chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Magnetic resonance imaging spinal normal
Clinical narrative: idiopathic Transverse Myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 05Mar2021, outcome "unknown", described as "idiopathic Transverse Myelitis". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: Normal. Clinical courses: Headache, cramping after 2nd injection; chills, fatigue, leg pain and difficulty walking by the second day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: This is a literature report based on a Health Authority database analysis.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event transverse myelitis  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms, Myelitis transverse, Pain in extremity
Clinical narrative: idiopathic Transverse Myelitis; This is a literature report. This is a literature report based on a Health Authority database analysis.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 05Mar2021 as dose 2, single (Batch/Lot number: unknown) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2, administration date: 12Feb2021, for COVID-19 immunisation. The following information was reported: MYELITIS TRANSVERSE (medically significant) with onset 05Mar2021, outcome "unknown", described as "idiopathic Transverse Myelitis". The patient underwent the following laboratory tests and procedures: Magnetic resonance imaging spinal: Normal. Clinical courses: Headache, cramping after 2nd injection; chills, fatigue, leg pain and difficulty walking by the second day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: This is a literature report based on a Health Authority database analysis.; Sender's Comments: Based on temporal association, the contribution of the suspect drug to the onset of event transverse myelitis  cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300065338 Same article/drug, similar event and different patient;
Age: 32.0
Sex: M
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received Pfizer Bivalent vaccine as 1st primary dose instead of monovalent.
Sex: U
Vaccine: VARZOS
Symptoms: Contusion, Pain, Swelling
Clinical narrative: Painful, it swelled up and turned blue/ It sting like a bee sting; Swelled up; Turned blue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful, it swelled up and turned blue/ It sting like a bee sting), local swelling (Verbatim: Swelled up) and bruise (Verbatim: Turned blue). The patient was treated with malus spp vinegar extract (Apple Cider Vinegar). The outcome of the pain was resolved and the outcome of the local swelling and bruise were not reported.   It was unknown if the reporter considered the pain, local swelling and bruise to be related to Shingles vaccine.     It was unknown if the company considered the pain, local swelling and bruise to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient had both shots and the shot it's self was so painful, it swelled up and turned blue. It stung like a bee sting so patient put apple cider vinegar on it and it took out the sting and felt much better. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Slight feeling of fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: Sore arm) and fatigue (Verbatim: Slight feeling of fatigue). The outcome of the pain in arm and fatigue were not reported.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051910, US2023AMR051911, US2023AMR051912   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient and her husband received the 2 shingles vaccines. neither of both had any side effects, other than a sore 3 arm and a slight feeling of fatigue the following day. The patient have heard many horror stories of people who have had shingles.  The follow-up could not be possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR051911:Same reporter - HUSBAND case US-GSK-US2023AMR051910:Same reporter US-GSK-US2023AMR051912:Same reporter - HUSBAND case
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Slight feeling of fatigue; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm (Verbatim: Sore arm) and fatigue (Verbatim: Slight feeling of fatigue). The outcome of the pain in arm and fatigue were not reported.   It was unknown if the reporter considered the pain in arm and fatigue to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and fatigue to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR051907, US2023AMR051910   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient wife via interactive digital media. The patient and his wife received the 2 shingles vaccines. neither of both had any side effects, other than a sore 3 arm and a slight feeling of fatigue the following day. The reporter have heard many horror stories of people who have had shingles.  The follow-up could not be possible as no contact details were available. This was 1 of the 4 cases, reported by the same reporter; Sender's Comments:  US-GSK-US2023AMR051910:Same rporter US-GSK-US2023AMR051907:Same reporter US-GSK-US2023AMR051912:Same reporter -  HUSBAND case
