chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pericardial drainage, Pericardial effusion, Pericarditis, Pyrexia
Clinical narrative: Symptoms: shortness of breath, chest pain, inability to sleep, loss of appetite
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Chest X-ray, Chest pain, Decreased appetite, Dyspnoea
Clinical narrative: Symptoms: shortness of breath, chest pain, inability to sleep, loss of appetite
Age: 13.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Echocardiogram, Electrocardiogram, Insomnia, Ultrasound scan
Clinical narrative: Symptoms: shortness of breath, chest pain, inability to sleep, loss of appetite
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Bone pain, Disturbance in attention, Feeling abnormal, Lethargy
Clinical narrative: Loss of taste Entire body hurt, even my bones felt like they hurt Mind fog/inability to concentrate Lethargy My period had started the day I took my second shot. It completely disappeared that night and hasn't returned as of writing. My flow is incredibly heavy the first two days, so I know I wasn't finished with my cycle.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Pain
Clinical narrative: Loss of taste Entire body hurt, even my bones felt like they hurt Mind fog/inability to concentrate Lethargy My period had started the day I took my second shot. It completely disappeared that night and hasn't returned as of writing. My flow is incredibly heavy the first two days, so I know I wasn't finished with my cycle.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac flutter, Chest discomfort, Disturbance in attention, Energy increased, Exercise tolerance decreased
Clinical narrative: Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and down arm, then odd feeling throughout my body and head by the afternoon (just very odd, not pain).   I did not have any cold fever or flu-like symptoms.  But, within the next day or two, more concerning symptoms appeared:  I felt, for lack of a better way to describe it, very "twitchy" from my chest, like a flutter.   I've felt restless and fatigued at the same time nearly all the time, like excess energy and exhaustion both at once.  I feel an uncomfortable feeling, like irregular heartbeat or arrhythmia in chest especially at night lying down, which as been interfering with sleep.  I have felt the restlessness and fatigue off and on night and day, interfering with focus and work.  This has gone on for over two months now since the first vaccine dose.  My overall health and how I felt were excellent the day prior to the vaccine.  There is definitely something off with my metabolism, in particular my cardiovascular and aerobic function, since the vaccine that has not yet resolved itself.  I can still exercise and feel better by doing so, but, it always feels at a lower performance level than before the vaccine.  The feeling in my chest, like a harder heartbeat than normal, and sometimes what fits some of the symptoms of congestive heart failure or possibly myocarditis, is most concerning.  I experience some periods where it feels like almost a wheezing in the back of my throat when I breathe.  This was persistent for awhile and now seems to be more off and on, becoming less often.  I am slender, exercise regularly and eat fairly healthy, am fit, and have never had any major health problems.  There definitely seems some kind of cardiovascular, aerobic and/or respiratory effect from the vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Heart rate irregular, Impaired work ability, Muscle twitching
Clinical narrative: Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and down arm, then odd feeling throughout my body and head by the afternoon (just very odd, not pain).   I did not have any cold fever or flu-like symptoms.  But, within the next day or two, more concerning symptoms appeared:  I felt, for lack of a better way to describe it, very "twitchy" from my chest, like a flutter.   I've felt restless and fatigued at the same time nearly all the time, like excess energy and exhaustion both at once.  I feel an uncomfortable feeling, like irregular heartbeat or arrhythmia in chest especially at night lying down, which as been interfering with sleep.  I have felt the restlessness and fatigue off and on night and day, interfering with focus and work.  This has gone on for over two months now since the first vaccine dose.  My overall health and how I felt were excellent the day prior to the vaccine.  There is definitely something off with my metabolism, in particular my cardiovascular and aerobic function, since the vaccine that has not yet resolved itself.  I can still exercise and feel better by doing so, but, it always feels at a lower performance level than before the vaccine.  The feeling in my chest, like a harder heartbeat than normal, and sometimes what fits some of the symptoms of congestive heart failure or possibly myocarditis, is most concerning.  I experience some periods where it feels like almost a wheezing in the back of my throat when I breathe.  This was persistent for awhile and now seems to be more off and on, becoming less often.  I am slender, exercise regularly and eat fairly healthy, am fit, and have never had any major health problems.  There definitely seems some kind of cardiovascular, aerobic and/or respiratory effect from the vaccine.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Restlessness, Sleep disorder, Wheezing
