatim: Needle stick). On an unknown date, the patient experienced syringe connection issue (Verbatim: Needle fell of the syringe) and pharmaceutical product complaint (Verbatim: Product complaint). On 02-MAY-2024, the outcome of the needle stick/puncture was resolving. The outcome of the syringe connection issue and pharmaceutical product complaint were unknown.   The reporter considered the needle stick/puncture to be related to Hiberix.     The company considered the needle stick/puncture to be related to Hiberix.   Additional Information: GSK receipt date 03 May 2024 It was reported that yesterday when giving vaccines, the reporter used the new hiberix syringe that had the ability to screw a needle onto the end. The needle came off of the syringe after the vaccine was given and although she thought she locked the needle, she hadn't before it fell off the syringe and when reporter went to pick up the needle she was poked in thumb. Both other nurses had stated that they found these new syringes have caused issues with the needle attaching. The needle could be pulled off of the syringe easily without being unscrewed, as the threading part of the syringe (see circled part of picture) seems to be loose or unable to really lock the needle well into place, even when physically holding the end well when screwing in the needle. Once the needle was screwed into the syringe, it had also noted to be crooked/unaligned properly. The reporter did not consent to follow up.
Sex: U
Vaccine: MEN, MENB, PNC20
Symptoms: Intercepted product storage error
Clinical narrative: Temperature excursion; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of intercepted product storage error in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Pneumococcal vaccine conj 20v (CRM197) (Prevnar 20) for prophylaxis and Meningococcal vaccine A/C/Y/W conj (tet tox) (Menquadfi) for prophylaxis.   On an unknown date, the patient received Bexsero, Prevnar 20 and Menquadfi. On an unknown date, an unknown time after receiving Bexsero, the patient experienced intercepted product storage error (Verbatim: Temperature excursion). The outcome of the intercepted product storage error was 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 2 May 2024: The reporter stated that PCV 20 and MCV4 had an excursion on 19 Apr 2024 for about 2 hours. Clarified the vaccines were the Prevnar 20 and MenQuadfi and the vaccines were not administered to any patients after the temperature excursion occurred. The reporter stated they reached the temperature of 49.9 degrees Fahrenheit; stats also had Bexsero that was in the excursion and stated the Bexsero was not administered to any patients after the excursion occurred, which led to intercepted drug storage error. The reporter asked on those vaccines are they able to use them.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: large red feverish circle; feverish circle; This non-serious case was reported by a consumer via call center representative and described the occurrence of erythema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27-NOV-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced erythema (Verbatim: large red feverish circle) and feeling hot (Verbatim: feverish circle). The outcome of the erythema and feeling hot were resolved (duration 7 days).   It was unknown if the reporter considered the erythema and feeling hot to be related to Shingrix.     It was unknown if the company considered the erythema and feeling hot to be related to Shingrix.   Additional Information: GSK Receipt Date: 04-MAY-2024 The patient self-reported this case. The reporter reported that he/she received the 1st dose Shingrix and he/she had a reaction of a large red feverish circle that lasted 7 days before going away. His/her sight said to not take the second shot if he/she had a reaction. The reporter asked did this type of reaction mean he/she should not take the second shot.
Sex: M
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: explained they accidentally administered only diluent portion of Rotarix; explained they accidentally administered only diluent portion of Rotarix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number L4749, expiry date 19-SEP-2024) for prophylaxis.   On 09-APR-2024, the patient received Rotarix lyophilized formulation. On 09-APR-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: explained they accidentally administered only diluent portion of Rotarix) and inappropriate dose of vaccine administered (Verbatim: explained they accidentally administered only diluent portion of Rotarix). The outcome of the inappropriate preparation of medication and inappropriate dose 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: 03-MAY-2024 The reporter explained they accidentally administered only diluent portion of Rotarix (lyophilized presentation) to patient, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The case had been linked to US2024056871 and US2024056874, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2024056871:Same reporter,Different patient US-GSK-US2024056874:Same reporter,Different patient
Sex: U
Vaccine: HEPAB
Symptoms: Extra dose administered
Clinical narrative: have a third shot of the hep b Heplisav-B, but the Heplisav-B is a 2 dose vaccine, Twinrix was given which is A and B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Heplisav-B (received first dose of Heplisav-B) and Heplisav-B (received second dose of Heplisav-B).     On an unknown date, the patient received the 1st dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced extra dose administered (Verbatim: have a third shot of the hep b Heplisav-B, but the Heplisav-B is a 2 dose vaccine, Twinrix was given which is A and B). The outcome of the extra dose administered was 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: 03-MAY-2024 The pharmacist reported patient had received the 2 shots of hepatitis b Heplisav B vaccine and thought that they needed to have the third shot of hepatitis b while Heplisav B was a 2 dose vaccine. But when they thought they were getting the third dose of hepatitis B, Twinrix was given which was A and B. Heplisav B was administered, and the scheme was completed. Patient received the third dose of hepatitis B antigen where Heplisav B was a 2 dose, which led extra dose administered of hepatitis B. The reporter refused to provide further information of the adverse event.
