chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 16.0
Sex: M
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; inadvertently administered dose of VARIVAX that had been improperly stored; This spontaneous report was received from a medical assistant regarding unspecified patients of unknown demographics. The patients' concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 12-SEP-2019 and 13-SEP-2019, the patients were inadvertently vaccinated with doses of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951, expiration date: 16-APR-2021 and lot # R018931, expiration date: 02-JUL-2020 (strength, dose, route of administration and anatomical location were not reported) for prophylaxis (product storage error). All lots of varicella virus vaccine live (oka/merck) (VARIVAX) were reconstituted with properly stored sterile diluent (unknown lot# and expiration date). The vaccines underwent temperature excursion of 25.68 degrees Fahrenheit for a duration of 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complaints were involved.  The case is considered non-valid, as no patient identifiers were provided.   Upon receipt of follow-up information on 24-MAR-2020 from medical assistant it was determined that this case is now valid because patient identifiers was reported. The case is regarding a 16-year-old male patient. On 12-SEP-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # S011951 and expiration date: 16-APR-2021.  This is one of the several reports received from the same reporter.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patients received an improperly stored dose of MMR II on unspecified dates; This spontaneous report was received from a nurse practitioner referring to a 15-years-old female patient. The patient's pertinent medical history and previous drug reaction, and allergies were not reported. The patient's concomitant therapy included sterile diluent injection.  On 14-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II) of lot # R028382, expiration date reported as 02-OCT-2020, but upon internal validation established as 10-MAR-2020 (exact dose, dose number and route of administration were not reported) for prophylaxis (product storage error). The sterile diluent injection used to reconstitute the vaccine was stored in the recommended temperature range. On an unknown date, the vaccine administered to the patient was exposed to the temperature excursion of -58 degree Fahrenheit and +46 degree Fahrenheit (35.1 Fahrenheit (F)) for 30 minutes, and at highest temperature above 47.1 degree Fahrenheit (47.1 F) for 30 minutes. There was previous temperature excursion at -58 degree Fahrenheit and +46 degree Fahrenheit (-35.8 F) for 30 minutes. There was no adverse effect reported (no adverse event). Digital data logger was involved. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA006066: US-009507513-2003USA010101: US-009507513-2003USA010169:
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patients received an improperly stored dose of MMR II on unspecified dates; This spontaneous report was received from a nurse practitioner referring to a 14-years-old male patient. The patient's pertinent medical history and previous drug reaction, and allergies were not reported. The patient's concomitant therapy included sterile diluent injection.  On 14-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II) of lot # R028382, expiration date reported as 02-OCT-2020, but upon internal validation established as 10-MAR-2020 (exact dose, dose number and route of administration were not reported) for prophylaxis (product storage error). The sterile diluent injection used to reconstitute the vaccine was stored in the recommended temperature range. On an unknown date, the vaccine administered to the patient was exposed to the temperature excursion of -58 degree Fahrenheit and +46 degree Fahrenheit (35.1 Fahrenheit (F)) for 30 minutes, and at highest temperature above 47.1 degree Fahrenheit (47.1 F) for 30 minutes. There was previous temperature excursion at -58 degree Fahrenheit and +46 degree Fahrenheit (-35.8 F) for 30 minutes. There was no adverse effect reported (no adverse event). Digital data logger was involved. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA006066: US-009507513-2003USA010168: US-009507513-2003USA010101:
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypoaesthesia, Hypotension, Injection site pain, Insomnia
Clinical narrative: Within hours very painful where shot was given, the next morning swelling redness went to work by that night sick to my stomach pain was awful couldn?t sleep couldn?t touch my arm, had to use left arm to move right arm.  Called doctors on 03/17/2020 got me in immediately, blood pressure very low excruciating pain in arm numbness , right hand was white and cold to touch they put me on Keflex.  No improvement getting worse on  03/19/2020 called doctors my regular doctor was in, got me in right away blood pressure very low no sleep going on 4 days right hand ice cold numb tingling whole right side cannot use.  Diagnosed me with brachial nerve neuritis.  Put me on Prednisone.  I have Currently one day left on medication, still have some issues with arm but doing excersises to help going to attempt back to work on 03/30/2020.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Nausea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Within hours very painful where shot was given, the next morning swelling redness went to work by that night sick to my stomach pain was awful couldn?t sleep couldn?t touch my arm, had to use left arm to move right arm.  Called doctors on 03/17/2020 got me in immediately, blood pressure very low excruciating pain in arm numbness , right hand was white and cold to touch they put me on Keflex.  No improvement getting worse on  03/19/2020 called doctors my regular doctor was in, got me in right away blood pressure very low no sleep going on 4 days right hand ice cold numb tingling whole right side cannot use.  Diagnosed me with brachial nerve neuritis.  Put me on Prednisone.  I have Currently one day left on medication, still have some issues with arm but doing excersises to help going to attempt back to work on 03/30/2020.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Peripheral coldness, Radiculitis brachial, Swelling, Tenderness
