chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had them this year / Suspected Vaccination failure; had them this year; pain; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had them this year / Suspected Vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: had them this year) and pain (Verbatim: pain). The patient was treated with triclosan (Vaseline). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2024 This case was reported by the patient via (social media) interactive digital media. The reporter had them (shingles) this year, the patient had the vaccine the shingles were not bad some pain but not much. The reporter read somewhere to put Vaseline on them and cover with band aid. Went away pretty quick. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure, Vomiting
Clinical narrative: still got shingles / Suspected vaccination failure; still got shingles; Horrible pain; to the point of vomiting; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: still got shingles / Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: still got shingles), pain (Verbatim: Horrible pain) and vomiting (Verbatim: to the point of vomiting). The outcome of the vaccination failure was unknown and the outcome of the shingles, pain and vomiting were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, pain and vomiting to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, pain and vomiting to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 03-MAR-2024 This case was reported by the patient via interactive digital media. The reporter had the shots and still got shingles. No rash or blisters. Horrible pain to the point of vomiting. Three trips to the emergency room. Ruled out lots of other things and finally figured it out. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Herpes zoster, Herpes zoster oticus, Ophthalmic herpes zoster, Pain
Clinical narrative: Patient had vaccine still got shingles/Suspected vaccination failure; they were on his left side of his face head ears; in his left eye; Shingles on his left side of his face head ears and in his left eye; Painful; Lost part of the sight in his eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had vaccine still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: they were on his left side of his face head ears) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: in his left eye) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on his left side of his face head ears and in his left eye), pain (Verbatim: Painful) and partial visual loss (Verbatim: Lost part of the sight in his eye). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, ophthalmic herpes zoster, shingles, pain and partial visual loss were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster, shingles, pain and partial visual loss to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster, shingles, pain and partial visual loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2024 This case was reported by patient's wife via  interactive digital media. The reporter stated that husband had the shot and the booster but still got shingles .They were on his left side of his face head ears and in his left eye. They had to go to eye doctor every other day lots of drops, so painful, lost part of the sight in his eye. He was 77. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination failure, Visual impairment
Clinical narrative: Patient had vaccine still got shingles/Suspected vaccination failure; they were on his left side of his face head ears; in his left eye; Shingles on his left side of his face head ears and in his left eye; Painful; Lost part of the sight in his eye; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a 77-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Patient had vaccine still got shingles/Suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster otitis externa (Verbatim: they were on his left side of his face head ears) (serious criteria GSK medically significant), ophthalmic herpes zoster (Verbatim: in his left eye) (serious criteria GSK medically significant), shingles (Verbatim: Shingles on his left side of his face head ears and in his left eye), pain (Verbatim: Painful) and partial visual loss (Verbatim: Lost part of the sight in his eye). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster otitis externa, ophthalmic herpes zoster, shingles, pain and partial visual loss were not reported.   It was unknown if the reporter considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster, shingles, pain and partial visual loss to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, herpes zoster otitis externa, ophthalmic herpes zoster, shingles, pain and partial visual loss to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2024 This case was reported by patient's wife via  interactive digital media. The reporter stated that husband had the shot and the booster but still got shingles .They were on his left side of his face head ears and in his left eye. They had to go to eye doctor every other day lots of drops, so painful, lost part of the sight in his eye. He was 77. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Death, Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This serious case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome 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 guillain barre syndrome (Verbatim: Guillain-Barre syndrome) (serious criteria death and GSK medically significant). The reported cause of death was guillain barre syndrome.   The reporter considered the guillain barre syndrome to be related to Shingles vaccine.     The company considered the guillain barre syndrome to be related to Shingles vaccine.   Additional Information: GSK received date: 06-Mar-2024 This case was reported by a patient's friend via interactive digital media. Reporter stated that, they had a dear friend (patient) die from Guillen-barre syndrome, caused by the shingles vaccine.  The follow-up could not be possible as no contact details were available.; Reported Cause(s) of Death: Guillain-Barre syndrome
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   The reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 29-FEB-2024 This case was reported by the consumer via (social media) interactive digital media. One lady thought that the vaccine caused her shingles.  The reporter did not knew what to do. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The case is linked with US2024AMR027981, by same reporter.; Sender's Comments:  US-GSK-US2024AMR027981:
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; ROTATEQ was given after possibly experiencing a temperature excursion. HBP did not provide details of the excursion at the time of the call. AE being filed as precaution. No additional information/clarification provided; This spontaneous report as received from a  health care business professional (HPB) reported as other concerning a 5 month old patient, gender unknown. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  On 25-JAN-2024, the patient was vaccinated with improperly stored dose of vaccine, reported as after possibly,  experiencing a temperature excursion of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), orally, (dose, lot # and expiration date was not mentioned) for prophylaxis (product storage error).  The HPB did not provide details of the excursion at the time of the call. No additional adverse event was reported.  Lot # is being requested and will be submitted if received
