chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Biopsy bone marrow normal, Biopsy lymph gland, Blood potassium decreased, Blood test normal, Chest X-ray normal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received PREVNAR 13 via an unspecified route of administration (at right arm, but not sure) in Oct2018 at single dose for prevention of pneumonia. Chest x-ray was all clear on the same day that he got the vaccine. Medical history included blood pressure high, borderline diabetes, cholesterol, pneumonia twice (first time was 15 years ago and second time he got pneumonia again back in Sep2018 and was told that he needed to get another pneumonia vaccine but that he should wait until the pneumonia cleared up). The patient got a pneumonia vaccine in Sep2016. Family medical history relevant to AEs was reported as none. Concomitant medication included metoprolol, atorvastatin, metformin, losartan. The patient he had a high fever in Oct2018, the fever began a couple of days after getting the vaccine. He went to the ER a couple days later because of the high fever and was admitted. He wasn't sure what he was admitted for exactly, just stated that there were 3 different doctors trying to figure out what was going on with him. He didn't remember the dates of his hospitalization. He thought he went in on a Tuesday and was released on a Thursday morning, and that this all occurred in Oct2018. The doctor thought he had cancer. His lymph nodes were enlarged so he had surgery to remove some of his lymph nodes to test them. They also drilled a hole in his bone to do a bone marrow biopsy. He was going to a Cancer Center where they were drawing his blood once a week, but in Nov2018 everything went back to normal. His lymph nodes went back to normal and there wasn't anything that resulted from the ones that were tested. There wasn't anything abnormal in his bone marrow. While he was in the hospital the doctor said that there was something messed up with his white blood cells, but those went back to normal too. After he got out of the hospital, he had to go to another doctor because his potassium was low. This other doctor took him off of the Metformin and Losartan in Nov2018 or late Oct2018 because his potassium was low. Onset of event potassium was low was 2018, rest of events occurred in Oct2018. The outcome of event potassium was low was unknown, outcome of rest events was recovered in Nov2018, duration was reported as 31 days. The patient stated that he was calling because his doctor didn't think that the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine caused all this. He had been trying to find out if he still needs to get another vaccination, or do it over.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Lymphadenopathy, Pyrexia, White blood cell count abnormal
Clinical narrative: This is a spontaneous report from a contactable consumer (patient).  A 56-year-old male patient received PREVNAR 13 via an unspecified route of administration (at right arm, but not sure) in Oct2018 at single dose for prevention of pneumonia. Chest x-ray was all clear on the same day that he got the vaccine. Medical history included blood pressure high, borderline diabetes, cholesterol, pneumonia twice (first time was 15 years ago and second time he got pneumonia again back in Sep2018 and was told that he needed to get another pneumonia vaccine but that he should wait until the pneumonia cleared up). The patient got a pneumonia vaccine in Sep2016. Family medical history relevant to AEs was reported as none. Concomitant medication included metoprolol, atorvastatin, metformin, losartan. The patient he had a high fever in Oct2018, the fever began a couple of days after getting the vaccine. He went to the ER a couple days later because of the high fever and was admitted. He wasn't sure what he was admitted for exactly, just stated that there were 3 different doctors trying to figure out what was going on with him. He didn't remember the dates of his hospitalization. He thought he went in on a Tuesday and was released on a Thursday morning, and that this all occurred in Oct2018. The doctor thought he had cancer. His lymph nodes were enlarged so he had surgery to remove some of his lymph nodes to test them. They also drilled a hole in his bone to do a bone marrow biopsy. He was going to a Cancer Center where they were drawing his blood once a week, but in Nov2018 everything went back to normal. His lymph nodes went back to normal and there wasn't anything that resulted from the ones that were tested. There wasn't anything abnormal in his bone marrow. While he was in the hospital the doctor said that there was something messed up with his white blood cells, but those went back to normal too. After he got out of the hospital, he had to go to another doctor because his potassium was low. This other doctor took him off of the Metformin and Losartan in Nov2018 or late Oct2018 because his potassium was low. Onset of event potassium was low was 2018, rest of events occurred in Oct2018. The outcome of event potassium was low was unknown, outcome of rest events was recovered in Nov2018, duration was reported as 31 days. The patient stated that he was calling because his doctor didn't think that the pneumococcal 13-val conj vac (dipht crm197 protein) vaccine caused all this. He had been trying to find out if he still needs to get another vaccination, or do it over.
