chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Tooth loss, Vaccination failure
Clinical narrative: got vaccine / shingles/suspected vaccination failure; shingles in my mouth; total teeth loss; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and loss of teeth. On an unknown date, the outcome of the vaccination failure, shingles and loss of teeth were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and loss of teeth to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and got shingles in a year in mouth total teeth loss. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus, Rash
Clinical narrative: had your two shingles shots and still got the shingles/suspected vaccination failure; shingles; Very painful; itch on head; burning in your face cheek; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus and burning sensation in face. On an unknown date, the outcome of the vaccination failure, shingles, pain, pruritus and burning sensation in face were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and burning sensation in face to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had two dose of shingles vaccine and still got the shingles, also mentioned very painful. The also asked what the best thing was to stop itch on head and burning in face cheek. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: had your two shingles shots and still got the shingles/suspected vaccination failure; shingles; Very painful; itch on head; burning in your face cheek; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, pruritus and burning sensation in face. On an unknown date, the outcome of the vaccination failure, shingles, pain, pruritus and burning sensation in face were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain, pruritus and burning sensation in face to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had two dose of shingles vaccine and still got the shingles, also mentioned very painful. The also asked what the best thing was to stop itch on head and burning in face cheek. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the time to onset and laboratory confirmation for shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Influenza like illness
Clinical narrative: Sick as a dog; flu-like symptoms; This case was reported by a consumer interactive digital media and described the occurrence of sickness 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 sickness and influenza-like symptoms. On an unknown date, the outcome of the sickness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and was sick as dog with flu-like symptoms. The patient was going to take her second dose on 29th November 2021 and he/she was scared to death due to symptoms from first dose. The patient hope that she did not go through the same symptoms after second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Suspected vaccination failure/I had both shots and I did not have a light case.; I certainly did not have a light case! don't want it again; pain; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient had both the shots and his/her provider said he/she certainly did not have had a light case. The patient stated he/she was sorry to say that this was an adequate description of some of the pain. The patient stated please god did not want them again. The follow-up could not be possible as no contact details were available. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had it ... DID get vaccinated/suspected vaccination failure; had it; 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: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and had shingles. The reporter had a couple of friends who got the vaccine and had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case has been linked with US2021AMR241238, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241238:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have couple of friends who had it/suspected vaccination failure; have couple of friends who had it; 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: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and had shingles. The reporter had a couple of friends who got the vaccine and had shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. This case has been linked with US2021AMR241233, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR241233:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Decreased activity, Herpes zoster, Pain, Rash
Clinical narrative: suspected vaccination failure/I have Shingles and I had already been vaccinated; shingles; very painful /burning pain on my body; burning feeling; I have more than a week of being inactive; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation and decreased activity. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation and decreased activity were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation and decreased activity to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and at the time of reporting, the patient had shingles, it was very painful and the burning feeling was unbearable. She had more than a week of being inactive because of the burning pain on her body. 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. Follow-up would not be possible as no contact details available.
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: suspected vaccination failure/I have Shingles and I had already been vaccinated; shingles; very painful /burning pain on my body; burning feeling; I have more than a week of being inactive; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation and decreased activity. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation and decreased activity were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation and decreased activity to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and at the time of reporting, the patient had shingles, it was very painful and the burning feeling was unbearable. She had more than a week of being inactive because of the burning pain on her body. 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. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Burning sensation, Herpes zoster, Malaise, Pain
Clinical narrative: have 2 shots & still got shingles/Suspected vaccination failure; shingles; Very painful; burning; blisters; still off for 3 weeks; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation, blister and malaise. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation, blister and malaise were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, blister and malaise to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the 2 shingles shot and still got shingles. The patient reported that it was very painful & burning blisters but it could had been worse without the shots. The patient was still off for 3 weeks. 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.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination failure
