chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Rash around rib cage, looks like a burn; Very painful (rash); 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 and pain. On an unknown date, the outcome of the rash and pain were recovered/resolved.   It was unknown if the reporter considered the rash and pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR134285   Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got his/her shots. The patient had a rash around his/her rib gage once and awhile very painful last about two weeks. No blisters and looks more like a burn. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR134285:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Haven't felt well sense; This case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell 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 feeling unwell. On an unknown date, the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient got the shingles shot a few years ago from reporting. The patient had not felt well since. Additional Supportive Information: Follow-up would not possible as no contact details were available.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Diarrhoea, Feeling abnormal, Flatulence, Gastrointestinal disorder
Clinical narrative: Pain in injected arm (bad reaction/ painful); Moving arm caused a great pain; Almost couldn't move arm; Fever; Diarrhea (gastrointestinal symptoms); GI symptoms, horrible gas pains, in bed due to this; gastrointestinal symptoms (diarrhea + abdominal gas pain); Swelling in the injected arm (bad reaction); This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2022, the patient received the 1st dose of Shingrix (intramuscular). In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm, pain in arm, pain upon movement, fever and diarrhea were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the gas pain and abdominal pain were not recovered/not resolved.   The reporter considered the swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter stated that after received Shingrix vaccine the patient experienced bad reaction on injected arm, patient experienced left arm was swollen and hurt painful, patient almost could not move it because even when she moved it the slightest bit it caused her great pain.  Patient stated that she wishes she would have strapped it down so that she wouldn't had moved it. The patient had a fever for the first 2-3 days after received Shingrix vaccine. The reporter reported that after received Shingrix vaccine on day 3 patient began experiencing gastrointestinal symptoms including horrible gas pains in her abdomen. Patient stated nothing relieves the gas pain, the pain was not relieved even if she passes gas because the pain comes right back. She had been used a heating pad on her stomach/abdomen. She had been in bed due to this. She was feeling a little better because she was out of bed on the day of reporting but these symptoms had not resolved. Patient had diarrhea as well. Her last episode of diarrhea was on 11th September 2022. Reporter stated patient GI(gastrointestinal) symptoms had not resolved yet she was not back to normal yet. The reporter did consent to follow up
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Mobility decreased, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pain in injected arm (bad reaction/ painful); Moving arm caused a great pain; Almost couldn't move arm; Fever; Diarrhea (gastrointestinal symptoms); GI symptoms, horrible gas pains, in bed due to this; gastrointestinal symptoms (diarrhea + abdominal gas pain); Swelling in the injected arm (bad reaction); This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2022, the patient received the 1st dose of Shingrix (intramuscular). In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm, pain in arm, pain upon movement, fever and diarrhea were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the gas pain and abdominal pain were not recovered/not resolved.   The reporter considered the swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter stated that after received Shingrix vaccine the patient experienced bad reaction on injected arm, patient experienced left arm was swollen and hurt painful, patient almost could not move it because even when she moved it the slightest bit it caused her great pain.  Patient stated that she wishes she would have strapped it down so that she wouldn't had moved it. The patient had a fever for the first 2-3 days after received Shingrix vaccine. The reporter reported that after received Shingrix vaccine on day 3 patient began experiencing gastrointestinal symptoms including horrible gas pains in her abdomen. Patient stated nothing relieves the gas pain, the pain was not relieved even if she passes gas because the pain comes right back. She had been used a heating pad on her stomach/abdomen. She had been in bed due to this. She was feeling a little better because she was out of bed on the day of reporting but these symptoms had not resolved. Patient had diarrhea as well. Her last episode of diarrhea was on 11th September 2022. Reporter stated patient GI(gastrointestinal) symptoms had not resolved yet she was not back to normal yet. The reporter did consent to follow up
