chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Itching all over his body; This case was reported by a other health professional via sales rep and described the occurrence of generalized pruritus in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced generalized pruritus. On an unknown date, the outcome of the generalized pruritus was not recovered/not resolved.   It was unknown if the reporter considered the generalized pruritus to be related to Shingrix.  Additional details were provided as follows: The age of vaccination was not reported. The reporter was sales representative who was reporting an adverse event about Shingrix with limited information about the event, patient, and vaccine. The reporter stated that a representative from one of her accounts reported that a patient was coming in to be seen due to having itching all over his body after his first Shingrix vaccine (Anatomical Site was reported as unknown). The reporter stated that the patient got the vaccine not from the healthcare professional's office from where he/she was reporting the adverse event. The reporter had no further details to report. The reporter consented to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia, Night sweats, Pyrexia
Clinical narrative: Achy joints; Fever; Sore muscles; Night sweats; Unable to move his arms; This case was reported by a consumer via call center representative and described the occurrence of joint pain in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th February 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In February 2022, less than a month after receiving Shingrix, the patient experienced joint pain, fever, muscle soreness, night sweat and mobility decreased. On an unknown date, the outcome of the joint pain, fever, muscle soreness, night sweat and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the joint pain, fever, muscle soreness, night sweat and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The patient received Shingrix in an unknown arm. The patient began to experienced achy joints, fever, sore muscles, night sweats and was unable to move his arms within few days. The patient was seen in the emergency room for these symptoms since they had been present for nearly 1 month. The lot number or expiration date of the vaccine was not known. The patient's wife wanted to know long term effects of vaccine.  The reporter consented to follow up.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Rash, Rash erythematous
Clinical narrative: sun burn like rash from his waist upwards on CHEST, BELLY, SIDES AND UPPER ARMS, BACK AND NECK; This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th January 2021, the patient received Shingrix. On 31st January 2021, 1 days after receiving Shingrix, the patient experienced rash. The patient was treated with triamcinolone (Triamcinolone Cream) and prednisone. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was patient's wife. The patient received the Shingrix vaccine at his doctors office, and the next day had a sun burn like rash from his waist upwards on chest, belly, sides and upper arms, back and neck.  The reporter said that it was still ongoing. A biopsy was carried out and the results showed that it was something in the vaccine that patient reacted to. The dermatologist prescribed medication and treatment was still ongoing. The patient was prescribed Prednisone for 10 days, then gave Triamcinolone cream twice a day. Batch numbers was unknown. The reporter consented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: receiving accidentally a second dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On 18th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The registered nurse (RN) reported that, the patient accidentally received a second dose of Kinrix, which led to extra dose administered. The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose on 20th May 2019 and 2nd dose in 8th June 2021; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 20th May 2019).   On 8th June 2021, the patient received the 2nd dose of Shingrix. On 8th June 2021, 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 details were provided as follows: The health care professional reported that, the patient had received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered Shingrix reconstituted with an Unapproved Diluent; administered Shingrix reconstituted with an Unapproved Diluent; This 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 58-year-old male patient who received Herpes zoster (Shingrix) (batch number B3F47, expiry date 10th April 2023) for prophylaxis.   On 25th February 2022, the patient received Shingrix. On 25th February 2022, unknown after receiving Shingrix, 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 details were provided as follows: Nurse administered Shingrix to the patient, which was reconstituted with an unapproved diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.  Healthcare professional realized this error on the date of reporting. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 72-year-old female patient who received TWINRIX (batch number dk23d, expiry date 8th February 2021) 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. On 22nd February 2022, the patient received TWINRIX and TWINRIX Pre-Filled Syringe Device. On 22nd February 2022, unknown after receiving TWINRIX and TWINRIX 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 details were provided as follows: Nurse reported that, a female patient was administrated with an expired dose of TWINRIX, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 36.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Engerix B pediatric given to adult patient; Engerix B pediatric given to adult patient; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 36-year-old female patient who received HBV (Engerix B pediatric) (batch number SFB9RH, expiry date 21st January 2023) for prophylaxis.   On 28th January 2022, the patient received the 3rd dose of Engerix B pediatric. On 28th January 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 details were provided as follows: The patient received Engerix B pediatric in left deltoid. The patient received a pediatric dose of the Engerix-B inadvertently, which led to underdose and adult use of a child product. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Only diluent/adjuvant was administered; Only diluent/adjuvant was administered; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 18-month-old female patient who received Hib (Hiberix) (batch number 5P244, expiry date 21st March 2023) and (batch number of diluent vial F22GH, expiry date 21st March 2023) for prophylaxis.   