chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Chills; extremely tired; This non-serious 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 03-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced chills (Verbatim: Chills) and tiredness (Verbatim: extremely tired).  The outcome of the chills and tiredness were not reported.   It was unknown if the reporter considered the chills and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the chills and tiredness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingrix a day before reporting and had chills and was extremely tired so slept great that day. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Erythema, Pruritus
Clinical narrative: Itching; Chills on and off; Red spot was size of saucer; This non-serious 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, an unknown time after receiving Shingles vaccine, the patient experienced chills (Verbatim: Chills on and off), localized erythema (Verbatim: Red spot was size of saucer) and pruritus (Verbatim: Itching).  The outcome of the chills was recovered/resolved (duration 2 days) and the outcome of the localized erythema was recovered/resolved (duration 2 weeks) and the outcome of the pruritus was not reported.   It was unknown if the reporter considered the chills, localized erythema and pruritus to be related to Shingles vaccine.     It was unknown if the company considered the chills, localized erythema and pruritus to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the first shot and had chills off and on for two days. The red spot was the size of a saucer and stayed there for way over two week, also had inching. The reporter was not sure if he/she would get second shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: didn't get the 2nd; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (1st shot received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: didn't get the 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 03-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the first shot of shingles vaccine but did not get the second. Additional Supportive Information:Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Severe pain/arm horribly sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Severe pain/arm horribly sore).  The outcome of the pain in arm was recovered/resolved (duration 3 weeks).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The reporter asked if everyone experienced severe pain after the first vaccination.  The patient's arm  was horribly sore for over 3 weeks.  The reporter was dreading the second  vaccine dose. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: 2nd shot put me down; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced unwell (Verbatim: 2nd shot put me down).  The outcome of the unwell was recovered/resolved (duration 72 hrs).   It was unknown if the reporter considered the unwell to be related to Shingles vaccine.     It was unknown if the company considered the unwell to be related to Shingles vaccine.   Additional Information: GSK receipt date: 04-MAR-2023 This case was reported by a patient via interactive digital media. The reporter reported that the second shot put him/her down for 72 hours, but it was not worse than actual shingles. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: felt like I was hit by a train; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (years ago from reporting extremely painful).   On 03-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: felt like I was hit by a train).  The outcome of the feeling abnormal was not reported.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023 This case was reported by the patient via interactive digital media. The patient was not getting the second shot and reported that he/she would take chances with shingles. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: low grade chills; This non-serious 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.   The patient's past medical history included shingles and pain. Previously administered products included Shingles vaccine with an associated reaction of no adverse event (1st dose received on an unknown date).   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 (Verbatim: low grade chills).  The outcome of the chills was not reported.   It was unknown if the reporter considered the chills to be related to Shingles vaccine.     It was unknown if the company considered the chills to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 05-MAR-2023. This case was reported by a patient via interactive digital media. The patient stated that first Shingles shot did not bother him/her at all.  The second shot gave some low-grade chills the next day.  The patient take that any day over the pain suffered through with shingles for a month. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lip dry, Pain, Peripheral swelling
Clinical narrative: Headaches; Pain; Swelling arm; Lips dry; This non-serious case was reported by a other health professional via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 10-MAR-2023, the patient received Shingles vaccine. On 10-MAR-2023, less than a day after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headaches), pain (Verbatim: Pain), swelling arm (Verbatim: Swelling arm) and lip dry (Verbatim: Lips dry). The outcome of the headache, pain, swelling arm and lip dry were not recovered/not resolved.   It was unknown if the reporter considered the headache, pain, swelling arm and lip dry to be related to Shingles vaccine.     It was unknown if the company considered the headache, pain, swelling arm and lip dry to be related to Shingles vaccine.   Additional Information: GSK receipt date: 14-Mar-2023 The heath care professional reported that the patient (reporter's mother) got the vaccine 4 day ago and since day one still had headaches, pain, swelling in the arm and lips dry. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 in arm (Verbatim: arm was sore). The outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm 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 stated that the vaccine was not as bad as everyone said it was, by far his or her arm was sore for a few days. Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: fever; chills; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (nearly 50 years ago) and pain (for more than 6 weeks). Previously administered products included cal lotion (cal lotion).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: fever) and chills (Verbatim: chills). The outcome of the fever and chills were not reported.   It was unknown if the reporter considered the fever and chills to be related to Shingles vaccine.     It was unknown if the company considered the fever and chills to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-Mar-2023 This case was reported by a patient via interactive digital media. The patient had shingles when he or she was in college nearly 50 years ago. It was horrible and the only treatment was cal lotion. when the shingles vaccine was introduced, he or she was in and even with the chills and fever that he or she got after the second shot, it was nothing like the pain he or she experienced for more than 6 weeks. The patient advised that if anyone do not want shingles, they should get the vaccine if they could. Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles 2 weeks later; 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 (Shingrix) for prophylaxis.   Previously administered products included Covid 19 vaccine (fully vaccinated and booster), Influenza vaccine (annually), pneumonia vaccine and polio vaccine (as a child).   On an unknown date, the patient received Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: shingles 2 weeks later). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-Mar-2023 This case was reported by a patient via  interactive digital media. The patient was a firm believer in vaccines. The patient was fully vaccinated and boosted against Covid. He or she took the flu vaccine annually. The patient had the pneumonia vaccine and a multitude of vaccines and polio vaccines as a child. He or she recently had the Shingrix vaccine and ended up breaking out with the shingles 2 weeks later.  Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Skin discomfort, Skin reaction
Clinical narrative: Reaction on abdomen and back; Discomforting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of skin reaction 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 skin reaction (Verbatim: Reaction on abdomen and back) and discomfort (Verbatim: Discomforting). The outcome of the skin reaction and discomfort were recovered/resolved.   It was unknown if the reporter considered the skin reaction and discomfort to be related to Shingles vaccine.     It was unknown if the company considered the skin reaction and discomfort to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he/she received Shingles vaccine and experienced reaction on his/her abdomen side and part of his/her back although it was very discomforting and he/she was coped with it. The patient stated that it was gone in about two weeks. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: It hurts so bad; 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 the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: It hurts so bad). 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 patient stated that the second shingle shit was a high volume shit. It hurt so bad. But it was worth it because shingles looked much worse.  Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: That sucker hurt for a few days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received Shingles vaccine. In MAR-2023, less than a week after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: That sucker hurt for a few days). In MAR-2023, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-Mar-2023 This case was reported by a patient via interactive digital media. The patient got the shot last week.  He or she suggested to make sure to get the shot in the arm someone would not sleep on.  He or she stated that sucker hurt for a few days but was well worth it. Follow-up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Hypoaesthesia, Pain, Pruritus
Clinical narrative: have it on my leg; Extreme pain; itching; numbness; burning cannot stand for anything to touch my leg; 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 the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: have it on my leg), pain (Verbatim: Extreme pain), pruritus (Verbatim: itching), numbness (Verbatim: numbness) and burning leg (Verbatim: burning cannot stand for anything to touch my leg). The outcome of the shingles, pain, pruritus, numbness and burning leg were not reported.   It was unknown if the reporter considered the shingles, pain, pruritus, numbness and burning leg to be related to Shingles vaccine.   It was unknown if the company considered the shingles, pain, pruritus, numbness and burning leg 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 had one shingles shot. The patient had shingles on his/her leg.  The patient experienced extreme pain, itching, numbness, burning could not stand for anything to touch his/her leg. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccine breakthrough infection
