chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 3 doses; This case was reported by a other health professional via sales rep and described the occurrence of extra dose administered in a adult unk patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of shingrix on an unknown date.) and Shingrix (Received 2nd dose of shingrix on an unknown date.).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follow: The case was reported by other health professional. No patient information was provided in this case. The patient received 1st and 2nd dose of shingrix on an unknown date. The patient was administered with 3rd dose of shingrix which leads to extra dose administered. The healthcare professional did not reported side effects. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021079379:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Malaise
Clinical narrative: has not been doing well; extremely weak / Weak; very tired; This case was reported by a consumer via (Shingrix GSK) interactive digital media and..... and described the occurrence of weakness in a 85-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE (COVID 19 VACCINE) for prophylaxis.   Previously administered products included Shingles vaccine (Received 1st dose of shingles vaccine on an unknown date.).   On 31st March 2021, the patient received the 2nd dose of Shingles vaccine. On 13th March 2021, the patient received the 2nd dose of COVID 19 VACCINE. On an unknown date, less than 2 weeks after receiving Shingles vaccine, the patient experienced weakness, tiredness and unwell. On an unknown date, the outcome of the weakness and tiredness were recovered/resolved and the outcome of the unwell was unknown.   It was unknown if the reporter considered the weakness, tiredness and unwell to be related to Shingles vaccine.  Additional details were provided as follow: The case was reported by patient's wife. On 13th March 2021, the patient received 2nd dose of COVID vaccine. Less than a week after receiving Shingles vaccine and less than a month after receiving Covid vaccine, the patient had not been doing well the last week, but mostly the day before reporting. Less than 2 weeks after receiving Shingles vaccine and less than a month after receiving Covid vaccine, the patient had been extremely weak and very tired of 2 days. The reporter wondered if it could have anything to do with vaccines, as the patient received close together and stated that could this had anything to do with it all. It was unknown if the reporter considered the weakness, tiredness and unwell to be related to Covid vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the sot and still got the shingles/Suspected vaccination failure; I had the sot and still got the shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was reporter itself. The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient received Shingrix and experienced shingles. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting
Sex: U
Vaccine: COVID19, VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Had my 2nd shingle fix shot / but the shingle have come back; This case was reported by a consumer via interactive digital media (Shingrix Chatbot) and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and COVID-19 VACCINE for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix, the 1st dose of Shingrix and the 1st dose of COVID-19 VACCINE. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient had 2nd shingle fix shot before COVID 19 shot. The patient was due to take 2nd COVID 19 shot but the shingle had come back after the patient took the 1st covid-19. The patient asked for further guidance. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. It was unknown if the reporter considered shingles to be related to the covid-19 vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Paraesthesia oral, Rash vesicular
Clinical narrative: Shingles type reaction; lips got tingly; This case was reported by a consumer via interactive digital media and described the occurrence of vesicular rash in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced vesicular rash and tingling lips. The patient was treated with prednisone. On an unknown date, the outcome of the vesicular rash and tingling lips were recovered/resolved.   It was unknown if the reporter considered the vesicular rash and tingling lips to be related to Shingrix.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as an adult as per vaccine indication. The patient had Shingrix dose, 2 months ago and had a reaction the following day. On chest the patient had a Shingles type reaction and also lips got tingly. The doctor treated patient with Prednisone and it went away. The patient reported he/she was due to get the second dose and wanted to know if should take Benadryl.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: My arm is still sore / 10 days later; My arm is still / red / 10 days later; My arm is still / swollen / 10 days later; My arm is still / warm 10 days later; This case was reported by a consumer and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd April 2021, the patient received the 1st dose of Shingrix. In April 2021, less than 2 weeks after receiving Shingrix, the patient experienced pain in arm, erythema of extremities, swelling arm and skin warm. On an unknown date, the outcome of the pain in arm, erythema of extremities, swelling arm and skin warm were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, swelling arm and skin warm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but selected as adult as per the vaccine indication. The patient reported that, till the day of reporting (it's been 10 days), his or her arm was sore, red, swollen and warm . The patient was asking if that was normal.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles on my side at plexus; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of shingles in an adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age group was not reported but was selected as an adult as per vaccine indication. The age at vaccination was not reported. The patient developed shingles on side at plexus.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: its been over 2 years never got 2nd shot / If 2nd shot was not given in 2 years; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles shot (1st dose received 2 years prior to the report).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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 at vaccnation was not applicable. Till the time of reporting, the patient did not received the 2nd dose of Shingles shot, which led to incomplete course of vaccination. The patient asked, if he/she need to get 1st shot again if it's been 2 years of never getting 2nd shot.