chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pyrexia, Skin warm
Clinical narrative: Patient came with her husband to get MENACTRA shot on 11-09-2017. On the same day, patient experienced redness around the inject site. The size of redness has progressed throughout the entire week. Patient reports that she had fever and the redness becomes painful to touch since 11-15-2017. Instruct patient to go to nearby urgent care to take a look. The site is warm to touch and it's all over the entire front forearm. Husband and the other 2 family member who got the same vaccination with same batch number have no problem.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Rash erythematous
Clinical narrative: Patient states he has a 2 inch red spot (rash) around the injection site. Patient doesn't have any shortness of breath or any other signs of an anaphylactic reaction. Patient called the local emergency room and they were not concerned. They told patient to call his pharmacy. I told patient to let us know if he develops any other signs or symptoms. Patient had no further questions or concerns.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Rash generalised
Clinical narrative: At 7:00 pm 48 hours after shots child broke out in rash covering entire body. Rash continued to spread. A visit to the Pediatrician determined the most likely cause was the vaccines. No other symptoms were present.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site nodule, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Soreness and a "knot" at injection site. Mild fever day after injection. Sore and warm area of redness above elbow of right arm. Mild swelling.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Cough, Impaired work ability, Lethargy, Malaise
Clinical narrative: Next day: chills, fever, aching all over, sore throat, coughing, lethargic. Still have severe coughing. Missed work. Symptoms subsided 4 days later. Still sick.
Age: 65.0
Sex: F
Vaccine: FLUC4
Symptoms: Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Next day: chills, fever, aching all over, sore throat, coughing, lethargic. Still have severe coughing. Missed work. Symptoms subsided 4 days later. Still sick.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Incorrect dose of FLUZONE given (0.25 mL instead of 0.5 mL)
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dizziness, Headache, Injection site erythema, Injection site pain, Pain
Clinical narrative: Redness and pain at injection site. Mom reports patient had dry heaves and vomiting, extreme body aches, dizzy, headache over course of 2 days.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Retching, Vomiting
Clinical narrative: Redness and pain at injection site. Mom reports patient had dry heaves and vomiting, extreme body aches, dizzy, headache over course of 2 days.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Antibody test negative, Arthralgia, Asthenia, Dizziness, Influenza virus test
Clinical narrative: Redness and pain at injection site. Mom reports patient had dry heaves and vomiting, extreme body aches, dizzy, headache over course of 2 days.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site warmth, Pain, Pyrexia, Sepsis
Clinical narrative: Redness and pain at injection site. Mom reports patient had dry heaves and vomiting, extreme body aches, dizzy, headache over course of 2 days.
Age: 12.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Vomiting, White blood cell count increased
Clinical narrative: Redness and pain at injection site. Mom reports patient had dry heaves and vomiting, extreme body aches, dizzy, headache over course of 2 days.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Headache, Injection site erythema, Injection site pain
Clinical narrative: LUE erythema and pain measuring 20 cm x 23 cm, warm and tender to touch. Fever/chills the first day, then fever in the evenings for a few days after. Nausea and headache. Decreased appetite.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Nausea, Pyrexia
Clinical narrative: LUE erythema and pain measuring 20 cm x 23 cm, warm and tender to touch. Fever/chills the first day, then fever in the evenings for a few days after. Nausea and headache. Decreased appetite.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cheilitis, Eyelid oedema, Pruritus, Rash generalised, Tachycardia
Clinical narrative: Itching body, swollen eyelids and lips rash head to toe. Itching throat/tongue tachycardic, no murmur. BENADRYL susp. 7.5 cc Prednisone 17 mg PO Allergy referral. Tx: IV saline, EPI Jr, PEPCID 8 mg IV.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Throat irritation, Tongue pruritus
Clinical narrative: Itching body, swollen eyelids and lips rash head to toe. Itching throat/tongue tachycardic, no murmur. BENADRYL susp. 7.5 cc Prednisone 17 mg PO Allergy referral. Tx: IV saline, EPI Jr, PEPCID 8 mg IV.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a 76 year old female consumer reporting on herself with heart condition, pacemaker and no drug reactions or allergies. The patient's medical history included heart attack when she was 38 years old in approximately 1977. The patient did not have any known drug reactions or allergies. In approximately 2014 (reported as about three years ago), the patient was vaccinated with an unspecified  dose of ZOSTAVAX (dose, lot #, expiration date and anatomical location were not reported) (route reported as "injection") for prevention of shingles. The vacine was reconstitued with sterile diluent (manufacturer unknown) (dosage schedule, lot number and expiration date were not reported). The patient's concomitant therapies included  "several unspecified medications." On 20-APR-2016, the patient developed shingles (herpes zoster). The shingles developed on her "left breast, underneath the left breast, on her stomach, and on her back." The patient stated that she had to go to the "Emergency Room" for treatment. The patient was given "oxycodone-apap cap 7.5-325." The patient stated that she recovered from shingles on an unspecified date; however, some areas on her back still itch. There were no lab diagnostic studies performed. The causality assessment between the adverse event and the suspect therapies was  not provided.