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pain in injected arm (bad reaction/ painful); Moving arm caused a great pain; Almost couldn't move arm; Fever; Diarrhea (gastrointestinal symptoms); GI symptoms, horrible gas pains, in bed due to this; gastrointestinal symptoms (diarrhea + abdominal gas pain); Swelling in the injected arm (bad reaction); This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2022, the patient received the 1st dose of Shingrix (intramuscular). In September 2022, less than 2 weeks after receiving Shingrix, the patient experienced swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain. The patient was treated with non-drug therapy (Heating Pad (Nos)). On an unknown date, the outcome of the swelling arm, pain in arm, pain upon movement, fever and diarrhea were recovered/resolved and the outcome of the mobility decreased was unknown and the outcome of the gas pain and abdominal pain were not recovered/not resolved.   The reporter considered the swelling arm, pain in arm, pain upon movement, mobility decreased, fever, diarrhea, gas pain and abdominal pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 12-SEP-2022 Reporter's Comment: The reporter was a patient. The reporter reported that the patient received Shingrix vaccine. The reporter stated that after received Shingrix vaccine the patient experienced bad reaction on injected arm, patient experienced left arm was swollen and hurt painful, patient almost could not move it because even when she moved it the slightest bit it caused her great pain.  Patient stated that she wishes she would have strapped it down so that she wouldn't had moved it. The patient had a fever for the first 2-3 days after received Shingrix vaccine. The reporter reported that after received Shingrix vaccine on day 3 patient began experiencing gastrointestinal symptoms including horrible gas pains in her abdomen. Patient stated nothing relieves the gas pain, the pain was not relieved even if she passes gas because the pain comes right back. She had been used a heating pad on her stomach/abdomen. She had been in bed due to this. She was feeling a little better because she was out of bed on the day of reporting but these symptoms had not resolved. Patient had diarrhea as well. Her last episode of diarrhea was on 11th September 2022. Reporter stated patient GI(gastrointestinal) symptoms had not resolved yet she was not back to normal yet. The reporter did consent to follow up
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: Bexsero exposed to 29.8 F and  administered; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number 459MC, expiry date 31st March 2024) 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 September 2022, 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: 13-SEP-2022 Reporter's Comment: The CMA (Certified Medical Assistant) reported that the patient received Bexsero vaccine which was exposed to 29.8 degree F. The reporter consented to follow-up via mail. Additional supportive information: The Bexsero vaccine was exposed to temperature 29.8 degree F, which led to incorrect storage of drug. This was one of the 5 cases reported by same reporter.; Sender's Comments:  US-GSK-US2022132077:Same reporter. US-GSK-US2022132076:Same reporter. US-GSK-US2022132079:Same reporter. US-GSK-US2022132078:Same reporter.
Age: 81.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: Off label use, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: needed a Boostrixbooster due to a cat bite; 81 YO given Infanrix; Patient given Infanrix instead of Adacel; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 81-year-old female patient who received DTPa (Infanrix) (batch number Y4259, expiry date 3rd March 2024) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis and DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix. Concurrent medical conditions included animal bite.   On 13th September 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, the patient received Boostrix. On 13th September 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and not applicable after receiving Boostrix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the patient experienced off label use. On an unknown date, the outcome of the inappropriate age at vaccine administration, wrong vaccine administered and off label use 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: 14-SEP-2022 Reporter's Comments: The case was reported by nurse. Nurse stated 81 year old patient was inadvertently given Infanrix instead of Adacel yesterday (from the day of reporting). As of the time of this call the patient had not reported any reactions. Nurse noted the patient last received Boostrix in 2019 but needed a booster dose due to being bitten by a cat. Additional supportive information: Patient was inadvertently given Infanrix instead of Adacel, which led to wrong vaccine administered and inappropriate age at vaccination administration. The patient needed a booster dose due to being bitten by a cat, which led to off label use. Reporter consented to follow up. No further details were provided.
Age: 62.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Received an expired dose of Twinrix; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 62-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th September 2022, the patient received the 1st dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 15th September 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-Sep-2022 Reporter's comment: The medical assistant reported that the patient received an expired dose of Twinrix. The vaccine was expired on 7th August 2022. There were no symptoms reported. The healthcare professional consented to follow-up via regular mail. Additional Supportive Information: The patient received expired dose of Twinrix, which led to expired vaccine used.
