chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Electrocardiogram normal, Feeling abnormal, Ultrasound breast normal
Clinical narrative: heart pain; shingles; pain; pain went from back to left breast; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 1st August 2019, the patient experienced cardiac pain (serious criteria GSK medically significant), shingles, back pain and breast pain. On 24th July 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the cardiac pain, shingles, back pain and breast pain were not recovered/not resolved.   It was unknown if the reporter considered the cardiac pain, shingles, back pain, breast pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient reported that the pain went from her back to her left breast.   The patient planned to continue follow up with her physician on an unknown date. The patient required emergency room visit due to these events. The patient consented to follow up. There was a discrepancy in the reported outcomes of the events cardiac pain, shingles, back pain and breast pain. In XML, outcome was mentioned as recovering/resolving and in the database, it was autoloaded as recovered/resolved. However outcome of all these events is captured as autoloaded in database.
Age: 69.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Angina pectoris, Back pain, Breast pain, Herpes zoster, Influenza like illness
Clinical narrative: heart pain; shingles; pain; pain went from back to left breast; flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of cardiac pain in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd July 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms. On 1st August 2019, the patient experienced cardiac pain (serious criteria GSK medically significant), shingles, back pain and breast pain. On 24th July 2019, the outcome of the influenza-like symptoms was recovered/resolved. On an unknown date, the outcome of the cardiac pain, shingles, back pain and breast pain were not recovered/not resolved.   It was unknown if the reporter considered the cardiac pain, shingles, back pain, breast pain and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient reported that the pain went from her back to her left breast.   The patient planned to continue follow up with her physician on an unknown date. The patient required emergency room visit due to these events. The patient consented to follow up. There was a discrepancy in the reported outcomes of the events cardiac pain, shingles, back pain and breast pain. In XML, outcome was mentioned as recovering/resolving and in the database, it was autoloaded as recovered/resolved. However outcome of all these events is captured as autoloaded in database.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Blood magnesium, Borrelia test, Chills, Condition aggravated, Culture urine
Clinical narrative: Patient received vaccines on 08/5/19. She felt sick ( flu like symptoms) on 8/7/19. She was admitted to the hospital.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Differential white blood cell count, Dizziness, Drug level, Eye irritation, Fatigue
Clinical narrative: Patient received vaccines on 08/5/19. She felt sick ( flu like symptoms) on 8/7/19. She was admitted to the hospital.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Fibrin D dimer, Full blood count, Heart rate increased, Liver function test, Metabolic function test
Clinical narrative: Patient received vaccines on 08/5/19. She felt sick ( flu like symptoms) on 8/7/19. She was admitted to the hospital.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Migraine, Pain, Polymerase chain reaction, Pyrexia, Respiratory viral panel
Clinical narrative: Patient received vaccines on 08/5/19. She felt sick ( flu like symptoms) on 8/7/19. She was admitted to the hospital.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Sepsis, Staphylococcus test, Urine analysis, Vaccination site cellulitis, Vaccination site infection
Clinical narrative: Patient received vaccines on 08/5/19. She felt sick ( flu like symptoms) on 8/7/19. She was admitted to the hospital.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient received vaccines on 08/5/19. She felt sick ( flu like symptoms) on 8/7/19. She was admitted to the hospital.
Age: 39.0
Sex: F
Vaccine: HEP, PPV, HEP, PPV
Symptoms: Infection, Influenza like illness, Malaise
Clinical narrative: Patient received vaccines on 08/5/19. She felt sick ( flu like symptoms) on 8/7/19. She was admitted to the hospital.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Bedridden, Cough, Dizziness, Dysphonia
Clinical narrative: Hoarseness  Cough Nasal congestion  Fever Hives on face Vomiting  Dizziness  Weakness
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Irritability, Lower respiratory tract congestion, Nasal congestion, Pyrexia, Urticaria
Clinical narrative: Hoarseness  Cough Nasal congestion  Fever Hives on face Vomiting  Dizziness  Weakness
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Hoarseness  Cough Nasal congestion  Fever Hives on face Vomiting  Dizziness  Weakness
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Contraindication to vaccination, Extra dose administered
Clinical narrative: Patient received a third dose in error and also was on immunocomprising therapy. The vaccine prescription was under our collaborative practice agreement, but since CDC/ACIP recommendations do not support giving shingrix to patients on immunocompromising therapy, this should not have been given under those circumstances. The combination of immunocompromising therapy and patient receiving a third dose I wanted to report in the event any adverse events do arise.
