chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I had gotten a Shingle shot at our health dept./Suspected vaccination failure; Had shingles twice/ the second time was the worse; Lots of pain; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles twice. The second time was the worst. The patient stated that, they were really really bad and had lots of pain. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the singles vaccine, got Shingles anyway/Suspected vaccination failure; shingles; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, 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.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got shingles anyway. The patient stated that, so much for vaccines. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Herpes zoster, Pain, Stress, Vaccination failure
Clinical narrative: I have had both shingles vaccines, I have had shingles 2 times since/suspected vaccination failure; I have had shingles 2 times since.; The worse pain I have ever dealt with the 2nd time; Stress; sheer exhaustion/tired; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, stress and exhaustion. On an unknown date, the outcome of the vaccination failure, shingles, pain, stress and exhaustion were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, stress and exhaustion to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient got of shingles 2 times since. It was the worst pain he/she had ever dealt with the 2nd time. The patient took medications, it was horrible. The patient was thankful he/she took the shots, thankful it was no worst and stated he/she had to believe the vaccines helped at least some, if any worst, he/she could not have handle it. The patient stated that, in all fairness, he/she had a daughter that was in a car accident and she was hospitalized for 5 months. The patient had them during that time and he/she believed the stress and sheer exhaustion was what caused him/her to have them and stated, learning how to care for her was taxing. The patient stated that, they still bother him/her some when he/she was tired, but nothing like at first. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: I've also have had the vaccine, recommended two shots and still got shingles/suspected vaccination failure; Still got shingles; Pain; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 22-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media and described the occurrence of suspected vaccination failure. After receiving Shingles vaccine, the patient still got bad case of shingles. The patient stated that, prescriptions medications helped but still suffered with pain. The patient suggested to read comments and if did not get vaccinations, got them. Additional supportive information: This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got shingles from the vaccine/Suspected vaccination failure; I got shingles from the vaccine; This 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, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient got shingles from the shingles vaccine. Additional Supportive Information: 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 follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: have shingles, but have the 2 shots already/suspected vaccination failure; shingles; nerves damage on my legs/pain, most painful thing; This 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, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the post herpetic neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient self-reported this case. The patient had already received 2 shots and had shingles a year ago and felt some nerves damage on his/her leg.  The patient stated that this pain was the most painful thing that he/she have had ever. The patient stated that every one 50 and older such have that. Additional Supportive Information: This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up could not be possible as no contact details were available. Note: As it was reported that patient already received 2 shots therefore 2 suspect was coded.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: I was down for 2 days after each injection. Miserable!; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR084029   Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. the patient received 1st dose of Shingles vaccine and had reaction that could not be imagine what Shingles feels like. The patient was down for 2 days after 1st dose and it was miserable. Additional Supportive Information: For tolerance of 2nd dose of Shingles vaccine refer linked case US2022AMR084029, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084029:Same Reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Immediate post-injection reaction, Symptom recurrence
Clinical narrative: shingles/my husband got shingles right after he was vaccinated for them and still suffers from; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was received from the patient's spouse via interactive digital media. The patient never had reactions to any childhood vaccinations that they were aware of.  The patient got shingles right after he was vaccinated for them and still suffers from recurring symptoms. Additional Supportive Information: Follow-up could not be possible as no contact details were available. The case was linked with case US2022AMR084030, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084030:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Vaccine positive rechallenge
Clinical narrative: I was down for 2 days after each injection. Miserable!; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date, refer linked case US2022AMR084026).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced feeling miserable. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the feeling miserable was recovered/resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR084026   Additional Information: GSK Receipt Date: 23-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. the patient received 2nd dose of Shingles vaccine and had reaction that could not be imagine what Shingles feels like. The patient was down for 2 days after 2nd dose and it was miserable.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR084026:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypersomnia
Clinical narrative: brain fog; slept for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of hypersomnia in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced hypersomnia and foggy feeling in head. On an unknown date, the outcome of the hypersomnia and foggy feeling in head were recovered/resolved.   It was unknown if the reporter considered the hypersomnia and foggy feeling in head to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received 2nd shingles shot along with his/her booster (unspecified vaccine) shot and slept for 3 days with brain fog. The patient was back to normal now. The patient never want shingles ever, ever again. It was unknown if the reporter considered the hypersomnia and foggy feeling in head to be related to booster (unspecified vaccine) shot. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: kicked my butt for a day; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In May 2022, the patient received the 2nd dose of Shingles vaccine. In May 2022, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell. In May 2022, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingles vaccine last week and felt it kicked his/her butt for a day or so but so glad to had it behind him/her. Additional supportive information: The follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Ankle fracture, Mobility decreased
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of ankle fracture in a patient who received Herpes zoster (Shingrix) for prophylaxis. n an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced ankle fracture. On an unknown date, the outcome of the ankle fracture was unknown. It was unknown if the reporter considered the ankle fracture to be related to Shingrix. Additional Information: GSK Receipt Date: 24-MAY-2022. Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received dose of Shingrix vaccine 3 years ago from reporting date but could not get the second shot because he/she had broken an ankle and could not get out of the house. The patient asked should he/she start the series over or forget the second shot altogether. Additional supportive information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Can I take second after 6 months; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient miscalculated time for his/her second Shingles shot. The patient asked could he/she take his/her second shot after 6 months. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingles vaccine, which led to incomplete course of vaccination. The follow-up would not possible, as no contact, details were available.
