chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 02-NOV-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # M037533 with an expiration date 17-MAY-2018 (dose and route were not provided). No adverse effect was reported. The administered dose of PNEUMOVAX 23 experienced the temperature excursion form 47 to 77 degrees Fahrenheit for 7 hours and 50 minutes. There was no previous temperature excursion. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1712USA004521: US-009507513-1712USA004522:
Sex: M
Vaccine: HPVX
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a male patient of unknown age who was reporting on himself. The patient's concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated with one dose of GARDASIL 9, for prophylaxis (lot#, expiration date and route of administration were not reported). On an unknown date, the patient returned to the office for his second dose of GARDASIL 9 but he have might received one dose of GARDASIL, for prophylaxis (lot#, expiration date and route of administration were not reported) because his chart was marked with GARDASIL instead GARDASIL 9. No adverse reaction was reported.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age. The patient's concomitant medication, pertinent medical history, drug reactions and allergies were not provided. On 01-DEC-2017, the patient was vaccinated with expired ZOSTAVAX vial 19400PFU, lot # M042504; expiry date 30-NOV-2017 (dose and route of administration were not provided) reconstituted with properly stored sterile diluent. No adverse effect were reported.
Age: 13.0
Sex: F
Vaccine: FLUX, HPV9
Symptoms: Autoimmune disorder, Muscle spasms, Tic, Vaccination complication
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 13-year-old female patient. The patient did not have any concurrent conditions or medical history. The patient's concomitant therapies were not reported. On 08-NOV-2017, the patient was vaccinated with the first dose of GARDASIL 9 lot # N020352, expiration date: 10-APR-2020, intramuscularly (dose was not reported) as human papilloma virus (HPV) vaccine. On the same day, the patient was also vaccinated with influenza virus vaccine (unspecified) (dose, route of administration, lot# and expiration date were not reported). On 11-NOV-2017, the patient visited an emergency room and was diagnosed with right shoulder spasms and tics (tic disorder) and subsequently was hospitalized. On 13-NOV-2017, the patient returned to the physician's office and was referred to a neurologist. On 04-DEC-2017, the patient visited the neurologist, where she was diagnosed with auto-immune reaction to GARDASIL 9 vaccine. No lab diagnostics or studies were performed. The outcome of the events was reported as not recovered. The causality betweentic disorder and GARDASIL 9 was not provided. The autoimmune reaction was considered to be related to GARDASIL 9. The events of tic disorder and autoimmune reaction were determined to be medically significant by the reporter.
Sex: U
Vaccine: PER, TTOX
Symptoms: Allergy to vaccine
Clinical narrative: Initial unsolicited report received from a pharmacist and healthcare professional via other company (Pfizer) (Manufacturer Report Number: 2017366848) on 25-Oct-2017. This case involves a patient of unknown age and gender, who was vaccinated with a dose of TETANUS TOXOID and with a dose of PERTUSSIS VACCINE (batch number, expiration date, dose, dose in series, route and site of administration were not reported for both); both on an unspecified date. Patient's medical history and concomitant medications were not reported. On an unspecified day, following the vaccination, the patient had developed allergy to components of the Pertussis and Tetanus vaccine. Laboratory investigations and corrective treatment were unknown. Outcome of the event was not reported. List of documents held by sender: none.
