chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I just had sore arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Jul-2022. Reporter's Comments: This case was reported by the patient via interactive digital media. The patient had completed 2 shots and he/she did not get sick.  The patient just had sore arm. Additional Supportive Information: The follow-up would not possible as no contact details were available. From  the narrative it was not clear after which dose patient had sore arm  hence only 1 suspect without dose number was captured in the case.; Sender's Comments:  US-GSK-US2022AMR117884:Same reporter
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: One shot years ago, have shingles now; Apparently I should have been updated; 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.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine and did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and not applicable after receiving Shingles vaccine, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 29-Jul-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient had one shot years ago and had shingles at the time of reporting. The patient stated that should have been updated and this was the second time. The patient advised that if it was only one shot be sure to check with your Doctor. Additional Supportive Information: Till the time of reporting the patient had not received the second dose of Shingles vaccine, which led to incomplete course of vaccination. Follow up was not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Shots are painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR117906   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that shots were painful but it was a few seconds. The patient stated that after 1st dose he/she had no soreness. Additional Supportive Information: The follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2022AMR117906:Same reporter.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB37AA, expiry date 31st July 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 5th August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th August 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 Information: GSK Receipt Date: 5-Aug-2022 Reporter's comment: A healthcare professional reported that they administered an expired dose of Bexsero to a patient by mistake. The reporter consented to follow up. Additional Supportive Information: Patient received a dose of Bexsero on 5th August 2022 which was expired on 31st July 2022, which led to expired vaccine used.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: The vaccine was given out of the recommended schedule. Patient was monitored for a period of time. No adverse events resulted
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Injected limb mobility decreased, Joint swelling, Myalgia
Clinical narrative: On 10-9-2021, I noticed fatigue, muscle aches all over, fever up to 102.0, sweating and left arm soreness to the point that I was having problems lifting it I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. I did not call or go to the doctor.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: On 10-9-2021, I noticed fatigue, muscle aches all over, fever up to 102.0, sweating and left arm soreness to the point that I was having problems lifting it I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. I did not call or go to the doctor.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Anti-thyroid antibody increased, Chest pain, Urticaria
Clinical narrative: chronic hives Chest pain
Age: 0.17
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV1
Symptoms: Death, Respiratory arrest, Resuscitation
Clinical narrative: Pt seen for well visit in the AM on 8/11.  Brought to ER on 8/12 at about 2AM.  Not breathing - CPR performed - pt died.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient <18 years of age
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Bundle branch block right, COVID-19, Cardiac failure congestive, Cardiac monitoring
Clinical narrative: 7/23/2022 Presented with complaints of weakness. Symptoms began possibly 2 days ago. Hospitalized with concerns of COVID infection without evidence of pneumonia. History of CHF with concerns of mild acute exacerbation, also elevated cardiac enzyme.  Febrile at 101.3F on admission, O2 2L after desat to 83. Plan to be started on doxycycline, dexamethasone along with albuterol as needed and supplemental oxygen therapy as needed for the COVID infection. CHF to be treated with Lasix 40 mg IV daily along with cardiac monitoring with telemetry and echocardiogram.  Supplemental oxygen, wean as tolerated. -Albuterol PRN, no duonebs or aerosolizing procedures. -Remdesivir- not a candidate, no PNA -Dexamethasone 6mg 10d. - Empiric abx with Doxy -Covid labs per protocol -Home oxygen evaluation possible prior to DC.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac telemetry, Chest X-ray normal, Condition aggravated, Echocardiogram, Electrocardiogram abnormal
