chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Headache, Joint swelling, Limb discomfort, Paraesthesia
Clinical narrative: tingling in the body; felt heaviness in the arms; involuntary movements; left knee was swollen; she felt heaviness also in her leg; Severe headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 26 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypoglycaemia" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: known_allergies: Penicilina, Nansev. Concomitant medication(s) included: CLARITIN ALLERGIC; FLONASE ALLERGY RELIEF. The following information was reported: DYSKINESIA (non-serious) with onset Mar2021, outcome "not recovered", described as "involuntary movements"; JOINT SWELLING (non-serious) with onset Mar2021, outcome "not recovered", described as "left knee was swollen"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "she felt heaviness also in her leg"; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe headaches"; PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "tingling in the body"; LIMB DISCOMFORT (non-serious) with onset 17Mar2021, outcome "not recovered", described as "felt heaviness in the arms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyskinesia, joint swelling, limb discomfort, headache, paraesthesia, limb discomfort. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included :Claritin, Flonasec. Treatment received for the adverse event included: Ibuprofeno, vitamina B 12. On the first day she involuntary movements (twitches) in her left side, her left knee was swollen and she felt heaviness also in her leg. Severe headaches (for 2 weeks). On 17Mar began tingling in the body and did not feel legs and felt heaviness in the arms. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. known allergies included: Penicillin, Nansev  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: tingling in the body; felt heaviness in the arms; involuntary movements; left knee was swollen; she felt heaviness also in her leg; Severe headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 26 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) at the age of 26 years as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Hypoglycaemia" (unspecified if ongoing); "Penicillin" (unspecified if ongoing), notes: known_allergies: Penicilina, Nansev. Concomitant medication(s) included: CLARITIN ALLERGIC; FLONASE ALLERGY RELIEF. The following information was reported: DYSKINESIA (non-serious) with onset Mar2021, outcome "not recovered", described as "involuntary movements"; JOINT SWELLING (non-serious) with onset Mar2021, outcome "not recovered", described as "left knee was swollen"; LIMB DISCOMFORT (non-serious) with onset Mar2021, outcome "not recovered", described as "she felt heaviness also in her leg"; HEADACHE (non-serious) with onset Mar2021, outcome "not recovered", described as "Severe headaches"; PARAESTHESIA (non-serious) with onset 17Mar2021, outcome "not recovered", described as "tingling in the body"; LIMB DISCOMFORT (non-serious) with onset 17Mar2021, outcome "not recovered", described as "felt heaviness in the arms". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of dyskinesia, joint swelling, limb discomfort, headache, paraesthesia, limb discomfort. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination included :Claritin, Flonasec. Treatment received for the adverse event included: Ibuprofeno, vitamina B 12. On the first day she involuntary movements (twitches) in her left side, her left knee was swollen and she felt heaviness also in her leg. Severe headaches (for 2 weeks). On 17Mar began tingling in the body and did not feel legs and felt heaviness in the arms. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. known allergies included: Penicillin, Nansev  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported; patient was administered an expired dose of VAQTA.; This spontaneous report as received from a registered nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 10-NOV-2021, a patient was administered an expired dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S001832 has been verified to be a valid lot number, expiration date reported as 12-MAY-2021, but upon internal validation established as 12-MAY-2020; dose, strength and route were unknown by reporter) for prophylaxis (expired product administered). The reporter confirmed the suspect vaccine experienced no temperature excursions. The reporter was provided the not supported disclaimer based on the information in the post expiry memo. No additional AE reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse regarding a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, concomitant therapies, drug reactions and allergies were not provided. On 26-OCT-2021, the patient was vaccinated with an improperly stored dose (product storage error) of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter, once,  lot number U019287 and expiration date 15-DEC-2022 (route of administration was not provided) for prophylaxis. There was no additional adverse event reported. Administered doses of vaccine experienced the temperature excursion of 5.7 degrees Fahrenheit (°F) for 6 minutes There was no previous temperature excursion.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications. On 11-NOV-2021, the patient was vaccinated with hepatitis B vaccine (recombinant) (RECOMBIVAX HB), pre-filled syringe, 1 dose, lot #S002769 for prophylaxis (route and site of administration were not reported), which had expired on 04-NOV-2021 (expired product administered). The reporter confirmed no other adverse event occurred (no adverse event).