Age: 90.0
Sex: M
Vaccine: FLU3
Symptoms: Tinnitus
Clinical narrative: Initial unsolicited report received from a consumer on 24-Oct-2017. This case involves a 90-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HD (batch number, expiry date and site of administration were not reported) via intramuscular route on 18-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe ringing in ears which resolved and now has a persistent buzzing in his head. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient was recovered with sequelae from events. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Fatigue, Feeding disorder
Clinical narrative: Initial unsolicited report received from a consumer (patient-herself) on 25-Oct-2017. This case involves a 72-year-old female patient, who was vaccinated with a dose of 0.5 ml of FLUZONE HIGH-DOSE via intramuscularly once (batch number, expiry date, dose in series were not reported) in the right deltoid on 16-Oct-2017. The patient's medical history and concomitant medications was not reported. On an unspecified date, following the vaccination, the patient felt like sick as a dog, can't eat, nauseated, diarrhea, thirsty, weak, light headed, fatigued and thirsty. Lab data and corrective treatment was not reported. The outcome was not reported. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Nausea, Thirst
Clinical narrative: Initial unsolicited report received from a consumer (patient-herself) on 25-Oct-2017. This case involves a 72-year-old female patient, who was vaccinated with a dose of 0.5 ml of FLUZONE HIGH-DOSE via intramuscularly once (batch number, expiry date, dose in series were not reported) in the right deltoid on 16-Oct-2017. The patient's medical history and concomitant medications was not reported. On an unspecified date, following the vaccination, the patient felt like sick as a dog, can't eat, nauseated, diarrhea, thirsty, weak, light headed, fatigued and thirsty. Lab data and corrective treatment was not reported. The outcome was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Initial unsolicited report received from an office staff on 25-Oct-2017. This case involves a female patient of unknown age who was vaccinated with a intradermal dose of FLUZONE INTRADERMAL (batch number, expiry date and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced whole upper arm was completely swollen and red. The patient's laboratory data and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Therapeutic response unexpected
Clinical narrative: Initial unsolicited report received from a consumer on 14-Nov-2017. This case involves a 56-year-old male patient, who was vaccinated with 0.5ml dose at frequency once of FLUZONE QUADRIVALENT (batch number and expiration date was unknown), intramuscularly on an unknown site on 08-Nov-2017. Medical history included bilateral vascular necrosis in hips and herniated disc along with walking difficulty, pain and numbness right foot. Concomitant medication was not reported. On 09-Nov-2017, one-day post vaccination, the patient returned to baseline of walking difficulty, pain and numbness right foot i.e. walking without pain, able to touch toes, had feeling in right foot, able to move and walk well. It was reported that, the patient had relief of pain and ability to walk lasted for 5 days following vaccination (Nov-2017). Patient's lab test and corrective treatment was not reported. Outcome of the event was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 01-Dec-2017. This case involves a female patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (batch number, expiry date, route, dose, dose in series and site of administration were not reported) on an unspecified date in 2013. (The reporting patient stated that she did not know name of flu vaccine she had received). The patient medical history and concomitant medication was not reported. On an unknown date, following vaccination the patient experienced hives on her chest, arms, thighs and calves. Relevant lab test and corrective treatment was not reported. On an unknown date, patient recovered from the event. List of documents held by sender: none.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Rash, Skin warm
Clinical narrative: Pt stopped in Pharmacy 72 hrs after shot. Her right arm was very red and warm. The redness was at least 3 inches away from where the shot was given however I told her to call MD. Pt sopped in 48 hrs later. Rash resolved but MD started KEFLEX as precaution.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Fatigue, Nausea, Pain, Pyrexia
Clinical narrative: Pain, swelling, redness, w/in 10 min, nausea, fatigue and fever at night.
Age: 37.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: Pain, swelling, redness, w/in 10 min, nausea, fatigue and fever at night.
Age: 58.0
Sex: U
Vaccine: PPV
Symptoms: Eye swelling, Fatigue, Oropharyngeal pain, Rash
Clinical narrative: Sore throat, fatigue, rash on face, periorbital swelling.
Age: 25.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt presented to health center today with redness and itching to left deltoid. Pt states painful at first then itchy. Better today. Cetirizine 10 mg tablet administered to pt.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Ongoing pain in LLE that has been worsening since injection. No redness at injection site.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Malaise, Nausea, Peripheral swelling, Pruritus generalised
Clinical narrative: A week later my arm was swollen, red, itchy and hot. Talk with doctor and received prescription for Triamcinolone lotion 0.1%. I did not used prescription first let it go away on it's own. Took 4 days. I felt itchy all over and had slight rash. Felt nauseated and unwell.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Skin warm
Clinical narrative: A week later my arm was swollen, red, itchy and hot. Talk with doctor and received prescription for Triamcinolone lotion 0.1%. I did not used prescription first let it go away on it's own. Took 4 days. I felt itchy all over and had slight rash. Felt nauseated and unwell.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Site swollen-cold compress, raised, redden, warm to touch, fever-TYLENOL.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Upper left arm swelling, redness, inflammed, warm to the touch. patient was seen by two different providers. First time was 2 days after injection and again 4 days after injection as it was reactions were worsening.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Pt got very first flu shot on 09/26/2017 at 13:35. Pt says 2 hours later she had redness, itchiness at the site. The next day it had swollen to a quarter size. Pt used cold pack as treatment.