Clinical narrative: Within hours very painful where shot was given, the next morning swelling redness went to work by that night sick to my stomach pain was awful couldn?t sleep couldn?t touch my arm, had to use left arm to move right arm.  Called doctors on 03/17/2020 got me in immediately, blood pressure very low excruciating pain in arm numbness , right hand was white and cold to touch they put me on Keflex.  No improvement getting worse on  03/19/2020 called doctors my regular doctor was in, got me in right away blood pressure very low no sleep going on 4 days right hand ice cold numb tingling whole right side cannot use.  Diagnosed me with brachial nerve neuritis.  Put me on Prednisone.  I have Currently one day left on medication, still have some issues with arm but doing excersises to help going to attempt back to work on 03/30/2020.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Fever and myalgias for 2 days.  Observation, tylenol and hydration.  Full recovery
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Gingival pain, Gingival swelling, Injection site pain, Myalgia
Clinical narrative: The same day as the vaccine, the arm where I got the vaccine was very sore, I also had significant muscle pain in my shoulders and was very tired. This passed within a few days. About 5 days after the vaccine my gums swelled up, and I got a cold sore on the corner of my mouth. I also had a raised bump on my tongue. The gums hurt for 4 or 5 days starting in a deep pocket around one of my teeth where I food gets caught so at first I thought it was a dental issue, then it spread to all of my gums. About 2 days after the gums swelled up the cold sore and bump on my tongue presented. About 7-8 days after the gums swelled up, all symptoms went away. The bump on the tong went away first, then the gum swelling, and more slowly, the cold sore. I didn't take anything throughout the period except routine vitamins and Ibuprofen. I did rinse my mouth with Peridex that I had on hand 2x per day for 3-4 days as this helped with the sore gums
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes, Tongue disorder, Vaccination site pain
Clinical narrative: The same day as the vaccine, the arm where I got the vaccine was very sore, I also had significant muscle pain in my shoulders and was very tired. This passed within a few days. About 5 days after the vaccine my gums swelled up, and I got a cold sore on the corner of my mouth. I also had a raised bump on my tongue. The gums hurt for 4 or 5 days starting in a deep pocket around one of my teeth where I food gets caught so at first I thought it was a dental issue, then it spread to all of my gums. About 2 days after the gums swelled up the cold sore and bump on my tongue presented. About 7-8 days after the gums swelled up, all symptoms went away. The bump on the tong went away first, then the gum swelling, and more slowly, the cold sore. I didn't take anything throughout the period except routine vitamins and Ibuprofen. I did rinse my mouth with Peridex that I had on hand 2x per day for 3-4 days as this helped with the sore gums
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Uterine pain
Clinical narrative: Patient came in to  pharmacy on 03/03/2020 to report that the day (06/18/2019) after she received 2nd shingles vaccine she had pain in her left arm muscle and in her uterus. She reported that the pain stopped that evening.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling, Urticaria
Clinical narrative: Started having swelling, itching, pain, welting at injection site. Patient's husband is an MD and treated patient at home. Swelling reached up to 5" wide and 4" long
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to clinic for vaccination to work with children. Patient needed MMR, Varicella, and TB test placed. Patient returned two days later and complained of red, swollen, and painful to touch at site of injection site.  Swelling and redness about the size of patients palm. denied any other issues with other vaccination sites.  All vaccinations placed in separate sites. Patient could not receive additional care here but was advised to to take benadryl and if it does not get any better or rather if it gets worst to goto ER or to see her Primary Care Provider.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Fall, Gait disturbance, Muscular weakness, Pain in extremity, Urinary incontinence
