chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Burning sensation, Chromaturia, Dermatitis, Haematuria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general pruritus in a 65-year-old male patient who received FLULAVAL QUADRIVALENT. The patient's past medical history included hyperlipidemia. Concurrent medical conditions included type II diabetes mellitus (has had it a long time) and hypertension. Concomitant products included AFRIN, atenolol, Atorvastatin, Metformin, Pioglitazone Hydrochloride and glipizide. On 27th December 2017, the patient received FLULAVAL QUADRIVALENT. In December 2017, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced general pruritus, musculoskeletal stiffness, hematuria, weakness, skin inflammation and skin peeling. The patient was treated with BENADRYL. On an unknown date, the outcome of the general pruritus, musculoskeletal stiffness, hematuria, weakness and skin inflammation were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. The reporter considered the general pruritus, musculoskeletal stiffness, hematuria, weakness, skin inflammation and skin peeling to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The health care professional was the daughter of the patient, and had no vaccine lot or expiry date. The patient stated that his physician did not think it was vaccine related but the patient saw a dermatologist who thought it might be vaccine related, and not related to his comorbidities. The patient had narrated the events like itching all over his body, inflamed skin that felt like it was on fire, reddish urine and inability to close his hands. The peeling skin had not resolved. The patient was only treated with BENADRYL injection at Emergency Room and sent home with antihistamines that he stopped taking because they made him drowsy.
Age: 65.0
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Musculoskeletal stiffness, Pruritus generalised, Skin exfoliation
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of general pruritus in a 65-year-old male patient who received FLULAVAL QUADRIVALENT. The patient's past medical history included hyperlipidemia. Concurrent medical conditions included type II diabetes mellitus (has had it a long time) and hypertension. Concomitant products included AFRIN, atenolol, Atorvastatin, Metformin, Pioglitazone Hydrochloride and glipizide. On 27th December 2017, the patient received FLULAVAL QUADRIVALENT. In December 2017, 4 days after receiving FLULAVAL QUADRIVALENT, the patient experienced general pruritus, musculoskeletal stiffness, hematuria, weakness, skin inflammation and skin peeling. The patient was treated with BENADRYL. On an unknown date, the outcome of the general pruritus, musculoskeletal stiffness, hematuria, weakness and skin inflammation were recovered/resolved and the outcome of the skin peeling was not recovered/not resolved. The reporter considered the general pruritus, musculoskeletal stiffness, hematuria, weakness, skin inflammation and skin peeling to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The health care professional was the daughter of the patient, and had no vaccine lot or expiry date. The patient stated that his physician did not think it was vaccine related but the patient saw a dermatologist who thought it might be vaccine related, and not related to his comorbidities. The patient had narrated the events like itching all over his body, inflamed skin that felt like it was on fire, reddish urine and inability to close his hands. The peeling skin had not resolved. The patient was only treated with BENADRYL injection at Emergency Room and sent home with antihistamines that he stopped taking because they made him drowsy.
Age: 70.0
Sex: F
Vaccine: FLUA3
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity, X-ray limb normal
Clinical narrative: I went to the hospital to get my flu usually yearly flu shot. It was not available at the hospital. They advised me that I could go to my local pharmacy to have it done. I went to the pharmacy. The Pharmacist did it. However, since receiving the shot in my right arm, I am having pains in the arm and is unable to use the arm to the full capacity. I have to be taking ALEVE and rubbing it with alcohol, ointments and I have to use my left hand to lift the right hand into place. The pain is excruciating and limit me to what I can and cannot do. I went to the ER and they xrayed the hand and said everything looks fine and it will take time to go away but 2 months later I am still in pain. Is that really normal?
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Bradycardia, Cardiac pacemaker insertion, Cardiac stress test, Electrocardiogram
Clinical narrative: Received flu vaccine on Thursday 9/6/2017, started to feel symptoms of flu by 9/8/2017 reported illness related to flu vaccine on Monday 9/11/2017, placed off of work till 9/13/2017 returned to work feeling weak and continued to suffer with flu symptoms. Went to scheduled yearly check up on 9/25/2017, diagnosed with bradycardia (heart rate of 38), rushed to cardiologist for review, diagnosis confirmed given stress test and given ZIO PATCH patch x2 weeks at end of 2 week period sent in ZIO PATCH, patch, received call the next day informing me that I needed a pacemaker immediately. Apparently there was a 8 second gap in my heart beat (I beat(I could have died). did). Pacemaker placed within 2 days (as quickly as it could be done. done). No other medical issues and very active individual before flu shot, running 5.8 miles per day.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Heart rate irregular, Impaired work ability, Influenza
Clinical narrative: Received flu vaccine on Thursday 9/6/2017, started to feel symptoms of flu by 9/8/2017 reported illness related to flu vaccine on Monday 9/11/2017, placed off of work till 9/13/2017 returned to work feeling weak and continued to suffer with flu symptoms. Went to scheduled yearly check up on 9/25/2017, diagnosed with bradycardia (heart rate of 38), rushed to cardiologist for review, diagnosis confirmed given stress test and given ZIO PATCH patch x2 weeks at end of 2 week period sent in ZIO PATCH, patch, received call the next day informing me that I needed a pacemaker immediately. Apparently there was a 8 second gap in my heart beat (I beat(I could have died). did). Pacemaker placed within 2 days (as quickly as it could be done. done). No other medical issues and very active individual before flu shot, running 5.8 miles per day.