Age: 42.0
Sex: F
Vaccine: FLUR3
Symptoms: Pruritus generalised, Rash generalised, Wheezing
Clinical narrative: Employee reports 10 to 15 minutes after the injection she developed overall body itching and rash. Throughout the day she had wheezing and reported using her inhaler a few times during the day. She also took two doses of BENADRYL. The symptoms lasted a few days and slowly went away.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: Later that day Dec 5, 2017 after the vaccination it becomes sore and the pain got worse as the day went by. On Dec 11, 2017 she pass by the pharmacy because she was still in pain on the injection site and bothers her so I told her to put a cold compress which she did for an hour and the pain was gone. Today, 12/13/2017 I called her to check on her and told me everything is okay after she put cold compress.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Rash
Clinical narrative: Rash, redness.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, MMR
Symptoms: Pyrexia, Seizure, Viral infection, White blood cell count increased
Clinical narrative: Mother stated that patient developed a fever about 10 days after receiving vaccinatons injections and the fever spiked and the patient had 1 seizure while setting the table for dinner. Mother stated that she took patient to local hospital ER and patient was given Ibuprofen and Tylenol for fever and observed and released. Blood work done during ER visit showed elevated WBC and physician suggested patient had a viral infection. Mother stated that patient did not have any more seizures after first one and his temperature decreased as well.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Gait disturbance, Injected limb mobility decreased, Musculoskeletal stiffness, Sleep disorder
Clinical narrative: The patient experienced muscle stiffness in her back and arm and her joints on the left side were burning and stinging. On some days it was difficult for the patient to walk (left foot) and she needed an ankle brace. The patient also experienced difficulty sleeping on her left side and it was hard to lift her left arm.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Asthenia, Blood creatine phosphokinase normal, Diarrhoea, Fatigue
Clinical narrative: Within 24 hrs developed nausea, vomiting, diarrhea, fever, swollen arm, with diffuse arthralgias and myalgias. This was severe for 24-48 hrs then was left with severe weakness, fatigue, arthralgias and myalgias diffusely. These latter symptoms have continued.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Full blood count normal, Metabolic function test normal, Myalgia, Nausea, Peripheral swelling
Clinical narrative: Within 24 hrs developed nausea, vomiting, diarrhea, fever, swollen arm, with diffuse arthralgias and myalgias. This was severe for 24-48 hrs then was left with severe weakness, fatigue, arthralgias and myalgias diffusely. These latter symptoms have continued.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: Within 24 hrs developed nausea, vomiting, diarrhea, fever, swollen arm, with diffuse arthralgias and myalgias. This was severe for 24-48 hrs then was left with severe weakness, fatigue, arthralgias and myalgias diffusely. These latter symptoms have continued.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Later on the same day that the flu vaccine was administered, patient developed a localized reaction including redness, heat, swelling, pain and firmness at the site of the vaccine, size of the child's hand, approximately. Provider advised diphenhydramine for the next 24 hours, ice and acetaminophen as needed.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction
Clinical narrative: Later on the same day that the flu vaccine was administered, patient developed a localized reaction including redness, heat, swelling, pain and firmness at the site of the vaccine, size of the child's hand, approximately. Provider advised diphenhydramine for the next 24 hours, ice and acetaminophen as needed.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a 12-year-old patient. No information regarding the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, when the patient was 10 years old, they were vaccinated with GARDASIL (dose, route of administration, lot # and expiration date were not reported). On an unknown date, when the patient was 12 years old, they were vaccinated with GARDASIL 9, 0.5 ml via intramuscular route (lot # and expiration date were not reported). No adverse effects were reported.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Bronchitis, Malaise
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer reporting for herself. This 70-year-old female patient of an unspecified race/ethnicity received a pneumococcal vaccine (trade name unknown) at single dose via an unspecified route of administration on 16Nov2017  for immunization. Medical history included asthma that was turning into bronchitis at the time of vaccination. The patient's concomitant medications were not reported. The patient stated that she has been very sick since the vaccination. She ended up in the emergency room (ER) on 01Dec2017 and was diagnosed with a recurrence of bronchitis which was lingering. She received a double dose of prednisone as treatment and she was referred to a pulmonologist. Outcome was unknown. Pfizer is a marketing authorization holder of pneumococcal vaccine in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal vaccine has submitted the same report to the regulatory authorities. The information on the lot number has been requested.
Sex: F
Vaccine: TD
Symptoms: Urticaria
Clinical narrative: Initial unsolicited report received from a pharmacist via other company (Merck) (Manufacturer Report Number: 00624653) on 30 October 2017. This case was linked with 2017SA212777 (same patient). This case involves a female patient of unknown age, who was vaccinated with a dose of DIPHTHERIA AND TETANUS TOXOIDS (TD) (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications was not reported. On an unspecified date, following the vaccination, the patient developed hives. Lab data and corrective treatment was not reported. The outcome was recovered on an unspecified day. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial unsolicited report received from a pharmacist on 01-Nov-2017. This case involves a patient of unknown age and gender vaccinated with FLUZONE HIGH-DOSE (batch number, expiry date, dose in series, route, site were not reported) on an unknown date. Patient medical history not reported. It was also reported that patient had no known drug allergy and chronic illness. Concomitant medications were not reported. On an unknown date, after the vaccination, the patient's arm had swelled up. Lab data and corrective treatment were not reported. The event's outcome was not reported. List of documents held by sender: none.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Pain, Throat tightness, Vaccination site pain
Clinical narrative: Generalized body ache. Mild closing of throat happned 2x. Vaccine site swollen, warm to the touch, tender, Red. Chills .