Age: 0.33
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Received dose on 09Jan2015; invalid extra dose on 13Jan2015; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 4-month-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP VACCINE) and DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (DTAP VACCINE).   On 13th January 2015, the patient received the 3rd dose of DTaP vaccine. On 13th January 2015, unknown after receiving DTaP vaccine, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 17-May-2022 Reporter's comments: The physician reported that she was trying to get a 7-year-old patient caught up on vaccine schedule. The patient received DTaP vaccines at 10 weeks age on 31st October 2014, at 4 months age on 9th January 2015 and again at 4 months age on 13th January 2015 and last one at 20 months age on 17th May 2016. The healthcare professional did not know which DTaP vaccines the patient received, as they were given at a different practice. The consent to follow up was given. Additional Supportive Information: The patient received 3rd dose of DTaP vaccine earlier than recommended time frame, which led to shortening of interval between vaccine doses. This case was linked with case US2022079727, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022079727:Same reporter
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient was administrated with Pediarix an extra dose of Sanofi IPV; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 3-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 5n259, expiry date 5th October 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis and POLIOMYELITIS VACCINE INACTIVATED (IPV VACCINE) for prophylaxis.   On 17th May 2022, the patient received the 1st dose of Pediarix, Pediarix Pre-Filled Syringe Device and IPV VACCINE. On 17th May 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose 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: 17-May-2022 Reporter's comments: Medical assistance reported that the patient was administrated with Pediarix and an extra dose of Sanofi IPV vaccine on same day. No adverse event was reported. The vaccine administration facility was the same as primary reporter. The consent to follow up was given. Additional Supportive Information: The patient received Pediarix and an extra dose of Sanofi IPV vaccine on same day, which led to overdose.
Sex: M
Vaccine: MENB
Symptoms: Accidental underdose, Product complaint, Syringe issue, Underdose
Clinical narrative: syringe leaked as it was being administered, then administered using new prefilled syringe; Syringe leaked as it was being administered; Product Complaint; This case was reported by a other health professional via call center representative and described the occurrence of accidental under dose in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXC05AA, expiry date 31st March 2023) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced accidental underdose, syringe leak and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, syringe leak and pharmaceutical product complaint 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: 18-May-2022 Reporters comment: The Health care professional (practice manager) was the reporter. Neither she nor anyone else has previously reported this complaint to our company. The reporter stated that the syringe leaked between the needle and the syringe's luer lok tip as it was being administered. The reporter stated that the leak occurred after the needle was inserted into the patient's skin and as the plunger was being depressed. The reporter stated that the experienced nurse felt the patient didn't receive much of the dose (related adverse event: partial dose).  The reporter stated that the dose was then administered using a new prefilled syringe. The reporter confirmed all operations were performed appropriately before defect discovered. The following questions were asked. The reporter asked where did it leak, at the luer lok tip, between needle and syringe. Was the syringe pre-assembled with needle some time before administration: NO, just prior to administration. What size gauge needle was used: 25Gauge. Was the blister and/or carton damaged: No. If leaking from plunger stopper, are there any liquid traces observed on the plunger stopper rings: n/a. Was the luer lok damaged: No. Was the needle which was used, available: Yes. Will return to GlaxoSmithKline with syringe. Was there any damage/breakage on the syringe barrel: No. The suspect product was available and the doctor's office will return the syringe with needle and the box to GlaxoSmithKline. Reporter requested to send return shipping label/packaging to Health care professional (reporter). The reporter consented to follow up with Health care professional. Additional Supportive Information: The patient did not receive the full dose of Bexsero, which led to accidental underdose.
