chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Dermatitis contact, Rash
Clinical narrative: Poison ivy and a rash in the crease between my belly and right hip; Poison ivy; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th March 2022, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced rash and poison ivy rash. The patient was treated with prednisone. On an unknown date, the outcome of the rash was unknown and the outcome of the poison ivy rash was not recovered/not resolved.   It was unknown if the reporter considered the rash and poison ivy rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-JUL-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had some poison ivy and a rash in the crease between belly and right hip. The patient asked whether to get the second shot while patient would be starting a prednisone taper prescription for poison ivy. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only MenCYW-135 liquid; received only MenCYW-135 liquid; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, 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 Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comments: The registered nurse reported that the patient received only vial containing MenCYW-135 liquid and this Menveo vaccine required reconstitution with liquid and powder and this was not done prior to administration. The reporter reported that this was an error that would have been caught if used GlaxoSmithKline bands. The reporter asked were GlaxoSmithKline interested in having bands delivered to the site. Additional Supportive Information: The registered nurse reported that the patient received only vial containing MenCYW-135 liquid of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 56.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Product preparation issue
Clinical narrative: charged syringe with both vaccines at the same time; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate reconstitution technique in a 56-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB39AB, expiry date 31st July 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 and MENACTRA for prophylaxis.   On 6th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, the patient received MENACTRA. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate reconstitution technique. On an unknown date, the outcome of the inappropriate reconstitution technique 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: 8-Jul-2022 Reporter's Comments: A physician assistant reported a coadministration of Menactra and Bexsero at the same time.  The professional charged the syringe with both vaccines at the same time by mistake. The reporter consented to follow up. Additional Supportive Information: The professional charged the syringe with both vaccines (Menactra and Bexsero) at the same time by mistake, which led inappropriate reconstitution technique.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient was administered a dose of Bexsero on 08Jul2022 from lot number ABXA87AZ, which had an expiration date of 31Jan2022.; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 18-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Meningococcal B Vaccine Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th July 2022, the patient received the 1st dose of Bexsero and Meningococcal B Vaccine Pre-Filled Syringe Device. On 8th July 2022, unknown after receiving Bexsero and Meningococcal B Vaccine 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 - 08 July 2022 Reporters comment: The medical assistant reported the patient was administered a dose of Bexsero which had an expiration date of 31st January 2022. This was the patient's first dose in the series. At the time of reporting repeat dose was not administered. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive information: The patient received Bexsero which was already expired which led to expired vaccine used.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Patient was administered (8-July-2022) only the liquid portion of the shingrix vaccine inadvertently.; Only the liquid portion of the shingrix vaccine inadvertently.; This case was reported by a physician via call center representative and described the occurrence of inappropriate preparation of medication in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th July 2022, the patient received the 2nd dose of Shingrix. On 8th July 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 Information: GSK receipt date :08-July-2022 Reporters comment: Physician reported a patient was administered only the liquid portion of the shingrix vaccine inadvertently. The patient received shingrix in left deltoid. The reporter consent for follow-up. Additional Supportive information: The patient received 2nd dose of only the liquid portion of the shingrix vaccine which led to Inappropriate dose of vaccine administered and Inappropriate preparation of medication.
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in her arms, hands, and fingers; Tingling in her arms, hands, and fingers; This case was reported by a physician via call center representative and described the occurrence of numbness of upper extremities in a adult female patient who received Herpes zoster (Shingrix) (batch number E4E39, expiry date 24th August 2023) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 day after receiving Shingrix, the patient experienced numbness of upper extremities and tingling. On an unknown date, the outcome of the numbness of upper extremities and tingling were recovered/resolved.   It was unknown if the reporter considered the numbness of upper extremities and tingling to be related to Shingrix.     Additional Information: GSK receipt date :08July 2022 Reporters comment: The reporter consent for follow-up. The reporter IS physician he reported that the female patient received first dose of shingrix vaccine and experienced Tingling and numbness in arm hand and figure. Additional Supportive information:As per source document narrative mentioned ''the day after''as patient experienced event after the vaccination so TTO captured as 1 day
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix 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 62-year-old female patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   On 24th June 2022, the patient received Havrix. On 24th June 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: 8-Jul-2022 Reporter's Comments: Medical Assistant reported 62-year-old female was administered a dose of Havrix on 24th Jun 2022, which had an expiration date of 17th June 2022. Medical Assistant was not sure which dose in the series this was for the patient.  At the time of reporting, dose had not been repeated. The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter. Additional Supportive Information: The patient had Havrix on 24th Jun 2022, which had an expiration date of 17th June 2022, which led to expired vaccine used.