Clinical narrative: 7/23/2022 Presented with complaints of weakness. Symptoms began possibly 2 days ago. Hospitalized with concerns of COVID infection without evidence of pneumonia. History of CHF with concerns of mild acute exacerbation, also elevated cardiac enzyme.  Febrile at 101.3F on admission, O2 2L after desat to 83. Plan to be started on doxycycline, dexamethasone along with albuterol as needed and supplemental oxygen therapy as needed for the COVID infection. CHF to be treated with Lasix 40 mg IV daily along with cardiac monitoring with telemetry and echocardiogram.  Supplemental oxygen, wean as tolerated. -Albuterol PRN, no duonebs or aerosolizing procedures. -Remdesivir- not a candidate, no PNA -Dexamethasone 6mg 10d. - Empiric abx with Doxy -Covid labs per protocol -Home oxygen evaluation possible prior to DC.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Myocardial infarction, Myocardial necrosis marker increased, Nodal rhythm, Oxygen saturation decreased
Clinical narrative: 7/23/2022 Presented with complaints of weakness. Symptoms began possibly 2 days ago. Hospitalized with concerns of COVID infection without evidence of pneumonia. History of CHF with concerns of mild acute exacerbation, also elevated cardiac enzyme.  Febrile at 101.3F on admission, O2 2L after desat to 83. Plan to be started on doxycycline, dexamethasone along with albuterol as needed and supplemental oxygen therapy as needed for the COVID infection. CHF to be treated with Lasix 40 mg IV daily along with cardiac monitoring with telemetry and echocardiogram.  Supplemental oxygen, wean as tolerated. -Albuterol PRN, no duonebs or aerosolizing procedures. -Remdesivir- not a candidate, no PNA -Dexamethasone 6mg 10d. - Empiric abx with Doxy -Covid labs per protocol -Home oxygen evaluation possible prior to DC.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, QRS axis abnormal, SARS-CoV-2 test positive
Clinical narrative: 7/23/2022 Presented with complaints of weakness. Symptoms began possibly 2 days ago. Hospitalized with concerns of COVID infection without evidence of pneumonia. History of CHF with concerns of mild acute exacerbation, also elevated cardiac enzyme.  Febrile at 101.3F on admission, O2 2L after desat to 83. Plan to be started on doxycycline, dexamethasone along with albuterol as needed and supplemental oxygen therapy as needed for the COVID infection. CHF to be treated with Lasix 40 mg IV daily along with cardiac monitoring with telemetry and echocardiogram.  Supplemental oxygen, wean as tolerated. -Albuterol PRN, no duonebs or aerosolizing procedures. -Remdesivir- not a candidate, no PNA -Dexamethasone 6mg 10d. - Empiric abx with Doxy -Covid labs per protocol -Home oxygen evaluation possible prior to DC.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with expired beyond-use-date. Vaccine administered to the patient 7 days past beyond-use-date. No adverse events reported.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, Fatigue, Hyperhidrosis, Hypothyroidism, Injected limb mobility decreased
Clinical narrative: On 5-13-2022, I noticed fatigue, muscle aches all over, feelings of fever but did not check temp, sweating and right arm soreness to the point that I was having problems lifting it. I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. This was almost an identical reaction to dose 3. Two months after vaccination, I still noticed edema to my ankles and hands along with weight gain and this was unusual for me so I made an appointment for 7-13-2022, and I went to my primary care doctor's office and seen the physicians assistant. She ordered quite a few labwork tests. She stated everything was normal except my TSH thyroid panel which showed clinical hypothyroidism. She wants me to return in September to re-evaluate thyroid blood levels. I do still have edema in my ankles and hands and some fatigue as well.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Laboratory test normal, Mobility decreased, Myalgia, Oedema peripheral
Clinical narrative: On 5-13-2022, I noticed fatigue, muscle aches all over, feelings of fever but did not check temp, sweating and right arm soreness to the point that I was having problems lifting it. I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. This was almost an identical reaction to dose 3. Two months after vaccination, I still noticed edema to my ankles and hands along with weight gain and this was unusual for me so I made an appointment for 7-13-2022, and I went to my primary care doctor's office and seen the physicians assistant. She ordered quite a few labwork tests. She stated everything was normal except my TSH thyroid panel which showed clinical hypothyroidism. She wants me to return in September to re-evaluate thyroid blood levels. I do still have edema in my ankles and hands and some fatigue as well.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Thyroxine, Tri-iodothyronine
