chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Six patients vaccinated with expired Jynneos vaccine; Case reference number US-BN-2023-001033 is a spontaneous case report initially received from other health professional via Communications (reference number: USBAV23-0776) on 19-Jun-2023 and concerns six patients of unknown demographics.  The patients' medical history and concomitant medication details were not provided.  On unspecified dates, reported as since January 25th, Jynneos vaccine (batch number unknown) was in the refrigerator.  On an unspecified date, the Jynneos (batch number unknown) vaccine was past the beyond use date (BUD) and six patients were vaccinated with a dose of the expired Jynneos vaccine (batch number unknown), at unknown dose, subcutaneously, at unknown anatomical site of administration, for indication reported as smallpox/monkeypox prophylaxis (explicitly coded as 'expired vaccine used').  At the time of initial report, it was unknown if the patients experienced any adverse event due to Jynneos vaccination.  Additional information received on 20-Jun-2023 included the local case ID.; Reporter's Comments: Six patients of unknown demographics were vaccinated with a dose of the expired Jynneos vaccine, at unknown dose, subcutaneously, at unknown anatomical site of administration, for indication reported as smallpox/monkeypox prophylaxis, which is considered as expired vaccine used. It was unknown if the patients experienced any adverse event due to Jynneos vaccination. Expired product administered is considered as listed per company convention. The patients' relevant medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: Six patients of unknown demographics were vaccinated with a dose of the expired Jynneos vaccine, at unknown dose, subcutaneously, at unknown anatomical site of administration, for indication reported as smallpox/monkeypox prophylaxis, which is considered as expired vaccine used. It was unknown if the patients experienced any adverse event due to Jynneos vaccination. Expired product administered is considered as listed per company convention. The patients' relevant medical history and concomitant medication details were not provided. Expired product administered has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: Beyond use date was on 07-Jun-2023 and Jynneos was given on 13-Jun-2023; Case reference number US-BN-2023-001049 is a spontaneous case report initially received from other health professional via Communications (reference number: USBAV23-0787) on 21-Jun-2023 and concerns a patient of unknown demographics.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos vaccine (batch number not provided), at unknown dose, route and site of administration for indication reported as smallpox/monkeypox prophylaxis.  On 13-Jun-2023, an unknown amount of time after the first Jynneos dose, the patient was vaccinated with the second dose of Jynneos vaccine (batch number not provided) that was past the beyond use date (BUD) which was on 07-Jun-2023, at unknown dose, route or site of administration (explicitly coded as 'expired vaccine used').  At the time of initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received on 22-Jun-2023 included local case ID number.; Reporter's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos for smallpox/monkeypox prophylaxis, via unspecified route of administration. It was found that the vaccine was past the beyond use date, which is considered expired product administered. No associated adverse events were reported. Expired product administered is considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Expired product administered is assessed as not related to Jynneos, but to human error. The case is non-serious.; Sender's Comments: A patient of unknown demographics was vaccinated with the second dose of Jynneos for smallpox/monkeypox prophylaxis, via unspecified route of administration. It was found that the vaccine was past the beyond use date, which is considered expired product administered. No associated adverse events were reported. Expired product administered is considered listed per company conventions. The patient's medical history and concomitant medication details were not provided. Expired product administered is assessed as not related to Jynneos, but to human error. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Underdose
Clinical narrative: Jynneos vaccine squirted out during the administration to the patient and a substantial amount came out; Case reference number US-BN-2023-001122 is a spontaneous case report initially received from a pharmacist via Communication (reference number: USBAV23-0842) on 28-Jun-2023 and concerns a 67-year-old male patient.  The patient's relevant medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with the first dose of Jynneos (batch number: unknown) at an unknown dose, route or site of administration, for monkeypox prophylaxis.  On an 28-Jun-2023, an unknown amount of time after the first dose, the patient was vaccinated with a second dose of Jynneos (batch number: FDP00015) at initial dosage of 0.5 miliiters that squirted out during the administration and a substantial amount came out, administered subcutaneously in the back of the arm (explicitly coded as 'vaccine underdose'). As reported, new syringe was used and the issue was reported as resolved (to be confirmed).  As reported, gloves were used during the administration and the pharmacist had no contact with the product but was wondering if the patient needs to be revaccinated.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccination.  Additional information received from on 29-Jun-2023 included local case ID.  