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: pediatric patient received adult dose; pediatric patient received adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number 7YA99, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th May 2022, the patient received the 2nd dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 19th May 2022, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child 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: 20-MAY-2022 Reporter's Comments: The NP (nurse practitioner) reported that an adult dose of Havrix was given to the pediatric patient. The patient were twins. The reporter consented to follow up by postal. Additional supportive information: The use of an adult dose of Havrix to pediatric patient, which led to overdose, adult product administered to child. This case is linked with case US2022081896 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022081896:Same reporter
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Jul 21st 2021 never continue the series; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 49-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 21-Jul-2021 with batch no. X239D and expiry date 7-Aug-2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 20-MAY-2022 Reporter's Comments: The pharmacist reported that now, the patient would like to continue the series. The reporter gave consent to follow up. Additional supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: MENB
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received 1st dose on Sepetember 2021 and wanted to get 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Bexsero (received 1st dose in September 2021).   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 20-MAY-2022 Reporter's Comments: The pharmacist reported that the patient was administered Bexsero at intervals of greater than 1 month.  The patient wanted to get second dose.  The reporter wanted to know if patient needed to restart schedule. The reporter give consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Bexsero, which led to incomplete course of vaccination.
Age: 30.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received an unknown Tdap on 5/17/2021, Boostrix on 5/20/22; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 30-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   Previously administered products included tdap (on 17th May 2021 the patient received unknown Tdap).   On 20th May 2022, the patient received Boostrix. On 20th May 2022, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments: The reporter was a medical assistant. The reporter stated that the patient received an unknown Tdap and now received Boostrix. The reporter inquired what to look for and how to proceed. The reporter consented to follow up. Additional Supportive Information: The patient received an unknown Tdap and now received Boostrix prior to recommended interval, which led to shortening of vaccination schedule
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered
Clinical narrative: partial dose administered; Dripped down the patient's arm; Dripped down the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a 81-year-old male patient who received Herpes zoster (Shingrix) (batch number X2X35, expiry date 12th May 2023) for prophylaxis.   On 23rd May 2022, the patient received the 2nd dose of Shingrix. On 23rd May 2022, unknown after receiving Shingrix, the patient experienced incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the incomplete dose administered, inadvertent exposure to vaccine and exposure via skin contact were unknown.       Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments:  The pharmacist stated a Shingrix syringe malfunctioned and most of the vaccine dripped down the patient's arm. It was unknown what was volume administered successfully. This was supposed to be the patient's second dose. The reporter was consented to follow up. No further details provided during call, pharmacist grants permission for safety and quality to follow up. Additional Supportive Information: A Shingrix syringe malfunctioned and most of the vaccine dripped down the patient's arm, which led to incomplete dose administered, exposure via skin contact, Inadvertent exposure to vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: Patient was injected only with the adjuvant; Patient was injected only with the adjuvant; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-MAY-2022 Reporter's Comments:  The reporter reported the patient was injected only with the adjuvant of Shingrix. No adverse event was reported. The reporter did not consent to follow-up. No patient's identifiers provided, no lot number and expiration date provided, no vaccination date provided, unknown amount of patient that were vaccinated. Additional Supportive Information: The patient was injected only with the adjuvant of Shingrix, which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache
Clinical narrative: Headache; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number A725Y, expiry date 30th May 2023) for prophylaxis.   On 21st May 2022, the patient received the 1st dose of Shingrix. On 21st May 2022, less than a day after receiving Shingrix, the patient experienced headache and fatigue. On 23rd May 2022, the outcome of the headache and fatigue were recovered/resolved.   It was unknown if the reporter considered the headache and fatigue to be related to Shingrix.     Additional Information: GSK receipt date: 23-May-2022 Reporter's comment: The case was reported by patient's wife. The patient received a dose of Shingrix on the afternoon and that evening he developed a headache and fatigue. The headache and fatigue lasted about a day and a half and were now resolved.  She had nothing else to report. The reporter declined to provide email addresses but might follow-up with heath care professional. The reporter consented to follow-up. Additional Supportive Information: This case has been linked to the US2022082828 case reported by the same reporter. Note: Duration was auto calculated as per mentioned date as partial outcome date and duration of 1 and half day we did not captured.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022082828:Same Reporter
Sex: F
Vaccine: MNQ
Symptoms: Intercepted product prescribing error
