chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: A mild fever; headache; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: A mild fever) and headache (Verbatim: headache). The outcome of the fever and headache were not reported.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.     It was unknown if the company considered the fever and headache to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR111144   Additional Information: GSK Receipt date: 14-AUG-2023 This case was reported by a consumer via interactive digital media. The patient hated the shingle shots because it was a two part series. The 1st shot was not bad, minor residue effects. A mild fever and headache. The 2nd one hit me like a bat to the head. Headache, fever, lethargic etc. But it was worth it. The patient had friends who had shingles and they hated life. For tolerance of 2nd dose refer case US2023AMR111144.; Sender's Comments:  US-GSK-US2023AMR111144:
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Pyrexia
Clinical narrative: fever; headache; lethargic; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pyrexia (1st dose received on an unknown date and experienced headache).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced fever (Verbatim: fever), headache (Verbatim: headache) and lethargy (Verbatim: lethargic). Rechallenge with Shingrix was positive. The outcome of the fever, headache and lethargy were not reported.   It was unknown if the reporter considered the fever, headache and lethargy to be related to Shingrix.     It was unknown if the company considered the fever, headache and lethargy to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR111119   Additional Information: GSK Receipt date: 14-AUG-2023 This case was reported by a consumer via interactive digital media. The 2nd one hit me like a bat to the head. Headache, fever, lethargic etc. But it was worth it. The patient had friends who had shingles and they hated life.; Sender's Comments:  US-GSK-US2023AMR111119:
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administration of Kinrix (probably instead of Pediarix); Kinrix - Inappropriate age; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 2-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 03-AUG-2023, the patient received Kinrix. On 03-AUG-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: administration of Kinrix (probably instead of Pediarix)) and inappropriate age at vaccine administration (Verbatim: Kinrix - Inappropriate age). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2023 The healthcare professional asked for guidance on this situation. The reporter did not provide Kinrix lot number and expiration date. The reporter consented to follow up. The reporter reported that the administration of Kinrix to a 2 year old patient (probably instead of Pediarix), which led to wrong vaccine administered and inappropriate age at vaccine administration.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Haematuria, Laboratory test abnormal
Clinical narrative: bloody urine after getting SHINGRIX; This non-serious case was reported by a consumer via call center representative and described the occurrence of hematuria in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included hematuria (had a history of bloody urine after certain medications).   On 09-AUG-2023, the patient received the 2nd dose of Shingrix. On 10-AUG-2023, 1 days after receiving Shingrix, the patient experienced hematuria (Verbatim: bloody urine after getting SHINGRIX). On 11-AUG-2023, the outcome of the hematuria was resolved (duration 24 hrs).   It was unknown if the reporter considered the hematuria to be related to Shingrix.     It was unknown if the company considered the hematuria to be related to Shingrix.   Additional Information: GSK receipt date: 11-Aug-2023 The patient received a dose of Shingrix and stated that next morning she had bloody urine. Spoken as per package inset and offered package insert. Medical information phone number was provided. Referred to health care professional.  The reporter did not consent to follow-up.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Infanrix instead of Tdap; Inappropriate age at vaccine administration; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received DTPa (Infanrix) (batch number 7C9NJ, expiry date 02-NOV-2024) for prophylaxis.   On 14-AUG-2023, the patient received Infanrix. On 14-AUG-2023, an unknown time after receiving Infanrix, the patient experienced wrong vaccine administered (Verbatim: Infanrix instead of Tdap) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 18-AUG-2023 Nurse calls to report Infanrix was given by mistake instead of Tdap wrong vaccine administered and inappropriate age at vaccine administration. The reporter consented to follow up via email agreed. The vaccine administration facility is the same as primary reporter.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest X-ray, Chills, Computerised tomogram, Fatigue, Gait disturbance
Clinical narrative: 12 hours after injection fever, chills, and fatigue. I had an episode of my body  wanting to fall to right as walking. I slept rest of day.  Day 2 still tired but forced my self to be active and complete some tasks. On third day felt better and did several chores throughout the day. At 5 pm I had a sudden surge of my body to pull right then immediate spin of room. I went to the floor as I knew I would faint.  I did not lose consciousness but had to be transported by ambulance to hospital to stabilize. Vomited 12-15 times. Was administered Zofran, Compazine, Ativan in the ER to help with spinning in my head. My thought is that this vaccine triggered my . Meniere disease. This vaccine maybe should have a warning  for Meniere' patients about this so no one else has to go through what I did.  Today is day five and my spinning is gone but am very wiped out from the experience.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersomnia, Magnetic resonance imaging, Pyrexia, Vertigo, Vomiting
Clinical narrative: 12 hours after injection fever, chills, and fatigue. I had an episode of my body  wanting to fall to right as walking. I slept rest of day.  Day 2 still tired but forced my self to be active and complete some tasks. On third day felt better and did several chores throughout the day. At 5 pm I had a sudden surge of my body to pull right then immediate spin of room. I went to the floor as I knew I would faint.  I did not lose consciousness but had to be transported by ambulance to hospital to stabilize. Vomited 12-15 times. Was administered Zofran, Compazine, Ativan in the ER to help with spinning in my head. My thought is that this vaccine triggered my . Meniere disease. This vaccine maybe should have a warning  for Meniere' patients about this so no one else has to go through what I did.  Today is day five and my spinning is gone but am very wiped out from the experience.