Age: 93.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 93-year-old female patient who received HAV (Havrix) (batch number J95H7, expiry date 22nd May 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 6th July 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix 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: 8-Jul-2022 Reporter's Comments: A nurse reported that a female patient received an expired dose of Havrix. Additional Supportive Information: The patient had Havrix on 6th July 2022, which had an expiration date of 22nd May 2022, which led to expired vaccine used.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain
Clinical narrative: shooting nerve pain; Radiating pain; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 27th May 2022, immediately after receiving Shingrix, the patient experienced injection site pain. On 28th May 2022, the patient experienced nerve pain and radiating pain. On an unknown date, the outcome of the injection site pain, nerve pain and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nerve pain and radiating pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 11 July 2022 Reporter's Comments: Reporter stated patient got Shingrix vaccine. Soon after she got the shot, patient had soreness at the injection site. This soreness had resolved. Patient also reported that the next night, patient started with shooting nerve pain that went from her left shoulder to her left hand. She states that it only happens at night and is ongoing. On 28th May 2022 1 day after receiving Shingrix, the patient experienced nerve pain and Radiating pain. Reporter did not consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Electric shock sensation, Injection site pain, Pain
Clinical narrative: shooting nerve pain; Radiating pain; soreness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th May 2022, the patient received the 1st dose of Shingrix (intramuscular) .5 mg/ml. On 27th May 2022, immediately after receiving Shingrix, the patient experienced injection site pain. On 28th May 2022, the patient experienced nerve pain and radiating pain. On an unknown date, the outcome of the injection site pain, nerve pain and radiating pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, nerve pain and radiating pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 11 July 2022 Reporter's Comments: Reporter stated patient got Shingrix vaccine. Soon after she got the shot, patient had soreness at the injection site. This soreness had resolved. Patient also reported that the next night, patient started with shooting nerve pain that went from her left shoulder to her left hand. She states that it only happens at night and is ongoing. On 28th May 2022 1 day after receiving Shingrix, the patient experienced nerve pain and Radiating pain. Reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Hypoaesthesia, Injection site swelling, Palpitations, Paraesthesia
Clinical narrative: swelling at injection site; Numbness; Tingling; episodic palpitations; Chest pain; Throat Swelling; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In April 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling. On an unknown date, the outcome of the injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling were unknown.   It was unknown if the reporter considered the injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling to be related to Shingrix.  Additional Information: GSK Receipt Date: 12-July-2022 Reporter's Comments: The patient received the Shingrix series in February and April and experienced chest pain, palpitations, throat swelling swelling at injection site, tingling, numbness and episodic palpitations. The reporter wanted to know if it was associated with the vaccine. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal swelling
Clinical narrative: swelling at injection site; Numbness; Tingling; episodic palpitations; Chest pain; Throat Swelling; This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   In April 2022, the patient received the 2nd dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling. On an unknown date, the outcome of the injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling were unknown.   It was unknown if the reporter considered the injection site swelling, numbness, tingling, palpitations, chest pain and throat swelling to be related to Shingrix.  Additional Information: GSK Receipt Date: 12-July-2022 Reporter's Comments: The patient received the Shingrix series in February and April and experienced chest pain, palpitations, throat swelling swelling at injection site, tingling, numbness and episodic palpitations. The reporter wanted to know if it was associated with the vaccine. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: the vaccine had an expiration date of 22Jun2022; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a adult patient who received HAV (Havrix) (batch number unknown, expiry date 22nd June 2022) for prophylaxis.   On 11th July 2022, the patient received Havrix. On 11th July 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: 12-July-2022 Reporter's Comments: The Pharmacy technician reports a nurse administered a dose of Havrix to an adult patient and after the administration the nurse realised the vaccine has expired. The reporter did not have lot number of vaccine and did not have any patient information at the time of reporting, only that the patient was an adult. At the time of reporting, the dose has not been repeated. The reporter consented to follow up. Additional supportive information: The patient received vaccine beyond the expiration date, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st: May20211, 2nd: late; This case was reported by a consumer 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 (1st dose received in May 2021 (exact date unknown)).   