Age: 19.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Havrix to a 19 year old patient; pediatric dose of Havrix to a 19 year old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 19-year-old female patient who received HAV (Havrix 720) (batch number G79C4, expiry date 20-SEP-2025) for prophylaxis.   On 06-MAY-2024, the patient received the 2nd dose of Havrix 720. On 06-MAY-2024, an unknown time after receiving Havrix 720, the patient experienced underdose (Verbatim: pediatric dose of Havrix to a 19 year old patient) and adult use of a child product (Verbatim: pediatric dose of Havrix to a 19 year old patient). 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: 06-MAY-2024 The medical assistant administered a pediatric dose of Havrix to a 19 year old patient which led to underdoes and adult use of child product.  The dose was the patient's second in the series.  The patient had already left the office.  The vaccine administration facility was the same as primary reporter.
Age: 0.5
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: 3rd dose of Rotarix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number FJ442, expiry date 26-APR-2025) for prophylaxis.   Previously administered products included Rotarix (received 1st dose on 5th January 2024, lot number Y4NG3, expiry date: 3rd October 2025). Concomitant products included Rotavirus vaccine live oral 1v (Rotarix).   On 06-MAY-2024, the patient received the 3rd dose of Rotarix lyophilized formulation. On 06-MAY-2024, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: 3rd dose of Rotarix administered). The outcome of the extra dose administered was 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-MAY-2024 The patient was inadvertently administered a third dose of Rotarix which led to extra dose administered.
Sex: M
Vaccine: HIBV
Symptoms: Accidental exposure to product, Exposure via skin contact, Product complaint, Syringe issue
Clinical narrative: leaked on leg; Exposure via skin contact; the hub leaked; Product Complaint; This non-serious case was reported by a nurse via sales rep and described the occurrence of accidental exposure while administering drug in a 1-year-old male patient who received Hib (Hiberix) (batch number Y24T9, expiry date 14-MAR-2026) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Hiberix. On an unknown date, an unknown time after receiving Hiberix, the patient experienced accidental exposure while administering drug (Verbatim: leaked on leg), exposure via skin contact (Verbatim: Exposure via skin contact), syringe leak (Verbatim: the hub leaked) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the accidental exposure while administering drug, exposure via skin contact, syringe leak and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 06-MAY-2024 The nurse reported that when preparing to administer a Hiberix vaccine the hub leaked and medication leaked on he patient's leg which led to Accidental exposure while administering drug and exposure via skin contact. The reporter consented to follow up.
Age: 87.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Joint swelling, Peripheral swelling
Clinical narrative: diagnosed him with Shingles; right arm was all swollen with blisters; right arm was all swollen with blisters, up to the shoulder; right arm was all swollen with blisters, up to the shoulder; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 87-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30-APR-2024, the patient received the 1st dose of Shingrix. On 02-MAY-2024, 2 days after receiving Shingrix, the patient experienced shingles (Verbatim: diagnosed him with Shingles), blister (Verbatim: right arm was all swollen with blisters), swelling arm (Verbatim: right arm was all swollen with blisters, up to the shoulder) and swollen joints (Verbatim: right arm was all swollen with blisters, up to the shoulder). The outcome of the shingles, blister, swelling arm and swollen joints were unknown.   It was unknown if the reporter considered the shingles, blister, swelling arm and swollen joints to be related to Shingrix.   It was unknown if the company considered the shingles, blister, swelling arm and swollen joints to be related to Shingrix.   Additional Information: GSK Receipt Date: 07-MAY-2024. The reporter was the patient who stated he received Shingrix 1st dose and noticed his right arm was all swollen with blisters, up to the shoulder.  The patient called his primary care doctor who advised him to go to the hospital.  The patient went and was seen by a doctor who diagnosed him with shingles.  The patient was prescribed Valtrex 100 mg upon discharge same day. The reporter consented to follow up.