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Shot was bad enough; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of malaise 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 malaise (Verbatim: Shot was bad enough). The outcome of the malaise was not reported.   It was unknown if the reporter considered the malaise to be related to Shingles vaccine.     It was unknown if the company considered the malaise to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 17-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that, the shot to prevent shingles was bad enough. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: Was so sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced sickness (Verbatim: Was so 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: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient wasn't planning on getting vaccinated, but he/she had a transplant and they wouldn't let me proceed without one. The patient was guaranteed to get shingles if he/she didn't get the shot. The patient had no complications! well, if patient did he/she wouldn't have noticed.  The patient was so sick 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 hurts, had bad reaction; 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 still hurts, had bad reaction). 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: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient got the shingles vaccine last summer and her/his arm still hurts. apparently patient had a bad reaction. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got 1st dose, forgot 2nd; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incomplete course of vaccination (Verbatim: Got 1st dose, forgot 2nd). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 18-MAR-2023 This case was reported by a patient (daughter/ son) via interactive digital media. The reporter reported that, her/his mom got her first vaccine and when she had to go for the second one she didn't come back, she forgot it. Now she has to get two again or just get the vaccine that is missing. The follow-up could not be possible as no contact details were available. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Felt lousy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling bad 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 feeling bad (Verbatim: Felt lousy). The outcome of the feeling bad was resolved.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.     It was unknown if the company considered the feeling bad to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR052758   Additional Information: GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine and felt lousy. The patient stated that he or she did not have issue, he or she may never gotten but was proactive. The patient stated that anything that gave you an edge is worth doing. This case had been linked with US2023AMR052758 by same reporter for same patient.  Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR052758:Same reporter, 2nd dose
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Felt lousy; GSK Receipt Date: 18-MAR-2023 This case was reported by a patient via  interactive digital media. The patient reported that he or she received both doses of Shingles vaccine close together and felt lousy. The patient stated that he or she did not have issue, he or she may never gotten but was proactive. The patient stated that anything that gave you an edge is worth doing. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR052754:Same reporter, 1st dose
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.   On 17-MAR-2023, the patient received the 1st dose of Shingles vaccine. In MAR-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm). The outcome of the pain in arm was unknown.   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: 18-MAR-2023 This case was reported by a patient via interactive digital media. The patient have been reading this every day and putting off getting the shot. The patient got her/his first shot, so happy, sore arm, go back in two months and get the last thanks to all for pushing her/him. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Painful; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: Painful). The outcome of the pain was not reported.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK receipt date: 18-MAR-2023 This case was reported by a patient husband via interactive digital media. The reporter stated that, the vaccine was ten times more painful than a tetanus shot. The reporter asked is there any way you could make the shingles vaccine less painful. The reporter wife took the vaccine and she said it was ten times worse than the vaccine against tetanus. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK receipt date: 19-MAR-2023 This case was reported by a patient via interactive digital media. The patient stated that nothing more than her/his arm being a little sore. so, no real side side effects. The follow-up could not be possible as no contact details were available.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Induration, Injection site erythema, Injection site induration, Injection site pain, Tenderness
