chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Not an adverse event. Vaccine error report: Patient insisted to get Moderna booster 11/24/2021 because he received Moderna first and second dose. Per research, this was an error. However, we had a letter from his immunologist ordering the COVID-19 vaccine under immunization guidelines due to common variable immunodeficiency despite the patient's age of 16 at the time. To my recollection, neither vaccine is specifically authorized for under 18.  Patient administered Moderna 3/24/2021 and 4/22/2021 under the written order from the immunologist. Patient did not report any adverse reaction.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Cardiac stress test, Catheterisation cardiac normal, Chest pain, Computerised tomogram
Clinical narrative: Symptoms started week after first dose, high heart rate, shortness of breath. Feeling tired. Then after the second dose the symptoms got worse. Feeling faint, low blood pressure, shortness of breath could not walk up a flight of stairs, high heart rate. Started seeing a cardiologist and had a treadmill stress test and it was abnormal. My echo was abnormal.  Symptoms increased and was hospitalized on 7/29/21-7/31/21 for chest pain and elevated d dimer.  Was given heparin. Then discharged. Then readmitted on 8/1/21-8/3/21 and had heart catheterization done. The heart looked ok and now seeing neurologist because they believe the COVID vaccine antibodies caused POTS.  Currently seeing pulmonary specialist as well and have been off work on medical leave. I can not focus, fatigued, headache and over all feeling of not being well.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Dyspnoea, Dyspnoea exertional, Echocardiogram abnormal
Clinical narrative: Symptoms started week after first dose, high heart rate, shortness of breath. Feeling tired. Then after the second dose the symptoms got worse. Feeling faint, low blood pressure, shortness of breath could not walk up a flight of stairs, high heart rate. Started seeing a cardiologist and had a treadmill stress test and it was abnormal. My echo was abnormal.  Symptoms increased and was hospitalized on 7/29/21-7/31/21 for chest pain and elevated d dimer.  Was given heparin. Then discharged. Then readmitted on 8/1/21-8/3/21 and had heart catheterization done. The heart looked ok and now seeing neurologist because they believe the COVID vaccine antibodies caused POTS.  Currently seeing pulmonary specialist as well and have been off work on medical leave. I can not focus, fatigued, headache and over all feeling of not being well.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Exercise electrocardiogram abnormal, Fatigue, Fibrin D dimer increased, Headache
Clinical narrative: Symptoms started week after first dose, high heart rate, shortness of breath. Feeling tired. Then after the second dose the symptoms got worse. Feeling faint, low blood pressure, shortness of breath could not walk up a flight of stairs, high heart rate. Started seeing a cardiologist and had a treadmill stress test and it was abnormal. My echo was abnormal.  Symptoms increased and was hospitalized on 7/29/21-7/31/21 for chest pain and elevated d dimer.  Was given heparin. Then discharged. Then readmitted on 8/1/21-8/3/21 and had heart catheterization done. The heart looked ok and now seeing neurologist because they believe the COVID vaccine antibodies caused POTS.  Currently seeing pulmonary specialist as well and have been off work on medical leave. I can not focus, fatigued, headache and over all feeling of not being well.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Hypotension, Hysterectomy, Impaired work ability, Malaise
Clinical narrative: Symptoms started week after first dose, high heart rate, shortness of breath. Feeling tired. Then after the second dose the symptoms got worse. Feeling faint, low blood pressure, shortness of breath could not walk up a flight of stairs, high heart rate. Started seeing a cardiologist and had a treadmill stress test and it was abnormal. My echo was abnormal.  Symptoms increased and was hospitalized on 7/29/21-7/31/21 for chest pain and elevated d dimer.  Was given heparin. Then discharged. Then readmitted on 8/1/21-8/3/21 and had heart catheterization done. The heart looked ok and now seeing neurologist because they believe the COVID vaccine antibodies caused POTS.  Currently seeing pulmonary specialist as well and have been off work on medical leave. I can not focus, fatigued, headache and over all feeling of not being well.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Postural orthostatic tachycardia syndrome, X-ray
