chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEP
Symptoms: Product storage error
Clinical narrative: 17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child 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, Flu Seasonal QIV  (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv  pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix 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 Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix 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-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
Sex: U
Vaccine: DTAP, DTAPHEPBIP, DTAPIPV, FLU4, HEP
Symptoms: Product storage error
Clinical narrative: 17 patients, were inadvertently administered vaccines, deemed to be nonviable from excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a child 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, Flu Seasonal QIV (FluLaval Quadrivalent) for prophylaxis, flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis, dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix 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 Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric, Engerix B Pre-Filled Syringe Device, FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Kinrix, Kinrix Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Infanrix and Infanrix 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-17-MAY-2022 Reporters comment- The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371. Registered nurse manager called in to inquire about the time interval for repeat dose and if it was safe. The reporter was unable to provide any vaccine or patient details. The reporter consented to follow up. Additional supportive information: The patient was inadvertently administered vaccines Infanrix, Pediarix, Kinrix, Flulaval, Engerix that were deemed to be nonviable from excursion on case 01361371, which led to incorrect storage of drug. This was one of 17 linked cases reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: mild case of Shingles/suspected vaccination failure; mild case of Shingles 2 weeks ago; This case was reported by a nurse via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In May 2022, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with acyclovir (Aciclovir). On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 17-May-2022 Reporter's comment: The patient was vaccinated with both the doses of Shingrix but presented with a mild case of Shingles 2 weeks ago from reporting date. The patient provided a script for Aciclovir and told to contact office if shingles did not clear up. Nurse practitioner had not heard back from the patient. The reporter did not consent to follow-up. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Pain in extremity, Pyrexia
Clinical narrative: I had fever; Felt yucky for a couple of days; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain in extremity (received 1st dose on an unknown date and only had a sore arm, refer case US2022AMR081003).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever and feeling abnormal. On an unknown date, the outcome of the fever and feeling abnormal were recovered/resolved.   It was unknown if the reporter considered the fever and feeling abnormal to be related to Shingles vaccine.  Linked case(s) involving the same patient: US2022AMR081003   Additional Information: GSK Receipt Date: 16-MAY-2022 Reporter's Comment: This case was reported by the patient via interactive digital media. The patient waited months to get second shingles shot. The patient got the 2 shingles vaccine and had fever and felt yucky for a couple of days.  The reporter stated that, it was worth feeling yucky to know he/she would not have to go through the horrible things as these other people had and were going through, he/she thought and prayed for all of them. Additional Supportive Information: The follow up would not possible as no contact details were available.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR081003:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Social problem
Clinical narrative: Due to covid restrictions didn't get 2nd shot yet; This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 21st July 2020).   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 social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. Due to Covid restrictions the patient did not get his/her second shot yet. The patient asked was it too late for his/her second shot now. Additional supportive information:  The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Got only one dose, skipped the 2 dose; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose about a year ago from reporting date).   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: 17-MAY-2022 Reporter's Comments: The case was reported by patient's wife via interactive digital media. The reporter said that the patient was already vaccinated with Shingrix but only one dose. The reporter asked by skipping the 2nd dose, the patient would need to start with the 2 doses again. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. The follow-up would not possible as no contact details were available.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pruritus, Erythema, Induration, Pain in extremity, Scratch
Clinical narrative: welts, hard, on face and neck; welts, hard, on face and neck; ear is very itchy; pain in the right arm; very large red mark on right arm; wants to scratch her ear off because it is so very itchy.; This case was reported by a consumer via call center representative and described the occurrence of welts in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Gel shots (received gel shot's in knee few weeks ago).   On 5th May 2022, the patient received Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced welts, induration, ear pruritus, pain in arm, erythema of extremities and scratch. On an unknown date, the outcome of the welts, induration, ear pruritus and scratch were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the erythema of extremities was recovering/resolving.   