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 84.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 47.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 32.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inadvertently given second Shingrix dose about 5 weeks after the first dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number 5D5Z4, expiry date 25-OCT-2024) for prophylaxis.   Concurrent medical conditions included immunocompromised. Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 04-AUG-2023, the patient received the 2nd dose of Shingrix. On 04-AUG-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: inadvertently given second Shingrix dose about 5 weeks after the first dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt date: 14-AUG-2023 Pharmacist reports 75 year old immunocompetent patient was inadvertently given second Shingrix dose about 5 weeks after the first dose which led to shortening of vaccinations schedule.   The doses were given on 26June 2023 and 04 August 2023. The reporter consented to follow up. The vaccine administration facility is the same as primary reporter. Reporter gave permission for follow-up.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Injection site reaction, Injection site warmth, Neuralgia, Paraesthesia, Rash erythematous
Clinical narrative: Patient reported having felt tingling nerve pains up from vaccination to placement to the shoulder which dissipated after 1 or 2 hours. The following day she developed a warm, red rash at the injection site. The rash was still present 2 days after injection when she reported to the pharmacy.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Vaccination site reaction
Clinical narrative: Patient reported having felt tingling nerve pains up from vaccination to placement to the shoulder which dissipated after 1 or 2 hours. The following day she developed a warm, red rash at the injection site. The rash was still present 2 days after injection when she reported to the pharmacy.
Age: 81.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 68.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC15, RV5, DTPPVHBHPB, PNC15, RV5
Symptoms: Rash
Clinical narrative: a rash errupted all over patients skin.
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 78.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past its expiration date. We contacted Moderna , the mfg, who performed an analysis of the lot #043H22A, They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at the time of the administration."
Age: 57.0
Sex: F
Vaccine: COVID19-2
Symptoms: Acoustic stimulation tests, Deafness unilateral, Magnetic resonance imaging, Sudden hearing loss
Clinical narrative: Sudden hearing loss in left ear only.
Age: 49.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Twinrix in March 2020 and then a second dose in 5-22-2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 49-year-old female patient who received HAB (Twinrix) (batch number 2PG39, expiry date 19-SEP-2025) for prophylaxis.   Previously administered products included Twinrix (received 1st dose in March 2020).   On 22-MAY-2023, the patient received the 2nd dose of Twinrix. On 22-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: first dose of Twinrix in March 2020 and then a second dose in 5-22-2023). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:15-AUG-2023 The reporter consented to follow up via email agreed. The Vaccine Administration Facility was the same as Primary Reporter. The patient received 2nd dose of Twrinrix later than the recommended schedule , which led to lengthening of vaccination schedule.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: two year old patient inadvertently received a dose of Kinrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 07-OCT-2024) for prophylaxis.   On 14-AUG-2023, the patient received Kinrix. On 14-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: two year old patient inadvertently received a dose of Kinrix.). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt date: 15-AUG-2023 The reporter reported that patient inadvertently received a dose of Kinrix. The reporter did consent to follow up. At the time of reporting, Kinrix was given to a 2 years old patient, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix back on 12/1/2020 and never followed through on getting the second vaccine.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 1st December 2020 batch number 7TB74).   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:  first dose of Shingrix back on 12/1/2020 and never followed through on getting the second vaccine.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-AUG-2023 Medical Assistant called to inquire how to proceed with the second dose of Shingrix. Should patient start over the series or should we give the second dose. Medical Assistant reported a patient over 50 years old received first dose of Shingrix back on 12/1/2020 and never followed through on getting the second vaccine. Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient inadvertently received a dose of Kinrix; 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 15-month-old female patient who received DTPa-IPV (Kinrix) (batch number 25ZH4, expiry date 27-OCT-2024) for prophylaxis.   On 07-AUG-2023, the patient received Kinrix. On 07-AUG-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: patient inadvertently received a dose of Kinrix). The outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Aug-2023 The reporter consented to follow-up. The patient received a dose of Kinrix inadvertently at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: M
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: administration of Rotarix dose that was 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 4-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number 7D7RY, expiry date 25-FEB-2024) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation (oral). On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced wrong solution used in drug reconstitution (Verbatim: administration of Rotarix dose that was reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution 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: 15-AUG-2023 A nurse reported that administration of Rotarix dose that was reconstituted with sterile water instead of the accompanying diluent in the prefilled oral applicator, which led to wrong solution used in drug reconstitution. The reporter asked for guidance on this situation.  The reporter consented to follow up.
