chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, FLU3, HEP, HEPA, HPV9, IPV, TDAP, VARCEL
Symptoms: Wrong patient
Clinical narrative: I gave the wrong vaccines to the patient. She got her sister's vaccines instead, after realizing what I did wrong, I called my coordinator and followed the steps to correct the issue. I then gave the patient the corrected dose of vaccines.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child recieved a dose of PedvaxHIB at the 6 month visit although the child was not due for the vaccine at this time.
Age: 0.5
Sex: M
Vaccine: COVID19, DTAPHEPBIP, FLU3, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child recieved a dose of PedvaxHIB at the 6 month visit although the child was not due for the vaccine at this time.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child recieved a dose of PedvaxHIB at the 6 month visit although the child was not due for the vaccine at this time.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child recieved a dose of PedvaxHIB at the 6 month visit although the child was not due for the vaccine at this time.
Sex: F
Vaccine: DTAPHEPBIP, HEP, MMRV
Symptoms: Extra dose administered
Clinical narrative: 2 Hep B given on the same day.
Age: 87.0
Sex: M
Vaccine: FLU3
Symptoms: Brain fog, Dizziness
Clinical narrative: dizzy, could not think straight , in a fog mentally, could not reason ect.
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Anion gap, Atelectasis, Basophil count decreased, Basophil percentage decreased, Blood albumin normal
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood bilirubin normal, Blood calcium normal, Blood chloride increased, Blood creatinine normal, Blood glucose normal
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Computerised tomogram thorax
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Creatinine renal clearance decreased, Differential white blood cell count, Dizziness, Electrocardiogram, Eosinophil count decreased
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Eosinophil percentage decreased, Fibrin D dimer increased, Glomerular filtration rate normal, Haematocrit normal, Haemoglobin normal
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Immature granulocyte count, International normalised ratio normal, Lung opacity, Lymphocyte count decreased, Lymphocyte percentage decreased
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Mean cell haemoglobin concentration normal, Mean cell haemoglobin increased, Mean cell volume increased, Mean platelet volume normal, Memory impairment
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Monocyte count normal, Monocyte percentage, Neutrophil count normal, Neutrophil percentage increased, Platelet count normal
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Protein total normal, Prothrombin time normal, Pulmonary embolism, Red blood cell count decreased, Red blood cell nucleated morphology
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 56.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Red cell distribution width increased, White blood cell count normal
Clinical narrative: 1-Multiple subsegmental pulmonary emboli without acute cor pulmonale,  Small volume subsegmental pulmonary emboli without evidence of heart strain. 2. Mosaic pattern in the lungs could represent perfusion changes or small airways disease.                                                                                                                                                                                                                 3- Mild atelectasis.                                                                                                                                                                                                                                                                    4-Dizziness, memory issues,
Age: 49.0
Sex: F
Vaccine: PNC21
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Intense pain, swelling, and redness at injection site. "Much worse than any other vaccine I've ever had, and I've had a lot of vaccines." Severe arm pain, not the typical muscle soreness, much more severe on Day 1.  On Day 2, patient reports feeling "horrible" body aches, fever, extremely sick feeling. Day 3 redness is spreading out around injection site and further down upper arm and is now itching severely and not just on skin, feels like it is itching in the muscle.
Age: 49.0
Sex: F
Vaccine: PNC21
Symptoms: Malaise, Pain
Clinical narrative: Intense pain, swelling, and redness at injection site. "Much worse than any other vaccine I've ever had, and I've had a lot of vaccines." Severe arm pain, not the typical muscle soreness, much more severe on Day 1.  On Day 2, patient reports feeling "horrible" body aches, fever, extremely sick feeling. Day 3 redness is spreading out around injection site and further down upper arm and is now itching severely and not just on skin, feels like it is itching in the muscle.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC20
Symptoms: Extra dose administered
Clinical narrative: Vares completed 2/21
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Red area around shot site, rash from site to his elbow right arm and rash on face
Age: 76.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19, COVID19, COVID19
Symptoms: Death
Clinical narrative: Patient expired on 2/19/2025.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child was not due for.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal X-ray, Abdominal discomfort, Abdominal pain, Abdominal pain upper, Blood test normal
Clinical narrative: Nausea, abdominal pain, cramping, stomach upset, loss of appetite, headache,  inability to eat solid food due to stomach pain
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea
Clinical narrative: Nausea, abdominal pain, cramping, stomach upset, loss of appetite, headache,  inability to eat solid food due to stomach pain
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Hypoaesthesia
Clinical narrative: Also had trivalent flu vaccine on 11/15/24, presented to ER on 1/25/25 with numbness from neck down and gait instability
Age: 0.5
Sex: M
Vaccine: COVID19, DTAPHEPBIP, FLU3, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child was not due for.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC20
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Child came in for a visit to the office at 6 months and received a 3rd dose of PedvaxHIB that child was not due for.