Sex: M
Vaccine: PPV, PPV
Symptoms: Arthralgia, Inappropriate schedule of product administration, Mobility decreased
Clinical narrative: Inappropriate schedule of vaccine administered; severe shoulder pain; hard time lifting his arm; This spontaneous report was received from a pharmacist concerning a male patient of unknown age. No information about his current condition, medical history or concomitant therapy was reported.   On 09-OCT-2020, the patient was vaccinated with first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, route and lot# were not reported) as prophylaxis. On 08-NOV-2021, he was administered the second dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (at the dose of 0.5 ml, route was not reported; lot#T032761, expiry date 30-MAY-2022) again as prophylaxis (inappropriate schedule of product administration).   After the second time of injection, in November 2021, the patient was complaining of sever should pain and having a hard time lifting his arm. No treatment was given for the events. At the time of reporting, all the events were not resolved. Action taken with suspect vaccine was not applicable.   The causality between the events and suspect vaccine was not reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; expired VAQTA was administered; This spontaneous report was received from a registered nurse referring to an adult patient of unknown gender.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications  On 15-NOV-2021, the patient was vaccinated with hepatitis A vaccine, inactivated (VAQTA) pre-filled syringe, lot # T017179, 1 milliliter, for prophylaxis (route and site of administration were not reported).    According to the reporter, the vaccine expired on 26-OCT-2021 (expired product administered).  The vaccine did not have any temperature excursions.  No adverse events or product quality complains were reported (no adverse event).
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Craniocerebral injury, Crying, Eye disorder, Gait inability, Gene mutation
Clinical narrative: He has now been diagnosed with traumatic brain injury related to the vaccines he received; the reaction started with injection site swelling; flu like symptoms that sent him to that hospitals that night; he has a gene mutation that would be more affected from receiving vaccines; This spontaneous report has been received from the patient's mother referring to a male patient of unknown age. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# 647523/0633R, expiration date not reported, but upon internal validation established as 13-JUN-2007; strength, dose, and route were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (human serum albumin (HAS)) (M-M-R II) (lot# 649754/0378R, expiration date not reported, but upon internal validation established as 24-MAR-2007; strength, dose, and route were not reported) for prophylaxis.  On an unknown date, the patient experienced injection site swelling and the flu like symptoms. He was sent to the hospital that night. Then, on an unknown date, the patient cried no stop for two weeks and his eyes went side away, it was also reported that he became like a vegetable (for example, not able to walk, or take care of himself). The reporter stated that he had stayed this way for years and his recovery had been really slow. He was diagnosed with traumatic brain injury related to the vaccines. The patient had sought medical attention. Treatment (unspecified) was given. A gene mutation was also found out that would be more affected from receiving vaccines. The mother reported that she wrote letters to the company years ago when the events happened and did not received any response back. Currently, the patient still needed a lot of help for activities of daily living, he was still per mother healing. The outcome of traumatic brain injury was not recovered. The outcome of injection site swelling, the flu like symptoms, and gene mutation was unknown.  The reporter considered all the events to be related to the vaccines.  Upon internal review, traumatic brain injury was determined to be medically significant.