Sex: U
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect reported; inadvertently administered a second dose of PROQUAD; This spontaneous report was received from an office manager referring to an patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 17-JUN-2019, the patient was received measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, route, frequency, lot# and expire date were not reported) for prophylaxis. On 09-JUL-2019, the patient was inadvertently administered a second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(rHA)(PROQUAD) (lot#: R030801, expire date: 22-APR-2019, dose, route and frequency were not reported)(Extra dose administered), no adverse effect. The outcome of the event was unknown.
Sex: F
Vaccine: HEP, MMR, UNK
Symptoms: Hepatitis B antibody negative, Measles antibody negative
Clinical narrative: The patient had serologic testing on 05-16-2018 due to being a healtcare professional to check immunity and had no antibodies to measles or Hepatitis B; The patient had serologic testing on 05-16-2018 due to being a healtcare professional to check immunity and had no antibodies to measles or Hepatitis B; This spontaneous report was received from a nurse practicioner referring to a 44 year old female patient, who was a health care professional. The patient's concurrent conditions included hayfever and she saw a cardiologist for an unspecified reason.  The patient had no drug allergies. She was a tobacco user. The patient's medical history included coronary artery bypass graft (CABG) in 2009 secondary to a thrombosis. Concomitant therapies included lisinopril, metoprolol and aspirin.     On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and with unspecified hepatitis B vaccine (manufacturer unknown) (dose, frequency, route, lot/batch # and expiration date were not provided) for prophylaxis. The vaccine was reconstituted with Merck's sterile diluent (lot number and expiration date were unknown). The reporter stated that on 16-MAY-2018,due to being a healthcare professional, the patient had a serologic testing to check for immunity and had no antibodies to measles or hepatitis B (measles antibody negative and hepatitis b antibody negative). The outcome of measles antibody negative and hepatitis b antibody negative was reported as not resolved.        The causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: treated for shingles; Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-OCT-2015, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot number, dosage and route of administration not provided) at a pharmacy, for the long term prevention of shingles and zoster related conditions. Subsequently, the patient was treated in a hospital, since he experienced shingles on unspecified date. As a direct and proximate result of the patient's use of zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not provided and the causality of the events was related.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Herpes zoster, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: SHINGLES; This spontaneous report was received from a pharmacist and refers to a 35-year-old female non-pregnant patient. She had no pertinent medical history and drug reactions or allergies. Concomitant therapies were not provided.  On 17-JUL-2019, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) injection, subcutaneously in arm (lot # R035226 and expiry date 04-DEC-2020; exact dose was not reported) for vaccination. The vaccine was reconstituted with sterile diluent. After receiving varicella virus vaccine live (Oka/Merck) (VARIVAX), the patient was given an unspecified "allergy shot" in different arm. On an unknown date in July 2019, she developed rash at the injection site, described as reddened area with small bumps. There was no itching but a small amount of pain while touching. On an unknown date in July 2019, the patient was examined by her physician and diagnosed with shingles. At the time of this report, she was treated with valacyclovir hydrochloride (VALTREX) (also described as antiviral therapy). The pharmacist stated that the rash was healed in 90 %. No laboratory diagnostics were performed. The outcome of the event of shingles was reported as not recovered.  The causality assessment was not provided.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; on 7/22/2019 a patient was administered improperly stored RECOMBINAX HB; This spontaneous report ws received from a registered nurse refering to a patient of unknown age and gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 22-JUL-2019,the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant)(RECOMBIVAX HB) lot # R001529 and expiration date 07-NOV-2020 (strength, dose, frequency and route of administration were not reported) for prophylaxis. No adverse event was reported. The temperature excursion was reported as above 47 degrees Fahrenheit / 9 degrees centigrades (mainly 9.9 degrees centigrades) during a time frame of 1 hour and 50 minutes. No previous temperature excursion was reported. No digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1908USA004312: US-009507513-1908USA001033:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Post-Herpetic Neuralgia; Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 65-year-old female patient (pt). The pt's concurrent conditions, medical history and concomitant medications were not reported.  