chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Neck pain, Pain in extremity, Product administered at inappropriate site
Clinical narrative: arm begin to ache; Headache; radiated down into her neck; placement was too high on her deltoid / didn't pinch her arm during administration; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included hypertension.   On 9th August 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 9th August 2021, 2 hrs after receiving Shingrix, the patient experienced pain in arm, headache, neck pain and vaccine administered at inappropriate site. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the pain in arm, headache and neck pain were recovering/resolving and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the pain in arm, headache and neck pain to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient herself. The patient received Shingrix in the left deltoid. Two hours after the vaccination, the patient's arm began to ache and also stated that later in the evening developed a headache that started at the top of her head and then radiated down into her neck.  The patient stated that she felt as if the placement was too high on her deltoid and noted that he didn't pinch her arm during administration, which led to vaccine administered at inappropriate site. The patient took Tylenol and had some moderate relief. The patient was referred to health care professional. The reporter consented to follow up.
Age: 21.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received two vials of / diluent without reconstitution; received two vials of / diluent without reconstitution; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 21-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAVA418A, expiry date 31st October 2021) 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 details were provided as follows: The medical assistant reported that a patient received two vials of Menveo diluent without reconstitution with the MenA lyophilized powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The health care professional only agreed to follow up via email.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: administered / first dose during september 2019; This case was reported by a pharmacist 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 September 2019 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter stated that, the patient 's age was unkown, only reported that the patient was older than 50 years old. The reporter consented to follow up.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Balance disorder, Gait disturbance, Headache, Muscular weakness, Nausea
Clinical narrative: headache; unsteady; can´t walk very well; nauseous; wobbly legs; This case was reported by a consumer via call center representative and described the occurrence of headache in a 11-year-old female patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On 9th August 2021, the patient received Tdap Vaccine. On 10th August 2021, 1 days after receiving Tdap Vaccine, the patient experienced headache, unsteadiness and walking difficulty. In August 2021, the patient experienced nausea and lower extremities weakness of. On an unknown date, the outcome of the headache, unsteadiness, nausea, lower extremities weakness of and walking difficulty were unknown.   It was unknown if the reporter considered the headache, unsteadiness, nausea, lower extremities weakness of and walking difficulty to be related to Tdap Vaccine.  Additional case details were provided as follows: The case was reported by patient's mother or father. The age at vaccination was not reported. The reporter asked how to treat minor symptoms of vaccine side effects. The patient received Tdap vaccine one day before of the reporting date and was complaining of a headache and was unsteady on the day of reporting. The patient also experienced nauseous and wobbly legs and a could not walk very well. Initially the reporter was confused if the vaccine was Meningitis or Tdap. Later confirmed that the vaccine administered was a Tdap vaccine and not a Meningitis, but he did not have the brand name.  Permission for follow up was not asked.
Sex: F
Vaccine: MNQ
Symptoms: Incomplete course of vaccination
Clinical narrative: one dose of Menveo when was 2 months old; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Menveo (1st dose received in January 2010, at the age of 2 months old, batch number A410A818A).   On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of menveo,which led to incomplete course of vaccination. The reporter was not sure that it was a Menveo vaccine and the lot number was not clear. no expiration date The reporter conented to follow up. This case was linked with case US2020213887 and US2019073149, reporte by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020213887:same reporter US-GLAXOSMITHKLINE-US2019073149:same reporter
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: administrated / batch recall on April 26 2021/ recall date 10FEB2021; administrated / batch recall on April 26 2021/ recall date 10FEB2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 26th April 2021, the patient received Shingrix. On 26th April 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from  recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169129:Same reporter. US-GLAXOSMITHKLINE-US2021169133:Same reporter. US-GLAXOSMITHKLINE-US2021169134:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: patient was administrated/ recall on May 17 2021/ recall cate 10feb2021; patient was administrated/ recall on May 17 2021/ recall cate 10feb2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 62-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 17th May 2021, the patient received Shingrix. On 17th May 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169129:Same reporter US-GLAXOSMITHKLINE-US2021169132:Same reporter. US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169134:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: administrated /batch recall on July 6 2021. /recall date 10feb2021; administrated /batch recall on July 6 2021. /recall date 10feb2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 6th July 2021, the patient received Shingrix. On 6th July 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. The Vaccine Administration Facility was the same as primary reporter. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169133:Same reporter US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Saem reporter US-GLAXOSMITHKLINE-US2021169129:Same reporter US-GLAXOSMITHKLINE-US2021169135:Same reporter