It was unknown if the reporter considered the welts, induration, ear pruritus and scratch to be related to Shingrix. The reporter considered the pain in arm and erythema of extremities to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shingrix in right arm on Thursday and she developed 3 welts.  The patient stated that they were hard and about the size of a large mosquito bite. One in on her face, on her cheek near the jaw bone and she had 2 on her neck, also her ear was very itchy.  She said that she wanted to scratch her ear off because it was so very itchy.  She did had pain in the right arm (which had been resolved) and she did had a very large red mark on the right arm but that was going away now.  She was calling GlaxoSmithKline on the day of reporting to see if she was experiencing a reaction from the Shingrix. She said that she reported her face/neck symptoms to her pharmacist and her pharmacist did not thought it was due to Shingrix. She said the only other thing she had was in the last few weeks she got gel shots in her knee.  She did not specified if it was shot 1 or shot 2 of the series. She did not want to provide her email address.  She did not had the lot number/expiration date of the Shingrix because she stated she did not receive any paperwork from the pharmacy, but she provided the pharmacy's phone number who should had that information on file.  No further questions were asked, reporter did not want to answer further questions. Did not consent to follow-up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin reaction, Urticaria
Clinical narrative: welts, hard, on face and neck; welts, hard, on face and neck; ear is very itchy; pain in the right arm; very large red mark on right arm; wants to scratch her ear off because it is so very itchy.; This case was reported by a consumer via call center representative and described the occurrence of welts in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Gel shots (received gel shot's in knee few weeks ago).   On 5th May 2022, the patient received Shingrix. In May 2022, less than a week after receiving Shingrix, the patient experienced welts, induration, ear pruritus, pain in arm, erythema of extremities and scratch. On an unknown date, the outcome of the welts, induration, ear pruritus and scratch were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved and the outcome of the erythema of extremities was recovering/resolving.   It was unknown if the reporter considered the welts, induration, ear pruritus and scratch to be related to Shingrix. The reporter considered the pain in arm and erythema of extremities to be related to Shingrix.     Additional Information: GSK receipt date: 11-May-2022 Reporter's comment: The patient self reported this case. The patient received a dose of Shingrix in right arm on Thursday and she developed 3 welts.  The patient stated that they were hard and about the size of a large mosquito bite. One in on her face, on her cheek near the jaw bone and she had 2 on her neck, also her ear was very itchy.  She said that she wanted to scratch her ear off because it was so very itchy.  She did had pain in the right arm (which had been resolved) and she did had a very large red mark on the right arm but that was going away now.  She was calling GlaxoSmithKline on the day of reporting to see if she was experiencing a reaction from the Shingrix. She said that she reported her face/neck symptoms to her pharmacist and her pharmacist did not thought it was due to Shingrix. She said the only other thing she had was in the last few weeks she got gel shots in her knee.  She did not specified if it was shot 1 or shot 2 of the series. She did not want to provide her email address.  She did not had the lot number/expiration date of the Shingrix because she stated she did not receive any paperwork from the pharmacy, but she provided the pharmacy's phone number who should had that information on file.  No further questions were asked, reporter did not want to answer further questions. Did not consent to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: gave a pediatric doee of Havrix to an adult patient; gave a pediatric dose of Havrix to an adult patient; This case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HAV (Havrix pediatric) 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 pediatric and Havrix Pre-Filled Syringe Device. On an unknown date, 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: 12-MAY-2022 Reporter's Comments: Case was received afterhours via online. Web form submitted afterhours on 12th May 2022 and retrieved by medical information at start of business on 13th May 2022. The reporter reported that one of their nurses gave a pediatric does of Havrix to an adult patient by mistake for hepatitis A immunization.  The reporter asked should he come back in and get an adult dose instead or would this still confer some protection and reporter also asked any possible negative reactions or was it literally the same formula but just half the amount.  No further details were provided.  The reporter reported that Submitting all details as provided on form. The reporter consented to follow up. Additional supportive information: The reporter reported that an adult patient received a pediatric dose of Havrix, which led to underdose and adult use of child product.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: swelling at the injection site; redness  at the injection site; pain at the injection site; This case was reported by a consumer and described the occurrence of injection site swelling in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th May 2022, the patient received the 2nd dose of Shingrix (intramuscular). On 11th May 2022, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site erythema and injection site pain. On an unknown date, the outcome of the injection site swelling, injection site erythema and injection site pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site erythema and injection site pain to be related to Shingrix.     Additional Information: GSK receipt date: 13-May-2022 Reporter's comment: The patient self reported this case. The patient received her second dose two days ago in unknown arm and on the date of vaccination (that evening) she developed pain, redness and swelling at the injection site. The pain, redness and swelling was continued. The patient had nothing else to report. The patient did not use email. Consented to follow-up and might follow-up with health care professional.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong product administered
