chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Redness, hardness at injection site started on 10/24/2022 after receiving vaccines at  Pharmacy at  on 10/23/22 Cellulitis at injection site, left arm
Age: 1.92
Sex: M
Vaccine: UNK
Symptoms: Adenoidal disorder, Asthma, Ear tube insertion, Hypersensitivity, Product administered to patient of inappropriate age
Clinical narrative: THIS VACCINE WAS GIVEN TO MY SON AT 23 MONTHS, THIS VACCINE WAS HPV4 HUMAN PAPILLOMAVIRUS, QUADRIVALENT MANUFACTURER MERK AND CO.,INC. DOSE:00.50 THIS SHOULD NOT HAVE BEEN GIVEN TO MY SON ALSO ANOTHER VACCINE WAS GIVEN THAT SHOULDN'T HAVE BEEN GIVEN ONLY 2 DOSE SHOULD BE DONE THIS ONE  WOULD OF BEEN A 3RD ONE. HPV VACCINES ARE  NOT GIVE TO KIDS UNTIL THEY ARE 12 YEARS MY SON WAS 23 MONTHS. THIS IS HORRIBLE AND SHOULD NEVER HAPPENED. MY SON HAS BEEN HAVING GASTROINTESTINAL PROBLEMS SINCE HE WAS BABY AND STILL GOING, ASTHMA AND ALLLERGIES, HAD TONSILS ADNOIDS AND TUBES IN EARS. HIS SISTER HAS NO ISSUES. FACILITY HAS DISSAPPOINTED ME AND IM LOOKING FOR A LAWYER. FINDING THIS OUT NOW HURTS. SEEING GASTRO SPECIALIST
Age: 1.92
Sex: M
Vaccine: UNK
Symptoms: Tonsillar disorder
Clinical narrative: THIS VACCINE WAS GIVEN TO MY SON AT 23 MONTHS, THIS VACCINE WAS HPV4 HUMAN PAPILLOMAVIRUS, QUADRIVALENT MANUFACTURER MERK AND CO.,INC. DOSE:00.50 THIS SHOULD NOT HAVE BEEN GIVEN TO MY SON ALSO ANOTHER VACCINE WAS GIVEN THAT SHOULDN'T HAVE BEEN GIVEN ONLY 2 DOSE SHOULD BE DONE THIS ONE  WOULD OF BEEN A 3RD ONE. HPV VACCINES ARE  NOT GIVE TO KIDS UNTIL THEY ARE 12 YEARS MY SON WAS 23 MONTHS. THIS IS HORRIBLE AND SHOULD NEVER HAPPENED. MY SON HAS BEEN HAVING GASTROINTESTINAL PROBLEMS SINCE HE WAS BABY AND STILL GOING, ASTHMA AND ALLLERGIES, HAD TONSILS ADNOIDS AND TUBES IN EARS. HIS SISTER HAS NO ISSUES. FACILITY HAS DISSAPPOINTED ME AND IM LOOKING FOR A LAWYER. FINDING THIS OUT NOW HURTS. SEEING GASTRO SPECIALIST
Age: 0.58
Sex: F
Vaccine: FLUA4
Symptoms: Extra dose administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Provider ordered flu vaccine. RN administered vaccine as ordered. Patient had received the same vaccine on 10/14/2022. No adverse reactions occurred after administration.
Age: 1.17
Sex: M
Vaccine: HEPA, HIBV, PPV
Symptoms: Incorrect product formulation administered
Clinical narrative: Pneumococcal 23 given instead of Pneumococcal 13
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Death, General physical health deterioration, Respiratory failure, SARS-CoV-2 test positive
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. They were vaccinated with the Moderna product on 01/16/2021, 02/13/2021, and 11/02/2021. They tested positive for COVID-19 on 08/13/2022. They were admitted to hospital same day. They were found to be experiencing hypoxic respiratory failure. Their condition deteriorated and they were placed on Hospice care. They died on 08/16/2022.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: This is an instance of breakthrough COVID-19 after which death occurred. They were vaccinated with the Moderna product on 01/16/2021, 02/13/2021, and 11/02/2021. They tested positive for COVID-19 on 08/13/2022. They were admitted to hospital same day. They were found to be experiencing hypoxic respiratory failure. Their condition deteriorated and they were placed on Hospice care. They died on 08/16/2022.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Fatigue, Injection site pain, Injection site swelling, Irritability, Product preparation issue
Clinical narrative: Undiluted dose was administered at 3:22pm, in less than 1 hour, swelling and soreness at injection site. Irritability, tiredness. Pharmacy contacted parent at 4:29pm to inform that an undiluted dose had been administered. No other advice was provided. Parents contacted primary care physician but have not yet had communication with PCP.
