chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: and got shingles/suspected vaccination failure; and got shingles; He said it was the worst pain affliction he ever had in his life.; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: and got shingles/suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: and got shingles) and pain (Verbatim: He said it was the worst pain affliction he ever had in his life.). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   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: 01-AUG-2023 This case was reported by patient via interactive digital media. The reporter states that he/she heard that a lot of people who got the covid vaccine and boosters are more prone to get shingles.  The reporter states that the vaccine weak your innate immune system, and then the dormant shingles virus manifests.  He/she heard that shingles cases are on the rise because of this, he/she know someone who got vaccinated to retain his job, and got shingles. He said it was the worst pain affliction he ever had in his life. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: nearly killed me; This serious case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced near death experience (Verbatim: nearly killed me) (serious criteria GSK medically significant and life threatening). The outcome of the near death experience was not reported.   It was unknown if the reporter considered the near death experience to be related to Shingles vaccine.     It was unknown if the company considered the near death experience to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 02-Aug-2023 This case was reported by a patient via interactive digital media. The reporter reported that the Shingles vaccine dose nearly killed him or her. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; two vaccinations and I still got it; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: two vaccinations and I still got it). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 02-AUG-2023 This case was reported by a patient via interactive digital media. The patient had two vaccinations and still got the Shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Nervous system disorder
Clinical narrative: Developed shingles; Nerve involvement; This non-serious case was reported by a other health professional via sales rep and described the occurrence of shingles in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles (Verbatim: Developed shingles) and neurological disorder nos (Verbatim: Nerve involvement). The outcome of the shingles and neurological disorder nos were not reported.   It was unknown if the reporter considered the shingles and neurological disorder nos to be related to Shingrix.     It was unknown if the company considered the shingles and neurological disorder nos to be related to Shingrix.   Additional Information: GSK receipt date: 31-JUL-2023 The health care professionals (HCP) reported that the patient developed shingles with a few days of post vaccination and had nerve involvement post vaccination of 3 to 4 weeks. The reporter agrees to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: I've had nerve damage; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles Vaccine (on an unknown date received 1st dose.).   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 nerve damage (Verbatim: I've had nerve damage). The outcome of the nerve damage was not resolved.   It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine.     It was unknown if the company considered the nerve damage to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 30-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received 2nd round of shingles and he/she had the shot both times and also he/she had nerve damage that still never goes away.  The patient states that he/she feel like the shot only helps a bit. Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity, Sunburn
Clinical narrative: Arm is still sore; Sunburnt; Felt like I was hit by a bus; 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 28-JUL-2023, the patient received Shingles vaccine. On 29-JUL-2023, 1 days after receiving Shingles vaccine, the patient experienced feeling abnormal (Verbatim: Felt like I was hit by a bus). On 30-JUL-2023, the patient experienced pain in arm (Verbatim: Arm is still sore) and sunburn (Verbatim: Sunburnt). The outcome of the pain in arm was not resolved and the outcome of the sunburn and feeling abnormal were not reported.   It was unknown if the reporter considered the pain in arm, sunburn and feeling abnormal to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm, sunburn and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine on Friday morning. The patient stated that he or she felt like he or she was hit by a bus on Saturday and on Sunday his or her arm was still sore and looks sunburnt. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm hurts a little for a day; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurts a little for a day). The outcome of the pain in arm was resolved (duration 1 day).   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: 29-JUL-2023 This case was reported by a patient via interactive digital media. It was reported that the patient got the Shingles vaccine and his/her arm hurted for a day but patient stated that was nothing to worry about. The follow up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Horrible itching mainly on back; 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.   In JUL-2023, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced pruritus (Verbatim: Horrible itching mainly on back). The outcome of the pruritus was not resolved.   It was unknown if the reporter considered the pruritus to be related to Shingles vaccine.     