Age: 81.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Blister, Product administered at inappropriate site, Pruritus
Clinical narrative: Blisters, 2 dime sized, 1 smaller; Occasionally itched; Shingrix and Pneumonia Vx on the same arm; This case was reported by a consumer via call center representative and described the occurrence of blister in a 81-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) for prophylaxis.   On 18th August 2022, the patient received the 1st dose of Shingrix and PNEUMONIA VACCINE. On 18th August 2022, unknown after receiving Shingrix, the patient experienced vaccine administered at inappropriate site. In September 2022, the patient experienced blister and pruritus. On an unknown date, the outcome of the blister was not recovered/not resolved and the outcome of the pruritus was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown.   It was unknown if the reporter considered the blister and pruritus to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-Sep-2022 Reporter's comment: This case was self reported by patient. The patient received first dose of Shingrix on left arm.  The patient also received a pneumonia vaccine at the same time and in the same arm. About 2 weeks later, the patient developed 2 dime sized blisters on right arm, which occasionally itched, and had since healed over.  The patient developed a blister on left arm that was smaller than the previous blisters on left arm.  The customer could not recall which pneumonia vaccine patient received Patient provided consent to follow up with HCP The reporter consent to follow up. Additional Supportive Information: The patient received a pneumonia vaccine at the same time and in the same arm, which led to vaccine administered at inappropriate site. It was unknown if the reporter considered the blister and pruritus to be related to PNEUMONIA VACCINE.
Age: 53.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 53 y/o patient received Engerix-B pediatric; 53 y/o patient received Engerix-B pediatric; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 53-year-old female patient who received HBV (Engerix B pediatric) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th September 2022, the patient received Engerix B pediatric 10 ug and Engerix B Pre-Filled Syringe Device. On 8th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-SEP-2022 Reporter's Comments:  The Nurse reported that a 53 year old patient received a pediatric 10 mcg dose of Engerix-B prefilled syringe. The reporter give consent to follow up. Additional Supportive Information: 53 year old patient received a pediatric 10 ug dose which led to underdose and adult use of child product.; Sender's Comments:  US-GSK-US2022133285:Same reporter.
Age: 5.0
Sex: U
Vaccine: DTAP, DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: Received both vaccines on the same day in error; This case was reported by a pharmacist via sales rep and described the occurrence of accidental overdose in a 5-year-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix, Kinrix Pre-Filled Syringe Device, Infanrix and Infanrix 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: 17-SEP-2022 Reporter's comment:  Field representative submitted a request form on behalf of pharmacist.  The reporter had a medical question regarding Infanrix and Kinrix. Could you help him/her to obtain information regarding if a patient had received both vaccines on the same day in error. The reporter would like to have any documentation to support their variance and patient supportive care.  No further details available via form. The reporter had consented to follow-up. Additional supportive information: The patient had received Infanrix and Kinrix on the same day in error which had led to accidental overdose.