Additional information received from on 07-Jul 2023: New information included confirmation that did not supply the syringe in question and no PQC should be captured and information about revaccination with a new syringe that was potentially done to be confirmed.; Reporter's Comments: A 67-year-old male patient was vaccinated with a second dose of Jynneos, at initial dosage of 0.5 miliiters that squirted out during the administration and a substantial amount came out, administered subcutaneously in the back of the arm, which is considered as vaccine underdose. It was unknown if the patient experienced any adverse event due to Jynneos vaccination. Underdose is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Underdose has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 67-year-old male patient was vaccinated with a second dose of Jynneos, at initial dosage of 0.5 miliiters that squirted out during the administration and a substantial amount came out, administered subcutaneously in the back of the arm, which is considered as vaccine underdose. It was unknown if the patient experienced any adverse event due to Jynneos vaccination. Underdose is considered as listed per company convention. The patient's relevant medical history and concomitant medication details were not provided. Underdose has been considered as not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis, Urticaria
Clinical narrative: BLOOD CLOT; HIVES;   This is a solicited report received from a contactable reporter(s) (Consumer or other non HCP) from License Party (Company). Other Case identifier(s): US-BRISTOL-MYERS SQUIBB COMPANY-2023-096396 (Company).  Information was received from a Consumer/other non health professional concerning a Female patient, enrolled in the post-marketing study who received Suspect product APIXABAN for Product used for unknown indication, lot number:Unknown. On an unknown date, the patient had thrombosis (blood clot), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the thrombosis was unknown. On an unknown date, the patient had urticaria (hives), which was considered non-serious. It is unknown if treatment was provided. The outcome of the urticaria was unknown. Patient stated she is currently taking Eliquis. Patient mentioned she has a developed a blood clot after taking Pfizer booster. Patient also mentioned experiencing hives during the same time. The action taken with APIXABAN medication was unknown. Concomitant medications were not reported. The reporter did not provide a causality assessment for events thrombosis and urticaria to APIXABAN. Tracking of Changes: 07-Jul-2023: Initial information was received  Eliquis is under agreement with Company.; Sender's Comments: Company Medical Evaluation Comment: This patient had thrombosis while on apixaban therapy. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspect, treatment given and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban could have contributed to the event thrombosis.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Husband had the shot still got them /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 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: Husband had the shot still got them /Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUL-2023 This case was reported by a patient wife via interactive digital media. The reporter reported that her husband received Shingles vaccine still experienced shingles. This case was considered as suspected vaccination failure as details regarding completion of primary schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Headache, Herpes zoster, Hypoaesthesia, Pruritus
Clinical narrative: I have had the vaccine but I have shingles/ Suspected vaccination failure; I have had the vaccine but I have shingles; itch; numb skin; knocked me off my feet; headache; 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: I have had the vaccine but I have shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have had the vaccine but I have shingles), headache (Verbatim: headache), pruritus (Verbatim: itch), numbness (Verbatim: numb skin) and feeling abnormal (Verbatim: knocked me off my feet). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, numbness and feeling abnormal were not reported and the outcome of the headache was resolved (duration 4 days).   It was unknown if the reporter considered the vaccination failure, shingles, headache, pruritus, numbness and feeling abnormal to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, headache, pruritus, numbness and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUL-2023 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine but he/she had shingles. The patient's case was less severe than those without the vaccine but still knocked him/her off his/her feet.  The headache that lasted for 4 days was worse than the itch in numb skin that you could not scratch. 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: Vaccination failure
Clinical narrative: I have had the vaccine but I have shingles/ Suspected vaccination failure; I have had the vaccine but I have shingles; itch; numb skin; knocked me off my feet; headache; 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: I have had the vaccine but I have shingles/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: I have had the vaccine but I have shingles), headache (Verbatim: headache), pruritus (Verbatim: itch), numbness (Verbatim: numb skin) and feeling abnormal (Verbatim: knocked me off my feet). The outcome of the vaccination failure was unknown and the outcome of the shingles, pruritus, numbness and feeling abnormal were not reported and the outcome of the headache was resolved (duration 4 days).   It was unknown if the reporter considered the vaccination failure, shingles, headache, pruritus, numbness and feeling abnormal to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure, shingles, headache, pruritus, numbness and feeling abnormal to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 14-JUL-2023 This case was reported by a patient via interactive digital media. The patient had the Shingles vaccine but he/she had shingles. The patient's case was less severe than those without the vaccine but still knocked him/her off his/her feet.  The headache that lasted for 4 days was worse than the itch in numb skin that you could not scratch. 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: Asthenia, Chills, Headache, Pyrexia, Vomiting