Sex: F
Vaccine: HEPA, MENB, MNQ
Symptoms: Erythema, Swelling
Clinical narrative: This is a spontaneous report from a contactable consumer received via a sales representative. A 16-year-old female patient received TRUMENBA, via an unspecified route of administration first dose on an unspecified date at a single dose for immunisation, MENACTRA, via an unspecified route of administration second dose on an unspecified date at 1 DF, single for immunization, HEPATITIS A, via an unspecified route of administration on an unspecified date at 1 DF, single for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, swelling, ring looking red circle that came and went over the course of 3 weeks. The outcome of the events was unknown. Information on the lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received PREVNAR 13, via an unspecified route of administration on an unspecified date (reported as "Feb27th") at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced have a major allergic reaction to the pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) shot given to her on Feb27th. The patient was very upset and wanted additional information so she can reach out to Pfizer. The outcome of the event was unknown. Information on the batch/lot number has been requested.
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Exposure during pregnancy, Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Patient states she received the pneumonia vaccine on Friday to the left upper arm. The next day, she noted redness and swelling at the injection site. She outlined the redness with a pen, believing it could be infectious. She otherwise feels well, she is concerned about the mild swelling and discomfort. She is currently about 23 weeks pregnant. She does mention 3 episodes of emesis today associated with lunch. She has had some similar episodes throughout her pregnancy associated with eating. She reports T-max at 99.0.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Laboratory test, Measles post vaccine, Nasopharyngitis, Pyrexia, Rash
Clinical narrative: Flat red rash on back, then fever of 103, cold symptoms then the rash spread to stomach and face. The fever went away and the rash then got worse more brighter red, raised like hives all over his body, face, head everywhere then it went to his feet. The whole thing lasted 2 almost 3 weeks.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Rash erythematous, Urticaria
Clinical narrative: Flat red rash on back, then fever of 103, cold symptoms then the rash spread to stomach and face. The fever went away and the rash then got worse more brighter red, raised like hives all over his body, face, head everywhere then it went to his feet. The whole thing lasted 2 almost 3 weeks.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Burning sensation, Injection site pain, Pain
Clinical narrative: Called to report on going right arm pain since getting a Pneumonia vaccine 2/5/19. States that on 2/5/19 later that day after getting her vaccine she developed a burning sensation that came and went away in her right arm starting at the injection site (3 or 4 fingers from her acromion bone) and radiating down to her elbow. No swelling in the arm, redness normal, no heat at injection site, No shortness of breath, headaches fever nausea after immunization, no seizure or unusual health concern. No injection site bruising or abnormal tenderness. No unusual or increased pain with injection. A: Pain described as a burning pain 5 or 6/10. It last for 20 minutes at times, it is worse at night. She states that the frequency of the pain has improved over time. Frequency today was twice. No arm weakness or numbness, no problems with function. Pain occasionally after working out. Will defer to MD for recommendation.
Age: 7.0
Sex: M
Vaccine: MNQ
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient immunization record was transcribed, and second dose of MENACTRA was indicated as overdue in SHOTS. This writer was not aware that Agency guidelines state that MENACTRA is for patients over the age of eleven years and administered the second dose after reading the manufacturer administration is "For 9 months through 55 years of age".
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: 1st dose of SHINGRIX in left deltoid 3/20/2019 3:50pm - patient stayed for 15-20 minutes, noticed tingling across shoulders (both sides) after a few minutes of receiving the vaccination. Advised patient to sit and inquired about any chest pain or heaviness, any shortness or breath or any lightheadedness/dizziness. He denied any and said the tingling was not severe. We continued to monitor him for the 20 minutes following the vaccination and he denied any worsening or new symptoms. The tingling had resolved before he left. Followed up 3/20/2019 5:50pm via phone and he had not had any issues since he left. Said he felt completely fine.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Full blood count, Injection site cellulitis, Metabolic function test, Peripheral swelling
Clinical narrative: Patient had cellulitis of right arm that started just at the injection site. Redness and swelling spread down into forearm and parents brought him to the ER. Itching was also noted on ED notes.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, White blood cell count increased
Clinical narrative: Patient had cellulitis of right arm that started just at the injection site. Redness and swelling spread down into forearm and parents brought him to the ER. Itching was also noted on ED notes.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall
Clinical narrative: Pt received 1st GARDASIL and at 1 min after injection, pt stiffened, fell back onto exam table and twitched. Episode lasted at 1 min. Pt was conscious but doesn't remember what happened. Vitals stable. Pt remained in exam room extra 30 min and left with baseline behavior and vitals.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions/allergies were not provided. On 28-FEB-2019, the patient was vaccinated with GARDASIL 9 (Lot # N017686, expiration date 02-FEB-2020) (strength, dose and frequency were not provided) via intramuscular route for prophylaxis following a temperature excursion. No adverse effects were reported in the patient. The GARDASIL 9 was stored at a temperature of 47.7 degree Fahrenheit, for a time frame of 25 days and there was no previous temperature excursion. Digital data logger was involved. There was no PQC involvement.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain
Clinical narrative: Headache, chills, injection site pain. Tx: TYLENOL and Ice PRN. Pt instructed to call if symptoms persist or worsen.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation
Clinical narrative: Burning sensation under skin on lower back radiating to bilateral lower extremities after receiving SHINGRIX vaccine in left deltoid on 11/26/2018.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation issue
Clinical narrative: No adverse event - forgot to mix vaccine, pt. only received the diluent. She return and we administer correctly.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Erythema, Gait disturbance, Injection site swelling, Nerve injury, Product administered at inappropriate site
Clinical narrative: Vaccines administered in Quad muscle not vastus lateralis. 1 of the two vaccines had 3 injection sites unknown which of the two. Localized reaction of rednes, swelling at injection sites, minor nerve damage expect to resolve over the next several days. Not bearing full weight on left leg. Left leg turned inward.