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Lost part of the use of her left hand / Has limited use of her left hand; Immediate pain / down arm / that settled in thumb and index fingers and is persisting; Immediate / tingling down arm / that settled in thumb and index fingers and is persisting; This case was reported by a consumer via other manufacturer and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd February 2020, the patient received Shingrix. On 22nd February 2020, immediately after receiving Shingrix, the patient experienced pain in arm and tingling of extremity. On an unknown date, the patient experienced injected limb mobility decreased. On an unknown date, the outcome of the injected limb mobility decreased was unknown and the outcome of the pain in arm and tingling of extremity were not recovered/not resolved.   It was unknown if the reporter considered the injected limb mobility decreased, pain in arm and tingling of extremity to be related to Shingrix.  Additional details were provided as follows:  The reporter was patient's husband. The age at vaccination was not reported.  The patient received Shingrix vaccine in left deltoid and she felt immediate pain and tingling down her left arm that settled into her thumb and index finger and was persisting to this day and less than a year after receiving Shingrix, she had limited use of her left hand because of the pain and tingling. The reporter consent to follow up. For tolerance of flu vaccine refer case US2021AMR082961.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR082961:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Borrelia test, Injected limb mobility decreased, Pain in extremity, Radial nerve palsy, Radiculitis brachial
Clinical narrative: Some kind of autoimmune response / Doctors / said she has brachial Neuritis; Drop hand of right hand; Lost part of the use of her right hand / Can't open right hand; Pain in / right elbow that traveled to her right forearm / Pain settled in / hand; This case was reported by a consumer via other manufacturer and described the occurrence of brachial neuritis in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 22nd February 2020, refer case US2021AMR082921.).   On 23rd November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced brachial neuritis, wrist drop, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the brachial neuritis, wrist drop and injected limb mobility decreased were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the brachial neuritis, wrist drop, injected limb mobility decreased and pain in arm to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows:  The reporter was patient's husband. The age at vaccination was not reported.  The patient received flu vaccine in right deltoid and had pain in her right elbow that traveled to her right forearm, about 2 months after that the pain settled in her hand and less than 5 months after receiving Flu vaccine, she had drop hand now in that hand and could not open her right hand but still had full grip strength. The reporter stated that doctors and neurologist had not been able to pin down a firm cause and less than 5 months after receiving Flu vaccine, said she had brachial neuritis. The reporter stated that perhaps it was some kind of autoimmune response to the vaccines. They did all kinds of testing and to ruled out diabetes, rheumatoid, lyme disease, just about everything per caller. The reporter also asked was it possible for his wife to get the vaccine in a different location such as her rear end or thigh. The reporter and his wife had not been able to get any information on if she could get the Covid vaccine and was concerned about her getting the vaccine, did not know if she should get it; or was there some safer way for her to take it. The reporter confirmed his wife had not had any doses of any of the Covid Vaccines thus far and stated they were hoping since these vaccines were newer technology and not dead viruses might be it would be different for his wife. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR082921:Same reporter
Sex: F
Vaccine: FLUX
Symptoms: Rheumatoid factor
Clinical narrative: Some kind of autoimmune response / Doctors / said she has brachial Neuritis; Drop hand of right hand; Lost part of the use of her right hand / Can't open right hand; Pain in / right elbow that traveled to her right forearm / Pain settled in / hand; This case was reported by a consumer via other manufacturer and described the occurrence of brachial neuritis in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on 22nd February 2020, refer case US2021AMR082921.).   On 23rd November 2020, the patient received Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 5 months after receiving Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced brachial neuritis, wrist drop, injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the brachial neuritis, wrist drop and injected limb mobility decreased were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the brachial neuritis, wrist drop, injected limb mobility decreased and pain in arm to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows:  The reporter was patient's husband. The age at vaccination was not reported.  The patient received flu vaccine in right deltoid and had pain in her right elbow that traveled to her right forearm, about 2 months after that the pain settled in her hand and less than 5 months after receiving Flu vaccine, she had drop hand now in that hand and could not open her right hand but still had full grip strength. The reporter stated that doctors and neurologist had not been able to pin down a firm cause and less than 5 months after receiving Flu vaccine, said she had brachial neuritis. The reporter stated that perhaps it was some kind of autoimmune response to the vaccines. They did all kinds of testing and to ruled out diabetes, rheumatoid, lyme disease, just about everything per caller. The reporter also asked was it possible for his wife to get the vaccine in a different location such as her rear end or thigh. The reporter and his wife had not been able to get any information on if she could get the Covid vaccine and was concerned about her getting the vaccine, did not know if she should get it; or was there some safer way for her to take it. The reporter confirmed his wife had not had any doses of any of the Covid Vaccines thus far and stated they were hoping since these vaccines were newer technology and not dead viruses might be it would be different for his wife. The reporter consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR082921:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: low grade fever; This case was reported by a other health professional via other manufacturer and described the occurrence of low grade fever in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included heart rate increased and hyperactivity. Concurrent medical conditions included pain (being in pain all her life and was being followed by pain management) and rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz Xr).   