Clinical narrative: Within a couple hours of the vaccine, in addition to expected arm soreness, I felt tingling up and down arm, then odd feeling throughout my body and head by the afternoon (just very odd, not pain).   I did not have any cold fever or flu-like symptoms.  But, within the next day or two, more concerning symptoms appeared:  I felt, for lack of a better way to describe it, very "twitchy" from my chest, like a flutter.   I've felt restless and fatigued at the same time nearly all the time, like excess energy and exhaustion both at once.  I feel an uncomfortable feeling, like irregular heartbeat or arrhythmia in chest especially at night lying down, which as been interfering with sleep.  I have felt the restlessness and fatigue off and on night and day, interfering with focus and work.  This has gone on for over two months now since the first vaccine dose.  My overall health and how I felt were excellent the day prior to the vaccine.  There is definitely something off with my metabolism, in particular my cardiovascular and aerobic function, since the vaccine that has not yet resolved itself.  I can still exercise and feel better by doing so, but, it always feels at a lower performance level than before the vaccine.  The feeling in my chest, like a harder heartbeat than normal, and sometimes what fits some of the symptoms of congestive heart failure or possibly myocarditis, is most concerning.  I experience some periods where it feels like almost a wheezing in the back of my throat when I breathe.  This was persistent for awhile and now seems to be more off and on, becoming less often.  I am slender, exercise regularly and eat fairly healthy, am fit, and have never had any major health problems.  There definitely seems some kind of cardiovascular, aerobic and/or respiratory effect from the vaccine.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abnormal clotting factor, Cerebrovascular accident, Computerised tomogram, Echocardiogram, Magnetic resonance imaging
Clinical narrative: I had a stroke sometime between 11pm on April 22, 2021 and 8am on April 23, 2021.   I'd had the vaccine at 4pm on April 21, 2021.  I felt ill during the day on 4/22/2021 but took a nap and woke up feeling better before heading to bed at about 10pm.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Malaise
Clinical narrative: I had a stroke sometime between 11pm on April 22, 2021 and 8am on April 23, 2021.   I'd had the vaccine at 4pm on April 21, 2021.  I felt ill during the day on 4/22/2021 but took a nap and woke up feeling better before heading to bed at about 10pm.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Red circle appeared  RUA at injection site, itchy ?under the skin? on Friday,. Saturday it was about 1 inch  round.   Probably grew to about 2 inches round at 4 days post injection. Started getting smaller/better  on day 5 (Tues)?1 week after injection red spot is small and more like a bruise., but still a little itchy. We treated it with Tylenol, Ice to site,  benadryl for itching.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS; ITCHINESS; SWOLLEN
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Balance disorder, Blood pressure increased, Cerebral haemorrhage, Hemiparesis, Implantable cardiac monitor insertion
Clinical narrative: Approximately April 16 (2 weeks after second shot)  Left leg went out from under me unexpectledly. Few days later happened again but continued to be weaker and Blood pressure increased to 207/140 while I was out shopping. Drove myself to hospital ER and they admitted me. from 04/26 to 04/29. On 04/29 they did MRI brain scan and determined that I had suffered a right quadron brain bleed which left me left side leg weakness and balance issues. Sent me home on 04/29 and told me see primary Dr. right away.. They ordered in home therapy for a few weeks and in 2 weeks I start outpatient therapy . Since this 3 of my Dr's agreed to have a Heart loop monitor inserted in my chest which I agreed to. Staples come out next week.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging head abnormal, Magnetic resonance imaging spinal
