chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Arthralgia, Biopsy skin abnormal, Headache, Hypersensitivity vasculitis, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of leukocytoclastic vasculitis in a 22-year-old female patient who received ENGERIX B (batch number X9F7Y, expiry date 16th April 2019). Concomitant products included Hepatitis B vaccine and Hepatitis B vaccine. On 30th June 2017, the patient received the 3rd dose of ENGERIX B (intramuscular) 1 ml. On 30th June 2017, unknown after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On 3rd July 2017, the patient experienced leukocytoclastic vasculitis (serious criteria GSK medically significant and other) and rash. In July 2017, the patient experienced headache and joint pain. On an unknown date, the outcome of the leukocytoclastic vasculitis, rash, headache and joint pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the leukocytoclastic vasculitis, rash, headache and joint pain to be related to ENGERIX B. Additional details were reported as follows: The patient's concomitant medications also included birth control medication. The patient received 1st dose of hepatitis B vaccine on 21st April 2017. The patient received 2nd dose of hepatitis B vaccine on 22nd May 2017. No symptoms were documented after the first 2 doses. The manufacturer of the first two shots are unknown because they were given at a different facility. On 30th June 2017, the patient inadvertently received 3rd dose of ENGERIX B in left deltoid, which led to shortening of the vaccination schedule. The patient developed a rash and was diagnosed by a dermatologist via skin biopsy to have Leukocytoclastic vasculitis. Less than a week after vaccination, the patient also reported headaches and joint pain. The symptoms started shortly after the 3rd dose. The patient was now being followed by a rheumatologist and a dermatologist. The patient was treated with corticosteroids to ameliorate the symptoms and prevent further worsening of the rash.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of leukocytoclastic vasculitis in a 22-year-old female patient who received ENGERIX B (batch number X9F7Y, expiry date 16th April 2019). Concomitant products included Hepatitis B vaccine and Hepatitis B vaccine. On 30th June 2017, the patient received the 3rd dose of ENGERIX B (intramuscular) 1 ml. On 30th June 2017, unknown after receiving ENGERIX B, the patient experienced drug dose administration interval too short. On 3rd July 2017, the patient experienced leukocytoclastic vasculitis (serious criteria GSK medically significant and other) and rash. In July 2017, the patient experienced headache and joint pain. On an unknown date, the outcome of the leukocytoclastic vasculitis, rash, headache and joint pain were not recovered/not resolved and the outcome of the drug dose administration interval too short was unknown. It was unknown if the reporter considered the leukocytoclastic vasculitis, rash, headache and joint pain to be related to ENGERIX B. Additional details were reported as follows: The patient's concomitant medications also included birth control medication. The patient received 1st dose of hepatitis B vaccine on 21st April 2017. The patient received 2nd dose of hepatitis B vaccine on 22nd May 2017. No symptoms were documented after the first 2 doses. The manufacturer of the first two shots are unknown because they were given at a different facility. On 30th June 2017, the patient inadvertently received 3rd dose of ENGERIX B in left deltoid, which led to shortening of the vaccination schedule. The patient developed a rash and was diagnosed by a dermatologist via skin biopsy to have Leukocytoclastic vasculitis. Less than a week after vaccination, the patient also reported headaches and joint pain. The symptoms started shortly after the 3rd dose. The patient was now being followed by a rheumatologist and a dermatologist. The patient was treated with corticosteroids to ameliorate the symptoms and prevent further worsening of the rash.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Jugular vein thrombosis, Optic neuritis
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of optic neuritis in a 17-year-old female patient who received FLUARIX QUADRIVALENT (batch number 4A5K3, expiry date 22nd June 2016). Previously administered products included Influenza (Flu vaccine received on 12th August 2014). On 12th October 2015, the patient received FLUARIX QUADRIVALENT. On 13th November 2015, 32 days after receiving FLUARIX QUADRIVALENT, the patient experienced temporal headache. In November 2015, the patient experienced jugular vein thrombosis. In June 2017, the patient experienced optic neuritis (serious criteria GSK medically significant). On an unknown date, the outcome of the optic neuritis was not recovered/not resolved and the outcome of the jugular vein thrombosis and temporal headache were unknown. It was unknown if the reporter considered the optic neuritis to be related to FLUARIX QUADRIVALENT. The reporter considered the jugular vein thrombosis and temporal headache to be unrelated to FLUARIX QUADRIVALENT. Additional details were provided as follows: It was reported that, the patient had received previous flu shots prior to the 2015 dose, with the most recent prior dose administered on 12th August 2014 with no incident. It was reported that on 13th November 2015, the patient complained of right-sided temporal region headache, which doctors attributed to phentermine use at the age of 17 years old. On 27th November 2015, the patient was also admitted to the emergency room for a blood clot in the jugular vein, which healthcare professional was not believed to be attributed to the flu vaccine. it was reported that, the patient had not received flu shots since the 2015 dose and her current status of diagnosis optic neuritis at the time of reporting was unchanged. No further information was reported regarding the event.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Injection site atrophy, Injection site bruising, Injection site discolouration, Injection site induration, Injection site swelling