Age: 9.0
Sex: F
Vaccine: COVID19-2, COVID19-2
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Undiluted dose was administered at 3:22pm, in less than 1 hour, swelling and soreness at injection site. Irritability, tiredness. Pharmacy contacted parent at 4:29pm to inform that an undiluted dose had been administered. No other advice was provided. Parents contacted primary care physician but have not yet had communication with PCP.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: It started with a cough, and it lasted for about 8 days. I had a runny nose for about 5 days. I had a sore throat for about 2 days. I had fatigue for about 7 days. I was taking cold medication until I went to the clinic and got Paxlovid.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: It started with a cough, and it lasted for about 8 days. I had a runny nose for about 5 days. I had a sore throat for about 2 days. I had fatigue for about 7 days. I was taking cold medication until I went to the clinic and got Paxlovid.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: FIRST PATIENT OF THE DAY, AND THOUGHT A NEW VIAL WAS OPENED. UNFORTUNATELY IT WAS FROM THE PREVIOUS EVENING, AND 5 HOURS AFTER THE BEYOND USE TIME. WE CALLED PATIENT BACK IN AND RE-ADMINISTERED THE VACCINE WITH A FRESHLY OPENED VIAL AS PER PROTOCOL.
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Patient received second dose of infant Pfizer COVID-19 vaccine that was diluted with 0.22mL of diluent instead of 2.2mL of diluent in the vial. Error was discovered after patient had left clinic. Parent was contacted and indicated that her son appears to be okay and is running at a pumpkin patch. Parent was advised to call their healthcare provider if any signs seemed to be unmanageable. She agreed she would and mentioned he had received a flu vaccine as well.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: STANDARD MODERNA GIVEN NOT BIVALENT BOOSTER.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Rash
Clinical narrative: Rash.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: muscle hurts; This case was reported by a consumer via interactive digital media and described the occurrence of muscle pain 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 muscle pain. On an unknown date, the outcome of the muscle pain was unknown.   It was unknown if the reporter considered the muscle pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 18-AUG-2022 Reporter's Comment:  Patient reported experienced muscle hurts after receiving Shingle vaccination.
Age: 77.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Illness, Nasopharyngitis
Clinical narrative: Was sick with a cold; Was sick with a cold; Cough; This case was reported by a consumer via other manufacturer and described the occurrence of sickness in a 77-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   In September 2022, the patient received Flu vaccine. In September 2022, 24 hrs after receiving Flu vaccine, the patient experienced sickness, cold and cough. On an unknown date, the outcome of the sickness, cold and cough were unknown.   It was unknown if the reporter considered the sickness, cold and cough to be related to Flu vaccine.     Additional Information: GSK Receipt Date : 19-OCT-2022 Reporter's comment: The reporter had reported that the patient had to cancel her last provider appointment because she was sick with a cold, but her husband after the fact had realized that, the patient had the flu shot the day before, so the cough and all that had come 24 hours after the flu shot.  The reporter said that, it was at the end of September 2022. Follow-up would not possible as no contact details were available.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Injection site discolouration, Injection site erythema, Injection site pain
Clinical narrative: first vaccine on 8-27-2022, second on 10-10-2022; pain at injection site; redness at injection site; skin around injection site darkened; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (received 1st dose on 27th August 20222, refer link case US2022149849).   On 10th October 2022, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 10th October 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. In October 2022, the patient experienced injection site pain, injection site erythema and injection site discoloration. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain and injection site erythema were recovered/resolved and the outcome of the injection site discoloration was 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 injection site pain, injection site erythema and injection site discoloration to be related to Shingrix.     Linked case(s) involving the same patient:  US2022149849   Additional Information: GSK Receipt Date: 18-OCT-2022 Reporter's Comment: The case was reported by the patient. The patient reported that, she received her second Shingrix vaccine, in the left arm. (Inappropriate schedule of vaccine). After second Shingrix vaccine again had pain and redness at the injections site that has resolved, but this time the skin right around the injection site was darkened. The reporter reached out to her health care professional if it did not resolve.  The reporter did not consent to follow-up Additional Supportive Information: The patient received 1st dose on 27th August 2022 and received 2nd dose of Shingrix on 10th October 2022, which led to shortening of the recommended interval between vaccine doses.; Sender's Comments:  US-GSK-US2022149849:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Lip swelling, Swelling face
