chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Pruritus, Vaccination failure
Clinical narrative: Horrible pain; Itching; Patient had 2 shingrix vaccines and contracted shingles a month ago tomorrow/ Suspected vaccination failure; Shingles on scalp and left side ear; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In JUN-2023, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Patient had 2 shingrix vaccines and contracted shingles a month ago tomorrow/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles on scalp and left side ear). On an unknown date, the patient experienced pain (Verbatim: Horrible pain) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles, pain and pruritus to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 25-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received two doses of Shingrix vaccine 2.5 years ago and he or she contracted shingles a month ago tomorrow. The patient stated that he or she had shingles on his or her scalp and left side behind the ear. The patient had horrible pain and itching. The patient stated that hope the vaccine would protect him or her. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Death
Clinical narrative: shingles booster second shot killed my wife; This serious case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female 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 unknown cause of death (Verbatim: shingles booster second shot killed my wife) (serious criteria death and GSK medically significant). The reported cause of death was unknown.   The reporter considered the unknown cause of death to be related to Shingles vaccine.     The company considered the unknown cause of death to be related to Shingles vaccine.   Additional Information: GSK receipt date: 27-JUL-2023 This case was reported by a patient via interactive digital media. The case was reported by patient's husband. The reporter stated that shingles booster second shot killed his wife and stated that everybody should be aware and be forewarned about it. The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Unknown cause of death
Sex: U
Vaccine: VARZOS
Symptoms: Cough, Malaise, Pyrexia
Clinical narrative: Cough; Fever; Got Sick; 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 03-JUL-2023, the patient received Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Got Sick), cough (Verbatim: Cough) and fever (Verbatim: Fever). In JUL-2023, the outcome of the sickness was resolved (duration 12 days). The outcome of the cough and fever were not reported.   It was unknown if the reporter considered the sickness, cough and fever to be related to Shingles vaccine.     It was unknown if the company considered the sickness, cough and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 24-JUL-2023 This case was reported by consumer via interactive digital media. The reporter was a patient. The reporter reported that he or she got the vaccine and got sick for 12 days and also had cough and fever.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feeling Sick; 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: feeling Sick). The outcome of the sickness was not reported.   The reporter considered the sickness to be related to Shingles vaccine.     The company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK receipt date: 21-JUL-2023 This case was reported by a consumer via interactive digital media. The patient also got very sick, those crap vaccines affected him/her greatly.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, MMR
Symptoms: Injection site reaction, Skin discolouration
Clinical narrative: several patients were left with pencil-lead type tattooing at the vaccine administration site; little gray spot on infants after a vaccination; This non-serious case was reported by a nurse and described the occurrence of injection site reaction in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa (Infanrix) for prophylaxis and MMR (Priorix) for prophylaxis.   On an unknown date, the patient received Pediarix, Infanrix and Priorix. On an unknown date, an unknown time after receiving Pediarix, Infanrix and Priorix, the patient experienced injection site reaction (Verbatim: several patients were left with pencil-lead type tattooing at the vaccine administration site) and skin discoloration (Verbatim: little gray spot on infants after a vaccination). The outcome of the injection site reaction and skin discoloration were not reported.   It was unknown if the reporter considered the injection site reaction and skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Priorix and Priorix Pre-Filled Syringe Device.  It was unknown if the company considered the injection site reaction and skin discoloration to be related to Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix, Infanrix Pre-Filled Syringe Device, Priorix and Priorix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt Date: 06-JUL-2023 The reporter stated that not sure, if you recalled but when they first switched to GlaxoSmithKline vaccines, they observed that several patients were left with pencil-lead type tattooing at the vaccine administration site(s).  They documented these in our records as well as reporting them and filled out forms for each patient who experienced the tattooing. They had a patient who had again ended up with tattooing after subsequent vaccine administrations and was asking what the company had determined regarding this outcome. They were quite upset.  The reporter wanted to know if there was any update information regarding this issue and similar outcomes at other facilities. The aggregate results/investigation outcomes from the company and any information you may have would be helpful. The reporter stated that having an issue with GlaxoSmithKline vaccines leaving a little gray spot on infants after a vaccination.  They had turned in the adverse event forms on the cases that it had happened with. The clinics were looking for answers as to be this a side effect, was this harmful, how did they get rid of the spot etc.  The reporter did have a picture of one of the spots from one of our shots.  It was mostly happening with Pediarix but more recently, it had also happened with other vaccines from the GlaxoSmithKline portfolio.  Most of the information was below but he/she did have additional information as well.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Hurts all the body; not been able to recover my arm hurts; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUN-2023, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced general body pain (Verbatim: Hurts all the body) and pain in arm (Verbatim: not been able to recover my arm hurts). The outcome of the general body pain and pain in arm were not resolved.   It was unknown if the reporter considered the general body pain and pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Jul-2023 This case was reported by the patient via interactive digital media. The patient stated that he/she did not know which was more painful, that or the vaccination, he/she got vaccinated a month ago from reporting and it was horrible. The patient not recovered yet, arm hurts and full body hurts. The patient stated that he/she did not though that he/ she would get the 2nd dose, it was killing him/ her, goodness knew what they were did with the patient and he/she did not know if the person who vaccinated had heavy hand, or they touched the bone. The patient stated that the truth was that the vaccine did not went well, so he/she certainly did not recommend it.