Clinical narrative: Symptoms started week after first dose, high heart rate, shortness of breath. Feeling tired. Then after the second dose the symptoms got worse. Feeling faint, low blood pressure, shortness of breath could not walk up a flight of stairs, high heart rate. Started seeing a cardiologist and had a treadmill stress test and it was abnormal. My echo was abnormal.  Symptoms increased and was hospitalized on 7/29/21-7/31/21 for chest pain and elevated d dimer.  Was given heparin. Then discharged. Then readmitted on 8/1/21-8/3/21 and had heart catheterization done. The heart looked ok and now seeing neurologist because they believe the COVID vaccine antibodies caused POTS.  Currently seeing pulmonary specialist as well and have been off work on medical leave. I can not focus, fatigued, headache and over all feeling of not being well.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Breast oedema, Chest pain, Ear swelling, Erythema
Clinical narrative: Left sided Lymphadenopathy of head, neck, maxillary, left shoulder and left arm  edema and pain, pain and swelling left shoulder, scapula, arm, hand, fingers 1st and 2nd let hand, numbness to left arm ,numbness to left hand, arm and fingers, chest pain, left ear swelling, redness,  edema to left sided chin, neck, breast, supraclavicular adenopathy  and submandibular.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Face oedema, Hypoaesthesia, Localised oedema, Lymphadenopathy, Musculoskeletal pain
Clinical narrative: Left sided Lymphadenopathy of head, neck, maxillary, left shoulder and left arm  edema and pain, pain and swelling left shoulder, scapula, arm, hand, fingers 1st and 2nd let hand, numbness to left arm ,numbness to left hand, arm and fingers, chest pain, left ear swelling, redness,  edema to left sided chin, neck, breast, supraclavicular adenopathy  and submandibular.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Oedema peripheral, Pain in extremity, Swelling
Clinical narrative: Left sided Lymphadenopathy of head, neck, maxillary, left shoulder and left arm  edema and pain, pain and swelling left shoulder, scapula, arm, hand, fingers 1st and 2nd let hand, numbness to left arm ,numbness to left hand, arm and fingers, chest pain, left ear swelling, redness,  edema to left sided chin, neck, breast, supraclavicular adenopathy  and submandibular.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone swelling, Breast swelling, COVID-19, Chest pain, Ear swelling
Clinical narrative: Left sided Lymphadenopathy of head, neck, maxillary, left shoulder and left arm  edema and pain, pain and swelling left shoulder, scapula, arm, hand, fingers 1st and 2nd let hand, numbness to left arm ,numbness to left hand, arm and fingers, chest pain, left ear swelling, redness,  edema to left sided chin, neck, breast, supraclavicular adenopathy  and submandibular.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Lymphadenopathy, Oedema peripheral, Pain, Pain in extremity
Clinical narrative: Left sided Lymphadenopathy of head, neck, maxillary, left shoulder and left arm  edema and pain, pain and swelling left shoulder, scapula, arm, hand, fingers 1st and 2nd let hand, numbness to left arm ,numbness to left hand, arm and fingers, chest pain, left ear swelling, redness,  edema to left sided chin, neck, breast, supraclavicular adenopathy  and submandibular.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Swelling, Vaccination failure
Clinical narrative: Left sided Lymphadenopathy of head, neck, maxillary, left shoulder and left arm  edema and pain, pain and swelling left shoulder, scapula, arm, hand, fingers 1st and 2nd let hand, numbness to left arm ,numbness to left hand, arm and fingers, chest pain, left ear swelling, redness,  edema to left sided chin, neck, breast, supraclavicular adenopathy  and submandibular.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Vaccine breakthrough infection
Clinical narrative: Breakthrough COVID-19 infection
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: I don't know the brand of covid vaccine.  Forced by this format to select, I chose Pfizer because that is what her other two vaccines were.   Patient told me they required her to get the booster because there had been a covid case at the facility.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystectomy, Condition aggravated, Inflammation, Pain, Pyrexia