Sex: F
Vaccine: FLU4
Symptoms: Illness
Clinical narrative: Got sick from the flu shot; This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved.   The reporter considered the sickness to be related to FluLaval Quadrivalent and Flulaval Tetra 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.   Additional Information: GSK Receipt Date: 18-SEP-2022 Reporter's comment: The reporter stated that the FluLaval Quadrivalent shots made kids sick. The reporter stated that GlaxoSmithKline need not to sold that product because it made kids sick. No additional details were provided. Additional Supportive Information: This case had been linked with case US2022AMR134801, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR134801:Same reporter.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Havrix pediatric administered to adult; Havrix pediatric administered to adult; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 47-year-old female patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th September 2022, the patient received Havrix pediatric and Havrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 19-SEP-2022 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the pediatric dose of Havrix vaccine was administered to the adult patient. The reporter wanted to know how to proceed. The reporter did consent to follow up. Additional Supportive Information: The adult patient was administered a pediatric dose of Havrix, which led to underdose and adult use of a child product.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received second after six months/ First dose in Nov2020 and second dose on 30Apr2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number DP2D3, expiry date 25th May 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2020).   In April 2022, the patient received the 2nd dose of Shingrix. In April 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-Sept-022 Reporter's comment: The reporter did not consent to follow-up. The case was linked with case US2022134473, reported by same reporter. Additional supportive information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule.; Sender's Comments:  US-GSK-US2022134473:Same reporter
Age: 11.0
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Bexssro administered instead of Menveo; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 11-year-old male patient who received Men B NVS (Bexsero) (batch number A2X3Y, expiry date 28th February 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 8th September 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th September 2022, 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: 20-Sept-2022 Reporter's comment: The office manager called to get any safety information regarding Bexsero. The reporter did not consent to follow-up. Additional supportive information: The patient received Bexsero accidentally instead of Menveo vaccine, which led to wrong vaccine administered.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Shingrix only adjuvant; Received only the adjuvant; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NY45, expiry date 15th September 2023) for prophylaxis.   On 16th September 2022, the patient received Shingrix. On 16th September 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received only the adjuvant AS01B of shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose Dic 2021, appointment for second next week; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in December 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The pharmacist called to receive some guidance on Shigrix schedule because she had a patient that has an appointment for the second dose next week.  There were 10 month apart instead of 6. The reporter did not consent to follow-up. Additional supportive information: Till time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Engerix-B instead of 2nd dose of Twinrix; This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 28-year-old female patient who received HBV (Engerix B) (batch number 337TC, expiry date 29th March 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 19th September 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Engerix B and Engerix B 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: 20-Sept-2022 Reporter's comment: The pharmacist reported that Engerix-B was administered to a patient instead of 2nd dose of Twinrix. The 2nd dose of Twinrix was not administered. The adverse event contains all reported information. The reporter consented to safety team follow-up. Additional supportive information: The patient was administered Engerix-B instead of Twinrix (2nd dose), which led to wrong vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose on Jan 2021, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose in January 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The pharmacist stated that the patient's physician was the best person to make this decision whether to administer Shingrix late second dose or not. The reporter consented to follow-up via email. Additional supportive information: Till the time of reporting the patient did not receive the second dose of Shingrix, which led to incomplete course of vaccination.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 25Aug2022, second on 19Sep2022; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 64-year-old male patient who received Herpes zoster (Shingrix) (batch number 2J5BF, expiry date 6th October 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 19th September 2022, the patient received the 2nd dose of Shingrix. On 19th September 2022, unknown after receiving Shingrix, 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: 20-Sept-2022 Reporter's comment: The patient was not immunocompromised. At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose in 2019, did not receive second; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The patient did not receive his second dose of Shingrix. No additional details were provided by the patient. 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: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: adjuvant without active component; adjuvant only administered; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number AT772, expiry date 5th October 2023) for prophylaxis.   On 31st May 2022, the patient received Shingrix. On 31st May 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: The registered pharmacist called and reported that they provided Shingrix vaccine to a nursing home to be administered to a resident.  The reporter stated an registered nurse relayed to her that the resident was administered the vaccine adjuvant without active component.  The reporter consented to follow-up. Additional supportive information: The patient received adjuvant without active component of Shingrix vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: Expired dose administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 17-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4977T, expiry date 5th September 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 19th September 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 19th September 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: 20-SEP-2022 Reporter's comment: The nurse reported that a dose of Pediarix given to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Pediarix dose, which was already expired on 5th September 2022, which led to expired vaccine used.