Clinical narrative: My wife and I had our second Shingrix (shingles) vaccine shots on Tuesday, March 24th and 11:00am.  I had had a minimal reaction (sore arm, very slight fever)  to the first one given several months ago.    This time was radically different. I had the usual sore arm which I dutifully rubbed.  We had the shots at about 11:00 am and by afternoon I was very wobbly on my feet.  By evening I was having trouble walking due to weakness in my legs and before bed I lost bladder control.  When I tried to use the toilet, I fell and could not get up.  My wife?s first reaction was to want to call the paramedics to help get me off the floor, but she eventually pushed and pulled me and got me into the bed room where I crawled onto the bed as if i was climbing a mountain.  I had another fall during the night on another visit to the toilet.  Once again my wife managed to help get me back in bed.    I imagined that this is what it must feel  like to have ALS (Lou Gehrig?s disease).  I tried to use a hiking stick to support myself getting up and down and it did not help.  The next day I spent a lot of time in bed or on the couch.  Things improved gradually that day.  We read that muscle weakness might be an adverse reaction to Shingrix and so we decided to wait it out.    By day three I was getting back to normal and was able to shower safely and walk the dogs.  Now I am back to normal.   My wife had no adverse reaction whatsoever to either shot.  I still think it was a good idea and I have no complaints with the nice young man, who gave me the shot
Age: 44.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient fainted approximately 1 minute after giving Boostrix. Pt was unconscious for approximately 1 minute. Pt recovered and stated they have passed out before in the past but not with a vaccine. He did not each much before shot. Blood sugar might have been low, but cannot confirm.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Skin reaction, Urticaria
Clinical narrative: Day after shot  - Flu like symptoms Next day - Red welt of approx 6 inch diameter
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Edema, erythema (R) upper arm laterally almost to elbow
Age: 50.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Contusion, Mouth haemorrhage, Petechiae, Ultrasound scan normal
Clinical narrative: Patient reports spread of Petechiae starting on firearms and extending onto his trunk and lower legs and chest/face. Abnormal bruising localized to forearms. Few lesions in his mouth, mainly on tongue. Some bleeding from his mouth, could not identify source. Obtained ultrasound which confirmed no enlarged mass or DVT in (L) upper thigh. Told Patient that Petechia should resolve on its own but if it gets worse he needs to contact his Doctors office.
Age: 19.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Musculoskeletal stiffness
Clinical narrative: Patient reporting joint soreness and muscle stiffness of entire body. Patient has been using Aspirin/Tylenol with little relief for past week.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Rash, Rash papular
Clinical narrative: papulovesicular rash to b/l arms and hands, involving the palms
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: The influenza vaccination was mistakenly given to infant at 0754 on 20Mar2020 instead of the hepatitis vaccination. There were no adverse reactions noted from the incorrect administration. Infant was closely monitored for over 48hours. The Pediatrician and Immunologist followed care closely.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Blood test normal, Chest discomfort, Dizziness, Headache
Clinical narrative: Severe headache began day 2 and lasted 7 days, extreme dizziness began day 2 lasted 10+ days, stomach aches, no vomiting, tightness in chest, rapid heartbeat, severe swelling at injection site (golf ball size), severe redness at injection site
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased, Injection site erythema, Injection site swelling, Nausea, Urine analysis normal
Clinical narrative: Severe headache began day 2 and lasted 7 days, extreme dizziness began day 2 lasted 10+ days, stomach aches, no vomiting, tightness in chest, rapid heartbeat, severe swelling at injection site (golf ball size), severe redness at injection site
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Erythema, Pustule, Swelling
Clinical narrative: Redness, Bump, Puss.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Patient states that she had no issues with her injection site the day of the vaccine.  The next day she did have bruising, a bump at the injection site and warmness around the bump.  She states that it was very painful for about 7 to 10 days and she had trouble with arm mobility.  Those issues had disappeared for a while until about a week ago (31 days post injection), when she started noticing pain again in the injection area.  Last night she noticed a small lump in the injection site and it is tender to palpitation.  The lump was noticed to be smaller than the original bump that she discovered a month ago, but she is still experiencing pain in that area today.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient states that she had no issues with her injection site the day of the vaccine.  The next day she did have bruising, a bump at the injection site and warmness around the bump.  She states that it was very painful for about 7 to 10 days and she had trouble with arm mobility.  Those issues had disappeared for a while until about a week ago (31 days post injection), when she started noticing pain again in the injection area.  Last night she noticed a small lump in the injection site and it is tender to palpitation.  The lump was noticed to be smaller than the original bump that she discovered a month ago, but she is still experiencing pain in that area today.
Age: 57.0
Sex: M
Vaccine: MMR
Symptoms: Blood test, Cardiac monitoring, Computerised tomogram, Disorientation, Electrocardiogram
Clinical narrative: VERY DISORIENTED, FAINTED AND WAS NOT CONSCIOUS.  HAD TO BE RUSHED TO HOSPITAL AND WAS PUT IN THE ICU FOR A DAY.  ALSO HAD A VENTILATOR FOR SEVERAL HOURS.  WAS THEN KEPT IN HOSPITAL FOR THREE MORE DAYS.