On or about 11-AUG-2014, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, dose#, lot#, expiration date and route of administration were not provided) by a pharmacist in a pharmacy for the long-term prevention of shingles and zoster-related conditions. The pt was treated by the physician for herpes zoster and post-herpetic neuralgia from an unknown date, which resulted from pt's zoster vaccine live (ZOSTAVAX) use.   The outcome of herpes zoster and post-herpetic neuralgia was not reported. The events were considered to be related to zoster vaccine live (ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Tinnitus
Clinical narrative: tinnitus; herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 73 years old female patient (pt). There was no information about the pt's concurrent conditions, concomitant therapies or medical history provided.  On an unspecified date in 2017, the pt was vaccinated with a dose of zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, lot number and expiration date were not reported) as prescribed and/or administered by a healthcare provider, for the long-term prevention of shingles and herpes Zoster related conditions. On an unknown date, subsequent to the zoster vaccine live (ZOSTAVAX) inoculation, the pt experienced shingles (herpes zoster) and tinnitus. The pt was treated by a healthcare due to the events. It was reported that the pt would continue suffer ongoing injuries, losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the herpes zoster and tinnitus were not reported.   The reporter considered the herpes zoster and tinnitus to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; may have been stored improperly; This spontaneous report was received from a licensed practical nurse concerning to a patient of unknown age and gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 01-AUG-2019, the patients were vaccinated with improperly stored doses of varicella virus vaccine live (Oka/Merck) (VARIVAX) lot number R012638 with expiration date on 20-JUN-2020 and measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rha) lot number N024693 with expiration date on 08-SEP-2019. Dosage schedule, route and anatomical location were not reported for non of the vaccines, all of them were reconstituted with a properly stored sterile diluent and administered for prophylaxis.  Administered doses of vaccine had previously experienced no temperature excursion. The temperature of excursion was unknown as the vaccines were for 18 hours in a freezer that did not have a data logger. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects; One expired dose of MMR II was administered to patient on 8/9/2019.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not reported.       On 09-AUG-2019, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (expired product administered) lot # N020926 has been verified to be a valid lot number for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live expiration date reported and establish as 01-AUG-2019, for prophylaxis (strength, dose, frequency and route of administration were not reported).   No adverse effects reported.
Age: 0.75
Sex: M
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects were reported by the nurse; one dose of Recombivax HB was administered to one unspecified patient; This spontaneous report was received from a nurse, referring to a 9 month old male patient. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug allergies or reactions were not reported.     On 06-AUG-2019, the patient was vaccinated with an expired dose hepatitis b vaccine (recombinant)(RECOMBIVAX HB) for prophylaxis (strength, dose, frequency, route of administration, anatomical location of injection, lot # and expiration date were unknown) (expired drug administered). No adverse effects were reported by the nurse.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: No adverse effects reported; Pharmacist reports one dose of MMR II - was administered to patient - via the intramuscular rather than the subcutaneous route; Information has been received from a registered pharmacist reporting on a patient of unknown age and gender. There was no information regarding the patient's concomitant medication, pertinent medical history, drug reactions or allergies.  On 08-AUG-2019, the patient received an unspecified dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant Human albumin (rHA) (M-M-R II) for prophylaxis, lot # R031681, expiration date 01-NOV-2020 which was administered via intramuscular instead of subcutaneously. No adverse effects were reported.