Age: 1.17
Sex: M
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient had received a expired vaccine. The patient didn't show any sign of adverse reaction. The Provider was notified, and the provider said the patient will have to probably receive a new vaccine, so the patient gets the full dose of needed vaccine.
Age: 14.0
Sex: F
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pt was given MMRV instead of single dose of MMR and varicella given that pt is over the age of 12. Provider confirmed dose as valid per immunize.org . Parent notified at time of visit.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram neck normal, Disability, Fatigue, Lymphadenopathy
Clinical narrative: High fever up to 103 that persisted for five weeks. Swollen neck glands, body ache and fatigue.  No cold or flu symptoms.  Went to ER twice (two different facilities) and  and after multiple blood tests and cat scan of my neck (negative), negative Covid, neither ER could figute out what was causing my symptoms. I was completely dusabled for those five weeks andtook an additional month or two to fully recover my health.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: High fever up to 103 that persisted for five weeks. Swollen neck glands, body ache and fatigue.  No cold or flu symptoms.  Went to ER twice (two different facilities) and  and after multiple blood tests and cat scan of my neck (negative), negative Covid, neither ER could figute out what was causing my symptoms. I was completely dusabled for those five weeks andtook an additional month or two to fully recover my health.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Child was mistakenly given DTaP/IPV combination instead of age appropriate TDaP; patient experienced no adverse effects
Age: 75.0
Sex: F
Vaccine: PNC21
Symptoms: Confusional state, Erythema, Night sweats, Oral mucosal blistering, Pain in extremity
Clinical narrative: pt called 3 days after vaccine. Pt experienced mouth blister, red, sore arm, with swelling and shaking and night sweats, pt felt confused at one point in the day and felt that we was out of it and had a lapse of time awareness.
Age: 75.0
Sex: F
Vaccine: PNC21
Symptoms: Swelling, Tremor
Clinical narrative: pt called 3 days after vaccine. Pt experienced mouth blister, red, sore arm, with swelling and shaking and night sweats, pt felt confused at one point in the day and felt that we was out of it and had a lapse of time awareness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Abdominal X-ray, Abdominal pain, Haematochezia
Clinical narrative: He developed abdominal pain and blood in his stool that night/early the next morning.
Age: 78.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Eye contusion, Eyelid pain, Swelling of eyelid
Clinical narrative: PATIENT CALLED THE MORNING OF 2/21/25 AND STATED SHE "ESSENTIALLY HAS A BLACK EYE" WITH A SWOLLEN LOWER EYELID WHICH HAS TURNED BLACK AND IS PAINFUL. I ADVISED THE PATIENT SO GO SEE HER EYE DOCTOR AND A PRESCRIPTION FOR TOBRADEX WAS SENT IN.
Age: 0.17
Vaccine: HIBV, HIBV, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 15 children received a dose of PEDVAX HIB at 2 months old, 4 months old, and an extra dose at 6 months old; no additional AE reported.; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender.   The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.   On an unknown date, at the age of 2 months the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAX HIB), then, at the age of 4 months old, the patient was vaccinated with a second dose, and at the age of 6 months, the patient received an extra dose (Extra dose administered) (lot #s, dose descriptions, anatomical locations, routes of administration and expiration dates were not reported) as prophylaxis. No additional adverse event was reported.  This is 1 of 15 cases received from the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Influenza like illness, Pain, Pyrexia
Clinical narrative: fever; Flu like symptoms including; shivering; headache; body aches; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of fever in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-FEB-2025, the patient received Shingrix (left deltoid). On 14-FEB-2025, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever), influenza-like symptoms (Verbatim: Flu like symptoms including), shivering (Verbatim: shivering), headache (Verbatim: headache) and general body pain (Verbatim: body aches). On 14-FEB-2025, the outcome of the fever, influenza-like symptoms, shivering, headache and general body pain were resolved.   The reporter considered the fever, influenza-like symptoms, shivering, headache and general body pain to be related to Shingrix.     The company considered the fever, influenza-like symptoms, shivering, headache and general body pain to be related to Shingrix.   Additional Information: GSK Receipt Date: 14-FEB-2025 The reporter reported that patient received the Shingrix vaccine and experienced Flu like symptoms including fever, shivering, headache, body aches.