Age: 57.0
Sex: M
Vaccine: MMR
Symptoms: Electroencephalogram, Intensive care, Loss of consciousness, Mechanical ventilation, Syncope
Clinical narrative: VERY DISORIENTED, FAINTED AND WAS NOT CONSCIOUS.  HAD TO BE RUSHED TO HOSPITAL AND WAS PUT IN THE ICU FOR A DAY.  ALSO HAD A VENTILATOR FOR SEVERAL HOURS.  WAS THEN KEPT IN HOSPITAL FOR THREE MORE DAYS.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Bursitis, Injection site pain, Injection site reaction, Magnetic resonance imaging abnormal, Muscular weakness
Clinical narrative: Left arm never recovered from shot...was placed too high on the arm and caused bursitis. Arm remained weak and injection location muscle very sore, and I couldn't raise arm out to the side without pain. I used ice and tried to rest the arm for over 2 mo. and finally saw my general practitioner for an x-ray and he referred me to Ortho. Dr.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Left arm never recovered from shot...was placed too high on the arm and caused bursitis. Arm remained weak and injection location muscle very sore, and I couldn't raise arm out to the side without pain. I used ice and tried to rest the arm for over 2 mo. and finally saw my general practitioner for an x-ray and he referred me to Ortho. Dr.
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia
Clinical narrative: muscle pain that has subsided but has lasted about 3 weeks
Age: 70.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: muscle pain that has subsided but has lasted about 3 weeks
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Hypersomnia, Nausea, Pyrexia
Clinical narrative: Headache, nausea, tiredness, and fever. Patient slept over 15 hours and is still continuously sleeping throughout the day
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Paralysis
Clinical narrative: Loss  of strength in  arms and legs progress to near complete paralysis below the neck after 4 days. Preliminary diagnosis of Guillian Barre Syndrome. Five day treatment of IVIG.  Hospitalized for 12 days of which 6 in ICU and requiring oxygen for 1 day. Released (2-25-2020) to rehabilitation hospital for physical therapy for 4 weeks. Release 3-24-2020 moderately high functioning.  Extent of permanent disablity of any unknown at this early date.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Red rash on chest, back and abdomen; lasted 2 days
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Paraesthesia
Clinical narrative: A few hours after vaccination, soreness in the arm, tingling all the way down to the hand. By next morning, body aches, tingling,  headache, chills. Took Advil every four hours, felt somewhat better with the advil. Third day feel a bit better, body aches not so intense, soreness in the arm still there.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Skin reaction, Skin warm, Vaccination site nodule
Clinical narrative: Localized skin reaction with erythema, warmth, "feels like a knot under skin" at the vaccination site, and itching. No treatment other than observation for worsening symptoms.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Nausea, Pyrexia
Clinical narrative: PATIENT EXPERIENCED CHIILS, NAUSEA, FEVER, FLU LIKE SYMPTOMS.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Uveitis
Clinical narrative: Patient received the vaccine at the pharmacy n October and developed uveitis in November . His dr. thinks it could be a side effects to the shingrix vaccine he received , however they are not sure on it . Pt did not report this to us until recently
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Skin warm, Vaccination site haemorrhage
Clinical narrative: 7 DAYS AFTER VACCINATION 3-29-2020 PATIENT PRESENTED WITH 4X6 RAISED, RED AREA. THE AREA AFFECTED IS TO THE SIDE OF THE VACCINATION POINT.  DR SAYS THAT THE ARM IS WARM TO TOUCH,BUT NO PAIN ASSOCIATED WITH AFFECTED AREA. IMMEDIATELY AFTER VACCINATION ON 3-22-2020 - THERE WAS NO ILL EVENT EXCEPT FOR THE FACT THAT THERE WAS SLIGHT BLEEDING AFTER THE VACCINATION WHICH PRESENTED AS A BRUISE THE NEXT DAY.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site swelling
Clinical narrative: 7 DAYS AFTER VACCINATION 3-29-2020 PATIENT PRESENTED WITH 4X6 RAISED, RED AREA. THE AREA AFFECTED IS TO THE SIDE OF THE VACCINATION POINT.  DR SAYS THAT THE ARM IS WARM TO TOUCH,BUT NO PAIN ASSOCIATED WITH AFFECTED AREA. IMMEDIATELY AFTER VACCINATION ON 3-22-2020 - THERE WAS NO ILL EVENT EXCEPT FOR THE FACT THAT THERE WAS SLIGHT BLEEDING AFTER THE VACCINATION WHICH PRESENTED AS A BRUISE THE NEXT DAY.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Abdominal pain, Colonoscopy, Dyspnoea, Endoscopy, Epistaxis
Clinical narrative: Months later: Weakened immune system, constantly sick . Headaches, nose bleeds, chronic fatigue,  fevers,  allergies, abdominal pain, iron deficiency anemia, vitamin D deficiency,  leg cramps, shortness of breath, rashes, fructose malabsorption, colonoscopy and endoscopy-IBS, SIBO,
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Fructose intolerance, Gastrointestinal tube insertion, Headache, Hypersensitivity
Clinical narrative: Months later: Weakened immune system, constantly sick . Headaches, nose bleeds, chronic fatigue,  fevers,  allergies, abdominal pain, iron deficiency anemia, vitamin D deficiency,  leg cramps, shortness of breath, rashes, fructose malabsorption, colonoscopy and endoscopy-IBS, SIBO,