On 17th March 2021, the patient received the 2nd dose of Shingles vaccine. In March 2021, less than a week after receiving Shingles vaccine, the patient experienced low grade fever. On an unknown date, the outcome of the low grade fever was unknown.   It was unknown if the reporter considered the low grade fever to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was a clinician. The age at vaccination was not reported.  The patient prior to start of therapy having increase heart rate, and thought it was related to her being hyperactive (patient did not clarify hyperactive) and it was unknown if the physician was aware of it. The patient received 2nd dose of Shingrix and experienced low-grade fever and the physician was not aware of it. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient reported case for himself or herself. The age group was not reported but was captured as an adult as per the vaccine indication. The age at vaccination was not reported. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation were not provided. This case had been linked with case US2021AMR084136, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084136:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Immediate post-injection reaction
Clinical narrative: I'm miserable; This case was reported by a consumer via interactive digital media and described the occurrence of feeling miserable in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles. Previously administered products included shingles vaccine (received 1st dose in 2009).   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced feeling miserable. On an unknown date, the outcome of the feeling miserable was not recovered/not resolved.   It was unknown if the reporter considered the feeling miserable to be related to Shingles vaccine.  Additional details were reported as follows: The age at the vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient had received 1st dose of shingrix in 2009 and experienced shingles. The patient had just received 1st dose of two and felt miserable, hopefully it would be better in a couple of days. The reporter hoped this series would work.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: husband / received their Shingrix vaccines 3 yrs ago, late dose; 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 on an unknown date, 3 years before day of reporting).   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 follow: The case was reported by patient's wife. The patient received his 1st dose 3 years ago. The patient was late for 2nd dose of vaccination. Till the time of reporting, patient did not receive 2nd dose of vaccine which led to incomplete course of vaccination. No further information was provided. This case is linked with US2021083447 reported by same reporter. The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021083447:same reporter (reporter´s case)
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shinles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The age group was selected as adult as per vaccine indication. The patient received shot for shingles and a year later, the patient experienced the shingles The case was considered, as suspected vaccination failure since the details regarding dose number and laboratory confirmation was not provided.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination
Clinical narrative: got so so sick from the first Shingrix; I never went back for the second; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (received at 50 years of age).   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness and incomplete course of vaccination. On an unknown date, the outcome of the sickness and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The age group was not reported but was captured as per vaccine indication. The patient stated, the vaccine do not prevent shingles and shingrix had horrid side effects. The patient received 1st dose of Shingrix and was sick. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR084176:same reporter
Age: 0.33
Sex: U
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old infant received Kinrix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: It was reported that the 4 month old patient received Kinrix, which led to inappropriate age at vaccine administration. No adverse events reported. The reporter did not agree to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the. Shingles shot but still got the shingles, a couple of yrs. Later; This case was reported by a consumer  and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the dose of Shingles vaccine and had shingles couple of years later. It was stated that problem was not as bad, if the patient had not received the shot. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: My daughter got this shot and was seriously ill for 2wks; This case was reported by a consumer via  interactive digital media and described the occurrence of unwell in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced unwell (serious criteria other: Serious as per reporter). On an unknown date, the outcome of the unwell was recovered/resolved.   It was unknown if the reporter considered the unwell to be related to Meningococcal B vaccine.  Additional details were reported as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient received Meningococcal B vaccine and was seriously ill for 2 weeks. The reporter did not recommend getting this vaccine. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness, Loss of personal independence in daily activities, Nausea
Clinical narrative: Had to go to bed pretty much all day; I was very sick; Headache; Nausea; . This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, less than a day after receiving Shingles vaccine, the patient experienced sickness, headache, nausea and activities of daily living impaired. On an unknown date, the outcome of the sickness, headache, nausea and activities of daily living impaired were recovered/resolved.   It was unknown if the reporter considered the sickness, headache, nausea and activities of daily living impaired to be related to Shingles vaccine.   Additional details was reported as follows: The age at vaccination was not reported. The age group was not reported but captured adult as per vaccine indication. The patient received Shingles vaccine and was sick within 4 hours of receiving it, had headache, nausea and had to go to bed pretty much all day but next day was good. The patient received 2nd dose but had no problems with it