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Generalized body ache. Mild closing of throat happned 2x. Vaccine site swollen, warm to the touch, tender, Red. Chills .
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Contusion, Injection site erythema, Injection site induration, Injection site swelling, Rash erythematous
Clinical narrative: About 24hrs after the shot was given, there was swelling, redness and hardness of the muscle in the upper deltoid of the left arm. The size of the redness was about the size of an avocado. 48 hrs later  the redness grew to be as large as almost her whole upper arm, but the hardness had lessened. 56 hrs later, the patient was vomitting, but the redness decreased, hardness decreased and only a little bruising and rash like red dots were visible.
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Vomiting
Clinical narrative: About 24hrs after the shot was given, there was swelling, redness and hardness of the muscle in the upper deltoid of the left arm. The size of the redness was about the size of an avocado. 48 hrs later  the redness grew to be as large as almost her whole upper arm, but the hardness had lessened. 56 hrs later, the patient was vomitting, but the redness decreased, hardness decreased and only a little bruising and rash like red dots were visible.
Age: 56.0
Sex: M
Vaccine: FLU4
Symptoms: Inflammation, Injection site pain, Mobility decreased, Pain, Ultrasound scan
Clinical narrative: Patient received flu shot at the workplace clinic from Pharmacy. He noticed pain at the time of the shot and the next day began having considerable pain within his shoulder with limited movement. He waited several weeks hoping pain would subside but it did not. He saw his PCP and MD deduced that perhaps the immunization had been injected into the bursa or tendon and was causing inflammation and pain. The patient was given a cortisone injection (on 10/09/2017) to reduce inflammation and speed up healing. A second cortisone shot was needed a couple weeks later on 10/25/2017 for the pain and inflammation.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb
Clinical narrative: Vaccine given in high upper shoulder, since then c/o pain R shoulder- stated the shot was given very high up by bone. Unable to lift arm up. Called to call center regarding issue 12/11/17, evaluated by NP. 12/12/17, x-ray ordered, PT ordered.
Age: 0.67
Sex: F
Vaccine: HEP
Symptoms: Diarrhoea
Clinical narrative: Diarrhea, 2-3 times daily since vaccination.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Electroencephalogram, Fatigue, Fluid retention, Hypoaesthesia, Illusion
Clinical narrative: Right after getting the vaccine, patient had fluid accumulation/ swelling/redness  from left shoulder through the left elbow. It lasted for 5 days after treating with ice and benadryl. About a week after receiving the shot, patient felt beyond fatigued and her "perception changed eg, objects were moving. This lasted about 2 hours (1st episode). Neurologist called it a possible small seizure. Then she also felt numbness in top left back area of her head for about 10 hours on and off. This was on thursday (2nd episode 11/30/17) A third episode happened similar to 1st episode happened on saturday (dec 2).
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: Right after getting the vaccine, patient had fluid accumulation/ swelling/redness  from left shoulder through the left elbow. It lasted for 5 days after treating with ice and benadryl. About a week after receiving the shot, patient felt beyond fatigued and her "perception changed eg, objects were moving. This lasted about 2 hours (1st episode). Neurologist called it a possible small seizure. Then she also felt numbness in top left back area of her head for about 10 hours on and off. This was on thursday (2nd episode 11/30/17) A third episode happened similar to 1st episode happened on saturday (dec 2).