Sex: M
Vaccine: VARZOS
Symptoms: Movement disorder, Swelling
Clinical narrative: Could not move his arm; Swelled up; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of movement disorder in a male 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 movement disorder (Verbatim: Could not move his arm) and swelling (Verbatim: Swelled up). The outcome of the movement disorder and swelling were not reported.   It was unknown if the reporter considered the movement disorder and swelling to be related to Shingles vaccine.     It was unknown if the company considered the movement disorder and swelling to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 23-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that the patient received the Shingles vaccine and he could not move his arm and he swelled up. The reporter reported that it was very ugly. The case had been linked to the case US2023AMR103135 by same reporter for wife.; Sender's Comments:  US-GSK-US2023AMR103135:Original Case : US2023AMR101663/ Husband case
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: I got really sick with that vaccine; 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 Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: I got really sick with that vaccine). The outcome of the sickness was not reported.   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: 22-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that it was business, he or she got really sick with the Shingles vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Impaired work ability, Influenza like illness, Pain, Pyrexia
Clinical narrative: Day 1-2 I felt like I had the flu; 101 fever; Chills; Whole body aches; I tried to work, but gave up and just chilled; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (had moderate 3 episodes with my right arm over the last 7 years.) and itchy rash (had 3 episodes with my right arm over the last 7 years.).   In JUL-2023, the patient received the 1st dose of Shingles vaccine. In JUL-2023, 1 day after receiving Shingles vaccine, the patient experienced influenza (Verbatim: Day 1-2 I felt like I had the flu), fever (Verbatim: 101 fever), chills (Verbatim: Chills), general body pain (Verbatim: Whole body aches) and activities of daily living impaired (Verbatim: I tried to work, but gave up and just chilled). The outcome of the influenza, fever, chills, general body pain and activities of daily living impaired were resolving.   It was unknown if the reporter considered the influenza, fever, chills, general body pain and activities of daily living impaired to be related to Shingles vaccine.     It was unknown if the company considered the influenza, fever, chills, general body pain and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that today was the day 4 after 1st Vaccination shot and finally felt better.  The patient stated that on day 1 to 2 he or she felt like he or she had the flu, 101 fever, chills, whole body aches and frequent bathroom trips. The patient tried to work, but gave up and just chilled.  The patient definitely plan to give himself or herself a few days to recoup with the 2nd dose.  The patient had 3 episodes with his or her right arm over the last 7 years.  The patient had moderate pain for a time followed by a itchy rash. The rash never blisters like he or she have seen online and only last a couple of weeks.  The patient stated that each episode was worse and said it was not Shingles and had not yet found a diagnosis.  The patient stated that well it was happened yet again a month back, so he or she decided to get the vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Day 1-2 I felt like I had the flu; 101 fever; Chills; Whole body aches; I tried to work, but gave up and just chilled; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included pain (had moderate 3 episodes with my right arm over the last 7 years.) and itchy rash (had 3 episodes with my right arm over the last 7 years.).   In JUL-2023, the patient received the 1st dose of Shingles vaccine. In JUL-2023, 1 day after receiving Shingles vaccine, the patient experienced influenza (Verbatim: Day 1-2 I felt like I had the flu), fever (Verbatim: 101 fever), chills (Verbatim: Chills), general body pain (Verbatim: Whole body aches) and activities of daily living impaired (Verbatim: I tried to work, but gave up and just chilled). The outcome of the influenza, fever, chills, general body pain and activities of daily living impaired were resolving.   It was unknown if the reporter considered the influenza, fever, chills, general body pain and activities of daily living impaired to be related to Shingles vaccine.     It was unknown if the company considered the influenza, fever, chills, general body pain and activities of daily living impaired to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that today was the day 4 after 1st Vaccination shot and finally felt better.  The patient stated that on day 1 to 2 he or she felt like he or she had the flu, 101 fever, chills, whole body aches and frequent bathroom trips. The patient tried to work, but gave up and just chilled.  The patient definitely plan to give himself or herself a few days to recoup with the 2nd dose.  The patient had 3 episodes with his or her right arm over the last 7 years.  The patient had moderate pain for a time followed by a itchy rash. The rash never blisters like he or she have seen online and only last a couple of weeks.  The patient stated that each episode was worse and said it was not Shingles and had not yet found a diagnosis.  The patient stated that well it was happened yet again a month back, so he or she decided to get the vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurts like you know what; 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 24-JUL-2023, the patient received the 2nd dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Hurts like you know what). 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: 25-Jul-2023 This case was reported the patient via interactive digital media. The patient got the 2nd shot yesterday (the day before reporting). And patient stated that hurt like you knew that.