Clinical narrative: Body weak; headache; Shivering; Fever; Vomiting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of weakness generalized in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced weakness generalized (Verbatim: Body weak), headache (Verbatim: headache), shivering (Verbatim: Shivering), fever (Verbatim: Fever) and vomiting (Verbatim: Vomiting). The outcome of the weakness generalized, headache, shivering, fever and vomiting were resolved.   It was unknown if the reporter considered the weakness generalized, headache, shivering, fever and vomiting to be related to Shingles vaccine.     It was unknown if the company considered the weakness generalized, headache, shivering, fever and vomiting to be related to Shingles vaccine.   Additional Information: GSK receipt date: 10-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she did got vaccinated and also had a bad reaction to the second vaccine. The patient's body was weak, had a headache, shivering, fever and vomiting but the patient still think it was better to go through that, as it was just a few days, because shingles was much worse. The patient's sister in law had it, and it was really hard to see her suffering, and it happened a while ago and she was still in pain, so patient thought they say that the aches and pains never go away. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm still sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 05-JUL-2023, the patient received Shingles vaccine. In JUL-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm still sore). The outcome of the pain in arm was not 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: 09-JUL-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine last Wednesday.  The patient's arm still hurt.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pyrexia
Clinical narrative: Feel badly; Fever; This non-serious case was reported by a consumer via sales rep and described the occurrence of feeling abnormal in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in past).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced feeling abnormal (Verbatim: Feel badly) and fever (Verbatim: Fever). The outcome of the feeling abnormal and fever were resolved.   It was unknown if the reporter considered the feeling abnormal and fever to be related to Shingrix.     It was unknown if the company considered the feeling abnormal and fever to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-JUL-2023 The reporter was a patient, older than age 50 year. The reporter reported that the she administered Shingrix vaccine and had 3 to 4 days of feeling badly with fever. The reporter said she had shingles in the past and no matter how bad the vaccine made her feel that she would still go on to get the second dose of Shingrix because even though the first Shingrix vaccine made her feel badly that it was still better that getting Shingles. The follow-up could not be possible as the as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness 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 sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     It was unknown if the company considered the sickness to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-JUL-2023 This case was reported by consumer via interactive digital media. The reporter reported that his/her friend got the shots it made her sick.  Follow up was not possible, as no contact details were available. This case was linked with case US2023AMR097176 with same reporter.; Sender's Comments:  US-GSK-US2023AMR097176:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore 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.   Additional patient notes included History: Patient never had any problems when he/she take immunization shots, no flu, no phenomenon shorts, not even the covid vaccination..   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: Sore arm). The patient was treated with paracetamol (Tylenol). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 13-JUL-2023 This case was reported by patient via interactive digital media. The patient reported that he or she never had any problems when he/she take immunization shots, no flu, no phenomenon shorts, not even the covid vaccination. The patient states that he/she so grateful he/she never get anything but a little sore arm, as soon as he/she went home and take Tylenol, he/she never let his/her arm start to hurt before he/she take something. Follow up was not possible, as no contact details were available. This case was linked with case US2023AMR097175 with same reporter.; Sender's Comments:  US-GSK-US2023AMR097175:same reporter
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered, Injection site mass
