chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shots, got shingles; Got shingles; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shots, got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Got shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The reporter said do not get shots. That was how he/she got shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: After got shot, has had them; Has had them 3 times; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: After got shot, has had them) (serious criteria GSK medically significant) and shingles (Verbatim: Has had them 3 times). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The reporter's brother in law never had them.  After patient got the shot to prevent them, he had them 3 times.  So much for the shot preventing.  This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got shot, got shingles/Suspected vaccination failure; Got shingles; Hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Got shingles) and pain (Verbatim: Hurts). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was recovered/resolved (duration 1 week).   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient's parent via interactive digital media. The reporter stated that shingles vaccine did not stop shingles.  The reporter further stated that it only hurt for a week or so but shingles would stay with you for years. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case had been linked to US2023AMR046167, reported by the same reporter, for a different patient.; Sender's Comments:  US-GSK-US2023AMR046167:Same reporter - Friend case
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Got shot, got shingles/suspected vaccination failure; Shingles; Hurts; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got shot, got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles) and pain (Verbatim: Hurts). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported and the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the Shingles vaccine did not stop the shingles. The reporter stated that his or her friend received the Shingles vaccine and experienced shingles. The reporter reported that it only hurt for a week or so but the shingles would stay for years. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available. This case had been linked with US2023AMR046164 by same reporter for different patient.; Sender's Comments:  US-GSK-US2023AMR046164:Same reporter- Daughter case
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: having them for the 3rd time/Suspected Vaccination Failure; shingles are in a class all their own/having them for the 3rd time; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: having them for the 3rd time/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: shingles are in a class all their own/having them for the 3rd time). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via  interactive digital media. The reporter stated that it was hard to describe a worse than scenario, shingles were in a class all their own. The reporter further stated that it was utterly miserable. At this moment, the patient was having shingles for the third time and he/she had three shingles vaccines. The reporter further stated that getting old was not for sissies that was for sure. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: has had the vaccine 2 times/Suspected Vaccination Failure; suffering from the shingles; horrific pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: has had the vaccine 2 times/Suspected Vaccination Failure) (serious criteria GSK medically significant), shingles (Verbatim: suffering from the shingles) and pain (Verbatim: horrific pain). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that someone he/she knew had the shingles vaccine two times and she was now in isolation suffering from the shingles and was in constant horrific pain. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I got the shot; won't get them as bad/a spot the size of my palm on my back; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: I got the shot) (serious criteria GSK medically significant) and shingles (Verbatim: won't get them as bad/a spot the size of my palm on my back). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The reporter said that the shot did not prevent you from getting shingles but if you do get shingles, you would not get them as bad.  The patient got the shot and year later got a spot the size of his/her palm on his/her back. The patient's son did not got shot but had shingles over most of his torso. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shot and then got shingles; Shingles very mild; This serious 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shot and then got shingles) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles very mild). The outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-Mar-2023 The reporter reported the case via interactive digital media. The patient got the shot and then got shingles, but it was very mild. Shingles went away fast, not nearly as bad as it could have been. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory confirmation were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the shot, still got the shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had the shot, still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reporter reported that he or she received Shingles vaccine and still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Bone pain, Herpes zoster, Pain, Vaccination failure