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.   GSK Receipt Date: 12-July-2022 Reporter's Comments: The patient was late for the 2nd dose. The reporter did not consent to follow-up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old female patient who received HAV (Havrix) (batch number 3A22R, expiry date 24th May 2022) for prophylaxis.   On 11th July 2022, the patient received Havrix. On 11th July 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: 12-Jul-2022 Reporter's comment: The lab tech reported that a patient received a dose of Havrix which was already expired on 24th May 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Administration after expiration date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA570A, expiry date 30th June 2022) for prophylaxis.   On 12th July 2022, the patient received Menveo. On 12th July 2022, unknown after receiving Menveo, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 13-Jul-2022 Reporter's comment: Medical assistant called to report that that 16 years old patient was vaccinated with an expired Menveo vaccine one day before the reporting date. The reporter stated that the vaccine was already discarded so no expiry date was available, but upon Lot provided expiration date shown on SFS was 30th June 2022. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Menveo vaccine, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Nausea
Clinical narrative: HEADACHE; CHILLS; feeling QUEEZY; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2022, the patient received the 2nd dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced headache, chills and queasy. On an unknown date, the outcome of the headache, chills and queasy were unknown.   It was unknown if the reporter considered the headache, chills and queasy to be related to Shingrix.     Additional Information: GSK Receipt Date: 13-JUL-2022 Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix and had chills, headache and was felt queasy. The reporter would like to know if she could take Tylenol. The reporter disconnected the call when asked to provide her name and contact information.  The reporter was unable to obtain any patient information or HCP (health care professional) information.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: adjuvant was not reconstituted with powder; patient received only  adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number A45FG, expiry date 23rd April 2023) for prophylaxis.   On 13th July 2022, the patient received Shingrix. On 13th July 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 Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The nurse reported a patient received only the Shingrix adjuvant (without reconstitution with powder on 13th July 2022 The reporter consented to follow up. Additional Supportive Information:  The patient only received shingrix adjuvant without reconstitution with powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106155:Same reporter. Patient 2
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: adjuvant was not reconstituted with powder; patient received only  adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a male patient who received Herpes zoster (Shingrix) (batch number A45FG, expiry date 23rd April 2023) for prophylaxis.   On 8th July 2022, the patient received Shingrix. On 8th July 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 Information: GSK Receipt Date: 13-Jul-2022 Reporter's Comments: The nurse reported a patient received only the Shingrix adjuvant (without reconstitution with powder on 8th July 2022 The reporter consented to follow up. Additional Supportive Information:  The patient only received shingrix adjuvant without reconstitution with powder, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This case is 1 of 2 cases reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022106154:Same reporter. Patient 1
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, Product prescribing error
Clinical narrative: physician was misinformed and sent in a prescription for a third dose of Shingrix; third dose administered; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number Kj937, expiry date 11th June 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th August 2019) and Shingrix (2nd dose received on 18th November 2019).   On 14th July 2022, the patient received the 3rd dose of Shingrix. On 14th July 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the patient experienced drug prescribing error. On an unknown date, the outcome of the extra dose administered and drug prescribing error were unknown.   Additional Information: GSK Receipt Date: 14-July-2022 Reporter's comment:  The reporter reported that a physician was misinformed and sent in a prescription for a third dose of Shingrix. The third dose was administered. It was unknown whether the patient was immunocompromised. The patient just had chronic health condition in their health history. The reporter did not consent to follow-up.  Additional supportive information: The patient received the 3rd dose of Shingrix which led to extra dose administered. This case has been linked to the case US2022AMR046791 reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR046791:Same reporter