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Immune system disorder, Iron deficiency anaemia, Irritable bowel syndrome, Laboratory test abnormal, Malaise
Clinical narrative: Months later: Weakened immune system, constantly sick . Headaches, nose bleeds, chronic fatigue,  fevers,  allergies, abdominal pain, iron deficiency anemia, vitamin D deficiency,  leg cramps, shortness of breath, rashes, fructose malabsorption, colonoscopy and endoscopy-IBS, SIBO,
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Muscle spasms, Oropharyngeal pain, Pyrexia, Rash, Small intestinal obstruction
Clinical narrative: Months later: Weakened immune system, constantly sick . Headaches, nose bleeds, chronic fatigue,  fevers,  allergies, abdominal pain, iron deficiency anemia, vitamin D deficiency,  leg cramps, shortness of breath, rashes, fructose malabsorption, colonoscopy and endoscopy-IBS, SIBO,
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Vitamin D deficiency
Clinical narrative: Months later: Weakened immune system, constantly sick . Headaches, nose bleeds, chronic fatigue,  fevers,  allergies, abdominal pain, iron deficiency anemia, vitamin D deficiency,  leg cramps, shortness of breath, rashes, fructose malabsorption, colonoscopy and endoscopy-IBS, SIBO,
Age: 0.58
Sex: M
Vaccine: TDAP
Symptoms: Abnormal behaviour, Aphasia, Autism spectrum disorder, Blood test abnormal, Decreased eye contact
Clinical narrative: Patient immediately regressed, it was like the lights had turned out.  He lost words, babbling, laughing, smiling, eye contact.  He started clapping with fists instead of open hands.  He stopped trying new foods or touching new toys and now suffers from sensory processing issues, global developmental delay, as well as atypical Autism.  Patient was on track developmentally before this vaccine.
Age: 0.58
Sex: M
Vaccine: TDAP
Symptoms: Developmental delay, Immediate post-injection reaction, Laboratory test abnormal, Regressive behaviour, Sensory processing disorder
Clinical narrative: Patient immediately regressed, it was like the lights had turned out.  He lost words, babbling, laughing, smiling, eye contact.  He started clapping with fists instead of open hands.  He stopped trying new foods or touching new toys and now suffers from sensory processing issues, global developmental delay, as well as atypical Autism.  Patient was on track developmentally before this vaccine.
Age: 0.58
Sex: M
Vaccine: TDAP
Symptoms: Stool analysis abnormal
Clinical narrative: Patient immediately regressed, it was like the lights had turned out.  He lost words, babbling, laughing, smiling, eye contact.  He started clapping with fists instead of open hands.  He stopped trying new foods or touching new toys and now suffers from sensory processing issues, global developmental delay, as well as atypical Autism.  Patient was on track developmentally before this vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Hypersensitivity, Hypoaesthesia, Immunodeficiency, Myelitis transverse
Clinical narrative: Myelitis transverse; shingles; immunodeficient; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 03-SEP-2014, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after to patient's inoculation, the patient suffered paresthesia and numbness in lower extremities and hypersensitivity in the midthoracic region resulting in a diagnosis of transverse myelitis; additionally, the patient became immunodeficient and was also diagnosed with shingles. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had resulted in physical limitation not present prior to vaccination, The patient had also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  At the time of the report, the outcome of  myelitis transverse, shingles (herpes zoster) and immunodeficiency were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the events myelitis transverse was considered as medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: Myelitis transverse; shingles; immunodeficient; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a male patient of an unspecified age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around 03-SEP-2014, the patient was vaccinated with a dose of vaccine live (ZOSTAVAX) (the dosage regimen was not reported) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown date, shortly after to patient's inoculation, the patient suffered paresthesia and numbness in lower extremities and hypersensitivity in the midthoracic region resulting in a diagnosis of transverse myelitis; additionally, the patient became immunodeficient and was also diagnosed with shingles. As a direct and proximate result use of the vaccine live (ZOSTAVAX) vaccine, the patient's had resulted in physical limitation not present prior to vaccination, The patient had also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury.  At the time of the report, the outcome of  myelitis transverse, shingles (herpes zoster) and immunodeficiency were not recovered. The reporter considered the events previously mentioned to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review the events myelitis transverse was considered as medically significant.