Clinical narrative: At the time of the visit (6/21/17) Mom reported patient's left upper thigh looked more swollen and slightly bruised. Mom thought it may have looked that way before her 6 month vaccinations. No significant redness, bruising, sores, blisters noted with the exception of a firm area on her upper leg after one vaccine that resolved on its own. Mom could not recall which leg. No apparent pain, itching or distress by patient. No increase in fussiness or change in behavior. No recent fever, known trauma to area or sores on skin noted. Area was not hot to touch. Infant bearing weight well and using legs equally. Examination by physician noted left lateral midthigh localized area of decreased subcutaneous fat. Skin with faintly visible violacious vascular markings around the area. No palpable subcutaneous lesion. Non-tender area. Patient referred to dermatologist. His report, 8/18/17, states patient has lipoatrophy of the left thigh. He suspects that it is related to immunization, although it would be uncommon. Could be related to immunization and trauma. It is more common when it is given in fat (not muscle) especially in the buttocks; and may be more common in a child with more normal adipose. There is no specific treatment. Time may improve the appearance. Digital images were taken to monitor progress to insure no other process is going on. Follow up in 6-8 weeks time.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal discomfort, Erythema, Influenza like illness, Skin warm, Swelling
Clinical narrative: Patient's husband called the pharmacy and reported swelling the size of a silver dollar, along with redness, warmth, feeling of the "flu" and upset stomach. They did not elaborate when asked if they needed to go to the doctor based on their symptoms.
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Nausea
Clinical narrative: Nausea, joint pain. Nausea treated with Dimenhydrinate two 50mg tablets. Joint pain treated with Ibuprophen 400mg. By morning these symptoms were gone.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster in a previously vaccinated individual. Patient had a painful unilateral rash located in 1 dermatome, beginning 4/19/2017 and lasting less than 4 weeks. Patient was given acyclovir.
Age: 4.0
Sex: F
Vaccine: MMR
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster in a previously vaccinated individual. Painful, unilateral, 1 dermatome rash lasting less than 4 weeks. Onset of 8/7/2017. VALTREX was given to the patient
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient was given HPV and Flu vaccines at approximately 10:00 a.m. mom refused to wait the 20 minutes and signed the waiver and walked to check out and patient was standing there and passed out. He did not hit his head. Pt was assessed by Dr and LPN. B/p was 130/74 and HR was 104. Pt was sat in a chair to monitor cool compresses were applied, then pt was taken to exam room to lie on a bed. B/P was 118/68 and HR was 78 prior to leaving. Left with no visible injuries or ill effects.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Eye swelling, Oropharyngeal pain, Pharyngeal oedema, Rash, Swelling face
Clinical narrative: Swollen eyes, swollen cheek, swollen throat, sore throat, small rash on various parts of body.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy, right axila.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: Acute respiratory distress syndrome, Biopsy, Computerised tomogram, Drug reaction with eosinophilia and systemic symptoms, Specialist consultation
Clinical narrative: DRESS syndrome. My father was in the hospital from 8-12-17 through 8-28-17. First hospital 8-12-17 through 8-21-17 then second hospital 8-21-17 through 8-28-17. He suffered severely and almost died due to ARDS. Once the correct diagnosis was made he ultimately recovered by IV methylprednisolone.
Age: 81.0
Sex: M
Vaccine: PNC13
Symptoms: X-ray
Clinical narrative: DRESS syndrome. My father was in the hospital from 8-12-17 through 8-28-17. First hospital 8-12-17 through 8-21-17 then second hospital 8-21-17 through 8-28-17. He suffered severely and almost died due to ARDS. Once the correct diagnosis was made he ultimately recovered by IV methylprednisolone.
Age: 1.08
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Herpes zoster, Polymerase chain reaction positive, Rash, Varicella virus test positive
Clinical narrative: Herpes Zoster in a previously vaccinated individual. Patient had a painful, unilateral 1 dermatome rash lasting less than 4 weeks. Onset was 6/8/2017. Patient was not given an antiviral.
Age: 1.17
Sex: M
Vaccine: HIBV
Symptoms: Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Vomiting lasting 1 day, diarrhea lasting about 1 week and fever lasting 1 day.