Age: 57.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrixa 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 57-year-old male patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 14th July 2022, the patient received Havrix. On 14th July 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: 14-Jul-2022 Reporter's Comments: On 14th July 2022, the patient received a dose of Havrix that had expired on 18th June 2022. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Havrix that had already expired on 18th June 2022, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose was administered in 2021, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 27th December 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: 14-Jul-2022 Reporter's Comments: The reporter stated that at the time of the reporting, the second dose of the Shingrix vaccine was not yet administered to the patient and asked for guidance on how to proceed. The reporter consented to follow up. Additional Supportive Information: GSK Receipt Date: 14-Jul-2022 Reporter's Comments: The reporter stated that at the time of the reporting, the second dose of the Shingrix vaccine was not yet administered to the patient and asked for guidance on how to proceed. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administrated with Shingrix subcutaneously; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 75387, expiry date 26th August 2023) for prophylaxis.   On 12th July 2022, the patient received the 1st dose of Shingrix (subcutaneous). On 12th July 2022, unknown after receiving Shingrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 14-July-2022 Reporter's comment:  The patient was administrated with Shingrix subcutaneously. No adverse event was reported. The reporter consented to follow up. Additional supportive information: The patient received the Shingrix vaccine subcutaneously which led to incorrect route of administration.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: vaccine was reconstituted with sterile water; vaccine was reconstituted with sterile water; 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 female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   In February 2022, the patient received Menveo. In February 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: 14-July-2022 Reporter's comment:  The reporter was the pharmacy intern reported that the patient was given an incorrectly reconstituted dose of Menveo in February 2022. The vaccine was reconstituted with sterile water. The reporter consented to follow up via mail. Additional supportive information: Menveo reconstituted with sterile water, instead of the supplied diluents, was administered in error which led to wrong solution used in drug reconstitution error and Inappropriate dose of vaccine administered.
Age: 6.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the diluent portion; administered only the 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 6-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA673A, expiry date 30th March 2023) for prophylaxis.   On 11th July 2022, the patient received Menveo. On 11th July 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 Information: GSK Receipt Date: 14-July-2022 Reporter's comment:  The reporter asked how to proceed if by accident they administered only the diluent portion of Menveo. The reporter consented to follow up. Additional supportive information: Menveo was not reconstituted, only the diluent portion was administered which led to Inappropriate preparation of medication and Inappropriate dose of vaccine administered.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19, Diarrhoea
Clinical narrative: HORRIBLE INTESTINAL DISTRESS; DIARRHEA; COVID-19 INFECTION; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 36 year old white female. The patient's weight, height, and medical history were not reported. Patient was not pregnant at the time of vaccination. The patient previously received covid-19 vaccine (unspecified manufacturer) (Dose number in series 1) (form of admin, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, administered on unspecified date for COVID-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of 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, batch number and expiry date were not reported) dose was not reported, 1 total administered on 01-MAR-2021 for COVID-19 prophylaxis. Age at time of vaccination 35 years old. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. Concomitant medications included escitalopram oxalate.  In JUN-2022, the patient experienced COVID-19 infection (Dose number in series 2) (latency 15 months) and received non company suspect paxlovid (form of administration and route of administration were not reported and batch number: unknown, expiry: unknown) dose was not reported, administered from 28-JUN-2022 till 29-JUN-2022 for covid-19 treatment. On 29-JUN-2022, the patient experienced horrible intestinal distress with paxlovid and bad diarrhea (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and paxlovid was drug discontinued. The outcome of the horrible intestinal distress, diarrhea and covid-19 infection was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: REOCCURRENCE OF DRIPPING AND STUFFY NOSE; This spontaneous report received from a patient concerned a 66 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergy. The patient was previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total, administered on 09-APR-2021 at left arm for covid-19 prophylaxis. 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, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 1 total administered on 23-NOV-2021 at left arm for covid-19 prophylaxis. Age at time of vaccination 66 years old. The batch number was not reported and has been requested. No concomitant medications were reported.  On 02-JUL-2022, the patient experienced reoccurrence of dripping and stuffy nose (Dose number in series 2). Non company suspect drugs included: Nirmatrelvir/ritonavir (Paxlovid) (form of admin, route of admin, batch number were not reported and expiry: unknown) dose and frequency were not reported, started from 23-JUN-2022 to 27-JUN-2022 for treatment of covid-19. The action taken with covid-19 vaccine ad26.cov2.s and paxlovid was not applicable. The patient was recovering from reoccurrence of dripping and stuffy nose. This report was non-serious.