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Administration of a second dose of Havrix an Hiberix to a patient. First doses for each vaccine were given on 10Mar2021 / second doses on 17Mar2021; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 2-year-old female patient who received Hib (Hiberix) (batch number J3Z99, expiry date 7th November 2021) for prophylaxis.   Co-suspect products included HAV (Havrix) (batch number 532H4, expiry date 21st August 2022) for prophylaxis.   Concomitant products included HAV (Havrix) and Hib (Hiberix).   On 17th March 2021, the patient received Hiberix and Havrix. On 17th March 2021, unknown after receiving Hiberix and Havrix, the patient experienced drug dose administration interval too short. The action taken with Havrix was unknown. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details was reported as follows: The reporter wanted guidance in for the administration of a second dose of Havrix an Hiberix to a patient. First doses for each vaccine were given on 10th March 2021 and second doses on 17th March 2021. The reporter confirmed that the doses received on 10th March 2021 should had been last doses for the patient.  The reporter consented to follow up.  Follow up received from physician on 10th April 2021: The patient's demographic details were updated. The patient was erroneously given the vaccines hepatis A and HIB on 17th March 2021. Patient had already received these vaccines on 10th March 2021.  Interval between vaccines too short. On 18th March 2021, the reporter made a follow up phone call, spoke to the patient's father, the reported patient was doing well. VAERS information also updated.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Some of the vaccine rolling down patient's arm; Some of the vaccine rolling down patient's arm; Some of the vaccine rolling down patient's arm; This case was reported by a consumer via call center representative and described the occurrence of accidental underdose in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 7th April 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the patient experienced inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were provided as follows: The patient reported that some of the vaccine was rolling down her arm, which lead to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Paraesthesia
Clinical narrative: had right arm tingling / tingling in his right arm again; abdomen hurt / he was hurting in his abdomen; This case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose of shingrix on an unknown date). Concurrent medical conditions included chronic bronchitis, allergic reaction (to the IV contrast dye) and sinus disorder. Concomitant products included COVID-19 MRNA-1273 VACCINE (COVID 19 VACCINE MODERNA), fluticasone propionate, salmeterol xinafoate (Advair), salbutamol (Albuterol), budesonide and ipratropium bromide, salbutamol sulfate (Duoneb).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced tingling of extremity and stomach pain. On an unknown date, the outcome of the tingling of extremity and stomach pain were unknown.   It was unknown if the reporter considered the tingling of extremity and stomach pain to be related to Shingrix.  Additional details were provided as follow: The case was reported by the patient. The patient had last Moderna  shot  was 2 and 1/2 weeks  before the 2nd shingrix dose and he noted that the second Moderna shot caused  low grade fever,  chills and he hurt all over for about 36 hours then it resolved. The patient received his last Shingrix dose, 3 weeks before his first injection of Nucala, which was on 26th March 2021. He noted after the second Shingrix dose, he had right arm tingling and his abdomen hurt. He did receive both Shingrix and Moderna in the right arm. The patient also received Nucala and had adverse events, for tolerance refer case US2021AMR080126. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incorrect route of product administration
Clinical narrative: received Shingrix second dose SC instead of IM; Shingrix first dose was given SC too; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 7434N, expiry date 24th April 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7434N, expiry date 24th April 2022) for prophylaxis.   On 30th October 2020, the patient received the 1st dose of Shingrix (subcutaneous). On 1st April 2021, the patient received the 2nd dose of Shingrix (subcutaneous). On 30th October 2020, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On 1st April 2021, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route and intramuscular formulation administered by other route were unknown.  Additional details were provided as follows: This case was reported by nurse on behalf of patient. The patient said to nurse that Shingrix 1st dose was given subcutaneously, which led to intramuscular formulation administered by other route, so the nurse gives 2nd dose of Shingrix at an ambulatory clinic, subcutaneously instead of intramuscularly, which led to intramuscular formulation administered by other route.  The nurse was looking for safety information for this situation and stated that she needed to follow up with patient. The reporter consented to follow up at her private cellphone.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Blood sugar was elevated. / was 170; This case was reported by a consumer via call center representative and described the occurrence of blood sugar increased in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th April 2021, the patient received the 1st dose of Shingrix (intramuscular). On 8th April 2021, 2 days after receiving Shingrix, the patient experienced blood sugar increased. On an unknown date, the outcome of the blood sugar increased was not recovered/not resolved.   It was unknown if the reporter considered the blood sugar increased to be related to Shingrix.  Additional details was reported as follows: The patient received Shingrix and experienced blood sugar increased. The patient checked her blood sugar level on the day of reporting and her blood sugar was elevated. Her blood sugar was 170. The patient wanted to know if the Shingrix Vaccine causes an increase in blood sugar. Medical disclaimer provided to the patient. Shingrix PI used. Medial information number provided but refused. Shingrix PI provided but refused. The patient was referred to her healthcare provider. The patient was unable to provide the healthcare providers fax number, address, name of facility, expiration date of vaccine, and lot number of vaccine. The patient consented to follow up.
