chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: Shingles; first shot before Covid shots became available Can I still get second; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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 1st dose of Shingles vaccine and the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that they had received my first shot just before Covid shots became available. Second shingles was due at same time as first Covid available. The reporter had also asked if they can still get the second shingles or do, they need to start over. They had shingles already. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: felt a little sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (old shingles shot years ago).   In March 2022, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR118369   Additional Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient had the old shingles shot years ago back in March and felt a little sick the next day. The follow-up could not be possible as no contact details were available. For tolerance to the 2nd dose refer case US2022AMR118369.; Sender's Comments:  US-GSK-US2022AMR118369:Second dose case/Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pyrexia
Clinical narrative: was sick as hell/was sick all day the next day; temp which was 102-104 for hours; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included SHINGRIX VACCINE (received 1st dose in March 2022 and experienced sickness, refer case US2022AMR118367) and Shingles vaccine (had the old shingles shot years ago).   On 7th August 2022, the patient received the 2nd dose of Shingrix. In August 2022, less than a week after receiving Shingrix, the patient experienced sickness and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the sickness and fever were recovered/resolved.   It was unknown if the reporter considered the sickness and fever to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR118367   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The case was received from the patient via interactive digital media. The patient had the old shingles shot years ago and now had the shingrix 2 shot deal. This past Sunday, the patient got the 2nd dose and the patient was sick as hell and a temperature which was 102 to 104 degree Fahrenheit for hours and was sick all day the next day of course the patient called the doctor who gave some great advice. If the patient had known it would have made him/her so sick that the patient  wouldn't had taken the 2nd shot. The patient know this has happened to quite a lot of people so the patient wonder.  The patient was asking what had changed in the vaccine that it makes a person that ill. Just shouldn't be that bad. Additional supportive information: This case has been linked with the case US2022AMR118373, reported by same reporter. Follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR118367:Fist dose case/Same reporter US-GSK-US2022AMR118373:Hearsay case
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Shingrix dosing is over six months apart.; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received Shingrix dosing was over six months apart. The reporter wanted to knew there any requirement for booster shots. The follow-up could not be possible as no contact details were available. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles 3 weeks after Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 3 weeks after receiving Shingrix, the patient experienced shingles. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 2-AUG-2022 Reporter's Comments:  This case was received from consumer via interactive digital media. The reporter stated that patient got shingles 3 weeks after Shingrix and took antiviral meds helped tremendously. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: little sorness on your arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date:01-AUG-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter stated that, no not at all.  The patient experienced only a little soreness on his/her arm. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: FLUX
Symptoms: Illness, Muscle spasms, Myalgia
Clinical narrative: made me super sick; my leg muscles froze up very painfully; my leg muscles froze up very painfully; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (got shingles vaccine about 5 years ago). Concurrent medical conditions included friedreich's ataxia (had Fredrick's ataxia, a degenerative neuromuscular disease which is an autoimmune disease).   In September 2021, the patient received Flu vaccine. On an unknown date, less than a year after receiving Flu vaccine, the patient experienced sickness, myalgia of lower extremities and leg cramps. On an unknown date, the outcome of the sickness, myalgia of lower extremities and leg cramps were unknown.   