Clinical narrative: Approximately April 16 (2 weeks after second shot)  Left leg went out from under me unexpectledly. Few days later happened again but continued to be weaker and Blood pressure increased to 207/140 while I was out shopping. Drove myself to hospital ER and they admitted me. from 04/26 to 04/29. On 04/29 they did MRI brain scan and determined that I had suffered a right quadron brain bleed which left me left side leg weakness and balance issues. Sent me home on 04/29 and told me see primary Dr. right away.. They ordered in home therapy for a few weeks and in 2 weeks I start outpatient therapy . Since this 3 of my Dr's agreed to have a Heart loop monitor inserted in my chest which I agreed to. Staples come out next week.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Feeling abnormal, Lymphadenopathy, Mass
Clinical narrative: The first two nights I was not able to sleep because when I laid down my throat was too constricted. I did not realize at the time that it was a reaction to the shot. My glands have been swollen since that day. I have had a chronic cough since that day, to the point that it has been uncontrollable. Different atmosphere still affect my breathing. It is not nearly as bad as the first week but the first 45 days have been awful. After returning from vacation from a moist climate to a dry climate it seems a bit better but still keeps me awake at night. I tried to ask the pharmacist, they referred me to my Dr, who said it was allergies without even seeing me. After I developed a lump in my left arm on day 7 and site swelling at day 10 I went back to the pharmacist. Ironically I had to make a call to our local health department they referred me to the hospital who referred me back to my Dr who could not see me before I left on vacation. They referred me to Urgent care who refereed me to an ENT which I saw today. They are telling me it is allergies. I don't by it. So here I am.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Sleep disorder, Throat tightness
Clinical narrative: The first two nights I was not able to sleep because when I laid down my throat was too constricted. I did not realize at the time that it was a reaction to the shot. My glands have been swollen since that day. I have had a chronic cough since that day, to the point that it has been uncontrollable. Different atmosphere still affect my breathing. It is not nearly as bad as the first week but the first 45 days have been awful. After returning from vacation from a moist climate to a dry climate it seems a bit better but still keeps me awake at night. I tried to ask the pharmacist, they referred me to my Dr, who said it was allergies without even seeing me. After I developed a lump in my left arm on day 7 and site swelling at day 10 I went back to the pharmacist. Ironically I had to make a call to our local health department they referred me to the hospital who referred me back to my Dr who could not see me before I left on vacation. They referred me to Urgent care who refereed me to an ENT which I saw today. They are telling me it is allergies. I don't by it. So here I am.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests abnormal, Blood test normal, Hypoacusis, Tinnitus
Clinical narrative: Approximately one week after first Pfizer vaccine, I developed pronounced and constant high pitched  ringing in my ears(tinnitus).  It never stops. Surges louder.  Hearing test shows unusual partial  loss of hearing on left side as well. Oral steroids did not help. Steroid injection into ear drum has not helped.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Echocardiogram, Electrocardiogram, Heart rate increased, Myocardial necrosis marker
Clinical narrative: Rapid, fast rising heart rate Twice in about an hour and a half time period Second time went from resting heart rate about 70 to 180 in just a couple minutes No activity when it had happened. Was lying down trying to sleep
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Pruritus, Temporomandibular joint syndrome
Clinical narrative: Patient returned to pharmacy 30 min after injection complaining of generalized itching to head, neck, back and arms.  Denied SOB, dyspnea, facial swelling.  Observed x10 min.  Symptoms continuing.  Administered 50 mg diphenhydramine po.  Observed x15 min.  Symptoms continuing but not worsening.  Highly recommended pt get ride home.  Pt cannot get ahold of husband or daughter.  Offered to find ride home.  Pt declined as she lives close and doesn't want to leave car at store. Observed x15 min.  Itching somewhat better around head.  Preexisting TMJ pain starting.  Pt wants to drive home as it is close by.  Recommended to go to ER if she develops any facial swelling or difficulty breathing.  Pt left store and texted about 20 min later that she arrived home safe but itching is continuing.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest discomfort left side sharp in nature for about 2 weeks following vaccine. Worse with activity. Went away before second shot then returned for a shorter time (about one week) less severe following second shot
