chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: but the patient did not receive another dose of a varicella vaccine.; no other AE occurred.; This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition, drug reactions/allergies and concomitant medication was not provided.  On an unknown date (reported as at 1-year-old), the patient was vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (dose, strength, route, lot# and expiration date were not provided) for prophylaxis. The patient then received a single dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin) (M-M-R II) according to the dosing schedule (date unknown by reporter), but the patient did not receive another dose of a varicella vaccine (product dose omission issue) and no other adverse event occurred.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no AE; the vaccine was given four days after expiration; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 27-JAN-2022, the patient was vaccinated with expired dose (four days after expiration) of varicella virus vaccine live (oka/merck) (VARIVAX) (lot#T002843, expiration date: 23-JAN-2022) in dose 0.5 milliliter for prophylaxis (dose number, route of administration and anatomical location were not reported). No additional adverse events were reported. The outcome of expired product administered was not provided.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; A patient was given an expired dose of PNEUMOVAX23 which was given 28-JAN-2022; This spontaneous report has been received from an office manager, concerning to an unknown gender and age patient. No information was provided regarding the patients' pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 28-JAN-2022, the patient was vaccinated with an expired pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) syringe at a dose of 0.5 milliliters (mL) (lot number T009743 has been verified to be a valid lot number, expiration date reported and established as 27-JAN-2022) as prophylaxis (vaccination scheme frequency, route of administration, and anatomical location of vaccination were not provided) (expired product administered). No additional adverse events (AE) reported (no adverse event).
Sex: U
Vaccine: VARZOS
Symptoms: Hemiplegia, Nervous system disorder
Clinical narrative: neurological issues and right sided paralysis.; neurological issues and right sided paralysis.; This spontaneous report was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On an unknown date, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date, after receiving the vaccine, the patient suffered neurological issues and right sided paralysis. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). Patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of zoster vaccine live (ZOSTAVAX), symptoms have resulted in physical limitations not present prior to using the vaccine and experienced mental and emotional distress due to resulting physical limitations and seriousness of the patient condition, in addition, the patient sustained severe and permanent personal injuries and suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  Upon internal review, right sided paralysis was considered a medically significant event.
Age: 0.58
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE information provided; Medical assistant calling to report that a 7-month old female patient was inadvertently administered VARIVAX today; This spontaneous report was received from a medical assistant referring to a 7-month-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 04-FEB-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 milliliter, lot number T010315, expiration date 24-MAR-2022 for prophylaxis (route of administration not reported) (product administered to patient of inappropriate age). No adverse event was reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Expired dose administered; This spontaneous report was received from a medical assistant and refers to a 6 months old patient of unknown gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 20-JAN-2022, the patient was vaccinated with expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # U007860, expiration date: 14-JAN-2022) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse events occurred. The outcome of expired dose administered was not reported.
Sex: U
Vaccine: MMR
Symptoms: Product storage error
Clinical narrative: Temperature 57.55F / time frame 8 hours and 30 minutes / Inadvertently administered improplerly stored vaccine; This spontaneous report was received from a medical student, concerning a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications, and previous drug reactions, or allergies were not reported.  On 03-DEC-2021, the patient was vaccinated with a improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot #T034380 has been verified to be a valid lot number, expiration date not reported, but upon internal validation established as 08-JAN-2022), as prophylaxis (strength, dose and route of administration were not provided). The vaccine was exposed to a temperature of 57.55 Fahrenheit (F) during a time frame of 8 hours and 30 minutes (product storage error). Multiple previous temperature excursions were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Vaccination failure
Clinical narrative: got the new shot. It was really bad/suspected vaccination failure; It was really bad; had a few blisters; 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.   Previously administered products included Shingles vaccine (received original one years ago from reporting date and got massive case of shingle and also had very few blisters).   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), shingles and blister. On an unknown date, the outcome of the vaccination failure, shingles and blister were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and blister to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was thankful to the earlier shot.  The patient got the new shot as soon as possible after healing up and stated shingles was really bad and only had a few blisters and so grateful it was not covered in blisters. The patient stated get the shot. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: First dose July 15 and is 2nd dose still good with it being almost 7 months? Or will I need to do a 3rd dose?; 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 (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th July 2021).   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 patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not received the second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The patient enquired if 2nd dose was still good with it being almost 7 months after the 1st dose or if he/she needed to do a 3rd dose. The follow-up would not be possible as no contact details were available.