Sex: U
Vaccine: MEN, MENB
Symptoms: Bell's palsy
Clinical narrative: Bells palsy after administration; This serious case was reported by a physician via sales rep and described the occurrence of bell's palsy in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included Meningococcal vaccine for prophylaxis.   On an unknown date, the patient received Bexsero and Meningococcal vaccine. On an unknown date, 1 day after receiving Bexsero, the patient experienced bell's palsy (Verbatim: Bells palsy after administration) (serious criteria GSK medically significant). The outcome of the bell's palsy was unknown.   It was unknown if the reporter considered the bell's palsy to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the bell's palsy to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 08-MAY-2024 The patient received MCV4 and MenB next day developed bells palsy.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never received the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first 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: never received the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 09-MAY-2024 The  patient had one dose (of Shingrix), and then never received the 2nd dose.  The reporter have a customer who received first dose in 2021, and he never came back, and now he came back, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Wrong diluent used; Wrong diluent used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2024, the patient received Shingrix. In MAY-2024, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Wrong diluent used) and inappropriate dose of vaccine administered (Verbatim: Wrong diluent used). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 09 May 2024: A healthcare professional called in and requested to be directed to where they could order a spare diluent for Shingrix after a pharmacist administered a dose with a sterile diluent possibly last week. They requested to remain anonymous for the report, did not provide data for the patient, vaccine. The reporter denied consent to follow up. The pharmacist administered shingrix dose with a sterile diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypersomnia, Pain
Clinical narrative: Body Aches; Feeling horrible; sleeping alot; This non-serious case was reported by a other health professional via sales rep and described the occurrence of general body pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16-FEB-2024, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Body Aches), feels awful (Verbatim: Feeling horrible) and sleep excessive (Verbatim: sleeping alot). The outcome of the general body pain, feels awful and sleep excessive were resolved (duration 3 weeks).   It was unknown if the reporter considered the general body pain, feels awful and sleep excessive to be related to Shingrix.     It was unknown if the company considered the general body pain, feels awful and sleep excessive to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-May-2024 The reporter was a certified medical assistant reported that the female patient received both her first and second doses of Shingrix in the physician's office and experienced feeling horrible, body aches and sleeping after receiving both doses. The reporter stated that the patient was sleeping a lot after the first dose. All the reported adverse events lasted for 3 weeks after the first dose. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: shingles after receiving a shingles vaccine/suspected vaccination failure; shingles after receiving a shingles vaccine; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female 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: shingles after receiving a shingles vaccine/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles after receiving a shingles vaccine). The outcome of the vaccination failure and shingles were unknown.   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 10 May 2024: The patient reported developing shingles after receiving a shingles vaccine. Patient was not able to identify which singles vaccine she received. The reporter did not know if it was Shingrix or Zostavax. 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 was not reported. The reporter did not consent to follow-up.
Age: 0.42
Sex: M
Vaccine: RV1
Symptoms: Extra dose administered, Haematochezia
Clinical narrative: bloody stools; Extra dose; This serious case was reported by a nurse via call center representative and described the occurrence of blood in stool in a 5-month-old male patient who received Rota (Rotarix liquid formulation) (batch number GG2YS, expiry date 18-OCT-2025) for prophylaxis.   Previously administered products included rotarix (on an unknown date received 1st dose. ) and Rotarix (on an unknown date received 2nd dose).   On 07-MAY-2024, the patient received the 3rd dose of Rotarix liquid formulation (oral). On 07-MAY-2024, an unknown time after receiving Rotarix liquid formulation, the patient experienced extra dose administered (Verbatim: Extra dose). On 13-MAY-2024, the patient experienced blood in stool (Verbatim: bloody stools) (serious criteria GSK medically significant). The outcome of the blood in stool was not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the blood in stool to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device.     It was unknown if the company considered the blood in stool to be related to Rotarix liquid formulation and Rotarix Pre-Filled Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-MAY-2024 The regular nurse called stating patient inadvertently received a 3rd dose of Rotarix Liquid and presented today with bloody stools this morning.  HCP sent patient to the hospital for a pediatric abdominal ultrasound. The reporter was unsure if patient was being seen at ER or was being hospitalized but was sent to the hospital The patient received 3rd dose of Rotarix, which led to extra dose administered. Consented to follow up.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID/she has it again this year; COVID/she has it again this year; This is a spontaneous report received from a Consumer or other non HCP from product quality group, Program ID.  