Clinical narrative: patient was supposed to receive a dose of Infanrix but received a dose of Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 12th May 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 12th May 2022, unknown after receiving Pediarix and Pediarix 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:13-May-2022 Reporter's comments: The patient was supposed to receive a dose of Infanrix but received a dose of Pediarix instead. The healthcare professional consented to follow-up via email. Additional Supportive Information: The patient received Pediarix instead of Infanrix, which led to wrong vaccine administered.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Expired product administered, Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: Patient received 3rd dose; 1st dose on 04SEP2019, 2nd dose on 04FEB2022; Expired vaccine used; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 70-year-old male patient who received Herpes zoster (Shingrix) (batch number FS52T, expiry date 11th June 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number P9733, expiry date 4th February 2020) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th September 2019 from batch number unknown, expiry date 4th September 2019).   On 13th May 2022, the patient received the 3rd dose of Shingrix (intramuscular). On 4th February 2022, the patient received the 2nd dose of Shingrix. On 4th February 2022, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long and expired vaccine used. On 13th May 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long, expired vaccine used and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 13-MAY-2022 Reporter's comment:  The reporter consented to follow up. Additional supportive information: The patient received the 2nd dose of Shingrix later than recommended interval also which was already expired in 4th February 2020, which led to lengthening of vaccination schedule and expired vaccine used.  The patient received the 3rd dose of Shingrix, which led to extra dose administered.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid; This case was reported by a other health professional via call center representative and described the occurrence of coronavirus test positive in a patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2021, the patient received the 1st dose of Shingrix. In May 2022, between 6 and 7 months after receiving Shingrix, the patient experienced coronavirus test positive. On an unknown date, the outcome of the coronavirus test positive was unknown.   It was unknown if the reporter considered the coronavirus test positive to be related to Shingrix.     Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's Comment: The patient received dose of Shingrix vaccine in November 2021 but last week patient was tested positive for covid. The patient needed Shingrix second dose but at the moment of the call the shot had not been given yet.  The permission for a follow-up was not asked during the call. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Age: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted Hiberix with sterile water; Reconstituted Hiberix 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 12-month-old female patient who received Hib (Hiberix) (batch number FL53S, expiry date 29th December 2022) for prophylaxis.   On 25th April 2022, the patient received Hiberix. On 25th April 2022, unknown after receiving Hiberix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 17-MAY-2022 Reporter's comment: The patient received Hiberix on left vastus lateralis. The clinical director called in to inquire if the dose was valid. The clinic director reported they reconstituted Hiberix lyophilized powder with sterile water and inadvertently administered to a patient.  The reporter did not consent to follow up. Additional supportive information: The patient received Hiberix for which lyophilized powder was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient who received in 2020 1st dose wants to get the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2020).   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: 17-MAY-2022 Reporter's comment: Registered pharmacist reported that a patient who received in 2020 first dose of Shingrix, wanted to get the second dose. It had been more than 6 months between doses so patient wanted to know if she could get second dose or what to do. The reporter accidentally forgot to ask for consent. The patient initials were not provided by health care professional. Lot number and expiration date of first dose was not provided by health care professional since health care professional stated this patient did not receive first dose at the same facilities. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: patient received Shingrix doses, then developed shingles on 17Sep2021/suspected vaccination failure; developed shingles on 17Sep2021; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number G7274, expiry date 13th March 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number 7F33X, expiry date 11th December 2021) for prophylaxis.   Concurrent medical conditions included rheumatoid arthritis. Concomitant products included tofacitinib citrate (Xeljanz).   On 24th February 2020, the patient received the 2nd dose of Shingrix. On 7th November 2019, the patient received the 1st dose of Shingrix. On 17th September 2021, 571 days after receiving Shingrix and 680 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comment: The patient was diagnosed with Rheumatoid Arthritis and started on immunosuppressant medication Xeljanz prior to receiving Shingrix series. Pharmacist reported that the patient received 2 doses of Shingrix and she then developed shingles.   The reporter consented to follow up. Additional Supportive Information: This case described the occurrence of suspected vaccination failure. This case was considered as suspected vaccination failure as details regarding laboratory test confirming shingles was unknown at the time of reporting.
