chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 27-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 28-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U015689 had been verified to be a valid number; expiration date 18-MAY-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; lots: U015689 and U010395 have been administered to patients since the excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.      On 23-SEP-2021, the patient was inadvertently administered with  an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dose for prophylaxis (strength, route of administration, and anatomical location were not reported; lot number U010395 had been verified to be a valid number; expiration date 01-APR-2023). The temperature  excursion was at -12.0 degree Celsius (C), for a time frame of 1 hour and 50 minutes. No had previous temperature excursion. No additional adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2109USA007144:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: got the shingles 3 days later; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 3 days after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to 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 got the shingles 3 days later. The patient would not get the Covid vaccine. The follow-up would not possible as no contact details were available. This case has been linked with case US2021AMR202770, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202770:Same reporter
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Axillary pain, Fatigue, Injection site erythema, Injection site pain, Lymphadenopathy
Clinical narrative: both arms were sore; sore armpit and tenderness in the armpit; slight redness near the injection site; Shingrix injection site is sore; lymph node reaction,; tired; overall achiness.; mild fever; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix and FLUZONE (FLU SHOT). In September 2021, several hours after receiving Shingrix, the patient experienced tiredness, general body pain, fever, pain in arm, axillary pain, localized erythema, injection site pain and enlargement of lymph nodes. On an unknown date, the outcome of the tiredness, general body pain, fever and pain in arm were recovered/resolved and the outcome of the axillary pain, localized erythema, injection site pain and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the tiredness, general body pain, fever, pain in arm, axillary pain, localized erythema, injection site pain and enlargement of lymph nodes 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 the Shingrix vaccine four days ago, (Day of reporting) along with the Fluzone high dose in the other arm. The patient usually experience sore arm for a day or two, but this time, several hours later patient got very tired and had overall achiness. The patient also experienced mild fever, both arms were sore and the armpit on the side with the Shingrix shot. There was also slight redness near the injection site. Now there was no soreness on the other side, but the Shingrix injection site was still a little sore, along with tenderness in the armpit, though it was getting better. The patient read that there could be more side effects with this vaccine than with most others, but was concerned that the soreness in the armpit, likely due to lymph node reaction, was not really mentioned as a possible minor side effect.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202774:same reporter US-GLAXOSMITHKLINE-US2021AMR202783:same reporter
Sex: U
Vaccine: FLU4, VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: both arms were sore; sore armpit and tenderness in the armpit; slight redness near the injection site; Shingrix injection site is sore; lymph node reaction,; tired; overall achiness.; mild fever; This case was reported by a consumer and described the occurrence of tiredness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (FLU SHOT)) for prophylaxis.   In September 2021, the patient received the 1st dose of Shingrix and FLUZONE (FLU SHOT). In September 2021, several hours after receiving Shingrix, the patient experienced tiredness, general body pain, fever, pain in arm, axillary pain, localized erythema, injection site pain and enlargement of lymph nodes. On an unknown date, the outcome of the tiredness, general body pain, fever and pain in arm were recovered/resolved and the outcome of the axillary pain, localized erythema, injection site pain and enlargement of lymph nodes were unknown.   It was unknown if the reporter considered the tiredness, general body pain, fever, pain in arm, axillary pain, localized erythema, injection site pain and enlargement of lymph nodes 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 the Shingrix vaccine four days ago, (Day of reporting) along with the Fluzone high dose in the other arm. The patient usually experience sore arm for a day or two, but this time, several hours later patient got very tired and had overall achiness. The patient also experienced mild fever, both arms were sore and the armpit on the side with the Shingrix shot. There was also slight redness near the injection site. Now there was no soreness on the other side, but the Shingrix injection site was still a little sore, along with tenderness in the armpit, though it was getting better. The patient read that there could be more side effects with this vaccine than with most others, but was concerned that the soreness in the armpit, likely due to lymph node reaction, was not really mentioned as a possible minor side effect.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202774:same reporter US-GLAXOSMITHKLINE-US2021AMR202783:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt under the weather; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was recovered/resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received a dose of Shingles vaccine and felt a little under the weather for about 24 hours. Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: I got Shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to 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 he/she got the Shingles vaccine and a week later got shingles. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Feeling really rough; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient got the first vaccine and had been feeling really rough and all.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of headache (patient received 1st dose on an unknown date and experienced headache and sore arm, refer case US2021AMR202845).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced headache and pain in arm. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the headache and pain in arm were unknown.   It was unknown if the reporter considered the headache and pain in arm to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient just had a headache the day after getting the Shingles shot and a sore arm. The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR202845:same reporter, same patient, same suspect, different dose (1st dose)