Clinical narrative: have 2 shots & still got shingles/Suspected vaccination failure; shingles; Very painful; burning; blisters; still off for 3 weeks; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain, burning sensation, blister and malaise. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles, pain, burning sensation, blister and malaise were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pain, burning sensation, blister and malaise to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the 2 shingles shot and still got shingles. The patient reported that it was very painful & burning blisters but it could had been worse without the shots. The patient was still off for 3 weeks. 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.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: was given the vaccine and still got shingles/ 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 male 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 the patient's parent. The age at vaccination was not reported. The patient got the shingle vaccine and still got shingles. The patient stated that the commercial for the shot said that it stops most cases. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure, Vaccine breakthrough infection
Clinical narrative: suspected vaccination failure/received the vaccine, had my first breakthrough round of Shingles; Shingles on my spine/ Shingles on a patch on my face near the left eye; 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. In November 2021, 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 are as follows: The case was reported by patient himself/herself. The age at vaccinations was not reported. The patient received the vaccine and this week had his/her first breakthrough round of Shingles. Shingles started on spine and a patch on face near the left eye. The patient further stated so far it was livable asked to get vaccinated. 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. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Feeling pretty awful; This case was reported by a consumer via interactive digital media and described the occurrence of feels awful in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 19th November 2021, the patient received the 2nd dose of Shingles vaccine. On 20th November 2021, 1 days after receiving Shingles vaccine, the patient experienced feels awful. On 21st November 2021, the outcome of the feels awful was recovered/resolved.   It was unknown if the reporter considered the feels awful to be related to Shingles vaccine.  Additional details were provided are as follows: The case was reported by patient for himself/herself. The age at vaccination was not reported. The patient had a shot of Shingles vaccine on Friday and felt pretty awful on Saturday. On the day of reporting, the patient was fine. The patient stated getting the shot was so worth it because the uncomfortable side effects of the shot were nothing like the devastating effects of having shingles. The follow-up could not be possible as no contact details were available.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Formication, Herpes zoster, Malaise, Nausea
Clinical narrative: sick (malaise); fever; weakness; chills; Shingles/pain from Shingles rash on back/spots on back/skin crawling/itching/dry heaves; This spontaneous report was received from a 63-year-old female patient via Glaxosmithkline GlaxoSmithKline, reporting on herself. Medical history included that she was diagnosed with shingles 13 years ago. Information regarding concurrent conditions and concomitant medication was not provided.  In approximately 2008, when the rash went away, she received zoster vaccine live (ZOSTAVAX) for prophylaxis (dosage information, route, lot number and expiration date not reported). On an unknown date, the patient was vaccinated with varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 (unk) (dosage information, route, lot number and expiration date not reported).      The patient referred that on an unknown date, when she had her first dose of varicella zoster vaccine rge (cho) (SHINGRIX), she was sick (malaise), fever and chills and couldn't get out of bed (weakness) and it lasted 2 days. These events resolved on an unknown date.   On 20-SEP-2021, she received the second dose of varicella zoster vaccine rge (cho) (SHINGRIX). Starting hours after the second dose, she had fever, chills, and she had been sicked all week, nausea, dry heaves and on Tuesday night when she took off the bra, on her back below the neck there was the first spot, kind of dime size. She went back to primary care on Wednesday (22-SEP-2021), started itching, the whole body, felt like her skin was crawling, and the spot on her back had turned into a rash. She was told to take some diphenhydramine (BENADRYL) and put cortisone cream on it, diphenhydramine (BENADRYL) did not help, cortisone cream made it worse, Wednesday was horrible, Thursday the rash was worse, she went back to the doctor and was diagnosed with shingles. The doctor told her to take pregabalin (LYRICA) for the pain from the shingles rash, but she did not take it. Fever, chills, nausea, and dry heaves are resolved. Itching, shingles rash, shingles rash pain, and skin crawling were not resolved. The outcome of shingles was unknown. The patient would like for it to be recorded that she is furious that varicella zoster vaccine rge (cho) (SHINGRIX) caused her shingles outbreak. The causality assessment between zoster vaccine live (ZOSTAVAX) and the events was not provided.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Pyrexia, Rash, Retching
Clinical narrative: sick (malaise); fever; weakness; chills; Shingles/pain from Shingles rash on back/spots on back/skin crawling/itching/dry heaves; This spontaneous report was received from a 63-year-old female patient via Glaxosmithkline GlaxoSmithKline, reporting on herself. Medical history included that she was diagnosed with shingles 13 years ago. Information regarding concurrent conditions and concomitant medication was not provided.  In approximately 2008, when the rash went away, she received zoster vaccine live (ZOSTAVAX) for prophylaxis (dosage information, route, lot number and expiration date not reported). On an unknown date, the patient was vaccinated with varicella zoster vaccine rge (cho) (SHINGRIX) 0.5 (unk) (dosage information, route, lot number and expiration date not reported).      The patient referred that on an unknown date, when she had her first dose of varicella zoster vaccine rge (cho) (SHINGRIX), she was sick (malaise), fever and chills and couldn't get out of bed (weakness) and it lasted 2 days. These events resolved on an unknown date.   