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient was vaccinated with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 64-year-old male patient who received HAV (Havrix) (batch number T035721, expiry date 15th April 2022) for prophylaxis.   On 18th May 2022, the patient received Havrix. On 18th May 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 18-MAY-2022 Reporter's Comments: The HCP (health care professional) reported that a dose of Havrix was given indivertibly to the patient and it was already expired. The reporter consented to follow up. Additional Supportive Information: The use of Havrix dose which was already expired on 15th April 2022, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Patient received 1st dose 2 years ago, 2nd dose has not been administered.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose of Shingrix series 2 years ago in 2020).   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: 18-MAY-2022 Reporter's comment: The pharmacist reported that patient received first dose of Shingrix series two years ago and dose was given at a different facility, so pharmacist did not have the date of administration, lot number, or expiration date information. Till the time of reporting, second dose of Shingrix has not been administered. The reporter declined to provide email address. The reporter consented to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Received higher than the recommended dose of vaccine.  0.20 micgrograms in 0.2 mL syringe given of both Pfizer vaccine lot Fl8094 Exp May 31, 2022 and vaccine lot Fk9894 Exp June 4,2022.  Pfizer report reference number LSGY86RU.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Moderna 2/25/21, 3/25/21. Positive on 5/19/22.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received more than the recommended dose of the vaccine.  0.20 micgrograms in 0.2 mL syringe given of both Pfizer vaccine lot Fl8094 Exp May 31, 2022 and vaccine lot Fk9894 Exp June 4,2022.  Pfizer report reference number LSGY86RU.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Patient developed urticaria within an hour of leaving our office. Was given oral anti-histamine when family called back for advice. No further progression that evening but woke up with hives in other places. Rechecked in office on 5/19 with urticaria noted to extremities and face. No oral mucosa or airway involvement. Was also seen evening of 5/19 at local ER due to concern with possible lip swelling.
Age: 4.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave pediatric covid vaccine even though pt not quite 5 years old
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received higher than the recommend dose of vaccine.  0.20 micgrograms in 0.2 mL syringe given of both Pfizer vaccine lot Fl8094 Exp and vaccine lot Fk9894 Exp.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Diagnosis date 4/12/2022, Admit date 4/12/2022, discharged 4/15/2022, no symptoms, signs listed
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Fatigue, Headache, Nasal congestion
Clinical narrative: Starting 05/11/2022, I thought I had allergies. Due to COVID being rampant, I decided to take 2 COVID at home tests and both were positive. My symptoms were headache, sore throat, cough, stuffy/runny nose and fatigue. I went to see a doctor to get meds. They gave me Paxlovid. I went home and rested, and stayed in my room for 5 days. Today, 05/20/2022, I am feeling good, but usually in the morning I am the best, but by afternoon I am fatigued and usually need a nap. I re-tested on 05/18/2022 and it was negative.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rhinorrhoea, SARS-CoV-2 test positive
Clinical narrative: Starting 05/11/2022, I thought I had allergies. Due to COVID being rampant, I decided to take 2 COVID at home tests and both were positive. My symptoms were headache, sore throat, cough, stuffy/runny nose and fatigue. I went to see a doctor to get meds. They gave me Paxlovid. I went home and rested, and stayed in my room for 5 days. Today, 05/20/2022, I am feeling good, but usually in the morning I am the best, but by afternoon I am fatigued and usually need a nap. I re-tested on 05/18/2022 and it was negative.