Clinical narrative: prescription for MENVEO, two dose series; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a adult female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (received a 1st dose of Menveo approximately 2 months ago while she was in the hospital). Concurrent medical conditions included cancer.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   Additional Information: GSK Receipt Date: 24-MAY-2022 Reporter's Comments:  The pharmacist reported that she had received a prescription for Menveo for an adult, cancer patient.  The patient had received a dose of Menveo approximately 2 months ago while she was in the hospital.  The prescription of the pharmacist was for Menveo to be administered after 17th May 2022.  The pharmacist reported that the physician wanted the patient to receive a two-dose series.  Till the time of reporting this second dose had not been administered. The reporter provided limited information. The pharmacist was not at the pharmacy at the time of reporting. Additional supportive information: The patient received the prescription for Menveo and physician wanted the patient to receive a two dose series but till the time of reporting this second dose had not been administered, which led to intercepted drug prescribing error.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent of menveo; received only the diluent of menveo; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA687A, expiry date 30th April 2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.    Additional Information: GSK Receipt Date: 24-May-2022 Reporter's comments: Medical assistant reported that the patient received only the diluent of Menveo. The consent to follow up was given.  Additional Supportive Information: The patient received only the diluent of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 0.83
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: given a dose that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 10-month-old female patient who received HBV (Engerix B pediatric) (batch number 9KG7R, expiry date 9th May 2022) for prophylaxis.   On 24th May 2022, the patient received Engerix B pediatric. On 24th May 2022, unknown after receiving Engerix B pediatric, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-May-2022 Reporter's comments: Medical assistant reported the patient received dose of Engerix-B that was already expired. The consent to follow up was given. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Coronary artery bypass, Intensive care, International normalised ratio
Clinical narrative: QUADRUPLE VESSEL BYPASS GRAFT; INTENSIVE CARE; This spontaneous report received from a patient via AbbVie concerned a 69 year old female of an unspecified race and ethnicity. The patient's weight was 135 pounds, and height was 63 inches. The patient's concurrent conditions included: non smoker, no alcohol use, and psoriasis. Patient was treated with 2 doses of non-company suspect vaccine tozinameran (Pfizer vaccine) (Dose number in series 1) (form of admin unknown, intramuscular, batch number and expiry was not reported) dose was not reported, administered on 05-MAR-2021 and 07-NOV-2021 for prophylactic vaccination. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number and expiry was not reported) dose, start therapy date were not reported, 1 in total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. On an unspecified date, the patient experienced quadruple vessel bypass graft and her medicines were discontinued. Patient was hospitalized from 27-DEC-2019 to 03-FEB-2020 for 38 days and was in intensive care unit for eleven months. Patient was hospitalized and was in intensive care for three times. The patient took no concomitant medication. Patients intensive care unit medicines were discontinued and patient was back on her medicine. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose was not reported, 1 time every 2 weeks from 27-DEC-2019 to 03-FEB-2020 for psoriasis. No concomitant medications were reported. Laboratory data (dates unspecified) included: International normalized ratio (NR: not provided) not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; action taken with tozinameran was not reported; and treatment with adalimumab was withdrawn on 03-FEB-2020. The patient recovered from quadruple vessel bypass graft, and intensive care. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220535287-covid-19 vaccine ad26.cov2.s-  Quadruple vessel bypass graft, Intensive care. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: Autism spectrum disorder
Clinical narrative: AUTISM; This spontaneous report received from a parent via social media via a company representative concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) 1 total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced autism. Reporter stated that, ""It was nurses who shot vaccines full of mercury into my normal son to cause his autism. The psychos who planned this attack on our babies lied to the nurses". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of autism was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0- 20220538898-covid-19 vaccine ad26.cov2.s-Autism. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Influenza like illness, Off label use
Clinical narrative: BAD FLU LIKE SYMPTOMS; OFF LABEL USE; INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTERED; This spontaneous report received from a pharmacist via other company (Pfizer Inc.) concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received dose 1 with covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The reporter stated that after giving the vaccine, he and the rest of the pharmacy staff realized they were uncertain how long the vaccine had been left out in the pharmacy prior to administration, but assumed it was greater than two hours which was out of specification product use and incorrect product storage (Dose number in series 1). The patient received dose 2 with covid-19 vaccine ad26.cov2.s (unspecified manufacturer), (Dose number in series 2), (suspension for injection, route of admin, and batch number and expiry date were not reported) dose, start therapy date were not reported for prophylactic vaccination. The reporter stated that the second vaccine was given within few days of the first dose which was off label use, and inappropriate schedule of vaccine administered (Dose number in series 2). The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced real bad flu like symptoms after re-vaccination with dose 2 of covid-19 vaccine ad26.cov2.s (Dose number in series 2). The patient went to the hospital because she was worried as she was having tremendous backlash from the vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad flu like symptoms, off label use and inappropriate schedule of vaccine administered was not reported. This report was non-serious. This case, involving the same patient is linked to 20220551589 (Dose number in series 1).; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as the case is assessed as non serious
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: TESTED POSITIVE FOR COVID; This spontaneous report received from a pharmacist concerned a 47 year old female of an unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series: 1) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 12-APR-2021 for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (Dose number in series: 1). The patient received covid-19 vaccine ad26.cov2.s (Booster) (Dose number in series: 2) (suspension for injection, route of administration not reported, batch number: Unknown and expiry: Unknown) dose was not reported, 1 total administered on 21-NOV-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On 23-DEC-2021, the patient tested positive for covid (Dose number in series: 2). Laboratory data included: COVID-19 virus test (NR: not provided) positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tested positive for covid was not reported. This report was non-serious.