Age: 70.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus, Rash, Suspected COVID-19, Urticaria
Clinical narrative: ITCHY; EXTENDED HAND SIZE RED PUFFY PATCHES IN SEVERAL SPOTS AROUND UPPER LEGS AND HIP AREAS; RASH INCREASING IN SIZE; WELTS INCREASING IN SIZE ESPECIALLY AT NIGHT; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient via another pharmaceutical company concerned a 72 year old male. The patient's weight, height, and medical history were not reported. On 10-MAR-2021, the patient received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of admin not reported, batch number: 1805018 expiry: UNKNOWN) dose was not reported, 1 total administered for covid-19 prophylaxis. The age at time of vaccination was 70 years. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (dose number in series: 1). On 21-OCT-2021, the patient received non-company suspect vaccine elasomeran (Moderna vaccine) (dose number in series: 2) (form of admin and route of admin were not reported, batch number: 039021A expiry: UNKNOWN) dose was not reported, administered for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date in 2022, the patient experienced covid-19 (coded as suspected covid-19) (dose number in series: 2). On 22-JUN-2022, the patient was initiated treatment with non-company suspect drug Paxlovid (form of admin, route of admin and batch number were not reported, expiry: unknown) dose was not reported, administered for covid-19. On 24-JUN-2022, the patient experienced rash increasing in strength each of the five day treatment, itchy welts increasing in size especially at night resulting in extended hand size red puffy patches in several spots simultaneously (dose number in series: 2). On 27-JUN-2022, the patient completed the five day treatment of Paxlovid. The action taken with covid-19 vaccine ad26.cov2.s and elasomeran was not applicable, and action taken with Paxlovid was not reported. The patient recovered from itchy, extended hand size red puffy patches in several spots around upper legs and hip areas, rash increasing in size, and welts increasing in size especially at night on 2022, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Mammogram
Clinical narrative: LUMP UNDER LEFT ARM; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. 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: 1809878, expiry: UNKNOWN) dose was not reported, 1 total, administered on 01-JUL-2021 to left arm for covid-19 prophylaxis. On 01-JUL-2021, after receiving the first dose of covid-19 vaccine ad26.cov2.s, the patient noticed that she had a lump under her left arm (Dose number in series 1). About 3 weeks after receiving the injection, she had a mammogram and everything was normal. The lump went away on its own shortly after the mammogram. The patient recovered from lump under left arm on JUL-2021. The patient additionally received booster dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1822811, expiry: UNKNOWN) dose was not reported, 1 total, administered on NOV-2021 for covid-19 prophylaxis. No concomitant medications were reported. On an unspecified date in NOV-2021, following vaccination with covid-19 vaccine ad26.cov2.s, the patient experienced lump under left arm, a lump appeared and disappeared but after booster the recovery was faster (Dose number in Series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lump under left arm on an unspecified date in 2021. This report was non-serious. This case, involving the same patient is linked to 20220728819 (Dose number in series 1).