Clinical narrative: Had shingles vaccine and still got shingles/suspected vaccination failure; Shingles; Worst pain; Back bones felt like they were being twisted; This serious case was reported by a consumer via interactive digital media and described the occurrence of 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, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Had shingles vaccine and still got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), pain (Verbatim: Worst pain) and bone pain (Verbatim: Back bones felt like they were being twisted). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and bone pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and bone pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and bone pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine and still experienced shingles. The patient stated that he or she had worst pain ever but did not break out. The patient stated that his or her back bone felt like they were being twisted. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort
Clinical narrative: GI symptoms; This non-serious case was reported by a nurse via sales rep and described the occurrence of gastrointestinal upset in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced gastrointestinal upset (Verbatim: GI symptoms). The outcome of the gastrointestinal upset was not reported.   It was unknown if the reporter considered the gastrointestinal upset to be related to Shingrix.     It was unknown if the company considered the gastrointestinal upset to be related to Shingrix.   Additional Information: GSK receipt date: 16-MAR-2023 The health care professional (HCP) stated that in general patients stated that they experience Gastrointestinal upset (GI) symptoms after 2nd dose. The reporter did not agree to follow up from GSK.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sore forming in nose; This non-serious case was reported by a consumer via call center representative and described the occurrence of cold sores in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 13-MAR-2023, the patient received Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced cold sores (Verbatim: cold sore forming in nose). The outcome of the cold sores was not recovered/not resolved.   It was unknown if the reporter considered the cold sores to be related to Shingles vaccine.     It was unknown if the company considered the cold sores to be related to Shingles vaccine.   Additional Information: GSK receipt date:16-MAR-2023 The reporter enquired that did Lysine 1000 milligram effect the effectiveness of the Shingles vaccine. The patient had cold sore formed on his/her nose as a result of getting the vaccine on Monday.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Bone pain, Haemorrhage, Herpes zoster, Pain
Clinical narrative: Shots hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Shots hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she had shingles and deep bone pain for 2 months that was very worst. The reporter told to the patient to receive the vaccine and patient stated that the vaccine hurts. The reporter stated that there was no pain anywhere amount to the pain, blistering, scabs sticking to clothes then ripping scabs off then bleeding, weeping and screaming for weeks or months so get the vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR046152:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Scab, Skin irritation, Skin weeping
Clinical narrative: Shots hurt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Shots hurt). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that he or she had shingles and deep bone pain for 2 months that was very worst. The reporter told to the patient to receive the vaccine and patient stated that the vaccine hurts. The reporter stated that there was no pain anywhere amount to the pain, blistering, scabs sticking to clothes then ripping scabs off then bleeding, weeping and screaming for weeks or months so get the vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR046152:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Acne, Condition aggravated, Erythema, Eye pain, Eye swelling
Clinical narrative: Still has nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain, whiteheads (white head above eyebrow), eye swelling, skin red, eye pain, forehead headache and nerve pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: Still has nerve pain). The outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.   It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that painful, fast, lasting.  The reporter further stated that day 1 small white head above eyebrow and day 2 eye swollen shut and reddish skin and day 3 pain-eye, forehead and connected nerves. The doctor called as soon as possible saved his/her sight but still nerve pain many years later and also got shingles shots but concerned they were never tested on those who already had shingles.  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Neuralgia
Clinical narrative: Still has nerve pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain, whiteheads (white head above eyebrow), eye swelling, skin red, eye pain, forehead headache and nerve pain.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: Still has nerve pain). The outcome of the nerve pain was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.   It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that painful, fast, lasting.  The reporter further stated that day 1 small white head above eyebrow and day 2 eye swollen shut and reddish skin and day 3 pain-eye, forehead and connected nerves. The doctor called as soon as possible saved his/her sight but still nerve pain many years later and also got shingles shots but concerned they were never tested on those who already had shingles.  