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Anxiety, Blood test, Chest pain
Clinical narrative: Stubbing chest pain for a couple times for 1 day, bloating and pain stomach and anxiety (in the morning of July 4th and a few hours in afternoon) Following day mild chest pain and anxiety ( July  5th late afternoon and night) July 6th in morning I went to Emergency room to get checked.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, X-ray
Clinical narrative: Stubbing chest pain for a couple times for 1 day, bloating and pain stomach and anxiety (in the morning of July 4th and a few hours in afternoon) Following day mild chest pain and anxiety ( July  5th late afternoon and night) July 6th in morning I went to Emergency room to get checked.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: Chest tightness after second dose 40-45 minutes afterwards. No wheezing. Experienced Shortness of breath upon activity. Difficulty exhaling. O2 level was 96%. Took mucus, no relief. Multiple inhalations of Pro-Air, no relief. Took Albuterol nebulizer treatment, no relief. Took children?s  Benadryl approximately 4:30 PM and experienced immediate relief in 20 minutes.  Took more Benadryl proper to bedtime. Woke up next AM  and felt  like I felt prior to the vaccine.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Feeling cold, Muscle spasms
Clinical narrative: 15 seconds after second dose, could not breathe,  nausea, dizziness, lost completely feeling in both arms, side cramps, chest tightness, uncontrollable shaking, feeling super cold. Vision suddenly got narrow , began seeing stars,  black patches   Got an epipen injected and was finally able to breathe.   Paramedics arrived and took vitals and I stayed for 45 mins until vitals were back to normal. Suggested I drive in the ambulance to the ER to be monitored but it wasn?t bad enough for me to ride. Someone separately drove me to the hospital just in case and I was ok.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Paraesthesia, Tremor, Visual impairment
Clinical narrative: 15 seconds after second dose, could not breathe,  nausea, dizziness, lost completely feeling in both arms, side cramps, chest tightness, uncontrollable shaking, feeling super cold. Vision suddenly got narrow , began seeing stars,  black patches   Got an epipen injected and was finally able to breathe.   Paramedics arrived and took vitals and I stayed for 45 mins until vitals were back to normal. Suggested I drive in the ambulance to the ER to be monitored but it wasn?t bad enough for me to ride. Someone separately drove me to the hospital just in case and I was ok.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Allergy test negative, Urticaria
Clinical narrative: My body broke out into hives 2-4 hours after receiving the vaccine. This lasted approx 4 days, while taking Benedryl for symptoms.   I broke out into hives again on 6/21/2021 and they are still present on 7/8/2021.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Injection site pain
Clinical narrative: patient complains of pain & weakness in left arm 4 hours after vaccine
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac failure, Cerebrovascular accident, Death, Dyspnoea, Intensive care
Clinical narrative: My previously healthy brother received the Pfizer vaccine (1st dose) and 4 days after he was hospitalized with shortness of breath, heart failure, blood clots in his arm, lungs and leg along with a stroke and many medical conditions kept arising as he was hospitalized. He was in the CICU for a week and a half. Unfortunately, my brother passed away from the Pfizer vaccine. Until his last day the doctors still "didn't know" what was wrong with him. A lot happened during his hospital stay, but this is just a brief statement. They have been keeping his medical records from me. They tested him repeatedly there from covid and he wa salways negative. They had no other explanation to what was happening and all along they wanted it to be COVID-19 and were so quick to say it was not the vaccine.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pulmonary thrombosis, SARS-CoV-2 test negative, Thrombosis