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: had some injection site pain for a few days but no other problems.; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Family history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced injection site pain (Verbatim: had some injection site pain for a few days but no other problems.). The outcome of the injection site pain was resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix and Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 17-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the two part Shingrix vaccine last year (2024) and had some injection site pain for a few days but no other problems.  The patient saw his/her father go through several bouts of shingles.
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I got the shot and still got shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: I got the shot and still got shingles). The outcome of the vaccination failure and shingles were not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine. It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-FEB-2025 This case was reported by a patient via interactive digital media. The patient got the shot and still got shingles. The patient said just because someone got the shot did not meant anything. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure?is a listed event which, due to the following criteria (insufficient information provided about the clinical description, details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of disease) is considered unrelated to GSK vaccine  Shingles vaccine.
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: I had the first shingles shot five years ago; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 5 years ago).   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: I had the first shingles shot five years ago). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date 18-FEB-2025 The reported asked if he/she should take the second one now or did she/he have to get both again. Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Vaccine: MENB
Symptoms: Injection site pain, Product quality issue, Syringe issue
Clinical narrative: pain at injection site; several BEXSERO syringes having too much air and administered one dose which included the air bubble; Product Complaint; This non-serious case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a patient who received Men B NVS (Bexsero) (batch number 3L339, expiry date 30-SEP-2027) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced injection site pain (Verbatim: pain at injection site), syringe issue (Verbatim: several BEXSERO syringes having too much air and administered one dose which included the air bubble) and pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the injection site pain, syringe issue and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the injection site pain and syringe issue to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 23-JAN-2025 The reporter reported that patient had experienced problems with several Bexero syringes having too much air.  The physician had have tried to expel the air with and without the syringe attached and suspect syringes have been discarded.  The Physician now knows to save the suspect syringes if it happens again so attempted to enter both batch numbers into the M-ERP template, but it will not accept one of them.  Two recent batches affected are: 3L339 and XX33P. They state that this has been happening intermittently with all batches since the new syringe presentation. They are aware of the documentation stating they did administer the vaccine with the air.  They state that they did administer one dose which included the air bubble and the patient complained of lasting pain with the injection. The description of approximate size, shape, and color as 0.3-0.4 mL OF clear air. The physician explained that different from other syringes as vaccine cloudier, deposit more difficult to put in suspension, color was different but able to expel air from syringes.  No visible damage present on the syringe and any temperature excursions during storage. The product at room temperature when particle observed at times out of fridge 10 to 15 minutes as per norm.; Sender's Comments:  US-GSK-US2025009568:same reporter
Sex: F
Vaccine: RV1
Symptoms: Extra dose administered
Clinical narrative: Extra Dose; This non-serious case was reported by a physician via call center representative and described the occurrence of extra dose administered in a female patient who received Rota (Rotarix liquid formulation) for prophylaxis.   Previously administered products included Rotarix (received 1st dose of vaccine on unknown date) and Rotarix (received 2nd dose of vaccine on unknown date).   On an unknown date, the patient received the 3rd dose of Rotarix liquid formulation (oral). On an unknown date, an unknown time after receiving Rotarix liquid formulation, the patient experienced extra dose administered (Verbatim: Extra Dose). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 23-JAN-2025 The pediatrician called on the day of reporting and stated that a child was given 3 doses of the vaccine Rotarix by mistake instead of two, which led to extra dose administered.
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: develop Shingles; This non-serious case was reported by a physician via sales rep and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 weeks after receiving Shingrix, the patient experienced shingles (Verbatim: develop Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK Receipt Date: 28-JAN-2025 The Health Care Professional reported to have two different patients who developed shingles within 2 weeks of first dose. He would like to know if there was a correlation between receiving the vaccine and developing shingles and states this appears to be more than a coincidence.
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Early 2nd 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 patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   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 drug dose administration interval too short (Verbatim: Early 2nd dose). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 30-JAN-2025 A pharmacist reported that a patient received Shingrix, the initial dose and then 10 days later inadvertently got the second dose, which led to shortening of the vaccination schedule.