On 20-SEP-2021, she received the second dose of varicella zoster vaccine rge (cho) (SHINGRIX). Starting hours after the second dose, she had fever, chills, and she had been sicked all week, nausea, dry heaves and on Tuesday night when she took off the bra, on her back below the neck there was the first spot, kind of dime size. She went back to primary care on Wednesday (22-SEP-2021), started itching, the whole body, felt like her skin was crawling, and the spot on her back had turned into a rash. She was told to take some diphenhydramine (BENADRYL) and put cortisone cream on it, diphenhydramine (BENADRYL) did not help, cortisone cream made it worse, Wednesday was horrible, Thursday the rash was worse, she went back to the doctor and was diagnosed with shingles. The doctor told her to take pregabalin (LYRICA) for the pain from the shingles rash, but she did not take it. Fever, chills, nausea, and dry heaves are resolved. Itching, shingles rash, shingles rash pain, and skin crawling were not resolved. The outcome of shingles was unknown. The patient would like for it to be recorded that she is furious that varicella zoster vaccine rge (cho) (SHINGRIX) caused her shingles outbreak. The causality assessment between zoster vaccine live (ZOSTAVAX) and the events was not provided.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy, Extra dose administered
Clinical narrative: pregnant 16 year old pediatric patient at 20 weeks and 3 days gestation; given Fluarix on 10/14/2021 and then given FluLaval on 10/18/2021; pregnant 16 year old pediatric patient at 20 weeks and 3 days gestation; This prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 15-year-old female patient who received Flu Seasonal QIV (FluLaval Quadrivalent 2021-2022 season) (batch number 24BM2, expiry date unknown) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 7LX9G, expiry date unknown) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2021, the patient received FluLaval Quadrivalent 2021-2022 season. On 14th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received FluLaval Quadrivalent 2021-2022 season at an unknown time during the pregnancy. On 14th October 2021, not applicable after receiving FluLaval Quadrivalent 2021-2022 season and unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On 18th October 2021, the patient experienced vaccine exposure during pregnancy and extra dose administered. On an unknown date, the outcome of the vaccine exposure during pregnancy, vaccine exposure during pregnancy and extra dose administered were unknown. The pregnancy was ongoing.   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: At the time of reporting the patient's age was 16 years. The nurse reported that pregnant pediatric patient at 20 weeks and 3 days gestation received Fluarix and FluLaval, which led to vaccine exposure during pregnancy. The patient received FluLaval quadrivalent 4 days apart after Fluarix, which led to extra dose administered. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Product complaint, Syringe issue, Underdose
Clinical narrative: Problems with the plastic / Looks like the liquid was coming from the vial / It is "like it wasn't sealed; Half of the liquid or more sprayed down on patient´s arm during the injection; Sprayed down on patient´s arm during the injection; Inadvertent exposure to vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 58-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 7J2CA, expiry date 30th June 2022) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 17th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the accidental underdose, exposure via skin contact, inadvertent exposure to vaccine and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter stated that the Fluarix vaccine had problems with the plastic and half of the liquid or more was sprayed down on the patient´s arm during the injection, which led to accidental underdose, exposure via skin contact and inadvertent exposure to vaccine. The reporter stated that, it looks like the liquid was coming from the vial itself and the injection typically did not come off. The certified technician who prepared/administered the dose stated she was experienced with giving flu shots. The reporter stated that there was leak between the syringe barrel body and plunger stopper. The syringe was pre-assembled with needle maximum of 5 minutes prior to administration and used 25-gauge 1-inch size gauge needle. There was no blister or carton damaged.  The reporter did not believe so that there were any liquid traces observed on the plunger stopper rings. The luer lok not damaged. The needle which was used was in the sharps container. There was no any damage or breakage on the syringe barrel. The reporter consented to follow up by email.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: muscle knot at the injection site; swelling at the injection site; redness at the injection site; Pain at ithe njection site; This case was reported by a consumer and described the occurrence of injection site nodule in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced injection site nodule, injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site nodule, injection site swelling and injection site erythema were recovered/resolved and the outcome of the injection site pain was not recovered/not resolved.   It was unknown if the reporter considered the injection site nodule, injection site swelling, injection site erythema and injection site pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported but it could be 63 or 64 years. The patient received her 1st Shingrix dose and had pain, redness, swelling and a muscle knot at the injection site for about the week after the injection. The pain at injection site was recurring and she had nothing else to report. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Hypersensitivity
Clinical narrative: had an allergic reaction / allergic to Bexsero; This case was reported by a other health professional via other manufacturer and described the occurrence of allergic reaction in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant reported that the patient received Bexsero and had allergic reaction. The medical assistant declines to provide additional information. The reporter would like to know if the patient could receive the Pfizer Covid-19 vaccine The reporter did not consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: neuralgic pain; This case was reported by a consumer via call center representative and described the occurrence of neuralgia in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles outbreak 2 years ago from reporting date, before he received Shingrix).   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced neuralgia. On an unknown date, the outcome of the neuralgia was not recovered/not resolved.   It was unknown if the reporter considered the neuralgia 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 Shingrix vaccine 2 years ago from reporting date and had neuralgic pain that was wrapping around the right side of his back, similar to when he had an outbreak of shingles 2 years ago from reporting date (before he received Shingrix dates were unknown). The reporter consented to follow up