Clinical narrative: Swelling in lips; Swelling in cheek; This case was reported by a consumer via interactive digital media and described the occurrence of lip swelling in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 14th October 2022, the patient received the 2nd dose of Shingles vaccine. On an unknown date, less than a week after receiving Shingles vaccine, the patient experienced lip swelling and cheek swelling. On an unknown date, the outcome of the lip swelling and cheek swelling were not recovered/not resolved.   It was unknown if the reporter considered the lip swelling and cheek swelling to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments:  This case was received from patient via interactive digital media. The reporter stated that the patient got 2nd shot on Friday and experiencing swelling in lips and cheek.  The reporter wants to know what should need to do. Additional supportive information: The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: 2nd dose hurt, achiness; Low grade fever; Little headache; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (an unknown date received 1st dose refer case US2022AMR151277).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 day after receiving Shingrix, the patient experienced pain, fever and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain, fever and headache were unknown.   It was unknown if the reporter considered the pain, fever and headache to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR151277   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The patient received the dose of Shingrix for shingles.  The second dose hurt much worse and next day patient experiencing low grade fever, achiness and little headache. The reporter wanted to know was that normal since patient did not had that the first dose. Additional supportive information: The follow-up could not be possible as no contact details were available.  ; Sender's Comments:  US-GSK-US2022AMR151277:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The 1st shot hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain 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, unknown after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR151276   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comments: This case was received from consumer via interactive digital media. The reporter stated that the first shot hurts but had no side effects reported with it. The reporter wanted to know, if it was that normal since the patient did not had those effects during the first dose. The follow-up could not be possible as no contact details were available. Additional supportive information: For tolerance of 2nd dose, refer case US2022AMR151276 which was reported by Same reporter.; Sender's Comments:  US-GSK-US2022AMR151276:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash is not listed; This case was reported by a consumer via interactive digital media and described the occurrence of rash 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 rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 19-OCT-2022 Reporters comment: This case was reported by a consumer via interactive digital media. The patient received shingle vaccine and experienced rash and reported it was not listed.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash, annoying; This case was reported by a consumer via call center representative and described the occurrence of rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Flu unspecified (Flu vaccine) and covid-19 vaccine (Covid 19 Booster).   On 9th September 2022, the patient received the 1st dose of Shingrix. In October 2022, between 1 and 2 months after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   The reporter considered the rash to be possibly related to Shingrix.     Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The patient self-reported this case. The patient received the Flu shot, Covid booster and then first dose of Shingrix from August to end of September. The patient thought he/she had a rash from the Shingrix vaccination. The patient in the past few days experiencing a rash, unusual for him/her and wonder that if it was possible side effect. The patient was asking that it means the Shingrix did not work for him/her. The patient reported that it was just annoying and not terrible. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Eye disorder
Clinical narrative: forehead/eye popped backup. It's mild; This case was reported by a consumer via interactive digital media and described the occurrence of eye disorder in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In October 2022, the patient received Shingles vaccine. In October 2022, less than 2 weeks after receiving Shingles vaccine, the patient experienced eye disorder. On an unknown date, the outcome of the eye disorder was unknown.   It was unknown if the reporter considered the eye disorder to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-Oct-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient just had his/her shot about 2 weeks ago and the place on his/her forehead/eye popped back up.  It was mild but wow. Additional supportive information: The follow-up could not be possible as no contact detail were available.
