chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: did not receive second shot; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose 3 years ago).   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 incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Had the vaccine now have shingles / Suspected vaccination failure; now have shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, more than 2 years 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the vaccine 3 years before day of reporting and now had shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots and have shingles / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had both shots and had shingles 3 times since. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suffering from shingles. Had the 2 shot / suspected vaccination failure; suffering from shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, more 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 case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient had the two shot regimen a couple of years before day of reporting. The patient currently suffering from shingles and everyone was surprised, especially patient itself. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation was unknown at the time of reporting. The follow up was not required.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: took shot shingles comes back / suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient took shot and shingles came back monthly if not weekly. The reporter stated it was not always good. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel like crap; This case was reported by a consumer via media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 21st September 2021, the patient received the 2nd dose of Shingles vaccine. In September 2021, less than a day after receiving Shingles vaccine, the patient experienced feeling unwell. On an unknown date, the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.  Additional details were reported as follows: This case was reported by the patient for herself or himself. The age at vaccination was not reported. The patient got shingles vaccine and felt like crap. The follow-up would not be possible as contact information was not available.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Illness, Pain
Clinical narrative: sick; head ache; body aches; This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced headache, general body pain and sickness. On an unknown date, the outcome of the headache and general body pain were recovered/resolved and the outcome of the sickness was unknown.   It was unknown if the reporter considered the headache, general body pain and sickness to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingles vaccine and experienced body aches and a headache for 2 days. The patient asked did anyone feel sick after getting the shot. The follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Granuloma annulare, Rash, Vaccine positive rechallenge
Clinical narrative: granuloma annulare; severe rash; This case was reported by a consumer via call center representative and described the occurrence of granuloma annulare in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash (1st dose received on an unknown date, refer case US2021200847).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced granuloma annulare and rash. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the granuloma annulare was unknown and the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the granuloma annulare and rash to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced more severe rash. The patient stated that she had the more severe rash for almost 6 months. The patient also stated that the dermatologist had diagnosed the rash as granuloma annulare. The patient inquired if Shingrix causes granuloma annulare. The patient also inquired what she should do for treatment. The patient did provide consent to contact healthcare professional. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021200847:same patient different dose
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had 2 dose and still get Shingles/ suspected Vaccination failure; Shingles; This case was reported by a consumer via  interactive digital media and described the occurrence of suspected 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. On an unknown date, unknown after receiving Shingrix and 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 details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, had the 2 dose Shingrix vaccine and still get Shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: I got the 2 dose shindig vaccine but this year got shingles/ suspected vaccination failure; got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles on face 4 years ago).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and 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 details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the 2 dose Shingrix vaccine but this year got shingles in same place. The reporter asked should get the Shingrix vaccine again. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vax and get shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's son or daughter. The age at vaccination was not reported. The reporter stated that, his or her father got the shingles vaccine and still get a terrible outbreak of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with case US2021AMR201261 and US2021AMR201259, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201261:tag at post US-GLAXOSMITHKLINE-US2021AMR201259:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vax and get shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in an unspecified number of patients 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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, seen plenty of people get the shingles vaccine and still got a terrible outbreak of shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided. This case was linked with case US2021AMR201252 reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR201252:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: vax but got shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles outbreak).   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 and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The reporter stated that, got the shingles vaccine but also got my second shingles outbreak, it was terrible ,worst then my first outbreak. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the vaccine and got shingles/uspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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.   Additional details were reported as follows: The case was reported by the patient's friend. The age at vaccination was not reported. The patient got the vaccine, and still got shingles, apparently, it must fall under the Center for Disease Control and Prevention (CDC's) guidelines as the covid vaccine.  The reporter also said, in other words, it was not. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got them after the vaccine/suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced 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.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got them two after the vaccine but it was not as bad, thank God. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots, got shingles/suspected vaccination failure; got mild case of shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected 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, unknown 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 details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got the shots, but got mild case of shingles. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose 2019, second dose 2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number NP55Z, expiry date 22nd October 2021) for prophylaxis.   Previously administered products included SHINGRIX (received 1st dose in June 2019, lot no XL972, expiry date 29th August 2021).   On 19th September 2021, the patient received the 2nd dose of Shingrix. On 19th September 2021, 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 case details were reported as follows: In June 2019, the patient never went back for the second dose. On 19th September 2021, the patient received the second dose of Shingrix, later than recommended time interval, which led to lengthening of vaccination schedule. No further details were provided at the time of reporting. The reporter consented to follow up. This case has been linked with US2021010473, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021010473:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: only administered the adjuvant; only administered the adjuvant; This case was reported by a consumer via call center representative and described the occurrence of inappropriate dose of vaccine administered in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate dose of vaccine administered and inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The reporter stated that she was dispensed Shingrix by her pharmacy to be administered at her doctor's office. The nurse at the doctor's office only administered the adjuvant, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication. The reporter consented to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Diplopia