Sex: U
Vaccine: VARZOS
Symptoms: Insomnia, Pain
Clinical narrative: lot of pain; couldn't sleep at night; 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: lot of pain) and difficulty sleeping (Verbatim: couldn't sleep at night). The outcome of the pain and difficulty sleeping were not reported.   It was unknown if the reporter considered the pain and difficulty sleeping to be related to Shingles vaccine.   It was unknown if the company considered the pain and difficulty sleeping to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-JUL-2023 This case was reported by a patient via interactive digital media. The second shingles vaccine dose caused him/her a lot of pain, to the extent that he/she could not sleep at night for the pain.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Feeling abnormal, Herpes zoster, Incomplete course of vaccination, Pain
Clinical narrative: had it twice; pain; itching; burning; feeling bad; Patient not received 2nd dose yet; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had it twice), pain (Verbatim: pain), pruritus (Verbatim: itching), burning sensation (Verbatim: burning), feeling bad (Verbatim: feeling bad) and incomplete course of vaccination (Verbatim: Patient not received 2nd dose yet). The outcome of the shingles, pain, pruritus, burning sensation and feeling bad were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles, pain, pruritus, burning sensation and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the shingles, pain, pruritus, burning sensation and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-JUL-2023 This case was reported by patient via interactive digital media The patient stated that he/she had it twice and he/she hope did not get it again.  He/she took the medicine the doctor ordered and it came back. It's terrible, the pain, the burning, the itching and how bad it felt.  The patient had already been vaccinated once and he/she missing the other vaccine and he/she hope they get vaccinated and do not delay in getting it. Till the time of reporting the patient had not received the second dose of Shingles vaccine, which led to incomplete course of vaccination. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus
Clinical narrative: had it twice; pain; itching; burning; feeling bad; Patient not received 2nd dose yet; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles (Verbatim: had it twice), pain (Verbatim: pain), pruritus (Verbatim: itching), burning sensation (Verbatim: burning), feeling bad (Verbatim: feeling bad) and incomplete course of vaccination (Verbatim: Patient not received 2nd dose yet). The outcome of the shingles, pain, pruritus, burning sensation and feeling bad were not reported and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles, pain, pruritus, burning sensation and feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the shingles, pain, pruritus, burning sensation and feeling bad to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 21-JUL-2023 This case was reported by patient via interactive digital media The patient stated that he/she had it twice and he/she hope did not get it again.  He/she took the medicine the doctor ordered and it came back. It's terrible, the pain, the burning, the itching and how bad it felt.  The patient had already been vaccinated once and he/she missing the other vaccine and he/she hope they get vaccinated and do not delay in getting it. Till the time of reporting the patient had not received the second dose of Shingles vaccine, which led to incomplete course of vaccination. Follow up was not possible, as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: whole body ached; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of general body pain 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 general body pain (Verbatim: whole body ached). The outcome of the general body pain was not reported.   It was unknown if the reporter considered the general body pain to be related to Shingles vaccine.     It was unknown if the company considered the general body pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUL-2023 The case was received by the patient via interactive digital media. This case was linked with case US2023AMR101663 same reporter but different patient.; Sender's Comments:  US-GSK-US2023AMR101663:Same reporter but different patient. Wife case
Sex: F
Vaccine: MNQ
Symptoms: Bone pain, Pain
Clinical narrative: body and bone aches; body and bone aches; This non-serious case was reported by a physician via sales rep and described the occurrence of general body pain in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Previously administered products included Covid vaccine with an associated reaction of bone pain (had body and bone aches experienced with the COVID vaccine).   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced general body pain (Verbatim: body and bone aches) and bone pain (Verbatim: body and bone aches). The outcome of the general body pain and bone pain were not reported.   It was unknown if the reporter considered the general body pain and bone pain to be related to Menveo.     It was unknown if the company considered the general body pain and bone pain to be related to Menveo.   Additional Information: GSK receipt date: 27-JUL-2023 Reporter was the patient. She received Menveo 5-year booster due to research in the Congo in August. She shared that she had body and bone aches that worse than what she experienced with the COVID vaccine. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: patient took first shot of Shingrix and was fatigued to the point of returning to bed.; This non-serious case was reported by a physician via sales rep and described the occurrence of fatigue in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   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 fatigue (Verbatim: patient took first shot of Shingrix and was fatigued to the point of returning to bed.). The outcome of the fatigue was not reported.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 25-JUL-2023 The patient (physician) self-reported this case. The patient took first shot of Shingrix and was fatigued to the point of returning to bed.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pruritus