On 1st March 2022, the patient received Hiberix. On an unknown date, the dose was an unknown dose. On 1st March 2022, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient received Hiberix in right vastus lateralis. The patient had been given Hiberix incorrectly, only the vaccine diluent/adjuvant was administered without an active component, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter provided a consent to follow up with herself.  The reporter's contact information was collected. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Never received the second dose; This case was reported by a other health professional 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 1st dose in September 2019).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter enquired how to proceed with 2nd dose of Shingrix and asked for recommendations if any. The patient was wondering if he could get the 2nd dose. The reporter was unable to provide vaccine and some of patient details. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose one year after the 1st dose; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 07th October 2020).   On 6th October 2021, the patient received the 2nd dose of Shingrix. On 6th October 2021, 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 details were provided as follows: The patient self-reported the case. The age at vaccination was not reported. The route of administration of Shingrix was reported as injection. The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. The patient inquired if she needed to get another dose since the 2nd dose was late.  The reporter did not consent to follow-up. The patient declined to give consent to contact her for follow up and did not want to give any contact information and full demographic information.  The patient did not provide healthcare professional contact information.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the diluent portion; Patient received only the diluent portion; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the diluent portion of the Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 9/2020 and 2nd dose on 10/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number J5255, expiry date 13th November 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in September 2020).   In October 2021, the patient received the 2nd dose of Shingrix. In October 2021, 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 details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended schedule, which led to lengthening of vaccination schedule. Pharmacist enquired if the patient needed to restart the Shingrix. Pharmacist declined follow up from safety. The reporter did not consent to follow up.
Age: 42.0
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose was administered to a patient by error; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 42-year-old patient who received HAV (Havrix) (batch number EK59B, expiry date 26th February 2022) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Havrix. On 1st March 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 details were provided as follows: The patient received an expired dose of Havrix by error, which led to expired vaccine used. The reporter consented to follow up by postal.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administrated only diluent portion; administrated only diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number amva6028, expiry date 31st August 2022) for prophylaxis.   On 1st March 2022, the patient received Menveo. On 1st March 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The patient was inadvertently received only the diluent portion of the Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No further events were reported.  The reporter did not consent to follow-up.
Age: 12.0
Sex: F
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: was to receive menactra instead received bexsero; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB29BA, expiry date 30th June 2022) 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.   On 25th August 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 25th August 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received Bexsero instead of Menactra, which led to wrong vaccine administered. The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2020, late for 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in January 2020).   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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter did not have the patient's initials, date of birth, and specific vaccination information available at the time of reporting. The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Product storage error
Clinical narrative: Vaccine administered after an excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   On 28th February 2022, the patient received Havrix. On an unknown date, unknown after receiving Havrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.  Additional details were provided as follows: The nurse reported a patient received havrix vaccine in left thigh after an excursion, which led to incorrect storage of drug.  The reporter consented to follow up. This is 1 of 6 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039273:same reporter US-GLAXOSMITHKLINE-US2022039271:same reporter US-GLAXOSMITHKLINE-US2022039274:Same reporter. US-GLAXOSMITHKLINE-US2022039275:Same reporter. US-GLAXOSMITHKLINE-US2022039277:Same reporter.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the AS01BAportion; Patient received only the AS01BAportion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 85-year-old male patient who received Herpes zoster (Shingrix) (batch number 2F9M5, expiry date 19th May 2023) for prophylaxis.   On 2nd March 2022, the patient received the 1st dose of Shingrix. On 2nd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that the patient received only the AS01BA portion of the Shingrix vaccine in right arm which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The case has been linked with the case US2022039281 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039281:Same reporter.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient received only the AS01BAportion; Patient received only the AS01BAportion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 82-year-old female patient who received Herpes zoster (Shingrix) (batch number 2F9M5, expiry date 19th May 2023) for prophylaxis.   On 2nd March 2022, the patient received the 1st dose of Shingrix. On 2nd March 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The nurse reported that patient received only the AS01BA portion of the Shingrix vaccine which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. The case has been linked with the case US2022039279 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039279:Same reporter.