It was unknown if the reporter considered the sickness, myalgia of lower extremities and leg cramps to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2022AMR119892   Additional Information: GSK Receipt Date: 04-AUG-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that most vaccines can give you Guillaume Barre syndrome. Every vaccine can given to themselves. This includes shingles, Flu and even Botox. Read the provided warnings. Guillaume Barre symptoms are quite the same as the disease they had which was Fredrick's attaxia, a degenerative neuromuscular disease which was an autoimmune disease. Guillaume Barre Syndrome was also an auto immune disease. The reporter should have asked their doctor to checked themselves for Guillaume Barre Syndrome if they have had received multiple vaccines. They have not had a COVID vaccine simply because of their medical problems. They did get the shingles vaccine about 5 years ago. They had no problems with that. They had got a senior flu shot last September and it had made them super sick and their leg muscles was frozen up, very painfully. They are not sure about getting another flu shot. Too many chemicals were going into their body. The reporter was homeopathic, they do not believe in chemicals. When their mom had caught shingles they had went to whole foods and found a product that had really helped. It was the time, that we all should checked into more homeopathic cures and avoid the chemicals. Additional supportive information: This was one of the linked cases reported by same reporter as US2022AMR119892. Follow-up would not possible, as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR119892:Shingles vaccine case/Same reporter US-GSK-US2022AMR119885:Same reporter/Same case US-GSK-US2022AMR119888:Same reporter/Same case US-GSK-US2022AMR119892:Same reporter/Same case US-GSK-US2022AMR119885:Same case/Same reporter US-GSK-US2022AMR119888:Same reporter/Same case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Urticaria
Clinical narrative: Broke out with shingles; Broke out in hives; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had two times in an unmentionable spot). Previously administered products included Valtrex and Ointment.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles and hives. On an unknown date, the outcome of the shingles and hives were unknown.   It was unknown if the reporter considered the shingles and hives to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-AUG-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient had Shingles first time, the patient thought it was insect bites. The second time patient took a picture and sent to the doctor, and patient got ointment and Valtrex. The patient decided to get the Shingles shots, it was a series of two shots. After receiving vaccine, the patient had every stinking side effect listed, the patient experienced broke out in hives and a week later patient had Shingles for third time. The patient would not get the second shot, patient never had an adverse reaction to any vaccine before this caught him off guard. The patient was not telling not get vaccine, patient asked please do research on it first to know the possibilities of reaction and could made informed decision. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bone fragmentation, Injected limb mobility decreased, Insomnia, Limb injury
Clinical narrative: Damage to shoulder after boostrix; Fluid in shoulder, debris in this fluid; Limited Range of Motion in left shoulder/cannot move arm; Great Pain, pain with certain motions; she cannot sleep on her left side due to the pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder injury in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2022, the patient received Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 2nd June 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping. The patient was treated with ambiguous medication nos (Cortisone (Nos)), ibuprofen, diphenhydramine hydrochloride + ibuprofen (Ibuprofen Pm) and opioids {nos} (Opioids). On an unknown date, the outcome of the shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping to be related to Boostrix and Boostrix 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-Aug-2022 Reporter's Comments: The patient self reported this case for herself.  The patient received Boostrix on 2nd June 2022. Later that day, she began to experience great pain and limited range of motion in her left shoulder. She can not pull up her pants, she can not reach out her arm and move it above it being straight out , she cannot sleep on her left side due to the pain. 3 weeks after receiving the vaccine, she was sent to have an MRI which showed damage to her shoulder, fluid in the shoulder and that there was debris in this fluid. Subsequently she was seen by an orthopedic doctor who gave her a cortisone shot in the shoulder on19th July 2022. At the time of the call, the pain in her shoulder still exists, but it was better than it was before and she had pain with certain motions and still can not sleep on her left side. She had been seen by physical therapy, in which she does daily exercises which helps with her range of motion. She had been taking Ibuprofen for the pain and Ibuprofen PM to help her sleep. She had been prescribed opioids prior to the ibuprofen but she was unable to tolerate them. The reporter consented to follow up. Additional supportive information: As the patient was taking medicine for sleep, difficulty in sleeping was captured as an event.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of personal independence in daily activities, Magnetic resonance imaging abnormal, Pain
Clinical narrative: Damage to shoulder after boostrix; Fluid in shoulder, debris in this fluid; Limited Range of Motion in left shoulder/cannot move arm; Great Pain, pain with certain motions; she cannot sleep on her left side due to the pain; This case was reported by a consumer via call center representative and described the occurrence of shoulder injury in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 224CG, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd June 2022, the patient received Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 2nd June 2022, less than a day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping. The patient was treated with ambiguous medication nos (Cortisone (Nos)), ibuprofen, diphenhydramine hydrochloride + ibuprofen (Ibuprofen Pm) and opioids {nos} (Opioids). On an unknown date, the outcome of the shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping were not recovered/not resolved.   