Age: 2.0
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Weight bearing difficulty
Clinical narrative: Vaccines administered in Quad muscle not vastus lateralis. 1 of the two vaccines had 3 injection sites unknown which of the two. Localized reaction of rednes, swelling at injection sites, minor nerve damage expect to resolve over the next several days. Not bearing full weight on left leg. Left leg turned inward.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Cyanosis, Drug screen, Febrile convulsion, Oral disorder, Pyrexia
Clinical narrative: Pt had 3 febrile seizures, one with cyanosis requiring oxygen. Pt was transported by ambulance to the hospital and admitted.
Age: 2.0
Sex: M
Vaccine: MMRV
Symptoms: Respiratory viral panel, Upper respiratory tract infection, Urine analysis
Clinical narrative: Pt had 3 febrile seizures, one with cyanosis requiring oxygen. Pt was transported by ambulance to the hospital and admitted.
Age: 19.0
Sex: F
Vaccine: HEP
Symptoms: Dysphagia, Dyspnoea, Feeling hot, Foaming at mouth, Malaise
Clinical narrative: 15 minutes after her vaccine, I went to check on the employee and she stated she didn't feel well. She was brought into an office for further evaluation. She stated she felt that her mouth was "foamy", had shortness of breath, and that she was hot. She was instructed to remove her lab coat and sit down. Vitals were monitored: BP-122/80, pulse- 76. A damp paper towel was placed on her neck and she was given a water and granola bar. She denied difficulty breathing. Approximately 5 minutes after that, she stated she couldn't swallow. EMS was activated at 08:55. An EPI PEN was administered at 09:00 in the right thigh. EMS arrived at 09:03 and the decision was made to transport her. She requested to be transported to the Facility. They left the center at 09:08.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Insomnia, Tremor
Clinical narrative: PATIENT DESCRIBED GETTING "CHILLS" AND SHAKING/COLD FEELING AROUND 2 AM. WOKE HIM FROM SLEEP. LASTED ABOUT 2-3 HOURS PER THE PATIENT'S MEMORY. NO OTHER ADVERSE EFFECTS. PATIENT'S SISTER EXPERIENCED SAME SIDE EFFECTS AFTER SHE RECEIVED SHINGRIX.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Limb discomfort, Pyrexia
Clinical narrative: A rash at the injection site, pain for several days in arm, feverish feeling.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error, Product preparation issue
Clinical narrative: Only diluent/Adjuvant given. No adverse reactions identified.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Swelling at vaccine site, redness, hot to touch.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Patient was given a double dose of varicella.
Age: 41.0
Sex: F
Vaccine: HEPAB, JEV1, PPV
Symptoms: Pruritus, Rash, Swelling
Clinical narrative: RIGHT ARM. ITCHING AND RASH/SWELLING GREATER THAN SIZE OF HAND. STARTED MIDDAY ON NEXT DAY, PATIENT DID NOT NOTICE SWELLING UNTIL LATER THAT EVENING. HAS NOT YET RESOLVED WITH BENADRYL AND HYDROCORTISONE CREAM.
Age: 62.0
Sex: M
Vaccine: HEPAB, MNQ, VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: Swelling at injection site.
Age: 31.0
Sex: M
Vaccine: FLU4, HEPA, MMR, TDAP
Symptoms: Confusional state, Disorientation, Feeling hot, Loss of consciousness
Clinical narrative: A few seconds shortly after injection of all four vaccines, patient lost consciousness for 5-10 seconds. patient awoke confused and disoriented. He proceeded to complain of feeling hot. Stated he might be dehydrated. Patient was given water and sat for 15 minutes at pharmacy. EMTs came to check on him but did not take him to the hospital.