Sex: F
Vaccine: HPV4
Symptoms: Arthritis, Heart rate increased, Hypoaesthesia, Neck pain, Paraesthesia
Clinical narrative: I went to my gynecologist's office the morning of 1/10/18 for an annual check up and was given the GARDASIL vaccine. Within 10 minutes I experienced an episode of syncope and rapid heart beat and I went to the ED department to sit with the Triage nurse. Soon thereafter I experienced numbness and tingling in my arms which has not dissipated. I also experienced extreme pain at the back of my neck that lasted for about 24 hours. I am currently struggling with what feels like arthritis in my hands. All of this happened the day the GARDASIL vaccine was given to me.
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: I went to my gynecologist's office the morning of 1/10/18 for an annual check up and was given the GARDASIL vaccine. Within 10 minutes I experienced an episode of syncope and rapid heart beat and I went to the ED department to sit with the Triage nurse. Soon thereafter I experienced numbness and tingling in my arms which has not dissipated. I also experienced extreme pain at the back of my neck that lasted for about 24 hours. I am currently struggling with what feels like arthritis in my hands. All of this happened the day the GARDASIL vaccine was given to me.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Exercise tolerance decreased, Feeling hot, Loss of personal independence in daily activities, Mobility decreased, Pain in extremity
Clinical narrative: Received PREVNAR 13 inj., 0.5 ML on above date. Arm hurt a little after receiving shot which I could understand. However, as time went on it got worse to a point I can't lift my right arm or carry anything. It appears there might be a lump in the arm and it feels hot at times. Went to the doctor and he prescribed ibuprofen with exercise to possibly work it out but unable to exercise much because of the pain. Said to check back in 3 weeks but didn't really seem sure about what the problem was. Could possibly be an infection. This limits my ability to not only do housework but also many outside activities.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Cardiac disorder, Eye disorder, Gastrointestinal disorder, Mental disorder, Metabolic disorder
Clinical narrative: After being injected with the last of 3 Hepatitis A and B vaccine I presents with 27 side effects that according to the information I received, only 1% of the population responds with. That's me and I'm still dealing with the side effects in 8 systems - Musculoskeletal, Psychological, GI, Respiratory, Occular, Metabolic, Cardio., Dermo. The symptoms are so varied that none of the specialists I went to could tie it into their specialty. It wasn't until I did deeper research and found that ALL my side effects were listed under the 1% effected category. Disgusting that my hepatologist didn't provide me with that information before I agreed to the vaccinations.
Age: 60.0
Sex: F
Vaccine: HEPAB
Symptoms: Musculoskeletal disorder, Respiratory disorder, Skin disorder
Clinical narrative: After being injected with the last of 3 Hepatitis A and B vaccine I presents with 27 side effects that according to the information I received, only 1% of the population responds with. That's me and I'm still dealing with the side effects in 8 systems - Musculoskeletal, Psychological, GI, Respiratory, Occular, Metabolic, Cardio., Dermo. The symptoms are so varied that none of the specialists I went to could tie it into their specialty. It wasn't until I did deeper research and found that ALL my side effects were listed under the 1% effected category. Disgusting that my hepatologist didn't provide me with that information before I agreed to the vaccinations.
Age: 0.5
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from the mother of a 27 week old male patient, concerning her son. No information was provided regarding the patient's medical history, concurrent condition or concomitant medications. On an unknown date, the patient was vaccinated with ROTATEQ dose 1, per oral route, for prophylaxis (lot number and expiration date were not reported) at 27 weeks old. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 11-DEC-2017 approximately six months earlier than recommended in the prescribing information, the patient was vaccinated with the first dose of M-M-R II lot # M037096, expiration date 23-AUG-2018 (dose and route was not reported) for prophylaxis. No adverse events reported.