It was unknown if the reporter considered the shoulder injury, bone shedding debris, injected limb mobility decreased, shoulder pain and difficulty sleeping to be related to Boostrix and Boostrix 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-Aug-2022 Reporter's Comments: The patient self reported this case for herself.  The patient received Boostrix on 2nd June 2022. Later that day, she began to experience great pain and limited range of motion in her left shoulder. She can not pull up her pants, she can not reach out her arm and move it above it being straight out , she cannot sleep on her left side due to the pain. 3 weeks after receiving the vaccine, she was sent to have an MRI which showed damage to her shoulder, fluid in the shoulder and that there was debris in this fluid. Subsequently she was seen by an orthopedic doctor who gave her a cortisone shot in the shoulder on19th July 2022. At the time of the call, the pain in her shoulder still exists, but it was better than it was before and she had pain with certain motions and still can not sleep on her left side. She had been seen by physical therapy, in which she does daily exercises which helps with her range of motion. She had been taking Ibuprofen for the pain and Ibuprofen PM to help her sleep. She had been prescribed opioids prior to the ibuprofen but she was unable to tolerate them. The reporter consented to follow up. Additional supportive information: As the patient was taking medicine for sleep, difficulty in sleeping was captured as an event.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included Shingrix (received 1st dose on 23rd December 2020). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown. Additional Information: GSK Receipt Date: 10-Aug-2022. Reporter's Comments: The reporter stated that a patient did not receive the 2nd dose of Shingrix till the time of reporting. The reporter consented to follow up via postal. Additional Supportive Information: Till the time of reporting the patient did not receive the2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Nov2018; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose of Shingrix received in November 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.      Additional Information: GSK receipt date:11-Aug-2022 Reporter comment: The healthcare professional reported that a patient received the first dose of Shingrix. The healthcare professional was asking that was there a need to restart the series or just to complete the second dose. At the time of the report, no mention was made about the administration of the second dose of Shingrix in the webform. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of engerix-b; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received HBV (Engerix B) (batch number D423N, expiry date 1st June 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received an expired dose of Engerix-B. The reporter consented to follow up.  Additional supportive information: The patient received a Engerix-B which was already expired, which led to expired vaccine used.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: dose of Bexsero 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 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB398C, expiry date 30th July 2022) 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.   On 2nd August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd August 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-AUG-2022 Reporter's comment: The clinic supervisor reported that a dose of Bexsero was given to the patient and it was already expired. The Vaccine Administration Facility was the same as primary reporter. The reporter did not consent to follow up. Additional Supportive Information: The use of Bexsero dose which was already expired on 30th July 2022, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2018, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-Aug-2022 Reporter's comment: The patient self-reported this case. The patient had not yet received the second dose of Shingrix. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose given 26days after 1st; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, 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: 11-Aug-2022 Reporter's comment: The patient received the second dose of Shingrix vaccine 26 days after the first dose. The HCP (Health Care Professional) had no demographics and didn't know the vaccination date. The reporter asked how to proceed. The reporter consented to follow-up. Additional Supportive Information: The patient received 2nd dose of Shingrix vaccine earlier than the recommended interval, which led to shortening of vaccination schedule.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired twinrix administered; This case was reported by a other health professional via sales rep and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAB (Twinrix) (batch number x239d, expiry date 7th August 2022) 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.   On 8th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 8th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-AUG-2022 Reporter's Comment: The reporter reported that, a patient was administered with an expired dose of Twinrix.  No adverse event was reported. The adverse event was reported by the supervisor of the facility to the sale representative. The reporter consented to follow up. Additional Supportive Information: The reporter reported that, a patient was administrated with an expired dose of Twinrix, which led to expired vaccine used.