Clinical narrative: Diplopia; Sore shoulder; This case was reported by a consumer via call center representative and described the occurrence of shoulder soreness in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ivth nerve paralysis (4th cranial nerve palsy).   On 13th August 2021, the patient received the 1st dose of Shingrix (intramuscular). On 13th August 2021, less than a day after receiving Shingrix, the patient experienced shoulder soreness. On 13th September 2021, the patient experienced diplopia. On an unknown date, the outcome of the shoulder soreness was recovered/resolved and the outcome of the diplopia was recovering/resolving.   It was unknown if the reporter considered the shoulder soreness and diplopia to be related to Shingrix.  Additional details provided were as follows: The reporter is the patient himself. The patient received a dose of Shingrix vaccine in left deltoid intramuscularly and at the night of vaccination had a sore shoulder and lasted for 2-3 days. The patient also stated that he also started experiencing diplopia and that he went to the emergency room for treatment with follow up with ophthalmologist. He stated that his diplopia was improving. The patient inquired if Shingrix can cause diplopia. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: 30 yrs old and her HCP prescribed shingrix; This case was reported by a consumer via call center representative and described the occurrence of product prescribing error in a 30-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (in the past (inappropriate age)). Concurrent medical conditions included clinical depression.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product prescribing error. On an unknown date, the outcome of the product prescribing error was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. This case was reported by the patient herself. The patient reported that, she was 30 years old and her HCP (health care professional) wrote her a prescription to get shingrix due to the fact that she has had shingles in the past (inappropriate age), which led to product prescribing error. The patient had not yet received the vaccine. The patient spoke per PI about dosing guidelines, approved in adults aged 18 years and older who were or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy. The reporter did not consent to follow up.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: received the adult dose of Engerix-B; received the adult dose of Engerix-B; This case was reported by a other health professional via call center representative and described the occurrence of adult product administered to child in a 8-year-old female patient who received HBV (Engerix B adult) (batch number 94dj5, expiry date 15th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st September 2021, the patient received the 2nd dose of Engerix B adult (intramuscular) and Engerix B Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Engerix B adult and Engerix B Pre-Filled Syringe Device, the patient experienced adult product administered to child and accidental overdose. On an unknown date, the outcome of the adult product administered to child and accidental overdose 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 details were reported as follows: The age at vaccination was not reported. A healthcare provider reported that a patient inadvertently received the adult dose of Engerix-B in the left deltoid which led to product administered to child and overdose. The reporter consented to follow up. The case had been linked with US2021199870 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021199870:Same reporter
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Boostrix dose 4 years ago and another Booster 2 years ago; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 67-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Previously administered products included Boostrix (received Boostrix 4 years ago).   In November 2019, the patient received Boostrix. In November 2019, unknown after receiving Boostrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient received Boostrix 4 years ago and another booster 2 years ago, earlier than the recommended interval, which led to shortening of vaccine schedule. The patient would like to take another booster, all boosters were due to grandbabies being born. The pharmacist was unable to provide date of first Boostrix. The reporter consented to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First dose on 19-AUG-2021 and second dose on 10-SEP-2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number TP2N2, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 10th September 2021, the patient received the 2nd dose of Shingrix. On 10th September 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The pharmacist reported that, the patient (who was not immunocompromised) received his first dose of Shingrix on 19th August 2021. The patient received his/her second dose on 10th September 2021, which led to drug dose administration interval too short. No further information reported. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: did not return to receive second dose; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 64-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 22nd June 2021, (lot number, expiry date unknown) via intramuscular route in the right deltoid).   On 21st September 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 21st September 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, 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.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The pharmacist reported that the patient did not return within the recommended time frame to receive the second dose. The second dose to be received on 21st September 2021 on the day of reporting, which would lead to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number HB7L7, expiry date 31st August 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th September 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th September 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient received an expired dose of Kinrix, which was expired on 31st August 2021, which led to expired vaccine used.  No patient data was provided. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: has not received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 0.5 ml of 1st dose on 12th November 2020, intramuscularly in left deltoid, batch number 453S4, expiry date 19th March 2022).   On an unknown date, the patient received 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 details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter gave a consent to follow-up with himself. He provided his email address.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dysphonia, Nervousness, Polymerase chain reaction
Clinical narrative: throat feels very irritated and raw; voice has become hoarse in the last month; dry cough; Chills; felt the heeby jeeby; felt the heeby jeeby; This spontaneous case was reported by a nurse and describes the occurrence of the second episode of NERVOUSNESS (felt the heeby jeeby), THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), the first episode of NERVOUSNESS (felt the heeby jeeby) and COUGH (dry cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03K20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD (patient has always had irritation in her throat.) and Barrett's esophagus (patient has always had irritation in her throat). Concomitant products included AMLODIPINE for Blood pressure, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), METFORMIN, VITAMIN D3, PRAVASTATIN, MAGNESIUM, ZINC, CALCIUM and NITROGLYCERIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of NERVOUSNESS (felt the heeby jeeby). On 12-Feb-2021, the patient experienced the second episode of NERVOUSNESS (felt the heeby jeeby). On an unknown date, the patient experienced THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), COUGH (dry cough) and CHILLS (Chills). At the time of the report, last episode of NERVOUSNESS (felt the heeby jeeby), THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), COUGH (dry cough) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2020, SARS-CoV-2 antibody test: negative (Negative) negative. On 07-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE. On 08-Sep-2021, SARS-CoV-2 antibody test: negative (Negative) NEGATIVE. On 09-Sep-2021, Polymerase chain reaction: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that there was no hypersensitivity to vaccine concomitant medication includes OTC Vitamins  No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: updated reporters qualification, lab test (Covid PCR/TMA - D) was negative on 9 sep 2021, past covid test data(29-04-2020) .