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Product dispensing error, Recalled product administered
Clinical narrative: Administrated / Shingrix / on July 9 2021 / batch recall date: February 10th, 2021; Administrated / Shingrix / on July 9 2021 / batch recall date: February 10th, 2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 9th July 2021, the patient received Shingrix. On 9th July 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: Health care professional reported that the patient was administered with recalled Shingrix vaccine lot, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This is 1 of the 6 cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169129:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Same reporter. US-GLAXOSMITHKLINE-US2021169133:Same reporter. US-GLAXOSMITHKLINE-US2021169134:Same reporter. US-GLAXOSMITHKLINE-US2021169135:Same reporter.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product dispensing error, Recalled product administered
Clinical narrative: administrated with / batch recall on  July 20 2021/ recall date 10FEB2021; administrated with / batch recall on  July 20 2021/ recall date 10FEB2021; This case was reported by a other health professional via call center representative and described the occurrence of recalled drug administered in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 9LH3Y, expiry date 7th February 2022) for prophylaxis.   On 20th July 2021, the patient received Shingrix. On 20th July 2021, unknown after receiving Shingrix, the patient experienced recalled drug administered and drug dispensing error. On an unknown date, the outcome of the recalled drug administered and drug dispensing error were unknown.  Additional details were provided as follows: The patient received Shingrix from recalled batch, which led to recalled drug administered and drug dispensing error. The Shingrix batch was recalled on 10th February 2021. No adverse event was reported. The reporter consented to follow up. This was 1 of 6 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169133:Same reporter US-GLAXOSMITHKLINE-US2021169136:Same reporter. US-GLAXOSMITHKLINE-US2021169132:Same reporter US-GLAXOSMITHKLINE-US2021169129:Same reporter US-GLAXOSMITHKLINE-US2021169134:Same reporter
Age: 69.0
Sex: F
Vaccine: MNQ
Symptoms: HIV infection, HIV test positive, Product administered to patient of inappropriate age
Clinical narrative: 69 year old patient/administered Menveo; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 69-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Additional patient notes included No history of Meningococcal vaccine..   On 10th August 2021, the patient received Menveo. On 10th August 2021, unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The registered nurse reported that a 69 year old patient was administered Menveo, which led to inappropriate age at vaccine administration. The patient was HIV positive and had no history of a Meningococcal vaccine.  The reporter did not consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Acute kidney injury, Blood creatinine increased, Blood pressure decreased, Diarrhoea, Feeling abnormal
Clinical narrative: Hospital told / her kidneys were shutting down; Hospital told her creatine level was at 8; Hospital told / her blood pressure was dropping; Diarrhea / took her to the hospital because she was still out of it; Vomiting / could not keep anything down / took her to the hospital because she was still out of it.; This case was reported by a consumer via call center representative and described the occurrence of kidney dysfunction in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th July 2021, several hours after receiving Shingrix, the patient experienced vomiting. On 20th July 2021, the patient experienced diarrhea. On 22nd July 2021, the patient experienced kidney dysfunction (serious criteria hospitalization and GSK medically significant), creatine increased (serious criteria hospitalization) and low blood pressure (serious criteria hospitalization). On 21st July 2021, the outcome of the vomiting and diarrhea were recovered/resolved. On 25th July 2021, the outcome of the kidney dysfunction, creatine increased and low blood pressure were recovered/resolved.   It was unknown if the reporter considered the kidney dysfunction, creatine increased, low blood pressure, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The patient received Shingrix in right arm at about 10 am and a few hours later she began vomiting and could not keep anything down. Next day on 20th July 2021, she was still vomiting along with diarrhea. On 22nd July 2021, the patient husband took her to the hospital because she was still out of it. The reporter reports the hospital told her creatine level was at 8 and her kidneys were shutting down, as well as her blood pressure was dropping. The health care professional  were able to save her and got her creatine back to 1 and her kidneys functioning, and her blood pressure stabilized by sunday 25th July 2021 when she was released from the hospital. The patient has had no problems since then. The reporter did not consented to follow up
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Renal impairment, Vomiting