Clinical narrative: Lump at vaccination site; Expired vaccine used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site lump in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A, expiry date 30-JUN-2023) for prophylaxis.   On 11-JUL-2023, the patient received the 1st dose of Menveo. On 11-JUL-2023, less than a day after receiving Menveo, the patient experienced injection site lump (Verbatim: Lump at vaccination site) and expired vaccine used (Verbatim: Expired vaccine used). The outcome of the injection site lump and expired vaccine used were unknown.   It was unknown if the reporter considered the injection site lump to be related to Menveo.     It was unknown if the company considered the injection site lump to be related to Menveo.   Additional Information: GSK receipt date: 13-Jul-2023 A certified medical assistant called in to report that a patient developed a lump at the site of vaccination after receiving a dose of Menveo and wished to know how to proceed.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Patient received a dose of Menveo which was already expired, which led to expired vaccine used. This case is linked with US2023096268, by same reporter.; Sender's Comments:  US-GSK-US2023096268:Same reporter
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: 2nd dose has not been administered 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 78-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose of Twinrix standard schedule on 29-MAR-2023).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: 2nd dose has not been administered yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUL-2023 The reporter asked how to proceed. The vaccine administration facility was the same as primary reporter. Reporter wishes to remain anonymous and did not consent to follow up. Till the time of reporting the did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Dose administered during active Shingles case/the second dose on; This non-serious case was reported by a other health professional via call center representative and described the occurrence of shingles in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included shingles (recurrent case of Shingles for the last 6 months).   On 01-APR-2023, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced shingles (Verbatim: Dose administered during active Shingles case/the second dose on). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date 13 Jul 2023 A pharmacy intern called in to request information about the validity, guidance and recommendations for Shingrix in a patient whom has had a recurrent case of Shingles for the last 6 months, received the first dose 3 months ago during an active flare and the second dose on 12th of July 2023, batch number: y77xy, expiry date 21 August 2024 whilst dealing with another active flare. Information about the vaccine, patient and event was provided. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Wrong Vaccine Administered; Extra dose administered; This non-serious case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA732A, expiry date 31-MAR-2024) for prophylaxis.   Concomitant products included MENVEO.   On 13-JUL-2023, the patient received the 3rd dose of Menveo (intramuscular) .5 ml. On 13-JUL-2023, an unknown time after receiving Menveo and an unknown time after receiving MENVEO, the patient experienced wrong vaccine administered (Verbatim: Wrong Vaccine Administered) and extra dose administered (Verbatim: Extra dose administered ). The outcome of the wrong vaccine administered and extra dose administered were unknown.   Additional Information: GSK receipt date 13 Jul 2023 The patient was administered a Menveo vaccine on the day of reporting, instead of a Bexsero. The patient received her second Menveo vaccine one month ago and received a third Menveo vaccine on the day of reporting. The patient was supposed to receive a Bexsero vaccine (Wrong Vaccine Administered). The reporter consented to follow up. The patient received 3rd dose of menveo vaccine instead of Bexsero vaccine which led to wrong Vaccine administered and extra dose administered.
Sex: F
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Twinrix in December 2022 and did not come back for the second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in December 2022).   On an unknown date, the patient did not receive the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced incomplete course of vaccination (Verbatim: first dose of Twinrix in December 2022 and did not come back for the second dose). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 13-JUL-2023 The reporter asked if the patient had to restart the series. The reporter did not provide patient´s initials, nor the lot number and expiry date of the first Twinrix dose. The reporter consented to follow up. Till the time of reporting the patient did not receive the 2nd dose of Twinrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Chills, Disorientation, Dizziness, Fall
Clinical narrative: Hallucinations; Disoriented; Dizzy; Weakness; high fever; Shivering; almost fell down; Scared; Patient was not received 2nd dose yet; This serious case was reported by a consumer via call center representative and described the occurrence of hallucination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm) and did not receive the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant), disorientation (Verbatim: Disoriented), dizziness (Verbatim: Dizzy), weakness (Verbatim: Weakness), fever (Verbatim: high fever), shivering (Verbatim: Shivering), fall (Verbatim: almost fell down), fear (Verbatim: Scared) and incomplete course of vaccination (Verbatim: Patient was not received 2nd dose yet). The patient was treated with paracetamol (Tylenol). The outcome of the hallucination, disorientation, dizziness, weakness, fever and shivering were resolved and the outcome of the fall was not reported and the outcome of the fear and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the hallucination, disorientation, dizziness, weakness, fever, shivering, fall and fear to be related to Shingrix.     It was unknown if the company considered the hallucination, disorientation, dizziness, weakness, fever, shivering, fall and fear to be related to Shingrix.   Additional Information: GSK Receipt date: 13-JUL-2023 A reporter reported about her self she had her 1st dose of Shingrix on her left arm in 2019 (no specific date provided), around 12PM, and at midnight the same day she woke up shivering, had a high fever (temperature not provided), hallucinations, weakness, was dizzy and almost fell down, and was disoriented Patient also reports that she took 2-3 Extra Strength Tylenol around this same time as the symptoms started, and because she was so disoriented, she could not read the Tylenol instructions that she found out the next day, said do not take more than 2 at a time. Patient reports that this all scared her, so she never went back for her 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter was did not consent to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fear, Hallucination, Incomplete course of vaccination, Pyrexia