Age: 68.0
Sex: F
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: she received Bexsero when she was 68 years old; This non-serious case was reported by a consumer via call center representative and described the occurrence of inappropriate age at vaccine administration in a 68-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy.   In AUG-2023, the patient received Bexsero. In AUG-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: she received Bexsero when she was 68 years old). 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: 31-JAN-2025 The patient received Bexsero when she was 68 years old which led to inappropriate age at vaccine administration. The patient stated that she received the vaccine as a recommendation from her doctor due to having her spleen removed by surgery.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Lyophilized vial reconstituted with sterile water; patients where administered with Menveo (2-vial) not reconstituted properly; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-FEB-2025, the patient received Menveo. On 06-FEB-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Lyophilized vial reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: patients where administered with Menveo (2-vial) not reconstituted properly). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-FEB-2025 The reporter reported that two 2 where administered with Menveo (2-vial) not reconstituted properly, since the lyophilized component was diluted with sterile water instead of the liquid component vial which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Lot number and expiration date for the vaccine was unknown by reporter.  It was the first dose of a Meningococcal vaccine for those two patients in that facility, but reporter did not know if any of the patients received a prior Meningococcal dose in another facility. This case is linked with US2025017240, reported by same reporter.; Sender's Comments:  US-GSK-US2025017240:Same reporter/Different patient
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Lyophilized vial reconstituted with sterile water and administered; Lyophilized vial reconstituted with sterile water and administered; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 06-FEB-2025, the patient received the 1st dose of Menveo. On 06-FEB-2025, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Lyophilized vial reconstituted with sterile water and administered) and inappropriate dose of vaccine administered (Verbatim: Lyophilized vial reconstituted with sterile water and administered). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 10-FEB-2025 Pharmacy manager explained that, 2 patients where administered with Menveo (2-vial) not reconstituted properly, since the lyophilized component was diluted with sterile water instead of the liquid component vial which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. Lot number and expiration date for the vaccine was unknown by caller. It was the first dose of a meningococcal vaccine for those two patients in that facility, but caller did not know if any of the patients received a prior meningococcal dose in another facility. This is 1 of the 2 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2025017237:Same reporter/Different patient
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Malaise
Clinical narrative: never got her second dose; she was sick; not feeling good; This non-serious case was reported by a consumer via call center representative and described the occurrence of sickness in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included COVID vaccine (had COVID vaccines prior to receiving Shingrix (no product information provided)).   In NOV-2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient received Shingrix. In NOV-2022, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness (Verbatim: she was sick) and feeling unwell (Verbatim: not feeling good). On an unknown date, the patient experienced incomplete course of vaccination (Verbatim: never got her second dose ). The outcome of the sickness and feeling unwell were resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the sickness and feeling unwell to be related to Shingrix.     It was unknown if the company considered the sickness and feeling unwell to be related to Shingrix.   Additional Information: GSK receipt date: 12-FEB-2025 Patient reported that she received her first dose of Shingrix in November 2022 and never got her second dose. Patient also reported that starting the day after the first dose of Shingrix, she was sick and not feeling good, and this lasted for a few days. Patient also stated that she had Covid vaccines prior to receiving Shingrix, no product information provided. The patient did not had Lot/Expiry/Location of Administration to provide. Till the time of reporting patient did not received 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix second dose was administered 6 months later and today patient wants to received the third dose ( 11 months apart).; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (patient that received Twinrix first dose back in March).   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix second dose was administered 6 months later and today patient wants to received the third dose ( 11 months apart).). 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: 14-FEB-2025 Other HCP reported that an adult patient that received Twinrix first dose back in March. Twinrix second dose was administered 6 months later, which led to drug dose interval too long and on the day of reporting patient wanted to received the third dose at 11 months apart. Reporter decided to discussed this question with patient's doctor before arriving to an answer.
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number H3SG9, expiry date 03-JAN-2025) for prophylaxis.   On 10-FEB-2025, the patient received the 1st dose of Twinrix. On 10-FEB-2025, an unknown time after receiving Twinrix, the patient experienced expired vaccine used (Verbatim: Expired dose 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: 18-FEB-2025 Registered nurse reported that a dose of Twinrix was administered on 10 February 2025, but then they noticed it had an expiration date of 03 January 2025 which led to expired vaccine used. No prior Hepatitis A or Hepatitis B vaccines were administered so far. Any patient demographics were not provided. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient recived frist dose five years ago but still not recived second dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose five 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 recived frist dose five years ago but still not recived second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 18-FEB-2025 The reporter reported that a patient who had received the first shingles vaccine about 5 years ago and asked what should do now because he did not know whether to start the series again. The patient going to contacted but had various questions over the years, and he  just wanted to know a definitive response. The patient did not have the information about the date of the 1st dose of Shingrix. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 60.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: Engerix on February 18th 2025 but vaccine had an expiration date of February 10th 2025; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 60-year-old female patient who received HBV (Engerix B) (batch number 9JG23, expiry date 10-FEB-2025) for prophylaxis.   On 18-FEB-2025, the patient received the 1st dose of Engerix B. On 18-FEB-2025, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: Engerix on February 18th 2025 but vaccine had an expiration date of February 10th 2025). The outcome of the expired vaccine used was not applicable.   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-FEB-2025 Pharmacist reported that a patient got Engerix B but vaccine was expired, which led expired vaccine used. The reporter consented to follow up.