Clinical narrative: My previously healthy brother received the Pfizer vaccine (1st dose) and 4 days after he was hospitalized with shortness of breath, heart failure, blood clots in his arm, lungs and leg along with a stroke and many medical conditions kept arising as he was hospitalized. He was in the CICU for a week and a half. Unfortunately, my brother passed away from the Pfizer vaccine. Until his last day the doctors still "didn't know" what was wrong with him. A lot happened during his hospital stay, but this is just a brief statement. They have been keeping his medical records from me. They tested him repeatedly there from covid and he wa salways negative. They had no other explanation to what was happening and all along they wanted it to be COVID-19 and were so quick to say it was not the vaccine.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Cardiac monitoring, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Sudden chest pain, near syncope, light headed, dizzy, shortness of breath. Went to urgent care and was sent home after negative EKG. Continue to have intermittent chest pain, light headedness, fatigue, and shortness of breath. Went to the hospital but EKG showed nothing abnormal. Referred to a cardiologist. Wearing a heart monitor and MRI scheduled. Continue to have fatigue, shortness of breath, and chest pains.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram normal, Fatigue, Magnetic resonance imaging, Presyncope, X-ray
Clinical narrative: Sudden chest pain, near syncope, light headed, dizzy, shortness of breath. Went to urgent care and was sent home after negative EKG. Continue to have intermittent chest pain, light headedness, fatigue, and shortness of breath. Went to the hospital but EKG showed nothing abnormal. Referred to a cardiologist. Wearing a heart monitor and MRI scheduled. Continue to have fatigue, shortness of breath, and chest pains.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test, Loss of personal independence in daily activities, Muscle spasms, Muscular weakness
Clinical narrative: Symptoms started with severe muscle cramping in calves and progressed to numbness and parasthesias in legs, arms, and torso. Muscle weakness and inability to continue workouts followed over weeks. Before my vaccine I was riding my bike 15 miles and running 6 miles. I now find it hard to walk one mile due to muscle cramping and weakness.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Symptoms started with severe muscle cramping in calves and progressed to numbness and parasthesias in legs, arms, and torso. Muscle weakness and inability to continue workouts followed over weeks. Before my vaccine I was riding my bike 15 miles and running 6 miles. I now find it hard to walk one mile due to muscle cramping and weakness.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: My kid reported both jaws pain in early morning on 8 July and he woke up with pain. I gave him Ibuprofen 200 mg 1 tablet after 1-2 hrs he feel relaxed. He got first dose of Pfizer vaccine on 6th July at 2 30 PM at Kroger Pharmacy
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test normal, Chest pain, Dizziness, Dyspnoea, Electrocardiogram normal
Clinical narrative: About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling. Still present, but not as painful. About 1 week post injection, began getting chest pains, difficulty breathing, and dizziness/lightheadedness. We to urgent care 1 week after symptoms started to appear as they got worse. EKG ran showing potential heart attach in past, but I don't think I've had one before. Was noted and told might have been due to crutches. Symptoms got worse next day so went to urgent care at different facility. Brought to ER for x-ray, blood , and EKG. Told no myocarditis, but potentially pericarditis.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, X-ray normal
Clinical narrative: About 4 hours post injection ring finger nerves became painful at tip with pins and needles feeling. Still present, but not as painful. About 1 week post injection, began getting chest pains, difficulty breathing, and dizziness/lightheadedness. We to urgent care 1 week after symptoms started to appear as they got worse. EKG ran showing potential heart attach in past, but I don't think I've had one before. Was noted and told might have been due to crutches. Symptoms got worse next day so went to urgent care at different facility. Brought to ER for x-ray, blood , and EKG. Told no myocarditis, but potentially pericarditis.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Enuresis, Headache, Myalgia, Pyrexia
Clinical narrative: Fever, muscular pain, dizziness, nocturnal diuresis, headache.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Cough, Dyspnoea
Clinical narrative: Cough; Minor breath problems; No energy; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6207), via an unspecified route of administration in the right arm on 14Mar2021 at 09:30 (at the age of 53-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. Concomitant medication included montelukast sodium (SINGULAIR) from unknown date for unspecified indication. The patient previously received acetylsalicylic acid (ASPIRIN) on unknown date for unspecified indication and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 22Mar2021, the patient experienced cough, minor breath problems, no energy. The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events cough, breathing difficult, loss of energy was recovered with sequelae.   No follow-up attempts are needed. No further information is expected.