Sex: F
Vaccine: UNK, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Urgent Care and was diagnosed with chickenpox; Information  has been received from a physician via a company representative reporting on a female married patient in her fifties. The patient's pertinent medical history included thyroid cancer. The patient's concomitant medication and drug reactions/ allergies were unknown by the reporter. The patient reported that her husband developed shingles. The patient never had had chicken pox or had an unknown varicella vaccination history.  On an unspecified date in August 2019 (reported as "in last 10 days"), the patient received an unspecified dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) subcutaneous for prophylaxis (lot number and expiration date were not reported) which was diluted with sterile diluent.  On an unspecified day recently (also reported as on "12-AUG-2019"), the patient reported to Urgent Care and was diagnosed with chickenpox. It was unknown if lab diagnostics/studies were performed. The patient was prescribed valacyclovir hydrochloride (VALTREX) and at the time of the report was doing fine (recovering).  The causal relationship between the event varicella and therapy with varicella virus vaccine live (Oka/Merck) (VARIVAX) or sterile diluent was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; patient was administered a expired dose; This spontaneous report was received from a medical assistant referring to a 30-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant medications were not provided.  On 09-AUG-2019, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (strength, dose, route, frequency, indication were not provided). Lot No. N017395 has been verified to be a valid lot number for [varicella virus vaccine live (oka/merck)], expiration date reported as 07-JUN-2019, and upon internal validation established as the same. The patient was administered an expired dose of properly stored varicella virus vaccine live (oka/merck) (VARIVAX). The vaccine was reconstituted with properly stored sterile diluent (lot # R001089 and with an expiration 18-SEP-2020). No adverse effects reported.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: no adverse effect were reported in the patient; 16 years old patient inadverently administerd adult dose of vaqta; This spontaneous report was received from a pharmacist refers to a 16 year old patient. Information on pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 12-AUG-2019, the patient was inadvertently vaccinated with an adult dose of hepatitis a vaccine, inactivated(VAQTA) 50/1.0 U/ml (lot # S012250, expiry date:07-JUL-2020, anatomical location and route were not reported) for prophylaxis (incorrect dose administered). No adverse effects were reported in the patient (No adverse event). No PQC was involved.
Sex: U
Vaccine: HEP
Symptoms: Therapy non-responder
Clinical narrative: No Immunity; Initial Report Received 08-Aug-2019  A hepatitis C Program Lead reported that an female patient (age: in the 60s) was administered 2 doses of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and had "no immunity".   Relevant medical history and concomitant medications were not provided.   On unknown dates, the patient was administered with two doses of HEPLISAV-B (lot #, expiration date, and NDC # unknown). It was unknown if the vaccine was administered from a vial or prefilled syringe.   On 08-Aug-2019, the hepatitis C Program Lead reported that she had a patient who received two doses of HEPLSIAV-B.  A titer drawn after a month showed no immunity. No further information was provided.     At the time of the report, no adverse events were reported.   The reporter did not provide a serious assessment for the event.   Company comment: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.; Sender's Comments: The company assessed the event of therapy non-responder as non-serious. The event of therapy non-responder is listed per HEPLISAV-B USPI.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pain; redness; swelling at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a elderly patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were received as follows: The patient was not a healthcare professional. The age vaccination was not reported. The age group was not reported but was selected as an adult per the vaccine indication. The patient asked about how long and how large of an area are Pain, redness, and swelling at the injection site after vaccination.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Febrile convulsion
Clinical narrative: febrile seizure; This case was reported by a nurse via call center representative and described the occurrence of febrile seizure in a 4-year-old female patient who received DTPa (Infanrix) (batch number AC14B119CA ?, expiry date unknown) for prophylaxis.   On 18th January 2011, the patient received Infanrix. In January 2011, less than a week after receiving Infanrix, the patient experienced febrile seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the febrile seizure was unknown.   It was unknown if the reporter considered the febrile seizure to be related to Infanrix.  Additional details were provided as follows: Within seven days of receiving Infanrixin 2011, the patient had significant febrile seizures. The reporter did not consent to follow-up. The reported batch number AC14B119CA was not available in sales data base, however it was captured as AC14B119CA ?