Sex: M
Vaccine: VARZOS
Symptoms: Oxygen saturation, Pain in extremity
Clinical narrative: Still with sore arm a week later; This case was reported by a pharmacist via sales rep and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The case was reported by the patient himself who was the registered pharmacist. The health care professional stated that he received the dose of Shingrix a week before reporting and still had a sore arm a week later till the time of reporting. The reporter did not agree to follow up from GlaxoSmithKline.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed shingles immediately after their booster shots; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by patient. Age at vaccination was not reported. The patient received booster shot of Shingles vaccine and experienced shingles immediately. Consent to follow up was not possible as no contact details were available. This case was linked to US2022AMR021507 from the same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR021507:Same Reporter
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Malaise, Nasopharyngitis, Nausea
Clinical narrative: arm all red; nausea; cold; freezing every bone; body ached; still not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities 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 erythema of extremities, nausea, cold, feeling cold, general body pain and feeling unwell. On an unknown date, the outcome of the erythema of extremities, nausea, cold, feeling cold and general body pain were unknown and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, nausea, cold, feeling cold, general body pain and feeling unwell 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 just had his/her last shot and it was worst shot. The patient had arm all red, nausea and got a cold and freezing every bone in his/her body ached. The patient was still not feeling well. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: arm all red; nausea; cold; freezing every bone; body ached; still not feeling well; This case was reported by a consumer via interactive digital media and described the occurrence of erythema of extremities 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 erythema of extremities, nausea, cold, feeling cold, general body pain and feeling unwell. On an unknown date, the outcome of the erythema of extremities, nausea, cold, feeling cold and general body pain were unknown and the outcome of the feeling unwell was not recovered/not resolved.   It was unknown if the reporter considered the erythema of extremities, nausea, cold, feeling cold, general body pain and feeling unwell 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 just had his/her last shot and it was worst shot. The patient had arm all red, nausea and got a cold and freezing every bone in his/her body ached. The patient was still not feeling well. The follow-up could not be possible as no contact details were available.
Age: 74.0
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: First shingirx in 2019, second on 2022; This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in 2019).   On 2nd February 2022, the patient received the 2nd dose of Shingrix. On 2nd February 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 details were reported as follows: The patient self-reported this case. The patient stated he/she received 2nd dose of Shingrix which was longer than the six months recommended schedule, which led to lengthening of vaccination schedule. The patient wanted to know if he/she was protected. The patient stated that a pharmacist said he/she was protected and wanted to verify the same. The patient was advised to refer his/her health care provider as his/her primary resource for patient care.  The patient was informed, the Food and Drug Administration (FDA) approved dosing schedule for Shingrix was the first dose at month 0, followed by a second dose 2-6 months after the first dose. GlaxoSmithKline had not done its own studies on the time frame greater than 6 months, but the Centers for Disease Control (CDC) had provided guidance that if it had been more than 6 months since a patient received the first dose, they should get the second dose as soon as possible; patients do not need to restart the vaccine series. They had no indications if it had been longer than 6 months between getting the two Shingrix vaccines that the coverage was any less. The patient was provided with the link for the package insert. The patient was further informed that Shingrix was shown to be over 90 percent effective at preventing shingles for people 50 years of age and older in clinical trials after receiving both doses. The patient appreciated the link and stated that was all he/she needed.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; had 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, several years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria 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 patient self-reported this case. The age at vaccination was not reported. The patient got the shot a few years ago and had shingles a couple months ago, further stated it was no fun. The follow-up would not be possible as no contact details were available. The case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: Shingles and I was vaccinated last year/Suspected Vaccination Failure; Painful case of shingles; Painful, still have pain; 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, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved and the outcome of the pain was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient was just getting over a very painful case of shingles and he/she was vaccinated last year. The patient was luckily put on antiviral right away.  