Age: 64.0
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 64 year old patient. The patient's medical history was not reported. On 18-DEC-2017, the patient was inadvertently vaccinated with VARIVAX lot # N019131, expiration date 22-JUN-2019 for prophylaxis instead of ZOSTAVAX. No adverse effects were reported.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Autopsy, Death
Clinical narrative: Initial unsolicited report received from a nurse on 10-Jan-2018. This case involves a six-month-old patient (gender not reported), who was vaccinated with first dose of 0.25 ml FLUZONE QIV via intramuscular route (batch number: UT5949KA; expiry date, route and site of administration not reported) and PEDIARIX (manufacturer: GSK) (batch number, expiry date, dose, route and site of administration not reported) and ROTAVIRUS VACCINE (batch number, expiry date, dose, route and site of administration not reported) and PNEUMOCOCCAL CONJUGATE VACCINE (PCV12) (manufacturer: Pfizer) (batch number, expiry date, dose, route and site of administration not reported) on 20-Dec-2017. Patient had a mild cough at time of vaccination. No fever. Concomitant medications were not reported. On 26-Dec-2017 in morning, six days following the vaccination, patient was found dead. Patient was previously vaccinated with all vaccines other than FLUZONE QIV twice. Lab test and corrective treatment was not reported. Reporter stated an autopsy was being performed to determine cause of death and rule out SIDS (sudden infant death syndrome). Patient's mother felt it was the flu shot (Fluzone QIV) that caused her child's demise. Documents held by sender: none.; Sender's Comments: Time to onset is compatible. The patient already had mild cough at the time of vaccination. No other medical history was reported. The patient also received Pediarix and Rotavirus vaccine on the same day as Fluzone QIV. Autopsy was being performed at the time of reporting to determine the cause of death and rule out SIDS. Considering that several different vaccines had been co-administered at the same time it is difficult to elicit role of each vaccine in reported event. Result of autopsy, patient medical history, past surgical history, and state of health at the time of vaccination would be helpful with identifying role of each vaccine in reported event.; Reported Cause(s) of Death: found dead the morning; Autopsy-determined Cause(s) of Death: found dead the morning
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, TDAP
Symptoms: Acne, Arthralgia, Arthritis, Fatigue, Head discomfort
Clinical narrative: The first reaction I had was inflammation in my ankle during the beginning of my spring break. Four months later the inflammation spread throughout my body. In the summer of 2008 I was given antibiotics to help reduce the swelling. My joints and muscles hurt. Especially when it is cold. Through diet, physical exercises which my then sport doctor gave, and getting 12 hours of sleep a night while my body was recovering I was able to somewhat regain and maintain my health. In the fall of 2009 it felt as if my muscles were being eaten. I took glucosamine to counter that. A couple of years later I developed severe allergies that I received shots for. I never had acne until after the vaccine. My dermatologist office says that I first started being treated for acne in September of 2009. My immune system is easily compromised, which was previously relatively strong. At times I have severe fatigue and need several more hours of sleep to be able to function. Whenever it is cold or I don't get at least 8 hours of sleep I feel pressure in the back of my head, sometimes on the side(s) and top of my head. This pressure makes me not be able to think clearly. It is like being in a daze and not being able to use or retrieve your knowledge. As a result I am not as intelligent as I once was. Thanks to my extremely healthy diet and lifestyle I am able to manage and somewhat succeed.
Age: 17.0
Sex: F
Vaccine: HPV4, IPV, TDAP
Symptoms: Immunodeficiency, Inflammation, Myalgia, Swelling, Thinking abnormal
Clinical narrative: The first reaction I had was inflammation in my ankle during the beginning of my spring break. Four months later the inflammation spread throughout my body. In the summer of 2008 I was given antibiotics to help reduce the swelling. My joints and muscles hurt. Especially when it is cold. Through diet, physical exercises which my then sport doctor gave, and getting 12 hours of sleep a night while my body was recovering I was able to somewhat regain and maintain my health. In the fall of 2009 it felt as if my muscles were being eaten. I took glucosamine to counter that. A couple of years later I developed severe allergies that I received shots for. I never had acne until after the vaccine. My dermatologist office says that I first started being treated for acne in September of 2009. My immune system is easily compromised, which was previously relatively strong. At times I have severe fatigue and need several more hours of sleep to be able to function. Whenever it is cold or I don't get at least 8 hours of sleep I feel pressure in the back of my head, sometimes on the side(s) and top of my head. This pressure makes me not be able to think clearly. It is like being in a daze and not being able to use or retrieve your knowledge. As a result I am not as intelligent as I once was. Thanks to my extremely healthy diet and lifestyle I am able to manage and somewhat succeed.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Swelling
Clinical narrative: She got a shot on Sat and later had a red mark. This was still there this morning and was swollen.