Sex: M
Vaccine: HEPA, MMR, RV5, VARCEL
Symptoms: Abdominal discomfort
Clinical narrative: This spontaneous report was received from a medical assistant and refers to an infant male patient. The patient's concurrent conditions included allergy to soy and dairy. His medical history and concomitant drugs were not reported. On unknown dates, the patient was vaccinated with ROTATEQ orally (exact dose, frequency, lot # and expiration date were not reported), VAQTA (exact dose, frequency, route and site of administration, lot # and expiration date were not reported), M-M-R II (exact dose, frequency, route and site of administration, lot # and expiration date were not reported) and VARIVAX (exact dose, frequency, route and site of administration, lot # and expiration date were not reported) for prophylaxis (reported as his 2 and 4 month vaccines). On an unknown date, the patient had quite a bit of gastrointestinal discomfort. The reporter inquired if any of suspected vaccines contained soy, dairy products or derivatives. The outcome of the event was unknown. The relatedness between the event and suspected vaccines was not reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant medications were not reported. On 22-FEB-2019, the patient was vaccinated with VARIVAX (strength, dose, frequency, route, lot # and expiry were not reported) for prophylaxis, reconstituted with expired sterile diluent (strength, dose, frequency were not reported) lot # M019891 and expiry date reported 11-OCT-2018 and no adverse effects were reported. This is one of the 3 reports concerning same reporter.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Headache, Laboratory test normal, Photophobia
Clinical narrative: This is a spontaneous report from a contactable physician. A 18-year-old female patient received the 2nd dose of TRUMENBA (lot# S58879CVX, exp date 30Jun2019, NDC 0005-0100-01), intramuscular in left arm, on 28Feb2018 at 07:30 PM, at 0.5 ml single, for immunisation. Medical history included ongoing attention deficit/hyperactivity disorder and ongoing headache. Concomitant medication included dexamethasone, ofloxacin hydrochloride (FOCALIN) from some years before and ongoing for attention deficit/hyperactivity disorder (prescribed by the neurologist). The patient previously took the 1st dose of TRUMENBA (lot# S58879CVX, exp date 30Jun2019) on 28Feb2018, for immunisation. The patient experienced headache and dizziness both on 11Mar2019, with outcome of recovering. Therapeutic measures were taken as a result of headache. The patient waited 10-15 minutes in physician's office before going home. When she was at the car she then started feeling dizzy and had a severe headache. She was asked to come back in and checked her vital signs, and they were stable. She was interacting and talking with her eyes closed like the lights were bothering her. She had her hand on her forehead like her head was hurting really bad. After 45 minutes the headache persisted all the way through. They gave her Pedialite and she took a few sips. The doctor asked if the patient eat and the patient said yes. The parents brought her to the emergency department and 1 hour later they went home. The patient slept through the night. Her headache reduced significantly. The events were considered serious as per medically significant by the reporter. Causality: This happened after giving the vaccine and there was nothing else to account for this. Her exam was normal.; Sender's Comments: Based on the information available, the Company cannot exclude that the suspect vaccine meningococcal group b rlp2086 contributed to the development of the reported events dizziness and headache.
Sex: U
Vaccine: HIBV
Symptoms: Unevaluable event
Clinical narrative: Initial information received on 18-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse by phone. This case involves patient of unknown demographics where something happened a while ago and got it, while received vaccine ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE (lot number: UI764AA, expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, something happened a while ago and a patient got it (unevaluable event) following the administration of HIB (PRP/T) VACCINE. No Lab data was reported. Final diagnosis was something happened a while ago and a patient got it. It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for something happened a while ago and a patient got it. Documents held by the sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Crying, Irritability, Poor quality sleep
Clinical narrative: Irritability, poor sleep, increase difficulty to console crying started the day after vaccination and continued.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient recently reported she experienced body aches; muscles felt like "ice picks sticking in them" improved after ibuprofen but did not feel well for 3 days. Arm was red, swollen and sore. Patient reported "psoriatic type rash" to torso which lasted approximately 3-3.5 weeks. Patient reports family history of rheumatological disease but patient denies ever being diagnosed with rheumatological or autoimmune type diseases.
Age: 83.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Limb discomfort
Clinical narrative: Arm pain lasted for about 2 months. Red/blue color around injection site which subsided with time. Visited rheumatologist and will receive physical therapy.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth, Pain, Pyrexia
Clinical narrative: Localized pain and hot to touch and fever.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Intraocular pressure test, Iritis, Nasal congestion, Ocular hyperaemia
Clinical narrative: Nasal and chest congestion set in about 2 weeks after the injection and has lasted 6 weeks (not sure if this is connected to the Zoster). Iritis in the right eye set in on March 11, 2019 with redness, pain and light sensitivity. The redness came on in the morning, the pain hit suddenly at 5:00 PM.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Photophobia, Pulmonary congestion
Clinical narrative: Nasal and chest congestion set in about 2 weeks after the injection and has lasted 6 weeks (not sure if this is connected to the Zoster). Iritis in the right eye set in on March 11, 2019 with redness, pain and light sensitivity. The redness came on in the morning, the pain hit suddenly at 5:00 PM.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: 2 weeks after administration she is experiencing redness and itching at site.