It was unknown if the company considered the pruritus to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 01-AUG-2023 This case was reported by a patient via interactive digital media. The patient reported that what is the shingles, certainly he or she had these symptoms and he or she received the second vaccination just three days ago. The patient stated he or she hoped that now the horrible itching mainly on his or her back and will go away. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: soreness at the injection site; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site 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 injection site pain (Verbatim: soreness at the injection site). The patient was treated with paracetamol (Tylenol). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     It was unknown if the company considered the injection site pain to be related to Shingles vaccine.   Additional Information: Receipt date: 02-AUG-2023 The case was received from the patient interactive digital media. The patient got the vaccine and it was a little soreness at the injection site for a couple days and take Tylenol it was a lot better than dealing with the full blown shingles pain. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Felt very bad pain in my body; awful fever; 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.   The patient's past medical history included shingles (patient had it at 35 years old) and pain (Due to Shingles the patient had horrible pain and patient was contorted with pain).   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 general body pain (Verbatim: Felt very bad pain in my body) and fever (Verbatim: awful fever). The outcome of the general body pain and fever were not reported.   It was unknown if the reporter considered the general body pain and fever to be related to Shingles vaccine.     It was unknown if the company considered the general body pain and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 02-AUG-2023 This case was reported by a patient via interactive digital media. The reporter stated that doctor told to get the vaccine because if the patient caught it again it could kill. The patient took first dose and felt very bad pain in body and an awful fever. The patient was afraid to take the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Little bit of pain in the arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Little bit of pain in the arm). The outcome of the pain in arm was resolved (duration 3 days).   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.   Linked case(s) involving the same patient:  US2023AMR104277   Additional Information: Receipt date: 31-JUL-2023 This case was reported by patient via interactive digital media. The patient stated that just two or three days of pain in the arm, that was all. The patient reported that he/she was fine with two doses, just a little bit of pain in the arm for about three days. Follow-up case was not provided as no contact details.; Sender's Comments:  US-GSK-US2023AMR104277:same patient, Case for second dose
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Raising at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; hot red and itchy rash at the injection site; Pain in right arm (injection site); Skin rash; Tachycardia; Fatigue/ Feeling Exhausted; Joint aches; Muscle pain; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUL-2023, the patient received the 1st dose of Shingrix (right arm). In JUL-2023, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in right arm (injection site)), injection site itching (Verbatim: Hot red and itchy skin at the injection site), injection site erythema (Verbatim: hot red and itchy rash at the injection site), injection site swelling (Verbatim: Raising at the injection site), injection site warmth (Verbatim: Hot red and itchy skin at the injection site), injection site rash (Verbatim: Hot red and itchy skin at the injection site), rash (Verbatim: Skin rash), tachycardia (Verbatim: Tachycardia), fatigue (Verbatim: Fatigue/ Feeling Exhausted), joint pain (Verbatim: Joint aches), muscle pain (Verbatim: Muscle pain) and fever (Verbatim: Fever). In JUL-2023, the outcome of the injection site pain, rash, tachycardia, fatigue, joint pain, muscle pain and fever were resolved (duration 30 hrs) and the outcome of the injection site swelling was resolved. The outcome of the injection site itching, injection site erythema, injection site warmth and injection site rash were resolving.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter reported that the patient received first dose of Shingrix on Thursday. Hours later she developed pain at the injection site and that night continued with fever, muscle pain, joint pain, tachycardia, fatigue, rash, arm was raising at the injection site and feeling exhausted.  According to the patient the symptoms went away in 30 hours.  Then 6 days later she developed a hot red and itchy rash at the injection site that extended 9 inches below the injection.  The reporter stated she was better on the day of reporting. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Raising at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; hot red and itchy rash at the injection site; Pain in right arm (injection site); Skin rash; Tachycardia; Fatigue/ Feeling Exhausted; Joint aches; Muscle pain; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUL-2023, the patient received the 1st dose of Shingrix (right arm). In JUL-2023, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in right arm (injection site)), injection site itching (Verbatim: Hot red and itchy skin at the injection site), injection site erythema (Verbatim: hot red and itchy rash at the injection site), injection site swelling (Verbatim: Raising at the injection site), injection site warmth (Verbatim: Hot red and itchy skin at the injection site), injection site rash (Verbatim: Hot red and itchy skin at the injection site), rash (Verbatim: Skin rash), tachycardia (Verbatim: Tachycardia), fatigue (Verbatim: Fatigue/ Feeling Exhausted), joint pain (Verbatim: Joint aches), muscle pain (Verbatim: Muscle pain) and fever (Verbatim: Fever). In JUL-2023, the outcome of the injection site pain, rash, tachycardia, fatigue, joint pain, muscle pain and fever were resolved (duration 30 hrs) and the outcome of the injection site swelling was resolved. The outcome of the injection site itching, injection site erythema, injection site warmth and injection site rash were resolving.