Sex: U
Vaccine: HEPA
Symptoms: Accidental overdose
Clinical narrative: Administered at least 5ml of Havrix; This case was reported by a consumer via interactive digital media and described the occurrence of accidental overdose in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix 5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she wants to get a 1ml dose of Hepatitis A vaccine, but by error the doctor's office gave him/her at least 5 ml of the Havrix vaccine. The patient stated that he thought that he was giving him/her the 1 ml dose. Additional supportive information: The patient wanted to receive 1ml dose but by error received at least 5ml of the Havrix vaccine, which led to accidental overdose. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Child dose administered to adult patient; Child dose administered to adult patient; This case was reported by a other health professional via other manufacturer and described the occurrence of underdose in a adult patient who received HAV (Havrix pediatric) for prophylaxis.   On an unknown date, the patient received Havrix pediatric. On an unknown date, unknown after receiving Havrix pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's comment: Health Care Professional (HCP) reported that the Havrix vaccine was given to an adult, and it was a child dose. No additional information was provided. No lot number and expiration date known by reporter. Customer was in a rush to get off phone therefore no additional adverse event questions asked and were marked as refused by agent. Additional Supportive Information: The Havrix pediatric administered to the adult patient, which led to Underdose and Adult use of a child product. The reporter consented to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: powder reconstituted with non approved diluent/ Received diluent only; powder reconstituted with non approved diluent/Received diluent only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The reporter reported that, they had 3 extra Shingrix  powder vials.  The medical information asked reporter if they knew what happened with the missing diluents and if they believed patients received diluent only.  The reporter seemed upset about this question and said did not  even go there, did not know what happened but there was no error. The reporter said that, they did not know what happened with the vials and asked medical information if the powder could be reconstituted with a non approved diluent. The reporter did not consent to follow-up. This is 1 of 3 linked cases reported by same reporter, different patients. Additional Supportive Information: The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid based upon verbatim that they believed patients received diluent only.; Sender's Comments:  US-GSK-US2022AMR152101:Same reporter US-GSK-US2022151415:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: powder reconstituted with non approved diluent/ received diluent only; powder reconstituted with non approved diluent/ received diluent only; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: The reporter reported that, they had 3 extra Shingrix  gE powder vials.  The medical information asked reporter if they knew what happened with the missing diluents and if they believed patients received diluent only.  The reporter seemed upset about this question and said did not  even go there, did not know what happened but there was no error. The reporter said that, they did not know what happened with the vials and asked medical information if the powder could be reconstituted with a non approved diluent. The reporter did not consent to follow-up. This is 1 of 3 linked cases reported by same reporter, different patients. Additional Supportive Information: The patient received only diluent of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The case was kept valid based upon verbatim that they believed patients received diluent only.; Sender's Comments:  US-GSK-US2022151415:Same reporter US-GSK-US2022AMR152100:Same reporter
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Gait disturbance, Herpes zoster, Incomplete course of vaccination
Clinical narrative: Could not bend the knee; barely walk; lower back pain; lower back swelling; 1st dose 27Sep2021, 2nd not yet; Circular Shingles Rash on stomach area; Knee Swelling; Pain behind the knee; This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 28th September 2021, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling of knees and knee pain. On 14th October 2021, the patient experienced shingles. On an unknown date, the patient experienced stiff joint, walking difficulty, low back pain, local swelling and incomplete course of vaccination. The patient was treated with prednisone and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, swelling of knees, knee pain, stiff joint, walking difficulty, low back pain, local swelling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, swelling of knees, knee pain, stiff joint, walking difficulty, low back pain and local swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: At the time of reporting, the patient age was over 50 years old. The patient received first dose of Shingrix and next morning, the patient had knee swelling and pain behind the knee. The patient reported that she could not bend the knee or barely walk also reported lower back swelling and lower back pain. The patient reported that she went to an emergency room walking clinic on 14th October 2021. On 14th October 2021 the patient was treated with Valtrex and Prednisone. The patient reported that she developed a circular shingles rash on the stomach area. The patient had not gotten the second dose of Shingrix. Emergency room visit required. The reporter reported that not all information was available, and lot and expiration date were not provided. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Joint stiffness, Joint swelling, Swelling
Clinical narrative: Could not bend the knee; barely walk; lower back pain; lower back swelling; 1st dose 27Sep2021, 2nd not yet; Circular Shingles Rash on stomach area; Knee Swelling; Pain behind the knee; This case was reported by a nurse via sales rep and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2021, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 28th September 2021, 1 days after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced swelling of knees and knee pain. On 14th October 2021, the patient experienced shingles. On an unknown date, the patient experienced stiff joint, walking difficulty, low back pain, local swelling and incomplete course of vaccination. The patient was treated with prednisone and valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles, swelling of knees, knee pain, stiff joint, walking difficulty, low back pain, local swelling and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles, swelling of knees, knee pain, stiff joint, walking difficulty, low back pain and local swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 05-OCT-2022 Reporter's Comments: At the time of reporting, the patient age was over 50 years old. The patient received first dose of Shingrix and next morning, the patient had knee swelling and pain behind the knee. The patient reported that she could not bend the knee or barely walk also reported lower back swelling and lower back pain. The patient reported that she went to an emergency room walking clinic on 14th October 2021. On 14th October 2021 the patient was treated with Valtrex and Prednisone. The patient reported that she developed a circular shingles rash on the stomach area. The patient had not gotten the second dose of Shingrix. Emergency room visit required. The reporter reported that not all information was available, and lot and expiration date were not provided. The reporter consented to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration
Clinical narrative: mistakenly received a second dose; 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 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H99J7, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Kinrix (On an unknown date 1st dose received .).   On 29th September 2022, the patient received the 2nd dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 29th September 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate schedule of 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: 18-OCT-2022 Reporters comment: The medical assistant reported that a child mistakenly received a second dose of kinrix. The date of the first dose was unknown. Nothing else was reported. The vaccine administration facility was same as primary reporter. The reporter consent to follow-up. Additional Supportive information: The child mistakenly received a second dose of kinrix, which led to Inappropriate schedule of vaccine administered.