Age: 12.0
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: a dose of PEDVAX HIB was given to a 12 year old patient by mistake; a dose of PEDVAX HIB was given to a 12 year old patient by mistake; a dose of PEDVAX HIB was given to a 12 year old patient by mistake instead of GARDASIL 9; No additional adverse events reported; This spontaneous report was received from a licensed practical nurse, referring to a 12 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not provided.     On 07-JUN-2021, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (lot # S036818, expiration date 22-APR-2022, 0.5 milliliter, route was not reported) for prophylaxis by nurse's mistake instead of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) that was ordered (product administered to patient of inappropriate age, product confusion and wrong product administered). No additional adverse events reported. Nurse also reported that the HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) vaccine had not been administered at that time and patient would have to come in at a later date for administration.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There have been no additional adverse experiences reported; A single dose of Rotateq was inadvertently administered to a 10 year old infant; This spontaneous report was received from a physician and refers to a 10-day old patient of an unknown gender. The patient pertinent medical history, concurrent conditions and concomitant therapies were not provided.  On 21-JUN-2021, the patient was inadvertently vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot # 1707408 and expiration date 07-JAN-2022) one single dose for prophylaxis.  No additional adverse experiences were reported as a result of the administration of the vaccine.
Sex: F
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, Pyrexia, Seizure, Vaccination complication
Clinical narrative: convulsions; very high fever; This spontaneous report has been received from a patient's father via Pfizer concerning a female patient of unknown age (reported as when she was younger). The patient's concurrent conditions, medical history and concomitant medications were not reported.    On an unknown date, the patient was vaccinated with Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (strength, dose, frequency, route, lot number and expiration date were not reported) for prophylaxis.    On an unknown date, the patient had a bad reaction including a very high fever and convulsions. She never received the second dose of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) due to this reaction. The patient had recovered from the events on unknown dates.  The reporter and his wife were told that the patient did not actually have a reaction to the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) itself but that she already had immunity that was passed through to her by her mother and that was what caused her to have a reaction to the first dose of the Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (manufacturer unknown) (causality was entered as related conservatively).    Upon internal review, the event convulsions was determined to be medically significant.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Nurse reports no other AE; administration of an expired dose of MMR II to a patient; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.     On 28-JUN-2021, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA)(M-M-R II) 0.5 milliliter, lot number S015962, expiration date 23-MAY-2021 (route of administration not provided) for prophylaxis. No adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: A pharmacist reported VARlVAX was improperly stored and administered; This spontaneous report has been received from a pharmacist, referring to a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, concurrent conditions, and previous drug reactions or allergies.  On 26-JUN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) 0.5 milliliter (mL) once (lot number T028306 and expiration date 20-AUG-2022 were verified as valid) (route of administration, vaccination scheme and anatomical site of vaccination were not provided) as prophylaxis.  The vaccine was improperly stored at 41 Fahrenheit degrees for 24 hours (product storage error). The temperature excursions were not detected by a data logger. There was no previous temperature excursion; Sender's Comments:  US-009507513-2107USA000237: US-009507513-2107USA000111:
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Menveo was given without reconstitution with Men A lyophilized conjugate; Menveo was given without reconstitution with Men A lyophilized conjugate; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The Menveo was given without reconstitution with Men A lyophilized conjugate, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The patient was unknown due to no documentation.