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter reported that the patient received first dose of Shingrix on Thursday. Hours later she developed pain at the injection site and that night continued with fever, muscle pain, joint pain, tachycardia, fatigue, rash, arm was raising at the injection site and feeling exhausted.  According to the patient the symptoms went away in 30 hours.  Then 6 days later she developed a hot red and itchy rash at the injection site that extended 9 inches below the injection.  The reporter stated she was better on the day of reporting. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Tachycardia
Clinical narrative: Raising at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; Hot red and itchy skin at the injection site; hot red and itchy rash at the injection site; Pain in right arm (injection site); Skin rash; Tachycardia; Fatigue/ Feeling Exhausted; Joint aches; Muscle pain; Fever; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20-JUL-2023, the patient received the 1st dose of Shingrix (right arm). In JUL-2023, several hours after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain in right arm (injection site)), injection site itching (Verbatim: Hot red and itchy skin at the injection site), injection site erythema (Verbatim: hot red and itchy rash at the injection site), injection site swelling (Verbatim: Raising at the injection site), injection site warmth (Verbatim: Hot red and itchy skin at the injection site), injection site rash (Verbatim: Hot red and itchy skin at the injection site), rash (Verbatim: Skin rash), tachycardia (Verbatim: Tachycardia), fatigue (Verbatim: Fatigue/ Feeling Exhausted), joint pain (Verbatim: Joint aches), muscle pain (Verbatim: Muscle pain) and fever (Verbatim: Fever). In JUL-2023, the outcome of the injection site pain, rash, tachycardia, fatigue, joint pain, muscle pain and fever were resolved (duration 30 hrs) and the outcome of the injection site swelling was resolved. The outcome of the injection site itching, injection site erythema, injection site warmth and injection site rash were resolving.   It was unknown if the reporter considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site itching, injection site erythema, injection site swelling, injection site warmth, injection site rash, rash, tachycardia, fatigue, joint pain, muscle pain and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter reported that the patient received first dose of Shingrix on Thursday. Hours later she developed pain at the injection site and that night continued with fever, muscle pain, joint pain, tachycardia, fatigue, rash, arm was raising at the injection site and feeling exhausted.  According to the patient the symptoms went away in 30 hours.  Then 6 days later she developed a hot red and itchy rash at the injection site that extended 9 inches below the injection.  The reporter stated she was better on the day of reporting. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash papular, Skin abrasion
Clinical narrative: excoriations in the injected arm; patient developed rash papular/ rash was similar to a dermatitis; This non-serious case was reported by a physician via call center representative and described the occurrence of excoriation in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included losartan, simvastatin, desvenlafaxine and colecalciferol (Vitamin D3).   In AUG-2019, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced excoriation (Verbatim: excoriations in the injected arm) and papular rash (Verbatim: patient developed rash papular/ rash was similar to a dermatitis). The outcome of the excoriation and papular rash were not reported.   It was unknown if the reporter considered the excoriation and papular rash to be related to Shingrix.     It was unknown if the company considered the excoriation and papular rash to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR104229   Additional Information: GSK Receipt Date:28-JUL-2023 The physician reported that the patient developed rash papular excoriations in the injected arm (no shingle rash) after getting the first dose of Shingrix on August 2019. The rash was similar to a dermatitis going from the back of the deltoid to the wrist at the time of vaccination. The  patient was under several medications (Statins, Losartan, simvastatin, desvenlafaxine, Vitamin D 3), the same medication that was using during Shingrix administration.  The reporter did not consent to follow up. The Vaccine Administration Facility was the same as Primary Reporter. This case had been linked with US2023AMR104229 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR104229:Same patient 2 dose