A 57-year-old female patient received BNT162b2 (BNT162B2 NOS), in 2023 as dose number unknown (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19", start date: 2022 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2024, outcome "unknown" and all described as "COVID/she has it again this year".Clinical course: Patient had mentioned that she had a COVID in 2022 and she has it again this year. It was around December, she thought so December-November. Yes, she did think it was around October or September because she did together. No, card no patient did not had with her in her chart, she did not had the access to the information. In her chart she did not had that. It was Pfizer vaccine for the COVID, all her vaccinations were Pfizer. She had been so bad, it was more than five doses for the vaccine.  Follow-up (10May2024): This is a follow-up report from product quality group. Updated information: medical history added. The information on the batch/lot number for [BNT162B2] will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400104765 same patient, different dose/event;US-PFIZER INC-202400105025 same patient, different dose/event;
Age: 65.0
Sex: M
Vaccine: PNC20
Symptoms: Blister, Erythema
Clinical narrative: Blisters on the arm; Big red spot on my arm/redness; This is a spontaneous report received from a Consumer or other non HCP.  A 65-year-old male patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), on 30Apr2024 as dose number unknown, single (Batch/Lot number: unknown) at the age of 65 years intramuscular, in left arm for immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: RASH MACULAR (non-serious) with onset 02May2024, outcome "not recovered", described as "Big red spot on my arm/redness"; BLISTER (non-serious) with onset 02May2024, outcome "recovered" (May2024), described as "Blisters on the arm". The events "blisters on the arm" and "big red spot on my arm/redness" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of blister, rash macular.  Additional information: The consumer stated the vaccine was possible Prevnar 20 (reported as "Is it 20") and "It is the one for 65".  The patient received a vaccine recently and he was having a pretty serious reaction to it. The patient started noticing some redness within 2-3 days of taking the vaccine. By the weekend 04May2024 - 05May2024 (as reported) the patient noticed blistering. He had blisters on the arm and a big red spot on his arm. The next week on 09May2024 the patient was able to go back to his doctors office, who gave it to him, to show the reaction of the vaccine and they had prescribed some steroid cream, for him to use on it. He was using the cold compresses at night and taking Benadryl. Treatment included Triamcinolone and Benadryl. The patient had had labs done. They are all normal.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) will be requested and submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 antibody test, Vaccination failure
Clinical narrative: tested positive three days ago; tested positive three days ago; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2 OMI XBB.1.5), in Jan2024 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2, for COVID-19 immunization, reaction(s): "malaise". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset May2024, outcome "unknown" and all described as "tested positive three days ago".  Clinical course: In Jan2024 patient received Company updated COVID 19 vaccination. Patient did this with some reluctance because he/she has experienced significant malaise from Pfizer vaccine in the past. But patient did not want to get COVID or at least not bad, so patient rolled up his/her sleeve and took it like a champ. It is now May2024 and patient was sick as a dog. Patient got the COVID, and he/she got it bad - tested positive three days ago in May2024.
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: feeling funny in her urinary area. All of a sudden she urinated without warning; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 72-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FE3184) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary Immunization series complete; unknown manufacturer), for Covid-19 Immunization. The following information was reported: URINARY INCONTINENCE (non-serious), outcome "unknown", described as "feeling funny in her urinary area. All of a sudden she urinated without warning". Additional information: Caller stated that she called about the first Pfizer Covid vaccine. Reported that about 3 days after the Covid vaccine started she feeling funny in her urinary area. All of a sudden she urinated without warning. Happened almost everyday of month. There was no warning or nothing and her mind goes off for a second and it happens. Wrote to Pfizer and sent in what was going on with her way back three years ago. Is still happening. Did notice when she looked on the internet that something similar was happening to people. No doctors seem to know what is going on. Did not have any issues until she had the Covid vaccine. Needed to know if other people have this issue, what can be done about it and what can she do. Does not like wearing a pad every day. Talked to Pfizer does not know what part about three years ago and sent a letter in explaining and was sent something filled a form out and sent it back to Pfizer. Provided a date of 30Aug2021. Read from the card Pfizer and provided a lot number of FE3184. Stated that it said third dose. Does not think she got another Pfizer but got Moderna after it.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021486100 same patient, different vaccine dose/event;US-PFIZER INC-202400106597 same patient, different vaccine dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Brain fog, Gait disturbance
Clinical narrative: brain fog; wobbliness; This is a spontaneous report received from a Consumer or other non HCP.  A patient (age and gender not provided) received BNT162b2 (BNT162B2), on 17Feb2021 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRAIN FOG (non-serious) with onset 18Feb2021, outcome "unknown"; GAIT DISTURBANCE (non-serious) with onset 18Feb2021, outcome "unknown", described as "wobbliness". Additional information: Side effects the next day was brain fog and wobbliness.  The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202400105884 same patient, different dose/event;US-PFIZER INC-202400105885 same patient, different dose/event;