chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: no additional AE details; Improperly stored VARIVAX administered; This spontaneous report has been received from a certified medical assistant, concerning a 1-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, and concomitant medications were not provided. The patient's birth weight was reported as 7 pounds.  On 31-MAR-2022, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (first dose) subcutaneous injection, lot #U025790, expiration date: 19-AUG-2023 (dose, vaccination scheme frequency and anatomical location were not provided) administered subcutaneously for prophylaxis.   The vaccine underwent a temperature excursion of -14 degrees Celsius (C) up to -10 degrees C for 3 hours (h), 0 minutes (min) and 0 seconds (sec); -10 degrees C up to 8 degrees C for 1 h, 30 min, 0 sec on 23-MAR-2022. No previous temperature excursion was reported. No additional adverse events were reported. It was also mentioned that the patient experienced a "device or device component malfunction" (Discrepant information).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA008004:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Incorrect product storage; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.      On 26-MAY-2022, the patient was vaccinated an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot # U024508 with expiration date: 02-FEB-2023, as prophylaxis (dose and route of administration were not reported). The vaccine suffered a temperature excursion at 8.3 F degrees for 15 minutes. There were no previous temperature excursions. No adverse event was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Had shot 11/11/21, more than recommended 6 months; This case was reported by a consumer 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 (1st dose received on 11th November 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 31-May-2022 Reporter's Comments: The patient had a Shingrix shot of 11th November 2022 and at the time of reporting on 31st May 2022. That was more than the recommended 6 months lag between shots. The patient was asking would the second shot be effective. Also asked do he/ she need to take both shots again. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose almost 8 months after 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on an unknown date 8 months prior to date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 31-May-2022 Reporter's Comments: The patient self-reported the case via interactive digital media. The patient asked if he/ she was protected. Additional Supportive Information: The patient received 2nd dose of Shingrix 8 months after 1st dose, later than the recommended standard schedule, which led to lengthening of the vaccination schedule. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 2nd shot In April and my arm is still sore.; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In April 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than 2 months after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 31-MAY-2022 Reporter's Comments:  The case was reported by patient via interactive digital media. The patient received 2nd dose of vaccine in April 2022 and arm was still sore. The patient asked any suggestions on what he/ she might did to relieve the aching pain.
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Shingrix vaccine instead of a Varicella vaccine/Patient was to receive varicella vaccine in preparation for an IVF embryo transfer; This case was reported by a nurse via sales rep and described the occurrence of wrong vaccine administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received Shingrix. In May 2022, unknown after receiving Shingrix, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.    Additional Information: GSK Receipt Date: 01-June-2022 Reporter's Comments: The patient was over 18 years of age. Patient received a Shingrix vaccine instead of a Varicella vaccine.  Patient was to receive varicella vaccine in preparation for an IVF embryo transfer.  No known adverse event reported from this maladministration. Additional Supportive Information: The patient received a Shingrix vaccine instead of a Varicella vaccine, which led to wrong vaccine administered.
Age: 36.0
Sex: M
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: adult patient was administered pediatric dose of EngerixB; adult patient was administered pediatric dose of EngerixB; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 36-year-old male patient who received HBV (Engerix B pediatric) (batch number fb9rh, expiry date 21st January 2024) for prophylaxis.   On 27th May 2022, the patient received Engerix B pediatric. On 27th May 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 31-May-2022 Reporter's comment: The registered pharmacist reported that an adult patient was administered pediatric dose of Engerix B. The reporter wanted to know how to proceed. The reporter consented to follow-up. Additional supportive information: The patient received the pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose "two years ago" and 2nd dose on 31-May-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose two years ago). Concurrent medical conditions included sjogren's disease.   On 31st May 2022, the patient received the 2nd dose of Shingrix. On 31st May 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.       Additional Information: GSK receipt date: 31-MAY-2022 Reporter's comment: A pharmacist reported that a patient received a first dose of Shingrix two years ago (as reported) and a second dose on 31st May 2022. This patient was taking an immunocompromising biologic medication for the treatment of Sjogren´s disease. The reporter consented to follow up. Additional Supportive Information: The reporter received 2nd dose of shingrix late which led to lengthening of vaccination schedule.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Angiogram pulmonary abnormal, Atelectasis, Chest pain, Dyspepsia, Dyspnoea
