chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered post the expiration or beyond use date; The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) in a 67-year-old male patient who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 013L20A, 030M20A and 058F21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Blood pressure high.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 16-Feb-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 30-Oct-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 2:10 PM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. In May 2022, the patient experienced PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022). On 19-May-2022 at 2:10 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter considered EXPIRED PRODUCT ADMINISTERED (Dose administered post the expiration or beyond use date) to be not related. No further causality assessment was provided for PRODUCT STORAGE ERROR (The vials were placed in refrigerator on 17-May-2022 and administred on 19-May-2022).    No concomitant medications was reported.  The medical history included Yodo.  The patient had no known allergies. It was unknown if the patient was diagnosed or tested positive for COVID-19. Also unknown if the patient had acute illnesses at the time of vaccination and up to one month before and unknown if prescriptions, over-the-counter medications, dietary supplements or herbal remedies were taken at time of vaccination and/or at the time of the adverse event. It was also unknown if the patient had experienced a similar event in the past.  The vaccines expired on 13-May-2022 and administered on 19-May-2022. The vials were placed in refrigerator on 17-May-2022.  No treatment drug details was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date; Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022) in a male patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) (batch nos. 003K21-2A, 031H21A, 011M20A and 011M20A) for COVID-19 prophylaxis.     It was unknown if patient had Allergies to medications, food and other products and it was unknown if patient was ever diagnosed or tested positive for COVID-19 and Acute illness at the time of vaccination and up to one month before was provided as unknown and it was unknown if patient had any Chronic or long standing health conditions.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) .5 milliliter. On 08-Mar-2021, received second dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .5 milliliter. On 04-Dec-2021, received third dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) dosage was changed to .25 milliliter. On 19-May-2022 at 8:48 AM, received fourth dose of mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular) dosage was changed to .25 milliliter. On 17-May-2022, the patient experienced PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022). On 19-May-2022 at 8:48 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines expired on 13-May-2022 were administered on 19-May-2022/Dose administered post the expiration or beyond use date) and PRODUCT STORAGE ERROR (Vials expired on 13-May-2022 were placed in refrigerator on 17-May-2022) outcome was unknown.        For mRNA-1273 (COVID 19 Vaccine Moderna) (Intramuscular), the reporter did not provide any causality assessments.   It was unknown if patient took any Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at time of vaccination and/or at the time of the adverse event was reported as unknown.  The event did not cause patient to seek medical care There were no other potential causes reported. Patient did not experience any similar events in the past.   This case was linked to MOD-2022-585601 (Patient Link).
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; Caller was Medical Assistant. Caller reported AE for Patient.  Patient was administered improperly stored RECOMBIVAX HB on 04/28/2022: Improperly Stored / Administered Vaccine Detail Summary is located within following space.  Caller gave permission; This spontaneous report has been received from a medical assistant and referred to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history, and drug reactions/allergies were not reported.  On 28-APR-2022, the patient has vaccinated one dose of improperly stored hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (valid lot# T021327 with expiration date 14-NOV-2022; strength, dose, frequency, and route were not reported) for prophylaxis (product storage error). The vaccine hepatitis b vaccine (recombinant) (RECOMBIVAX HB) had previous temperature excursions (It also reported the vaccines with lot# T021327/expiration date 14-NOV-2022 had encountered greater than 10 separate temperature excursions starting from 14-APR-2022). Regarding the 1st previous temperature excursion (on 14-APR-2022), the exact lowest temperature was 34.5 Fahrenheit (F) (below 36 F) and a total time of 18 hours (also reported as 57 minutes). There was no additional adverse event reported (no adverse event).