Age: 12.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Cognitive disorder, Communication disorder, Decreased eye contact, Dysgraphia, Regressive behaviour
Clinical narrative: Our son regress in cognitive abilities that he once had, such such writing, drawing, eye contact, and communication.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Hypersensitivity, Pruritus, Rash
Clinical narrative: Rash on lower extremities pruritus seen by me in clinic on 3/18/19 for continued "allergic -like reaction".
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Limb discomfort, Loss of consciousness, Pallor
Clinical narrative: My daughter got HPV, DTap and MMr vaccines for middle school all in same evening. Arms were sore but otherwise was fine till next morning. Around 6:00am the next morning my daughter crawled up to my bedroom and was pale as a ghost and complained of feeling like she was going to pass out. This has never happened before and has no medical issues. I stayed with her and got her something to eat. About 30 min later started to feel better. Unsure if due to vaccine or not but hasn't happened again since. Unsure rather to do 2nd vaccine?  Sorry concerned mom.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Muscle rigidity, Pruritus, Skin discolouration
Clinical narrative: Patient began to display slight darkening of skin ~10 minutes post vaccination and reported feeling itchy. Patient was given 1 120ml bottle of diphenhydramine 12.5mg/5ml to dose herself as she reported allergies some foods similar in effect in needing diphenhydramine, pepsin, and prednisone to manage reactions. At Pharmacist's recommendation a friend came to pick patient up after ~45 minutes. Condition did not worsen during that time.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Limb discomfort, Pain
Clinical narrative: Extreme fatigue. Aching all over body. Sore arm. Shivering.
Age: 1.08
Sex: F
Vaccine: VARCEL
Symptoms: Manufacturing product shipping issue, Unevaluable event
Clinical narrative: The Product Must Be Received On or By 02/12/2019 date printed on the packing slip, vaccine was received 02/13/2019, the vaccine was not delivered within the allowable time. Vaccines were stored and administered. Parents were been notified that they have received expired or non-viable vaccine will need doses repeated.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Headache, Pain
Clinical narrative: Large splotchy rash on upper half of arm, chills, body aches, headache and tiredness. No energy.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Large splotchy rash on upper half of arm, chills, body aches, headache and tiredness. No energy.
Age: 16.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Wrong product administered
Clinical narrative: Pt was ordered MENVEO a 2nd dose and BEXSERO 1st dose. Pt RECEIVED BEXSERO and TRUMENBA instead of MENVEO.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Phone call from foster mother reporting that child had quarter size area of redness and swelling at 6:30 on 03/19/2019. Stated this are grew to golf ball size area of redness and swelling on 03/20/2019 and on 03/21/2019, it had grown to softball size area of redness, swelling that is hot to touch. Has used warm moist compresses with no relief.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Rash, Transient acantholytic dermatosis
Clinical narrative: 2nd shot site reaction (pain, redness) lasted 9 days. Rash on torso and upper arms, appeared 2 weeks later. Diagnosed (by dermatologist) as Grover's Disease. Might be a coincidence, but I thought I'd better report it.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site reaction, Injection site warmth
Clinical narrative: Patient had injection site reaction approximately 5 cm in diameter. Area is hard, erythematous, and warm. Mildly tender.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported warm, red, swollen area of right arm that began 5 days after her first SHINGRIX vaccine and had gotten worse overnight. She did not report any pain, but stated the area was very pruritic. Patient reported that this is her first adverse event to any vaccine. I recommended that the patient mark the current area to watch for worsening symptoms and OTC hydrocortisone cream or BENADRYL for the itching. If it continues to worsen, I counseled the patient to see her provider.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Skin lesion
Clinical narrative: Shortly after vaccination the left thigh significantly swollen with some mottled redness. The left thigh measured 35 cm while the right high measured 32.5 cm. The child was treated with some BENADRYL and oral prednisolone. After 24 hours of medication the swelling and redness significantly decreased. Mother states she noticed these lesions on both of his feet and legs since yesterday, 3/20, also states its on his hand. Mother states he has had these before when he had ant bites, but has not recently gone outside. Denies: Itching, Fever, Headache, Myalgia.