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash of arm; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of rash in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced rash (Verbatim: Rash of arm). The outcome of the rash was resolving.   The reporter considered the rash to be related to Shingrix.     The company considered the rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 27-FEB-2024 The patient received a subsequent dose of Shingrix and had rash of arm.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Rash
Clinical narrative: rash; rash was feels like I have been kicked in the ribs; Shingles; 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. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). On an unknown date, the patient experienced rash (Verbatim: rash) and feeling abnormal (Verbatim: rash was feels like I have been kicked in the ribs). The outcome of the shingles, rash and feeling abnormal were not reported.   It was unknown if the reporter considered the shingles, rash and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the shingles, rash and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2024 The patient self-reported this case. Patient had the first vaccine. He/she just went to physician today (at the day of reporting). The patient developed shingles about 3 weeks ago (from the date of reporting). Where the rash was felt like he/she had been kicked in the ribs.
Sex: U
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: nerves pain is in whole body; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced nerve pain (Verbatim: nerves pain is in whole body). The outcome of the nerve pain was not reported.   It was unknown if the reporter considered the nerve pain to be related to Shingles vaccine.     It was unknown if the company considered the nerve pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2024 This case was reported by the patient via interactive digital media. The patient's nerves pain was in his/her whole body from the shot .
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: just a sore arm for a couple of 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.   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: just a sore arm for a couple of days). The outcome of the pain in arm was 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: 27-FEB-2024 This case was reported by a patient via interactive digital media. The patient stated that the vaccine did not made him/her sick just a sore arm for a couple of days, but still better than the shingles.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Myalgia
Clinical narrative: Muscle pain; Joint pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of muscle pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced muscle pain (Verbatim: Muscle pain) and joint pain (Verbatim: Joint pain). The outcome of the muscle pain and joint pain were not reported.   It was unknown if the reporter considered the muscle pain and joint pain to be related to Arexvy.     It was unknown if the company considered the muscle pain and joint pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 27-FEB-2024 The reporter enquired how long might muscle and/or joint pain last.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Feeling hot, Swelling
Clinical narrative: redness; swollen; warm; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of erythema in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (for tolerance of 1st dose of shingles vaccine, refer case US2024AMR027101).   In FEB-2024, the patient received the 2nd dose of Shingles vaccine. In FEB-2024, an unknown time after receiving Shingles vaccine, the patient experienced erythema (Verbatim: redness), swelling (Verbatim: swollen), feeling of warmth (Verbatim: warm) and tiredness (Verbatim: tiredness). The outcome of the erythema, swelling, feeling of warmth and tiredness were not reported.   It was unknown if the reporter considered the erythema, swelling, feeling of warmth and tiredness to be related to Shingles vaccine.     It was unknown if the company considered the erythema, swelling, feeling of warmth and tiredness to be related to Shingles vaccine.   Linked case(s) involving the same patient: US2024AMR027101   Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a patient via interactive digital media. The patient had received shingles vaccine five days ago from the date of reporting and had redness, swollen, warm and tiredness. The reporter stated that you must received the 2nd shot within 6 months.; Sender's Comments:  US-GSK-US2024AMR027101:case for 2nd shot
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: was having pain where his/her shingles were before them; 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 (Shingrix) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pain (Verbatim: was having pain where his/her shingles were before them). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingrix.   It was unknown if the company considered the pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2024 and 29-FEB-2024 This case was reported by a consumer via interactive digital media. The patient got the Shingrix vaccine and was having pain where his/her shingles were before when he/she had them. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Shingles; Painful; 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, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles) and pain (Verbatim: Painful). The outcome of the shingles and pain were resolved (duration 3 weeks).   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: 29-FEB-2024 This case was reported by a consumer via interactive digital media. The reporter stated that made the mistake of taking the shingles shot and two weeks later had the shingles. It was very painful but thankfully only lasted about three weeks. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Gastrooesophageal reflux disease, Somnolence
Clinical narrative: Feeling drowsy; reflux symptoms not unusual to me; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of drowsiness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-FEB-2024, the patient received Arexvy. In FEB-2024, an unknown time after receiving Arexvy, the patient experienced drowsiness (Verbatim: Feeling drowsy) and gastroesophageal reflux (Verbatim: reflux symptoms not unusual to me). The outcome of the drowsiness and gastroesophageal reflux were not reported.   It was unknown if the reporter considered the drowsiness and gastroesophageal reflux to be related to Arexvy.     It was unknown if the company considered the drowsiness and gastroesophageal reflux to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-FEB-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient had the Arexvy shot the day before reporting in afternoon, feeling drowsy and reflux symptoms not unusual to him/her.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 weeks after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.   It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-MAR-2024 This case was reported by a patient via interactive digital media. The patient stated that he/she got the shingles shot two weeks later got shingles.  The patient thought that he/she was protected by the shot obviously not and just turned 50 in October and was excited to get the shot but the doctor said he/she could still get it with the shot just not as severe.