Sex: U
Vaccine: VARZOS
Symptoms: Gaze palsy, Pain in extremity
Clinical narrative: My arm is so sore; I have a headache; This case was reported by a consumer via media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2021 10:00, the patient received the 2nd dose of Shingrix. On 24th September 2021, less than a day after receiving Shingrix, the patient experienced pain in arm and headache. On an unknown date, the outcome of the pain in arm and headache were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient just had second Shingrix vaccine at 10 am on the reporting date and his/her arm was so sore and had a headache.  The patient was asking if he/she could take an Aleve for that. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: had vaccine at schedule 0 and 6; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 24-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 reported as follows: This case was reported by the patient for herself. The age at vaccination was not reported. The patient reported that she had the Twinrix vaccine at schedule 0 and 6 instead of the intended 0, 1, 6. So I'd like to know what was the coverage and if next dose required, which led to drug dose administration interval too long. The patient also inquired about insurance coverage. The patient answered online questionair as she was not comfortable to share contact number but she was ready to share her email.
Sex: U
Vaccine: VARZOS
Symptoms: Mobility decreased
Clinical narrative: down in bed for three days; This case was reported by a consumer and described the occurrence of mobility decreased 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 mobility decreased. On an unknown date, the outcome of the mobility decreased was recovered/resolved.   It was unknown if the reporter considered the mobility decreased 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 Shingrix shot and was down in bed for three days. The patient got the second shot last week.  And had no reaction to it at all.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Erythema, Feeling hot, Herpes zoster, Pruritus
Clinical narrative: shingles; red spot forehead, bridge of nose and top of head; burning sensation; itchy; get hot; This case was reported by a consumer via media and described the occurrence of shingles 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, 13 days after receiving Shingles vaccine, the patient experienced shingles, localized erythema, burning sensation, pruritus and feeling hot. The patient was treated with antibiotics nos (Antibiotic (Active Ingredient Unknown)). On an unknown date, the outcome of the shingles, burning sensation and pruritus were unknown and the outcome of the localized erythema was not recovered/not resolved and the outcome of the feeling hot was recovered/resolved.   It was unknown if the reporter considered the shingles, localized erythema, burning sensation, pruritus and feeling hot 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 Shingrix vaccine and 13th days later woke up with red spots forehead, bridge of nose and top of head.  The patient felt it like a burning sensation and itchy. The Pharmacist informed see urgent care and they informed it was shingles, gave he/she antibiotic to take for 7 days and informed that red spots may still be visible, but that he/she wouldn't need any more medications. Two months later, still had some on forehead that were light colored. When the patient got hot, they sorta came back to life it seems, by being red spots. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot years ago then got shingles/Suspected vaccination failure; got shingles; 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) 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 reported as follows: The case was reported by the patient's sibling. The patient got the shot just a few years prior to the reporting and when she move back, she got the shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: look at testimonials on here of how it doesn't prevent you from getting shingles/Suspected vaccination failure; look at testimonials on here of how it doesn't prevent you from getting shingles; This case was reported by a consumer 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 taste disorder (refer case US2021AMR203490) and smell loss (refer case US2021AMR203490).   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.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. As per the patient, look at testimonials on here of how it did not prevent you from getting shingles. The patient was injured from the vaccine. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203490:Same reporter, same patient, different event
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and he get 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 reported as follows; The case was reported by the patient's sister in law. The age at vaccination was not reported. The reporter said generally that shot did not prevent the shingles just help you had a lighter case of the shingles. The patient had the shot and he still got the shingles just not as often. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via and described the occurrence of shingles 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, 1 week after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had shingles from the 1st shingle vaccine.  Apparently they ran out of the 2nd dose & could not gave the 2nd dose. The patient then got shingles a week after. The patient's physician refused to acknowledge that she had given me the shingles. For tolerance to 2nd dose, refer case US2021AMR203623.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203623:same reporter, same patient, Different dose
Sex: U
Vaccine: VARZOS
Symptoms: Product supply issue
Clinical narrative: they ran out of the 2nd dose; This case was reported by a consumer via interactive digital media and described the occurrence of product supply issue in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (1st dose receied on an unknown date, and had shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, had shingles from the 1st shingle vaccine. Apparently they ran out of the 2nd dose & could not gave the 2nd dose, which led to product supply issue. The patient then got shingles a week after. The patient's physician refused to acknowledge that she had given me the shingles. This case was linked with case US2021AMR203604, reported by same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR203604:same reporter same patient
Sex: U
Vaccine: VARZOS
Symptoms: Eczema
Clinical narrative: exema; This case was reported by a consumer via media and described the occurrence of eczema 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 eczema. On an unknown date, the outcome of the eczema was unknown.   It was unknown if the reporter considered the eczema to be related to 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 received a shot and shot gave him/her exema. The patient had a terrible response with this shot and vaccine caused him/her so much trouble and should not have gotten that 2nd shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bell's palsy, Herpes zoster