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dyspnoea, Feeling cold, Rash, Rash erythematous
Clinical narrative: After discharge while pt was still in the clinic she started to feel cold, and felt a burning sensation on her skin. She went to the bathroom where she noticed hives on her legs. Notified medical staff and she was brought to an exam room. I was notified and when I arrived she was sitting in a chair, alert but shivering. Erythematous urticarial rash noticed on b/l thighs and later on sides of abdomen and on arms. She started to complain of some shortness of breath and throat tightening. Paramedics were called. Lungs clear on exam and no edema of pharynx noted. O2 sat was 99%. She was administered EPIPEN 0.3mg IM to L thigh at 5:40pm and very soon after this she reported that throat tightening and shortness of breath were improving. Vitals at 5:42pm: BP 122/80, HR 92 bpm, O2 sat 99%. Paramedics arrived and pt was transported to ER. She was advised to return to sign ROI and schedule ER follow-up.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Skin burning sensation, Throat tightness, Urticaria
Clinical narrative: After discharge while pt was still in the clinic she started to feel cold, and felt a burning sensation on her skin. She went to the bathroom where she noticed hives on her legs. Notified medical staff and she was brought to an exam room. I was notified and when I arrived she was sitting in a chair, alert but shivering. Erythematous urticarial rash noticed on b/l thighs and later on sides of abdomen and on arms. She started to complain of some shortness of breath and throat tightening. Paramedics were called. Lungs clear on exam and no edema of pharynx noted. O2 sat was 99%. She was administered EPIPEN 0.3mg IM to L thigh at 5:40pm and very soon after this she reported that throat tightening and shortness of breath were improving. Vitals at 5:42pm: BP 122/80, HR 92 bpm, O2 sat 99%. Paramedics arrived and pt was transported to ER. She was advised to return to sign ROI and schedule ER follow-up.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Aphasia, Autism spectrum disorder, Detoxification, Electroencephalogram, Motor dysfunction
Clinical narrative: He started having hard ticks, rash, fever, stopped using his hands, stop talking, its been a year of detoxing him trying to get him back before the MMR and he has yet to do anything but regress.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash, Sleep study, Tic
Clinical narrative: He started having hard ticks, rash, fever, stopped using his hands, stop talking, its been a year of detoxing him trying to get him back before the MMR and he has yet to do anything but regress.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Biopsy skin, Blister, Injection site pruritus, Pemphigoid, Skin irritation
Clinical narrative: Patient started 3 days later with itching at injection site and the patient had been to the doctor, which had given him medications. A few days later the irritation became worse and the patient went to the ER. The patient was developing blisters and the ER gave him anti-allergy medication and sent him home. The patient was later hospitalized due increased number of blisters that was multiplying and was covering the torso and neck, and the upper part of his legs including his privates. The final diagnosis of the hospital was bullous pemphigoid.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Dyskinesia, Neurological examination normal
Clinical narrative: Day after vaccine patient developed jerking of R lower extremity. No generalized tonic clonic movements or eye deviation or postictal states.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Injection site swelling
Clinical narrative: 6.5x3.0 in swelling of L thigh.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Pharyngeal oedema, Pyrexia, Throat tightness
Clinical narrative: Patient stated that within 1 to 2 hours of receiving the vaccation her felt like her throat was closing/swelling, fever, chills.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On her left arm she has a bruise that has a red hot to touch circle around the bruised site. For pain she is can take MOTRIN or TYLENOL and giving BENADRYL for swelling.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Medical Assistant concerning to a patient of unknown age and gender. Medical history, concomitant medication and concurrent conditions were not provided. On 22-NOV-2017, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # N024384, the expiration date:18-MAY-2019 (dose and route were not reported) for prophylaxis. No adverse effects reported. There was no previous temperature excursion and the call was not due the data logger. The temperature reported was 12°F with a time frame of 5 hours.
Sex: F
Vaccine: VARCEL
Symptoms: Antibody test negative, Incorrect route of drug administration, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an adult female patient with unknown age. The patient's medical history, concurrent conditions, concomitant therapies, drug reactions, and allergies were not reported. On an unspecified date (reported as in her youth), the patient received immunization series of VARIVAX for prophylaxis (Dosage schedule, strength, route, anatomical location, lot number and expiration date were not reported); however on an unspecified date, the patient had a varicella virus test which showed lack of immunity to varicella virus. On approximately November 2017, the patient received another dose of VARIVAX for prophylaxis (Dosage schedule, strength, route, anatomical location, lot number and expiration date were not reported) and later at approximately December 2017, the patient was vaccinated with another dose of VARIVAX intramuscularly (lot number M049127 and Expiration date of 15-DEC-2018) (dosage schedule, anatomical location, and strength were not reported); however the reporter stated that the patient had no adverse events since her last vaccination. Other suspect therapies included a sterile diluent (Dosage schedule, strength, route, anatomical location, lot number and expiration date were not reported). The relatedness between the suspect therapies and the lack of immunity to varicella virus was not reported.