Age: 1.83
Sex: F
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: administered a Boostrix dose to a patient today on 8/15/23, instead of the intended Infanrix dose; Inappropriate age at vaccine administration; 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 22-month-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 34FR4, expiry date 23-SEP-2024) for prophylaxis.   On 15-AUG-2023, the patient received Boostrix (rt. vastus lateralis). On 15-AUG-2023, an unknown time after receiving Boostrix, the patient experienced wrong vaccine administered (Verbatim: administered a Boostrix dose to a patient today on 8/15/23, instead of the intended Infanrix dose) and inappropriate age at vaccine administration (Verbatim: Inappropriate age at vaccine administration). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 15-Aug-2023 The medical assistant called to inquired that how to proceed with the patient's series. The reporter stated this would had been an attempt at 4 of the 5th series of Dtap. The reporter did not consent to follow-up. The patient inadvertently administered Boostrix instead of intended Infanrix at an inappropriate age, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patient got the first dose of Shingrix 1.5 years ago and has not had a 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 1.5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patient got the first dose of Shingrix 1.5 years ago and has not had a 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The patient had not had a second dose of Shingrix yet. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: received on August 15th 2023 a dose of lyophilized Menveo reconstituted with sterile water.; received on August 15th 2023 a dose of lyophilized Menveo 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 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA733A, expiry date 31-MAR-2024) for prophylaxis.   On 15-AUG-2023, the patient received Menveo. On 15-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: received on August 15th 2023 a dose of lyophilized Menveo reconstituted with sterile water.) and inappropriate dose of vaccine administered (Verbatim: received on August 15th 2023 a dose of lyophilized Menveo 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 16 August 2023: The nurse reported the patient received a dose of lyophilized Menveo reconstituted with sterile water. The reporter asked how to proceed?  The reporter did not consent to follow-up.  The Vaccine Administration Facility was the same as Primary Reporter. The patient received a dose of lyophilized Menveo reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent; Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent; 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 patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter called to inquire on any guidance and any information on effectiveness. The reporter reported that they noticed they had an extra vial of Menveo diluent component and the lyophilized vial was missing.  The reporter was still investigating and was unsure if a patient was administered or not. The reporter was unable to provide any vaccine or patient details. The reporter did not consent to follow-up. The reporter mentioned that they thought a patient might had been administered with a Menveo powder component reconstituted with a non-GSK diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 15.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, MNQ, TDAP, VARCEL
Symptoms: Nausea, Vomiting
Clinical narrative: Patient complained of feeling nauseous after receiving the vaccines and immediately started vomiting. Stayed with the patient as he vomited, applied cold compress, gave him cold water after. He said he felt better. In post vac for 30 minutes. Advised mom to report any additional side effect if it happens.
Age: 73.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Superficial vein thrombosis
Clinical narrative: 7 months after vaccination developed superficial thrombophlebitis which is a clotting event.  No previous history of issues. No previous Covid-19 Infection.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site macule
Clinical narrative: Blotchy pink marking 2x3 inches Lateral right thigh
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 53.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute myocardial infarction, Coronary arterial stent insertion, Coronary artery occlusion
Clinical narrative: 7 months after mandated (IHS) injection  suffered 95-99% blockage of LAD STEMI in otherwise healthy active duty patient. resulted in hospitalization, cardiac stent, numerous medications
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 75.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 23.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: PATIENT RECEIVED VACCINE AFTER BUD.