Sex: U
Vaccine: RSV
Symptoms: Fatigue
Clinical narrative: I feel very tired; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of tiredness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, several hours after receiving Arexvy, the patient experienced tiredness (Verbatim: I feel very tired). The outcome of the tiredness was not resolved.   The reporter considered the tiredness to be probably related to Arexvy.     The company considered the tiredness to be probably related to Arexvy.   Additional Information: GSK Receipt Date: 01-MAR-2024 This case was reported by a consumer via (Open field AE monitoring) interactive digital media. The patient got his/her inoculation earlier at the time of reporting and now after several hours he/she felt very tired.  The reporter suspected it was probably from the vaccine and this confirmed that probability.
Sex: U
Vaccine: RSV
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Got extreme joint pain; Almost unable to walk; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of joint pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced joint pain (Verbatim: Got extreme joint pain) and unable to walk (Verbatim: Almost unable to walk). The outcome of the joint pain and unable to walk were not reported.   It was unknown if the reporter considered the joint pain and unable to walk to be related to Arexvy.     It was unknown if the company considered the joint pain and unable to walk to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-Mar-2024 This case was reported by a patient via interactive digital media. The patient received Arexvy vaccine and got extreme joint pain to the point of almost unable to walk. The patient had all symtoms except injection site pain. The patient get another shot of this sort, for sure and it scared him or her badly. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: RVX, RVX
Symptoms: Heart rate increased, Product administered to patient of inappropriate age
Clinical narrative: she experienced increased heart rate; patient is in her mid her 50s-60s/ possible inappropriate age at vaccine administration; HCP recommended a 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of heart rate increased in a adult female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of RSV vaccine and did not receive the 2nd dose of RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine and not applicable after receiving RSV vaccine, the patient experienced heart rate increased (Verbatim: she experienced increased heart rate), inappropriate age at vaccine administration (Verbatim: patient is in her mid her 50s-60s/ possible inappropriate age at vaccine administration) and intercepted product prescribing error (Verbatim: HCP recommended a 2nd dose). The outcome of the heart rate increased, inappropriate age at vaccine administration and intercepted product prescribing error were unknown.   It was unknown if the reporter considered the heart rate increased to be related to RSV vaccine.     It was unknown if the company considered the heart rate increased to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 27-FEB-2024 Pharmacist stated that a patient received the RSV vaccine and experienced increased heart rate. The reporter stated that patient's primary provider recommended her to get a 2nd dose, but reporter wanted to know if she should since she experienced the adverse effects.  The MI (medical information) informed health care professional (reporter) that at this time there was no recommendation for a 2nd or booster dose.  Upon probing, the reporter stated that the patient was in her mid-50s but after MI provided the age indication for Arexvy, he stated she was in her 50s to 60s and received RSV vaccine, which led to an inappropriate age at vaccine administration.  The reporter also stated that might be patient received another RSV vaccine, since her HCP (primary provider) recommended a 2nd dose, but he was not certain at this time, which led to an intercepted product prescribing error. The vaccine administration facility was the same as primary reporter. This might be a duplicate report as the reporter stated that the patient called and spoke to someone who stated that they could not assist her since she was not a healthcare provider.  The reporter declined to provide initials and did not have any additional information on the event.