Sex: M
Vaccine: DTAPIPVHIB, TDAP
Symptoms: Accidental overdose, Wrong product administered
Clinical narrative: administered Boostrix and Pentacel instead of Menveo; accidentally grabbed Pentacel and administered; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 11-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2024) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis and PENTACEL for prophylaxis.   On 18th October 2022, the patient received Boostrix, Boostrix Pre-Filled Syringe Device and PENTACEL. On 18th October 2022, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced accidental overdose and wrong vaccine administered. On an unknown date, the outcome of the accidental overdose and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 18-Oct-2022 Reporter's comment:  The nurse reported that the patient was administered with a dose of Boostrix. The patient was also supposed to administer Gardisil and Menveo.  Instead of the Menveo, the nurse accidentally grabbed and administered Pentacel. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter. Additional supportive information: The nurse administered Boostrix and accidentally grabbed Pentacel and administered, which led to accidental overdose and wrong vaccine administered.
Age: 8.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Pediarix administered to a 8 y/o; wrong vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number X9HS4, expiry date 25th March 2024) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th October 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 18th October 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's Comment: Reporter stated that 8 year old patient administered Pediarix. Following information was shared with 2nd line specialist. Reporter stated that patient was not intended to receive any vaccine during his visit but inadvertently received Pediarix. While the patient was waiting in the clinic, a nurse confused the patients and by error they administered Pedirix to this patient. Moreover, the reporter mentioned that the patient was up to date with his vaccinations. Reporter consented to follow. Additional supportive information: As patient inadvertently received Pediarix at 8 years of age which led to inappropriate age at vaccination and wrong vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: got the second in 8/2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   In August 2022, the patient received the 2nd dose of Shingrix. In August 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: 19-OCT-2022 Reporter's comments: The pharmacist had disconnected the call, while proceeding to ask for further questions about the vaccine and patient. The reporter did not consent to follow-up. Additional supportive information: The patient had received the second dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: HCP believes 40y/o patient is not immunocompromised; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 40-year-old patient who received Herpes zoster (Shingrix) (batch number J9B25, expiry date 14th September 2023) for prophylaxis.   Concurrent medical conditions included depression, hypertension, chronic kidney disease stage 3, gastric bypass, hyperlipidemia, hyperkalemia, hyperglycemia, impaired fasting glucose and immunocompromised.   On 19th October 2022, the patient received the 1st dose of Shingrix. On 19th October 2022, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 19-Oct-2022 Reporter's comment: The healthcare professional reported that the patient received the first dose of Shingrix. The provider ddi not believed that patient was immunocompromised. The patient had the following conditions depression, HTN, chronic kidney disease stage 3, gastric bypass, hyperlipidemia, hyperkalemia, hyperglycemia, impaired fasting glucose.  The reporter consented to follow up.  Additional supportive information: The 40 year patient received a dose of Shingrix, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: exposed to excursion and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 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 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 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.   Linked case(s) involving the same patient:  US2022150629   Additional Information: GSK Receipt Date: 19-OCT-2022 Reporter's comment: Nurse reported that their Bexsero was exposed to 11 degree Celsius for 53 hrs and 1.09 degree Celsius for 150 minutes with no prior excursions and the vaccine was administered administered to the patient. HCP (Health Care Professional) was not aware of patient´s gender when asked. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Bexsero vaccine after temperature excursion, which led to Incorrect storage of drug. This was one of the 3 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022150627:Same reporter US-GSK-US2022150629:FU1 - Deleted US-GSK-US2022150631:Same reporter US-GSK-US2022150632:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: exposed to excursion and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adult patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 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 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 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: 19-OCT-2022 Reporter's comment: Nurse reported that their Bexsero was exposed to 11 degree Celsius for 53 hrs and 1.09 degree Celsius for 150 minutes with no prior excursions and the vaccine was administered administered to the patient. HCP (Health Care Professional) was not aware of patient´s gender when asked. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional Supportive Information: The patient received dose of Bexsero vaccine after temperature excursion, which led to Incorrect storage of drug. This was one of the 3 cases reported by the same reporter.; Sender's Comments:  GSK-US2022150627:Same reporter GSK-US2022150628:Same reporter GSK-US2022150629:Same reporter GSK-US2022150632:Same reporter
Sex: U
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: exposed to excursion and administered; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a adolescent patient who received Men B NVS (Bexsero) (batch number ABXB06DA, expiry date 31st March 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 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 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: 19-OCT-2022 Reporter's comment: The nurse reported that in 2021, their Bexsero was exposed to 11 degree Celsius for 53 hours and 1.09 degree Celsius for 150 minutes with no prior excursions and the vaccine was administered to the patient. Health Care Professional (HCP) was not aware of patient gender when asked. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up by email. Additional Supportive Information: The patient had received a dose of Bexsero vaccine after temperature excursion, which had led to Incorrect storage of drug. This was one of the 5 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2022150629:Same reporter US-GSK-US2022150631:Same reporter US-GSK-US2022150628:Same reporter US-GSK-US2022150627:Same reporter
Sex: U
Vaccine: RV1
Symptoms: Product preparation error
Clinical narrative: vaccine mixed 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 patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution 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: 19-AUG-2022 Reporter's Comment: The reporter had a few questions regarding the Rotarix vaccine as he/she found that the liquid diluent contains calcium carbonate, sterile water, and xanthan. The reporter just wanted to confirm that there were no actual vaccine components in the diluent. If there were no actual vaccine components in the diluent, would the dose still be valid if the vaccine (powder) was accidentally mixed with sterile water only instead of the liquid diluent that comes in the kit and lastly, did the diluent work as an activator or was it simply used to dilute the vaccine (power). Additional supportive information: The patient received vaccine (powder) which was accidentally mixed with sterile water only instead of the liquid diluent, which led to wrong solution used in drug reconstitution.
Age: 0.25
Sex: F
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Kinrix administered intead of Infanrix; Kinrix administered to a 15 months old; Kinrix administered as a 4th dose of DTaP series; 14th Sept 2021 pediarix, 11th Nov 2021 Infanrix and 19th Jan 2022; Received infanrix after Pediarix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-month-old female patient who received DTPa-IPV (Kinrix) (batch number Q472N, 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, DTPa-HBV-IPV (Pediarix) for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device injection syringe for prophylaxis.   Concomitant products included PEDIARIX.   On 20th October 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th January 2022, the patient received Pediarix. On 11th November 2021, the patient received Infanrix and dtpa vaccine pre-filled syringe device. On 11th November 2021, unknown after receiving Infanrix and dtpa vaccine pre-filled syringe device, the patient experienced wrong vaccine administered. On 19th January 2022, the patient experienced drug dose administration interval too long. On 20th October 2022, the patient experienced wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the wrong vaccine administered, drug dose administration interval too long, wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Oct-2022 Reporter's comment: The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received Infanrix vaccine (as 2nd dose of DTap series) after Pediarix, which led to wrong vaccine administered. The patient received a dose of Pediarix vaccine (as 3rd dose of DTap and 2nd dose of IPV series) later the recommended interval, which led to lengthening of vaccine schedule. The patient received Kinrix dose (as 4th dose of DTap and 3rd dose of IPV series) instead of Infanrix at inappropriate age, which led wrong vaccine administered, inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. Dose number were not captured in structured field but convention was applied considered in DTap and IPV series.