Age: 1.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 05-JAN-2018, the patient was inadvertently vaccinated with a single dose of ZOSTAVAX, subcutaneously, lot# N025386 and expiration date: 08-DEC-2018, reconstituted with sterile diluent, lot# L025374 and expiration date: 27-MAR-2018, instead of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot# and expiration date were not reported). There were no adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report has been received from a nurse and refers to an unspecified number of children of unknown ages and genders. The patients' concurrent conditions, medical histories and drug reactions/allergies were not reported. On unknown dates, the patients were vaccinated with VARIVAX (doses routes of administration and frequencies were not reported) for prophylaxis. On unknown dates, the patients experienced varicella outbreaks at their school. At the reporting time, the outcome of varicella post vaccine was unknown. The reporter did not report a causal relationship between the event and the VARIVAX. This is one of several reports received from the same reporter (MARRS # 1712USA000896, 1712USA014554).; Sender's Comments: US-009507513-1712USA014554: US-009507513-1712USA000896:
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Ill-defined disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. A 67-year-old female patient received PREVNAR 13 (batch, lot and expiry date was not reported), via an unspecified route of administration on 06Oct2017 at a single dose for pneumonia prevention, given at a pharmacy. The patient's medical history was and concomitant medications were not reported. On 06Oct2017, the patient received the vaccine which she thought was a good idea but since then she has had intermittent problems with her left arm. The patient stated that a physician did not suggest she get it or tells her what to get or where to get it. It was not prescribed to her, she received it on her own at a (pharmacy name withheld) and she felt safe enough that the method and way in which it was done was good. The patient added that she put herself in kind of a Zen mode to make herself relax while she got the shot. The outcome of the event was recovering (reported as improved but are persisting). The patient had no lab work in response to getting the shot. The patient reported that she was still able to use her arm.
Age: 1.25
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HIBV
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: Patient was due for Dtap #4. Instead of administering Dtap (Infanrix) a dose of Dtap + Hep B + IPV (PEDIARIX) was administered. Results in an extra dose of IPV and Hepatitis B.
Age: 22.0
Sex: F
Vaccine: MENB
Symptoms: Immediate post-injection reaction, Syncope, Vomiting
Clinical narrative: Immediately after receipt patient fainted. She was on a couch, so assisted to lie down in recovery position. Faint lasted about 10 seconds. Patient roused after ammonia capsule, vomited into trash bin. BP 126/82, pulse 84. Rested and had sips of water under RN supervision until recovered. After 20 minutes stated she felt recovered, walked unassisted to lobby where she waited another 15 minutes for a friend to come pick her up. States she had fainted before after venipuncture and implant device but never with vaccination.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt had vaccine around 11am. Pt returned to our clinic at 4:00PM with c/o swelling/redness/pain at injection site. Area had 10cm induration with redness and was hot to the touch.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Chills, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Tdap IM Right deltoid localized angry red swollen to size of tennis ball. Site extremely sensitive to degree that it hurt to have a sleeve touch it. Had fever of 101 degrees F. for ~12-16 hours with shaking chills. No nausea, vomiting, headache,neuro-type symptoms, shortness of breath, tachycardia. Redness extended down to elbow. Redness/swelling lasted 4-5 days.
Age: 47.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Pyrexia, Tremor
Clinical narrative: Tdap IM Right deltoid localized angry red swollen to size of tennis ball. Site extremely sensitive to degree that it hurt to have a sleeve touch it. Had fever of 101 degrees F. for ~12-16 hours with shaking chills. No nausea, vomiting, headache,neuro-type symptoms, shortness of breath, tachycardia. Redness extended down to elbow. Redness/swelling lasted 4-5 days.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Cough, Fatigue, Influenza like illness, Myalgia, Pruritus
Clinical narrative: Flu like symptoms, fever, myalgia, cough, fatigue, itchy skin eruptions.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: Flu like symptoms, fever, myalgia, cough, fatigue, itchy skin eruptions.
Age: 92.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2018-01-15.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Arm still sore at inject site months later.
Age: 61.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Joint range of motion decreased, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Arm still sore at inject site months later.