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient complains of pain upon injection. Continued soreness over the subsequent weeks. The soreness has continued without improvement. Patient claims that she is unable to utilize her arm.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatinine increased, Renal function test
Clinical narrative: Almost immediately after the influenza vaccine, my already high but stable creatinine level of 3 began to ratchet higher. No other drugs or changes in lifestyle or environment happened when the creatinine began to spike (on 12/13/17 it was 8+).  I'm wondering if there is a correlation between the flu vaccine and the rapid acceleration of creatinine with previous toxicity due to Ifosfamide.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Peripheral swelling
Clinical narrative: Cellulitis - Arm swelling that extended to upper torso. Dr. prescribed cephalexin for cellulitis.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient had no adverse effects, but he was given FLUZONE QUAD instead of the Meningitis vaccine that he was requesting. Patient had already received his flu shot earlier in the year.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site bruising, Injection site inflammation
Clinical narrative: Patient called at 10:35AM on 12/13/2017 to inform RPh that she had noticed inflammation and bruising at the injection site when she woke up on 12/8/17. Pt didn't call pharmacy previously to this. While talking with pt she informed the RPh that the inflammation had gone down and that the bruising was going away. Pt also mentioned that she had bilateral numbness from her waist to her toes. Pt was encouraged to contact MD and be evaluated. RPh called Pt at 3PM on 12/13/2017 to see if pt had made an appointment with PCP and to confirm information contained in the VAERS. Pt confirmed information and that Pt had made an appointment with PCP for Monday 12/18/2017.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Feeling abnormal, Malaise, Seizure, Syncope
Clinical narrative: Patient at had stated that she was not feeling well, and asked for us to grab her water. Came back with water and was able to drink some water, but then fainted and started to have convulsions (all this while she stayed seated). After she back after convulsions, she was not 100% aware, and then did faint and had convulsions again. This second incident did not last as long. She came back again, and although was still feeling faint, her color was coming back but still was not feeling back to normal. Vomiting did occur after the 2nd incident while she was aware. 911 and EMTs were called after first incident of convulsions and they arrived after the patient had vomited. This occurred between 9:30am and 9:50am. Patient was taken to the hospital.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Patient at had stated that she was not feeling well, and asked for us to grab her water. Came back with water and was able to drink some water, but then fainted and started to have convulsions (all this while she stayed seated). After she back after convulsions, she was not 100% aware, and then did faint and had convulsions again. This second incident did not last as long. She came back again, and although was still feeling faint, her color was coming back but still was not feeling back to normal. Vomiting did occur after the 2nd incident while she was aware. 911 and EMTs were called after first incident of convulsions and they arrived after the patient had vomited. This occurred between 9:30am and 9:50am. Patient was taken to the hospital.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Blood urine present, Burning sensation, Fatigue, Headache, Irritability
Clinical narrative: Patient states that two hours after he received flu vaccine he started to urinate blood. He could not describe if he was a lot but he said it was "enough to notice." Patient also stated that he has had more burning and general pain throughout body; he says he is more forgetful, irritable, joint stiffness, fatigue and more frequent headaches. Patient did not continue to have visible blood in his urine. He did come in 5 days after he noticed blood in his urine and Provider ordered a urinalysis. No blood was found in urine sample results.
Age: 74.0
Sex: M
Vaccine: FLU4
Symptoms: Joint stiffness, Memory impairment, Pain, Urine analysis normal
Clinical narrative: Patient states that two hours after he received flu vaccine he started to urinate blood. He could not describe if he was a lot but he said it was "enough to notice." Patient also stated that he has had more burning and general pain throughout body; he says he is more forgetful, irritable, joint stiffness, fatigue and more frequent headaches. Patient did not continue to have visible blood in his urine. He did come in 5 days after he noticed blood in his urine and Provider ordered a urinalysis. No blood was found in urine sample results.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: Red Raised Lump, Some Slight Swelling. Patient Trying Warm Compress and Ibuprofen.