Sex: F
Vaccine: MMRV, UNK
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No symptomatic AEs / no additional AE details; administered an extra dose of PROQUAD after completing the series.; This spontaneous report was received from a healthcare professional and refers to an 11-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 27-JUN-2022, the patient was vaccinated with an extra dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, lot #, expiration date and route of administration were not provided) for prophylaxis, together with sterile diluent (STERILE DILUENT) (lot #, expiration date and route of administration were not provided) (Extra dose administered). No adverse events were reported (No adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called in to report a temperature excursion on VARIVAX and PROQUAD. HCP reports that 9 patients were administered VARIVAX. HCP reports that the VARIVAX administrations occurred on 6/21/22, 6/23/22, 6/27/22, and 6/28/22. The patients involved in t; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in June 2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin) subcutaneous injection, lot #U030591, expiration date: 29-MAR-2023, for prophylaxis (dose, strength, route of administration and anatomical location were not provided). The vaccine was administered after the temperature excursion (product storage error). No additional adverse event reported.; Sender's Comments:  US-009507513-2206USA008805: US-009507513-2206USA008806: US-009507513-2206USA008807: US-009507513-2206USA008808: US-009507513-2206USA008809: US-009507513-2206USA008810: US-009507513-2206USA008811: US-009507513-2206USA008804: US-009507513-2206USA008802: US-009507513-2206USA008801: US-009507513-2206USA008800: US-009507513-2206USA008799: US-009507513-2206USA008803:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called in to report a temperature excursion on VARIVAX and PROQUAD. HCP reports that 9 patients were administered VARIVAX. HCP reports that the VARIVAX administrations occurred on 6/21/22, 6/23/22, 6/27/22, and 6/28/22. The patients involved in t; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in June 2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, lot #U024765, expiration date: 10-AUG-2023, for prophylaxis (dose, strength, route of administration and anatomical location were not provided). The vaccine was administered after the temperature excursion (product storage error). No additional adverse event reported.  This is one of the 14 reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008492:
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HCP called in to report a temperature excursion on VARIVAX and PROQUAD. HCP reports that 9 patients were administered VARIVAX. HCP reports that the VARIVAX administrations occurred on 6/21/22, 6/23/22, 6/27/22, and 6/28/22. The patients involved in t; This spontaneous report was received from the medical assistant and refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in June 2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (recombinant human albumin) subcutaneous injection, lot #U030591, expiration date: 29-MAR-2023, for prophylaxis (dose, strength, route of administration and anatomical location were not provided). The vaccine was administered after the temperature excursion (product storage error). No additional adverse event reported.  This is one of the 14 reports from the same reporter.; Sender's Comments:  US-009507513-2206USA008492:
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: I felt like a slight case of flu for just one day after 1st and 2nd shot; This case was reported by a consumer via interactive digital media and described the occurrence of influenza like illness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced influenza like illness. On an unknown date, the outcome of the influenza like illness was recovered/resolved.   It was unknown if the reporter considered the influenza like illness to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR098941   Additional Information: GSK Receipt Date: 26-Jun-2022 Reporters comment: The patient self reported the case via interactive digital media. The patient received a dose of shingles vaccine and felt like had a slight case of flu for just one day. The patient thought it was worth it, not to get shingles. Follow up was not possible as no contact details were available. For tolerance to the 2nd dose refer case US2022AMR098941.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR098941:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Illness, Pyrexia
Clinical narrative: made me sick; fever 102 for 2 days; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 8 years ago and experienced shingles right after vaccination).   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 sickness and fever. On an unknown date, the outcome of the sickness and fever were recovered/resolved.   It was unknown if the reporter considered the sickness and fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-JUN-2022 Reporter's Comments: This case was reported by patient via interactive digital media. The patient got this booster vaccine as second dose of Shingles vaccine and felt sick, and fever 102 for two days. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: he was ache all over; his arm hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 24th June 2022, the patient received Shingles vaccine. On 24th June 2022, less than a day after receiving Shingles vaccine, the patient experienced pain in arm. On 25th June 2022, the patient experienced general body pain. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm and general body pain to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 25-Jun-2022 Reporters comment: The case was reported by patient's wife via interactive digital media. The patient received a dose of shingles vaccine and his arm hurt more than any other shot. Today (on the day of reporting), 1 day after receiving vaccination the patient was ache all over. The reporter wanted to know if anyone else had these symptoms after getting the shot. Follow up was not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Grandmom got it ,she broke out in shingles/Suspected vaccination failure; She broke out in shingles, suffered the rest of her life with them; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The reporter reported this case via interactive digital media. As soon as the patient got Shingles vaccine, she broke out in shingles and suffered the rest of her life with them. The reporter had also seen others done the same. The reporter stated that dont get these vaccines. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: had them  shots years ago, years later Dr said got shingles; shingles; itchy place on his Back; miserable; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, several years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles, pruritus and feeling miserable were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and feeling miserable to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The patient's wife reported this case via interactive digital media. The patient received shots of Shingles vaccine years ago and years later he had an itchy place on his Back. The reporter thought the patient had scratched it. The patient went to doctor and he said the patient got shingles. It ended up in 2 places. The patient was miserable but never complained. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Shingles/Suspected vaccination failure; shingles; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, 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 Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The reporter wanted to know if one gets the two shots last year from the day of reporting and now came down with shingles what to do for the future, if one should get more shots. 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 were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the two shots last year, now I came down with shingles/ suspected vaccination failure; I came down with shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, less than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient received the two shots last year but now he/she came down with shingles. The patient asked what should he/she do now. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible, as no contact, details were available.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Received the two shots husband has just come down with it/ Suspected vaccination failure; Husband has just come down with it; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a male 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. On an unknown date, several years after receiving Shingrix and unknown 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 was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comments: This case was reported by patient's wife via interactive digital media. The patient received both the shots of Shingrix a couple of years ago from reporting, thought he could not get shingles after it. However, the patient had just come down with Shingles. The reporter also had received both the shots and asked if that meant that they should get more shots. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding the laboratory test confirming shingles was unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Exposure during pregnancy
Clinical narrative: Bexsero in pregnant patient; This prospective pregnancy case was reported by a other health professional via call center representative and described the occurrence of vaccine exposure during pregnancy in a female patient who received Men B NVS (Bexsero) (batch number ABXC06AA, expiry date 31st March 2023) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th May 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Bexsero at an unknown time during the pregnancy. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced vaccine exposure during pregnancy. On an unknown date, the outcome of the vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.   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: 24-JUN-2022 Reporter's Comments: The HCP (health care professional) reported that the use of Bexsero in pregnant patient.  The reporter consented to follow up. Additional Supportive Information: The case PR2022097869 was identified as duplicate of this case. The case PR2022097869 was deleted and all future correspondence would be added in the present case which stands as case of record for this patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: received both doses 3 years ago, at the end of June 2021 had a shingles outbreak/ Suspected vaccination failure; June 2021 shingles outbreak on lower left back; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 61-year-old female 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 (intramuscular). In June 2022, the patient received the 1st dose of Shingrix. On 27th June 2021, more than a year after receiving Shingrix and unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Linked case(s) involving the same patient:  US2022AMR099103   Additional Information: GSK Receipt Date: 27-JUN-2022 Reporter's Comments: The patient self-reported this case. The patient received both doses of Shingrix about 3 years ago (not sure of the dates) from reporting. Received 2nd dose on unknown arm.  The reporter stated at end of June 2021 she had a shingles outbreak on her lower left back, healthcare professional verified it was shingles. The patient report shingles outbreak last Friday 24th June 2022 in the same spot on the lower left back.  Healthcare professional verified and started her on Valtrex. The reporter did not consent to follow-up her and her healthcare professional. Additional Supportive Information: This case was considered as suspected vaccination failure as detail regarding laboratory test confirming herpes zoster was unknown at the time of reporting. For tolerance of Valtrex, refer case US2022AMR099103, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR099103:Same patient, same reporter, different product