Age: 1.83
Sex: F
Vaccine: VARCEL
Symptoms: Nasal congestion, Pharyngeal erythema, Rash, Swelling face, Urticaria
Clinical narrative: Swollen face, hives, rash, stuffy nose, red throat.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, VARCEL
Symptoms: Discomfort, Injection site bruising, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 1/11/2018- bruising at the Dtap injection area. Redness around the IPV and Chickenpox injection sites RN advise cool pack on and off throughout day, TYLENOL or MOTRIN for discomfort. 1/12/2018- bruising at all three sites and redness. Hard and warm in AM. Treatment- Ice and MOTRIN. In the afternoon of 1/12/2018- site was soft and bruising fading.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Tdap IM Right deltoid localized angry red swollen to size of tennis ball. Site extremely sensitive to degree that it hurt to have a sleeve touch it. Site itchy. Had mild nausea, no vomiting, headache. No neuro-type symptoms, shortness of breath, or tachycardia. Redness extended down to elbow. Redness/swelling lasted 6-7 days.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Tdap IM Right deltoid localized angry red swollen to size of tennis ball. Site extremely sensitive to degree that it hurt to have a sleeve touch it. Site itchy. Had mild nausea, no vomiting, headache. No neuro-type symptoms, shortness of breath, or tachycardia. Redness extended down to elbow. Redness/swelling lasted 6-7 days.
Age: 68.0
Sex: F
Vaccine: FLUA3
Symptoms: Chills, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain from the injection site almost to elbow when I raised my arm very much, esp, raising my arm high to change or pull on and off shirts. I also had severe chills and a fever of 99.8 degrees my usual is 97.5 degrees. I'm still having pain in my upper left shoulder, when I change shirts and other activity.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX with lot #s M038856, expiration date 14-SEP-2018, and  N019839 and expiration date 13-JUL-2018 (route, dose, dose number, frequency and anatomical location were unknown); and doses of  PROQUAD with lot #s N020007 and expiration date 13-JAN-2019; N021726 and expiration date 06-FEB-2019; N014950 and expiration date 11-NOV-2018, and N020008 and expiration date 13-JAN-2019  (route, dose, dose number, frequency and anatomical location were unknown) for prophylaxis reconstituted with properly stored sterile diluent(MERCK STERILE DILUENT). Administered doses of vaccines experienced the temperature excursion of -14 C to-10 C degrees Celsius for 21 minutes. There was no adverse effect reported. A Data digital  logger was involved, and there were no previous excursions reported.
Sex: F
Vaccine: VARZOS
Symptoms: Tinnitus
Clinical narrative: This spontaneous report as received from a female patient of an unknown age concerning herself. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 20-SEP-2016, the patient was vaccinated with ZOSTAVAX (dose, route, lot number and expiration date were not reported) for prophylaxis. Concomitant therapies included sterile diluent (MERCK). On 01-OCT-2016, 12 days after onset of therapy, the patient experienced tinnitus. The outcome of tinnitus was not recovered. The causal relationship between the event and ZOSTAVAX was not reported.
Sex: F
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from non-healthcare professional (Employee) on 02 Jan 2018. This case involves 44 years old female patient who was vaccinated with dose of INFLUENZA VACCINE (INFLUENZA VACCINE) (batch number, expiry date, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medication were not reported. On an unspecified date, post vaccination few days ago, patient was diagnosed with influenza. Laboratory investigation and corrective treatment were not reported. Outcome of event was not reported. Upon internal review the case was considered as serious because of important medical event:Influenza. List of documents held by sender: none.; Sender's Comments: The time to onset was not reported. Patient's medical history, condition at the time of vaccination and tolerance to previous vaccinations was also not reported. Lab data confirming diagnosis such as PCR/serology were also not available at the time of reporting. Additional information regarding the same and latency would be required to further assess the causality with respect to the vaccine. Name or lot number along with dose number of the vaccine would also be required. Based upon reported information the role of the vaccine cannot be assessed.