Age: 78.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported 2 separate areas about 1 inch wide below the injection site. Patient stated that the irritated site is about 3 inches below the injection area and there is no redness/swelling  on the injection area, just below it. Patient reported they have a large area with redness and swelling and it is hot to the touch. Patient denied any hives or welts.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Inadvertently administered Varicella vaccine that was due on 09/12/2023. Noticed vial was expired (08/13/2023). Pt tolerated injection and there were no s/sx of adverse reaction status post administration of vaccine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, X-ray normal
Clinical narrative: Pt had first dose of Shingrix shot at our pharmacy 03/05/23. Pt complained of his shoulder pain (starting from elbow up to shoulder) the day after the shot until now. MD office did X-ray but it's negative. There's no inflammation nor other symptom. Pt saw MD & got Ibuprofen 600mg, but it didn't help much. Patient had to get Triamcinolone shot yesterday 8/22/23 at MD office because he didn't have money to get the shot since April 07/23  when pt saw MD the first time
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Rash, Rhinorrhoea, Screaming, Skin burning sensation
Clinical narrative: Runny nose for a few days after vaccine administration  Severe rash and burning skin starting on Aug 20th at night, much worse the next morning and has persisted daily. Rash is identical to the rash she had when eating eggs the first time. Screaming that her legs burn. Rash has circular spots and other spots that are large with jagged edges. Improves with Benadryl and cortisone cream but comes back throughout the day.
Age: 76.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of Lot # 043H22A. They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of the administration."
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: The Moderna vaccine was administered past it's expiration date. We contacted Moderna, the mfg who performed an analysis of Lot # 043H22A. They determined: "the vaccines administered from June 9, 2023 to July 5, 2023 maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of the administration."
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Burning sensation, Feeling abnormal, Immediate post-injection reaction, Injection site pain
Clinical narrative: On June 18th, 2018, patient took the HPV Vaccination (Gardasil 9). Upon the vaccination, patient immediately fell ill and fainted. She than later complained of severe Migraines, feeling out of body, severe abdominal pain , nausea, vomiting, paralysis, severe pain at the injection site and complaining that her brain was on fire. Patient was sent home, but returned later that evening with more severe symptoms. She was treated with multiple medications and sent to specialists for further examination.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Migraine, Nausea, Paralysis, Syncope
Clinical narrative: On June 18th, 2018, patient took the HPV Vaccination (Gardasil 9). Upon the vaccination, patient immediately fell ill and fainted. She than later complained of severe Migraines, feeling out of body, severe abdominal pain , nausea, vomiting, paralysis, severe pain at the injection site and complaining that her brain was on fire. Patient was sent home, but returned later that evening with more severe symptoms. She was treated with multiple medications and sent to specialists for further examination.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Vomiting
Clinical narrative: On June 18th, 2018, patient took the HPV Vaccination (Gardasil 9). Upon the vaccination, patient immediately fell ill and fainted. She than later complained of severe Migraines, feeling out of body, severe abdominal pain , nausea, vomiting, paralysis, severe pain at the injection site and complaining that her brain was on fire. Patient was sent home, but returned later that evening with more severe symptoms. She was treated with multiple medications and sent to specialists for further examination.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pyrexia
Clinical narrative: Fever of 101.7
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Death, Infant irritability, Lethargy, Respiration abnormal, Respiratory tract congestion
Clinical narrative: Noticed congested breathing, lethargic, fussy and irritable, normal soothing methods would not calm her after vaccines,  on 7.4.23 woke up to patient deceased.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: experienced tiredness and body aches; experienced tiredness and body aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of general body pain in a 50-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23-MAR-2021, the patient received the 1st dose of Shingrix. On 24-MAR-2021, 1 days after receiving Shingrix, the patient experienced general body pain (Verbatim: experienced tiredness and body aches) and tiredness (Verbatim: experienced tiredness and body aches). The outcome of the general body pain and tiredness were resolved (duration 24 hrs).   It was unknown if the reporter considered the general body pain and tiredness to be related to Shingrix.     It was unknown if the company considered the general body pain and tiredness to be related to Shingrix.   Linked case(s) involving the same patient:  US2023AMR109819   Additional Information: GSK Receipt date: 11-AUG-2023 The reporter was the wife of the patient, she reported that after the patient received the first dose of Shingrix, the patient experienced tiredness and body aches the next day, which lasted for 24 hours. For tolerance of 2nd dose refer case US2023AMR109819. The reporter consented to follow up.; Sender's Comments:  US-GSK-US2023AMR109819:same patient