Age: 68.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: PATIENT SAID HAD PAIN & SWOLLEN SAME EVENING IN RIGHT ARM AND NEXT MORNING IT WAS RED, SWOLLEN AND PAINFUL (NOT AT SITE OF INJECTION BUT AREA BELOW AND ABOVE ELBOW). ON 09/14/17 MORNING WENT TO URGENT CARE, THEY DIDN'T HAVE FACILITY TO TEST SO SEND THE PATIENT TO ER, WHERE SHE WAS ADMITTED AND TREATED FOR CELLULITIS AND RELEASED FROM HOSPITAL ON 09/23/17 SATURDAY AFTERNOON. WITH TWO RXS FOR ANTIBIOTICS DOXYCYCLINE AND CEPHALEXIN.
Age: 74.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site rash
Clinical narrative: PT REPORTS ARM RED AND INFLAME RASH ON HER UPPER LEFT ARM; APPROXIMATELY 6" AROUND HER UPPER LEFT ARM.  STARTED ON 9/19/2017.
Age: 29.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Right shoulder progressively got more and more sore, two days after injection I am unable to move my right shoulder in certain positions. There is a dull ache with bursts of excruciating pain with movement.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dysphonia, Wheezing
Clinical narrative: Wheezing cough and hoarseness that lasted about 8 hours.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a patient of unspecified age and gender. No information regarding patient's pertinent medical history or concomitant medications was provided. On an unspecified date in May 2016, patient received a dose of GARDASIL 9 and after that he/she received another dose in June 2017 and another on 23-AUG-2017 (exact dose, route of administration, anatomical location, lot# and expiration date were not provided for any dose). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report has been received from a medical assistant, concerning an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant medications were not provided. The reporter stated that the unspecified number of patients were vaccinated with an improperly stored doses between 15-AUG-2017 and 12-SEP-2017 of VARIVAX lot # N014366 and expiration date 09-MAY-2018 (dose, frequency and route of administration were not provided) for prophylaxis, which were reconstituted with an improperly stored sterile diluent (manufacturer unknown) exposed at a temperature of 59.4 Fahrenheit for 12 hours. The vaccines were stored at a temperature of 32.2 Fahrenheit, time frame 11.5 hours and previous temperature excursion of 46 Fahrenheit for 108 hours. Digital data logger was involved. No adverse effects reported.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature, Injection site erythema, Injection site swelling, Injection site warmth, Somnolence
Clinical narrative: This spontaneous report was received from a female patient of unknown age, who was reporting on herself. The patient's concurrent conditions, concomitant medications, pertinent medical history and drug reactions or allergies were not provided. On an unknown date, the patient was vaccinated with an unspecified pneumonia vaccine (manufacturer unknown) (strength, dose, route of administration, lot # and expiration date were not reported) and FLUZONE (strength, dose, route of administration, lot # and expiration date were not reported), High-Dose vaccines, in the same arm about an inch apart. On an unknown date, the patient experienced a temperature. On an unknown date, the site where she thought the unspecified pneumonia vaccine was given, was raised, hot, beet red. On an unknown date, all she wanted to do is sleep. The patient did not seek medical attention and no treatment was given for the events. The outcome of the events was reported as not recovered/not resolved. The relatedness between the events and the suspect therapies was not assessed by the reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On an unspecified date between mid-June and 14-SEP-2017, the patient was vaccinated with improperly stored dose of ROTATEQ, orally (dose number, exact dose were not reported; lot # M018958 with the expiration date of 03-MAR-2018), for prophylaxis. No adverse effects were reported. The dose of ROTATEQ underwent a temperature excursion of 34.57 degrees Fahrenheit for the time frame of 17 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA009961.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous initial report was received from a nurse referring to a patient with age and gender unknown. Patient medical history, concurrent conditions and concomitant medications were not reported. The nurse informed that on 15-JUN-2017 the patient was vaccinated with a first dose of M-M-R II (strength and dose unknown) subcutaneously, lot # M017346, albumin status reported as rHA (recombinant human albumin), indicated for prophylaxis. The nurse also reported that on 14-SEP-2017, 3 months after the first dose of M-M-R II, the patient inadvertently received a second dose of M-M-R II. No adverse event was reported.