The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Milder case of shingles; It was still uncomfortable; This non-serious 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 (Verbatim: Milder case of shingles) and discomfort (Verbatim: It was still uncomfortable). The outcome of the shingles and discomfort were not recovered/not resolved.   It was unknown if the reporter considered the shingles and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the shingles and discomfort to be related to Shingles vaccine.   Additional Information: GSK receipt date: 15-MAR-2023 The case  was received from the patient via interactive digital media. The patient had the vaccine and 3 days later came down with a much milder case of shingles. The patient stated that it was still uncomfortable. The follow-up could not be possible as no contact details were available.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of shingrix; This non-serious case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received two doses in 2021).   On 10-MAR-2023, the patient received the 3rd dose of Shingrix (left arm). On 10-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: received a 3rd dose of shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date:14-MAR-2023 The case was reported by the patient. The patient received another dose of Shingrix after receiving two doses of Shingrix because his doctor recommended it. The patient was unable to give lot number/expiration date of the Shingrix he received. The reporter consented to follow up. The reporter received another dose of Shingrix after receiving two doses of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Jul2022, not received another dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 1st July 2022, batch number:X239D, expiry date:7th August 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose in Jul2022, not received another dose). 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 Information: GSK Receipt Date: 15-MAR-2023 The reporter reported that Twinrix series for patient who missed 2nd dose and had returned for 3rd dose of Twinrix.  The patient had not received another dose of Twinrix at time of call.  The exact date of vaccine was unknown at time of call. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Age: 19.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Engerix-B 1ml given to a 19-year-old; Engerix-B 1ml given to a 19-year-old; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 19-year-old patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B 1 ml. On an unknown date, an unknown time after receiving Engerix B, the patient experienced inappropriate age at vaccine administration (Verbatim: Engerix-B 1ml given to a 19-year-old) and overdose (Verbatim: Engerix-B 1ml given to a 19-year-old). The outcome of the inappropriate age at vaccine administration and overdose were unknown.   Additional Information: GSK Receipt Date:15-MAR-2023  The pharmacist called to report the administration of Engerix-B (1ml dose) to a 19 year-old patient.  The reporter asked if there was information about how to proceed with the such patient.  The reporter did not provide patient identifiers nor information about the Engerix-B dose administered (lot number/expiry date/date of administration). The follow-up could not be possible as no contact details were available. The patient received Engerix-B above than the recommended age limit, which led to inappropriate age at vaccine administration. The patient received Engerix-B more than the recommended dose which led to overdose.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Decreased appetite, Dizziness, Faeces soft
Clinical narrative: Fever; Chills; Nausea; Vomiting; Iitching all over body; Soft stool, not liquid; Weakness; Tired; Light headedness; Loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tooth abscess (about a month and was taking Amoxicillin 3 times per day), post-traumatic stress disorder, benign prostatic hypertrophy, eosinophilic esophagitis and hypertension. Concomitant products included amoxicillin.   On 13-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 14-MAR-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), pruritus (Verbatim: Iitching all over body) and soft stools (Verbatim: Soft stool, not liquid). In MAR-2023, the patient experienced weakness (Verbatim: Weakness), tiredness (Verbatim: Tired), light headedness (Verbatim: Light headedness) and appetite lost (Verbatim: Loss of appetite). The outcome of the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting and pruritus were recovered/resolved and the outcome of the soft stools was unknown.   The reporter considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.     The company considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.   Additional Information: GSK receipt date:15-MAR-2023,16-MAR-2023 The patient reported that hours later having shingrix vaccine, he experienced weakness and being tired, light headedness, and loss of appetite. The next day he experienced fever, chills, nausea/vomiting, itching all over body and states his stool was soft but not liquid.  He said that he was taking shingrix vaccine has he was getting ready to take anothermedication Dupixent. He spoke to nurse because he had been ill the last couple of days with possible side effect. The nurse was very professional extremely kind, she gave helpful information from a nursing point of view pointing him to product information advising him to contact physician due to the issue.The patient was extremely impressed with her. He got the second round of these Shingrix shots and just because he was taking Dupixent. The reporter did not consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Malaise, Nausea, Pruritus, Pyrexia