The patient still had pain. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: 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 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 suspected vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the suspected vaccination failure and shingles were unknown.   It was unknown if the reporter considered the suspected vaccination failure and shingles to be related to Shingles vaccine.  Additional details were reported as follows: The reporter was patient's wife. The age at vaccination was not reported. The patient received a dose of Shingles vaccine and experienced shingles. Consent to follow up was not possible as no contact details were available. 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 was not provided. This case was linked to US2022AMR022236 from  same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR022236:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got shingles after the vaccine shot/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 (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 patient got shingles after receiving Shingles shot. The follow-up could not be possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation for shingles were unknown at the time of reporting. The case was linked with case US2022AMR022217, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR022217:Same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles 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, immediately after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was the patient's neighbor. The age at vaccination was not reported. The reporter stated that the patient got shingles right after getting her shingles vaccine. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: suspected vaccination failure/shingles; shingles; hurts so bad; 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 suspected vaccination failure (serious criteria medically significant), shingles and pain. On an unknown date, the outcome of the suspected vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the suspected vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were reported as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received Shingles vaccine and still got shingles  The patient stated that it hurt so bad. Consent to follow up was not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, COVID-19, Malaise, Myalgia, Pain
Clinical narrative: covid-19; Muscle pain/symptoms got worst; Joint pain; Soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, between 2 and 3 weeks after receiving Shingrix, the patient experienced muscle pain, joint pain and pain. In January 2022, the patient experienced covid-19. On an unknown date, the outcome of the muscle pain, joint pain, pain and covid-19 were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, joint pain, pain and covid-19 to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at the vaccination was unknown. The reporter did not feel comfortable providing his date of birth, therefore, he stated that he was more 70 years-old. The patient had received Shingrix in left deltoid. The reporter did not have lot/expiry date and dose of Shingrix.  The reporter reported that after two and a half weeks later (after the vaccination), he experienced muscle pan, joint pain, soreness.  The reporter stated that during the first week of January 2022, he was diagnosed with covid-19 and the symptoms got worst. However, currently the symptoms were back how they initially were (before covid-19 was diagnosed). In other words, symptoms had not been resolved.  The reporter did not give a consent to follow-up with healthcare professional. Therefore, healthcare professional contact information was not collected.
Sex: M
Vaccine: VARZOS
Symptoms: SARS-CoV-2 test positive
Clinical narrative: covid-19; Muscle pain/symptoms got worst; Joint pain; Soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st December 2021, the patient received the 1st dose of Shingrix (intramuscular). In December 2021, between 2 and 3 weeks after receiving Shingrix, the patient experienced muscle pain, joint pain and pain. In January 2022, the patient experienced covid-19. On an unknown date, the outcome of the muscle pain, joint pain, pain and covid-19 were not recovered/not resolved.   It was unknown if the reporter considered the muscle pain, joint pain, pain and covid-19 to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient. The age at the vaccination was unknown. The reporter did not feel comfortable providing his date of birth, therefore, he stated that he was more 70 years-old. The patient had received Shingrix in left deltoid. The reporter did not have lot/expiry date and dose of Shingrix.  The reporter reported that after two and a half weeks later (after the vaccination), he experienced muscle pan, joint pain, soreness.  The reporter stated that during the first week of January 2022, he was diagnosed with covid-19 and the symptoms got worst. However, currently the symptoms were back how they initially were (before covid-19 was diagnosed). In other words, symptoms had not been resolved.  The reporter did not give a consent to follow-up with healthcare professional. Therefore, healthcare professional contact information was not collected.