Clinical narrative: Hospital told / her kidneys were shutting down; Hospital told her creatine level was at 8; Hospital told / her blood pressure was dropping; Diarrhea / took her to the hospital because she was still out of it; Vomiting / could not keep anything down / took her to the hospital because she was still out of it.; This case was reported by a consumer via call center representative and described the occurrence of kidney dysfunction in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th July 2021, the patient received the 1st dose of Shingrix (intramuscular). On 19th July 2021, several hours after receiving Shingrix, the patient experienced vomiting. On 20th July 2021, the patient experienced diarrhea. On 22nd July 2021, the patient experienced kidney dysfunction (serious criteria hospitalization and GSK medically significant), creatine increased (serious criteria hospitalization) and low blood pressure (serious criteria hospitalization). On 21st July 2021, the outcome of the vomiting and diarrhea were recovered/resolved. On 25th July 2021, the outcome of the kidney dysfunction, creatine increased and low blood pressure were recovered/resolved.   It was unknown if the reporter considered the kidney dysfunction, creatine increased, low blood pressure, vomiting and diarrhea to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for herself. The patient received Shingrix in right arm at about 10 am and a few hours later she began vomiting and could not keep anything down. Next day on 20th July 2021, she was still vomiting along with diarrhea. On 22nd July 2021, the patient husband took her to the hospital because she was still out of it. The reporter reports the hospital told her creatine level was at 8 and her kidneys were shutting down, as well as her blood pressure was dropping. The health care professional  were able to save her and got her creatine back to 1 and her kidneys functioning, and her blood pressure stabilized by sunday 25th July 2021 when she was released from the hospital. The patient has had no problems since then. The reporter did not consented to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: was over the six month window; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter called to verify that if a patient has gone over the 2-6 month time frame for second dose of Shingrix they did not have to restart the vaccine series. Till the time off reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that, the husband (no information) of the consumer, called today stating the patient was over the six month window, and was wanting to know if the patient needed to restart the series.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error
Clinical narrative: mixed 2 vials of adjuvant together / antigen was not mixed. This mistake was caught before administering to the patient; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) (batch number 9zj25, expiry date 23rd January 2023) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error. On an unknown date, the outcome of the intercepted product preparation error was unknown.  Additional details were provided as follows: The reporter was the pharmacy manager. The age at vaccination was not reported. The reporter notify that her pharmacist colleague had accidentally mixed 2 vials of adjuvant together, instead of 1 vial of adjuvant and 1 vial of antigen. In this mixture, antigen was not mixed, which led to intercepted product preparation error. This mistake was caught before administering to the patient. No patient involvement. The reporter provided an email address and a fax number to the pharmacy. The reporter did not consent to follow up as no patient involvement.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient receiving second dose / prior to the recommended 2 month minimum time period after receiving the first dose; This case was reported by a physician 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 Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received second dose of Shingrix prior to the recommended 2 month minimum time period after receiving the first dose of Shingrix, which led to shortening of vaccination schedule. The reporter did not want to provide any patient demographics and provided only minimum information. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received just the diluent portion; received just the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number TP943, expiry date 28th January 2023) 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 details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received just the diluent portion of the Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. No reactions reported. The reporter consented to follow up.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patient vaccinated / with the powder portion / and another diluent; patient vaccinated / with the powder portion / and another diluent; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 9th August 2021, the patient received the 1st dose of Menveo. On 9th August 2021, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient was vaccinated with the powder portion of Menveo and another diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The health care professional did not want to share demographic data of the patient. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received his 1st dose / in 11/2018, and never came back for the 2nd one; This case was reported by a nurse 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 November 2018).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of repoting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: given to patients after those doses had been stored in the freezer; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Herpes zoster (Shingrix) (batch number L4RD3, expiry date 8th October 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. 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 details were provided as follows: The age at vaccination was not reported. The patient received Shingrix dose that had been stored in the freezer, which led to incorrect storage of drug. No more information available at the moment of call. The reporter consented to follow up. This case has been linked with 1 of 7 linked case reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021169172:Same reporter US-GLAXOSMITHKLINE-US2021AMR170441:Same reporter US-GLAXOSMITHKLINE-US2021AMR170442:Same reporter US-GLAXOSMITHKLINE-US2021AMR170444:Same reporter US-GLAXOSMITHKLINE-US2021AMR170446:Same reporter US-GLAXOSMITHKLINE-US2021AMR170445:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received the first dose and has not received the second dose yet; This case was reported by a pharmacist 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 received in 2019 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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter did not have available information about the patient neither information about the first dose. The reporter consented to follow up. The VAERS details were reported for 1st dose of Shingrix.