Clinical narrative: Fever; Chills; Nausea; Vomiting; Iitching all over body; Soft stool, not liquid; Weakness; Tired; Light headedness; Loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tooth abscess (about a month and was taking Amoxicillin 3 times per day), post-traumatic stress disorder, benign prostatic hypertrophy, eosinophilic esophagitis and hypertension. Concomitant products included amoxicillin.   On 13-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 14-MAR-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), pruritus (Verbatim: Iitching all over body) and soft stools (Verbatim: Soft stool, not liquid). In MAR-2023, the patient experienced weakness (Verbatim: Weakness), tiredness (Verbatim: Tired), light headedness (Verbatim: Light headedness) and appetite lost (Verbatim: Loss of appetite). The outcome of the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting and pruritus were recovered/resolved and the outcome of the soft stools was unknown.   The reporter considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.     The company considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.   Additional Information: GSK receipt date:15-MAR-2023,16-MAR-2023 The patient reported that hours later having shingrix vaccine, he experienced weakness and being tired, light headedness, and loss of appetite. The next day he experienced fever, chills, nausea/vomiting, itching all over body and states his stool was soft but not liquid.  He said that he was taking shingrix vaccine has he was getting ready to take anothermedication Dupixent. He spoke to nurse because he had been ill the last couple of days with possible side effect. The nurse was very professional extremely kind, she gave helpful information from a nursing point of view pointing him to product information advising him to contact physician due to the issue.The patient was extremely impressed with her. He got the second round of these Shingrix shots and just because he was taking Dupixent. The reporter did not consent to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Fever; Chills; Nausea; Vomiting; Iitching all over body; Soft stool, not liquid; Weakness; Tired; Light headedness; Loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of weakness in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included tooth abscess (about a month and was taking Amoxicillin 3 times per day), post-traumatic stress disorder, benign prostatic hypertrophy, eosinophilic esophagitis and hypertension. Concomitant products included amoxicillin.   On 13-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 14-MAR-2023, 1 days after receiving Shingrix, the patient experienced fever (Verbatim: Fever), chills (Verbatim: Chills), nausea (Verbatim: Nausea), vomiting (Verbatim: Vomiting), pruritus (Verbatim: Iitching all over body) and soft stools (Verbatim: Soft stool, not liquid). In MAR-2023, the patient experienced weakness (Verbatim: Weakness), tiredness (Verbatim: Tired), light headedness (Verbatim: Light headedness) and appetite lost (Verbatim: Loss of appetite). The outcome of the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting and pruritus were recovered/resolved and the outcome of the soft stools was unknown.   The reporter considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.     The company considered the weakness, tiredness, light headedness, appetite lost, fever, chills, nausea, vomiting, pruritus and soft stools to be possibly related to Shingrix.   Additional Information: GSK receipt date:15-MAR-2023,16-MAR-2023 The patient reported that hours later having shingrix vaccine, he experienced weakness and being tired, light headedness, and loss of appetite. The next day he experienced fever, chills, nausea/vomiting, itching all over body and states his stool was soft but not liquid.  He said that he was taking shingrix vaccine has he was getting ready to take anothermedication Dupixent. He spoke to nurse because he had been ill the last couple of days with possible side effect. The nurse was very professional extremely kind, she gave helpful information from a nursing point of view pointing him to product information advising him to contact physician due to the issue.The patient was extremely impressed with her. He got the second round of these Shingrix shots and just because he was taking Dupixent. The reporter did not consent to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Bedridden, Chills, Fatigue, Headache, Malaise
Clinical narrative: Headache; Shivering; Fever of 101F; Fatigue; Bedridden; Quite ill; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (injection, left arm). On an unknown date, 1 hr after receiving Shingrix, the patient experienced headache (Verbatim: Headache), shivering (Verbatim: Shivering), fever (Verbatim: Fever of 101F), fatigue (Verbatim: Fatigue), bedridden (Verbatim: Bedridden) and unwell (Verbatim: Quite ill). The outcome of the headache, shivering, fever, fatigue, bedridden and unwell were recovered/resolved.   It was unknown if the reporter considered the headache, shivering, fever, fatigue, bedridden and unwell to be related to Shingrix.     It was unknown if the company considered the headache, shivering, fever, fatigue, bedridden and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date:15-MAR-2023  The patient self-reported this case. The reporter reported that within 1 to 6 hours (probably closer to 5 to 6 hours) after receiving his dose of Shingrix, he experienced headache, shivering, a fever, and fatigue that left him bed ridden and quite ill for 2 and half days. The reporter had not spoken with his doctor about his adverse reactions but would at his appointment later that month.  The reporter consented to follow up with health care professional.