chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.08
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Skin discolouration
Clinical narrative: reaction/faint grey dot; This case was reported by a nurse via sales rep and described the occurrence of skin discoloration in a 1-month-old patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAEMOPHILUS B CONJUGATE VACCINE (TETANUS) (ACTHIB) for prophylaxis and PNEUMOCOCCAL 13 VALENT CONJUGATE VACCINE (PREVNAR) for prophylaxis.   On 10th June 2022, the patient received the 1st dose of Pediarix and Pediarix Pre-Filled Syringe Device. On an unknown date, the patient received ACTHIB and PREVNAR. On an unknown date, less than 3 months after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced skin discoloration. On an unknown date, the outcome of the skin discoloration was unknown.   It was unknown if the reporter considered the skin discoloration to be related to Pediarix and Pediarix Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Linked case(s) involving the same patient:  US2022AMR149551   Additional Information: GSK Receipt Date: 14-OCT-2022 Reporter's Comment: Prevnar and Acthib were also given with Pediarix in same leg so were not sure which vaccine caused the reaction. The faint grey dot was the adverse event that followed vaccination. Additional Supportive Information: For tolerance to the 2nd dose US2022AMR149551. This case is linked to the case US2022AMR148961, US2022AMR148919, US2022AMR149560 and US2022AMR149561 reported by the same reporter. It was unknown if the reporter considered the depigmentation spot to be related to Prevnar and Acthib.; Sender's Comments:  GSK-US2022AMR148961:same reporter GSK-US2022AMR148919:same reporter GSK-US2022AMR149551:same reporter GSK-US2022AMR149560:same reporter GSK-US2022AMR149561:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Broke out in shingles, same day of 1st dose; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 16-OCT-2022 Reporter's Comments: This case was received from consumer via  interactive digital media. The patient received 1st shingles dose of Shingrix and broke out in shingles the same day. The patient wanted to know should he/she get the 2nd dose. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: injection site swelling  incresing each day; This case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient experienced injection site swelling that was increasing each day. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
Age: 0.5
Sex: M
Vaccine: UNK
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Second dose one week after first; This case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too short in a 6-month-old male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3393T, expiry date 30th June 2023) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT).   On 10th October 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device. On 10th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short 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: 10-OCT-2022 Reporter's comments: A physician had called to ask for information about the administration of Flulaval vaccine to a 6 month-old patient one week after the first dose administration instead of waiting at least 4 weeks as written in the Product Information (PI). Reporter mentioned that patient did not suffer from any adverse reaction and she wanted to know how to proceed with the patient vaccination. Additional supportive information: The patient received the second dose of Flulaval vaccine earlier than the recommended interval, which had led to shortening of vaccination schedule.
Age: 9.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered as 1st dose for dTap serie catch-up; Kinrix administered as 1st dose for dTap serie catch-up; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate schedule of vaccine administered in a 9-year-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2m, 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.   On 6th October 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 6th October 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate schedule of vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 10-OCT-2022 Reporter's comments: Medical assistant had reported on 10 October 2022 that a 9 years of age patient had received Kinrix on 6th October 2022. Patient had not received any previous vaccines (including previous dTap immunization)  The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: At the time of reporting, the patient was 9 years old and had received Kinrix as 1st dose in the series, which had led to Inappropriate schedule of vaccine administered and Inappropriate age at vaccine administration.
Sex: F
Vaccine: MNQ
Symptoms: Exposure via eye contact, Occupational exposure to product, Product closure issue, Product complaint
Clinical narrative: Menveo went in eye; Menveo went in eye; vial stopper leakage; defect was classified as Vial stopper integrity issue.; This case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while preparing product for administration in a female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced occupational exposure while preparing product for administration, exposure via eye contact, vial stopper damage and pharmaceutical product complaint. On an unknown date, the outcome of the occupational exposure while preparing product for administration, exposure via eye contact, vial stopper damage and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 10-OCT-2022 and 17-OCT-2022 Reporter's comment: Health Care Professional reported that after reconstituting the Menveo it exploded and some went in her eye.  The reporter wanted to know if we had guidance.  The reporter said she will call back tomorrow with lot and expiration. The vaccine administration facility was the same as primary reporter. As per the QA department the reported defect was classified as vial stopper integrity issue. The reporter consented to follow-up. Additional Supportive Information: After reconstituting the Menveo it exploded and some went in her eye, which led to Occupational exposure while preparing product for administration, Exposure via eye contact, Vial stopper damage and Pharmaceutical product complaint.