Clinical narrative: Itching; I got very intense burning pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus 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 pruritus (Verbatim: Itching) and pain burning (Verbatim: I got very intense burning pain). The outcome of the pruritus and pain burning were not reported.   It was unknown if the reporter considered the pruritus and pain burning to be related to Shingles vaccine.     It was unknown if the company considered the pruritus and pain burning to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and 3 days later experienced very intense burning pain and itching. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never followed up with the second injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date 4 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: never followed up with the second injection). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-JUL-2023 The reporter stated that if a patient never followed up with the second injection, were they required to repeat the initial injection? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a 90-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In JUL-2023, the patient received the 1st dose of Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm a little sore). The outcome of the pain in arm was not reported.   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: 26-JUL-2023 This case was reported by a patient via interactive digital media. The patient received 1st dose of Shingles 2 days ago from reporting and had arm a little sore. The patient would receive 2nd dose in 2 months.
Age: 65.0
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years); pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years); This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 65-year-old patient who received HBV (Engerix B 10 mcg) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 20-JUL-2023, the patient received the 3rd dose of Engerix B 10 mcg. On 20-JUL-2023, an unknown time after receiving Engerix B 10 mcg, the patient experienced underdose (Verbatim: pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years)) and adult use of a child product (Verbatim: pediatric dose of Enegrix-B (10 mcg) was administered to an adult (65 years)). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 24-Jul-2023 The reporter consented to follow-up. An adult patient received a pediatric dose of Engerix-B (10 mcg), which led to underdose and adult use of a child product.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Hadn't received the 2nd dose 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 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2018).   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: Hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Product administered at inappropriate site, Sleep disorder
Clinical narrative: Pain/arm was very painful/pain goes all the way down her left arm through her elbow to her hand; Cannot move arm; Uncomfortable to Sleep; lumpy in her arm; Wrong Injection Technique; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain/arm was very painful/pain goes all the way down her left arm through her elbow to her hand), movement disorder (Verbatim: Cannot move arm), sleep disorder (Verbatim: Uncomfortable to Sleep), upper extremity mass (Verbatim: lumpy in her arm) and vaccine administered at inappropriate site (Verbatim: Wrong Injection Technique). The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm, movement disorder, upper extremity mass and vaccine administered at inappropriate site were not resolved and the outcome of the sleep disorder was unknown.   It was unknown if the reporter considered the pain in arm, movement disorder, sleep disorder and upper extremity mass to be related to Shingrix.     It was unknown if the company considered the pain in arm, movement disorder, sleep disorder and upper extremity mass to be related to Shingrix.   Additional Information: GSK receipt date: 24-JUL-2023 The reporter was a patient that reported that she received her 1st dose of Shingrix either 7th May 2023 or 9th MAY 2023 (she could not remember which date specifically), and that when the pharmacist administered the vaccine, it was very high on her arm like up where the socket was and it was very painful when the pharmacist was pushing the syringe into her arm. The patient reported when she got home from receiving the 1st dose of Shingrix, that it felt like there was something lumpy in her arm (specifics were not provided), her arm was very painful, it was uncomfortable to sleep, but she did not think she had a fever; however, she took Tylenol (specifics about product unknown) that evening.  The patient reported that she had to keep rubbing her arm for the pain, cannot move her left arm freely, this pain went all the way down her left arm through her elbow to her hand, and she was still having all of this till on the day of reporting. The reporter did not consent to follow-up.  The patient received Shingrix vaccine very high on her arm like up where the socket was, which led to vaccine administered at inappropriate site.