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Vasculitis
Clinical narrative: VASCULITIS AFTER BEING INOCULATED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not 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 covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced vasculitis after being inoculated. Laboratory data (dates unspecified) included: Blood test a finding in blood, had vasculitis. The doctors do not know what it was, there was a suspicion that it was something plastic or metal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vasculitis after being inoculated was not reported. This report was non-serious. This case, from the same reporter is linked to 20220732360.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Caller stated she is 28 weeks pregnant.; she is not experiencing any side effects at this time.; She was seen in her provider's office today and was expecting to receive TDap, but was accidently administered GARDASIL 9 instead.; Caller stated she received her first dose of GARDASIL 9 when she was in high school (approximately her freshman orsophomore year of high school) and was not going to receive the second dose, but was accidentlyadministered GARDASIL 9 today.; This spontaneous prospective report was received from a pregnant 22-year-old female patient reporting about herself. The patient's medical history and concurrent conditions were not reported. The concomitant therapy included minerals NOS (+) vitamins NOS (PRENATAL VITAMINS).  On an unknown date (reported as "when she was in high school"), she received the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered as prophylaxis (dosage regimen, lot #, expiry date, anatomical location and route of administration were not provided).  On 15-DEC-2021, the patient had her last menstrual period (LMP) and on 29-DEC-2021, she became pregnant (estimated date of conception) (estimated delivery date was 21-SEP-2022).  On 29-JUN-2022, the patient accidentally received the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (dosage regimen, lot #, expiry date, and anatomical location were not provided) (Inappropriate schedule of product administration) instead of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) (Wrong product administered). At the time of vaccination, she was 28 weeks pregnant (Exposure during pregnancy). The patient stated that she was not experiencing any side effects at the time of reporting (No adverse event). No additional adverse events and product quality issues were reported. At the time of reporting, the outcome of wrong product administered was unknown, the outcome of the pregnancy was pending, and the fetal outcome was unknown.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: they received the Moderna on 08Jun2022 refrigerated with 30 day use by date of 08Jul2022.; adult patient received Moderna COVID-19 vaccine after 30 day BUD; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna COVID-19 vaccine after 30 day BUD) and PRODUCT STORAGE ERROR (they received the Moderna on 08Jun2022 refrigerated with 30 day use by date of 08Jul2022.) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014B22A) for COVID-19 prophylaxis.     The patient had no known drug allergy (KNDA). It was unknown whether the patient was never diagnosed/tested positive for COVID-19.  It was unknown whether the patient had any acute illness at the time of vaccination and up to one month before it.  Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE on 15-May-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Hypertension, Hypercholesterolaemia and Diabetes. Concomitant products included LEVOTHYROXINE, WARFARIN, SIMVASTATIN and METOPROLOL for an unknown indication.    On 09-Jul-2022 at 9:56 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milligram. On 09-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna COVID-19 vaccine after 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (they received the Moderna on 08Jun2022 refrigerated with 30 day use by date of 08Jul2022.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna COVID-19 vaccine after 30 day BUD) and PRODUCT STORAGE ERROR (they received the Moderna on 08Jun2022 refrigerated with 30 day use by date of 08Jul2022.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (adult patient received Moderna COVID-19 vaccine after 30 day BUD) and PRODUCT STORAGE ERROR (they received the Moderna on 08Jun2022 refrigerated with 30 day use by date of 08Jul2022.) to be not related.    The vial was initially stored in the refrigerator on 08-Jun-2022. The best use by date was 08-Jul-2022. The patient had inadvertently given one day past the 30-day refrigeration date. The patient had no adverse reaction.  The patient did not seek medical care in response to the event.  The patient did not experience similar event in the past.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2022: Follow up received include significant information removed classification of invalid, reporter details, patient initials, age, ethnic, race, added historical vaccine and suspect vaccine details, added concomitant medications, updated reporter causality from not provided to not related and narrative updated.