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Impaired self-care, Influenza like illness, Injection site swelling, Loss of personal independence in daily activities, Vaccination complication
Clinical narrative: He has now been diagnosed with traumatic brain injury related to the vaccines he received; the reaction started with injection site swelling; flu like symptoms that sent him to that hospitals that night; he has a gene mutation that would be more affected from receiving vaccines; This spontaneous report has been received from the patient's mother referring to a male patient of unknown age. Concomitant medication, pertinent medical history, and drug reactions/allergies were not reported.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) (lot# 647523/0633R, expiration date not reported, but upon internal validation established as 13-JUN-2007; strength, dose, and route were not reported) and Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (human serum albumin (HAS)) (M-M-R II) (lot# 649754/0378R, expiration date not reported, but upon internal validation established as 24-MAR-2007; strength, dose, and route were not reported) for prophylaxis.  On an unknown date, the patient experienced injection site swelling and the flu like symptoms. He was sent to the hospital that night. Then, on an unknown date, the patient cried no stop for two weeks and his eyes went side away, it was also reported that he became like a vegetable (for example, not able to walk, or take care of himself). The reporter stated that he had stayed this way for years and his recovery had been really slow. He was diagnosed with traumatic brain injury related to the vaccines. The patient had sought medical attention. Treatment (unspecified) was given. A gene mutation was also found out that would be more affected from receiving vaccines. The mother reported that she wrote letters to the company years ago when the events happened and did not received any response back. Currently, the patient still needed a lot of help for activities of daily living, he was still per mother healing. The outcome of traumatic brain injury was not recovered. The outcome of injection site swelling, the flu like symptoms, and gene mutation was unknown.  The reporter considered all the events to be related to the vaccines.  Upon internal review, traumatic brain injury was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician, and refers to a patient of unknown age and gender. There was no information about the patient's medical history, concurrent conditions or concomitant medication. On 07-DEC-2021, the patient was vaccinated inadvertently with an expired dose of measles, mumps, and rubella (Wistar ra 27-3) virus vaccine, live(M-M-R II), dose: 0.5 ml, lot # S039319, expiration date: 04-DEC-2021 as prophylaxis (anatomical location and route of administration were not provided) (expired product administered). No temperature excursion involved and no additional information was provided. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Hyperaesthesia
Clinical narrative: Fever / Fever 100 and I am normally 97; severe chills; muscle aches all over; HA; back pain; neck pain; and tired; left inner thigh is sensitive to touch; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th June 2021, the patient received the 1st dose of Shingles vaccine. In June 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, chills, generalized muscle aches, headache, back pain, neck pain, tiredness and touch sensitivity increased. On an unknown date, the outcome of the fever, chills, generalized muscle aches, headache, back pain, neck pain, tiredness and touch sensitivity increased were unknown.   It was unknown if the reporter considered the fever, chills, generalized muscle aches, headache, back pain, neck pain, tiredness and touch sensitivity increased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced Fever, severe chills , muscle aches all over, headache, back pain, neck pain and tired, fever 100 and patient normally 97 degree F. The patient left inner thigh was sensitive to touch . The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia, Neck pain, Pyrexia
Clinical narrative: Fever / Fever 100 and I am normally 97; severe chills; muscle aches all over; HA; back pain; neck pain; and tired; left inner thigh is sensitive to touch; This case was reported by a consumer and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 11th June 2021, the patient received the 1st dose of Shingles vaccine. In June 2021, less than a week after receiving Shingles vaccine, the patient experienced fever, chills, generalized muscle aches, headache, back pain, neck pain, tiredness and touch sensitivity increased. On an unknown date, the outcome of the fever, chills, generalized muscle aches, headache, back pain, neck pain, tiredness and touch sensitivity increased were unknown.   It was unknown if the reporter considered the fever, chills, generalized muscle aches, headache, back pain, neck pain, tiredness and touch sensitivity increased to be related to Shingles vaccine.  Additional details were provided as follows: The patient self reported the case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced Fever, severe chills , muscle aches all over, headache, back pain, neck pain and tired, fever 100 and patient normally 97 degree F. The patient left inner thigh was sensitive to touch . The reporter consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Radiculopathy