Clinical narrative: chest pain; heart burn; congestion of the lungs; bivascular atelectasis with mild plural thickening; bivascular atelectasis with mild plural thickening; difficulty breathing; rib pain; lung pain; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to animal (allergic to Hamsters).   On 25th May 2022 09:00, the patient received the 1st dose of Shingrix. On 25th May 2022 19:00, 10 hrs after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), atelectasis, pleural thickening, difficulty breathing, rib pain and pulmonary pain. On 27th May 2022, the patient experienced chest pain and heartburn. On an unknown date, the outcome of the lung congestion and difficulty breathing were not recovered/not resolved and the outcome of the atelectasis, pleural thickening, rib pain, pulmonary pain, chest pain and heartburn were unknown.   It was unknown if the reporter considered the lung congestion, atelectasis, pleural thickening, difficulty breathing, rib pain, pulmonary pain, chest pain and heartburn to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-Jun-2022 Reporter's Comments: The patient stated that by 19.00 that evening, she experienced congestion of the lungs, lung pain, rib pain and difficulty breathing. Two days after vaccination, she also began to experience heart burn and chest pain. The patient stated at that time, she was seen by her primary care physician (PCP) who then sent her to the emergency department (ED).  The PCP was associated with this ED.  While in the ED she received a CT angiogram which resulted in a diagnosis of bivascular atelectasis with mild plural thickening. The patient stated that she was allergic to hamsters. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal chest pain, Pleural thickening, Pulmonary congestion, Pulmonary pain
Clinical narrative: chest pain; heart burn; congestion of the lungs; bivascular atelectasis with mild plural thickening; bivascular atelectasis with mild plural thickening; difficulty breathing; rib pain; lung pain; This case was reported by a consumer via call center representative and described the occurrence of lung congestion in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergy to animal (allergic to Hamsters).   On 25th May 2022 09:00, the patient received the 1st dose of Shingrix. On 25th May 2022 19:00, 10 hrs after receiving Shingrix, the patient experienced lung congestion (serious criteria GSK medically significant), atelectasis, pleural thickening, difficulty breathing, rib pain and pulmonary pain. On 27th May 2022, the patient experienced chest pain and heartburn. On an unknown date, the outcome of the lung congestion and difficulty breathing were not recovered/not resolved and the outcome of the atelectasis, pleural thickening, rib pain, pulmonary pain, chest pain and heartburn were unknown.   It was unknown if the reporter considered the lung congestion, atelectasis, pleural thickening, difficulty breathing, rib pain, pulmonary pain, chest pain and heartburn to be related to Shingrix.     Additional Information: GSK Receipt Date: 01-Jun-2022 Reporter's Comments: The patient stated that by 19.00 that evening, she experienced congestion of the lungs, lung pain, rib pain and difficulty breathing. Two days after vaccination, she also began to experience heart burn and chest pain. The patient stated at that time, she was seen by her primary care physician (PCP) who then sent her to the emergency department (ED).  The PCP was associated with this ED.  While in the ED she received a CT angiogram which resulted in a diagnosis of bivascular atelectasis with mild plural thickening. The patient stated that she was allergic to hamsters. The reporter consented to follow up.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: vaccine had an expiration date of 24May2022; The patient in question had a series of this vaccine when younger; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   Previously administered products included Havrix (patient in question had a series of this vaccine when younger).   On 31st May 2022, the patient received Havrix. On 31st May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used and extra dose administered. On an unknown date, the outcome of the expired vaccine used and extra dose administered were unknown.    Additional Information: GSK Receipt Date: 01-June-2022 Reporter's Comments: The reporter was now 18 years old. Nurse reported patient was administered a dose of Havrix on 31st May 2022, and after the dose was administered it was noted the vaccine had an expiration date of 24th May 2022. At the time of reporting, dose had not been repeated. The reporter consented to follow up. Additional supportive information: Patient in question had a series of this vaccine when younger and received another dose, which led to extra dose administered which was already expired.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water instead of the supplied CYW liquid conjugat; Nurse administered a dose that was reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA690A, expiry date 31st October 2022) for prophylaxis.   On 25th May 2022, the patient received Menveo. On 25th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date 1 June 2022: Reporter's comment: Nurse reports that a fellow nurse administered dose of Menveo that was reconstituted with sterile water instead of the supplied CYW liquid conjugate. At the time of reporting, the dose was not repeated. The reporter did not have any patient details aside from gender. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received dose of Menveo reconstituted with sterile water instead of the supplied CYW liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 16.0
Sex: M
Vaccine: MENB, MENB
Symptoms: Incorrect dose administered