Age: 1.25
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix given to a 15 month old patient; Kinrix administered instead of Dtap (infanrix); This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 15-month-old male patient who received DTPa-IPV (Kinrix) (batch number E2L54, expiry date 3rd March 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: It was reported that the 15 months old patient received Kinrix instead of Dtap (infanrix), which led to inappropriate age at vaccine administration and wrong vaccine administered. The vaccine history series was for 15 month old was 4th dose for dtap and 4th dose for ipv. The reporter consented to follow up. This case has been linked with case US2022039286 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022039286:same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Incomplete course of vaccination, Influenza like illness
Clinical narrative: flu-like symptoms; received her 1st dose over 1 year ago, perhaps  2; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced influenza-like symptoms and incomplete course of vaccination. On an unknown date, the outcome of the influenza-like symptoms and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient receive 1st dose of Shingrix and experienced flu-like symptoms. The patient stated that she received her 1st dose of Shingrix over 1 year ago, perhaps 2 years ago. Till the time of reporting the patient did not receive 2nd dose, which led to incomplete course of vaccination. The reporter provided limited information. Spoke per content. The reporter was given Medical Advice disclaimer and was referred to HCP (health care professional). The reporter did not consent to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated with an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) (batch number dk23d, expiry date 8th February 2022) 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.   On 2nd March 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 2nd March 2022, unknown after receiving Twinrix and Twinrix 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 without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient was administrated with an expired dose of Twinrix, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up.  No patient's identifiers provided. The case has been linked with the case US2022AMR039976 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR039976:same reporter
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: A 21 year old received the pediatric dose of Engerix-b; A 21 year old received the pediatric dose of Engerix-b; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 21-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, 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.     This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: It was reported that the 21 year old patient received the pediatric dose of Engerix b, which led to underdose and adult use of a child product.  No side effects were reported. The reporter consented follow up via email.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Underdose
Clinical narrative: a PEDIATRIC dose was given to a 27 year old; a PEDIATRIC dose was given to a 27 year old; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 27-year-old female patient who received HBV (Engerix B pediatric) (batch number K32, expiry date 24th April 2023) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd March 2022, the patient received the 3rd dose of Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 2nd March 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, 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.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The health care professional reported that a pediatric dose was given to a 27 year old patient which led to underdose and adult use of a child product. No reaction was reported.  The reporter consented to follow up via email.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Emotional distress, Suspected COVID-19
Clinical narrative: FELT UPSET; FELT DEPRESSED; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 33 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the patient experienced felt upset, felt depressed, and suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the felt upset, felt depressed and suspected covid-19 infection was not reported. This report was non-serious. This case, from the same reporter is linked to 20220301169.; Sender's Comments: V0-  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 53 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no illness at the time of vaccination and no history of similar event. Patient had no adverse event after any previous vaccination(s). Patient had no history of allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1805029 expiry: Unknown) dose was not reported, 1 total, administered on 13-MAR-2021 in left 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 covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total, administered on 20-DEC-2021 in right arm for prophylactic vaccination. No concomitant medications were reported.  On 20-DEC-2021, the patient was administered expired vaccine (Dose number in series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260995, 20220261000, 20220261014, 20220261024, 20220261030, 20220261042, 20220261043, 20220261048, 20220261011 and 20220261063.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED UNINTENTIONALLY; This spontaneous report received from a pharmacist concerned a 55 years old male patient of an unspecified race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no Illness at the time of vaccination, no history of similar event, no adverse event after any previous vaccination, no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days with cause, no family history of any disease (relevant to vaccination) or allergy. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 201A21A, expiry: Unknown) dose was not reported, dose number in series 1, 01 total, administered on left arm on 09-JUN-2021 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 additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, dose number in series 2, 01 total, administered on right arm on 23-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2021, expired vaccine was administered unintentionally (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered unintentionally was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261042, 20220261063, 20220261011, 20220261024, 20220261048, 20220261092 and 20220261014. .