Clinical narrative: nerve root irritation; This case was reported by a consumer via interactive digital media and described the occurrence of nerve root irritation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced nerve root irritation. On an unknown date, the outcome of the nerve root irritation was recovered/resolved. It was unknown if the reporter considered the nerve root irritation to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 1st dose of Shingles shot on left side and patient stated that it irritated the nerve in the shoulder and neck on the side where he/she got the shot. For tolerance of 2nd dose refer case US2021AMR163732.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR163732:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Radiculopathy, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of nerve root irritation in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of radiculopathy (1st dose received on unknown date, for tolerance refer case US2021AMR163721). On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced nerve root irritation. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the nerve root irritation was not recovered/not resolved. It was unknown if the reporter considered the nerve root irritation to be related to Shingles vaccine. Additional details were provided as follows: The case was reported by the patient himself/herself. The age at vaccination was not reported. The patient received the 2nd dose of Shingles shot on left side and after the vaccination the patient stated that it irritated the nerve in the shoulder and neck on the side where he/she got the shot. The reporter stated that since his/her 2nd dose it's been 6 weeks and patient was under his/her doctor care to tried to get it resolved, hoping soon.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR163721:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were recovering/resolving. It was unknown if the reporter considered the muscle pain and joint pain to be related to Shingrix. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt reaction. The patient also suffering with muscle pain and joint pain months later. The patient stated above events were improving but wont take the second shot. The follow-up would not possible as no contact details were available. This case has been linked with case US2021AMR200703, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR200703:same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain; Joint pain; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several months after receiving Shingrix, the patient experienced muscle pain and joint pain. On an unknown date, the outcome of the muscle pain and joint pain were recovering/resolving. It was unknown if the reporter considered the muscle pain and joint pain to be related to Shingrix. Additional details were provided as follows: Age at vaccination was not applicable to this report. The reporter reported that many patients experienced the reaction to the new shingrix shot. The reporter also reported that many patients were still suffering with muscle pain and joint pain months after first shot. The reporter stated above events were improving but wont take the second shot The follow-up would not possible as no contact details were available. This case has been linked with case US2021AMR200678, reported by the same reporter. Sender's Comments. US-GLAXOSMITHKLINE-US2021AMR200678:same reporter.
Age: 40.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Pain in extremity
Clinical narrative: Moderate soreness in left arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 40-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2)) (batch number 330308D, expiry date unknown) for prophylaxis.   Previously administered products included Zinacef with an associated reaction of hypersensitivity, Pfizer BionTech (1st dose received on 9th March 2021 Lot No: EL3247 intramuscular in left arm) and Pfizer BionTech (2n dose received on 1st April 2021 Lot No: EPF955 intramuscular in left arm).   On 21st November 2021, the patient received the 1st dose of Influenza vaccine Quadrivalent 2021-2022 season and the 3rd dose of PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2) (intramuscular). On an unknown date, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patent for himself. The patient received on same day same location flu shot and COVID-19 vaccine and experienced moderate soreness in left arm (injection arm for both the COVID booster and the GSK flu shot). It was unknown if the reporter considered the pain in arm to be related to PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2).
Age: 40.0
Sex: M
Vaccine: COVID19, FLUX, COVID19
Symptoms: Immunisation, Pain in extremity, Product use issue
Clinical narrative: Moderate soreness in left arm; This case was reported by a consumer via other manufacturer and described the occurrence of pain in arm in a 40-year-old male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included TOZINAMERAN (PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2)) (batch number 330308D, expiry date unknown) for prophylaxis.   Previously administered products included Zinacef with an associated reaction of hypersensitivity, Pfizer BionTech (1st dose received on 9th March 2021 Lot No: EL3247 intramuscular in left arm) and Pfizer BionTech (2n dose received on 1st April 2021 Lot No: EPF955 intramuscular in left arm).   On 21st November 2021, the patient received the 1st dose of Influenza vaccine Quadrivalent 2021-2022 season and the 3rd dose of PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2) (intramuscular). On an unknown date, less than 2 weeks after receiving Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2021-2022 season.  Additional details were reported as follows: This case was reported by the patent for himself. The patient received on same day same location flu shot and COVID-19 vaccine and experienced moderate soreness in left arm (injection arm for both the COVID booster and the GSK flu shot). It was unknown if the reporter considered the pain in arm to be related to PFIZER BIONTECH VACCINE FOR COVID-19 (BNT162B2).