Sex: U
Vaccine: VARZOS
Symptoms: COVID-19, Incorrect route of product administration, SARS-CoV-2 test positive
Clinical narrative: have COVID-19 / currently still have symptoms; route was reported intercostal; This case was reported by a pharmacist via call center representative and described the occurrence of covid-19 in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intercostal). On an unknown date, unknown after receiving Shingrix, the patient experienced covid-19 and intramuscular formulation administered by other route. On an unknown date, the outcome of the covid-19 and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the covid-19 to be related to Shingrix.  Additional details were provided as follows: The reporter called on behalf of a patient.  The reporter did not have any patient demographic information. The age at vaccination was not reported. The route of administration was reported intercostal, which led to intramuscular formulation administered by other route. The reporter called to inquire if a patient could have the 2nd dose of Shingrix as they were due, but had Covid-19 and currently still had symptoms.  The reporter also reported that the patient received monoclonal antibodies and inquired if the patient could still had the 2nd dose of Shingrix or if they had to wait a period of time.  Monoclonal antibodies was suspect in this case.  The reporter did not have any further details apart from the patient was tested positive for covid-19 a few days ago and they received antibodies.  The reporter reported that the patient was due for her 2nd dose on 2nd February 2022 (6 months from 1st dose). It was unknown if the reporter considered the covid-19 to be related to monoclonal antibodies. The consent to follow up was granted.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: first dose on September 2021, only first administrated; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 68-year-old male 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 (received 1st dose 7th September 2021 with batch no gg3s5, expiry date 28th February 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 age at vaccination was not applicable for this report. The pharmacist reported that the patient was late for the second dose of Twinrix.  Till the time of reporting, the patient did not receive 2nd dose of Twinrix, which led to incomplete course of vaccination. No adverse event was reported . The reporter did not consent to follow-up.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Rotarix lyohpilized powder lot G973H with diluents of lot M4AR7; Rotarix lyohpilized powder lot G973H with diluents of lot M4AR7; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) (batch number G973H, expiry date unknown) and (batch number M4AR7, expiry date unknown) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, the dose was an unknown dose. On an unknown date, the patient started Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   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 nurse reported that the patients received dose of Rotarix lyohpilized powder lot G973H with the diluents of lot M4AR7(mismatched diluent/powder lot numbers), which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further information reported. The reporter consented to follow-up.
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: sterile water was used instead of the solution in the packaging; sterile water was used instead of the solution in the packaging; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   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 reporter was a nurse practitioner at clinic. The age at vaccination was not reported. The reporter stated that someone in her clinic administered Rotarix with the wrong diluent. She advised sterile water was used instead of the solution in the packaging, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted details on how to proceed after vaccination and if they need to be re-vaccinated. No information available on the patient or who administered the vaccine. Prescriber of vaccination was not known. The reporter did not consent to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Chills, Malaise, Muscle spasms
Clinical narrative: Severe abdominal pain; cramping; Chills; Malaise; This case was reported by a consumer via call center representative and described the occurrence of abdominal pain in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in August 2021). Concomitant products included paracetamol (Tylenol).   On 1st February 2022, the patient received the 2nd dose of Shingrix. On 1st February 2022, less than a day after receiving Shingrix, the patient experienced abdominal pain, cramp, chills and malaise. On an unknown date, the outcome of the abdominal pain, cramp, chills and malaise were unknown.   It was unknown if the reporter considered the abdominal pain, cramp, chills and malaise to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix a day before reporting and since receiving the second dose the patient had been experiencing severe abdominal pain and cramping, chills and malaise. The patient had also received Tylenol for unknown indication. The caller was requesting information regarding the side effects associated with the Shingrix vaccine. Spoke from Shingrix frequently asked questions content and the Shingrix package insert.  Provided medical advice disclaimer.  Caller provided permission to contact health care professional. No additional details were provided by the caller. The reporter consented to follow-up.