Clinical narrative: On 5-13-2022, I noticed fatigue, muscle aches all over, feelings of fever but did not check temp, sweating and right arm soreness to the point that I was having problems lifting it. I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. This was almost an identical reaction to dose 3. Two months after vaccination, I still noticed edema to my ankles and hands along with weight gain and this was unusual for me so I made an appointment for 7-13-2022, and I went to my primary care doctor's office and seen the physicians assistant. She ordered quite a few labwork tests. She stated everything was normal except my TSH thyroid panel which showed clinical hypothyroidism. She wants me to return in September to re-evaluate thyroid blood levels. I do still have edema in my ankles and hands and some fatigue as well.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: On 5-13-2022, I noticed fatigue, muscle aches all over, feelings of fever but did not check temp, sweating and right arm soreness to the point that I was having problems lifting it. I stayed in bed for 3 days. On day 4,  i noticed swelling to my ankles and hands but I started feeling a little better and was able to get out of the bed and move to a different room. This was almost an identical reaction to dose 3. Two months after vaccination, I still noticed edema to my ankles and hands along with weight gain and this was unusual for me so I made an appointment for 7-13-2022, and I went to my primary care doctor's office and seen the physicians assistant. She ordered quite a few labwork tests. She stated everything was normal except my TSH thyroid panel which showed clinical hypothyroidism. She wants me to return in September to re-evaluate thyroid blood levels. I do still have edema in my ankles and hands and some fatigue as well.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Dizziness, Headache
Clinical narrative: Felt lightheaded, severe headache
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product use issue
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects.
Age: 42.0
Sex: F
Vaccine: SMALLMNK
Symptoms: Feeling hot, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: Patient received vaccine at 1031. At approx 1037 she reported mild tongue numbness. She denied SOB or chest tightness. At 1041 she also developed facial numbness/warmth and continued to deny respiratory distress. Vitals at 1044 were HR 102, RR 18, BP 151/97, O2 97%. By 1102 she reported improvement of symptoms. Vitals at this time were HR 89, RR 18, BP 137/97, O2 97%. We continued monitoring patient for 1 full hour at which point she reported complete resolution of symptoms. No medication intervention was necessary.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pharmacist unknowingly pulled vaccine from package with a past beyond use date. Vaccine was administered to the patient 7 days past beyond use date. No reported adverse effects
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Trigeminal neuralgia
Clinical narrative: Acute onset of Trigeminal Neuralgia on right side of face within 30 minutes of receiving vaccine. Pain did not subside after five days and went to emergency room the morning of 8/12/22. Given a shot of Toradol, a six-day cycle of methylprednisolone, Gabapentin 300mg up to three times a day, ibuprofen 800mg around the clock, and a prescription for Norco. Following up with general practitioner on 8/15/22.
Age: 6.0
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at the injection site
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE; HCP calling to report administration of expired MMR II vaccine.  Caller asking if re-vaccination is necessary. No additional AEs/no PQCs reported.; This spontaneous report as received from a medical assistant referring to a 12 month old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.      On 22-JUL-2022, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered) lot # U018893, Expiration Date: 02-JUN-2022, 0.5 milliliter , first dose, for prophylaxis.   Expiration date reported as 02-JUN-2022, but upon internal validation was confirmed as 16-JUN-2023, conflicting information, vaccine probably not expired.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No additional AE; patient that received their 3rd dose of GARDASIL 9 today 28JUL2022. Dose was given 4 months late.; This spontaneous report was received from a medical assistant and refers to a 28-year-old, non-pregnant female patient. Her concomitant medications, pertinent medical history, concurrent conditions, drug reactions or allergies were not reported.  On 28-JUL-2022, the patient was vaccinated with 3rd dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered (dose, lot #, expiry date, and route of administration were not provided) for prophylaxis, which was reported to be administered as 4 months late (Inappropriate schedule of product administration). No additional adverse event was provided. administered on 28-JUL-2022 in the right arm. No other vaccines were administered on the same day or within 4 weeks. The patient did not have an illness on the day of vaccination.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; ROTATEQ was inadvertently administered to a patient after being improperly stored during a supported excursion; This spontaneous report was received from a medical assistant regarding to a patient of unspecified age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in August 2022 (reported as "within past 4 days"), the patient was inadvertently vaccinated with an improper storage dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), lot #W004503, expiration date 15-MAY-2023, taken orally (strength and dosage regimen were not provided) as prophylaxis (Product storage error).  