Age: 12.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: received Infanrix instead of a TDaP; 12-year-old received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) (batch number LS444, expiry date 16th September 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-AUG-2022 Reporter's Comments: The nurse reported that the 12-year-old patient received Infanrix instead of a TDaP. The reporter consent to follow up. Additional Supportive Information: The patient received Infanrix vaccine instead of TDaP, which led to wrong vaccine administered. 12 years old patient received Infanrix vaccine, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: expired dose of Twinrix was administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a male patient who received HAB (Twinrix) (batch number unknown, expiry date 7th August 2022) 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.   On 11th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 11th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11-AUG-2022 Reporter's Comments: A Pharmacist stated that an expired dose of Twinrix was administered to a patient.  The reporter consented to follow up. The healthcare professional did not have the lot number at the time of the call and declined to provide the initials or DOB for the patient. He also did not know what dose number this was for the patient.  Additional supportive information: Patient received a dose of Twinrix on 11th August 2022 which was expired on 7th August 2022, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Shingrix stored in the freezer, used in patients; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Herpes zoster (Shingrix) (batch number 9CR25, expiry date 24th September 2023) and (batch number 95G27, expiry date 10th September 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 12-Aug-2022 Reporter's comment: The registered nurse reported that Shingrix that had been stored in the freezer from shipment.  The Shingrix had been used in patients.  The reporter did not know exactly how many patients had been administered the Shingrix. The reporter stated that there were 3 boxes of Shingrix stored in freezer (1 with same lot).  The reporter reported that unknown patients had been administered Shingrix, no additional patient demographics available or dates of administration.  The shipment date was unknown. The reporter consented to follow-up. Additional supportive information: The patients received Shingrix that had been stored in the freezer, which led to incorrect storage of drug.
Age: 50.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 50-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 229AN, expiry date 5th July 2022) for prophylaxis.   On 9th August 2022, the patient received Boostrix. On 9th August 2022, unknown after receiving Boostrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments: The pharmacist reported that a male patient received an dose of Boostrix which was expired on 5th July 2022. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Boostrix, which led to expired vaccine used. This case has been linked with case US2022119634 reported by same reporter.; Sender's Comments:  US-GSK-US2022119634:Same reporter. Patient 2.
Sex: U
Vaccine: COVID19
Symptoms: Death, Epistaxis
Clinical narrative: DEATH; BLEEDING THROUGH NOSE; This spontaneous report received from a consumer concerned multiple patients of unspecified age, gender, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patients experienced bleeding through nose and then later died. On an unspecified date, the patients died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patients died of death on an unspecified date, and the outcome of bleeding through nose was not reported. This report was serious (Death).; Sender's Comments: V0- 20220830199-covid-19 vaccine ad26.cov2.s -Death. 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 37.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient via other company(pfizer) concerned a 38 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1808982 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 10-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 37 years old. Concomitant medications included bupropion, dexmethylphenidate, ibuprofen, loperamide, and simeticone for drug used for unknown indication. The patient received Non-company suspect vaccine elasomeran (Moderna) (dose number in series: 2) (form of admin, route of admin, and were not reported) dose was not reported, batch number: 939903 expiry: UNKNOWN, dose 2, administered to left arm on 26-OCT-2021 for covid-19 prophylaxis. On 29-JUL-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration, batch number and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 02-AUG-2022.  On 05-AUG-2022 and 06-AUG-2022, Laboratory data included: COVID-19 PCR test Negative. On 08-AUG-2022, the patient experienced return of mild fever, congestion, sore throat, diarrhea (confirmed covid-19 infection) (dose number in series: 2). Symptoms milder than original infection and so far do not include the joint pain and chills (dose number in series:2). On 09-AUG-2022, the patient tested positive for covid-19 virus test (confirmed clinical vaccination failure) (dose number in series: 1). The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable, paxlovid was drug discontinued. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000246766.; Sender's Comments: V0- 20220832710 -COVID-19 VACCINE Ad26.COV2.S- Confirmed clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient had COVID positive test or diagnosis; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (patient had COVID positive test or diagnosis) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Drug allergy (Imitrex), Drug allergy (Niacin), Diabetes, Congestive heart failure, Hypothyroidism and Colon cancer. Concomitant products included METOPROLOL, INSULIN ASPART (NOVOLOG), MEMANTINE HYDROCHLORIDE (NAMENDA), ASPIRIN [ACETYLSALICYLIC ACID], DONEPEZIL HYDROCHLORIDE (ARICEPT), PANCREATIN (CREON), ROSUVASTATIN CALCIUM (CRESTOR), FENOFIBRATE, LEVOTHYROXINE SODIUM (SYNTHROID), QUETIAPINE FUMARATE (SEROQUEL), SERTRALINE HYDROCHLORIDE (ZOLOFT) and VALPROATE SEMISODIUM (DEPAKOTE) for an unknown indication.   