Sex: F
Vaccine: VARZOS
Symptoms: Wrong technique in product usage process
Clinical narrative: Pain/arm was very painful/pain goes all the way down her left arm through her elbow to her hand; Cannot move arm; Uncomfortable to Sleep; lumpy in her arm; Wrong Injection Technique; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In MAY-2023, the patient received the 1st dose of Shingrix (left arm). In MAY-2023, immediately after receiving Shingrix, the patient experienced pain in arm (Verbatim: Pain/arm was very painful/pain goes all the way down her left arm through her elbow to her hand), movement disorder (Verbatim: Cannot move arm), sleep disorder (Verbatim: Uncomfortable to Sleep), upper extremity mass (Verbatim: lumpy in her arm) and vaccine administered at inappropriate site (Verbatim: Wrong Injection Technique). The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm, movement disorder, upper extremity mass and vaccine administered at inappropriate site were not resolved and the outcome of the sleep disorder was unknown.   It was unknown if the reporter considered the pain in arm, movement disorder, sleep disorder and upper extremity mass to be related to Shingrix.     It was unknown if the company considered the pain in arm, movement disorder, sleep disorder and upper extremity mass to be related to Shingrix.   Additional Information: GSK receipt date: 24-JUL-2023 The reporter was a patient that reported that she received her 1st dose of Shingrix either 7th May 2023 or 9th MAY 2023 (she could not remember which date specifically), and that when the pharmacist administered the vaccine, it was very high on her arm like up where the socket was and it was very painful when the pharmacist was pushing the syringe into her arm. The patient reported when she got home from receiving the 1st dose of Shingrix, that it felt like there was something lumpy in her arm (specifics were not provided), her arm was very painful, it was uncomfortable to sleep, but she did not think she had a fever; however, she took Tylenol (specifics about product unknown) that evening.  The patient reported that she had to keep rubbing her arm for the pain, cannot move her left arm freely, this pain went all the way down her left arm through her elbow to her hand, and she was still having all of this till on the day of reporting. The reporter did not consent to follow-up.  The patient received Shingrix vaccine very high on her arm like up where the socket was, which led to vaccine administered at inappropriate site.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Rash papular, Skin warm
Clinical narrative: Red hot burning; skin rash in the middle half right arm; Red hot burning; raised skin rash; This non-serious case was reported by a consumer via call center representative and described the occurrence of burning skin in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17-MAY-2023, the patient received the 1st dose of Shingrix (right arm). In MAY-2023, 4 days after receiving Shingrix, the patient experienced burning skin (Verbatim: Red hot burning), rash (Verbatim: skin rash in the middle half right arm), erythema of extremities (Verbatim: Red hot burning) and swelling arm (Verbatim: raised skin rash). The outcome of the burning skin, rash, erythema of extremities and swelling arm were resolved.   It was unknown if the reporter considered the burning skin, rash, erythema of extremities and swelling arm to be related to Shingrix.   It was unknown if the company considered the burning skin, rash, erythema of extremities and swelling arm to be related to Shingrix.   Additional Information: GSK Receipt Date: 25-JUL-2023 The reporter was the patient who stated that she received Shingrix in her right arm.  4 days later, she developed a red-hot burning and raised skin rash in the middle half right arm.  The symptoms lasted a couple of weeks then went away.  The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo + administration of liquid portion only; Menveo + administration of liquid portion only; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA723Z, expiry date 31-AUG-2023) for prophylaxis.   On 21-JUL-2023, the patient received Menveo. On 21-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Menveo + administration of liquid portion only) and inappropriate dose of vaccine administered (Verbatim: Menveo + administration of liquid portion only). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 25-JUL-2023 The Clinical manager reported that patient received only the liquid portion only of Menveo and asked how to proceed. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received only the liquid portion only of Menveo , which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Accidental overdose, Wrong product administered
Clinical narrative: received 2 doses of Kinrix; patient was supposed to get Kinrix and Proquad; This non-serious case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 4-year-old female patient who received DTPa-IPV (Kinrix) (batch number MZ379, expiry date 25-JAN-2025) for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIO VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On 25-JUL-2023, the patient received Kinrix. On 25-JUL-2023, an unknown time after receiving Kinrix, the patient experienced accidental overdose (Verbatim: received 2 doses of Kinrix) and wrong vaccine administered (Verbatim: patient was supposed to get Kinrix and Proquad). The outcome of the accidental overdose and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 25-JUL-2023 The vaccine administration facility is the same as primary reporter. The reporter consented to follow up via postal. The patient received 2 doses of Kinrix and was supposed to get Kinrix and Proquad, which led to accidental overdose and wrong vaccine administered.