The improper storage vaccine underwent a temperature excursion of 34 degrees Fahrenheit (F) for 19 hours and 15 minutes without previous excursions. No adverse events were reported.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: HCP called for temperature stability evaluation of vaccines and reported that 10 pediatric patients received PROQUAD vaccine since excursion date on 7/14/2022.; This spontaneous report was received from a medical assistant referring to a 5-year-old female patient. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies was not provided.   On 14-JUL-2022, the administered dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant Human albumin, rHA) (PROQUAD)  lot number: W002781, expiration date 27-JUL-2023, experienced a temperature excursion.   On an unknown date in 2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin, rHA) (PROQUAD), dose of 0.5 mL, lot number: W002781, expiration date 24-JUL-2023 (dose number, route of administration and anatomical location were not reported) for prophylaxis (product storage error).  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2208USA003812: US-009507513-2208USA003988: US-009507513-2208USA004011: US-009507513-2208USA004012: US-009507513-2208USA004255: US-009507513-2208USA004086: US-009507513-2208USA004105: US-009507513-2208USA004223: US-009507513-2208USA004255:
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Pain, Vaccine positive rechallenge
Clinical narrative: Shots are painful; This case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of pain (for tolerance of 1st dose refer linked case US2022AMR117903).   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 pain. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the pain was recovered/resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     Linked case(s) involving the same patient:  US2022AMR117903   Additional Information: GSK Receipt Date: 29-JUL-2022 Reporter's Comments: This case was reported by the patient via interactive digital media. The patient reported that shots were painful but it was a few seconds.  After patient had no soreness. Follow up would not be possible as no contact details available; Sender's Comments:  US-GSK-US2022AMR117903:Same reporter.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Rotarix reconstituted with sterile water/diluent; Rotarix reconstituted with sterile water/diluent; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 35T34, expiry date 18th February 2024) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 27th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 27th July 2022, 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 Information: GSK receipt date: 05-Aug-2022 Reporter comment: Licensed practical nurse reported that a patient received a Rotarix. The Rotarix was reconstituted with sterile water instead of using diluent. The GlaxoSmithKline vaccine representative filled an adverse event effect for Rotarix with limited information. The representative stated that a nurse from one of her accounts reported that a patient was given a dose of Rotarix with a sterile diluent used versus the accompanying GlaxoSmithKline diluent. The representative had no further information regarding the event, patient, or vaccine. The reporter consented to follow up with HCP. Additional Supportive Information: Rotarix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The case US2022115896 was identified as duplicate of US2022115894. The case US2022115896 would be voided, and all the future correspondence would be added in this case US2022115896 which stands as a case of record for this patient.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Pain, Pain of skin, Rash
Clinical narrative: blisters have dried; blisters have dried; rash on left side of med-section; first dose and second dose, developed shingles; shingles; skin became painful to the touch; pain/pain is much better but not completely gone; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female 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 (she had a case of shingles on 28th December 2018 on her left face and neck area).   On 14th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2022, 860 days after receiving Shingrix and 924 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin tenderness and pain. On 29th July 2022, the patient experienced rash. On an unknown date, the patient experienced scab and blister. The patient was treated with gabapentin and antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the vaccination failure, shingles, skin tenderness and rash were unknown and the outcome of the scab, blister and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, scab, blister, skin tenderness, pain and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's comments: The reporter was the patient herself who reported that she had received her Shingrix in the left arm. The patient developed shingles on her left mid-side on 22nd July 2022. On 22nd July 2022, her skin had became painful to the touch. On 29th July 2022 she had developed the rash on the left side of her med-section. She had a video conference on 30th July 2022 with an urgent care Medicine of Doctorate (MD). The MD had started her on an anti-viral for 7 days. The patient had then spoken to her regular MD on 5th August 2022 and was given gabapentin for the pain. The blisters had dried and the pain was much better but not had completely gone. The Healthcare Professional (HCP) did not consented to follow-up, however the patient was fine to be contacted to her. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Scab, Vaccination failure