Sex: M
Vaccine: FLU4
Symptoms: Bronchitis, Influenza, Influenza A virus test positive, Vaccination failure
Clinical narrative: This case was reported by a consumer via patient support programs and described the occurrence of vaccination failure in a elderly male patient who received Influenza vaccine. Concomitant products included ADVAIR DISKUS and VENTOLIN HFA. In October 2017, the patient received Influenza vaccine. On 2nd January 2018, less than a year after receiving Influenza vaccine and an unknown time after starting ADVAIR DISKUS and VENTOLIN HFA, the patient experienced vaccination failure (serious criteria GSK medically significant) and influenza A virus infection (serious criteria hospitalization). On an unknown date, the patient experienced bronchitis (serious criteria hospitalization). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the influenza A virus infection and bronchitis were recovering/resolving. The reporter considered the vaccination failure, influenza A virus infection and bronchitis to be unrelated to Influenza vaccine. Additional details were reported as follows: The patient was transferred from the Program. The age at vaccination was not reported. The patient stated he had been taking ADVAIR DISKUS and VENTOLIN HFA for many years dates unknown. He stated he tried stopping ADVAIR DISKUS for awhile (missed doses), dates unknown, but it didn't work and he got sicker, so his physician told him he must stay on it. The patient did not know the manufacturer of the flu vaccine he received, but understood that many flu shots this year are ineffective against the flu strain. The patient said that he gets bronchitis all the time and he thought he was experiencing bronchitis either end of December 2017 or early January 2018 and was hospitalized on 2nd January 2018 for several days and was diagnosed with Type A Influenza (lack of drug effect). At the reporting date, the patient stated he was finally starting to feel a lot better. The patient was also upset that he has to make selections in the phone tree when calling the GSK Program. He appreciated the medications he receives from GSK but did not appreciate what he calls the system around getting these medications being so unhelpful. The patient has denied permission to contact their physician and did not provide information of the same. The patient did not wish to receive any follow up mailings about this report but would speak by phone. The patient declined to provide all the details for this report.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient states about 15 minutes after getting her immunization she had redness at the injection site.  Throughout the day her upper left arm started swelling and feels hot. Patient states that her arm is still swollen. I explained to patient that reactions like that can happen and told patient to see the doctor if it worsens.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Feeling cold, Inflammation, Pain, Pain in extremity, X-ray limb abnormal
Clinical narrative: Severe arm pain, unable to put down. Patient also experienced feeling cold a few hours after receiving vaccine.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Redness to arm below injection site by 5am measuring 9.5 cm x 5 cm. Seen by provider, recommended BENADRYL, ice, caladryl lotion or cortisone cream if becomes itchy.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: After the injection I had what I thought the normal soreness at the injection site, but after 4 days I had a hard time moving my left arm. I did not think anything of it and just tried to keep exercising it thinking that maybe I pulled a muscle, but now it has been 2 months and the muscle hurts constantly and it is hard to move my arm in different positions. I am going to finally seek medical care for it because it has gone on long enough. I am not sure if it is from the flu vaccination, but I thought it was important enough to report.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Insomnia, Pain in extremity
Clinical narrative: I was given the SHINGRIX vaccine at around 11:00 a.m. on January 16, 2018. A couple of hours later, my right arm became sore at the injection site and following down my right arm. At about 9:00 p.m. on the same date, I started to have flu-like symptoms. My fever rose to 101 degrees F, and I became very shaky. I had difficulty sleeping and I finally got out of bed around 11:00 a.m. the next morning (01/17/2018). I still have a slightly elevated temperature level (100.3), but I feel better--if not very drained. I called the pharmacy and spoke with the pharmacist who was filling in for the day. He was not the administrator of the shot. However, he was helpful in describing some possible side effects although he did not think my condition arose from the vaccination, but rather the current flu that is quickly traveling around the country. I countered his comments with the observation that I thought it was an unlikely coincidence that I had flu-like symptoms after receiving the vaccination.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Tremor
Clinical narrative: I was given the SHINGRIX vaccine at around 11:00 a.m. on January 16, 2018. A couple of hours later, my right arm became sore at the injection site and following down my right arm. At about 9:00 p.m. on the same date, I started to have flu-like symptoms. My fever rose to 101 degrees F, and I became very shaky. I had difficulty sleeping and I finally got out of bed around 11:00 a.m. the next morning (01/17/2018). I still have a slightly elevated temperature level (100.3), but I feel better--if not very drained. I called the pharmacy and spoke with the pharmacist who was filling in for the day. He was not the administrator of the shot. However, he was helpful in describing some possible side effects although he did not think my condition arose from the vaccination, but rather the current flu that is quickly traveling around the country. I countered his comments with the observation that I thought it was an unlikely coincidence that I had flu-like symptoms after receiving the vaccination.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: After injection was given, a painful, inflamed, swollen, red bump appeared at the injection site.  The patient reported that the spot was so painful that it hurt to put clothes on or sleep  on. After it healed, it left a brown spot, like a scar.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Blood test normal, Disturbance in attention, Dizziness postural, Fatigue, Loss of personal independence in daily activities
Clinical narrative: Patient began to complain of dizziness and nausea upon standing and loss of ability to concentrate at school or on homework. General fatigue and exhaustion.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Mononucleosis heterophile test negative, Nausea
Clinical narrative: Patient began to complain of dizziness and nausea upon standing and loss of ability to concentrate at school or on homework. General fatigue and exhaustion.