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Injection site redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was recovered/resolved.   It was unknown if the reporter considered the injection site erythema to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced redness at the injection site. The patient consented to follow up. This case has been linked with case US2019142240, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: Injection site pain; This case was reported by a physician via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was recovered/resolved.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The reporter stated that, the unspecified number of patient after receiving vaccine experienced pain at the injection site. The reporter did not have patient specifics, the patients were just generally reporting adverse events. This case has been linked with case US2019142242, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Cerebral disorder, Muscle twitching
Clinical narrative: twitch / Lip twitch; Bain zap; This case was reported by a consumer via call center representative and described the occurrence of twitching facial in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included anti-depressant medication (patient claims that she has had a history of brain zaps from stopping anti-depressant medications in the past).   On 2nd August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd August 2019, less than a day after receiving Shingrix, the patient experienced twitching facial. In August 2019, the patient experienced brain disorder nos. On an unknown date, the outcome of the twitching facial was recovering/resolving and the outcome of the brain disorder nos was recovered/resolved.   It was unknown if the reporter considered the twitching facial and brain disorder nos to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in left arm The patient reported that after receiving the Shingrix vaccine, she experienced a lip twitch on her lower lip on the left side that started the night of vaccination and was still unresolved.  Less than a week after vaccination the patient also reported brain zaps.  The patient claimed that she had a history of brain zaps from stopping anti-depressant medications in the past so she was familiar with the feeling.  The patient claimed that the brain zaps remained for a couple of nights and then subsided.  The patient did not provide any specific names of her previous anti-depressant medications. The reporter gave permission to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pustular
Clinical narrative: Rash on arm side and leg; pustular rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 7457P, expiry date 2nd October 2021) for prophylaxis.   On 17th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 weeks after receiving Shingrix, the patient experienced rash and pustular rash. On an unknown date, the outcome of the rash and pustular rash were unknown.   It was unknown if the reporter considered the rash and pustular rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix and developed on the same side of the vaccine, on her arm, side and leg, rash and some part of the rash was pustular.
Sex: F
Vaccine: HEP
Symptoms: Syncope
Clinical narrative: Fainting; This case was reported by a pharmacist via call center representative and described the occurrence of fainting in a female patient who received HBV (Engerix B) for prophylaxis.   The patient's past medical history included fainting (when receiving injection).   On an unknown date, the patient received the 1st dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced fainting (serious criteria GSK medically significant). On an unknown date, the outcome of the fainting was unknown.   It was unknown if the reporter considered the fainting to be related to Engerix B.  Additional details were reported as follows: The age at vaccination was not reported. The patient fainted after receiving dose of Engerix B. The reporter could not provide patient demographics, lot number, or expiration date of dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness
Clinical narrative: lost hearing; This case was reported by a pharmacist via call center representative and described the occurrence of hearing loss in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th August 2019, the patient received the 2nd dose of Shingrix. On 6th August 2019, less than a day after receiving Shingrix, the patient experienced hearing loss (serious criteria GSK medically significant). On an unknown date, the outcome of the hearing loss was unknown.   It was unknown if the reporter considered the hearing loss to be related to Shingrix.  Additional details were reported as follows: The immunizing pharmacist gave the 2nd dose of Shingrix to one of her customers last Tuesday before the reporting date and she said last Tuesday before the reporting date she lost hearing on the side where vaccine was given. The reporter wanted to know if this had been seen before filing adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Inappropriate schedule of vaccine; Flu like symptoms; This case was reported by a other health professional via call center representative and described the occurrence of influenza-like symptoms in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced influenza-like symptoms and drug dose administration interval too short. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved and the outcome of the drug dose administration interval too short was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The batch number and expiry date of Shingrix was not reported. The office manager reported that, 1st dose was administered in error, the medical assistant should have administered Prevnar. The patient received 2nd dose of Shingrix approximately 39 days after receiving 1st dose, which led to shortening of vaccination schedule. The reporter reported that, flu like symptoms, lasted for a week. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Hurt; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unknown number of adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was captured as adult as per vaccine indication. The pharmacist reported that some patients said they didn't want to get the second dose because the first one hurt. The reporter consented to follow up.  The reporter had no specific patient information or lot/expiry to provide.