Clinical narrative: Bell's Palsy; shingles; This case was reported by a consumer and described the occurrence of bell's palsy 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 bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the bell's palsy and shingles were unknown.   It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Bells palsy and had shingles 2 times post vaccination. The patient asked if anyone had the shot and still had shingles. The patient stated that he/she was not told anything about needing the 2nd shot.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pain, Vaccination failure
Clinical narrative: had shingles after I had the vaccine/ suspected vaccination failure; shingles; nerve pain; painful; 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), shingles, nerve pain and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, nerve pain and pain to be related to Shingles vaccine.  Additional information was provided as follows: The age at vaccination was not reported. The patient had shingles after vaccination. The patient had nerve pain in the area of the shingles at the time of reporting. The reporter stated they were painful and took several weeks to heal. The patient had the vaccination when it was first was available and he was told that the new one was better. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: have the new vaccine and still got the 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 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 had new vaccine and still got the shingles. 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: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: The vaccine help but his will have it/suspected vaccination failure; has it on the optic nerve of his eye; doesn't feel well; stress; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster (had it for over 30 years).   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), ophthalmic herpes zoster (serious criteria GSK medically significant), feeling unwell and stress. On an unknown date, the outcome of the vaccination failure, feeling unwell and stress were unknown and the outcome of the ophthalmic herpes zoster was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster, feeling unwell and stress to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by patient's wife. The age at vaccination was not reported. The patient got the shingles on the optic nerve of his eye and had it for over 30 years.  It comes on when patient doesn't feel well or was under a lot of stress.  The vaccine had helped the severity, but would always have it. 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, Pain, Vaccination failure
Clinical narrative: It hurts like hell and I had the shot/ suspected vaccination failure; It hurts like hell and I had the shot; hurts; 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), 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.  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 years ago and still got shingles. The patient stated that the shingles hurt like hell. 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: Chills
Clinical narrative: 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 (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced chills. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills 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 felt severe chills. The event severe chills was lasted for four hours. The follow-up would not possible as no contact details were available. For 2nd dose refer case US2021AMR204606, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR204606:same patient
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Vaccine positive rechallenge
Clinical narrative: 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 (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of chills (1st dose received on an unknown date, refer case US2021AMR204564).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced chills. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the chills was recovered/resolved.   It was unknown if the reporter considered the chills 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 felt severe chills. The event severe chills was lasted for four hours. The follow-up would not possible as no contact details were available. This case has been linked with case US2021AMR204564, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR204564:same patient
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received her first dose of Shingrix in November-2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on November 2020, 0.5 ml intramuscular in unknown deltoid).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter was the pharmacist, the patient was female at her pharmacy.  It was reported that the second dose was planned, but was not administered at the time of reporting which led to incomplete course of vaccination. The reporter consented to follow up. The VAERS details reported for 1st dose of shingrix.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received the second dose yet; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date in 2019).   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 nurse reported that a patient who received the first dose of Shingrix and had not received the second dose till the time of reporting, which led to incomplete course of vaccination. The reporter consented to follow up via email. The VAERS details reported for 1st dose of shingrix.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose at less than recommended interval; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number JH25S, expiry date 4th November 2021) for prophylaxis.   Concomitant products included ZOSTER VACCINE RECOMBINANT, ADJUVANTED (NON-LIVE) (SHINGRIX).   On 25th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, 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 provided as follows: The patient received 1st dose of Shingrix on 1st May 2021. The pharmacist reported that a patient received 2nd dose of Shingrix at less than the recommended minimum interval of 2 months after the first dose, which led to shortening of vaccination schedule. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: given only the liquid component; given only the liquid component; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA584A, expiry date 30th April 2023) for prophylaxis.   On 22nd September 2021, the patient received Menveo. On 22nd September 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The physician's assistant reported that, the patient was given only the liquid component without the lyophilized component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No symptoms reported. The reporter consented to follow up.