Age: 24.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 24-year-old female patient who received HAV (Havrix adult) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 20th June 2022, the patient received the 1st dose of Havrix adult. On 20th June 2022, unknown after receiving Havrix adult, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 Reporter's Comment: The reporter was medical assistant. The reporter stated that, the patient was administered with an expired dose of Havrix vaccine. Transferred reporter to Medical information for further instruction. The reporter consented to follow up. Additional Supportive Information: The patient received an expired dose of Havrix, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose March 23rd 2017, 2nd dose on June 28th 2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 299J9, expiry date 1st July 2023) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 23rd March 2017 in an unknown facility).   On 28th June 2022, the patient received the 2nd dose of Shingrix. On 28th June 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: 28-JUN-2022 Reporter's Comments: The pharmacist reported that the patient received second dose late. The reporter did not consent to follow up. Additional Supportive Information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule. The Vaccine Administration Facility is the same as primary reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired vaccine to 5 patients; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) (batch number unknown, expiry date 22nd May 2022) for prophylaxis.   On an unknown date, the patient received Shingrix. 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: 29-JUN-2022 Reporter's Comment: The pharmacist reported a clinic inadvertently administered expired Shingrix vaccine to a patient. Health care professional (HCP) had no information at time of chat for lot or patient details but said she could get it and might follow up via email or telephone. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.  Additional Supportive Information: The patient inadvertently received expired Shingrix vaccine, which led to expired vaccine used. This is 1 of 5 cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR100398:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100400:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100403:Same case/same reporter US-GLAXOSMITHKLINE-US2022AMR100404:Same case/same reporter
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; CHILLS; TIRED; This spontaneous report received from a patient concerned a 60 year old male and unspecified race. The patient's height, and weight were not reported. The patient's concurrent conditions included: pollen allergy, dust allergy, allergic to Iodine and drug allergy (sulfamethoxazole/trimethoprim). On 09-MAR-2021 at 10:45 AM, the patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1802070 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm for prophylactic vaccination. Age at time of vaccination 60 years old.  Concomitant medications included rosuvastatin. On same day, the patient experienced chills and was tired after vaccination about 3 hours after administration (dose number in series 1). On an unspecified date, the patient experienced suspected clinical vaccination failure (dose number in series 1). On 28-NOV-2021, at 10:00 AM, the patient received non-company suspect vaccine included: elasomeran (moderna) (dose number in series 2) (form of admin and route of admin were not reported, batch number: 027H21B expiry: UNKNOWN), dose was not reported, administered to left arm prophylactic vaccination. Age at time of vaccination 60 years old.  On same day, the patient experienced chills and was tired after vaccination about 3 hours after administration (dose number in series 2).  On an unspecified date, the patient experienced suspected covid-19 infection (dose number in series 2).  On 13-JUN-2022, the patient received non-company suspect drug: Paxlovid) (form of admin and route of admin were not reported, batch number: GA3594 expiry: UNKNOWN), dose was not reported, administered for treatment of COVID-19 and discontinued on 17-JUN-2022. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and elasomeran was not applicable and with Paxlovid was drug discontinued. The patient recovered from chills, and tired, and the outcome of suspected clinical vaccination failure and suspected covid-19 infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20220657867-COVID-19 VACCINE AD26.COV2.S-Suspected clinical vaccination failure. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vertigo
Clinical narrative: VERTIGO; TINGLING IN LEGS; This spontaneous report received from a patient via other manufacturer (Abbvie) concerned a 54 year old female of unspecified race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: vertigo which resolved in 2016. The patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 16-MAR-2021 for prophylactic vaccination. Age at time of vaccination 53 years old. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1).  The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, intramuscular, batch number: unknown, expiry: unknown) dose was not reported, 1 total, administered on 13-JAN-2022 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Age at time of vaccination 54 years old. It was unknown whether patient had any adverse events following vaccination with second dose of covid-19 vaccine ad26. cov2.s (dose number in series 2). No concomitant medications were reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. Non-company suspect drugs included: adalimumab (solution for injection, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. The patient received additional dose of spikevax (elasomeran) (dose number in series 3), (form of administration not reported, Route of Admin was intramuscular, batch number: unknown, expiry: unknown) dose and was not reported, 1 total, administered on an unspecified date in 2022 for prophylactic vaccination.  On an unspecified date in 2022, the patient experienced tingling in legs (dose number in series 3). On an unspecified date in MAY-2022, the patient experienced vertigo (dose number in series 3). The action taken with elasomeran (spikevax) was not applicable. The outcome of the vertigo and tingling in legs was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Systemic lupus erythematosus