Age: 27.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a 27 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 15-SEP-2017, the patient was vaccinated with a dose of PROQUAD lot # M044718, expiry date 07-MAY-2018 (exact dose and route of administration were not reported) for prophylaxis reconstituted with sterile diluent injection lot# L015432 and expiry date 24-JAN-2018 instead of VARIVAX (dose, route of administration, lot# and expiration date were not provided) for prophylaxis. No adverse effects were 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 and gender. There was no information about the patient's concurrent conditions or medical history provided. On 05-SEP-2017, the patient was vaccinated with expired dose of ZOSTAVAX 19400 PFU vial, lot # M032651 with expiration date on 15-JUN-2017 for prophylaxis (dose, route and site of administration were not reported). Concomitant therapies included sterile diluent (MRK). There was no adverse effects reported.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age or gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On an unspecified date between mid-June and 14-SEP-2017, the patient was vaccinated with improperly stored dose of ROTATEQ, orally (dose number, exact dose were not reported; lot # M018958 with the expiration date of 03-MAR-2018), for prophylaxis. No adverse effects were reported. The dose of ROTATEQ underwent a temperature excursion of 34.57 degrees Fahrenheit for the time frame of 17 minutes. Digital data logger was used to capture the temperature excursion. There were no previous temperature excursions reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1709USA007917.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Depressed level of consciousness, Dizziness, Presyncope, Vomiting
Clinical narrative: Patient felt normal when left exam room and at check-out window. While walking to car in parking lot, became dizzy and vomited (about 2:40pm). Returned to office and observed. Vitals check multiple times. Patient was alert, no LOC but doesn't remember episode. Near syncopal. Not cardiovascular collapse. Strong heart rate, alert and interactive. On second attempt to leave about 3:15, patient felt like he was going to pass out walking down hall. Returned to exam room and was observed and vitals check multiple times for 30 minutes then wheeled to car and stable for transport. Family was called 45 minutes after leaving and still stable.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Arthralgia, Bursitis, Loss of personal independence in daily activities, Neck pain, Swelling
Clinical narrative: Student reports severe shoulder joint pain, swelling occurring 1 week post injection. Pain radiates up her neck and inhibits her ability to dress herself. Seen at the health center for bursitis and tendinitis in the left shoulder. She was prescribed cyclobenzaprine HCL 10 mg and high dose ibuprofen. Currently, she is at the clinic waiting for a reassessment and steroid pack.
Age: 23.0
Sex: F
Vaccine: FLUC4
Symptoms: Tendonitis
Clinical narrative: Student reports severe shoulder joint pain, swelling occurring 1 week post injection. Pain radiates up her neck and inhibits her ability to dress herself. Seen at the health center for bursitis and tendinitis in the left shoulder. She was prescribed cyclobenzaprine HCL 10 mg and high dose ibuprofen. Currently, she is at the clinic waiting for a reassessment and steroid pack.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient received Tdap vaccine postpartum at 2137 and reports pain in left deltoid soon thereafter. Provider at bedside to discharge patient at approximately 1200 the following day when 3x5cm raised, erythematous and indurated area noted at injection site. Warm to touch and tender to palpation, per patient. No overt signs of infection at this time. Patient will continue to monitor for signs of infection upon discharge home.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: Patient received Tdap vaccine postpartum at 2137 and reports pain in left deltoid soon thereafter. Provider at bedside to discharge patient at approximately 1200 the following day when 3x5cm raised, erythematous and indurated area noted at injection site. Warm to touch and tender to palpation, per patient. No overt signs of infection at this time. Patient will continue to monitor for signs of infection upon discharge home.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Injection site reaction, Loss of personal independence in daily activities, Pain, Tendonitis
Clinical narrative: Tendinitis and Bursitis in the R shoulder joint. Student is unable to dress herself due to pain. Has not seen a MD but is using ice and ibuprofen for pain. Reported to me following a discussion between another student with similar symptoms. Instructed to make appointment with MD for steroids.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Lingering shoulder pain.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth
Clinical narrative: Bruising and reddness at the site of injection. Reddness that spread to almost the entire upper arm. Warms at the site of injection reported by the patients. Pt came in yesterday 8/19/17 to report the event. Followed up with patient this morning, 9/20/17 and was told the area looks much better.
Age: 85.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Reports no latex allergy; reports area is red and war; swelling is receding and is not as mad as day before; suggested APAP 325 and diphenhydramine 25 and to go to ER if gets any worse.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Burning sensation, Injected limb mobility decreased, Neck pain, Pain, Pain in extremity
Clinical narrative: Patient reported severe pain (burning sensation) from her neck to her right arm. The pain started at night around 9pm and continue through at the time of report. Patient has trouble raising arm due to pain. She stated her fingers are swollen and part of her arm feels swollen too. Patient was advised to go visit her primary doctor to evaluate her symptoms immediately. Patient said she might have trouble getting an appointment with her primary, therefore she will go to the emergency room to get evaluated.