Clinical narrative: During the first dose I only experienced pain in the arm from the pinch, in the second dose at dawn the next day fever, severe pain throughout the body, vomiting and daily for 4 days and from then on there is a lot of inflammation of the body and pain in the bones and in the 3rd dose fever, body aches and vomiting. An inflammatory picture was presented again, especially abdominal. I had a chronic inflammation of my organs that required surgery and removal of my gallbladder. I am still recovering and that 3rd dose was on October 7, 2021.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: During the first dose I only experienced pain in the arm from the pinch, in the second dose at dawn the next day fever, severe pain throughout the body, vomiting and daily for 4 days and from then on there is a lot of inflammation of the body and pain in the bones and in the 3rd dose fever, body aches and vomiting. An inflammatory picture was presented again, especially abdominal. I had a chronic inflammation of my organs that required surgery and removal of my gallbladder. I am still recovering and that 3rd dose was on October 7, 2021.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anion gap decreased, Blood glucose increased, Contusion, Dysarthria, Electrocardiogram abnormal
Clinical narrative: Immediately after vaccination I instantly had a headache that couldnt get rid of for 3-4 days. 9-10 days after receiving covid 19 vaccination I Developed blood clot in left leg located on left side of knee/thigh area. Started off painful then turned into severe bruising. Day 11 post vaccination I was rushed to ER for numbness on leg side of body. While waiting in ER I started having numbness in my head and slurred speech. Nurse noticed speech slurring when pushing me in wheelchair to do ultrasound on my leg. Ultrasound was postponed and stroke alert was alarmed. Ecg results came back abnormal, platelets high, glucose high, anion gap Low, electrolyte imbalance.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Electrolyte imbalance, Headache, Hypoaesthesia, Immediate post-injection reaction, Pain in extremity
Clinical narrative: Immediately after vaccination I instantly had a headache that couldnt get rid of for 3-4 days. 9-10 days after receiving covid 19 vaccination I Developed blood clot in left leg located on left side of knee/thigh area. Started off painful then turned into severe bruising. Day 11 post vaccination I was rushed to ER for numbness on leg side of body. While waiting in ER I started having numbness in my head and slurred speech. Nurse noticed speech slurring when pushing me in wheelchair to do ultrasound on my leg. Ultrasound was postponed and stroke alert was alarmed. Ecg results came back abnormal, platelets high, glucose high, anion gap Low, electrolyte imbalance.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Platelet count increased, Thrombosis
Clinical narrative: Immediately after vaccination I instantly had a headache that couldnt get rid of for 3-4 days. 9-10 days after receiving covid 19 vaccination I Developed blood clot in left leg located on left side of knee/thigh area. Started off painful then turned into severe bruising. Day 11 post vaccination I was rushed to ER for numbness on leg side of body. While waiting in ER I started having numbness in my head and slurred speech. Nurse noticed speech slurring when pushing me in wheelchair to do ultrasound on my leg. Ultrasound was postponed and stroke alert was alarmed. Ecg results came back abnormal, platelets high, glucose high, anion gap Low, electrolyte imbalance.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: This outcome happened around one to two weeks after I received the vaccination. The right side of my face went numb and I had no facial muscle control. It lasted less than a minute. I have decided to report this after my friend told me about a similar incident she read about.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram
Clinical narrative: Patient is a 14-year-old male who presented to Hospital ED with chest pain after having Covid vaccine yesterday (6/8/21). EKG shows no evidence Brugada, ACS, pericarditis, arrhythmia, ectopy, SVT. He was given IV fluid, Toradol and reassessed and he felt significantly improved and was chest pain-free at time of discharge.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness unilateral, Pain in extremity, Palpitations
Clinical narrative: Numbing pain left arm, sharp pain left foot, difficult hearing of left ear and palpitations.