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
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 Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2021-2022 season) for prophylaxis. Co-suspect products included Flu seasonal, pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 18th November 2021, the patient received FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent 2021-2022 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 reported. The patient was administered Flulaval vaccine after a temperature excursion, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Blister, Diarrhoea, Fatigue, Inappropriate schedule of product administration
Clinical narrative: Fatigue; Upset stomach; Diarrhea; Few blisters on stomach/side; 2 Shingrix vaccines only 3 weeks apart; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In July 2021, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In July 2021, unknown after receiving Shingrix and an unknown time after receiving SHINGRIX, the patient experienced drug dose administration interval too short. On 1st August 2021, the patient experienced fatigue, upset stomach, diarrhea and blister. On an unknown date, the outcome of the fatigue, upset stomach, diarrhea and blister were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   The reporter considered the fatigue, upset stomach, diarrhea and blister to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. In June 2021, the patient received 1st dose of Shingrix intramuscularly in left arm. The patient received 2nd dose in the right arm. The patient received 1st dose of Shingrix in right arm and experienced fatigue, upset stomach, diarrhea, and a few blisters on her stomach or side, and symptoms were off and on as well as ongoing. The patient asked if the side effects experiencing could be from getting 2 doses of Shingrix too close together. The patient received 2nd dose of Shingrix early than the recommended time interval, which led to shortening of vaccination schedule. The patient also asked if she should get her COVID booster with her symptoms. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Dizziness, Dyspnoea exertional, Feeling hot, Heart rate increased
Clinical narrative: Dizziness; Increased heart rate; Shortness of breath with exertion; Nausea; Abdominal pain; Numbness; Tingling in hands and feet; Tremors; Felt feverish; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 28th October 2021, less than a day after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot. On an unknown date, the outcome of the dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by a nurse for herself. The patient received Fluarix and within three hours developed dizziness, increased heart rate, shortness of breath with exertion, nausea, abdominal pain, numbness and tingling in her hands and feet, tremors and she felt feverish but did not have a fever. The reporter consented to follow up. The patient had nothing else to report.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Nausea, Paraesthesia, Tremor
Clinical narrative: Dizziness; Increased heart rate; Shortness of breath with exertion; Nausea; Abdominal pain; Numbness; Tingling in hands and feet; Tremors; Felt feverish; This case was reported by a nurse via call center representative and described the occurrence of dizziness in a 34-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th October 2021, the patient received Fluarix Quadrivalent 2021-2022 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. On 28th October 2021, less than a day after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot. On an unknown date, the outcome of the dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, heart rate increased, exertional dyspnea, nausea, abdominal pain, numbness, tingling, tremor and feeling hot to be related to Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: This case was reported by a nurse for herself. The patient received Fluarix and within three hours developed dizziness, increased heart rate, shortness of breath with exertion, nausea, abdominal pain, numbness and tingling in her hands and feet, tremors and she felt feverish but did not have a fever. The reporter consented to follow up. The patient had nothing else to report.
Sex: U
Vaccine: DTAP, FLU4, HEP, HEPA, TDAP
Symptoms: Product storage error
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 DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th November 2021, the patient received Boostrix, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 reported. The practice administrator reported temperature of 24.4 Fahrenheit, which patients having received the vaccinations after the temperature excursion, which led to incorrect storage of drug. The reporter consented to follow up.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Feeling abnormal, Frequent bowel movements
Clinical narrative: Pain at the injection site; Rough flu like symptoms; Fever; Chills; Increased bowel movements; First 24 hours after brutal symptoms started, was in bed; Next 24 hours was still moping around; Was still barely eating; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 61-year-old male patient who received Herpes zoster (Shingrix) (batch number 27PA5, expiry date 3rd February 2023) for prophylaxis.   On 22nd October 2021, the patient received the 1st dose of Shingrix (intramuscular). In October 2021, 12 hrs after receiving Shingrix, the patient experienced injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite. On an unknown date, the outcome of the injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite were recovered/resolved.   It was unknown if the reporter considered the injection site pain, influenza-like symptoms, fever, chills, frequent bowel movements, feels awful, asthenia and decreased appetite to be related to Shingrix.  Additional details were reported as follows: The pharmacist, who was also the patient reported that he received the first dose of Shingrix in his left deltoid.  Twelve hours after the injection the patient started experiencing pain at the injection site, rough flu like symptoms, fever, chills and increased bowel movements.  The first 24 hours after the symptoms started, the patient was in bed, the next 24 hours symptoms started improving but he was still moping around and barely eating. Symptoms started improving after the third 24 hours and disappeared the next day.  The symptoms were reported as brutal. The reporter consented to follow up. This case had been linked with case US2021239187, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021239187:Same reporter.