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache; Shivering; Fever of 101F; Fatigue; Bedridden; Quite ill; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In NOV-2022, the patient received the 1st dose of Shingrix (injection, left arm). On an unknown date, 1 hr after receiving Shingrix, the patient experienced headache (Verbatim: Headache), shivering (Verbatim: Shivering), fever (Verbatim: Fever of 101F), fatigue (Verbatim: Fatigue), bedridden (Verbatim: Bedridden) and unwell (Verbatim: Quite ill). The outcome of the headache, shivering, fever, fatigue, bedridden and unwell were recovered/resolved.   It was unknown if the reporter considered the headache, shivering, fever, fatigue, bedridden and unwell to be related to Shingrix.     It was unknown if the company considered the headache, shivering, fever, fatigue, bedridden and unwell to be related to Shingrix.   Additional Information: GSK Receipt Date:15-MAR-2023  The patient self-reported this case. The reporter reported that within 1 to 6 hours (probably closer to 5 to 6 hours) after receiving his dose of Shingrix, he experienced headache, shivering, a fever, and fatigue that left him bed ridden and quite ill for 2 and half days. The reporter had not spoken with his doctor about his adverse reactions but would at his appointment later that month.  The reporter consented to follow up with health care professional.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Terrible Itching at injection site; redness at injection site/ recurrence with more severe redness at the injection site; sore arm at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 91-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-MAR-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown arm). On 11-MAR-2023, less than a day after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site/ recurrence with more severe redness at the injection site) and injection site pain (Verbatim: sore arm at injection site). On 14-MAR-2023, the patient experienced injection site itching (Verbatim: Terrible Itching at injection site). On 13-MAR-2023, the outcome of the injection site pain was recovered/resolved (duration 2 days). The outcome of the injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain and injection site itching to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain and injection site itching to be related to Shingrix.   Additional Information: GSK Receipt date: 15-MAR-2023 She experienced redness and a sore arm at the injection site beginning the day after receiving her vaccine. These symptoms resolved after a day or two, but beginning on March 14, 2023, she noticed a recurrence with more severe redness at the injection site and terrible itching. The patient was asking how long to expect these effects to last and if they are something she should be concerned about. The reporter was offered medical disclaimer, referred to HCP, spoke per package insert and content. The reported consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Medication error, Wrong technique in product usage process
Clinical narrative: Needle attached to PFS, stored until next day; The needle was attached to a prefilled syringe stored until the next day; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong technique in product usage process in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced wrong technique in product usage process (Verbatim: Needle attached to PFS, stored until next day) and circumstance or information capable of leading to medication error (Verbatim: The needle was attached to a prefilled syringe stored until the next day). The outcome of the wrong technique in product usage process and circumstance or information capable of leading to medication error 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 Information: GSK Receipt date: 15-MAR-2023 The reporter was the nurse. The reporter reported that a needle was attached to a prefilled syringe around 3:00 pm, after receiving the recommendations to the disease control on this matter, nurse stated that such vaccine was going to be stored until the next morning.  The reporter did not consent to follow-up. The needle was attached to a prefilled syringe stored until the next day which led to wrong technique in product usage process and Circumstance or information capable of leading to medication error.
Sex: U
Vaccine: HEP, MENB
Symptoms: Product storage error
Clinical narrative: May have received vaccines possibly compromised; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   On an unknown date, the patients received Bexsero and Engerix B. On an unknown date, an unknown time after receiving Bexsero and Engerix B, the patients experienced incorrect storage of drug (Verbatim: May have received vaccines possibly compromised). 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 Information: GSK receipt date: 16-Mar-2023 A clinic manager reported that data logger for the fridge was not recording temperature from 14th December 2022 to 20th February 2023.  A total of 165 patients (including vaccines from other manufacturer) might had received vaccines that might had been compromised. The reporter stated that could be a possible adverse event but yet to determined. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patients might received Engerix-B and Bexsero vaccines after temperature excursion, which led to incorrect storage of drug.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Have not yet received 2nd dose; This non-serious case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first Shingrix vaccine about 3 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Have not yet received 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 16-Mar-2023 Lot number was unavailable. The health care professional was not provided. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.