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 57 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. Patient did not report any illness at the time of vaccination. Patient had no history of similar event, had no adverse events related to previous vaccinations, no history of allergy to vaccine, drug, or food. Patient did not report any history of pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization and had no family history of any disease. Patient was not pregnant nor breastfeeding at the time of reporting. On 14-JUN-2021, the patient was previously vaccinated with covid-19 vaccine ad26. cov2.s (dose number in series: 1) (suspension for injection, intramuscular, batch number: 203A21A and Expiry: Unknown) 1 total, to left arm for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2.s (dose number in series: 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series: 2) (suspension for injection, intramuscular, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, 1 total, administered to right arm on 20-DEC-2021 for prophylactic vaccination. Vaccine was administered to right arm. The vaccine was stored at 2-8 degrees Celsius. The vaccine was removed thrice from the storage and kept out for 10 minutes. Then returned to refrigerator. The gauze/length of the needle was 25G, 1 inch. No concomitant medications were reported. On 20-DEC-2021, the patient received expired vaccine (Dose number in series: 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261048, 20220261011, 20220261063, 20220261042, 20220261024, 20220261039, 20220261092, 20220261043 and 20220261022.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 38 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness at the time of vaccination, no past history of similar events, no adverse event after any previous vaccination, no history of allergy to vaccine drug or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause, no family history of any disease (relevant to vaccination) or allergy, not pregnant at time of vaccination and not currently breastfeeding. The patient previously received covid-19 vaccine ad26. cov2.s (dose number in series 1) (suspension for injection, intramuscular and batch number: 201A21A, expiry: unknown) dose was not reported, 1 total, administered on 22-May-2021 on left (location unspecified) 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 additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, and batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, 1 total administered on 23-DEC-2021 on left (location unspecified) for prophylactic vaccination. No concomitant medications were reported.  On 23-DEC-2021, the patient received expired vaccine administered (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220261039, 20220261092, 20220261063, 20220260967, 20220261043, 20220261022, 20220261030, 20220261000, 20220261048, 20220261014, 20220260995, 20220261024 and 20220261042.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no illness at the time of vaccination, no history of similar event, no adverse event after any previous vaccination (s), no history of allergy to vaccine, drug, or food, no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, with cause and no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 27-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 27-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261042, 20220261011, 20220261063, 20220261048, 20220261092, 20220261039, 20220261022, 20220261000, 20220261030, 20220260995, 20220261043 and 20220260995.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient was not having any illness at the time of vaccination. patient was not having any history of similar events. patient was not having adverse event after any previous vaccination(s). patient was not having any food, drug, or vaccine allergy. patient was not having any pre-existing acute illness 30 days prior to vaccination. patient was not having the history of hospitalization in last 30 days. patient was not having any family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, administered on 15-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 57 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no history of similar event, had no illness at the time of vaccination. The patient had no adverse event after any previous vaccination, no history of allergy to vaccine, drug or food, had no pre-existing acute illness 30 days prior to vaccination, no history of hospitalization in last 30 days, no family history of any disease or allergy. The patient was not pregnant at time of vaccination and was not currently breastfeeding. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number: 1808978, and expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 on left site 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 additionally received booster covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, intramuscular, batch number: 211A21A, expiry: 14-DEC-2021) dose was not reported, 1 total administered on 15-DEC-2021 on left site for prophylactic vaccination. No concomitant medications were reported.  On 15-DEC-2021, the patient was administered with expired vaccine (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261011, 20220261042, 20220261039, 20220261092, 20220261043, 20220261022, 20220261000, 20220261048, 20220260995, 20220261014, 20220261063 and 20220261030.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a 44 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient had no illness at time of vaccination. Patient had no past history of similar event. Patient had no adverse event after any previous vaccination(s). Patient had no history of allergy to vaccine, drug, or food. Patient had no pre-existing acute illness 30 days prior to vaccination. Patient had no history of hospitalization in last 30 days, with cause. Patient had no family history of any disease (relevant to vaccination) or allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 22-DEC-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-DEC-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20220210382, 20220260967, 20220261011, 20220261063, 20220261042, 20220261024 and 20220261092.