Age: 58.0
Sex: M
Vaccine: FLU4, PPV, TDAP
Symptoms: Bacterial infection, Chills, Pyrexia, Rash
Clinical narrative: Patient had a high fever for 3 days and chills. Two or three days post injection the patient started to develop a rash on his left arm. After visiting the doctor/hospital, they diagnosed him with a bacteria infection.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Fatigue
Clinical narrative: Per pt she was so tired after receiving the vaccine and  and was having the tightness on the chest that she used her oxygen and took a rest for 24 hours after she feels better.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Needle issue
Clinical narrative: Patient was given the vaccine using a 5/8'' needle instead of recommended 1'' needle. Patient plans to return to pharmacy for revaccination.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Confusional state, Dysarthria, Laryngitis, Nervous system disorder, Speech disorder
Clinical narrative: Patient states she experienced extreme CNS effects like inability to form words, slurred speech, confusion. On 12/12/17 she was diagnosed with Laryngitis which she attributes to the vaccine.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Burning sensation, Computerised tomogram, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Pain, numbness and burning in bilateral hips and bilateral lower extremities. Was hospitalized for five and a half days with many diagnostic tests including lumbar puncture, blood patch, CT scan of L spine with and without contrast, MRI of CSpine, TSpine and LSpine with and without contrast and lab work. Diagnosis is early acute inflammatory demyelinating polyneuropathy, Guillian-Barre Syndrome Treatment is 75 milligrams of LYRICA trice a day and possibly IVIG treatments/blood transfusions. Following up with neurology every six weeks.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Laboratory test, Lumbar puncture, Nuclear magnetic resonance imaging spinal, Pain in extremity, Scan with contrast
Clinical narrative: Pain, numbness and burning in bilateral hips and bilateral lower extremities. Was hospitalized for five and a half days with many diagnostic tests including lumbar puncture, blood patch, CT scan of L spine with and without contrast, MRI of CSpine, TSpine and LSpine with and without contrast and lab work. Diagnosis is early acute inflammatory demyelinating polyneuropathy, Guillian-Barre Syndrome Treatment is 75 milligrams of LYRICA trice a day and possibly IVIG treatments/blood transfusions. Following up with neurology every six weeks.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Ache in right arm and shoulder beginning the day after the flu shot to present (almost 2 months). Range of motion is limited: cannot move right arm over left shoulder or behind right side of the back. Difficult to put on shirt. Cannot lay on right side in bed. Doctor assigned physical therapy exercises as of 12/12/2017.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Petechiae
Clinical narrative: Patient experienced severe petechial.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Blood lactate dehydrogenase increased, C-reactive protein normal, Crying, Decreased activity, Excessive eye blinking
Clinical narrative: Simple febrile seizure, crying, twitching, stiffening 2-3 minutes, fever, ER-observation -> Resolution. Chief Complaint: Seizure-like activity. This morning, just before 8:00 a.m., the dad heard the patient crying, went into the room, and then saw the patient stiffen up, had twitching of his hands, eyes were fluttering and some slight extension of his neck. He then fell asleep afterwards. Dad estimated that the twitching episode happened for approximately 2-3 minutes. He did not pay attention to how long he was sleepy after, but he kind of got sleepy. He sat up then and then drank some water and then wanted to go back to sleep. The parents are telling me that leading up to today, he has not been having any URI symptoms. He has been happy, playful, tolerating good amounts of oral intake, making appropriate amounts of urine output. He did get his immunizations earlier in the week and the mother stated that last time he got his immunizations, he did not spike a fever until the end of the week, so she says that she was expecting it. She felt that he was tactilely warm yesterday, so she did start rotating MOTRIN and TYLENOL for him. He had a slight decrease in his oral intake yesterday and was a little bit crankier than usual, but otherwise, he was fine. They deny any trauma. They deny any falls. They did give him TYLENOL at 8:00 a.m. after he had had the episode and they had last given him MOTRIN last evening. He has tolerated oral intake, but he continued to be somewhat decreased in his activity level. He still feels febrile to the parents. They did not measure it. They brought him immediately into the Emergency Room because of the shaking episode. No sick contacts that they are aware of. Again, no difficulty in breathing. He has been making good urine output until today. No other medications being given other than the MOTRIN and TYLENOL. No other aggravating or relieving factors for the chief complaint.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Febrile convulsion, Full blood count, Hypophagia, Irritability, Metabolic function test