Sex: M
Vaccine: PPV
Symptoms: Arthritis, Confusional state, Inflammation, Magnetic resonance imaging, Pain in extremity
Clinical narrative: the patient experienced confusion/ the patient would say things that did not make sense; the patient experienced excruciating pain; the patient received an MRl of the shoulder because of a lesion ( described as an unknown physician believes it is inflamed; This spontaneous report was received from a patient's wife referring to her 83-year-old male husband. The patient's pertinent medical history included blood urine present, two tumors on the kidney (renal neoplasm), nephrectomy, adrenalectomy, splenectomy and vena cava was reconstructed (venous operation) and the organs were flushed. His concomitant medications and previous drug reactions were not provided.  On 02-MAR-2020 the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in his left arm as prophylaxis (concentration, number of dose administered, route of administration, lot number and expiration date were not reported). On the same date, 3 hours after the patient was received the vaccine he experienced excruciating pain (pain in extremity).   On 10-MAR-2020, the patient received pembrolizumab (KEYTRUDA) with (INLYTA) (for both therapies, strength, dose, frequency, route of administration, lot number and expiration date were not provided) for renal cell carcinoma. On 19-MAR-2020, the patient experienced confusion (also reported as he said things that did not make any sense) (confusional state). On an unspecified date in 2020, the patient received magnetic resonance imaging (MRI)  of the shoulder because of a unspecified lesion, the wife stated that, the physician believed that the shoulder was inflamed (arthritis). On 23-MAR-2020, the patient started daily treatment of prednisone for the inflamed shoulder. The patient sought medical attention.  The outcome of pain in extremity was reported as not recovered because she still had pain in his left arm., however the outcome of confusional state and arthritis was not reported.  The causality assessment between pembrolizumab (KEYTRUDA) and the events arthritis and confusional state was not reported and for the event pain in extremity was not related. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with the aforementioned events was not reported.  This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2003USA009835:
Sex: M
Vaccine: PPV
Symptoms: Skin lesion
Clinical narrative: the patient experienced confusion/ the patient would say things that did not make sense; the patient experienced excruciating pain; the patient received an MRl of the shoulder because of a lesion ( described as an unknown physician believes it is inflamed; This spontaneous report was received from a patient's wife referring to her 83-year-old male husband. The patient's pertinent medical history included blood urine present, two tumors on the kidney (renal neoplasm), nephrectomy, adrenalectomy, splenectomy and vena cava was reconstructed (venous operation) and the organs were flushed. His concomitant medications and previous drug reactions were not provided.  On 02-MAR-2020 the patient was vaccinated with one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection in his left arm as prophylaxis (concentration, number of dose administered, route of administration, lot number and expiration date were not reported). On the same date, 3 hours after the patient was received the vaccine he experienced excruciating pain (pain in extremity).   On 10-MAR-2020, the patient received pembrolizumab (KEYTRUDA) with (INLYTA) (for both therapies, strength, dose, frequency, route of administration, lot number and expiration date were not provided) for renal cell carcinoma. On 19-MAR-2020, the patient experienced confusion (also reported as he said things that did not make any sense) (confusional state). On an unspecified date in 2020, the patient received magnetic resonance imaging (MRI)  of the shoulder because of a unspecified lesion, the wife stated that, the physician believed that the shoulder was inflamed (arthritis). On 23-MAR-2020, the patient started daily treatment of prednisone for the inflamed shoulder. The patient sought medical attention.  The outcome of pain in extremity was reported as not recovered because she still had pain in his left arm., however the outcome of confusional state and arthritis was not reported.  The causality assessment between pembrolizumab (KEYTRUDA) and the events arthritis and confusional state was not reported and for the event pain in extremity was not related. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) with the aforementioned events was not reported.  This is one of two reports from the same patient.; Sender's Comments:  US-009507513-2003USA009835:
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received from a lawyer and an elderly female patient (pt) of unknown age regarding a case in litigation. Information about the pt's concurrent condition, medical history and concomitant medication was not reported.   In 2013, the pt was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for prophylaxis.   On an unknown date, as a result of zoster of her receipt of vaccine live (ZOSTAVAX), the pt was caused to suffer shingles, including any an all of its sequelae. The pt had suffer severe personal injuries, pain, suffering, and emotional distress as well as to incur substantial economic damages. The pt was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. The pt required and/or would require more health care and services and incurred medical, health, incidental and related expenses. The pt was informed and believed and further alleged that she would in the future be required to obtain further medical and/or hospital care, attention and services.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 60-year-old female patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  On 04-FEB-2014, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) for prophylaxis. As a result of her receipt of vaccination, on 14-APR-2014 it was caused to suffer shingles, including all its sequelae. It has been caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and medications. At the time of the report, the patient's outcome was unknown, and the reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event to be disabling.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a 65-year-old female patient. Information about the patient's concurrent condition, concomitant medication or medical history was not provided.  In September 2016, the patient was vaccinated with a dose of Zoster Vaccine Live (ZOSTAVAX) (dosage, route, lot # and expiration date were not provided) at the pharmacy, for prophylaxis. As a result of her receipt of vaccination, in September 2016 was caused to suffer shingles, including all its sequelae. It has been caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which were permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. At the time of the report, the patient's outcome was unknown, and the reporter considered shingles to be related to Zoster Vaccine Live (ZOSTAVAX).  The reporter considered the event of shingles to be disabling.
Sex: F
Vaccine: SMALL
Symptoms: Exposure to vaccinated person, Furuncle, Secondary transmission, Vaccinia virus infection
Clinical narrative: Vaccinia infection due to secondary exposure; It was believed that the vaccinia was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions; Information received on 13DEC2019 from a consumer.  A female patient who experienced "vaccinia infection due to secondary exposure" (PT: Vaccinia virus infection) and "it was believed that the vaccinia was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 (smallpox (vaccinia) vaccine, live) and improper precautions (PT: Exposure to vaccinated person). On 26SEP2019, a 40-year-old male (boy friend of patient) received pre-employment vaccination with ACAM2000. On an unknown date in October 2019, his girlfriend was hospitalized. Unspecified testing revealed that she had vaccinia infection due to secondary exposure. Her symptoms included boils on her face. It was believed that the vaccinia was contracted from the male's recent immunization with ACAM2000 and the boyfriend's failure to take certain precautions for the two week period after being vaccinated. She had recovered from the reported event "Vaccinia infection due to secondary exposure" while the outcome of the event "It was believed that the vaccinia was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions" was unknown.  Company Comment: It was believed that the vaccinia infection was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions (Vaccinia virus infection, exposure to vaccinated person). The patient was hospitalized for Vaccinia virus infection and was recovered form the event. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection to household members and close contacts by accidental (contact) inoculation, and the causality of vaccinia virus infection and exposure to vaccinated person is assessed as possible. The case is considered serious due to the medical significance of the Vaccinia virus infection which led to the hospitalization of the patient. Vaccinia virus infection and exposure to vaccinated person is listed as per Agency.; Sender's Comments: It was believed that the vaccinia infection was contracted by secondary exposure from her boyfriend's recent immunization with ACAM2000 and improper precautions (Vaccinia virus infection, exposure to vaccinated person). The patient was hospitalized for Vaccinia virus infection and was recovered form the event. ACAM2000 is a live virus vaccine and has a potential to cause vaccinia infection to household members and close contacts by accidental (contact) inoculation, and the causality of vaccinia virus infection and exposure to vaccinated person is assessed as possible. The case is considered serious due to the medical significance of the Vaccinia virus infection which led to the hospitalization of the patient. Vaccinia virus infection and exposure to vaccinated person is listed as per Agency.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Hyperhidrosis, Pruritus, Rash, Urticaria
Clinical narrative: Dizziness, Rash, UrticariaPruritus, & Urticaria; diaphoresis
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Malaise, Peripheral swelling, Pyrexia
Clinical narrative: patient had red swollen arm, mailaise and fever
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, Joint stiffness, Joint swelling, Laboratory test, Musculoskeletal disorder