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 15 -month-old patient received Boostrix; received Boostrix instead of a dTAP in error; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date 14th August 2021) for prophylaxis.   On 9th August 2021, the patient received Boostrix (intramuscular). On 9th August 2021, unknown after receiving Boostrix, the patient experienced inappropriate age at vaccine administration and accidental underdose. On an unknown date, the outcome of the inappropriate age at vaccine administration and accidental underdose were unknown.  Additional details were provided are as follows: A 15 months old patient received Boostrix instead of a dTAP  in error, which led to inappropriate age at vaccine administration and accidental underdose. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: the first and second dose of Shingrix was administered 5 weeks apart; 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 patient who received Herpes zoster (Shingrix) (batch number 393C7, expiry date 25th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and an unknown time 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 detailos were provided as follows: The age at vaccination was not reported. The Intern stated a patient received the first and second dose of Shingrix was administered 5 weeks apart, which led to shortening of vaccination schedule. The reporter stated that, the patient was immunocompetent. The pharmacy Intern unable to provide any vaccine or patient details. The reporter did not consent to follow up.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: 17 years old received Havrix adult dose; 17 years old received Havrix adult dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 17-year-old female patient who received HAV (Havrix adult) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2021, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Havrix 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 details were provided as follows: The nurse reported that a 17 year old patient received Havrix adult, which led to overdose and adult product administered to child. The reporter did not consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Product complaint, Underdose
Clinical narrative: less than half of the dose was injected; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a patient who received Men B NVS (Bexsero) (batch number ABXA82AA, expiry date 31st January 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 10th August 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced accidental underdose and pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose 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 details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient was administered with Bexsero and the plunger got stuck before entire dose was administered, which led to accidental underdose. Nurse thought that less than half dose was administered to the patient. Nurse enquired that if she should administered another first dose. The healthcare professional did not gave patient's demographic details. The reporter consented to follow up via email.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Patient received an expired dose of PEDIARIX; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 6-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number D93B4, expiry date 14th June 2021) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2021, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 10th August 2021, unknown after receiving Pediarix and Pediarix 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 details were provided as follows: Health care professional reported that the patient received Pediarix which was expired on 14th June 2021, which led to expired vaccine used. No further events were reported at the time of the call. The reporter stated that in case he needed follow-up would call back.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient /1st dose / 2 years ago but never completed the series; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose of shingrix vaccine received 2 years ago).   On an unknown date, the patient received 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 details were reported as follows: The age vaccination was not applicable for this report. Lot and expiration date were unknown. The reporter stated that the patient never completed the series with 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter stated that not all information was available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose / in November, 2018 / never went back to get her second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in November 2018).   On an unknown date, the patient received 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 case details were provided as follows: The age at vaccination was not applicable for this report. Pharmacist report that a patient had never went back to get her 2nd dose which led to incomplete course of vaccination. Health care professional (HCP) called to know how to proceed with the case. Health care professional did not know the lot number or expiration date of dose 1st that the patient received in 2018 since the vaccine was given in another facility. No further events were reported at the time of the call. The reporter did not consent to follow-up. Health care professional did not consent follow-up, she just wanted the medical information data. VAERS details were reported for 1st dose of Shingrix.