Clinical narrative: Dose of Bexsero was given concomitantly with a dose of Trumenba on 05/16/2022; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number Abxc06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis and MENINGOCOCCAL B VACCINE (TRUMENBA) for prophylaxis.   On 16th May 2022, the patient received Bexsero, Bexsero Pre-Filled Syringe Device and TRUMENBA. On 16th May 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced overdose. On an unknown date, the outcome of the overdose was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date 1 June 2022: Reporter's comment: Nurse reporting a dose of Bexsero was given concomitantly with a dose of Trumenba. The reporter consented to follow up. Additional Supportive Information: The patient received Bexsero and Trumenba concomitantly which led to overdose.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received Infanrix instead of Boostrix; 60 year-old female patient received Infanrix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 60-year-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10th June 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, 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: 1 June 2022 Reporter's comment: The Lead Nurse reported that the patient received Infanrix by error instead of Boostrix. The HCP did not know which number of Dtap was this last shot on patient´s history. The reporter consented to follow up by email. Additional Supportive Information: The patient received Infanrix by error instead of Boostrix which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: received only first dose over three years ago; This 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 on over three years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.       Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The reporter stated that the clinic had a patient that received only the first dose of Shingrix over three years ago. The reporter did not have any further information at the time of the reporting. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 39-year-old female patient who received HBV (Engerix B adult) (batch number L5C49, expiry date 17th May 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st June 2022, the patient received Engerix B adult and Engerix B Pre-Filled Syringe Device. On 1st June 2022, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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 1 June 2022: Reporter's comment: Program manager reported that a patient received an expired dose of Engerix-B on the day of reporting. LOT lookup confirmed. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Engerix B, which led to expired vaccine used.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: administered dose on 24May2022, expiration date 22May2022; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   On 24th May 2022, the patient received the 1st dose of Havrix. On 24th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The pharmacist stated that the patient was administered a dose of Havrix, which had an expiration date of 22nd May2022. At the time of reporting, dose was not repeated. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Age: 31.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number j95h7, expiry date 22nd May 2022) for prophylaxis.   On 24th May 2022, the patient received Havrix. On 24th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.       Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The patient received expired dose of Havrix. The reporter consented to follow up. Additional Supportive Information: The patient received expired dose of Havrix, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Abnormal sensation in eye, Exposure via eye contact, Exposure via skin contact, Occupational exposure to product, Oropharyngeal pain
Clinical narrative: eyes "feel funny"; Sore Throat; sprayed out onto his face and eyes; sprayed out onto his face and eyes; sprayed out onto his face and eyes; This case was reported by a pharmacist via call center representative and described the occurrence of abnormal sensation in eye in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st May 2022, the patient received Shingrix. On 31st May 2022, less than a day after receiving Shingrix, the patient experienced abnormal sensation in eye, sore throat, occupational exposure while administering product, exposure via skin contact and exposure via eye contact. On an unknown date, the outcome of the abnormal sensation in eye, sore throat, occupational exposure while administering product, exposure via skin contact and exposure via eye contact were unknown.   It was unknown if the reporter considered the abnormal sensation in eye and sore throat to be related to Shingrix.     Additional Information: GSK receipt date 1 June 2022: Reporter's comment: The pharmacist reported that he was going to give a Shingrix vaccine and the reconstituted vaccine sprayed out onto his face and eyes. He did flush with water.  He tried to go to the ER but the wait was too long. The planned to go back to ER on the day of reporting. He stated his eyes feel funny and throat was sore. The reporter did not have vaccine lot number/expiration date information available at the time of reporting. The reporter Consented to follow up.  Additional Supportive Information: While pharmacist was going to give a Shingrix vaccine and the reconstituted vaccine sprayed out onto his face and eyes, which led to exposure while administering product, exposure via skin contact and exposure via eye contact.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: received expired vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-year-old female patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st June 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 1st June 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, 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: 1 June 2022 Reporter's comment: Medical Assistant reported that patient received Infanrix expired vaccine. The reporter consented to follow up by email. Additional Supportive Information: The patient received expired dose of Infanrix which led to expired vaccine used.
Age: 53.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Twinrix on 8/21/2019, received the 2nd dose 01-JUN-2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 53-year-old male patient who received HAB (Twinrix adult) (batch number 4F3YY, expiry date 1st January 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix adult (1st dose received on 21st August 2019).   On 1st June 2022, the patient received the 2nd dose of Twinrix adult and Twinrix Pre-Filled Syringe Device. On 1st June 2022, unknown after receiving Twinrix adult and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, 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: 01-June-2022 Reporter's Comments: Pharmacist stated that a patient received the 2nd dose on date of reporting 1st June 2022. The reporter consented to follow up via email. Additional Supportive Information: The patient received the 2nd dose later than the recommended standard interval, which led to lengthening of the vaccination schedule.