Age: 0.5
Sex: M
Vaccine: HIBV
Symptoms: Product preparation issue
Clinical narrative: administration of only diluent portion of Hiberix to a patient; administration of only diluent portion of Hiberix to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 6-month-old male patient who received Hib (Hiberix) (batch number 4BC5L, expiry date 14-NOV-2028) for prophylaxis.   On 13-FEB-2025, the patient received Hiberix. On 13-FEB-2025, an unknown time after receiving Hiberix, the patient experienced inappropriate preparation of medication (Verbatim: administration of only diluent portion of Hiberix to a patient) and inappropriate dose of vaccine administered (Verbatim: administration of only diluent portion of Hiberix to a patient). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date 19-FEB-2025 The reporter reported that administration of only diluent portion of Hiberix to a patient.  Patient was administered the diluent of Hiberix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Vaccine: COVID19
Symptoms: Faeces discoloured, Vomiting
Clinical narrative: had light dark green stools; was throwing up; This spontaneous report received from a health care professional concerned a patient of unspecified age and sex. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, route of admin not reported, batch number not reported) dose, frequency and therapy dates not reported, for .  No concomitant medications were reported.  On an unspecified date, the patient experienced had light dark green stools and was throwing up.  The action taken with janssen covid-19 vaccine was not applicable.  The outcome of had light dark green stools and was throwing up was not reported.  This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: atrial fibrillation; This spontaneous report received from a patient concerned a male patient of unspecified age. The patient's height and weight were not reported. Age at time of vaccination was unknown.  No past medical history, concurrent conditions or pre-existing medical conditions were reported.  The patient received janssen covid-19 vaccine (suspension for injection, intramuscular, batch number not reported) dose, frequency and therapy dates not reported, additional dosage information included: dose series 1, for covid-19 prophylaxis. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers.  No concomitant medications were reported.  On an unspecified date, the patient experienced atrial fibrillation. (dose series 1) The action taken with janssen covid-19 vaccine was not applicable.  The outcome of atrial fibrillation was not reported.  The reporter considered the causality between janssen covid-19 vaccine and atrial fibrillation as related. Company causality between janssen covid-19 vaccine and atrial fibrillation as possible.  This report was serious (other medically important condition).; Sender's Comments: V0; Atrial fibrillation; The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: consumer has COVID after taking booster shot of Moderna and again has COVID this time; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (consumer has COVID after taking booster shot of Moderna and again has COVID this time) in a 60-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19. Previously administered products included for COVID-19: Paxlovid in July 2022. Past adverse reactions to the above products included No adverse effect with Paxlovid.    On 03-Oct-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (consumer has COVID after taking booster shot of Moderna and again has COVID this time). The patient was treated with Nirmatrelvir, Ritonavir (Paxlovid) (oral use) ongoing from 06-Feb-2025 for COVID-19, at a dose of 300-100 mg 3 tablets two times a day for five day; Ibuprofen at an unspecified dose and frequency; Dextromethorphan hydrobromide, Guaifenesin (Mucinex dm) at an unspecified dose and frequency; Zinc at an unspecified dose and frequency; Ergocalciferol (Vitamin d) at an unspecified dose and frequency; Ascorbic acid (Vitamin C) at an unspecified dose and frequency and Acetylsalicylic acid, Caffeine, Paracetamol (Excedrin) at an unspecified dose and frequency. At the time of the report, COVID-19 (consumer has COVID after taking booster shot of Moderna and again has COVID this time) outcome was unknown.            The patient was unsure of the patient's weight but it was about 155 (units : not reported).  No concomitant medication was reported.  Patient had Paxlovid before in Jul-2022 and then she had COVID-19 and received Paxlovid again.  Patient received booster dose of Moderna vaccine and also received all of the booster doses.