Age: 89.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Death
Clinical narrative: deceased
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: Up to date with vaccination admitted to hospital with symptomatic COVID
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Muscle pain Fatigue
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Blood test, Cardiac ablation, Cardiac stress test, Dizziness
Clinical narrative: Dec 13 th  irregular heart beat d. with PVCs. Never had this arrhythmia before no history of high blood pressure. Dizzy and lightheaded periods of feeling faint .Medications to treat were no successful due to reaction to medication. May 17 2022 had successful cardiac ablation
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Heart rate irregular, Magnetic resonance imaging heart, Ventricular extrasystoles
Clinical narrative: Dec 13 th  irregular heart beat d. with PVCs. Never had this arrhythmia before no history of high blood pressure. Dizzy and lightheaded periods of feeling faint .Medications to treat were no successful due to reaction to medication. May 17 2022 had successful cardiac ablation
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Pain, Pollakiuria
Clinical narrative: hourly urination - from 11PM day of booster until 6PM next day (19 hours) severe chills- from 3AM until 7pm (16 hours) body aches- from 3am until 7pm (16 hours) painful swollen lump in left armpit (Lymph node?) started sometime next morning after shot and is still not totally gone today, May 20, 2022
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Blood sodium decreased, COVID-19, Cough, Dehydration
Clinical narrative: Hospitalized (05/17/2022-05/19/2022); COVID-19 positive (05/17/2022); fully vaccinated plus booster  HOSPITAL COURSE: this is a very pleasant 88-year-old lady with past medical history as listed who presents to the ER from her nursing facility with concerns of hypoxia.  Patient states that she does not know why they brought her to the emergency department.  Patient states that she has tested positive for bad yesterday.  Patient is vaccinated and blistered.  Patient denies any fever chills sweats.  Patient has some nausea but denies any vomiting diarrhea.  Patient does have a dry cough.  Patient denies any chest pain or shortness of breath.  Patient was confirmed to have COVID-19.  Her sodium level was low and she was started on IV fluid hydration for dehydration.  On her right wrist assessment patient had very dry mucous membranes.  Per nursing and EMS patient was not hypoxic however they are having a hard time getting a good plaque.     Patient did well during her hospital course.  She did not require supplemental oxygen.  She was hydrated and was anxious to go back to her facility.  Patient will need repeat basic metabolic profile to monitor her sodium and renal function as well as a complete metabolic profile to monitor her white count.   1. Hyponatremia Secondary to dehydration.  Patient was adequately hydrated.  Repeat BMP at facility 2. COVID-19 Patient is vaccinated and boosted.  Will hold off on dexamethasone as it is not clear if patient was actually hypoxic and there could be an interaction with her medications.  Patient has not required supplemental oxygen. 3. Hypoxic Uncertain if event occurred.  Patient has not been hypoxic for EMS nursing or required supplemental oxygen. 4. Chronic kidney disease stage 3 Monitor renal function.  Avoid nephrotoxins.  Appears around baseline  5. Leukopenia Likely secondary to her meds related to multiple myeloma as well as her underlying infection.  Patient showed follow-up with her oncologist and have a complete blood count drawn at the facility to determine further workup 6. Pneumonia There was a question if patient had underlying bacterial pneumonia.  Patient will be discharged with Ceftin for 5 days.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Hyponatraemia, Hypoxia, Leukopenia, Metabolic function test, Mucosal disorder