Clinical narrative: Simple febrile seizure, crying, twitching, stiffening 2-3 minutes, fever, ER-observation -> Resolution. Chief Complaint: Seizure-like activity. This morning, just before 8:00 a.m., the dad heard the patient crying, went into the room, and then saw the patient stiffen up, had twitching of his hands, eyes were fluttering and some slight extension of his neck. He then fell asleep afterwards. Dad estimated that the twitching episode happened for approximately 2-3 minutes. He did not pay attention to how long he was sleepy after, but he kind of got sleepy. He sat up then and then drank some water and then wanted to go back to sleep. The parents are telling me that leading up to today, he has not been having any URI symptoms. He has been happy, playful, tolerating good amounts of oral intake, making appropriate amounts of urine output. He did get his immunizations earlier in the week and the mother stated that last time he got his immunizations, he did not spike a fever until the end of the week, so she says that she was expecting it. She felt that he was tactilely warm yesterday, so she did start rotating MOTRIN and TYLENOL for him. He had a slight decrease in his oral intake yesterday and was a little bit crankier than usual, but otherwise, he was fine. They deny any trauma. They deny any falls. They did give him TYLENOL at 8:00 a.m. after he had had the episode and they had last given him MOTRIN last evening. He has tolerated oral intake, but he continued to be somewhat decreased in his activity level. He still feels febrile to the parents. They did not measure it. They brought him immediately into the Emergency Room because of the shaking episode. No sick contacts that they are aware of. Again, no difficulty in breathing. He has been making good urine output until today. No other medications being given other than the MOTRIN and TYLENOL. No other aggravating or relieving factors for the chief complaint.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Muscle twitching, Musculoskeletal stiffness, Posture abnormal, Pyrexia, Seizure like phenomena
Clinical narrative: Simple febrile seizure, crying, twitching, stiffening 2-3 minutes, fever, ER-observation -> Resolution. Chief Complaint: Seizure-like activity. This morning, just before 8:00 a.m., the dad heard the patient crying, went into the room, and then saw the patient stiffen up, had twitching of his hands, eyes were fluttering and some slight extension of his neck. He then fell asleep afterwards. Dad estimated that the twitching episode happened for approximately 2-3 minutes. He did not pay attention to how long he was sleepy after, but he kind of got sleepy. He sat up then and then drank some water and then wanted to go back to sleep. The parents are telling me that leading up to today, he has not been having any URI symptoms. He has been happy, playful, tolerating good amounts of oral intake, making appropriate amounts of urine output. He did get his immunizations earlier in the week and the mother stated that last time he got his immunizations, he did not spike a fever until the end of the week, so she says that she was expecting it. She felt that he was tactilely warm yesterday, so she did start rotating MOTRIN and TYLENOL for him. He had a slight decrease in his oral intake yesterday and was a little bit crankier than usual, but otherwise, he was fine. They deny any trauma. They deny any falls. They did give him TYLENOL at 8:00 a.m. after he had had the episode and they had last given him MOTRIN last evening. He has tolerated oral intake, but he continued to be somewhat decreased in his activity level. He still feels febrile to the parents. They did not measure it. They brought him immediately into the Emergency Room because of the shaking episode. No sick contacts that they are aware of. Again, no difficulty in breathing. He has been making good urine output until today. No other medications being given other than the MOTRIN and TYLENOL. No other aggravating or relieving factors for the chief complaint.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Skin warm, Somnolence, White blood cell count decreased
Clinical narrative: Simple febrile seizure, crying, twitching, stiffening 2-3 minutes, fever, ER-observation -> Resolution. Chief Complaint: Seizure-like activity. This morning, just before 8:00 a.m., the dad heard the patient crying, went into the room, and then saw the patient stiffen up, had twitching of his hands, eyes were fluttering and some slight extension of his neck. He then fell asleep afterwards. Dad estimated that the twitching episode happened for approximately 2-3 minutes. He did not pay attention to how long he was sleepy after, but he kind of got sleepy. He sat up then and then drank some water and then wanted to go back to sleep. The parents are telling me that leading up to today, he has not been having any URI symptoms. He has been happy, playful, tolerating good amounts of oral intake, making appropriate amounts of urine output. He did get his immunizations earlier in the week and the mother stated that last time he got his immunizations, he did not spike a fever until the end of the week, so she says that she was expecting it. She felt that he was tactilely warm yesterday, so she did start rotating MOTRIN and TYLENOL for him. He had a slight decrease in his oral intake yesterday and was a little bit crankier than usual, but otherwise, he was fine. They deny any trauma. They deny any falls. They did give him TYLENOL at 8:00 a.m. after he had had the episode and they had last given him MOTRIN last evening. He has tolerated oral intake, but he continued to be somewhat decreased in his activity level. He still feels febrile to the parents. They did not measure it. They brought him immediately into the Emergency Room because of the shaking episode. No sick contacts that they are aware of. Again, no difficulty in breathing. He has been making good urine output until today. No other medications being given other than the MOTRIN and TYLENOL. No other aggravating or relieving factors for the chief complaint.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Left leg started with redness and rash day after the shot, the second day patient would not walk on leg and seemed worse, went to emergency department and put on BENADRYL and antibiotic. Came to see pediatrician 3 days after event, no fever, walking fine, Mom says still was the same. Nurse practitioner states rash was "impressive" itchy and painful. Mom and grandmother state pt had vaccines Friday, redness/swelling small area on L lateral thigh near injection site yesterday, worse today. No fever some nasal congestion no diff breathing. Unsure which vaccine pt got in LLE but had on R that looked okay. No allergies known. In with mom, pt seen 3 days ago, with 4yr shots. Seemed fine. That dad was C/O about leg hurting. Mom said started with redness and rash just on one leg. Was not walking on it yesterday and seemed worse. Mom took patient to ED and put on BENADRYL and antibiotic. Mom says pharmacy was closed so has not started yet. No fever. Does seem to be walking fine today. Mom says looks about the same, today.