On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 19-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 18-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. In February 2022, the patient experienced COVID-19 (patient had COVID positive test or diagnosis) (seriousness criterion hospitalization). At the time of the report, COVID-19 (patient had COVID positive test or diagnosis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2022, SARS-CoV-2 test: (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine. Treatment information was not provided. Company comment: This spontaneous case concerns a 70-year-old female patient, with no relevant medical history, who experienced the serious (due to hospitalization), unexpected AESI of COVID-19, approximately a month after the third dose of mRNA-1273 vaccine. No further details on clinical course, lab test results and treatment were reported. The benefit -risk relationship of mRNA -1273 is not affected by this report.   This case was linked to MOD-2022-628582, MOD-2022-628596 (Patient Link).; Sender's Comments: This spontaneous case concerns a 70-year-old female patient, with no relevant medical history, who experienced the serious (due to hospitalization), unexpected AESI of COVID-19, approximately a month after the third dose of mRNA-1273 vaccine. No further details on clinical course, lab test results and treatment were reported. The benefit -risk relationship of mRNA -1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: patient had only 18 percent immunity; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNODEFICIENCY (patient had only 18 percent immunity) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2022, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNODEFICIENCY (patient had only 18 percent immunity) (seriousness criterion medically significant). At the time of the report, IMMUNODEFICIENCY (patient had only 18 percent immunity) outcome was unknown.            No concomitant medications were reported by the reporter. No treatment information was provided by the reporter.  The patient received Moderna vaccine booster dose on 01-Mar-2022. Company comment:  This spontaneous case concerns an unknown-years-old patient, with  no medical history reported who experienced the unexpected events of sensation of immunodeficiency,  unknown days after a booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.; Sender's Comments: This spontaneous case concerns an unknown-years-old patient, with  no medical history reported who experienced the unexpected events of sensation of immunodeficiency,  unknown days after a booster dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 is not affected by this report. Events seriousness was assessed based on medical judgement.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19 immunisation, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022), COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event) in an 8-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 vaccination. Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. On 15-Jul-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2022, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022), COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INTERCHANGE OF VACCINE PRODUCTS (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022) and COVID-19 IMMUNISATION (Received a mixed primary series. 1st dose was the Moderna COVID-19 vaccine, administered on 15-Jul-2022 and 2nd dose was the Pfizer COVID-19 vaccine, administered on 13-Aug-2022). The patient did not have any adverse reactions from the 1st dose of Moderna. It was reported that the patient arm was tender and sore after receiving the Pfizer vaccine. Patient also felt warm that morning, but did not had a fever. No treatment information was reported.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Daughter was diagnosed with Covid. It was a very mild case) in a 2-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1414B) for COVID-19 vaccination. No Medical History information was reported. On 24-Jun-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jul-2022, the patient experienced COVID-19 (Daughter was diagnosed with Covid. It was a very mild case). At the time of the report, COVID-19 (Daughter was diagnosed with Covid. It was a very mild case) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2022, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and Treatment medication information was not provided. It was reported that the symptoms improved and had to seek medical care. Allergies and medical history relating to mentioned AE and both acute and chronic illnesses at the time of vaccination were unknown. She did not experience a similar event in the past. It was unknown if patient was given any other vaccine within 1 month prior to Moderna COVID-19 vaccine. Company Comment: This spontaneous case concerns a 2-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 7 days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient tested positive for SARS-CoV-2 on the same day after receiving the vaccine. After 7 days, the patient was diagnosed with COVID-19. No symptoms were reported, however, the reporter stated that it was a very mild case. The patient was brought for consultation, however, no details were provided. Treatment information was also not provided. However, the event had resolved at the time of the report. The patient's young age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 2-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious AESI of COVID-19. The event occurred 7 days after receiving the first dose of the mRNA-1273 vaccine. It was reported that the patient tested positive for SARS-CoV-2 on the same day after receiving the vaccine. After 7 days, the patient was diagnosed with COVID-19. No symptoms were reported, however, the reporter stated that it was a very mild case. The patient was brought for consultation, however, no details were provided. Treatment information was also not provided. However, the event had resolved at the time of the report. The patient's young age (high risk for infections) remains a confounder. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.