Clinical narrative: Pain, painful; Hardness at werid spot, hardness has decreased; Red area, diffused and lighten in color; Tender, tenderness still there; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-APR-2023, the patient received the 2nd dose of Shingrix (unknown deltoid). On 02-APR-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Pain, painful) and injection site induration (Verbatim: Hardness at werid spot, hardness has decreased). In APR-2023, the patient experienced erythema of extremities (Verbatim: Red area, diffused and lighten in color) and tenderness (Verbatim: Tender, tenderness still there). The outcome of the injection site pain and tenderness were not resolved and the outcome of the injection site induration and erythema of extremities were resolving.   It was unknown if the reporter considered the injection site pain, injection site induration, erythema of extremities and tenderness to be related to Shingrix.     It was unknown if the company considered the injection site pain, injection site induration, erythema of extremities and tenderness to be related to Shingrix.   Additional Information: GSK Receipt Date: 03-APR-2023 The reporter was the patient.  The next day of vaccination the patient noticed pain and hardness at a weird spot to where the injection was administered.  The injection site where it was administered was below the red area. The redness was more toward the upper area on top of patient's deltoid area, more toward the front of the arm.  The patient reported that redness had grown and was hard, painful and tender.  The patient stated that it had diffused and lighten in color and also the hardness had decreased but the pain and tenderness was still there.  The reporter consented to follow up with her and healthcare professional.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Shingrix mixed with other diluent / inadvertently used sterile water to SHINGRIX; 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 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   On 31-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular, right deltoid). On 31-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix mixed with other diluent / inadvertently used sterile water to SHINGRIX). The outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 03-APR-2023 The reporter stated that they inadvertently used sterile water to reconstitute Shingrix and then administered to a patient. They did not use the adjuvant that comes in box, they used the diluent that comes with the Merk vaccines. Mixed different manufactured products in one syringe and then administered.  Shingrix reconstituted with merk sterile water diluent instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Adult dose given to 12MO patient; Adult dose given to 12MO patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received HAV (Havrix adult) (batch number 3J9G4, expiry date 30-AUG-2025) for prophylaxis.   On 03-APR-2023, the patient received Havrix adult. On 03-APR-2023, an unknown time after receiving Havrix adult, the patient experienced inappropriate age at vaccine administration (Verbatim: Adult dose given to 12MO patient) and overdose (Verbatim: Adult dose given to 12MO patient). The outcome of the inappropriate age at vaccine administration and overdose were unknown.   Additional Information: GSK receipt date: 04-APR-2023 The reporter asked for safety information regarding such situation.  The reporter consented to follow up. The patient administered the Havrix adult vaccine to infant which led to inappropriate age at vaccine administration and overdose.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Myalgia
Clinical narrative: Sore at injection site; Headaches; Muscle soreness; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 04-APR-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On 05-APR-2023, 1 days after receiving Shingrix, the patient experienced injection site pain (Verbatim: Sore at injection site), headache (Verbatim: Headaches) and muscle soreness (Verbatim: Muscle soreness). The outcome of the injection site pain, headache and muscle soreness were unknown.   It was unknown if the reporter considered the injection site pain, headache and muscle soreness to be related to Shingrix.     It was unknown if the company considered the injection site pain, headache and muscle soreness to be related to Shingrix.   Additional Information: GSK Receipt Date: 05-APR-2023 The case was self-reported by the patient. The patient received first dose of Shingrix vaccine in evening and woke up on the day of reporting with headaches, muscle soreness and sore at injection site. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This non-serious case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 2-year-old male patient who received HAV (Havrix) (batch number T57F3, expiry date 16-FEB-2023) for prophylaxis.   On 03-APR-2023, the patient received Havrix. On 03-APR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired Havrix administered). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 05-APR-2023  The physician reported an expired dose of Havrix was administered to a patient. The reporter consented to follow up via phone. The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: U
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Men B NVS (Bexsero) (batch number 59m3m, expiry date 28-FEB-2023) for prophylaxis.   On 05-APR-2023, the patient received Bexsero. On 05-APR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 05-APR-2023  The pharmacist reported a patient received an expired dose of Bexsero on the day of reporting.  The pharmacist did not had patient details.  The reporter consented to follow up via email. The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 1.25
Sex: M
Vaccine: MNQ
Symptoms: Wrong product administered