Clinical narrative: third time was after the first Shingrix shot; barely hurt at all; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles three times), blister (second time he//she only had a couple of blisters) and pain (the pain was even worse than the first time).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: third time was after the first Shingrix shot) and pain (Verbatim: barely hurt at all). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingrix.  It was unknown if the company considered the shingles and pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient had shingles third time was after the first Shingrix shot, a breakthrough case.  The reporter stated that one barely hurt at all.  The first dose of the Shingrix shot must had helped.  The patient got the second dose of Shingrix and had not had shingles since (knock wood). The follow up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Made her ill; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of illness in a female 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, an unknown time after receiving Shingles vaccine, the patient experienced illness (Verbatim: Made her ill). The outcome of the illness was not reported.   It was unknown if the reporter considered the illness to be related to Shingles vaccine.   It was unknown if the company considered the illness to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient's husband via interactive digital media. The patient just got the shingles shot and made her ill but the reporter told her still better than having the shingles like he/she did. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergic reaction 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 allergic reaction (Verbatim: Allergic reaction). The outcome of the allergic reaction was not reported.   It was unknown if the reporter considered the allergic reaction to be related to Shingles vaccine.   It was unknown if the company considered the allergic reaction 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 experienced allergic reaction. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Anxiety, Bedridden, Pyrexia
Clinical narrative: I thought I was going to die; high fever; couldn't get out of bed for 3 days; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of anxiety in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Covid-19 vaccine with an associated reaction of no adverse event (got covid-19 shots plus two boosters) and Shingles vaccine with an associated reaction of no adverse event (never had a reaction to 1st shingles shot). Concurrent medical conditions included diabetes.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced anxiety (Verbatim: I thought I was going to die), fever (Verbatim: high fever) and bedridden (Verbatim: couldn't get out of bed for 3 days). The outcome of the anxiety was not reported and the outcome of the fever and bedridden were recovered/resolved (duration 3 days).   It was unknown if the reporter considered the anxiety, fever and bedridden to be related to Shingles vaccine.   It was unknown if the company considered the anxiety, fever and bedridden 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 got both shingle shots.  The reporter stated that never had a reaction to any shot he/she had ever gotten a couple of. The reporter stated that the second shingle shot and he/she thought he/she was going to die man.  The reporter further stated that a high fever and he/she could not even get out of bed last year for 3 days. The reporter further stated that his/her guessed was better than having shingles.  Then he/she went to the internet and that tried to find out why and any internet he/she said most people had bad reaction to the second shingles shot and he/she was going to tell you what he/she did not want shingles but it was the worst 3 days of his/her life. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Sore on left side; Itching; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In MAR-2023, the patient received the 1st dose of Shingles vaccine (left arm). In MAR-2023, less than 2 weeks after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore on left side) and pruritus (Verbatim: Itching). The outcome of the pain in arm and pruritus were not reported.   The reporter considered the pain in arm to be possibly related to Shingles vaccine. It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     The company considered the pain in arm to be possibly related to Shingles vaccine. It was unknown if the company considered the pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 13-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she received Shingles vaccine in last week in his or her left arm. The patient stated that when he or she sleep on his or her left side or he/she did then it was sore from the shot. The patient stated that this week he/she noticed some itching but still can not sleep on his/her left side maybe in another week. The patient reported that something to think about when you get your first shot. The patient stated that the he/she receive second dose is in six months and going to receive vaccine in the right arm next time. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had Shingrix in 2021, still need to get 2nd dose; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a 68-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (had a 1st shingles shot in 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Had Shingrix in 2021, still need to get 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 This case was reported by a patient via interactive digital media. The patient had a shingles shot in 2021 and still need to get the 2nd one shingle shot.  The reporter stated that at this age, we could not get a live virus.  The reporter further stated that please let people knew this or, at least people liked him/her with autoimmune diseases. Till the time of reporting , the patient did not receive the 2nd dose of shingles vaccine, which led to incomplete course of vaccination. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; pain; 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: Shingles) and pain (Verbatim: pain). The outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the shingles and pain to be related to Shingles vaccine.   It was unknown if the company considered the 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 stated that pain, got the shingles shot and third day afterwards he/she had shingles. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick for 24h; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Sick for 24h). The outcome of the sickness was recovered/resolved (duration 24 hrs).   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.   It was unknown if the company considered the sickness 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 had his/her first shingles shot, next month he/she would get his/her next one, was paying for it.  The reporter stated that it did make him/her sick for 24 hours. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Asthenia, Headache
Clinical narrative: Headache; Lack of energy; This non-serious case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In FEB-2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headache) and loss of energy (Verbatim: Lack of energy). The outcome of the headache and loss of energy were not recovered/not resolved.   It was unknown if the reporter considered the headache and loss of energy to be related to Shingles vaccine.     It was unknown if the company considered the headache and loss of energy to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 3-Mar-2023 The patient received second shingles vaccine one week ago and was continuing to have headache and lack of energy. He or she asked if it was normal. Follow-up was not possible, as no contact details were available.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Twinrix expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 42-year-old female patient who received HAB (Twinrix) (batch number P9LT9, expiry date 01-JAN-2023) for prophylaxis.   On 06-MAR-2023, the patient received the 1st dose of Twinrix. On 06-MAR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Twinrix expired dose administered). The outcome of the expired vaccine used 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: 08-Mar-2023 On 8th March 2023, a pharmacist called to inform that a patient was administered a dose of Twinrix on 6th March 2023, but such dose had already expired on 1st January 2023. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received vaccine, which was already expired on 1st January 2023, which led to expired dose administered.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose after 6 months of 1st; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a adult male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (on an unknown date 6 month ago the patient received 1st dose).   On 14-MAR-2023, the patient received the 2nd dose of Engerix B. On 14-MAR-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: 2nd dose after 6 months of 1st). 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 Information: GSK Receipt Date: 14-MAR-2023 Pharmacist reported that patient over 50 years of age (no exact date of birth) received the first dose of Engerix B in an unknown facility 6 month ago and today (on the day of reporting) received the 2nd dose. The reporter wanted to know should restart the series. How long to wait for 3rd dose. The Vaccine Administration Facility is the same as Primary Reporter. HCP did not want to provide identifiers, lot number or expiry date.  No option to as for possible follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo without proper reconstitution; Menveo without proper reconstitution; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA902A, expiry date 31-JAN-2024) for prophylaxis.   On 13-MAR-2023, the patient received Menveo. On 13-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo without proper reconstitution) and inappropriate dose of vaccine administered (Verbatim: Menveo without proper reconstitution). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The nurse enquired that one day before reporting, a patient received the liquid portion only of Menveo without proper reconstitution and asked how to proceed. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow up.
Age: 12.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-year-old male patient who received Men B NVS (Bexsero) (batch number A2x3y, expiry date 28-FEB-2023) for prophylaxis.   On 07-MAR-2023, the patient received Bexsero. On 07-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used 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: 14-MAR-2023 The reporter was health care professional (HCP).   The HCP reported that a patient received an expired dose of Bexsero.   Adverse event (AE) filed. The reporter consented to follow up.
Age: 24.0
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: accidentally gave Pediatric/Adolescent Havrix; 24 yo patient got pediatric havrix; This non-serious case was reported by a nurse via sales rep and described the occurrence of underdose in a 24-year-old patient who received HAV (Havrix) for prophylaxis.   On an unknown date, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced underdose (Verbatim: accidentally gave Pediatric/Adolescent Havrix) and adult use of a child product (Verbatim: 24 yo patient got pediatric havrix). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The Sales representative reported via on behalf of a nurse whom accidentally gave Pediatric/Adolescent Havrix to a 24 year old adult on an unknown date, which led to underdose and adult use of a child product. No additional adverse event (AE) information available at this time.