Sex: F
Vaccine: UNK, UNK
Symptoms: Accidental overdose, Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Extra dose/both flulaval administered on the same day; administered intradermally in the forearm; administered intradermally in the forearm; This case was reported by a physician via call center representative and described the occurrence of accidental overdose in a female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis and flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season (intradermal) .1 ml, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season (intramuscular) .5 ml and Flulaval Tetra Pre-Filled Syringe Device. On 10th October 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, FluLaval Quadrivalent 2022-2023 season and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced accidental overdose, intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the outcome of the accidental overdose, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 11-OCT-2022 Reporter's Comment: The reporter reported that, a patient received an extra dose of Flulaval. One Flulaval 0.5 cc dose administered intramuscularly and then another Flulaval 0.1cc dose intradermally in the forearm both administered on same day.  The reporter stated that, the nurse accidentally administered the extra 0.1cc dose but was trying to give a TB test but withdrew the Flulaval instead.  No other details were provided.  MD was unable to provide vaccine and patient details.  The reporter did not consent to follow-up Additional Supportive Information: The patient received one Flulaval 0.5 cc dose administered intramuscularly and then another Flulaval 0.1cc dose intradermally in the forearm both administered on same day, which led to accidental overdose, intramuscular formulation administered by other route and vaccine administered at inappropriate site.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA791A, expiry date 31st January 2024) for prophylaxis.   On 11th October 2022, the patient received Menveo. On 11th October 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: 11-OCT-2022 Reporter's Comment: The reporter called to inquire that if we need to repeat the vaccine. The reporter reported, they reconstituted the Menveo lyophilized powder with sterile water instead of the GSK approved Menveo diluent and inadvertently administered to a patient at the time of reporting. No other details were provided, the reporter was unable to provide any patient details.  The reporter stated that, vaccine was administered at an alternate facility site. The reporter did not consent to follow-up. Additional Supportive Information: The reporter reported, they reconstituted the Menveo lyophilized powder with sterile water instead of the GSK approved Menveo diluent and inadvertently administered to a patient at the time of reporting, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Possible administration of expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a male patient who received DTPa-HBV-IPV (Pediarix) (batch number BF722, expiry date 27th February 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 28th February 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 28th February 2022, unknown after receiving Pediarix and Pediarix 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: 12-Oct-2022 Reporter's Comments: The nurse called and asked for information about the possible administration of an expired dose of Pediarix to a patient.  The reporter wanted to verify the lot number of the vaccine administered since she realized that in her records it was written that the expiration date. The lot number she reported was BF722 but this number did not match with Pediarix lot number. The reporter consent to follow up. Additional Supportive Information: The patient received an expired dose of Pediarix, which led to expired vaccine used.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexsero administered instead of Menveo; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a male patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, 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 by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 12-OCT-2022. Reporter's Comments: The reporter stated that a dose of Bexsero was given to a patient who was supposed to receive his first dose of Menveo.  The patient had never received a dose of Bexsero prior to this. The reporter did not ask about follow-up. The vaccine administration facility is the same as primary reporter. Additional Supportive Information: The patient received Bexsero instead of Menveo which lead to Wrong vaccine administered.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: baby patient who received Havrix second dose 4 months apart the first dose; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (1st dose received on 2nd May 2022).   On 21st September 2022, the patient received the 2nd dose of Havrix. On 21st September 2022, unknown after receiving Havrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.    Additional Information: GSK receipt date: 12-OCT-2022 Reporters comment: The baby 1 year 5 month old patient who received Havrix second dose 4 months apart the first dose. HCp was looking for information about how to proceed.  The reporter did not consent to follow-up. Additional Supportive information: The patient received 1st dose on 02nd May 2022 and 2nd dose on 22nd September 2022 which led to shortening of vaccinations schedule.
Age: 56.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: patient was administrated with an expired dose of Havrix; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 56-year-old female patient who received HAV (Havrix) (batch number 7y499, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 7th October 2022, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 7th October 2022, 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: 13-Oct-2022 Reporter's comment: The nurse reported on 13th October 2022 that the patient was administrated with an expired dose of Havrix on 7th October 2022.  The vaccine expired on 30th September 2022.  There was no adverse event reported. The consent to follow-up was granted. Additional Supportive Information: The patient was administrated with an expired dose of Havrix, which led to expired vaccine used.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: patient received an expired Bexsero vaccine; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 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 12th October 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 12th October 2022, unknown after receiving Bexsero and Bexsero 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: 13-Oct-2022 Reporter's comment: The medical assistant called on 13th October 2022 and reported that yesterday on 12th October 2022 the patient received an expired Bexsero vaccine.  The health-care professional reported that this was 2nd dose.  The vaccine administration facility was the same as primary reporter. The consent to follow-up was granted via email. Additional Supportive Information: The patient was administrated with an expired dose of Bexsero, which led to expired vaccine used.