Age: 67.0
Sex: M
Vaccine: HEP
Symptoms: Malaise
Clinical narrative: being sick; This case was reported by a pharmacist via call center representative and described the occurrence of sickness in a 67-year-old male patient who received HBV (Engerix B) for prophylaxis.   On 8th March 2019, the patient received the 1st dose of Engerix B. On an unknown date, less than 5 months after receiving Engerix B, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Engerix B.  Additional details were reported as follows: The patient was unable to return for the 2nd dose within the recommended time frame due to being sick for a long time. The second dose was administered on 5th August 2019, but caller was inquiring on how to proceed with the 3rd dose? After probing in reference to the sickness, caller stated that he did not have details about the patient's sickness.  The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Depressed level of consciousness, Dyskinesia, Dyspnoea, Lethargy
Clinical narrative: AFTER 20 MINUTE WAITING PERIOD CHILD WAS DISCHARGED FROM CLINIC.  SHORTLY AFTE CHILD PRESENTED TO THE EMERGENCY ROOM WITH SHORTNESS OF BREATH, LETHARGIC AT HOME AND HARD TO ARUSE BUT ON THE WAY TO ER MOM REPORTS VIGOROUS JERKING OF HIS ENTIRE BODY
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site oedema, Injection site pruritus
Clinical narrative: Pt presented to clinic on 8/8/19 with mother. Pt reported itching of right deltoid same day of vaccination. Mother gave patient Benadryl at home as well as ibuprofen and ice pack for pain. Pt exhibits edema (Right upper arm : 18cm up from olecranon process is  34 cm on right and 31 cm on left). Mother was advised to continue Benadryl as needed as well as cool compresses. Advised to contact office if no improvement.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Induration, Injection site pain, Injection site warmth
Clinical narrative: Baseball-sized induration with redness.  Painful at the site and warm to touch.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Muscular weakness, Pain in extremity
Clinical narrative: The first week the injection site was red, hot and painful.  Once the rash went away and a month later, I still experience pain and weakness in the left arm
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: The first week the injection site was red, hot and painful.  Once the rash went away and a month later, I still experience pain and weakness in the left arm
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Malaise, Pyrexia
Clinical narrative: Chills, mild fever, weak, general mailse
Age: 60.0
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The patient recieved a pediatric dose of Hepatitis A instead of receiving the correctly ordered state supplied Tetanus vaccine. There was no harm/adverse reaction at the time or following administration of the vaccine.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Peripheral swelling, Rash
Clinical narrative: sever blisters, rash , swelling in right arm between elbow and wrist
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Immunisation, No adverse event, Product preparation issue
Clinical narrative: Clinical team member administered the adjuvant only.  After realizing, she advised patient and then correctly mixed the shingrix with the adjuvant and administered the vaccine.  No immediate adverse symptoms.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Asthenia, Dizziness, Dysuria, Fatigue, Injected limb mobility decreased
Clinical narrative: Next dase experienced loss of mobility on left arm, fevers, loss of energy, and painful urination.   Called the doctor but the office was closed.   2 days ago painful urination resolved; cranberry juice helped.  Mobility in arm is back and pain around vaccine area reduced. Also, dizziness and fevers resolved. Energy is slowly coming back and fatigued easily.   Did not take any medication or tried any other treatment.   Recovery at 90%  Patient reports no problems after the first dose.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: Next dase experienced loss of mobility on left arm, fevers, loss of energy, and painful urination.   Called the doctor but the office was closed.   2 days ago painful urination resolved; cranberry juice helped.  Mobility in arm is back and pain around vaccine area reduced. Also, dizziness and fevers resolved. Energy is slowly coming back and fatigued easily.   Did not take any medication or tried any other treatment.   Recovery at 90%  Patient reports no problems after the first dose.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site rash, Pruritus, Skin warm, Urticaria