Age: 15.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered infanrix /Date of birth Mar 12th 2006; administered infanrix /Date of birth Mar 12th 2006; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-year-old male patient who received DTPa (Infanrix) (batch number 49TN3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th August 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 25th August 2021, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: A health care professional administered infanrix to a patient when Boostrix was the vaccine indicated for the patient which led to wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up. This case was 1 of 7 case reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201380:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter
Age: 12.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered Kinrix to a patient, Date of birth Feb 14th 2009; administered Kinrix/Boostrix was the vaccine indicated; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 8th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 age at vaccination was not reported. A health care professional administered Kinrix to a patient, when Boostrix was the vaccine indicated for the patient. The reporter consented to follow up. This was 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021201378:same reporter US-GLAXOSMITHKLINE-US2021201377:same reporter US-GLAXOSMITHKLINE-US2021201379:same reporter US-GLAXOSMITHKLINE-US2021201375:same reporter US-GLAXOSMITHKLINE-US2021201373:same reporter US-GLAXOSMITHKLINE-US2021201376:same reporter
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Flulaval to be stored at temperature below what is recommended; This case was reported by a pharmacist via sales rep and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Tetra) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Tetra and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Tetra 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 applicable to this report. The reporter stated that the Flulaval was stored at temperature below what was recommended, which led to incorrect storage of drug. The pharmacist did administer the suspect Flulaval to patients. The reporter did not consent to follow-up.  No additional information was provided.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: not have received the full dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete dose administered in a patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incomplete dose administered. On an unknown date, the outcome of the incomplete dose administered was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported that pediatric patient did not receive the full dose of Havrix due to patient was moving, which led to incomplete dose administered. No additional information provided.  The reporter did not consent to follow-up.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: administered a Pediatric dose instead of an Adult dose; 22 YO patient administered a Pediatric dose; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 22-year-old female patient who received HBV (Engerix B pediatric) (batch number MY3RA, expiry date 21st September 2022) for prophylaxis.   On 23rd September 2021, the patient received the 1st dose of Engerix B pediatric. On 23rd September 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional details were reported as follows: The patient was administered a Pediatric dose of Engerix B instead of an adult dose, which led to underdose and adult use of a child product. The reporter consented to follow-up.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose in 2017, now wants to complete full schedule; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 39-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device injection syringe for prophylaxis.   Previously administered products included Engerix B (received 2nd dsoe on 13th January 2017) and Engerix B (received 1st dose on 12th December 2016).   On an unknown date, the patient received the 3rd dose of Engerix B and hepatitis B vaccine pre-filled syringe device. On an unknown date, unknown after receiving Engerix B and hepatitis B vaccine pre-filled syringe device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination wasnot applicable for this report. The pharmacist reported that a patient wanted to complete the full schedule of EngerixB. Till the time of reporting, the patient did not receive 3rd dose of Engerix B, which led to incomplete course of vaccination. The reporter consented to follow up.