Age: 3.0
Sex: M
Vaccine: HEP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: received an extra dose of Engerix B pediatric dosage; By mistake instead of HepA, HepB was administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 3-year-old male patient who received HBV (Engerix B pediatric) (batch number 333M4, expiry date 7th April 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Hepatitis B vaccine (completed the HepB primary series before 20th May 2022).   On 20th May 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 20th May 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced extra dose administered and wrong vaccine administered. On an unknown date, the outcome of the extra dose administered and wrong vaccine administered 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: 02-JUN-2022 Reporter's Comments: The pharmacist reported that a pediatric patient received a dose of Engerix B when Hepatitis A vaccine was needed. The pharmacist reported that patient received by mistake instead of HepA (Hepatitis A), HepB (Hepatitis B) was administered.  The Vaccine Administration Facility is the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The pharmacist reported that a pediatric patient received extra dose of Engerix B vaccine instead of Hepatitis A vaccine, which led to extra dose administered and wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose 15Jul2020, has not yet received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 90-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 15th July 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.    Additional Information: GSK Receipt Date: 2-Jun-2022 Reporter's Comments: The patient had not yet received the second dose of Shingrix.  The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not received the second dose which led to incomplete course of vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Cardiac function test, Foetal exposure during pregnancy, Neonatal dyspnoea
Clinical narrative: PROBLEMS WITH BREATHING; FOETAL EXPOSURE DURING PREGNANCY; This solicited pregnancy report received from a consumer concerned a male neonate of unspecified race and ethnicity.  The patient was enrolled in a non-company sponsored study. The patient's weight was 11 pounds, and height was 19 inches (At the time of birth). The neonate's birth weight was 8 pounds and 3 ounces. No birth defects, genetic or inherited disorders have been diagnosed since birth. The male neonate's mother received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total (first dose),administered on 10-MAR-2021 for COVID-19 immunisation and neonate was exposed via transplacental route. Gestational age was seven weeks and three days at the time of vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. Concomitant medications included prenatal vitamins (minerals nos; vitamins nos).  On 10-MAR-2021, the patient experienced foetal exposure during pregnancy. Event duration was 229 days. Reaction first and last time was 1 day. At gestational age 40 weeks, the mother delivered a live, full-term, male neonate via caesarean method of delivery (C-section). Primary reason for C-section was reported to be a previous C-section. On an unspecified date, the neonate had problems and he was admitted in the neonatal intensive care unit (NICU) and hospitalized. The number of days of hospitalization was not provided.  In OCT-2021, Laboratory data included: Cardiac function test and Hearing test was performed, results not reported.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from foetal exposure during pregnancy on 24-OCT-2021, and the outcome of problems with breathing was not reported. The reporter considered the causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, and foetal exposure during pregnancy as not related. The company causality between covid-19 vaccine ad26.cov2.s, and problems with breathing, and foetal exposure during pregnancy was not related.  This report was serious (Hospitalization Caused / Prolonged). This parent/child case is linked to 20211139855.; Sender's Comments: V0: 20220606249 - covid-19 vaccine ad26.cov2.s Neonatal Dyspnoea. The event(s) shows an incompatible temporal relationship. Therefore, this event(s) is considered not related. (Considering latency more than 7 months) 20220606249 - covid-19 vaccine ad26.cov2.s Fetal exposure during pregnancy. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 23 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 02-APR-2021 in right arm for prophylactic vaccination.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26.cov2.s (dose number in series 1).  The patient received additional dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: UNKNOWN) dose was not reported, 1 total, administered on 29-NOV-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 01-JAN-2022, the patient experienced covid-19 infection with harsh symptoms (dose number in series 2). The infection was confirmed by PCR (polymerase chain reaction) test (confirmed clinical vaccination failure, and confirmed covid-19 infection). The patient visited physician office for covid-19 infection (dose number in series 2). On 07-MAY-2022, the patient again experienced covid-19 infection (dose number in series 2). Patient got infected from his brother and the infection was confirmed by a rapid test (suspected covid-19 infection and suspected clinical vaccination failure). He reported that the symptoms of the second infection were not as bad (dose number in series 2). Patient reported that the vaccination did not prevent him from getting the disease but helped him with the symptoms. On 01-JUN-2022, the patient called to report exposure to Covid-19 positive individual. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint.; Sender's Comments: V0: 20220602071-Covid-19 vaccine ad26.cov2.s-confirmed clinical vaccination failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: 3 DIFFICULT DAYS; This spontaneous report received from a consumer via social media concerned a female patient of an unspecified age, race and ethnicity. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination. It was reported that the patient had no adverse events following vaccination with first and second dose of Sinovac (covid-19 vaccine inact (vero) cz02) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (third dose) (dose number in series 2) (suspension for injection, route of admin, batch number were not reported, expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced 3 difficult days (coded as adverse event nos) (dose number in series 2). It was reported that "24 hours after the (4th ag. COVID19) vaccination with Novavax: how is my Mother, how am I, We are perfect: absolutely no consequences, work and sport at 100 percent, it is like after the 1st and 2nd with Sinovac. (I still remember 3 difficult days after Janssen)". The patient additionally received fourth dose of Novavax (Nvx cov 2373) (dose number in series 3) (form of admin, route of admin, and batch number were not reported, expiry: Unknown) dose, start therapy date were not reported administered for prophylactic vaccination. It was reported that the patient was perfect and had no consequences, and mentioned work and sport at 100 percent following vaccination with Novavax (Nvx cov 2373) (dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of 3 difficult days was not reported. This report was non-serious. This case, from the same reporter is linked to 20220603569.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: SICK; This spontaneous report received from a consumer via a company representative concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20220603706 and 20220604218.