Age: 71.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired Twinrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 71-year-old male patient who received HAB (Twinrix) (batch number 4F3YY, expiry date 01-JAN-2023) for prophylaxis.   On 14-MAR-2023, the patient received Twinrix. On 14-MAR-2023, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired Twinrix administered). The outcome of the expired vaccine used 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: 14-MAR-2023 No reaction was reported. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up via email. The patient received a Twinrix vaccine which was already expired, which led to expired vaccine used.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Third dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number XY22F, expiry date 27-MAY-2024) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 10th July 2019) and Shingrix (received 2nd dose on 9th September 2019).   On 13-MAR-2023, the patient received the 3rd dose of Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Third dose administered). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 14-MAR-2023 The reporter reported that the patient was inadvertently administered a third dose of Shingrix. The reporter consented to follow up. The patient was inadvertently administered a third dose of Shingrix, which led to extra dose administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: Expired Kinrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 03-MAR-2023) for prophylaxis.   On 14-MAR-2023, the patient received Kinrix. On 14-MAR-2023, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Expired Kinrix administered). The outcome of the expired vaccine used 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: 14-MAR-2023 A nurse informed that earlier that day, a dose of Kinrix that had expired and was administered to a patient, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2.5 years ago, 2nd not received; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received around 2.5 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: 1st dose 2.5 years ago, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 13-MAR-2023 The reporter stated that patient was told it was only 1 vaccine she needed. The reporter called the pharmacy to verify, and it was only one dose of Shingrix she received.  She did not remember the date or site of injection.   Phone number provided.  The patient was referred to health care professional (HCP).  Medical disclaimer and survey offered. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Rotarix-reconstituted formulation was administered to a 4 month old via IM instead of oral; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 2339G, expiry date 01-FEB-2024) for prophylaxis.   On 13-MAR-2023, the patient received Rotarix lyophilized formulation (intramuscular). On 13-MAR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Rotarix-reconstituted formulation was administered to a 4 month old via IM instead of oral). The outcome of the inappropriate route 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: 14-MAR-2023 Nurse reported that Rotarix-reconstituted formulation was administered to a 4 month old via intramuscular instead of oral. MA(medical assistant) took a syringe from the office and drew the Rotarix out if the vial and administered intramuscularly.  RN called medical information for guidance and patient was due to come back in for follow up on 18-MAR-2023. The reporter consented to follow up. Rotarix-reconstituted formulation was administered to a 4 month old via intramuscular instead of oral which led to inappropriate route of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose Oct2021, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2021).   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: 1st dose Oct2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 14-Mar-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 15.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero Administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 15-year-old female patient who received Men B NVS (Bexsero) (expiry date 28-FEB-2023) for prophylaxis.   On 14-MAR-2023, the patient received Bexsero. On 14-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero Administered). The outcome of the expired vaccine used 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: 14-Mar-2023 No further details such as lot number of the vaccine or patient´s details were available at the moment of the call. The reporter consented to follow-up by email. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Injected limb mobility decreased, Injection site pain, Injection site warmth
Clinical narrative: 1st dose 13Sep2022, 2nd 09Mar2023; Can't lift arm; Injection site tenderness; Warm to touch; This non-serious case was reported by a nurse via call center representative and described the occurrence of injected limb mobility decreased in a 18-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   Previously administered products included Menveo (received one dose of Menveo on 13th September 2022 at an out state pharmacy).   On 09-MAR-2023, the patient received the 2nd dose of Menveo (left deltoid). On 09-MAR-2023, an unknown time after receiving Menveo, the patient experienced extra dose administered (Verbatim: 1st dose 13Sep2022, 2nd 09Mar2023). In MAR-2023, the patient experienced injected limb mobility decreased (Verbatim: Can't lift arm), injection site tenderness (Verbatim: Injection site tenderness) and injection site warmth (Verbatim: Warm to touch). The outcome of the injected limb mobility decreased, injection site tenderness and injection site warmth were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the injected limb mobility decreased, injection site tenderness and injection site warmth to be related to Menveo.     It was unknown if the company considered the injected limb mobility decreased, injection site tenderness and injection site warmth to be related to Menveo.   Additional Information: GSK receipt date: 14-Mar-2023 The registered nurse had a patient complaining of injection site tenderness, warm to touch, could lift arm.  The patient was not aware at the time of injection that patient also received dose in September 2022. No records in electronic medical record or with state immune registry.   The patient received vaccine out of state at a pharmacy.  The patient asked that how long should a patient be experiencing any potential injection site reactions from Menveo. The reporter showed a documented dose of 27th July 2016 and 9th September 2023.   After vaccine was given, patient family called back to the office stating same vaccine was given 13th September 2022 at an out of state pharmacy. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via email. The patient received 2nd dose of Menveo, which led to extra dose administered.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Received 3rd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number XG7RF) for prophylaxis.   On 14-MAR-2023, the patient received the 3rd dose of Shingrix. On 14-MAR-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Received 3rd dose). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 14-Mar-2023 The reporter consented to follow-up. The patient received a third dose of Shingrix, which led to extra dose administered.