Age: 26.0
Sex: F
Vaccine: MMRV, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Vaccine med error. Client inadvertently given MMRV in place of Varicella vaccine. Client alert. No issues or symptoms noted after vaccine administration.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site irritation, Pruritus, Urticaria
Clinical narrative: My back became red and itchy approximately 8 hours after the injection. By the next morning, my chest was red and hives were starting. By Wednesday morning, it had also moved to the injection site.  I sought out medical attention on Wednesday. Both Dr and I think it had to do with the vaccine, especially since the injection site showed irritation. I had allergy testing done on Friday, so Dr wants me to talk to the allergist to see if that could have sensitized my system. He also wants to know if I should get the second dose and if so, pre load my system with steroids and antihistamines.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Computerised tomogram, Electrocardiogram, Fall, Incoherent, Laboratory test
Clinical narrative: The patient was nervous so I administered all 3 vaccines in the left deltoid. Patient was fine right after vaccines. He was talking  and saying how the injections didn't hurt as bad as he thought. I begin to help mom fill out paperwork. Patient was talking and stopped about 3 minutes after vaccine . I turned to patient and he seized up and fell to the ground. Patient hit the ground hard and was shaking. Mom grabbed patient and was holding his head. I gave mom paper towels to apply pressure to head laceration while calling cold blue. Patient became coherent less than a minute from falling and knew who he was but didn't know where he was or how he got on the floor. Medics came and took patient to ER for further evaluation .
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Nervousness, Seizure, Skin laceration, Tremor
Clinical narrative: The patient was nervous so I administered all 3 vaccines in the left deltoid. Patient was fine right after vaccines. He was talking  and saying how the injections didn't hurt as bad as he thought. I begin to help mom fill out paperwork. Patient was talking and stopped about 3 minutes after vaccine . I turned to patient and he seized up and fell to the ground. Patient hit the ground hard and was shaking. Mom grabbed patient and was holding his head. I gave mom paper towels to apply pressure to head laceration while calling cold blue. Patient became coherent less than a minute from falling and knew who he was but didn't know where he was or how he got on the floor. Medics came and took patient to ER for further evaluation .
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Electrocardiogram normal, Fall, Head injury, Loss of consciousness, Scan normal
Clinical narrative: The patient was nervous so I administered all 3 vaccines in the left deltoid. Patient was fine right after vaccines. He was talking  and saying how the injections didn't hurt as bad as he thought. I begin to help mom fill out paperwork. Patient was talking and stopped about 3 minutes after vaccine . I turned to patient and he seized up and fell to the ground. Patient hit the ground hard and was shaking. Mom grabbed patient and was holding his head. I gave mom paper towels to apply pressure to head laceration while calling cold blue. Patient became coherent less than a minute from falling and knew who he was but didn't know where he was or how he got on the floor. Medics came and took patient to ER for further evaluation .
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ, FLUX, MENB, MNQ
Symptoms: Suture insertion, Syncope
Clinical narrative: The patient was nervous so I administered all 3 vaccines in the left deltoid. Patient was fine right after vaccines. He was talking  and saying how the injections didn't hurt as bad as he thought. I begin to help mom fill out paperwork. Patient was talking and stopped about 3 minutes after vaccine . I turned to patient and he seized up and fell to the ground. Patient hit the ground hard and was shaking. Mom grabbed patient and was holding his head. I gave mom paper towels to apply pressure to head laceration while calling cold blue. Patient became coherent less than a minute from falling and knew who he was but didn't know where he was or how he got on the floor. Medics came and took patient to ER for further evaluation .
Age: 36.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, Extra dose administered, Wrong product administered
Clinical narrative: Patient is currently pregnant; EDD: 5-3-19. Was seen on 3-7-19 for OB visit, was 31.6 weeks on this day and due to Tdap. Inadvertently given a FLUBLOK injection. Patient had apparently already received flu shot at another location in November. We have no record of this flu vaccine and no information in records. Location where shot given in November is apparently now closed. Medical Director notified as well as CNM and contacted Maternal Fetal Specialist who informed us he knew of no adverse reactions from patient receiving a second flu vaccine. Was subsequently seen again for OB FU on 3/18/19 and reported no adverse reactions to CNM.