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: the patient did not experience any other AE; the patient received PEDVAXHIB after it experienced a temperature excursion; This spontaneous report was received from a consumer, referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 19-NOV-2021, the patient was vaccinated with 1 dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # t037648, expiration date 20-JUL-2023; strength, dose and route were not provided) for prophylaxis after it experienced a temperature excursion (product storage error). The patient did not experience any other adverse event (AE).        The vaccines were exposed to temperature excursion of 8.5 degree Celsius for 30 minutes. There was no previous temperature excursion. The digital data logger was involved.  This is one of several report from the same reporter.; Sender's Comments:  US-009507513-2112USA008421: US-009507513-2112USA008367:02080039
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received first dose of GARD ASIL 9 in 2017 but has not received second dose until 2021; No additional AEs or PQC reported; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported.  On an unknown date in 2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route, lot# and expiration date were unknown) for prophylaxis.   The patient had not received second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, exact dose, route, lot# and expiration date were unknown) for prophylaxis until 2021 (inappropriate schedule of vaccine administered). No additional adverse events.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: feeling exhausted; This spontaneous report was received from a consumer via company representative referring to a male patient of unknown age. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On an unknown date, the patient was received the second dose of zoster vaccine live(ZOSTAVAX) (dose, route of administration, lot number and expiration date not reported) for prophylaxis.         On an unknown date, the patient experienced fatigue.      The outcome of fatigue as well as its causal relationship with the vaccine were not reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a 72-years-old female patient. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On or about 06-JUL-2017, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the prophylaxis.  In February 2019, subsequent to the patient vaccination, the patient was treated by a physician for the following injuries resulting from the zoster vaccine live (ZOSTAVAX) vaccination: shingles, including any and all of its sequelae. As a result of her receipt of the zoster vaccine live (ZOSTAVAX) vaccine, Plaintiff had severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages, other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the reporting time, the outcome of the event was unknown.  The reporter considered the events of shingles to be related to zoster vaccine live (ZOSTAVAX).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired vaccine used; This spontaneous report has been received from  a nurse regarding a patient of unknown age and gender.  The patient's concurrent conditions, medical history, and concomitant therapies were not reported.   On 18-JAN-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)  0.5 milliliter (Route of administration and frequency were not provided; lot # reported as: T001214, expiration date 12-JAN-2022).    It was reported that the vaccine did not experience any temperature excursions prior to administration. No additional information was provided. No additional adverse event (AE) was reported. No PQC reported. The outcome of the event was not reported.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccine was administered to a patient after undergoing a temperature excursion; No additional AE; This spontaneous report has been received from a nurse concerning to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On an unspecified date, the patient was vaccinated with Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (dose, dose number, route of administration and anatomical location was not provided) (lot#: U012705 and expiration date: 16-SEP-2023) as prophylaxis after undergoing a temperature excursion (product storage error). No additional adverse event's and no product quality complaints (PQC's) were reported.
Sex: M
Vaccine: HPV9
Symptoms: Feeling abnormal, Hypersomnia, Irritability, Product administered to patient of inappropriate age
Clinical narrative: Patient was fussy; patient slept a little more than usual; GARDASIL 9 was accidentally administered to an infant patient; This spontaneous report was received from a nurse from the physician's office referring to a 6 month old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were unknown by the reporter.      On 07-JAN-2022, the patient was accidentally vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, lot #, and expiration date were not reported) (product administered to patient of inappropriate age) as well as he received another vaccines.         On 07-JAN-2022, the patient was fussy and slept a little more than usual. The patient was no hospitalized.  The outcome of irritability and hypersomnia was unknown.     The causal relationship between the events and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) was not reported.
Age: 14.0
Sex: U
Vaccine: FLUN4
Symptoms: Product storage error
Clinical narrative: PATIENT ADMINISTERED VACCINE AFTER TEMPERATURE EXCURSION; A spontaneous report has been received from a health professional. The report concerns a patient of unknown gender of Unknown ethnic origin (age 13 years).    No medical history was reported.     No concomitant products were reported.    The patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number NH2013), via nasal route, on 09-DEC-2021.     No malfunction has been reported for FLUMIST QUADRIVALENT.    On 09-DEC-2021, the patient experienced patient administered vaccine after temperature excursion (preferred term: Product temperature excursion issue).     It is unknown if any action was taken with Flumist Quadrivalent (influenza vaccine live reassort 4v).     The outcome of the event was unknown.    The event was considered non-serious.     Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: Product Role: Suspect
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: one single bubble of a shingle; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received the first dose of Shingrix and was in the window of the second dose but noticed one single bubble of a shingle. The patient enquired if he/she could get the second dose of the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Swollen arm pit; This case was reported by a consumer via interactive digital media and described the occurrence of local swelling 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 local swelling. On an unknown date, the outcome of the local swelling was unknown.   It was unknown if the reporter considered the local swelling to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had swollen arm pit after 1st shot. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Syncope