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test, Throat irritation
Clinical narrative: throat feels very irritated and raw; voice has become hoarse in the last month; dry cough; Chills; felt the heeby jeeby; felt the heeby jeeby; This spontaneous case was reported by a nurse and describes the occurrence of the second episode of NERVOUSNESS (felt the heeby jeeby), THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), the first episode of NERVOUSNESS (felt the heeby jeeby) and COUGH (dry cough) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03K20A and 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included GERD (patient has always had irritation in her throat.) and Barrett's esophagus (patient has always had irritation in her throat). Concomitant products included AMLODIPINE for Blood pressure, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), METFORMIN, VITAMIN D3, PRAVASTATIN, MAGNESIUM, ZINC, CALCIUM and NITROGLYCERIN for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced the first episode of NERVOUSNESS (felt the heeby jeeby). On 12-Feb-2021, the patient experienced the second episode of NERVOUSNESS (felt the heeby jeeby). On an unknown date, the patient experienced THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), COUGH (dry cough) and CHILLS (Chills). At the time of the report, last episode of NERVOUSNESS (felt the heeby jeeby), THROAT IRRITATION (throat feels very irritated and raw), DYSPHONIA (voice has become hoarse in the last month), COUGH (dry cough) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Apr-2020, SARS-CoV-2 antibody test: negative (Negative) negative. On 07-Sep-2021, SARS-CoV-2 antibody test: positive (Positive) POSITIVE. On 08-Sep-2021, SARS-CoV-2 antibody test: negative (Negative) NEGATIVE. On 09-Sep-2021, Polymerase chain reaction: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter stated that there was no hypersensitivity to vaccine concomitant medication includes OTC Vitamins  No treatment medication was reported   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: updated reporters qualification, lab test (Covid PCR/TMA - D) was negative on 9 sep 2021, past covid test data(29-04-2020) .
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Body temperature, Chills, Diarrhoea
Clinical narrative: Got really sick; Diarrhea; sick to her stomach; Ache; Headache; Chills; fever of 102 F; felt so weak; could not go out to do grocery shopping; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping), ILLNESS (Got really sick), DIARRHEA (Diarrhea) and ABDOMINAL DISCOMFORT (sick to her stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised (moderately immunodeficient).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted). On 17-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Ache), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F). On 19-Aug-2021, ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F) had resolved. At the time of the report, ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted) outcome was unknown and PAIN (Ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: 102f (High) fever of 102 F.         Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-320913 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Loss of personal independence in daily activities, Pain
Clinical narrative: Got really sick; Diarrhea; sick to her stomach; Ache; Headache; Chills; fever of 102 F; felt so weak; could not go out to do grocery shopping; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping), ILLNESS (Got really sick), DIARRHEA (Diarrhea) and ABDOMINAL DISCOMFORT (sick to her stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised (moderately immunodeficient).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted). On 17-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Ache), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F). On 19-Aug-2021, ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F) had resolved. At the time of the report, ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted) outcome was unknown and PAIN (Ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: 102f (High) fever of 102 F.         Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-320913 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Got really sick; Diarrhea; sick to her stomach; Ache; Headache; Chills; fever of 102 F; felt so weak; could not go out to do grocery shopping; Exhausted; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping), ILLNESS (Got really sick), DIARRHEA (Diarrhea) and ABDOMINAL DISCOMFORT (sick to her stomach) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 002B21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Immunocompromised (moderately immunodeficient).   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted). On 17-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), PAIN (Ache), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F). On 19-Aug-2021, ILLNESS (Got really sick), DIARRHEA (Diarrhea), ABDOMINAL DISCOMFORT (sick to her stomach), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (fever of 102 F) had resolved. At the time of the report, ASTHENIA (felt so weak), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (could not go out to do grocery shopping) and FATIGUE (Exhausted) outcome was unknown and PAIN (Ache) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Aug-2021, Body temperature: 102f (High) fever of 102 F.         Concomitant product information was not provided. Treatment information was not provided.   This case was linked to MOD-2021-320913 (Patient Link).