Clinical narrative: Menveo given instead of Hib vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA165A, expiry date 15-MAY-2023) for prophylaxis.   On 05-APR-2023, the patient received Menveo. On 05-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong vaccine administered (Verbatim: Menveo given instead of Hib vaccine). The outcome of the wrong vaccine administered was unknown.   Additional Information: GSK receipt date: 05-APR-2023  A medical assistant reported that a patient was accidentally given a dose of Menveo instead of the Hib vaccine.  They provided information about the vaccine and patient. The vaccine administration facility was the same as primary reporter. They accepted to receive follow-up via e-mail. The patient received received Menveo instead of Hib vaccine, which led to wrong vaccine used.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix pediatric given to an adult; Engerix pediatric given to an adult; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental underdose in a 20-year-old female patient who received HBV (Engerix B pediatric) (batch number F22EZ, expiry date 03-JUN-2023) for prophylaxis.   On 05-APR-2023, the patient received Engerix B pediatric 10 ug. On 05-APR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced accidental underdose (Verbatim: Engerix pediatric given to an adult) and adult use of a child product (Verbatim: Engerix pediatric given to an adult). The outcome of the accidental underdose and adult use of a child product 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: 06-APR-2023 The Medical Assistant called to inquire. It was reported an Engerix pediatric (10 mcg, Prefilled) dose was inadvertently administered to an adult patient. The reporter mentioned the dose was administered at an alternate facility. The reporter did not consent to follow-up. Engerix-B was inadvertently administered a pediatric dose to an adult patient, which led to accidental underdose and adult use of a child product.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: Expired Boostrix administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 58-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number GC5NG, expiry date 01-APR-2023) for prophylaxis.   On 03-APR-2023, the patient received Boostrix. On 03-APR-2023, an unknown time after receiving Boostrix, the patient experienced expired vaccine used (Verbatim: Expired Boostrix administered). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Apr-2023 The office manager called to inquired that how to proceed, the dose was still good. The reporter did not consent to follow-up. The patient inadvertently received an expired dose of Boostrix in reporter's facility, which led to expired vaccine used.
Age: 61.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Herpes zoster, Rash, Scar
Clinical narrative: Scarring where the rash occurred; Shingles/ Lack of effect; Rash on torso, in patches; This non-serious case was reported by a consumer via call center representative and described the occurrence of shingles in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Influenza vaccine) for prophylaxis.   The patient's past medical history included shingles. Concomitant products included valaciclovir hydrochloride (Valtrex).   On 18-JAN-2023, the patient received the 1st dose of Shingrix (left arm) and Influenza vaccine (right arm). On 30-JAN-2023, 12 days after receiving Shingrix and Influenza vaccine, the patient experienced shingles (Verbatim: Shingles/ Lack of effect) and patchy rash (Verbatim: Rash on torso, in patches). On an unknown date, the patient experienced scar (Verbatim: Scarring where the rash occurred). On 06-APR-2023, the outcome of the patchy rash was resolved (duration 2 months 7 days). The outcome of the shingles was unknown and the outcome of the scar was not reported.   It was unknown if the reporter considered the shingles, patchy rash and scar to be related to Shingrix and Influenza vaccine.     It was unknown if the company considered the shingles, patchy rash and scar to be related to Shingrix and Influenza vaccine.   Additional Information: GSK receipt date: 06-Apr-2023  The case was reported by patient's wife.  The reporter stated that the patient received first dose of Shingrix and on 30 January 2023, the patient developed a rash on his torso on the right side, front and back.  The rash was right above his nipple on his front side and the rash was in patches extending to the mid-line of his back.  The reporter stated that the patient also had the flu vaccine (unknown which manufacturer) administered at the same time in the right arm.  The patient contacted his physician on 01 February 2023 and the rash confirmed as Shingles.  The physician started the patient on Valtrex.  The reporter stated that today on the day of reporting the rash has cleared up but the patient does have some scarring where the rash occurred.  The reporter consented to follow up. This case had been linked with US2023050865, US2023AMR051192 same reporter.; Sender's Comments:  US-GSK-US2023AMR051192:Same reporter - wife case US-GSK-US2023050866:Same reporter - wife case
Sex: F
Vaccine: VARZOS
Symptoms: Bone swelling, Product administered at inappropriate site, Swelling