Clinical narrative: blisters have dried; blisters have dried; rash on left side of med-section; first dose and second dose, developed shingles; shingles; skin became painful to the touch; pain/pain is much better but not completely gone; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 68-year-old female 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 (she had a case of shingles on 28th December 2018 on her left face and neck area).   On 14th March 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 10th January 2020, the patient received the 1st dose of Shingrix (intramuscular). On 22nd July 2022, 860 days after receiving Shingrix and 924 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, skin tenderness and pain. On 29th July 2022, the patient experienced rash. On an unknown date, the patient experienced scab and blister. The patient was treated with gabapentin and antivirals nos (Anti-Viral Medicine (Nos)). On an unknown date, the outcome of the vaccination failure, shingles, skin tenderness and rash were unknown and the outcome of the scab, blister and pain were recovering/resolving.   It was unknown if the reporter considered the vaccination failure, shingles, scab, blister, skin tenderness, pain and rash to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's comments: The reporter was the patient herself who reported that she had received her Shingrix in the left arm. The patient developed shingles on her left mid-side on 22nd July 2022. On 22nd July 2022, her skin had became painful to the touch. On 29th July 2022 she had developed the rash on the left side of her med-section. She had a video conference on 30th July 2022 with an urgent care Medicine of Doctorate (MD). The MD had started her on an anti-viral for 7 days. The patient had then spoken to her regular MD on 5th August 2022 and was given gabapentin for the pain. The blisters had dried and the pain was much better but not had completely gone. The Healthcare Professional (HCP) did not consented to follow-up, however the patient was fine to be contacted to her. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: soreness at injection site; Fatigue; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In 2018, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and fatigue. On an unknown date, the outcome of the injection site pain and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site pain and fatigue to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR116707   Additional Information: GSK Receipt Date: 08-AUG-2022. Reporter's Comments: The patient received 1st doses of Shingrix in 2018.  The reporter stated that the patient experiencing soreness at injection site and fatigue after 1st dose. Did not consent to follow-up. For tolerance of 2nd dose refer case US2022AMR116707.; Sender's Comments:  US-GSK-US2022AMR116707:Same report
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shinrgix 1st dose on 2021, didn't received 2nd; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 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.       Linked case(s) involving the same patient:  US2022116412   Additional Information: GSK receipt date:08-AUG-2022 Reporters comment: The patient received only one dose of shingrix on 2021 and did not received 2nd dose  The reporter given consent to follow-up. Additional Supportive information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. This case was linked with case US2022116412, reported by same reporter.; Sender's Comments:  US-GSK-US2022116412:Same repoter
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash papular
Clinical narrative: Itchiness in area; 4-5 Bumps lighter red in left arm; Redish area below injection site/bumps which are a lighter red; This case was reported by a consumer via call center representative and described the occurrence of pruritus in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 5th August 2022, the patient received Shingrix. On 8th August 2022, 3 days after receiving Shingrix, the patient experienced pruritus, papular rash and erythema. On an unknown date, the outcome of the pruritus, papular rash and erythema were not recovered/not resolved.   It was unknown if the reporter considered the pruritus, papular rash and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comment: The case was reported by the patient. The patient received a Shingrix vaccine on Friday.  On the day of reporting, he noticed that his left arm had a reddish area of 3 inches by 2 inches below the injections site and within this area, there were 4 to 5 bumps which were a lighter red.  The reporter also stated that he had itchiness in this area.  The reporter consented to follow up. Patient gave consent to follow up with health care professional.