Age: 64.0
Sex: M
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Pain
Clinical narrative: Patient was given the ADACEL on 03/08/19 and came back to the pharamcy on 03/21/2019 complaining of left shoulder pain. He was having pain when he was lifting his left arm laterally. I recomended that he get in contact with his Dr right away to have it looked at.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood test, Electroencephalogram normal, Hepatic cyst, Irritability, Lumbar puncture
Clinical narrative: Per Dr.'s note on 3/12 "Dad relates that he was holding fussy patient during this time when she had what he thought was a seizure and he ended up calling 911 and they brought her via ambulance to regional Hospital emergency room. There she had an additional seizure that lasted about 3-1/2 minutes. They started an evaluation with blood and urine, Medical Center pediatrics was consulted and the initial plan was her to be admitted for overnight observation. She then had an additional seizure lasting 2 minutes and a decision at that point was made to transfer her to Medical Center." Prior to transfer she had an LP which was reassuring, she was loaded on KEPPRA and transported to location. In route she received an IM dose of ceftriaxone. For additional history see Medical Center discharge note. Patient ended up having a full evaluation at Medical Center which included an EEG and an MRI of her brain. There had been some prior question about abnormalities of the spinal cord and as a result the MRI also included her spine. These were read as being completely normal. On the MRI however, patient had some evidence of cysts on her right lobe of her liver. Pediatric surgery was consulted with recommendation for follow-up ultrasound on her liver in 3 months. There had been some concerns about her ovaries and urinary tract and pediatric urology (who would been involved previously as patient has had bilateral hydronephrosis and ureters and bilateral ureteroceles that have been drained) but on review it was felt as though this was considered normal. The patient has been on prophylactic MACRODANTIN on a daily basis since soon after birth. She had a recent dose adjustment for her weight last week. She has pediatric urology follow-up with Dr. in location in August 2019. Dad reports that since discharge she has done well. She got back to location about 3 nights ago. The first night she had some increased fussiness but after that there have been no concerns. She has had normal P.O. intake, urine output and stooling. She has had normal activity without runny nose, cough nor fever."
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lumbar puncture normal, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging abdominal abnormal, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging brain normal
Clinical narrative: Per Dr.'s note on 3/12 "Dad relates that he was holding fussy patient during this time when she had what he thought was a seizure and he ended up calling 911 and they brought her via ambulance to regional Hospital emergency room. There she had an additional seizure that lasted about 3-1/2 minutes. They started an evaluation with blood and urine, Medical Center pediatrics was consulted and the initial plan was her to be admitted for overnight observation. She then had an additional seizure lasting 2 minutes and a decision at that point was made to transfer her to Medical Center." Prior to transfer she had an LP which was reassuring, she was loaded on KEPPRA and transported to location. In route she received an IM dose of ceftriaxone. For additional history see Medical Center discharge note. Patient ended up having a full evaluation at Medical Center which included an EEG and an MRI of her brain. There had been some prior question about abnormalities of the spinal cord and as a result the MRI also included her spine. These were read as being completely normal. On the MRI however, patient had some evidence of cysts on her right lobe of her liver. Pediatric surgery was consulted with recommendation for follow-up ultrasound on her liver in 3 months. There had been some concerns about her ovaries and urinary tract and pediatric urology (who would been involved previously as patient has had bilateral hydronephrosis and ureters and bilateral ureteroceles that have been drained) but on review it was felt as though this was considered normal. The patient has been on prophylactic MACRODANTIN on a daily basis since soon after birth. She had a recent dose adjustment for her weight last week. She has pediatric urology follow-up with Dr. in location in August 2019. Dad reports that since discharge she has done well. She got back to location about 3 nights ago. The first night she had some increased fussiness but after that there have been no concerns. She has had normal P.O. intake, urine output and stooling. She has had normal activity without runny nose, cough nor fever."
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Nuclear magnetic resonance imaging spinal normal, Seizure, Urine analysis
Clinical narrative: Per Dr.'s note on 3/12 "Dad relates that he was holding fussy patient during this time when she had what he thought was a seizure and he ended up calling 911 and they brought her via ambulance to regional Hospital emergency room. There she had an additional seizure that lasted about 3-1/2 minutes. They started an evaluation with blood and urine, Medical Center pediatrics was consulted and the initial plan was her to be admitted for overnight observation. She then had an additional seizure lasting 2 minutes and a decision at that point was made to transfer her to Medical Center." Prior to transfer she had an LP which was reassuring, she was loaded on KEPPRA and transported to location. In route she received an IM dose of ceftriaxone. For additional history see Medical Center discharge note. Patient ended up having a full evaluation at Medical Center which included an EEG and an MRI of her brain. There had been some prior question about abnormalities of the spinal cord and as a result the MRI also included her spine. These were read as being completely normal. On the MRI however, patient had some evidence of cysts on her right lobe of her liver. Pediatric surgery was consulted with recommendation for follow-up ultrasound on her liver in 3 months. There had been some concerns about her ovaries and urinary tract and pediatric urology (who would been involved previously as patient has had bilateral hydronephrosis and ureters and bilateral ureteroceles that have been drained) but on review it was felt as though this was considered normal. The patient has been on prophylactic MACRODANTIN on a daily basis since soon after birth. She had a recent dose adjustment for her weight last week. She has pediatric urology follow-up with Dr. in location in August 2019. Dad reports that since discharge she has done well. She got back to location about 3 nights ago. The first night she had some increased fussiness but after that there have been no concerns. She has had normal P.O. intake, urine output and stooling. She has had normal activity without runny nose, cough nor fever."