Clinical narrative: Clavicle and neck swollen; neck swollen; Vaccine administered too high on arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of bone swelling in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of headache (first dose received on an unknown date, refer case id US2023AMR051192).   On an unknown date, the patient received the 2nd dose of Shingrix (right arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced bone swelling (Verbatim: Clavicle and neck swollen), neck swelling (Verbatim: neck swollen) and vaccine administered at inappropriate site (Verbatim: Vaccine administered too high on arm). The outcome of the bone swelling, neck swelling and vaccine administered at inappropriate site were unknown.   It was unknown if the reporter considered the bone swelling and neck swelling to be related to Shingrix.     It was unknown if the company considered the bone swelling and neck swelling to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR051192   Additional Information: GSK receipt date: 03-Apr-2023  The patient received the second dose of Shingrix. After the second Shingrix vaccination, the patient experienced clavicle and neck swollen.  The consumer reported that the vaccine was given higher up on her arm and she commented to the administrator that she thought it was administered too high (wrong injection technique). The reporter consented to follow up. This case had been linked with US2023050865 same reporter. The patient received the vaccine too high on arm which led to vaccine administered at inappropriate site.; Sender's Comments:  US-GSK-US2023AMR051192:Same reporter US-GSK-US2023050865:Same reporter - husband case
Sex: F
Vaccine: VARZOS
Symptoms: Injection site papule, Injection site pruritus
Clinical narrative: Itchy at injection site; Skin bumps at injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 49EL9, expiry date 07-FEB-2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced injection site itching (Verbatim: Itchy at injection site) and injection site papule (Verbatim: Skin bumps at injection site). The outcome of the injection site itching and injection site papule were unknown.   It was unknown if the reporter considered the injection site itching and injection site papule to be related to Shingrix.     It was unknown if the company considered the injection site itching and injection site papule to be related to Shingrix.   Additional Information: GSK receipt date: 06-Apr-2023  The patient developed itchy skin bumps at the injection site. The reporter consented to follow up.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 06Feb2022, 2nd 10Feb2023; 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 60-year-old female patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (received first dose on 6th February 2022).   On 10-FEB-2023, the patient received the 2nd dose of Twinrix. On 10-FEB-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 06Feb2022, 2nd 10Feb2023). 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: 7-Apr-2023 The patient did not get the second dose until 10th February 2023.  The pharmacist called to inquired that how to proceed with Twinrix series. The reporter reported a patient did not follow the dosing schedule for Twinrix.  The patient was in pharmacy now with interest in the third dose.  The reporter asked that how should they proceed. The reporter unable to provide past vaccine details. The reporter consented to follow-up. The patient received the second dose of Twinrix later than the recommended interval, which led to lengthening of vaccine schedule.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Inappropriate schedule of product administration, Product prescribing error
Clinical narrative: Dr. prescribed a 3rd dose; 1st dose 26Sep2019, 2nd 07Feb2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 2722H, expiry date 08-FEB-2024) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 26th September 2019).   On 07-FEB-2023, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. On 07-FEB-2023, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 26Sep2019, 2nd 07Feb2023). On an unknown date, the patient experienced drug prescribing error (Verbatim: Dr. prescribed a 3rd dose). The outcome of the drug dose administration interval too long and drug prescribing error were unknown.   Additional Information: GSK receipt date: 7-Apr-2023 The reporter asked that was that correct. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. A physician prescribed third dose to the patient, which led to drug prescribing error.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent administered; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patients received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patients experienced inappropriate preparation of medication (Verbatim: Only diluent administered) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 7-Apr-2023 The health care professional reported that there were a number of patients that might had received the Shingrix with diluent only.  The reporter would like one dose vs 3 dose efficacy of Shingrix and already received Shingrix administration recommendations when only the diluent was given.  No patient identifiers and no reactions were reported.  The reporter did not state whether he would vaccinate patients with a 3rd dose or not vaccinating with an additional dose after just the diluent was given.  The reporter was the middle man and did not had additional information to share. The reporter consented to follow-up via email. The patients received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: HEP