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: and just got both again, the 2nd today; got both, forgot about it, and got both again; This case was reported by a consumer via  interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (got both doses in summer 2019).   On 1st December 2021, the patient received Shingrix. On an unknown date, the patient received Shingrix. On 1st December 2021, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had got both Shingrix vaccines in summer 2019 and had frankly forgotten about it. The patient had just got both again, the 2nd one today, and just now had checked and realized the he/she already had the Shingrix vaccine. The patient enquired if he/ she should see the doctor or do anything.
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: 2nd dose interrupted and delayed by covid pandemic; This case was reported by a consumer via (Shingrix GSK Chatbot) interactive digital media and described the occurrence of social problem in a 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 social problem. On an unknown date, the outcome of the social problem was unknown.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient reporter that second dose of Shingrix was interrupted and delayed by the covid pandemic well over a year ago, which led to social problem. The patient asked would it still receive the second dose now or had to start over.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: 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 patient who received Herpes zoster (Shingrix) for prophylaxis. On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced 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 coordinator reported that, the patient vaccinated with the powder component of Shingrix reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter could not identify the patient or the vaccination date, but found 3 AS01B Adjuvant. The reporter consented to follow up. This case was linked with case US2021248441 and US2021248437, reported by same reporter for different patient.; Sender's Comments: US-GLAXOSMITHKLINE-US2021248437:Same reporter US-GLAXOSMITHKLINE-US2021248441:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling cold
Clinical narrative: Shivering due to cold chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2021, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills. On an unknown date, the outcome of the chills was not recovered/not resolved.   It was unknown if the reporter considered the chills to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received 2nd dose of Shingrix and was shivering due to cold chills. The patient enquired what type of medication can he/she take for this. Follow up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Deafness, Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine. Then I had shingles AGAIN/ suspected vaccination failure; lost some hearing; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles and shingles.   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), hearing loss (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, hearing loss and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. The reporter considered the hearing loss to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had Shingles twice.  The patient stated he/she got the Shingles vaccine and had shingles again and lost some hearing from Shingles vaccine. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: Blurred vision; This case was reported by a consumer via(Shingrix GSK Chatbot) call center representative and described the occurrence of blurred vision in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was unknown.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional details were reported as follows: This case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient reported that he/she had blurred vision after receiving Shingrix. The patient asked if there was any possibility of this as the patient could see clearly without spect than with it.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Have shingles, I got the shingles vx/ Suspected vaccination failure; Think I have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of (suspected) vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had shingles but got the Shingles vaccine at least 4 years ago of reporting. The patient asked could he/she still get shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: having the vaccine but had a light case/ suspected vaccination failure; light case; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she went through free having the vaccine but had a light case of shingles. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. In November 2021, the patient received Menveo. In November 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 received the powder portion of the Menveo vaccine by reconstituting with Sterile Water and not the diluent that comes with the vaccine, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No other details were available. The reporter consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Accidental overdose, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number 3B55B, expiry date 18th December 2022) for prophylaxis. Concomitant products included Herpes zoster (Shingrix).  On 30th November 2021, the patient received the 2nd dose of Shingrix. On 30th November 2021, 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 patient experienced accidental overdose. On an unknown date, the outcome of the drug dose administration interval too short and accidental overdose were unknown. Additional details were reported as follows: The nurse reported that patient received his 1st dose of Shingrix on 30th November 2021 and accidentally received a 2nd dose about 30 minutes later, which led to drug dose administration interval too short and accidental overdose. No symptoms reported. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: HEPAB, HEPAB
Symptoms: Wrong product administered