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Mistakenly received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an unknown date received 1st dose) and Shingrix (on an unknown date received 2nd dose).   On an unknown date, the patient received the 3rd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Mistakenly received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 31-Jul-2023 The health care professionals (HCP) reported that a patient mistakenly received a third dose of Shingrix because he forgot that he had received 2 doses, which led to extra dose administered. Nothing else was reported. The reporter consented to follow up. This case is linked with US2023104119, by same reporter.; Sender's Comments:  US-GSK-US2023104119:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: mistakenly received a third dose of Shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On an unknown date received, first dose) and Shingrix (On an unknown date, received second dose).   On an unknown date, the patient received the 3rd dose of Shingrix (intramuscular, unknown deltoid). On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: mistakenly received a third dose of Shingrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 31-JUL-2023 The reporter stated that the patient mistakenly received a third dose of Shingrix because she forgot she had already received two doses. Nothing else was reported. The reporter consented to follow up. The reporter reported that the patient mistakenly received a third dose of Shingrix because she forgot she had already received two doses, which lead to extra dose administered. The case had been linked to the case US2023104118  reported by same reporter.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Overdose
Clinical narrative: received two Bexsero on same day; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number TH9NR, expiry date 31-JAN-2027) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced overdose (Verbatim: received two Bexsero on same day). The outcome of the overdose 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: 01-AUG-2023 A health care professional reported that a patient received during the same visit two different Meningococcal B vaccines which led to overdose. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: received an expired vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number H755H, expiry date 09-JUN-2023) for prophylaxis.   On 13-JUL-2023, the patient received the 1st dose of Shingrix. On 13-JUL-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: received an expired vaccine). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 01-AUG-2023 The reporter consented to follow up. The pharmacist reported a patient received an expired Shingrix vaccine inadvertently, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: got only the diluent and not the full dose of Menveo; got only the diluent and not the full dose of Menveo; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA758A) for prophylaxis.   On 22-JUN-2023, the patient received Menveo. On 22-JUN-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: got only the diluent and not the full dose of Menveo) and inappropriate dose of vaccine administered (Verbatim: got only the diluent and not the full dose of Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 01-AUG-2023 The nurse reported that in a box of 5 vials of Menveo, one powder was left behind and she believed that 1 out of the 5 patient probably got only the diluent and not the full dose of Menveo which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 46-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number HF2YA, expiry date 15-JUL-2023) for prophylaxis.   On 01-AUG-2023, the patient received Boostrix. On 01-AUG-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 02-AUG-2023 At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  The patient received an expired dose of Boostrix, which led to expired vaccine used.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered
Clinical narrative: a few drops (around 2-3) of the vaccine came out of the needle; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA950A, expiry date 31-JUL-2024) for prophylaxis.   On 02-AUG-2023, the patient received Menveo. On 02-AUG-2023, an unknown time after receiving Menveo, the patient experienced incomplete dose administered (Verbatim: a few drops (around 2-3) of the vaccine came out of the needle). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK receipt date: 2-Aug-2023 Nurse reported that a medical assistant administered a dose of Menveo to a patient.  At the time of reporting, the dose had not been repeated. The Vaccine Administration Facility was the same as Primary Reporter. The reporter gave permission for follow-up. The medical assistant stated that just prior to administration, a few drops (around 2 to 3) of the vaccine came out of the needle, which led to incomplete dose administered.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 13th April 2018).   On 03-JUN-2023, the patient received the 2nd dose of Twinrix. On 03-JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Aug-2023 The pharmacist had 2 patients. The reporter was in a hurry to provide any other details. The reporter consented to follow-up. This is 1 of 2 linked patients reported by the same reporter for different patient. The patient received second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.; Sender's Comments:  US-GSK-US2023105227:Same reporter, 2nd patient
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: recieved their 1st dose of Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 13th April 2018).   On 03-JUN-2023, the patient received the 2nd dose of Twinrix. On 03-JUN-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: recieved their 1st dose of Twinrix in April 13th 2018 and 2nd dose in June 3rd 2023.). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Aug-2023 The pharmacist had 2 patients. The reporter was in a hurry to provide any other details. The reporter consented to follow-up. This is 2 of 2 linked patients reported by the same reporter for different patient. The patient received second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.; Sender's Comments:  US-GSK-US2023105225:Same reporter, 2nd patient
Age: 0.17
Sex: U