Age: 59.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: inadvertently administered Arexvy vaccine to patient under the age of 60; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 59-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number GX3T4, expiry date 20-AUG-2025) for prophylaxis.   On 26-FEB-2024, the patient received Arexvy. On 26-FEB-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: inadvertently administered Arexvy vaccine to patient under the age of 60). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The pharmacist reported that the one of the locations that he/she was work for inadvertently administered Arexvy vaccine to patient under the age of 60 years, which led to an inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. This was 1 of the 4 linked cases, reported by same reporter.; Sender's Comments:  US-GSK-US2024025761:Same reporter / different patient US-GSK-US2024025764:Same reporter / different patient US-GSK-US2024025765:Same reporter / different patient
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: hasnt received a second 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 08-MAY-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: hasnt received a second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2024 The pharmacist reported that a patient received the first dose of Shingrix and had not receive a second dose yet (till the time of reporting), which led to incomplete course of vaccination.  The vaccine administration facility was the same as primary reporter.
Age: 80.0
Sex: F
Vaccine: RSV
Symptoms: Extra dose administered
Clinical narrative: a patient received 2 doses of Arexvy,; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 80-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number Z7KM4, expiry date 18-AUG-2025) for prophylaxis.   Concomitant products included RSV vaccine prot. subunit PreF3 (Arexvy).   On 26-JAN-2024, the patient received the 2nd dose of Arexvy. On 26-JAN-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: a patient received 2 doses of Arexvy, ). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 28-FEB-2024 The Vaccine Administration Facility was the same as Primary Reporter The pharmacist stated that a patient received 2 doses of Arexvy, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Wrong technique in product usage process
Clinical narrative: Used two pediatric doses to make an adult dose for a 36 year old female; They used two pediatric doses to make an adult dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of adult use of a child product in a 36-year-old female patient who received HAV (Havrix 720) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.   On 16-FEB-2024, the patient received Havrix 720. On 16-FEB-2024, an unknown time after receiving Havrix 720, the patient experienced adult use of a child product (Verbatim: Used two pediatric doses to make an adult dose for a 36 year old female) and wrong technique in product usage process (Verbatim: They used two pediatric doses to make an adult dose). The outcome of the adult use of a child product and wrong technique in product usage process 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: 28-Feb-2024 The reporter reported that their facility inadvertently ordered the pediatric formulation of Havrix, so they used two pediatric doses to made an adult dose for a 36 year old female, which led to adult use of a child product and wrong technique in product usage process. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy
Clinical narrative: Chemotherapy after two doses of Shingrix; This serious case was reported by a pharmacist via call center representative and described the occurrence of chemotherapy in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced chemotherapy (Verbatim: Chemotherapy after two doses of Shingrix) (serious criteria clinically significant/intervention required). The outcome of the chemotherapy was unknown.   It was unknown if the reporter considered the chemotherapy to be related to Shingrix.     It was unknown if the company considered the chemotherapy to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-FEB-2024 The pharmacist would like to know if a 3rd dose of shingrix would benefit a patient who was done with the Shingrix series 2 years ago and went through chemotherapy after Shingrix doses. The reporter consented to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: MAJOR BLOOD CLOT IN RIGHT LEG; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced major blood clot in right leg (dose series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of major blood clot in right leg was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:  Thrombosis;  The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Immune thrombocytopenia
Clinical narrative: ITP; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (dose series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced itp (Idiopathic thrombocytopenic purpura) (dose series 1). It was reported that she will never take a shot. My daughter got the Covid shot for work, she did her research and chose JJ because it did not adhere to DNA, she has a life threatening blood disorder now ITP which was directly linked to the shot. Three years later she takes a weekly injection and daily cancer drugs to avoid bleeding out or going to the hospital. She would sue JJ but they are protected by the government because we were in a pandemic which now that we aren't maybe we can revisit that! My granddaughter was three she will never get the Covid shot. Reading the his almost made me sick" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of itp was not reported. This report was serious (Life Threatening).; Sender's Comments: V0- Immune thrombocytopenia. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.