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2019, wants to continue the series; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Hepatitis B vaccine for prophylaxis.   Previously administered products included Hepatitis B vaccine (received first dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Hepatitis B vaccine. On an unknown date, an unknown time after receiving Hepatitis B vaccine, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 2019, wants to continue the series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 7-Apr-2023 A pharmacist called in to report that a patient wishes to continue the vaccine series for the Hepatitis B vaccine. The reporter did not know the age of the patient at the time they received the first dose, did not know the brand, nor place of the vaccination. The call was escalated to second line. The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Hepatitis-B, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only powder portion given with other diluent; Only powder portion given with other diluent; 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 patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA903A, expiry date 31-JAN-2024) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: Only powder portion given with other diluent) and inappropriate dose of vaccine administered (Verbatim: Only powder portion given with other diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-APR-2023 The medical assistant reported that the patient received only the powder portion of Menveo might have been given to a patient. The healthcare professional reported that she found that only one diluent left in the box so a powder with other diluent might had been given but was unsure of vaccination date or patient. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by email. The patient received only the powder portion of Menveo with other diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Powder vial reconstituted with sterile water; Powder vial 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 18-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA977A, expiry date 31-MAY-2024) for prophylaxis.   On 10-APR-2023, the patient received the 2nd dose of Menveo. On 10-APR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Powder vial reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Powder vial 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: 11-APR-2023 The nurse practitioner noticed that they have an extra vial of Menveo vaccines.  The nurse have a potential 18 year patient that could has probably received Menveo powder vial reconstituted with sterile water from another vaccine. Follow up accepted but health care practitioner (HCP) prefers a first contact by phone. The reporter consented to follow up. The patient that could has probably received Menveo powder vial reconstituted with sterile water from another vaccine, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
Sex: U
Vaccine: COVID19
Symptoms: Deafness, Vertigo
Clinical narrative: HEARING LOSS; VERTIGO; This spontaneous report was received from literature. The objective of this study was to describe cases of tinnitus after COVID-19 vaccination mainly to raise awareness of this possibility and prompt referral for audiology and otolaryngology evaluation for possible concurrent sudden sensorineural hearing loss and treatment as appropriate. The patient's weight, height, and medical history were not reported. This study involved 27 patients out of which 4 patients received JANSSEN COVID-19 VACCINE. The patients ranged in age from 41 to 84 years old including seven male and twenty female patients. Patients were included if they are having possible covid vaccine related tinnitus and reported tinnitus onset within four weeks of any COVID-19 vaccine dose, no other attributable cause was identified, had an audiogram after onset of symptoms and at least one visit with our Otolaryngologists. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, within four weeks after vaccination, the patient experienced hearing loss, and vertigo (dizziness and tinnitus experienced by the patient were subsumed under vertigo). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vertigo and hearing loss was not reported. The authors concluded that there is no definite correlation could be established between COVID-19 vaccine and tinnitus with this retrospective study with such few cases. However, patients will still present to their medical providers with tinnitus with and without hearing loss after a COVID-19 vaccination. In cases of sudden hearing loss, treatment with oral and/or intratympanic steroids within the recommended time frame should be considered based on prior clinical practice guidelines as causation by COVID-19 vaccination has not been proven. Improvement in tinnitus after steroids is not clearly shown and providers should use their discretion in each individual case. This report was serious (Other Medically Important Condition). This case, from Same Literature article is linked to 20230410678, 20230427728 and 20230424648.; Sender's Comments: V0: 20230424639-Hearing loss. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: UNEXPLAINABLE CARDIAC EPISODE; This spontaneous report received from a patient concerned a 30 year old of unspecified sex. The patient's weight was 140 pounds, and height was 68 inches. The patient's pre-existing medical conditions included: The patient had no high cholesterol or an unhealthy eating habit. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced unexplainable cardiac episode. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unexplainable cardiac episode was not reported. This report was non-serious.