Age: 0.33
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Maladministration into a 4 months old female patient.; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number 7T5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 patient received Kinrix at 4 months old, which led to inappropriate age at vaccine administration. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on stomach and thighs; This case was reported by a consumer via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th December 2021, the patient received the 1st dose of Shingrix. On 15th December 2021, less than a day after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not reported. The patient had rash on the same of day of vaccination on stomach.  At the time of reporting, the rash was on stomach and thighs and not resolved yet. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered dose which expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number Abxa87az, expiry date 31st January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 2nd February 2022, unknown after receiving Bexsero and Bexsero 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 provided as follows: The patient received dose of Bexsero in left deltoid. The medical assistant reported that, the patient received expired dose of Bexsero, which led to expired vaccine used. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Dose one of Shingrix almost 2 years ago; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date, almost 2 years ago).   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. The reporter stated that the patient was past due for dose two of Shingrix, which led to incomplete course of vaccination. The reporter could not provide patient demographics, lot number or expiration date.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: A 102 year old male patient had received the first dose of Shingrix on  11SEP2019 and  had not yet received the second dose of Shingrix.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 102-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 11th September 2019).   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 the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. No further events were reported.  The reporter agreed to be contacted for follow up. The Vaccine Administration Facility is the same as Primary Reporter.
Age: 62.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: severe urticaria; This case was reported by a physician via call center representative and described the occurrence of urticaria in a 62-year-old female patient who received HBV (Engerix B adult) (batch number bg92z, expiry date 4th July 2022) for prophylaxis.   Previously administered products included Engerix B adult (received 1st and 2nd dose on an unknown date).   On 27th December 2021, the patient received the 3rd dose of Engerix B adult (intramuscular) 1 ml. On 28th December 2021, 1 days after receiving Engerix B adult, the patient experienced urticaria. On an unknown date, the outcome of the urticaria was unknown.   It was unknown if the reporter considered the urticaria to be related to Engerix B adult.  Additional details were provided as follows: The patient received Engerix B adult, at noon, in right deltoid. Following morning after receiving Engerix B adult, the patient developed severe urticaria. The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered, Product administered to patient of inappropriate age
Clinical narrative: expired dose administered; 65 year old received dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 67-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA87AZ, expiry date 30th January 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 3rd February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used and inappropriate age at vaccine administration. On an unknown date, the outcome of the expired vaccine used and inappropriate age at vaccine administration 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 provided as follows: The reporter stated that the 67 year old patient was administered an expired dose of Bexsero vaccine, which led to expired vaccine used and inappropriate age at vaccine administration. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: received third and fourth dose; received third and fourth dose; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 3rd October 2018) and Shingrix (received 2nd dose on 13th March 2019).   On 28th January 2020, the patient received the 4th dose of Shingrix. On 19th October 2019, the patient received the 3rd dose of Shingrix. On 19th October 2019, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced extra dose administered. On 28th January 2020, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered and extra dose administered were unknown.  Additional details were provided as follows: The case was self-reported by the patient. The patient received 3rd and 4th dose of Shingrix, which led to extra dose administered. The reporter was inquiring if he should be concerned and what potential side effects could he experience from receiving four doses of the Shingrix vaccine.  Provided medical advice disclaimer. Referred to Healthcare professional and provided number to Medical information. No additional details were provided by the reporter. The reporter consented to follow up. The reporter provided permission to contact Healthcare professional.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 19 years patient received an adult dose; 19 years patient received an adult Engerix dose; This case was reported by a nurse via call center representative and described the occurrence of overdose in a 19-year-old female patient who received HBV (Engerix B adult) for prophylaxis.   On 4th August 2021, the patient received Engerix B adult. On 4th August 2021, unknown after receiving Engerix B adult, the patient experienced overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the overdose and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: Nurse practitioner reported that the patient was currently 19 years old and received an adult dose of Engerix B, which led to overdose and inappropriate age at vaccine administration. Followed by a pediatric Engerix dose on 4th September 2021. The reporter asked should they continue with adult dose. Nurse Practitioner called in to inquire how to proceed with Engerix series. The reporter did not provide vaccine details. The reporter did not consent to follow-up.