Clinical narrative: welts; redness/red spots; itchy; hot/welts" which were hot; Localized rashes at injection site; This case was reported by a nurse via call center representative and described the occurrence of welts in a 62-year-old female patient who received Herpes zoster (Shingrix) (batch number TT9BR, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 13th May 2019).   On 5th August 2019, the patient received the 2nd dose of Shingrix. On 6th August 2019, 1 days after receiving Shingrix, the patient experienced welts, erythema, pruritus, skin warm and injection site rash. The patient was treated with hydrocortisone and benadryl (nos) (Benadryl). On an unknown date, the outcome of the welts, erythema, pruritus, skin warm and injection site rash were unknown.   The reporter considered the welts, pruritus and injection site rash to be possibly related to Shingrix. It was unknown if the reporter considered the erythema and skin warm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left deltoid and experienced welts which were hot, itchy, and red spots. They were behind her knees, and also over her left thigh a day after the 2nd  dose of Shingrix.  The patient was instructed to use hydrocortisone and Benadryl for the symptoms. Two patients out of 10 Shingrix doses resulted the rash with same lot number, the clinic had 5 unused vaccines and had not heard back from 3 out of 10 Shingrix doses. The rash was found in the Product Information as a possible event from Shingrix. The reporter consented to follow up. This case has been linked with case US2019AMR143698, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes virus infection
Clinical narrative: herpes; This case was reported by a consumer via call center representative and described the occurrence of herpes virus infection in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   In June 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced herpes virus infection. On an unknown date, the outcome of the herpes virus infection was unknown.   It was unknown if the reporter considered the herpes virus infection to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had a vaccine 6 weeks ago from the time of reporting and developed herpes last week from the time of reporting. The patient want to know if having an outbreak had anything to do with the vaccine. The patient asked had anyone reported such event. The physician replied that it can lay dormant in the body for years. The patient want to know if the vaccine had anything to do with the outbreak.
Age: 16.0
Sex: F
Vaccine: HEP, MNQ
Symptoms: Myalgia, Panic attack, Paraesthesia oral
Clinical narrative: Visit at ~10am for vaccination, note from ED about visit at 12pm same day 8/8/2019. Reported myalgias, paresthesias around mouth, physician diagnosed panic attack. Discharged 3pm from ED.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Chest pain, Headache, Pain in extremity, Swelling
Clinical narrative: 1330 got immunization at clinic; 1500 began to have arm and chest pain, back pain, headache. Exam noted tenderness and swelling. Examined in ED. Discharged 1900 from ED.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Tenderness
Clinical narrative: 1330 got immunization at clinic; 1500 began to have arm and chest pain, back pain, headache. Exam noted tenderness and swelling. Examined in ED. Discharged 1900 from ED.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Cold sweat, Fall, Head injury, Malaise, Pallor
Clinical narrative: Patient was given her HPV and then went to the bathroom to give a urine. When in the bathroom a thud was heard by a co-worker. I knocked on the door and asked the patient if she was okay? The patient responded , yes. I then went to the lab to grab a pregnancy test. When I returned my co-worker said you may want to check on the patient, she stated that she was not feeling well. The patient was in room 204 with the trash can. Her skin color was pale, she had dry heaved, and her skin was cool and clammy. I took the patient's blood pressure which was 94/52. I gave her a cool wash cloth to put on the back of her neck and gave her some apple juice and peanut butter crackers. We were then able to transfer her to the bed where she laid down and put her feet up. We moved the wash cloth to her forehead. Dr. was notified. While Dr. was in the room I ran the pregnancy test. When I went back in to give results I heard the patient tell Dr. that she fell in the bathroom and hit her head. She has a nickel size lump on the right side of her head. I had the patient lay there for another 15 minutes until her color returned, her skin was no longer clammy and she stated she felt okay. She had eaten 3 crackers and drank a quater of her juice. She was given 400 mg of ibuprofen for complaints of a headache. Advised her to call with any visual disturbances, continued headache, or any change in her mental status.