Sex: F
Vaccine: TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: patient was administrated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number x2xj7, expiry date 8th August 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 11th August 2021, unknown after receiving Boostrix and Boostrix 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 details were provided as follows: The nurse reported that the patient received Boostrix which was expired on 8th August 2021, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up via email.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered Menveo Diluent only; inadvertently administered Menveo Diluent only; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) 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 details were provided as follows: The age at vaccination was not reported. The quality assurance specialist called to report that, the patient inadvertently administered menveo diluent only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter was unable to provide any patient or vaccines details. The reporter also declined follow up from safety. The reporter did not consent to follow up. This case was 1 of 11 linked cases, reported by same reporter for different patients.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021170620:same reporter US-GLAXOSMITHKLINE-US2021AMR170925:same reporter US-GLAXOSMITHKLINE-US2021AMR170926:same reporter US-GLAXOSMITHKLINE-US2021AMR170927:same reporter US-GLAXOSMITHKLINE-US2021AMR170928:same reporter US-GLAXOSMITHKLINE-US2021AMR170929:same reporter US-GLAXOSMITHKLINE-US2021AMR170930:same reporter US-GLAXOSMITHKLINE-US2021AMR170931:same reporter US-GLAXOSMITHKLINE-US2021AMR170932:same reporter US-GLAXOSMITHKLINE-US2021AMR170933:same reporter US-GLAXOSMITHKLINE-US2021AMR170934:same reporter
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Off label use
Clinical narrative: Administration of Shingrix to patient suspected of having shingles; This case was reported by a other health professional via call center representative and described the occurrence of off label use in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   The patient's past medical history included feeling unwell (feeling kind of yucky prior to vaccination) and tiredness (felling tired prior to vaccination). Concurrent medical conditions included shingles (suspected of having a shingles before vaccination, no signs or symptoms of clinical definite shingles rash, blisters, pain).   On 9th August 2021, the patient received Shingrix. On 9th August 2021, unknown after receiving Shingrix, the patient experienced off label use. On an unknown date, the outcome of the off label use was unknown.  Additional details were provided as follows: The pharmacy Intern reported that, the administration of Shingrix to patient suspected of having shingles, which led to off label use. The titer testing was negative but was discovered to be the incorrect testing.  The patient experienced feeling kind of yucky, tired prior to vaccination, no signs or symptoms of clinical definite shingles (rash, blisters, pain) noted per health care professional. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Pain in extremity, Pyrexia
Clinical narrative: "didn't feel well"; Fever; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th June 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 10th June 2021, less than a day after receiving Shingrix, the patient experienced feeling unwell, fever and pain in arm. On 11th June 2021, the outcome of the feeling unwell and fever were recovered/resolved. On 13th June 2021, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the feeling unwell, fever and pain in arm to be related to Shingrix.  Additional details were reported as follows: The patient reported that she received dose of Shingrix vaccine. Later that day the patientdid not feel well, had a fever and a sore arm. The first two symptoms lasted about 24 hours. The reporter stated she had a sore arm for a few days. The lot number and expiration date was unknown. The reporter did not consent to follow-up. The reporter declined to provide health care professional information. This case is linked to the case US2021AMR171305,reported by the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR171305:Same reporter
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Lymphadenopathy
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence abdominal pain (patient experience abdomen pain described as similar kidney stones) and lymphadenopathy (2 swollen lymph nodes in her stomach) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Apr 29, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 11, 2021, patient experienced abdominal pain (patient experience abdomen pain described as similar kidney stones) and lymphadenopathy (2 swollen lymph nodes in her stomach). On May 12, 2021, patient experienced abdominal pain (abdomen pain described as similar kidney stones) and lymphadenopathy (2 swollen lymph nodes in her stomach): resolved. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant or treatment medications provided. Most recent follow-up information incorporated above includes: On Jun 17, 2021: Non-significant follow-up. AE contact information updated. On Jul 22, 2021: Follow-up information received on Jul 22, 2021 contained no new information.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Hard time breathing; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Hard time breathing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included FLUTICASONE PROPIONATE (FLOVENT HFA) for an unknown indication.    On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Jun-2021, the patient experienced DYSPNOEA (Hard time breathing). At the time of the report, DYSPNOEA (Hard time breathing) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications was  provided by the reporter. Concomitant medication include OTC drugs.