Clinical narrative: Hospitalized (05/17/2022-05/19/2022); COVID-19 positive (05/17/2022); fully vaccinated plus booster  HOSPITAL COURSE: this is a very pleasant 88-year-old lady with past medical history as listed who presents to the ER from her nursing facility with concerns of hypoxia.  Patient states that she does not know why they brought her to the emergency department.  Patient states that she has tested positive for bad yesterday.  Patient is vaccinated and blistered.  Patient denies any fever chills sweats.  Patient has some nausea but denies any vomiting diarrhea.  Patient does have a dry cough.  Patient denies any chest pain or shortness of breath.  Patient was confirmed to have COVID-19.  Her sodium level was low and she was started on IV fluid hydration for dehydration.  On her right wrist assessment patient had very dry mucous membranes.  Per nursing and EMS patient was not hypoxic however they are having a hard time getting a good plaque.     Patient did well during her hospital course.  She did not require supplemental oxygen.  She was hydrated and was anxious to go back to her facility.  Patient will need repeat basic metabolic profile to monitor her sodium and renal function as well as a complete metabolic profile to monitor her white count.   1. Hyponatremia Secondary to dehydration.  Patient was adequately hydrated.  Repeat BMP at facility 2. COVID-19 Patient is vaccinated and boosted.  Will hold off on dexamethasone as it is not clear if patient was actually hypoxic and there could be an interaction with her medications.  Patient has not required supplemental oxygen. 3. Hypoxic Uncertain if event occurred.  Patient has not been hypoxic for EMS nursing or required supplemental oxygen. 4. Chronic kidney disease stage 3 Monitor renal function.  Avoid nephrotoxins.  Appears around baseline  5. Leukopenia Likely secondary to her meds related to multiple myeloma as well as her underlying infection.  Patient showed follow-up with her oncologist and have a complete blood count drawn at the facility to determine further workup 6. Pneumonia There was a question if patient had underlying bacterial pneumonia.  Patient will be discharged with Ceftin for 5 days.
Age: 88.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nausea, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Hospitalized (05/17/2022-05/19/2022); COVID-19 positive (05/17/2022); fully vaccinated plus booster  HOSPITAL COURSE: this is a very pleasant 88-year-old lady with past medical history as listed who presents to the ER from her nursing facility with concerns of hypoxia.  Patient states that she does not know why they brought her to the emergency department.  Patient states that she has tested positive for bad yesterday.  Patient is vaccinated and blistered.  Patient denies any fever chills sweats.  Patient has some nausea but denies any vomiting diarrhea.  Patient does have a dry cough.  Patient denies any chest pain or shortness of breath.  Patient was confirmed to have COVID-19.  Her sodium level was low and she was started on IV fluid hydration for dehydration.  On her right wrist assessment patient had very dry mucous membranes.  Per nursing and EMS patient was not hypoxic however they are having a hard time getting a good plaque.     Patient did well during her hospital course.  She did not require supplemental oxygen.  She was hydrated and was anxious to go back to her facility.  Patient will need repeat basic metabolic profile to monitor her sodium and renal function as well as a complete metabolic profile to monitor her white count.   1. Hyponatremia Secondary to dehydration.  Patient was adequately hydrated.  Repeat BMP at facility 2. COVID-19 Patient is vaccinated and boosted.  Will hold off on dexamethasone as it is not clear if patient was actually hypoxic and there could be an interaction with her medications.  Patient has not required supplemental oxygen. 3. Hypoxic Uncertain if event occurred.  Patient has not been hypoxic for EMS nursing or required supplemental oxygen. 4. Chronic kidney disease stage 3 Monitor renal function.  Avoid nephrotoxins.  Appears around baseline  5. Leukopenia Likely secondary to her meds related to multiple myeloma as well as her underlying infection.  Patient showed follow-up with her oncologist and have a complete blood count drawn at the facility to determine further workup 6. Pneumonia There was a question if patient had underlying bacterial pneumonia.  Patient will be discharged with Ceftin for 5 days.