Age: 32.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: received Havrix expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 32-year-old female patient who received HAV (Havrix) (batch number KM72C, expiry date 18th June 2022) for prophylaxis.   On 6th August 2022, the patient received Havrix. On 6th August 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-AUG-2022 Reporter's Comments: The patient received Havrix expired dose. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix expired dose which led to expired vaccine used.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: HCP did not reconstitute the vaccine; patient was only administered the liquid portion; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA713A, expiry date 30th June 2023) for prophylaxis.   On 8th August 2022, the patient received Menveo. On 8th August 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comment:  The nurse reported that she administered a dose of Menveo to patient, but she did not reconstitute the vaccine, so the patient was only administered the liquid conjugate portion.  At the time of reporting, dose had not been repeated.  The reporter consented to follow up. Additional Supportive Information: The reporter reported that a patient received liquid conjugate portion of Menveo without reconstitution, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with saline solution; reconstituted with saline solution; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number Y44ZT, expiry date 10th July 2023) for prophylaxis.   On 8th August 2022, the patient received the 1st dose of Shingrix. On 8th August 2022, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 09-Aug-2022 Reporter's Comments: The patient received Shingrix and the lyophilized portion was reconstituted incorrectly with Saline solution instead of the accompanying adjuvant. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The Shingrix lyophilized portion was reconstituted incorrectly with saline solution instead of the accompanying adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on Aug2019, not yet received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comments: The reporter was the patient.  The patient received first dose of Shingrix in August of 2019 and till the time of reporting he not yet received the second dose. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 30.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Patient received a dose of Twinrix that had expired; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 30-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 9th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 9th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's Comments: The radiology technician reported that a patient received a dose of Twinrix that had expired on 7th August 2022, which led to expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age, Vaccination error, Wrong product administered
Clinical narrative: given in error a KINRIX vaccine; error a KINRIX vaccine she was a 41 year old female; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 41-year-old female patient who received DTPa-IPV (Kinrix) (batch number 5R3KX, expiry date 26th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered 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 Information: GSK Receipt Date: 09-AUG-2022. Reporter's Comments: The reporter stated that the patient in their care was given in error a Kinrix vaccine. She was a 41-year-old and was to get a TDAP. The reporter gave consent to follow up. Additional supportive Information: The 41-year-old patient received in error a Kinrix vaccine instead of TDAP, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 1 month old was given Havrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 1-month-old male patient who received HAV (Havrix) (batch number 4cy9h, expiry date 28th April 2023) for prophylaxis.   On 1st July 2022, the patient received the 1st dose of Havrix (intramuscular) .5 ml. On 1st July 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 09-AUG-2022 Reporter's comments: The reporter was a physician stating that a 1 month old was given Havrix. The patient was not having any side effects from the vaccine. The reporter did not consent to follow-up to the Healthcare Professional (HCP). Additional supportive information: The patient was 1 month old while he had received Havrix vaccine which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: DTAPIPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Younger than 4 yo was administrated Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) (batch number 2kl4k, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, 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 Information: GSK Receipt Date: 10-AUG-2022 Reporter's Comments: The medical assistance reported on 10th August 2022 that the patient younger than 4 years old was administrated with Kinrix.  No adverse event was reported. No patient's identifiers provided. No vaccination date provided. The reporter consented to follow up. Additional Supportive Information: The patient younger than 4 years old was administrated with Kinrix which led to inappropriate age at vaccine administration.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero was administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB39AA, expiry date 30th January 2006) 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 1st August 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 1st August 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 Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The health care professional reported that expired dose of Bexsero was administered to a patient. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Age: 45.0
Sex: M
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: Received a 3 days expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 45-year-old male patient who received HAB (Twinrix) (batch number X239D, expiry date 7th August 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th August 2022, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 10th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-Aug-2022 Reporter's comment: The medical assistant reported that a patient received a three days expired dose of Twinrix vaccine on the day of reporting. The reporter consented to follow-up. Additional supportive information: The patient received an expired dose of Twinrix, which led to expired vaccine used.