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: 2 months old baby received Engerix-B adult formulation by error; 2 months old baby received Engerix-B adult formulation by error; This non-serious case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 2-month-old patient who received HBV (Engerix B adult) for prophylaxis.   On an unknown date, the patient received Engerix B adult. On an unknown date, an unknown time after receiving Engerix B adult, the patient experienced adult product administered to child (Verbatim: 2 months old baby received Engerix-B adult formulation by error) and accidental overdose (Verbatim: 2 months old baby received Engerix-B adult formulation by error). The outcome of the adult product administered to child and accidental overdose were unknown.   Additional Information: GSK Receipt date: 02-AUG-2023 A pharmacist tec reported that he/she noticed that 7 months ago from reporting, probably back on December or November, a 2-month-old baby received Engerix-B adult formulation by error, which led to overdose and adult product administered to child. The patient was okay.  The reporter consented to follow up by email.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient received the powder of Shingrix reconstituted with sterile water; patient received the powder of Shingrix reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received the powder of Shingrix reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: patient received the powder of Shingrix reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 02-AUG-2023 A pharmacist reported that a patient received the powder of Shingrix reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a patient received a dose of Infanrix (DTap) instead of a Tdap dose; inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa (Infanrix) for prophylaxis.   On 02-AUG-2023, the patient received Infanrix. On 02-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: a patient received a dose of Infanrix (DTap) instead of a Tdap dose) and inappropriate age at vaccine administration (Verbatim: inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 2-Aug-2023 The reporter did not consent to follow-up. The patient received a dose of Infanrix instead of Tdap dose at an inappropriate age, earlier on the day of reporting, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 5-year-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK Receipt Date: 03-AUG-2023 Nurse reported that patient was administered with Havrix vaccine. On 15Jun2023 vaccine was exposed to a low temperature of 31.5 degrees Fahrenheit. The reporter was not sure on which date vaccine was administered. According to reporter it was administered between 15Jun2023 and 21Jun2023. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The patient was administered with vaccine, which was stored at low temperature which led to, Incorrect storage of drug. The reporter consented to follow up. This is 1 of 8 linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2023105926:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105916:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105927:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105917:same reporter
Age: 0.92
Sex: M
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: exposed to a low temperature of 31.5 degrees Fahrenheit; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 11-month-old male patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit). The outcome of the incorrect storage of drug was unknown.   Additional Information: Receipt Date: 03-AUG-2023 Nurse reported that patient was administered with Havrix vaccine. On 15Jun2023 vaccine was exposed to a low temperature of 31.5 degrees Fahrenheit . The reporter was not sure on which date vaccine was administered.  According to reporter it was administered between 15Jun2023 and 21Jun2023. At the time of reporting, the dose has not been repeated. The vaccine administration facility was the same as primary reporter. The patient was administered with vaccine which was stored at low temperature which led to, Incorrect storage of drug. The reporter consented to follow up. This is 1 of 8  linked report, reported by same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105927:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105917:same reporter
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 2 year old male patient received a dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number T343J, expiry date 25-JAN-2025) for prophylaxis.   On 02-AUG-2023, the patient received Kinrix. On 02-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 year old male patient received a dose). The outcome of the inappropriate age at vaccine administration 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: 03-AUG-2023 The medical assistant reported that a patient received a dose of Kinrix with no symptoms reported. The vaccine was the fourth dose of each (per report to the 2nd line agent). A 2 year patient received Kinrix, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received a dose of Menveo that had been reconstituted with sterile water; received a dose of Menveo that had been reconstituted with sterile water; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 31-JUL-2023, the patient received Menveo. On 31-JUL-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received a dose of Menveo that had been reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: received a dose of Menveo that had been reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date:4-Aug-2023 A registered nurse wished to know how to proceed. The partial information about the vaccine, event and patient given as the record seemed to had been erased. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. The patient received accidentally received a dose of Menveo that had been reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.