Clinical narrative: LUPUS; This spontaneous report received from a patient via a social media via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient was diagnosed with lupus and she never had any health issues. She was barely getting out of bed and very sick from vaccine. "The reporter stated,  Don't tell me there aren't 1000's like her". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of lupus was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20220661401-covid-19 vaccine ad26.cov2.s- Lupus. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via social media a company representative concerned a patient of unspecified age, sex, race and ethnicity. Initial information was processed along with the additional information received on 30-JUN-2022 The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26.cov2.s (Unspecified manufacturer) (dose number in series 1) (form of admin, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination.  It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s(Unspecified manufacturer) (dose number in series 1). On an unspecified date, the patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected covid-19 infection and suspected clinical vaccination failure. It was reported "My household- 1 vaxxed and boosted, 3 unvaxed. The vaxed got Covid, passed it on to the others and had it the worst", (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000239078. The suspected product quality complaint has been confirmed to be the reported allegation could not be determined. a manufacturing related root cause could not be identified. based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20220663278 -Covid-19 vaccine ad26.cov2.s -Suspected Clinical Vaccination Failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired healing, Loss of personal independence in daily activities, Psoriasis
Clinical narrative: Slow healing / Wound healing delayed; Activities of daily living impaired; Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED HEALING (Slow healing / Wound healing delayed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) and PSORIASIS (Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    The patient's past medical history included Hip replacement. Concurrent medical conditions included Plaque psoriasis.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In 2022, the patient experienced IMPAIRED HEALING (Slow healing / Wound healing delayed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) and PSORIASIS (Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves). At the time of the report, IMPAIRED HEALING (Slow healing / Wound healing delayed), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Activities of daily living impaired) and PSORIASIS (Few of plaque spots/skin really blew up/psoriasis skin flare ups have continued to come in waves) had not resolved.            No concomitant medications were provided by the reporter.  Patient had taken SKYRIZI in the form of Solution for injection in pre-filled pen.  No treatment information was provided.  For co-suspect SKYRIZI product reporter causality was given as not reported for all the events.   This case was linked to MOD-2022-597480 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: side effects to the Moderna vaccines; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effects to the Moderna vaccines) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy (Patient's reaction was violent nausea and vomiting, fine the next day (09-Mar-2021) and had resolved) from 08-Mar-2021 to March 2021. Concurrent medical conditions included Allergy to antibiotic, Alpha-1 antitrypsin deficiency (No recent changes in the status) since 2015 and Diabetes (2 years ago. No recent changes in the status.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effects to the Moderna vaccines). At the time of the report, IMMUNISATION REACTION (side effects to the Moderna vaccines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information provided. Patient had never tested positive or diagnosed with COVID-19  No other vaccine was taken by the patient within one month prior to Moderna COVID-19 Vaccine.  On 17-APR-2021, the patient received second dose of Moderna COVID-19 Vaccine. No treatment medication information provided.   This case was linked to MOD-2022-597763, MOD-2022-597762 (Patient Link).
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bell's palsy
Clinical narrative: side effects to the Moderna vaccines; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (side effects to the Moderna vaccines) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     The patient's past medical history included Bell's palsy (Patient's reaction was violent nausea and vomiting, fine the next day (09-Mar-2021) and had resolved) from 08-Mar-2021 to March 2021. Concurrent medical conditions included Allergy to antibiotic, Alpha-1 antitrypsin deficiency (No recent changes in the status) since 2015 and Diabetes (2 years ago. No recent changes in the status.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (side effects to the Moderna vaccines). At the time of the report, IMMUNISATION REACTION (side effects to the Moderna vaccines) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication information provided. Patient had never tested positive or diagnosed with COVID-19  No other vaccine was taken by the patient within one month prior to Moderna COVID-19 Vaccine.  On 17-APR-2021, the patient received second dose of Moderna COVID-19 Vaccine. No treatment medication information provided.   This case was linked to MOD-2022-597763, MOD-2022-597762 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: experienced COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (experienced COVID) in a 63-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis.   On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram every two weeks. In June 2022, the patient experienced COVID-19 (experienced COVID). At the time of the report, COVID-19 (experienced COVID) had not resolved. Not Provided      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.       The patient number was reported as 1382149. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. No concomitant medication information was provided. No treatment medication was provided.  Company comment: This spontaneous case concerns a 63-year-old, female patient with no relevant medical history reported, who experienced the unexpected non serious event of Covid-19, which occurred unspecified dose of mRNA-1273 vaccine. Current ongoing pandemia is confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a 63-year-old, female patient with no relevant medical history reported, who experienced the unexpected non serious event of Covid-19, which occurred unspecified dose of mRNA-1273 vaccine. Current ongoing pandemia is confounder for the event. The benefit-risk relationship of mRNA-1273 is not affected by this report.