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Crying, Dyspnoea, Injection site erythema, Injection site rash
Clinical narrative: The vaccine of DTAP was administered in left deltoid in the morning of January 26th, 2017. Later that evening, I developed a fever of 103 and severe joint and body pain and visible red, hot rash at injection site and arm. I was unable to move on my own and needed assistance to go to the restroom and get up out of the bed. I was also pregnant with my first pregnancy at 32-35 weeks. My arm and joints were swollen. The pain was excruciating to the point of crying. I had a difficult time breathing. When I went the next day to the office of OBGYN, - I was seen by his PA. I was assisted by my mother in law who helped get me to the Doctors office as I needed help walking and moving. I was still running a fever but was low-grade as I had taken a fever reducer that is said to be safe during pregnancy. I was told that I had an immunologic response and was dismissed. The pain lasted for 5 days and decreased as time went on. I continued to take over the counter medication to manage pain and decrease fever. I then switched care providers to Dr. who is my General Practitioner. She has advised that I do not take a repeat dose of Tdap vaccine.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth, Joint swelling, Pain, Peripheral swelling, Pyrexia
Clinical narrative: The vaccine of DTAP was administered in left deltoid in the morning of January 26th, 2017. Later that evening, I developed a fever of 103 and severe joint and body pain and visible red, hot rash at injection site and arm. I was unable to move on my own and needed assistance to go to the restroom and get up out of the bed. I was also pregnant with my first pregnancy at 32-35 weeks. My arm and joints were swollen. The pain was excruciating to the point of crying. I had a difficult time breathing. When I went the next day to the office of OBGYN, - I was seen by his PA. I was assisted by my mother in law who helped get me to the Doctors office as I needed help walking and moving. I was still running a fever but was low-grade as I had taken a fever reducer that is said to be safe during pregnancy. I was told that I had an immunologic response and was dismissed. The pain lasted for 5 days and decreased as time went on. I continued to take over the counter medication to manage pain and decrease fever. I then switched care providers to Dr. who is my General Practitioner. She has advised that I do not take a repeat dose of Tdap vaccine.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Walking aid user
Clinical narrative: The vaccine of DTAP was administered in left deltoid in the morning of January 26th, 2017. Later that evening, I developed a fever of 103 and severe joint and body pain and visible red, hot rash at injection site and arm. I was unable to move on my own and needed assistance to go to the restroom and get up out of the bed. I was also pregnant with my first pregnancy at 32-35 weeks. My arm and joints were swollen. The pain was excruciating to the point of crying. I had a difficult time breathing. When I went the next day to the office of OBGYN, - I was seen by his PA. I was assisted by my mother in law who helped get me to the Doctors office as I needed help walking and moving. I was still running a fever but was low-grade as I had taken a fever reducer that is said to be safe during pregnancy. I was told that I had an immunologic response and was dismissed. The pain lasted for 5 days and decreased as time went on. I continued to take over the counter medication to manage pain and decrease fever. I then switched care providers to Dr. who is my General Practitioner. She has advised that I do not take a repeat dose of Tdap vaccine.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient said 6 hours later he experienced extreme nausea which led to multiple vomitting episodes. He also had a fever and chills, patient does not recall actual fever tempature. These symtoms lasted aproximately 12 hours.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Erythema, Hypophagia, Insomnia
Clinical narrative: Within 2-3 hours, arm became painful and began to swell; spent evening with ice to sight and took acetaminophen; difficulty sleeping as arm hurting so much; by morning arm swollen to below elbow, unable to arm much at all due to pain; feeling ill....nauseated, chilling, light headed; returned to bed....unable to dress or eat much that day. By following day, arm swollen clear to wrist and still very painful; Taking BENADRYL to help, but didn't seem to do much. I was able to bathe and dress but still felt ill. Some improvement to swelling in upper arm but whole arm red, warm and still very swollen. Over the course of a week, symptoms abated and swelling slowly receded. I have not been so ill in a very very long time.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Loss of personal independence in daily activities, Malaise, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Within 2-3 hours, arm became painful and began to swell; spent evening with ice to sight and took acetaminophen; difficulty sleeping as arm hurting so much; by morning arm swollen to below elbow, unable to arm much at all due to pain; feeling ill....nauseated, chilling, light headed; returned to bed....unable to dress or eat much that day. By following day, arm swollen clear to wrist and still very painful; Taking BENADRYL to help, but didn't seem to do much. I was able to bathe and dress but still felt ill. Some improvement to swelling in upper arm but whole arm red, warm and still very swollen. Over the course of a week, symptoms abated and swelling slowly receded. I have not been so ill in a very very long time.