Age: 17.0
Sex: F
Vaccine: HPV9
Symptoms: Retching, Swelling
Clinical narrative: Patient was given her HPV and then went to the bathroom to give a urine. When in the bathroom a thud was heard by a co-worker. I knocked on the door and asked the patient if she was okay? The patient responded , yes. I then went to the lab to grab a pregnancy test. When I returned my co-worker said you may want to check on the patient, she stated that she was not feeling well. The patient was in room 204 with the trash can. Her skin color was pale, she had dry heaved, and her skin was cool and clammy. I took the patient's blood pressure which was 94/52. I gave her a cool wash cloth to put on the back of her neck and gave her some apple juice and peanut butter crackers. We were then able to transfer her to the bed where she laid down and put her feet up. We moved the wash cloth to her forehead. Dr. was notified. While Dr. was in the room I ran the pregnancy test. When I went back in to give results I heard the patient tell Dr. that she fell in the bathroom and hit her head. She has a nickel size lump on the right side of her head. I had the patient lay there for another 15 minutes until her color returned, her skin was no longer clammy and she stated she felt okay. She had eaten 3 crackers and drank a quater of her juice. She was given 400 mg of ibuprofen for complaints of a headache. Advised her to call with any visual disturbances, continued headache, or any change in her mental status.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Hypoaesthesia, Injected limb mobility decreased, Pain, Pain in extremity
Clinical narrative: Patient reports that on day 1 her arm was difficult to move within 4 hours of injection. Had severe pain in her arm and was unable to get comfortable. Notes that she had mild numb sensation in a few of her fingertips but relieved by moving them. She took NSAID for patin and went to bed in the afternoon. Woke later in the evening with fever 100.2 and had fitfull night sleep due to arm pain. No headaches and fever did not last. Day 2-4 she was progressively more able to move her arm and the soreness began to lessen. Still having some dull pain with movement on day of report to pharmacy.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Poor quality sleep, Pyrexia
Clinical narrative: Patient reports that on day 1 her arm was difficult to move within 4 hours of injection. Had severe pain in her arm and was unable to get comfortable. Notes that she had mild numb sensation in a few of her fingertips but relieved by moving them. She took NSAID for patin and went to bed in the afternoon. Woke later in the evening with fever 100.2 and had fitfull night sleep due to arm pain. No headaches and fever did not last. Day 2-4 she was progressively more able to move her arm and the soreness began to lessen. Still having some dull pain with movement on day of report to pharmacy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dyspnoea, Feeling abnormal, Heart rate increased, Migraine
Clinical narrative: patient stated the next day she felt really bad, entire body hurt, splitting migraine, difficulty breathing, increased heart rate . But she said she didn't go to the emergency room or the doctor. she called the pharmacy on Monday 08/12/2019 at that point she said she was feeling much better. But she was not happy that it caused so much side effects and discomfort. She was not expecting so much body aches and pain.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: patient stated the next day she felt really bad, entire body hurt, splitting migraine, difficulty breathing, increased heart rate . But she said she didn't go to the emergency room or the doctor. she called the pharmacy on Monday 08/12/2019 at that point she said she was feeling much better. But she was not happy that it caused so much side effects and discomfort. She was not expecting so much body aches and pain.