Age: 52.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling
Clinical narrative: Patient reported severe pain (burning sensation) from her neck to her right arm. The pain started at night around 9pm and continue through at the time of report. Patient has trouble raising arm due to pain. She stated her fingers are swollen and part of her arm feels swollen too. Patient was advised to go visit her primary doctor to evaluate her symptoms immediately. Patient said she might have trouble getting an appointment with her primary, therefore she will go to the emergency room to get evaluated.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: Patient called the pharmacy 9/20/2017 to inquire on the reaction she thinks is from the flu shot she received on monday 9/18/2017. She came in so I could visually see the reaction site. There was redness and warm to the touch. With permission I was able to draw around the red reaction and measure across to be 4 inches. We gave her an ice pack and recommended topical benadry or hydrocortisone cream.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Pt said she felt dizzy, was told to lay down, passed out, put a cold rag on her, gave her a popsicle, felt better. We sat her back up after a few minutes she said that she felt dizzy again, we laid her back down, said she couldn't hear anything, we then gave her some crackers. She began to feel better, we did have her call a friend to come and get her. Pt said she had not eaten all day.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Patient came to pharmacy and presented with raised swelling at site of injection approximately 4cm x 10cm on 9.20.17 @12:30pm and reported it initially was itchy now it was not.
Age: 31.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Head injury, Syncope
Clinical narrative: Within seconds of giving both injections, the patient fainted while sitting and bumped her head on the immunization desk. Pharmacist attempted to alert patient, had an associate call 911, and the patient regained consciousness on her own with 15-20 seconds of fainting. Once the patient regained consciousness blood pressure was taken (137/85 PR of 60) and the patient was monitored until the EMS arrived.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia, Vomiting
Clinical narrative: Patient received vaccine at approx. 4:43 pm on Tues. 8/29.  Family called on-call physician at 8:22pm stating patient was vomiting. Telephone encounter states mom also sick but doesnt give her symptoms. Instructed to treat symptomatically.  Family calls again approx. seven hours later at 3:06am stating patient has awoken vomiting and "burning up" with fever. Discussed vaccine reaction vs. viral gastroenteritis and symptomatic treatment. If worse, to ED. Also instructed to call us in the morning  with an update.
Age: 40.0
Sex: F
Vaccine: FLUR4
Symptoms: Anxiety, Injection site swelling
Clinical narrative: At around 3:30 pm, patient's left upper arm began to swell at the injection site and she became very anxious. 911 was called and she was treated at the scene with steroids and sub-q epinephrine then transported to the emergency department.
Sex: U
Vaccine: HEP
Symptoms: Extra dose administered, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 02-SEP-2016, the patient was vaccinated with the first dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported);  On 05-JAN-2017, the patient was vaccinated with a second dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported); On 31-MAY-2017, the patient was vaccinated with a third dose of RECOMBIVAX HB for prophylaxis (dose, route of administration, lot number and expiration date were not reported); On 05-SEP-2017, the patient was vaccinated with a fourth dose of RECOMBIVAX HB for prophylaxis, lot number M042322  and expiration date 21-FEB-2017 (dose and route of administration were not reported). No adverse effects were reported.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a Nurse referring to a 29 year old female patient. The patient was in the 2nd trimester of her pregnancy. None pertinent medical history nor drug reactions/ allergies were reported. On unknown date in 2017, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. On 02-AUG-2017 the patient was vaccinated with M-M-R II (Lot # M045400, expiration date 14-NOV-2017) (dose and route of administration were not provided) for prophylaxis (vaccine exposure during pregnancy). Concomitant medication included Prenatal vitamins and folic acid. On 09-AUG-2017, an ultrasound was performed and the patient and her baby were OK. The primary reporter stated that the physician ordered this vaccine to be administered to the patient in error.
Age: 29.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Contraindicated product administered, Exposure during pregnancy, Ultrasound antenatal screen normal, Vaccination error
Clinical narrative: This spontaneous prospective pregnancy report as received from a Nurse referring to a 29 year old female patient. The patient was in the 2nd trimester of her pregnancy. None pertinent medical history nor drug reactions/ allergies were reported. On unknown date in 2017, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) were unknown. The pregnancy outcome was pending. On 02-AUG-2017 the patient was vaccinated with M-M-R II (Lot # M045400, expiration date 14-NOV-2017) (dose and route of administration were not provided) for prophylaxis (vaccine exposure during pregnancy). Concomitant medication included Prenatal vitamins and folic acid. On 09-AUG-2017, an ultrasound was performed and the patient and her baby were OK. The primary reporter stated that the physician ordered this vaccine to be administered to the patient in error.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist  and refers to a  unspecified patients of unknown ages and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On an unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 which had lots # of M039060 and N010105 with expiration dates of 22-MAY-2018 and 15-NOV-2018 respectively, for prophylaxis. No adverse effects reported. Temperature: 47°F to 77°F, Time frame: 5.5 hours, Previous temperature excursion: Yes, 47°F to 77°F for 7.5 hours. Was call because of a "data logger": No.