Clinical narrative: received 2 Twinrix instead of 2 Energix; received 2 Twinrix instead of 2 Energix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 59-year-old female patient who received HAB (Twinrix) (batch number 3y7nL, expiry date 24th May 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) (batch number 9355d, expiry date 14th March 2022) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B).   On 1st June 2021, the patient received the 2nd dose of Twinrix (intramuscular) 1 ml and Twinrix Pre-Filled Syringe Device. On 22nd December 2020, the patient received the 1st dose of Twinrix (intramuscular) 1 ml and Twinrix Pre-Filled Syringe Device. On 22nd December 2020, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and 36 days after receiving ENGERIX B, the patient experienced wrong vaccine administered. On 1st June 2021, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received 2 dose of Twinrix instead of 2 dsoe of Engerix B, which led to wrong vaccine administered. The patient was told that needed to get Havrix in order to be vaccinated against Hepatitis A. The reporter was asking about the dosing schedule for giving this vaccine. The reporter did not consent to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Feeling hot, Pyrexia
Clinical narrative: fever; trouble breathing; he felt hot; This case was reported by a consumer via call center representative and described the occurrence of difficulty breathing in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2021, the patient received the 2nd dose of Shingrix. On 2nd December 2021, 1 days after receiving Shingrix, the patient experienced fever. In December 2021, the patient experienced difficulty breathing and feeling hot. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the difficulty breathing and fever were not recovered/not resolved and the outcome of the feeling hot was unknown.   It was unknown if the reporter considered the difficulty breathing, feeling hot and fever to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient received his 2nd dose of Shingrix day before reporting. The patient stated that he had trouble breathing last night and continues to do so on the day of reporting. The patient also stated that he felt hot a dsy before reporting and had a fever on the day of reporting. The patient took some Tylenol for the fever dose unknown. The reporter did not consent to follow up.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barré Syndrome; This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 74-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was recovered/resolved.   It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine.  Additional details were provided as follows: The patient self-reported this case. At the time of reporting, the patient's age was 75 years. The age at vaccination was unknown. The reporter stated that, she had Guillain-Barre Syndrome with a flu shot last year (2020).  The reporter also stated that, her healthcare professional wanted her to get the Shingrix. The reporter was concerned of the recent warnings for Shingrix.  The reporter did not consent to follow up. No other information was provided.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old male patient who received HBV (Engerix B adult) (batch number n4ga4, expiry date 2nd January 2023) for prophylaxis. Co-suspect products included HBV (Engerix B adult) (batch number n4ga4, expiry date 2nd January 2023) for prophylaxis. On 29th September 2021, the patient received Engerix B adult. On 25th August 2021, the patient received Engerix B adult. On 25th August 2021, not applicable after receiving Engerix B adult and unknown after receiving Engerix B adult, the patient experienced inappropriate age at vaccine administration and overdose. On 29th September 2021, the patient experienced inappropriate age at vaccine administration and overdose. On an unknown date, the outcome of the inappropriate age at vaccine administration, overdose, inappropriate age at vaccine administration and overdose were unknown.  Additional details were reported as follows: The reporter reported that a patient of 19 years received two doses of Engerix B adult vaccine, which led to inappropriate age of vaccine administration and overdose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Product storage error, Syringe issue
Clinical narrative: 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 44E23, expiry date 1st July 2023) for prophylaxis. On 1st December 2021, 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 reported as follows: The age at vaccination was not reported. Health care professional (HCP) called to report that a Shingrix vaccine was reconstituted and withdrawn into a syringe. The syringe was refrigerated for 24 hours and later administrated to a patient, which led to incorrect storage of drug. No further events were reported. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not yet been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 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. The pharmacist reported that second dose of shingrix has not yet been administered, which led to incomplete course of vaccination. The reporter stated the first dose was given at a different facility so reporter does not have lot number, expiration date, or exact date of dose. The reporter could not provide patient initials. The reporter consented to follow up.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a 86-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis. Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 5th February 2019). On 5th March 2019, the patient received the 2nd dose of Shingrix. On 5th March 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional details were reported as follows: The reporter was patient's daughter. The patient received her 2nd dose of Shingrix later than the recommended interval, which led to drug dose administration interval too short. The reporter also reported that the vaccine information said Immunization intramuscular injection for severe respiratory. The reporter asked if GlaxoSmithKline keeps records of the immunizations of Shingrix. The reporter also requested no follow up be made to the patient's physician. The reporter did not consent to follow up.