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: DOSE OF JANSSEN VACCINE GIVEN ONE DAY AFTER PFIZER DOSE; This spontaneous report received from a health care professional (nurse) concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with Pfizer biontech covid-19 vaccine (Tozinameran) (dose number in series 1) (form of admin, route of admin not reported, batch number: unknown, expiry: unknown), was administered on 31-MAY-2022 for prophylactic vaccination. It was unknown whether the patient had any adverse events following vaccination with first dose of Pfizer biontech covid-19 vaccine (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 26-JUL-2022) dose was not reported, 1 total administered on 01-JUN-2022 for prophylactic vaccination. No concomitant medications were reported. On 01-JUN-2022, The nurse gave a dose of the Janssen covid vaccine to a patient thinking it was his initial dose. After vaccination she discovered that patient had gotten a initial dose of Pfizer mrna vaccine one day prior. She called back to confirm, and the patient agreed that he had Pfizer the day before (Inappropriate schedule of product administration) (dose number in series 2). The patient was kept for approximately 30 minutes after receiving Janssen vaccine and the nurse had not noticed any issues (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dose of janssen vaccine given one day after Pfizer dose was not reported. This report was non-serious.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Lethargy, Malaise
Clinical narrative: LETHARGIC MORE THAN USUAL; FELT HOT LIKE FEVER/FELT WARM IN VEIN; FELT NOT VERY GOOD; TIRED; This spontaneous report received from a patient concerned a 75 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: diabetic type 2, alcohol use (rarely), non-smoker, and ibuprofen allergy (possibly) and other pre-existing medical conditions included: the patient had no history of drug abuse or illicit drug use. Patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported and batch number: 1821286) dose was not reported, 1 total, administered on left arm on 16-MAY-2021 for prophylactic vaccination. On an unspecified date, the patient felt generally not so good, tired, lethargic more than usual, felt heat like fever, felt hot but not like boiling, warm in vein and took it easy for a day or two, patient did not feel well for a day or two so the patient rested and passed following the vaccination with first dose of covid-19 vaccine ad26. cov2. s (dose number in series 1). The patient recovered from lethargic more than usual, felt hot like fever/felt warm in vein, felt not very good, and tired. The patient additionally received first booster of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 213D21A expiry: UNKNOWN) dose was not reported, 1 total, administered on left arm on 28-NOV-2021 for prophylactic vaccination. Age at time of vaccination 75 years old. No concomitant medications were reported.  On an unspecified date after the booster dose, the patient felt generally not so good, tired lethargic more than usual. The patient felt heat like fever, felt hot but not like boiling, warm in vein and took it easy for a day or two. The patient stated that for booster dose she felt more than the primary dose (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lethargic more than usual, felt hot like fever/felt warm in vein, felt not very good, and tired. This report was non-serious. This case, involving the same patient is linked to 20220606162 (dose number in series 1).
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022 at 2:02 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 11-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administer a vaccine  that expired on the 29Apr2022 to less than 5 patients/Expired doses administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided. No treatment medication information provided.   This case was linked to MOD-2022-581769, MOD-2022-581743, MOD-2022-581765 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2022: Follow-up  received with non significant information On 01-Jun-2022: Significant follow up received contains: Patient details updated, Hcp reporter updated, suspect dosage details updated and Product coding updated.