Age: 74.0
Sex: M
Vaccine: PPV
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: Pain in arm from shoulder to hand. Left (arm only) same as shot was given. Pain more intense in joints from shoulder to elbow - wrist.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Injection site erythema
Clinical narrative: Erythema to her left thigh, cheeks and arms. Monitors with improvement and then sent home.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Agitation, Balance disorder, Electrocardiogram normal, Electroencephalogram, Eye movement disorder
Clinical narrative: -01/11/2018 MA: I administered HPV into his left arm. After the vaccine was administered the patient started to lean forward, like he was dizzy. I immediately asked him to lay down. He then asked for a glass of water. I got him the water and advised him to stay lying down. I went to the door to grab the pulse ox and the patient stood from the exam table, very unsteady. I again asked him to lay down. He was unresponsive and he slid to the floor near the exam table. I noticed his face was flushed, so I put my hands on the back of his head to lay him down on the floor, making sure he didn't hit his head. He started shaking, and at this point the rest of his body was also flushed. I was close enough to the door where I could open it to call for help and still be near the patient. At this point the patient was shaking and his eyes were rolling in the back of his head. Dr. came into the room and sat down on the floor next to myself and the patient. Dr. checked his pulse and was trying to talk to him, he was unresponsive, but breathing. A few moments later the patient quickly sat up and grabbed onto me, pulling me closer to the ground. He was unaware of what had happened or where he even was. Dr. continued talking to him as I got off the ground and moved aside. Patient asked where he was, and what happened. He was asking if this was a normal reaction to the vaccine, and if he was going to die. Dr. advised him that he was going to be okay but he needed to stay in the office for a while. I exited the room at that point. Dr.: After getting the HPV vaccine, he got up said he did not feel well, and had drank 5 cups of coffee and not eaten today. He laid down. (This part was told to me be staff, I did not witness it). I was called into the room. Patient was lying on the floor. Eyes open. Grunting and non-responsive. I think his arms were rigid. After about 30 seconds he became agitated and grabbed staff trying to put her in a bear hug as I struggled with him. After about 15 seconds of struggle, he became more lucid saying where am I and struggling for his phone and keys. After about 15 seconds of agitated looking for things he became more lucid and got up on the table to rest. He was thinking clearly at this point and remained so as he was observed in our office. I spoke with the neurologist on call Dr., who recommended that he be evaluated in the ED. Mother agrees with this plan and she will take him. 01/11/18 L. Staff: Received call on this date. She confirmed that the patient did not hit their head, and the patient had not had seizures in the past. Asked if person was aware and if she was going to be contactinng the manufacturer? Staff advised person was aware. Reviewed ED report, and patient's MRI was negative for findings and he was discharged home.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Flushing, Grunting, Malaise, Muscle rigidity, Nuclear magnetic resonance imaging brain normal
Clinical narrative: -01/11/2018 MA: I administered HPV into his left arm. After the vaccine was administered the patient started to lean forward, like he was dizzy. I immediately asked him to lay down. He then asked for a glass of water. I got him the water and advised him to stay lying down. I went to the door to grab the pulse ox and the patient stood from the exam table, very unsteady. I again asked him to lay down. He was unresponsive and he slid to the floor near the exam table. I noticed his face was flushed, so I put my hands on the back of his head to lay him down on the floor, making sure he didn't hit his head. He started shaking, and at this point the rest of his body was also flushed. I was close enough to the door where I could open it to call for help and still be near the patient. At this point the patient was shaking and his eyes were rolling in the back of his head. Dr. came into the room and sat down on the floor next to myself and the patient. Dr. checked his pulse and was trying to talk to him, he was unresponsive, but breathing. A few moments later the patient quickly sat up and grabbed onto me, pulling me closer to the ground. He was unaware of what had happened or where he even was. Dr. continued talking to him as I got off the ground and moved aside. Patient asked where he was, and what happened. He was asking if this was a normal reaction to the vaccine, and if he was going to die. Dr. advised him that he was going to be okay but he needed to stay in the office for a while. I exited the room at that point. Dr.: After getting the HPV vaccine, he got up said he did not feel well, and had drank 5 cups of coffee and not eaten today. He laid down. (This part was told to me be staff, I did not witness it). I was called into the room. Patient was lying on the floor. Eyes open. Grunting and non-responsive. I think his arms were rigid. After about 30 seconds he became agitated and grabbed staff trying to put her in a bear hug as I struggled with him. After about 15 seconds of struggle, he became more lucid saying where am I and struggling for his phone and keys. After about 15 seconds of agitated looking for things he became more lucid and got up on the table to rest. He was thinking clearly at this point and remained so as he was observed in our office. I spoke with the neurologist on call Dr., who recommended that he be evaluated in the ED. Mother agrees with this plan and she will take him. 01/11/18 L. Staff: Received call on this date. She confirmed that the patient did not hit their head, and the patient had not had seizures in the past. Asked if person was aware and if she was going to be contactinng the manufacturer? Staff advised person was aware. Reviewed ED report, and patient's MRI was negative for findings and he was discharged home.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Scan with contrast normal, Tremor, Unresponsive to stimuli