Clinical narrative: syncope; This case was reported by a nurse via sales rep and described the occurrence of syncope in a patient who received Men B NVS (Bexsero) 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 an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced syncope (serious criteria GSK medically significant). On an unknown date, the outcome of the syncope was unknown.   It was unknown if the reporter considered the syncope to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced syncope following a dose of Bexsero. Consent to follow up was denied.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia, Vaccination failure
Clinical narrative: had it, last time after second shingles shot/ suspected vaccination failure; had it 10 times so far, shingles; postherpetic neuralgia/ was very painful; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and post herpetic neuralgia. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)). On an unknown date, the outcome of the vaccination failure and post herpetic neuralgia were unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and post herpetic neuralgia to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had it 10 times so far. The last time the patient had it was after the second shingles shot.  The patient had been taking one of the antiviral drugs for over a year and still had gotten them.  The patient had been shingles free for a month now and was keeping fingers and toes crossed.  The patient stated that he/she would not wish it on anyone.  The patient also ended up with post herpetic neuralgia which was also extremely painful. The patient stated that the shots were expensive but all should try to get them.  The patient also asked why they were not covered by Medicare. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: have shingles now, had the vaccine/suspected vaccination failure; shingles, in hosp 5 days; in hosp 5 days for pain control; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria hospitalization and GSK medically significant), shingles (serious criteria hospitalization) and pain (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles vaccine and it was 4th time getting it in hospitalization for 5 days for pain control before they knew it was shingles. The patient had shingles at the time of reporting. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm was sore; 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 the 1st dose of 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 details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the first shot and arm was sore but that was it. The patient further stated that he/she must wait till March for second dose. The follow-up would not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shots-got the shingles/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the Shingles shots and got the shingles.  The patient stated that the shingles was not as bad as some, so they say was awful. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: husband got the vax and then got Shingles/ suspected vaccination failure; now has them, shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's husband. The age at vaccination was not reported. The patient got the Shingles shot to not get Shingles, and now had them. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available. This case was linked with US2022AMR010989, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure/same happened, got the shot and now has them!; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a shot and had shingles. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, time to onset and laboratory test confirmation were unknown at the time of reporting. The follow-up could not be possible as no contact details were available. The case has been linked with case US2022AMR010947, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR010947:same reporter
Sex: F
Vaccine: MENB
Symptoms: Decreased appetite, Nausea
Clinical narrative: has no appetite; feels nauseas; This case was reported by a consumer via interactive digital media and described the occurrence of appetite absent in a female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 2nd December 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, less than 2 months after receiving Bexsero and an unknown time after starting Bexsero Pre-Filled Syringe Device, the patient experienced appetite absent and nausea. On an unknown date, the outcome of the appetite absent and nausea were not recovered/not resolved.   It was unknown if the reporter considered the appetite absent and nausea to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter was the patient's parent. The patient received first dose of Bexsero and since then she had no appetite and felt nauseas on daily basis. The reporter wanted to know if this was a long term side effect of the vaccine. The follow-up would not be possible as no contact details were available.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Malaise, Migraine
Clinical narrative: Feels slightly nauseous when she eats; legs are week and wobbly; Arm hurts; Shivering; Tired; Dizzy; Not been feeling well; Migraine for 2 days; This case was reported by a consumer via call center representative and described the occurrence of nauseous in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2022, the patient received the 1st dose of Shingrix (injection). On an unknown date, less than a week after receiving Shingrix, the patient experienced nauseous, lower extremities weakness of, pain in arm, shivering, tiredness, dizzy, migraine and feeling unwell. On an unknown date, the outcome of the nauseous and pain in arm were not recovered/not resolved and the outcome of the lower extremities weakness of and feeling unwell were unknown and the outcome of the shivering, tiredness, dizzy and migraine were recovered/resolved.   It was unknown if the reporter considered the nauseous, lower extremities weakness of, pain in arm, shivering, tiredness, dizzy, migraine and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was unknown. Since receiving vaccine patient had not been feeling well. In January 2022, patient recovered from the events shivering, tiredness, dizzy and migraine. She had a migraine for 2 continuous days and at the time to reporting that had resolved. She felt dizzy, tired, shivering that had resolved at the time to reporting, arm was still hurting, legs were week and wobbly, and felt slightly nauseous when she eat. The reporter would like to know how long symptoms last.  Reporter did not want to provide full address and HCP information. Reporter refused to provide HCP details and full address. The outcome for tiredness and dizzy was reported as not recovered in source document, however it was updated to recovered as per information provided in the narrative.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Nausea, Pain in extremity