Age: 18.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypomenorrhoea
Clinical narrative: Shortened period length by 7 to 10 days every period after the vaccine. Average cycle length changed from 33 days to 23 and is still occurring
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Patient received 0.25ml of Moderna COVID-19 vaccine on 5/18/2022. Patient has no history of receiving a COVID-19 vaccine and eleigible to receive a first dose in a COVID-19 vaccine series. An additional 0.25ml of Moderna was administered immediately after. The patient received a total of 0.5ml of Moderna.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bundle branch block left, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/19/21 (EN6208) Pfizer Dose 2 4/14/21 (EW0153) COVID Positive 11/28/21 Discharged home 11/30/31 Hospitalized 11/28/21-11/30/21  12/8/21: The patient vaccinated for COVID-19, diagnosed with COVID-19 pneumonitis on November 28 and she was admitted to the hospital and observed and discharged home, for the last 3 days she had progressive shortness of breath with sputum productive cough and episodes of chills with epigastric discomfort and nausea and occasional vomiting and unable to tolerate p.o. intake last 24 hours with generalized weakness and fatigue, she does have dyspnea with minimal exertion while she is walking within her room and her home.  She is known to be asthmatic and was using her inhalers at home 2-3 times within  24 hours within the last 3 days without resolution in her cough and shortness of breath.  No wheezing noted test.  At baseline she does not use any oxygen.   At emergency she was hypoxic and require 3 L of oxygen to maintain SpO2 above 94%, her EKG show sinus rhythm with old left bundle branch block, troponin unremarkable, proBNP mildly elevated.  Chest x-ray reviewed personally and show vascular congestion and linear opacities.   At emergency she received Zofran and IV fluid.  12/10/21: She is a 79-year-old female recently admitted to hospital for severe COVID-19 infection complicated with pneumonia and hypoxia was discharged on 3 L of oxygen but came back to the emergency room on 12/08/2021 because of persistent SOB, nausea and poor appetite.  She was admitted and commenced on usual management for COVID-19 infection including restarting remdesivir, dexamethasone, IV antibiotics in addition to other supportive management.  On re-evaluation this morning she feels much better except for mild nausea.  She has a good appetite.  Her Sao2 on room air is 100%.  She will be discharged home on pre-admission medications.  She will follow-up with the PCP in 1-2 weeks.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Dyspnoea, Dyspnoea exertional, Electrocardiogram abnormal
Clinical narrative: COVID Vaccine Breakthrough Case  Pfizer Dose 1 3/19/21 (EN6208) Pfizer Dose 2 4/14/21 (EW0153) COVID Positive 11/28/21 Discharged home 11/30/31 Hospitalized 11/28/21-11/30/21  12/8/21: The patient vaccinated for COVID-19, diagnosed with COVID-19 pneumonitis on November 28 and she was admitted to the hospital and observed and discharged home, for the last 3 days she had progressive shortness of breath with sputum productive cough and episodes of chills with epigastric discomfort and nausea and occasional vomiting and unable to tolerate p.o. intake last 24 hours with generalized weakness and fatigue, she does have dyspnea with minimal exertion while she is walking within her room and her home.  She is known to be asthmatic and was using her inhalers at home 2-3 times within  24 hours within the last 3 days without resolution in her cough and shortness of breath.  No wheezing noted test.  At baseline she does not use any oxygen.   At emergency she was hypoxic and require 3 L of oxygen to maintain SpO2 above 94%, her EKG show sinus rhythm with old left bundle branch block, troponin unremarkable, proBNP mildly elevated.  Chest x-ray reviewed personally and show vascular congestion and linear opacities.   At emergency she received Zofran and IV fluid.  12/10/21: She is a 79-year-old female recently admitted to hospital for severe COVID-19 infection complicated with pneumonia and hypoxia was discharged on 3 L of oxygen but came back to the emergency room on 12/08/2021 because of persistent SOB, nausea and poor appetite.  She was admitted and commenced on usual management for COVID-19 infection including restarting remdesivir, dexamethasone, IV antibiotics in addition to other supportive management.  On re-evaluation this morning she feels much better except for mild nausea.  She has a good appetite.  Her Sao2 on room air is 100%.  She will be discharged home on pre-admission medications.  She will follow-up with the PCP in 1-2 weeks.