Clinical narrative: -01/11/2018 MA: I administered HPV into his left arm. After the vaccine was administered the patient started to lean forward, like he was dizzy. I immediately asked him to lay down. He then asked for a glass of water. I got him the water and advised him to stay lying down. I went to the door to grab the pulse ox and the patient stood from the exam table, very unsteady. I again asked him to lay down. He was unresponsive and he slid to the floor near the exam table. I noticed his face was flushed, so I put my hands on the back of his head to lay him down on the floor, making sure he didn't hit his head. He started shaking, and at this point the rest of his body was also flushed. I was close enough to the door where I could open it to call for help and still be near the patient. At this point the patient was shaking and his eyes were rolling in the back of his head. Dr. came into the room and sat down on the floor next to myself and the patient. Dr. checked his pulse and was trying to talk to him, he was unresponsive, but breathing. A few moments later the patient quickly sat up and grabbed onto me, pulling me closer to the ground. He was unaware of what had happened or where he even was. Dr. continued talking to him as I got off the ground and moved aside. Patient asked where he was, and what happened. He was asking if this was a normal reaction to the vaccine, and if he was going to die. Dr. advised him that he was going to be okay but he needed to stay in the office for a while. I exited the room at that point. Dr.: After getting the HPV vaccine, he got up said he did not feel well, and had drank 5 cups of coffee and not eaten today. He laid down. (This part was told to me be staff, I did not witness it). I was called into the room. Patient was lying on the floor. Eyes open. Grunting and non-responsive. I think his arms were rigid. After about 30 seconds he became agitated and grabbed staff trying to put her in a bear hug as I struggled with him. After about 15 seconds of struggle, he became more lucid saying where am I and struggling for his phone and keys. After about 15 seconds of agitated looking for things he became more lucid and got up on the table to rest. He was thinking clearly at this point and remained so as he was observed in our office. I spoke with the neurologist on call Dr., who recommended that he be evaluated in the ED. Mother agrees with this plan and she will take him. 01/11/18 L. Staff: Received call on this date. She confirmed that the patient did not hit their head, and the patient had not had seizures in the past. Asked if person was aware and if she was going to be contactinng the manufacturer? Staff advised person was aware. Reviewed ED report, and patient's MRI was negative for findings and he was discharged home.
Age: 22.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Agitation, Dizziness, Electroencephalogram, Eye movement disorder, Flushing
Clinical narrative: -01/11/2018 MA: I administered HPV into his left arm. After the vaccine was administered the patient started to lean forward, like he was dizzy. I immediately asked him to lay down. He then asked for a glass of water. I got him the water and advised him to stay lying down. I went to the door to grab the pulse ox and the patient stood from the exam table, very unsteady. I again asked him to lay down. He was unresponsive and he slid to the floor near the exam table. I noticed his face was flushed, so I put my hands on the back of his head to lay him down on the floor, making sure he didn't hit his head. He started shaking, and at this point the rest of his body was also flushed. I was close enough to the door where I could open it to call for help and still be near the patient. At this point the patient was shaking and his eyes were rolling in the back of his head. Dr. came into the room and sat down on the floor next to myself and the patient. Dr. checked his pulse and was trying to talk to him, he was unresponsive, but breathing. A few moments later the patient quickly sat up and grabbed onto me, pulling me closer to the ground. He was unaware of what had happened or where he even was. Dr. continued talking to him as I got off the ground and moved aside. Patient asked where he was, and what happened. He was asking if this was a normal reaction to the vaccine, and if he was going to die. Dr. advised him that he was going to be okay but he needed to stay in the office for a while. I exited the room at that point. Dr.: After getting the HPV vaccine, he got up said he did not feel well, and had drank 5 cups of coffee and not eaten today. He laid down. (This part was told to me be staff, I did not witness it). I was called into the room. Patient was lying on the floor. Eyes open. Grunting and non-responsive. I think his arms were rigid. After about 30 seconds he became agitated and grabbed staff trying to put her in a bear hug as I struggled with him. After about 15 seconds of struggle, he became more lucid saying where am I and struggling for his phone and keys. After about 15 seconds of agitated looking for things he became more lucid and got up on the table to rest. He was thinking clearly at this point and remained so as he was observed in our office. I spoke with the neurologist on call Dr., who recommended that he be evaluated in the ED. Mother agrees with this plan and she will take him. 01/11/18 L. Staff: Received call on this date. She confirmed that the patient did not hit their head, and the patient had not had seizures in the past. Asked if person was aware and if she was going to be contactinng the manufacturer? Staff advised person was aware. Reviewed ED report, and patient's MRI was negative for findings and he was discharged home.