Age: 42.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 19-SEP-2017, the patient was vaccinated with an expired dose of RECOMBIVAX 2.5/0.5 dosing form, injection, lot number L048208, expiration date 15-SEP-2017 (route and dose was not reported) for prophylaxis. No adverse effects were reported.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Urticaria
Clinical narrative: Hives on right side of face and stiffness in right arm and neck.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient is not of age to receive KINRIX. KINRIX is 4-6 years of age. Patient tolerated well. GSK contacted and awaiting to hear back.
Age: 70.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Skin warm
Clinical narrative: On 9/20 patient came to pharmacy with redness, pain, and swelling in right arm between shoulder and elbow. Arm was hot to the touch. Patient said it was very painful and she was unable to sleep last night. She stated that she had body chills as well. Patient said the arm had been more swollen last night and swelling and pain was getting better. I told her if it did not get better or got any worse to got to Medical Doctor for treatment.
Age: 70.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Sleep disorder
Clinical narrative: On 9/20 patient came to pharmacy with redness, pain, and swelling in right arm between shoulder and elbow. Arm was hot to the touch. Patient said it was very painful and she was unable to sleep last night. She stated that she had body chills as well. Patient said the arm had been more swollen last night and swelling and pain was getting better. I told her if it did not get better or got any worse to got to Medical Doctor for treatment.
Age: 70.0
Sex: F
Vaccine: PPV, FLUX, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: On 9/20 patient came to pharmacy with redness, pain, and swelling in right arm between shoulder and elbow. Arm was hot to the touch. Patient said it was very painful and she was unable to sleep last night. She stated that she had body chills as well. Patient said the arm had been more swollen last night and swelling and pain was getting better. I told her if it did not get better or got any worse to got to Medical Doctor for treatment.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Balance disorder, Coagulation test, Dysstasia, Full blood count, Gait disturbance
Clinical narrative: Complained of pain in Right leg, could not stand correctly while keeping her balance. She "limped" for 3 weeks. She could not run at all. She also had some sort of "virus" I was told that caused bleeding from her gums.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Gingival bleeding, Pain in extremity, Viral infection
Clinical narrative: Complained of pain in Right leg, could not stand correctly while keeping her balance. She "limped" for 3 weeks. She could not run at all. She also had some sort of "virus" I was told that caused bleeding from her gums.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Joint crepitation, Mobility decreased
Clinical narrative: Arm was red and had limited movement and started popping when she moved the arm.
Age: 10.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site hypoaesthesia
Clinical narrative: Numbness around the site of the vaccination lasting about an hour. No change in strength or other symptoms.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Abdominal pain lower, Dysuria, Flank pain, Full blood count, Injection site pruritus
Clinical narrative: Patient Arrived at ED on morning of 9/19/17 approx. 3:04am with LLQ abdominal, dysuria, flank pain R, flank pain L and nausea. DX with UTI and renal colic. Prescribed CIPRO, PYRIDIUM, NORCO and ZOFRAN by ED physician. Family called our office again 6:11pm 9/19 stating patient's left arm was swollen and itching at injection sites. Advised TYLENOL or ibuprofen for comfort and cold compress.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site swelling, Metabolic function test, Nausea, Renal colic, Urinary system X-ray
Clinical narrative: Patient Arrived at ED on morning of 9/19/17 approx. 3:04am with LLQ abdominal, dysuria, flank pain R, flank pain L and nausea. DX with UTI and renal colic. Prescribed CIPRO, PYRIDIUM, NORCO and ZOFRAN by ED physician. Family called our office again 6:11pm 9/19 stating patient's left arm was swollen and itching at injection sites. Advised TYLENOL or ibuprofen for comfort and cold compress.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: Patient Arrived at ED on morning of 9/19/17 approx. 3:04am with LLQ abdominal, dysuria, flank pain R, flank pain L and nausea. DX with UTI and renal colic. Prescribed CIPRO, PYRIDIUM, NORCO and ZOFRAN by ED physician. Family called our office again 6:11pm 9/19 stating patient's left arm was swollen and itching at injection sites. Advised TYLENOL or ibuprofen for comfort and cold compress.
Age: 86.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, International normalised ratio increased, Pain in extremity
Clinical narrative: 9-20-17 CAME BY PHARMACY AND REPORTED THAT THE WHOLE ARM THE SHOT WAS ADMINISTERED IN IS  SORE. SHE REPORTS THAT SHE IS UNABLE TO USE THE ARM TO DRIVE. SHE ALSO STATES THAT HER PROTIME WAS 6.5 AND THAT IT IS USUALLY AROUND 2.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Headache, Nausea, Ocular hyperaemia
Clinical narrative: HEADACHES, NAUSEA, RED EYES, AND DIARRHEA.