Clinical narrative: Hallucinations; Disoriented; Dizzy; Weakness; high fever; Shivering; almost fell down; Scared; Patient was not received 2nd dose yet; This serious case was reported by a consumer via call center representative and described the occurrence of hallucination in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (left arm) and did not receive the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced hallucination (Verbatim: Hallucinations) (serious criteria GSK medically significant), disorientation (Verbatim: Disoriented), dizziness (Verbatim: Dizzy), weakness (Verbatim: Weakness), fever (Verbatim: high fever), shivering (Verbatim: Shivering), fall (Verbatim: almost fell down), fear (Verbatim: Scared) and incomplete course of vaccination (Verbatim: Patient was not received 2nd dose yet). The patient was treated with paracetamol (Tylenol). The outcome of the hallucination, disorientation, dizziness, weakness, fever and shivering were resolved and the outcome of the fall was not reported and the outcome of the fear and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the hallucination, disorientation, dizziness, weakness, fever, shivering, fall and fear to be related to Shingrix.     It was unknown if the company considered the hallucination, disorientation, dizziness, weakness, fever, shivering, fall and fear to be related to Shingrix.   Additional Information: GSK Receipt date: 13-JUL-2023 A reporter reported about her self she had her 1st dose of Shingrix on her left arm in 2019 (no specific date provided), around 12PM, and at midnight the same day she woke up shivering, had a high fever (temperature not provided), hallucinations, weakness, was dizzy and almost fell down, and was disoriented Patient also reports that she took 2-3 Extra Strength Tylenol around this same time as the symptoms started, and because she was so disoriented, she could not read the Tylenol instructions that she found out the next day, said do not take more than 2 at a time. Patient reports that this all scared her, so she never went back for her 2nd dose of Shingrix which led to incomplete course of vaccination. The reporter was did not consent to follow-up.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: Inappropriate Schedule of Vaccine; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 28th September 2019).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate Schedule of Vaccine). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 14 Jul 2023 The pharmacist had a patient who received the first dose of Shingrix back and stated the patient just showed up for a second dose. The reporter asked if any guidance? The reporter did not consent to follow-up. Till the time of reporting the patient did not received 2nd dose which led to incomplete course of vaccine
Sex: M
Vaccine: HEPA
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: adolescent patient received an adult dose of Havrix; adolescent patient received an adult dose of Havrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of overdose in a adolescent male patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, an unknown time after receiving Havrix adult, the patient experienced overdose (Verbatim: adolescent patient received an adult dose of Havrix) and inappropriate age at vaccine administration (Verbatim: adolescent patient received an adult dose of Havrix). The outcome of the overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date 14 Jul 2023 The pharmacist reported an adolescent patient received an adult dose of Havrix.  The reporter did not consent to follow-up.  The pharmacist reported an adolescent patient received an adult dose of Havrix which led to overdose and inappropriate age at vaccine administration.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Product preparation issue, Wrong technique in product usage process
Clinical narrative: Vaccine exposure during pregnancy; Inappropriate Reconstitution Technique/not shaken prior administration; This non-serious prospective pregnancy case was reported by a consumer via call center representative and described the occurrence of wrong technique in drug usage process in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 14-JUL-2023, the patient received Boostrix. On 14-JUL-2023, an unknown time after receiving Boostrix, the patient experienced wrong technique in drug usage process (Verbatim: Inappropriate Reconstitution Technique/not shaken prior administration). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: Vaccine exposure during pregnancy). The outcome of the wrong technique in drug usage process and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Boostrix): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 14-JUL-2023 The patient was in her third trimester of pregnancy and was feeling fine. The phone number provided for healthcare professional. The reporter did not consent to follow-up. The reporter was a pregnant woman who stated that she received Boostrix at the time of reporting and noticed the vaccine was not shaken prior administration, which led to wrong technique in drug usage process.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Drug Used; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 56-year-old male patient who received Herpes zoster (Shingrix) (batch number 34l52, expiry date 06-JUL-2023) for prophylaxis.   On 14-JUL-2023, the patient received Shingrix. On 14-JUL-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired Drug Used). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter was a medical assistant. The reporter stated that the patient was accidently administered an expired dose of Shingrix at the time of reporting. The reporter consented to follow up. This was 1 of 2 cases, reported by the same reporter. The patient was administered with expired dose of Shingrix, which led to expired vaccine used.; Sender's Comments:  US-GSK-US2023097103:same reporter