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Body hives and whelps; This case was reported by a consumer via call center representative and described the occurrence of hives in a 9-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Concurrent medical conditions included milk allergy, egg allergy, peanut allergy and allergy to nuts.   On 12th October 2022, the patient received FluLaval Quadrivalent 2022-2023 season. On 12th October 2022, 2 hrs after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced hives. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to FluLaval Quadrivalent 2022-2023 season.     Additional Information: Reporter's comment: The case was reported by patient's parent on behalf of her daughter.  The reporter stated that the patient (daughter) received the Flulaval vaccine yesterday (before reporting day) at pediatrician's office. About two hours later, the patient experienced full body hives and whelps.  The adverse event was filed.  The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: only received the first dose of Engerix-b which was administrated on July 8 2022; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 46-year-old male patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 08th July 2022, with batch number-n4ga4 and expiry date - 02nd January 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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: 13-Oct-2022 Reporter's comment: The nurse reported that the patient was late for the second dose of Engerix-B.  There was no adverse event reported. The consent to follow-up was granted. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Engerix-B, which led to incomplete course of vaccination.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, HEP, HEPA, MENB, TDAP, UNK
Symptoms: Product storage error
Clinical narrative: Exposed at 30°F to 45°F, vaccines were administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Reduced antigen) (Boostrix) for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Men B NVS (Bexsero) for prophylaxis, meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 32P2F, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Pediarix, Pediarix Pre-Filled Syringe Device, Havrix, Engerix B, Boostrix, Kinrix, Kinrix Pre-Filled Syringe Device, Bexsero, Bexsero Pre-Filled Syringe Device, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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: 13-Oct-2022 Reporter's comment: The certified clinical medical assistant reported that since 16th September 2022 until the day of reporting, the refrigerator alarm was triggered several times.  The lowest temperature was 30 degree Fahrenheit and the highest was 45 degree Fahrenheit.  The vaccines involved were Pediarix, Havrix, Engerix-B, Boostrix, Kinrix, Fluarix QIV and Bexsero.  The vaccines were administered to patients.  No more data was available. The reporter consented to follow up via email. Additional supportive information: The patients received Pediarix, Havrix, Engerix-B, Boostrix, Kinrix, Fluarix QIV and Bexsero after temperature excursion, which led to incorrect storage of drug.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Flu-like symptoms; 1st dose on 13 Sep 2022, 2nd on 13 Oct 2022; Feeling bad; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 13th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 13th October 2022, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms and drug dose administration interval too short. In October 2022, the patient experienced feeling bad. On an unknown date, the outcome of the influenza-like symptoms and feeling bad were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the influenza-like symptoms and feeling bad to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The reporter was the patient who reported she received her first Shingrix vaccine on arm and her second Shingrix vaccine on left deltoid.  The patient started to feel like she had the flu-like symptoms through-out the night and less than a week after vaccination, was still feeling bad today (reporting day).  The patient realized she was given the dose early because she went online and saw the recommended dosing schedule.  The patient reported when she called the pharmacy the pharmacist said a technician gave her the vaccine, the technician was not aware of the dosing schedule when the caller told her she received the first Shingrix vaccine one month ago and the scheduling system must had failed.  The patient gave permission to follow-up with health-care professional. The consent to follow-up was granted. Additional supportive information: The patient received the 2nd dose earlier than the recommended interval, which led to shortening of vaccination schedule.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration
Clinical narrative: shingles after 1st dose; first dose of shingrix in 30th Dec 2019 and 2nd dose on Sep 3 2022; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 84-year-old female patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2022, the patient received the 2nd dose of Shingrix. On 30th December 2019, the patient received the 1st dose of Shingrix. On 3rd September 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced shingles. On an unknown date, the outcome of the shingles and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Additional Information: GSK Receipt Date: 14-Oct-2022 Reporter's comment: The pharmacist reported that the patient developed shingles after 1st dose of Shingrix and received late second dose. The vaccine administration facility was the same as primary reporter. The consent to follow-up was granted. Additional Supportive Information: The patient received 2nd dose longer than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 72.0
Sex: M
Vaccine: TDAP
Symptoms: Expired product administered