Age: 48.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: expired drug used; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 48-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 25-JUL-2023, the patient received Boostrix. On 25-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: expired drug used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 26-JUL-2023 Nurse reported that a dose of Boostrix was given to a patient, but it was expired, which led to expired vaccine used. The reporter did not consent to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: body aches; feels feverish; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 26-JUL-2023, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: body aches) and fever (Verbatim: feels feverish). The outcome of the general body pain and fever were not resolved.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix.     It was unknown if the company considered the general body pain and fever to be related to Shingrix.   Additional Information: GSK Receipt date: 26-JUL-2023 The reporter reported that a patient received his first Shingrix dose yesterday, 25-JUL-2023. On the day of reporting, he felt feverish and had body aches. The reporter did not consent to follow up.
Sex: U
Vaccine: RV1
Symptoms: Accidental underdose, Vomiting
Clinical narrative: vomited clear stuff; after 1.5hrs vomited clear stuff; This non-serious case was reported by a physician via sales rep and described the occurrence of vomiting in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, 1 hr 30 min after receiving Rotarix lyophilized formulation, the patient experienced vomiting (Verbatim: vomited clear stuff) and accidental underdose (Verbatim: after 1.5hrs vomited clear stuff). The outcome of the vomiting and accidental underdose were unknown.   It was unknown if the reporter considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.     It was unknown if the company considered the vomiting to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   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: 25-JUL-2023 The reporter reported that the Patient went home, took a nap, after 1.5hrs vomited clear stuff. The reporter wanted to know if the patient need another Rotarix dose. The reporter consented to follow up. The patient vomited clear stuff after vaccination which led to accidental underdose.
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient that received the 1st dose of Havrix back in 7/Mar/2023, received the 2nd dose of such vaccine on 7/Jun/2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 19-month-old male patient who received HAV (Havrix) (batch number 2YX23) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE (HAVRIX).   On 07-JUN-2023, the patient received the 2nd dose of Havrix. On 07-JUN-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: patient that received the 1st dose of Havrix back in 7/Mar/2023, received the 2nd dose of such vaccine on 7/Jun/2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 26-JUL-2023 The vaccine administration facility is the same as primary reporter. The reporter consented to follow up.  The patient received 2nd dose of Havrix earlier than recommended interval, which led to shortening of vaccination schedule.
Sex: M
Vaccine: MENB, MENB
Symptoms: Interchange of vaccine products
Clinical narrative: patient received the 1st dose of Bexsero on 26Jun2023 and was given Trumemba; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of interchange of vaccine products in a male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 26-JUN-2023, the patient received the 1st dose of Bexsero. On 26-JUL-2023, the patient received TRUMENBA. On an unknown date, an unknown time after receiving Bexsero, the patient experienced interchange of vaccine products (Verbatim: patient received the 1st dose of Bexsero on 26Jun2023 and was given Trumemba). The outcome of the interchange of vaccine products 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: 27-Jul-2023 The pharmacist did not had patient initials or date of birth at the time of report. The Bexsero was given at a different clinic. The reporter consented to follow-up via email. The patient received 1st dose of Bexsero and then Trumenba, which led to interchange of vaccine products.