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Fatigue
Clinical narrative: back pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back pain) and FATIGUE (fatigue) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS714513) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Sep-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular use) 1 dosage form. On 14-Sep-2022, the patient experienced BACK PAIN (back pain) and FATIGUE (fatigue). At the time of the report, BACK PAIN (back pain) and FATIGUE (fatigue) had not resolved.            Dose was mentioned as 02561 microgram.  The concomitant medication was not reported by reporter.  The treatment medication was not reported by reporter.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19
Clinical narrative: Covid-19 Breakthrough Infection
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Tired with aches; Tired with aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Feb2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Vaccine location: Left arm), administration date: 01Apr2022, when the patient was 65-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), PAIN (non-serious) all with onset 01Mar2023, outcome "recovered" (02Mar2023) and all described as "Tired with aches". Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: Known allergies and Other medical history: No  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Pain
Clinical narrative: Tired with aches; Tired with aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 28Feb2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 4 (BOOSTER), SINGLE, Vaccine location: Left arm), administration date: 01Apr2022, when the patient was 65-year-old, for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), PAIN (non-serious) all with onset 01Mar2023, outcome "recovered" (02Mar2023) and all described as "Tired with aches". Therapeutic measures were not taken as a result of fatigue, pain.  Additional information: Known allergies and Other medical history: No  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ageusia, Anosmia, Asthenia, Blood test normal, Brain fog
Clinical narrative: loss of sense of smell/taste; loss of sense of smell/taste; ongoing headaches; brain fog; feeling fatigued; difficulties focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FE3590), administration date: 12Oct2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: BRAIN FOG (non-serious) with onset 02Nov2021, outcome "not recovered"; DISTRACTIBILITY (non-serious) with onset 02Nov2021, outcome "not recovered", described as "difficulties focusing"; FATIGUE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "feeling fatigued"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 02Nov2021, outcome "not recovered" and all described as "loss of sense of smell/taste"; HEADACHE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "ongoing headaches". The events "loss of sense of smell/taste", "ongoing headaches", "brain fog", "feeling fatigued" and "difficulties focusing" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia, ageusia, headache, brain fog, fatigue, distractibility.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Computerised tomogram normal, Disturbance in attention, Fatigue, Headache, Migraine
Clinical narrative: loss of sense of smell/taste; loss of sense of smell/taste; ongoing headaches; brain fog; feeling fatigued; difficulties focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FE3590), administration date: 12Oct2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: BRAIN FOG (non-serious) with onset 02Nov2021, outcome "not recovered"; DISTRACTIBILITY (non-serious) with onset 02Nov2021, outcome "not recovered", described as "difficulties focusing"; FATIGUE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "feeling fatigued"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 02Nov2021, outcome "not recovered" and all described as "loss of sense of smell/taste"; HEADACHE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "ongoing headaches". The events "loss of sense of smell/taste", "ongoing headaches", "brain fog", "feeling fatigued" and "difficulties focusing" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia, ageusia, headache, brain fog, fatigue, distractibility.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Patient isolation, Weight increased
Clinical narrative: loss of sense of smell/taste; loss of sense of smell/taste; ongoing headaches; brain fog; feeling fatigued; difficulties focusing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 02Nov2021 as dose 2, single (Lot number: FF2593) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Batch/Lot No: FE3590), administration date: 12Oct2021, when the patient was 55-year-old, for COVID-19 immunization. The following information was reported: BRAIN FOG (non-serious) with onset 02Nov2021, outcome "not recovered"; DISTRACTIBILITY (non-serious) with onset 02Nov2021, outcome "not recovered", described as "difficulties focusing"; FATIGUE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "feeling fatigued"; ANOSMIA (non-serious), AGEUSIA (non-serious) all with onset 02Nov2021, outcome "not recovered" and all described as "loss of sense of smell/taste"; HEADACHE (non-serious) with onset 02Nov2021, outcome "not recovered", described as "ongoing headaches". The events "loss of sense of smell/taste", "ongoing headaches", "brain fog", "feeling fatigued" and "difficulties focusing" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of anosmia, ageusia, headache, brain fog, fatigue, distractibility.