Age: 7.0
Sex: F
Vaccine: DTAP, DTAPIPV, IPV
Symptoms: Inappropriate schedule of product administration, Neoplasm malignant, Product administered to patient of inappropriate age
Clinical narrative: Patient had cancer but nurse could not confirm whether cancer began before or after receiving previous doses of DTaP and IPV; Kinrix was given to a 7 year old patient; Patient was late for last dose of DTaP and IPV because had cancer; This case was reported by a nurse via call center representative and described the occurrence of cancer in a 7-year-old female patient who received DTPa (DTaP vaccine) for prophylaxis.   Co-suspect products included POLIOMYELITIS VACCINE INACTIVATED (IPV VACCINE) for prophylaxis, DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received DTaP vaccine and IPV VACCINE. On 21st January 2021, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 21st January 2021, not applicable after receiving DTaP vaccine and unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the patient experienced cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the cancer, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   It was unknown if the reporter considered the cancer to be related to DTaP vaccine.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 patient was late for their last dose of DTaP and IPV (5th and 4th respectively) because patient had cancer but nurse could not confirm whether cancer began before or after receiving previous doses of DTaP and IPV because they were new practice. The patient was administered Kinrix at the age of 7 years, which led to inappropriate age at vaccine administration. The reporter was inquiring about incident of Kinrix and wanted to make sure of what was the best method to continue with it. The reporter consented to follow-up.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: used saline diluent instead of the accompanying liquid conjugate vaccine; used saline diluent instead of the accompanying liquid conjugate vaccine; 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 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA434A, expiry date unknown) for prophylaxis.   On 7th April 2021, the patient received the 1st dose of Menveo (intramuscular) .5 ml. On 7th April 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 reporter administered the vaccine to the patient. She used saline diluent instead of the accompanying liquid conjugate vaccine component when reconstituting the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The batch number provided could not be found in the system but it was what the reporter provided. The batch number corrected to AMVA434A from the reported AMVA43AA excluding typo error as per sales data sheet. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose 1 of twinrix in October 2020 / is late for 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received in October 2020).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient was late for 2nd dose of Twinrix and till the time of reporting, he did not receive it, which led to incomplete course of vaccination. The reporter asked, if the patient need to restart the series. No other details of vaccine available. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Computerised tomogram normal, Laboratory test normal, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Muscle pain; Shivering; Interfering with daily activities; This case was reported by a consumer and described the occurrence of muscle pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2021, less than a day after receiving Shingrix, the patient experienced muscle pain (serious criteria hospitalization and disability) and shivering (serious criteria hospitalization and disability). On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the muscle pain and shivering were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the muscle pain, shivering and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. Extreme muscle pain and shivering following 1st dose of Shingrix.  The events ere unresolved and interfering with daily activities.  The patient also bounded with wheelchair.  Several emergency room (ER) and hospital visits required.  Medical facilities also visited by the patient.  Lab work and cat scans performed. Only diagnosis ascertained was muscle pain. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Wheelchair user
Clinical narrative: Muscle pain; Shivering; Interfering with daily activities; This case was reported by a consumer and described the occurrence of muscle pain in a 65-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st March 2021, less than a day after receiving Shingrix, the patient experienced muscle pain (serious criteria hospitalization and disability) and shivering (serious criteria hospitalization and disability). On an unknown date, the patient experienced activities of daily living impaired. On an unknown date, the outcome of the muscle pain and shivering were not recovered/not resolved and the outcome of the activities of daily living impaired was unknown.   It was unknown if the reporter considered the muscle pain, shivering and activities of daily living impaired to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. Extreme muscle pain and shivering following 1st dose of Shingrix.  The events ere unresolved and interfering with daily activities.  The patient also bounded with wheelchair.  Several emergency room (ER) and hospital visits required.  Medical facilities also visited by the patient.  Lab work and cat scans performed. Only diagnosis ascertained was muscle pain. The reporter consented to follow up.