Age: 52.0
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 09Jul2022, 3rd dose on 19Sep2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 52-year-old male patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 19th September 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 19th September 2022, unknown after receiving Twinrix and Twinrix 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: 20-Sept-2022 Reporter's comment: The pharmacist asked that the 3rd dose was considered to be valid or he has to come in for the full dose in January or any safety data for early 3rd dose. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received 3rd dose of Twinrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired antigen powder administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number 92C34, expiry date 4th June 2022) and (batch number 9G44C, expiry date 23rd September 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, the dose was an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 20-SEP-2022 Reporter's comment: The pharmacy student reported that a dose of Shingrix antigen powder given to the patient and it was already expired. The reporter reported that lot number (9G44C) and expiration date (23rd September 2022) for adjuvant suspension. The reporter did not consent to follow up. Additional Supportive Information: The use of Shingrix dose, which was already expired on 4th June 2022, which led to expired vaccine used.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: given a month early (8/18 was first dose); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 9254S, expiry date 18th September 2023) for prophylaxis.   Concomitant products included RECOMBINANT VARICELLA ZOSTER VIRUS SURFACE GLYCOPROTEIN E (SHINGRIX).   On 20th September 2022, the patient received the 2nd dose of Shingrix. On 20th September 2022, unknown after receiving Shingrix, 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: 20-Sept-2022 Reporter's comment: The pharmacist reported that the patient received 2nd dose of Shingrix on the day of reporting and only afterwards did the registered pharmacist noticed that it was given a month early. The reporter consented to follow-up. Additional supportive information: The patient received 2nd dose of Shingrix earlier than the recommended interval, which leg to shortening of vaccine schedule.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: 38 YO  was administered Engerix-B 0.5ml; 38 YO  was administered Engerix-B pediatric; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 38-year-old female patient who received HBV (Engerix B pediatric) (batch number YY2R3, expiry date 12th May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th September 2022, the patient received Engerix B pediatric .5 ml and Engerix B Pre-Filled Syringe Device. On 12th September 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Sept-2022 Reporter's comment: No reactions were reported. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix B, which led to underdose and adult use of a child product.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via a company representative via media concerned a 25 year old female of an unspecified 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 not reported, batch number: unknown, expiry date: unknown) dose not reported, 1 total administered on an unspecified date 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, in less than 3 days after first vaccination, the patient died from unknown cause of death. An autopsy was performed on an unspecified date. It was reported that "The first Covid shot to my female partner of 25 yrs, she was gone in less than 3 days. Of course her autopsy read differently. They didn't want any responsibility". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220940058-covid-19 vaccine ad26.cov2.s-Death. The event(s) has a compatible/suggestive 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: MADE ME THINK I WAS DYING; This spontaneous report received from a patient via company representative concerned a patient of unspecified age, sex, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series1) (form of admin, route of admin not reported, batch number: unknown expiry: unknown) dose not reported, 01 total administered on an unspecified date for covid-19 prophylaxis.  The patient had no adverse events following vaccination with covid-19 vaccine ad26.cov2.s (unspecified manufacturer) (dose number in series1) 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 expiry: unknown) dose not reported, 01 total administered on an unspecified date 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 thought patient was dying (dose number in series 2) and it was reported as " The only reason I got the shot was because I wanted to travel and the airports wanted proof that you had your shots. The first one did not affect me. The second one made me think that I was dying. It took months for me to begin to feel like myself. Still not able to travel." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from made me think i was dying. This report was non-serious.
Age: 34.0
Sex: M
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID-19) in a 34-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 prophylaxis. The patient had no medical history, concomitant disease or risk factor. On 03-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 18-Sep-2022, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Sep-2022, SARS-CoV-2 test: (Positive) Positive. For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient tested positive for COVID-19 on 18-Sep-2022 after having received omicron-specific booster on 03-Sep-2022. It was unknown if the patient experienced any additional symptoms/events. No treatment drugs were reported. Company comment: This spontaneous case concerns a 34-year-old male patient with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred 15 days after vaccination of a fourth dose of mRNA-1273.222. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Reporter did not allow further contact. Sender's Comments: This spontaneous case concerns a 34-year-old male patient with no reported medical history, who experienced unexpected, non-serious AESI Covid-19 (with positive Sars-CoV test), which occurred 15 days after vaccination of a fourth dose of mRNA-1273.222. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.