Age: 0.08
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Rash, Swelling
Clinical narrative: Rash/swelling.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Nervousness, Pain, Peripheral swelling, Skin warm
Clinical narrative: Patient came in on monday 9/18/17 evening presenting with a swollen left arm above the elbow and traveling around and under to the backside of the arm. She she was experiencing pain and said it was spreading. I touched her arm and it was warm to the touch, swollen and seemed  to be spreading on lower in the arm. I advised her to take aspirin and ice it and maybe even elevate  it when she was home. She said she was nervous about it and i agreed it did not look good and if she preferred she could seek medical attention at the ER. Not an urgent care. She said she was willing to do the above and if not better, she would go to hospital. I called today and she said the arm is better she did not go to  hospital but that she took aspirin, rested and iced it. Feeling much better.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity, Tenderness
Clinical narrative: Approximately 24 hours after injection of PNEUMOMVAX 23 in right arm (deltoid) patient experienced significant pain and tenderness in right arm. He states he had a hard time lifting his arm above his head. In the evening he noticed significant swelling and redness above the elbow on the posterior side. He slept with his arm above his heart to reduce the swelling and applied ice packs. On 9/20 he returned to the pharmacy; there was still significant swelling and redness on the posterior side of the right arm. He was instructed to ice the area and to take an NSAID and antihistamine to decrease the reaction and that the reaction should resolve with in a couple days.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Patient seen in our office on 9/19/2017 at 2:15 pm for a routine child health examination and weight check. Patient's 4 month vaccines given, as listed above. On 9/20/2017, patient was found infant unresponsive by parents. EMS called and arrived to find parents performing CPR. Patient transferred via EMS to ED. CPR unsuccessful. Time of death called at 7:34am in the ED.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Patient received Tdap on September13, 2017. She returned for additional vaccines today, 09/20/2017. Her left arm showed erythema of 65 x 70 with heat that had only started the day before about 5pm. She was seen by Dr. It was unusal that the reaction waited 6 days before it appeared. We are not aware of other possible causes.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Gait disturbance
Clinical narrative: Dizziness, unsteady gate.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Balance disorder, Cerebrovascular accident, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: Sudden lightheadedness beginning at 11:30am on 9/12/17, decreasing balance/stability, some difficulty focusing. Symptoms increasing. Went to the Emergency Department thinking she was developing a stroke, CT scan, Carotid ultrasound, EKG, labs all normal range. Symptoms eased after 3-4 hours. She went home and took the next day off of work due to lightheadedness and difficulty focusing.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Laboratory test normal, Ultrasound Doppler normal, Vision blurred
Clinical narrative: Sudden lightheadedness beginning at 11:30am on 9/12/17, decreasing balance/stability, some difficulty focusing. Symptoms increasing. Went to the Emergency Department thinking she was developing a stroke, CT scan, Carotid ultrasound, EKG, labs all normal range. Symptoms eased after 3-4 hours. She went home and took the next day off of work due to lightheadedness and difficulty focusing.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Vomiting
Clinical narrative: Pt had swelling and redness at site of injection and then vomited later that night. Next day she was fine.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: Injection site: redness, soreness, hives, rash. Systemic: general malaise, fatigue, loss of appetite for 24 hours. GI: sever stomach ache, cramps and loose stools.
Age: 13.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Injection site rash, Injection site urticaria, Malaise
Clinical narrative: Injection site: redness, soreness, hives, rash. Systemic: general malaise, fatigue, loss of appetite for 24 hours. GI: sever stomach ache, cramps and loose stools.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed a red rash from his knees up to his neck. Patient followed up with Medical two days following his vaccination.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Chest X-ray, Computerised tomogram, Dyspnoea, Migraine
Clinical narrative: Hives covering entire body which eventually constricted my airway to the point where I was unable to breath well. Went to ER Saturday morning 5am for help. They did chest xray, cat scan for blood clot in chest, blood tests, Iv fluids to flush, and triple doses of nebulizer for breathing. Released later that day and told to report information to my Dr. which I did. Hives are gone and breathing much better but since Saturday night been having Migraine headaches every day, which Dr. said is probably lingering effects from Shot.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Throat tightness, Urticaria
Clinical narrative: Hives covering entire body which eventually constricted my airway to the point where I was unable to breath well. Went to ER Saturday morning 5am for help. They did chest xray, cat scan for blood clot in chest, blood tests, Iv fluids to flush, and triple doses of nebulizer for breathing. Released later that day and told to report information to my Dr. which I did. Hives are gone and breathing much better but since Saturday night been having Migraine headaches every day, which Dr. said is probably lingering effects from Shot.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Pt came back a few minutes after vaccine, and she had itching and swelling around her ears. It was red and swollen. Pt took a Benadryl, and it started to get better.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient complains of arm soreness that continues to worsen, making it difficult to move her arm.