Age: 66.0
Sex: F
Vaccine: HEPAB, UNK
Symptoms: Lymphadenopathy, Neck mass, Neck pain
Clinical narrative: Sore neck / musculoskeletal discomfort; Feels like it's a lump / Mass; Swollen lymph node under her jaw; This case was reported by a physician via other manufacturer and described the occurrence of neck pain in a 66-year-old female 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 and abaloparatide (Tymlos) for senile osteoporosis.   Concurrent medical conditions included senile osteoporosis.   In May 2021, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On 18th May 2021, the patient started Tymlos (subcutaneous) 80 mcg/mg once daily (80 mcg/mg daily). On 23rd May 2021, less than 2 weeks after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced neck pain, mass and lymphadenopathy. The action taken with Tymlos was unknown. On an unknown date, the outcome of the neck pain, mass and lymphadenopathy were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, mass and lymphadenopathy to be related to Twinrix and Twinrix 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 patient received the Twinrix vaccine 2 weeks ago from reporting. On 23rd May 2021, 5 days after receiving Tymlos, the patient experienced neck pain, mass and lymphadenopathy. The patient experienced sore neck and feels like it was a lump, swollen lymph node under her jaw. The patient medical history was significant for age related osteoporosis without current pathological fracture. The relevant surgical, social, or substance-usage history was not provided and relevant concomitant medications were reported as none. No treatment information was provided. No relevant lab or diagnostic test were provided. No action was taken with Tymlos treatment. It was unknown if the reporter considered the neck pain, mass and lymphadenopathy to be related to Tymlos. No further information was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; I Had And Still Do Have The Shingles / I Have Had Them Again, After Vaccine; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles, burning sensation, pain and mastectomy.   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 case reported by the patient herself/himself The patient received the dose of Shingles vaccine and patient experienced shingles  The reporter stated that patient had shingles and that was rare case. The patient stated that the first time patient got shingles  The patient got vaccine and it did help to ease the pain but burning was unbelievable and he/she was like on fire. The burning was on side and back. The reporter stated that these all after the Mastectomy,which was much less painful than the shingles. The reporter stated that he/she would ran for the vaccine as he had it again and after the vaccine it did help a lot. This case was considered as suspected vaccination failure since the 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: Herpes zoster, Vaccination failure
Clinical narrative: suspected vaccination failure; they still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a unspecified number of patients 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 reporter stated that he/she knew the patients received the dose of Shingles vaccine and they still got shingles. The reporter stated that shingles could not be prevented unless you are completely stress free 100 percent of the time. This case was considered as suspected vaccination failure since the 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: Extra dose administered
Clinical narrative: I just got my third one Saturday I hope this is the last one; This case was reported by a consumer via interactive digital media and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The case reported by the patient herself/himself The patient received the 3rd dose of Shingrix,which led to extra dose administered. The reporter stated that he/she just got his/her third one Saturday and patient hoped that ws the last one.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: my arm was sore; i was very tired.but feeling good today; 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 and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter. The age at vaccination was not reported. The patient received 1st shot of Shingles vaccine and experienced arm sore and was very tired. On the day of reporting, the patient was feeling good today. The patient will get 2nd dose in November and asked if not going through that pain of shingles.
Age: 25.0
Sex: F
Vaccine: DTAP
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: pregnant women patient recieved a shot of Infanrix; 25 year old / recieved a shot of Infanrix; received Infanrix instead of Boostrix; This prospective pregnancy case was reported by a physician via call center representative and described the occurrence of vaccine exposure during pregnancy in a 25-year-old female patient who received DTPa (Infanrix) (batch number K92A4, expiry date 9th February 2021) for prophylaxis.   On an unknown date, the patient received Infanrix. The patient's last menstrual period was on an unknown date and estimated date of delivery was on an unknown date. The patient received Infanrix at an unknown time during the pregnancy. On an unknown date, unknown after receiving Infanrix, the patient experienced vaccine exposure during pregnancy and inappropriate age at vaccine administration. On an unknown date, the outcome of the vaccine exposure during pregnancy and inappropriate age at vaccine administration were unknown. The pregnancy was ongoing.  Additional details were provided as follows: The age at vaccination was not reported. The pregnant patient recieved a shot of Infanrix instead of Boostrix, which led to vaccine exposure during pregnancy and inappropriate age at vaccine administration. The reporter consented to follow up.  Doctor gave phone number office and personal cell phone.  Upon internal review below correction is done on 14th September 2020: Additional narrative updated.   Follow up information was received on 2nd July 2021: The additional event was added as wrong vaccine administered. The pregnancy outcome was updated as lost to follow up. No further information was reported.