Clinical narrative: Feels slightly nauseous when she eats; legs are week and wobbly; Arm hurts; Shivering; Tired; Dizzy; Not been feeling well; Migraine for 2 days; This case was reported by a consumer via call center representative and described the occurrence of nauseous in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th January 2022, the patient received the 1st dose of Shingrix (injection). On an unknown date, less than a week after receiving Shingrix, the patient experienced nauseous, lower extremities weakness of, pain in arm, shivering, tiredness, dizzy, migraine and feeling unwell. On an unknown date, the outcome of the nauseous and pain in arm were not recovered/not resolved and the outcome of the lower extremities weakness of and feeling unwell were unknown and the outcome of the shivering, tiredness, dizzy and migraine were recovered/resolved.   It was unknown if the reporter considered the nauseous, lower extremities weakness of, pain in arm, shivering, tiredness, dizzy, migraine and feeling unwell to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was unknown. Since receiving vaccine patient had not been feeling well. In January 2022, patient recovered from the events shivering, tiredness, dizzy and migraine. She had a migraine for 2 continuous days and at the time to reporting that had resolved. She felt dizzy, tired, shivering that had resolved at the time to reporting, arm was still hurting, legs were week and wobbly, and felt slightly nauseous when she eat. The reporter would like to know how long symptoms last.  Reporter did not want to provide full address and HCP information. Reporter refused to provide HCP details and full address. The outcome for tiredness and dizzy was reported as not recovered in source document, however it was updated to recovered as per information provided in the narrative.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Accidental underdose, Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: some of the vaccine run out down arm; some of the vaccine run out down arm; the vaccine to run out and down the patient's arm; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 57-year-old female patient who received Herpes zoster (Shingrix) (batch number D4CZ3, expiry date 10th April 2023) for prophylaxis.   On 14th January 2022, the patient received the 1st dose of Shingrix. On 14th January 2022, unknown after receiving Shingrix, the patient experienced accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. On an unknown date, the outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.  Additional details were reported as follows: The pharmacist reported that during administration of first dose of Shingrix series to the patient by a student, the seal between the needle and syringe leaked, causing some of the vaccine to run out and down the patient's arm, which led to accidental underdose, exposure via skin contact and accidental exposure to vaccine. The amount of product patient actually received was unknown. Till the time of reporting, the patient was not re-dosed. Consent to follow up was granted.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: receiving a 3 dose of SHINGRIX; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 59-year-old female patient who received Herpes zoster (Shingrix) (batch number 5393G, expiry date 1st April 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th July 2020) and Shingrix (2nd dose received on 8th October 2020).   On 22nd November 2021, the patient received the 3rd dose of Shingrix. On 22nd November 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The patient received 3 dose of Shingrix till date, which led to extra dose administered. The reporter consented to follow up.
Sex: M
Vaccine: HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Received the first dose on October 16th 2021 and has not received the 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 66-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 16th October 2021, batch number 3y7nl).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient received the first dose of Twinrix and had not received the 2nd dose till the time of reporting, which led to incomplete course of vaccination. The reporter cnsented to follow up.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: received an 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 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th January 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th January 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: Medical assistant reported that, the patient received an expired dose of Kinrix on the day of reporting, which led to expired  vaccine used. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dizziness
Clinical narrative: Chills; Weakness; Dizziness; This case was reported by a consumer via call center representative and described the occurrence of chills in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, weakness and dizziness. On an unknown date, the outcome of the chills, weakness and dizziness were not recovered/not resolved.   It was unknown if the reporter considered the chills, weakness and dizziness to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient received 2nd dose of Shingrix and he experienced chills, weakness and dizziness, which had not resolved. No other information was provided concerning this event. The reporter declined to answer any questions related to the patient and his adverse event. The reporter declined to provide health care professional information. The reporter did not consent to follow-up.
Age: 82.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: received a 3rd dose of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 82-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (already completed the original 2 dose Shingrix series in 2018).   In December 2021, the patient received the 3rd dose of Shingrix (intramuscular) 50 µg. In December 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The patient self-reported the case. The patient received a 3rd dose of Shingrix in December 2021 (exact date not given), which led to extra dose administered. She stated that, she restarted the series because her doctor had misplaced the records of her receiving the original 2 dose Shingrix series in 2018. The patient did not obtain the lot or expiration date of the Shingrix vaccine or the patient email. The reporter did not consent to follow-up to contact HCP (Health care professional) as she stated he was retired and she had not re-established with a new physician.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 8 months since he received the 1st dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, 8 months before the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient mentioned that, it had been 8 months since he received the 1st dose of the Shingrix Vaccine, which led to incomplete course of vaccination. The patient would like to know if he needed to restart the vaccine series or if he can take the 2nd dose. The reporter consented to follow up.