Age: 34.0
Sex: F
Vaccine: FLUC4
Symptoms: Induration
Clinical narrative: Induration, approximately 4cm X 3cm; ice pack PRN, monitoring.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site inflammation, Injection site pain, Pain in extremity, Peripheral swelling
Clinical narrative: PAIN AND INFLAMMATION OVER THE WHOLE LEFT SHOULDER AREA AND DOWN LEFT ARM (REDNESS, SWELLING, PAIN, AND HOT TO THE TOUCH).
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm
Clinical narrative: PAIN AND INFLAMMATION OVER THE WHOLE LEFT SHOULDER AREA AND DOWN LEFT ARM (REDNESS, SWELLING, PAIN, AND HOT TO THE TOUCH).
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported a red swollen sore arm that it made it hard to move her arm.
Age: 70.0
Sex: M
Vaccine: FLUX, PNC13, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: THE PROBLEM OCCURRED WHEN I ADMINISTERED THE  VACCINE, I INADVERTENTLY PICKED UP THE PREVNAR AND GAVE IT SUB-Q (I THOUGHT I HAD MY ZOSTAVAX IN MY HAND) ....I REALIZED THE MISTAKE IMMEDIATELY AFTER GIVING THE VACCINE. WE THEN CALLED PFIZER AND CONSULTED WITH THEM. THEY SAID THEY HAD ADMINISTERED SUB-Q DURING CLINICAL TRIALS AND IT WAS "WELL TOLERATED", ALTHOUGH THE RECOMMENDATION IS TO GIVE IM...WE PROCEEDED TO GIVE THE FLU VACCINE AND SHINGLES VACCINE CORRECTLY AND HAD THE PATIENT WAIT IN OUR VACCINATION AREA FOR A PERIOD OF TIME. UPON LEAVING ALL SEEMED FINE WITH HIM, WE WILL BE FOLLOWING UP WITH HIM THIS EVENING AND OVER THE NEXT TWO  DAYS TO ASSURE THAT HE IS FINE.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Abdominal pain upper, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt returned to the Clinic due to body aches, 2x2 red swollen tender area around injection site reaction, and 6x3 area of pain around the reddened area, body aches and fever of 101, belly pain, headache and sore throat. Rapid strep done in office Neg, Referral made to allergist and IBU and BENADRYL given to office.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Oropharyngeal pain, Pain, Pyrexia, Streptococcus test negative
Clinical narrative: Pt returned to the Clinic due to body aches, 2x2 red swollen tender area around injection site reaction, and 6x3 area of pain around the reddened area, body aches and fever of 101, belly pain, headache and sore throat. Rapid strep done in office Neg, Referral made to allergist and IBU and BENADRYL given to office.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient was given vaccine around 2:30pm. Arm was checked at 2:48pm and she had a 1/4 inch red circle at injection site. Patient called on 9/20 and came to pharmacy around 5:15pm to have pharmacist look at it. The red area was 4 inches in length and 1&1/2 inch in width. Patient had been taking diphenhydramine to help. She stated that it started itching today.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Loss of consciousness, Skin discolouration
Clinical narrative: Patient passed out about 5 minutes after receiving the vaccine. He was caught before hitting the floor and was slowly lowered to the floor. 911 was called and town rescue was dispatched. Patient refused ambulance service to the hospital because he only has catastrophic health insurance. Both myself and EMT insisted that he should be checked out. His blood pressure, pulse and oxygen was checked. All in normal range. His coloring was gray at first but did improve before he left the pharmacy. He called friends/family to drive him.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site nodule
Clinical narrative: As soon as injection was administered in the muscle, patient developed a golf ball sized knot.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Tremor, Vomiting
Clinical narrative: Patient complained of having chills, tremors and nausea and vomiting for 12 hours after. Patient recovered after 12 hours.
Age: 57.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Diarrhoea, Injection site erythema, Injection site pain, Oropharyngeal pain, Pyrexia
Clinical narrative: Patient reported diarrhea today x 2; had fever yesterday w/ 37.5C, no fever at the clinic today with temp of 98.2F. C/o sore throat and skin redness on her right deltoid with pain, soft to touch with measurements of 7cm x 13cm.