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 14 years old who received a shingrix dose.; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 14-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patientreceived dose of Shingrix at the age of 14 years old, which led to inappropriate age at vaccine administration. The pharmacist clarified that she was reporting the case, but the administration provides from  a clinic. So, the health care professional did not have more information about the patient or the vaccine. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: patient received 3 doses; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date) and Shingrix (2nd dose received on an unknown date).   On 28th June 2021, the patient received the 3rd dose of Shingrix. On 28th June 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 provided as follows: The age at vaccination was not reported. The pharmacist stated that, the patient received 3 doses of Shingrix, which led to extra dose administered. No further details were provided at the time of the call. The health care professional was in a hurry and did not provide any patient demographics, vaccine information or consent. The reporter did not consent to follow up.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Vision blurred
Clinical narrative: Now has a localized injection site reaction; Now has / blurred vision in his right eye.; This case was reported by a physician via call center representative and described the occurrence of injection site reaction in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th June 2021, the patient received the 2nd dose of Shingrix. On 30th June 2021, 2 days after receiving Shingrix, the patient experienced injection site reaction and blurred vision. On an unknown date, the outcome of the injection site reaction and blurred vision were unknown.   It was unknown if the reporter considered the injection site reaction and blurred vision to be related to Shingrix.  Additional details were reported as follows: This case was reported by a physician. The physician reported that, the patient received his second dose of the Shingrix Vaccine. The patient experienced a localized injection site reaction and blurred vision in his right eye. The reporter does not know the lot number or expiration dat e of the vaccine the patient received. Did not consent to follow-up.
Age: 35.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: patient inadvertently received an expired 3rd dose; patient inadvertently received an expired 3rd dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 35-year-old female patient who received HAV (Havrix) (batch number 37RY4, expiry date 6th March 2021) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 3rd November 2020). Concomitant products included HAV (Havrix).   On 28th June 2021, the patient received the 3rd dose of Havrix (intramuscular). On 28th June 2021, unknown after receiving Havrix and 23 days after receiving Havrix, the patient experienced extra dose administered and expired vaccine used. On an unknown date, the outcome of the extra dose administered and expired vaccine used were unknown.  Additional details were provided as follows: The patient received the second dose of Havrix on 5th June 2021and completed the series. However on 28th June 2021, the patient inadvertently received an expired 3rd dose of Havrix on left deltoid, which led to extra dose administered and expired vaccine used. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product prescribing error
Clinical narrative: doctor wants a 32 year old patient to get Shingrix / doctor sent the prescription / to a pharmacy / pharmacy declined it. (No mention of patient being administered); This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 32-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.  Additional details were reported as follows: This case was reported by a pharmacist. Age at vaccination was not applicable. Pharmacist called in to inquire on information on Shingrix and under 50 years of age. Pharmacist reported a doctor wants a 32 year old patient to get Shingrix and also mentioned the doctor sent the prescription for Shingrix to a pharmacy and the pharmacy declined it. (No mention of patient being administered), which led to intercepted drug prescribing error. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: experienced vomiting after a dose; This case was reported by a other health professional via sales rep and described the occurrence of vomiting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown.   It was unknown if the reporter considered the vomiting to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix and experienced vomiting. No additional information was provided. The reporter consented to follow up.