Sex: M
Vaccine: COVID19
Symptoms: Illness, Pain in extremity, Pyrexia, Rash papular
Clinical narrative: I recently had some red bumps appear on my toes; illness, fever and pain in my arm; illness, fever and pain in my arm; illness, fever and pain in my arm; This spontaneous case was reported by a patient and describes the occurrence of RASH PAPULAR (I recently had some red bumps appear on my toes), PAIN IN EXTREMITY (illness, fever and pain in my arm), ILLNESS (illness, fever and pain in my arm) and PYREXIA (illness, fever and pain in my arm) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PAPULAR (I recently had some red bumps appear on my toes), PAIN IN EXTREMITY (illness, fever and pain in my arm), ILLNESS (illness, fever and pain in my arm) and PYREXIA (illness, fever and pain in my arm). At the time of the report, RASH PAPULAR (I recently had some red bumps appear on my toes), PAIN IN EXTREMITY (illness, fever and pain in my arm), ILLNESS (illness, fever and pain in my arm) and PYREXIA (illness, fever and pain in my arm) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. It was reported that patient recently had some red bumps appear on his toes and after speaking to his nurse, she had advised that he speak to a doctor. He initially assumed it was athlete's foot but its looking more like "covid toes" as it's been coined. He has attached an image of the chilbain like lesions for reference and he was seeking further medical advice on how to proceed with the discomfort and help reduce the potential necrosis. He had the moderna vaccine twice since the vaccine has been available amd besides the expected illness, fever and pain in my arm, he had no other side effects. He understood this to be a side effect of the mrna vaccine which was not listed as a potential side effect at the time of injection. The treatment medication was not reported by reporter.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Had every pfizer COVID shot and up to date Booster, still Spouse and I got it and it was bad; Had every pfizer COVID shot and up to date Booster, still Spouse and I got it and it was bad; This is a spontaneous report received from a Consumer or other non HCP.  A female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Primary immunization series completed., Unknown manufacturer.), for COVID-19 Immunization; Bnt162b2;bnt162b2 omi ba.4-5 (Booster), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Had every pfizer COVID shot and up to date Booster, still Spouse and I got it and it was bad".  Clinical information: Severe COVID/Patient stated they felt like they were going to die.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202400031780 Same reporter/drug/event, different patient;
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 11Oct2023 at 15:00 as dose 1, single (Batch/Lot number: unknown) at the age of 73 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 5, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 4, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 3, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURE UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (Dose 1, MANUFACTURE UNKNOWN), for COVID-19 Immunization. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Feb2024) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 Included Paxlovid From 16Feb2024 to 21Feb2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a Physician.  A 55-year-old male patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Bactrim, reaction(s): "Known allergies: Bactrim". Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 4, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 5, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid From 26Feb2024 to 02Mar2024. The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162b2 omi xbb.1.5 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a Consumer or other non HCP.  A 69-year-old female patient received BNT162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Depression" (unspecified if ongoing); "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, unknown manufacturer), for COVID-19 immunization. The patient had no known allergies. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2024, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 25Feb2024 to 01Mar2024.  The information on the batch/lot number for BNT162b2 omi xbb.1.5 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: vaccine_brand_other=Johnson and Johnson/vaccine_brand=Pfizer / BioNTech; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a Consumer or other non HCP.  A 74-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Feb2021 at 12:30 as dose number unknown, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; COVID-19 vaccine nrvv ad26 (jnj 78436735) (JANSSEN COVID-19 VACCINE), on 17Sep2021 at 13:00 as dose number unknown, single), in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Past drug history included: Allergies: amoxicillin, reaction(s): "Allergies:amoxicillin"; Allergies: codeine, reaction(s): "Allergies:Codeine". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine_brand_other=Johnson and Johnson/vaccine_brand=Pfizer / BioNTech"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient was treated with Paxlovid from 26Feb2024 to 01Mar2024 as COVID 19 Treatment. The patient also took Advil from 22Feb2024 to 06Mar2024. The information on the batch/lot number for BNT162b2 will be requested and submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Heart rate, Heart rate increased
Clinical narrative: heart reactions has this vaccine caused; heartbeat has gone all the way up to 224 bpm; This is a spontaneous report received from a Consumer or other non HCP from medical information team.  A 42-year-old female patient received BNT162b2 (BNT162B2), in Feb2023 as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), administration date: Jan2023, for Covid-19 immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart reactions has this vaccine caused"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "heartbeat has gone all the way up to 224 bpm". Relevant laboratory tests and procedures are available in the appropriate section.