Clinical narrative: administered an expired vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 72-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number XK524, expiry date 8th October 2022) for prophylaxis.   On 14th October 2022, the patient received Boostrix. On 14th October 2022, unknown after receiving Boostrix, 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-OCT-2022 Reporter's Comment: The case was reported by pharmacist. The reporter administered an expired vaccine expired by 6 days, an expired Boostrix 8th October 2022 on 14th October 2022 in their facility. The reporter was seeking to get information for follow up. Alternate pharmacist inquired should patient repeat the dose. Reporter did not consent to follow. Additional supportive information: As patient administered expired dose which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose Oct2019, 2nd 17Oct2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2018).   On 17th October 2022, the patient received the 2nd dose of Shingrix. On 17th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 17-OCT-2022 Reporter's Comment: The patient self-reported this case. Reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Shingrix later than recommended interval, which led to lengthening of vaccination schedule.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Ophthalmological examination, Visual impairment
Clinical narrative: REDUCED EYE VISION/WENT FROM 20/25 TO 20/40 IN BOTH EYES; This spontaneous report received from a patient concerned a 73 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: shotgun vision (She had Retinada pigmentosa, a hereditary problem, it's called shotgun vision. She was born with it. And according to her eye doctor this condition had been stable since 2015.), cholesterol, and high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for covid-19 prophylaxis. Age at time of vaccination 73 years old. No concomitant medications were reported. On 12-APR-2021, the patient experienced reduced eye vision/went from 20/25 to 20/40 in both eyes. Laboratory data included: Eye exam went from 20/25 to 20/40 in both eyes. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from reduced eye vision/went from 20/25 to 20/40 in both eyes. This report was non-serious.; Sender's Comments: V0: V0:  Medical assessment comment not required as per standard procedure as the case is assessed as non serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Thrombosis
Clinical narrative: STROKE; CLOT; This spontaneous report received from a consumer via media via a company representative concerned a male of unspecified age, race and ethnicity. 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, batch number and expiry were not reported) dose, start therapy date were not reported, administered 1 in total 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 clot and then stroke. Reported as "J&J makes the "clot shot "father got his vex then the clot then the stroke, explicative your poison". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the clot and stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221033422-covid-19 vaccine ad26.cov2.s-stroke. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20221033422-covid-19 vaccine ad26.cov2.s-clot. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and is scientifically plausible. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Diplopia, Dysphagia, Dyspnoea, Muscle atrophy, Paralysis
Clinical narrative: PARTIAL PARALYSIS OF NECK AND ARM; LOSS OF MUSCLE; DIFFICULTY SWALLOWING FOOD; DOUBLE VISION; SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a 71 year old male of an unspecified race and ethnic origin. The patient's weight was 70 kilograms, and height was 182.88 centimeters. The patient's concurrent conditions included: non-alcohol user, and smoker (Two or three cigars a day), and other pre-existing medical conditions included: Patient had no history of drug abuse, no any other medical history or relevant preexisting conditions, patient was not on any medication at the time of adverse event started, no illness at the time of vaccination, no past 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 4381507, expiry: Unknown) dose was not reported, 1 total administered to right upper arm on 03-DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported.  On an unspecified date, the patient experienced fatigue, double vision, shortness of breath, partial paralysis of neck and arm, loss of muscle, and difficulty swallowing food. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from double vision, had not recovered from partial paralysis of neck and arm, and the outcome of loss of muscle, difficulty swallowing food and shortness of breath was not reported. This report was serious (Other Medically Important Condition). This case is a duplicate of 20220829713.; Sender's Comments: V0: 20221034082-covid-19 vaccine ad26.cov2.s-partial paralysis of neck and arm. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Lip swelling
Clinical narrative: SUSPECTED COVID-19; SLIGHTLY SWOLLEN UPPER LIP; This spontaneous report received from a patient via other manufacturer Pfizer concerned a 61 year old male of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient was not on any other medications or products within 2 weeks of starting COVID-19 treatment. Patient had unspecified drug allergy. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (unspecified manufacturer) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date 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 (unspecified manufacturer) (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on DEC-2021 for covid-19 prophylaxis. Age at time of vaccination 60 years old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient had Covid-19 (suspected Covid-19) (Dose number in series 2) and received non company suspect paxlovid (form of administration and route of administration were not reported, batch number: 1919255A, expiry: unknown) dose was not reported, administered from 07-OCT-2022 till 08-OCT-2022 for covid-19 treatment. On 08-OCT-2022 at 01:00, the patient experienced slightly swollen upper lip (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and paxlovid was drug discontinued on 08-OCT-2022. The patient was recovering from slightly swollen upper lip and the outcome of suspected covid-19 was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Therapy non-responder