Clinical narrative: received vaccine on 2/5, on 2/11 at 5pm he started to feel stiffness in hands, knees, feet, most joints. These all became very swollen. Couldn't use hands for about 2 weeks. saw md on 2/13 and they started a Medrol dose pack and also allegra 24 hour OTC. a week later he started taking meloxicam. About 3 weeks passed in total until his symptoms cleared up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Urine analysis
Clinical narrative: received vaccine on 2/5, on 2/11 at 5pm he started to feel stiffness in hands, knees, feet, most joints. These all became very swollen. Couldn't use hands for about 2 weeks. saw md on 2/13 and they started a Medrol dose pack and also allegra 24 hour OTC. a week later he started taking meloxicam. About 3 weeks passed in total until his symptoms cleared up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Chills, Dizziness, Headache
Clinical narrative: 2/12/2020 around 2 AM. Felt really sick, achy like she had the flu, had chills, hot flashes, bad headache. Also reports bad dizzy making her almost fall.  Felt like this for 2 days. Reports "breathing has been bad", reports no energy, breathing kept getting worse,  Now on inhaler where she never was on before.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Hot flush, Influenza like illness, Malaise, Respiration abnormal, SARS-CoV-2 test negative
Clinical narrative: 2/12/2020 around 2 AM. Felt really sick, achy like she had the flu, had chills, hot flashes, bad headache. Also reports bad dizzy making her almost fall.  Felt like this for 2 days. Reports "breathing has been bad", reports no energy, breathing kept getting worse,  Now on inhaler where she never was on before.
Age: 12.0
Sex: M
Vaccine: HPV9, TDAP
Symptoms: Lip swelling, Rash, Swelling face
Clinical narrative: Within 3hrs developed facial and lip swelling then facial rash that progressed slowly over 2-3 more days. Family called that evening and told to give Benadryl, symptoms slowly progressed and spoke gain 3/23 and started course of oral steroids.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Tendonitis
Clinical narrative: Tedionitos in left shoulder Physical Therapy. Still having pain in left shoulder.
Age: 10.0
Sex: M
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; patients received an improperly stored dose of MMR II on unspecified dates; This spontaneous report was received from a nurse practitioner referring to a 10-years-old male patient. The patient's pertinent medical history and previous drug reaction, and allergies were not reported. The patient's concomitant therapy included sterile diluent injection.  On 14-AUG-2019, the patient was vaccinated with improperly stored measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, recombinant Human albumin (M-M-R II) of lot # R028382, expiration date reported as 02-OCT-2020, but upon internal validation established as 10-MAR-2020 (exact dose, dose number and route of administration were not reported) for prophylaxis (product storage error). The sterile diluent injection used to reconstitute the vaccine was stored in the recommended temperature range. On an unknown date, the vaccine administered to the patient was exposed to the temperature excursion of -58 degree Fahrenheit and +46 degree Fahrenheit (35.1 Fahrenheit (F)) for 30 minutes, and at highest temperature above 47.1 degree Fahrenheit (47.1 F) for 30 minutes. There was previous temperature excursion at -58 degree Fahrenheit and +46 degree Fahrenheit (-35.8 F) for 30 minutes. There was no adverse effect reported (no adverse event). Digital data logger was involved. No product quality complaint was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1909USA006066: US-009507513-2003USA010168: US-009507513-2003USA010169:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Cholecystectomy, Computerised tomogram abdomen, Gallbladder disorder
Clinical narrative: On 11/23/19 presented with fever, chills, N/V, headache, backache. Went to ER, had abdominal sonogram and sent home with suspected GB attack. Returned to ER same day + admitted. Had routine work up + an abd. CT. Liver enzymes elevated. Admitted + several days passed. Decreased WBC + decreased platelets. Cholecystectomy 11/29/20. What triggered the attack???
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hepatic enzyme increased, Nausea, Platelet count decreased, Pyrexia
Clinical narrative: On 11/23/19 presented with fever, chills, N/V, headache, backache. Went to ER, had abdominal sonogram and sent home with suspected GB attack. Returned to ER same day + admitted. Had routine work up + an abd. CT. Liver enzymes elevated. Admitted + several days passed. Decreased WBC + decreased platelets. Cholecystectomy 11/29/20. What triggered the attack???
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Ultrasound abdomen abnormal, Vomiting, White blood cell count decreased
Clinical narrative: On 11/23/19 presented with fever, chills, N/V, headache, backache. Went to ER, had abdominal sonogram and sent home with suspected GB attack. Returned to ER same day + admitted. Had routine work up + an abd. CT. Liver enzymes elevated. Admitted + several days passed. Decreased WBC + decreased platelets. Cholecystectomy 11/29/20. What triggered the attack???