Age: 11.0
Sex: F
Vaccine: HEPA
Symptoms: Overdose
Clinical narrative: 11 year old female patient received a 1 mL dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 11-year-old female patient who received HAV (Havrix) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 13-JUL-2023, the patient received Havrix 1 ml. On 13-JUL-2023, an unknown time after receiving Havrix, the patient experienced overdose (Verbatim: 11 year old female patient received a 1 mL dose of Havrix). The outcome of the overdose was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 No symptoms reported. The reporter consented to follow up via email. 11 year old patient received 1 ml dose of Havrix, which led to overdose.
Age: 14.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Product Used; Extra Dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old female patient who received HAV (Havrix) (batch number F7X23, expiry date 25-MAY-2023) for prophylaxis.   Previously administered products included Hepatitis A vaccine (1st dose received on 14th October 2009) and Hepatitis A vaccine (2nd dose received on 5th April 2010).   On 13-JUL-2023, the patient received the 3rd dose of Havrix. On 13-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Product Used) and extra dose administered (Verbatim: Extra Dose). The outcome of the expired vaccine used and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 Health administrator reported that a patient was administered a dose of Havrix (after expiration date). Afterwards it was realized that this patient had already received hepatitis a series. The reporter was unsure if the first two doses were brand name Havrix. The vaccine administration facility is the same as primary reporter. The reporter consented to follow up. The patient received expired Havrix vaccine (3rd dose of hepatitis A component), which led to expired vaccine used and extra dose administered.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: diluent only administered; diluent only administered; 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 male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXZ723Z, expiry date 01-SEP-2023) for prophylaxis.   On 21-FEB-2023, the patient received Menveo. On 21-FEB-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: diluent only administered) and inappropriate dose of vaccine administered (Verbatim: diluent only administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal mail. The patient received only diluent component of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: Havrix incorrect schedule/a pediatric patient received three doses of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a infant male patient who received HAV (Havrix pediatric) for prophylaxis.   Previously administered products included Havrix pediatric (received 2 doses of Havrix pediatric on an unknown date).   On an unknown date, the patient received the 3rd dose of Havrix pediatric. On an unknown date, an unknown time after receiving Havrix pediatric, the patient experienced extra dose administered (Verbatim: Havrix incorrect schedule/a pediatric patient received three doses of Havrix). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 14-Jul-2023 The reporter consented to follow-up. A pediatric patient received three doses of Havrix, which led to extra dose administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Received Shingrix on 2020 Jan 30th Never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 82-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 30th January 2020).   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: Received Shingrix on 2020 Jan 30th Never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only the liquid portion of Menveo was administered to a patient; only the liquid portion of Menveo was administered to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA908A, expiry date 30-APR-2024) for prophylaxis.   On 10-JUL-2023, the patient received Menveo. On 10-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only the liquid portion of Menveo was administered to a patient) and inappropriate dose of vaccine administered (Verbatim: only the liquid portion of Menveo was administered to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 14-Jul-2023 The reporter consented to follow-up via postal. The patient only received the liquid portion of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Received expired dose of boostrix vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 374lb, expiry date 28-JUN-2022) for prophylaxis.   On 01-JUL-2023, the patient received Boostrix. On 01-JUL-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Received expired dose of boostrix vaccine). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 14-JUL-2023 The reporter was the patient's father. The reporter did consent to follow up. The patient received a Boostrix vaccine which was already expired, which led to expired vaccine used.