Clinical narrative: SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report was received from literature. This report concerned a 70 year old male. The objective of this article was to study immunogenicity of Ad26.COV2.S Prime and Two Subsequent doses of mRNA SARS-CoV-2 vaccines in solid organ transplant recipients. The patient's height, and weight were not reported. The patient's past medical history included: kidney transplant (45 years since transplant). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported, 01 total administered for covid-19 prophylaxis. The batch number was not reported and has been requested. Concomitant medications included mycophenolate mofetil (MMF) and steroids for drug used for unknown indication.   On an unspecified date laboratory test included: Antibody test (anti-RBD) which was less than 0.8 U/mL (Highest Post-D1 (ad26.cov2.s) Titers), 1273 U/mL (Highest post-D2 (elasomeran) titers), 2021 U/mL (Highest post-D3 (elasomeran) titers) and negative cutoff value was less than 0.8 U/mL or anti S1 less than 1.1. AU. Hence suspected immunological vaccine failure (Dose number in series 1). Days between D3 and Post-D3 titers was 19 days. The patient additionally received two doses of non-company suspect vaccine (Spikevax) (mRNA 1273) elasomeran (Dose number in series 2) (form of admin, route of admin, and batch number were not reported, expiry: UNKNOWN) dose was not reported, start therapy date were not reported for covid-19 prophylaxis. The vaccination days in between ad26.cov2.s and elasomeran was 259 days while second dose of elasomeran was after 27 days.  The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The outcome of the suspected immunological vaccine failure was not reported.  The authors emphasized on the awareness that despite suboptimal antibody response to the Ad26.COV2.S prime, two subsequent mRNA vaccines increased antibody titers to high levels for the majority of participants, with acceptable side effects. This series suggested that a heterologous vaccine regimen may be a reasonable option for SOTRs (Solid Organ Transplant Recipients) though lack of sero-response, despite two mRNA boosters, suggested that some recipients may remain at risk for SARS-CoV-2 infection.  This report was serious (Other Medically Important Condition). This case, from same Literature article is linked to 20221012832, 20221034707, 20221034755, 20221034752, 20221034754 and 20221034625. This report was associated with product quality compliant.; Sender's Comments: V0: 20221034742-covid-19 vaccine ad26.cov2.s-suspected immunological vaccine failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: CONMEDS-OTHER SUSPECT DRUGS, SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: PSORIASIS SYMPTOMS; This spontaneous report received from a patient concerned a 67 year old male. 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced psoriasis symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of psoriasis symptoms was not reported. This report was non-serious.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphonia, Pruritus, Rash, Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; RASH; ITCHING ON SCALP, ARMS AND STOMACH; HOARSENESS; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, ibsd, and penicillin allergy, and other pre-existing medical conditions included: The patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on APR-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. Age at time of vaccination 53 years old. No concomitant medications were reported. On 09-OCT-2022, the patient experienced rash, itching on scalp, arms and stomach, and hoarseness. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash, itching on scalp, arms and stomach, and hoarseness, and the outcome of suspected covid-19 infection was not reported. This report was non-serious.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pain in extremity, Rash
Clinical narrative: arm pain/pain is still there; rash; muscle pain; pulsing pain/throbbing; This spontaneous case was reported by a patient and describes the occurrence of PAIN (pulsing pain/throbbing), PAIN IN EXTREMITY (arm pain/pain is still there), RASH (rash) and MYALGIA (muscle pain) in a 71-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     The patient's past medical history included Kidney transplant. Concurrent medical conditions included Blood pressure high.    On 03-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Oct-2022, the patient experienced PAIN IN EXTREMITY (arm pain/pain is still there). In October 2022, the patient experienced PAIN (pulsing pain/throbbing), RASH (rash) and MYALGIA (muscle pain). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN (pulsing pain/throbbing), RASH (rash) and MYALGIA (muscle pain) outcome was unknown and PAIN IN EXTREMITY (arm pain/pain is still there) had not resolved.            Concomitant medication not reported.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; Received an expired Moderna COVID19 booster; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna COVID19 booster) and NO ADVERSE EVENT (No Adverse Event) in a 78-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 006m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 26-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna COVID19 booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received an expired Moderna COVID19 booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was reported that patient received an expired Moderna COVID19 booster.  Caller stated the vaccine expired on 16 Sep 2022, Vial expiration checker showed that the expiration date was 15 Sep 2022.  Treatment information was not provided.   This case was linked to MOD-2022-660008 (Patient Link).