Sex: U
Vaccine: HPV4
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. On 13-SEP-2017, the patient was vaccinated with an expired dose of GARDASIL (lot # J009243 and expiration date: 17-APR-2017) for prophylaxis. There were no adverse effects.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Induration, Injection site reaction, Local reaction, Rash erythematous
Clinical narrative: This spontaneous report was received from a company representative referring to her father, a 75 year old male patient. The patient did not have a pertinent medical history; he was not using any concomitant therapies and did not have any past drug reactions/allergies. The patient's concurrent conditions were not reported. On 07-OCT-2017 the patient was vaccinated with a dose of PNEUMOVAX 23 in the arm (not specified) (strength, route, lot # and expiration date were not reported) for prophylaxis. On an unknown date in October 2017, also reported as "shortly after receiving the dose of PNEUMOVAX 23", the patient experienced a local injection site reaction. The reporter stated that her father experienced a red, raised, and hard rash around his arm and elbow. The patient reported the incident to his physician who suggested to put ice on it. The reporter stated that after a few days of putting ice on the area the reaction subsided. The outcome of rash papular, injection site reaction and rash erythematous was recovered on an unknown date in 2017. The reporter did not assess a causal relationship between the aforementioned events and PNEUMOVAX 23.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: This spontaneous report has been received from a pharmacist refers to a 57 year old female patient with allergy to morphine. The patient had no medical history to be reported. On 11-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 (strength, dose, frequency and route of administration were not provided) lot # N019348, expiration date 18-FEB-2019, for prophylaxis. Concomitant therapies included atorvastatin, loratadine (CLARITIN), lisinopril, citalopram hydrobromide (CELEXA), atomoxetine hydrochloride (STRATTERA), bupropion hydrochloride, levothyroxine sodium and alendronate sodium (FOSAMAX). The reporter stated that on an unspecified date in 2017, soon after the vaccination with PNEUMOVAX 23, the patient experienced swelling (peripheral swelling) and a red rash on her arm (rash erythematous). Additionally, it was reported that the patient visited her primary physician on an unspecified date for the rash. The outcome of peripheral swelling, rash and rash erythematous was reported as recovered. At the time of this report, the causality between the events and PNEUMOVAX 23 was not reported.; Sender's Comments: US-009507513-1711USA001303: US-009507513-1711USA001291:
Sex: U
Vaccine: MMR
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 and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 08-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II (dose, frequency and route of administration were not reported) lot # M036544 and expiration date: 15-AUG-2018. The vaccine was reconstituted with an improperly stored sterile diluent (manufacturer unknown) (lot # M023895 and expiration date: 18-JAN-2019). No adverse effects were reported. On 08-NOV-2017, the M-M-R II and sterile diluent (manufacturer unknown) were stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006684: US-009507513-1711USA006683: US-009507513-1711USA006682: US-009507513-1711USA006685.
Sex: U
Vaccine: MMR
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 and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 14-NOV-2017, the patient was vaccinated with improperly stored dose of M-M-R II (dose, frequency and route of administration were not reported) lot # M036544 and expiration date: 15-AUG-2018. The vaccine was reconstituted with an improperly stored sterile diluent (manufacturer unknown) (lot # M023895 and expiration date: 18-JAN-2019). No adverse effects were reported. On 08-NOV-2017, the M-M-R II and sterile diluent (manufacturer unknown) were stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes and on 14-NOV-2017, between the same temperatures for 15 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006683: US-009507513-1711USA006684: US-009507513-1711USA006685: US-009507513-1711USA006084.
Sex: U
Vaccine: HIBV
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 and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-NOV-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (dose, frequency and route of administration were not reported) lot # N001348 and expiration date: 31-OCT-2019. No adverse effects were reported. On 08-NOV-2017, the PEDVAXHIB was stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006084: US-009507513-1711USA006682: US-009507513-1711USA006684: US-009507513-1711USA006685.
Sex: U
Vaccine: HIBV
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 and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-NOV-2017, the patient was vaccinated with improperly stored dose of LIQUID PEDVAXHIB (dose, frequency and route of administration were not reported) lot # N001348 and expiration date: 31-OCT-2019. No adverse effects were reported. On 08-NOV-2017, the LIQUID PEDVAXHIB was stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter.; Sender's Comments: US-009507513-1711USA006084: US-009507513-1711USA006682: US-009507513-1711USA006683: US-009507513-1711USA006685:
Sex: U
Vaccine: HIBV
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 and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 13-NOV-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (dose, frequency and route of administration were not reported) lot # N001348 and expiration date: 31-OCT-2019. No adverse effects were reported. On 08-NOV-2017, the PEDVAXHIB was stored in between 47 Fahrenheit degrees to 77 Fahrenheit degrees for 45 minutes. There was no previous temperature excursions. The digital data logger was involved in recording the temperature excursion. This is one of five reports received from the same reporter. Sender's Comments: US-009507513-1711USA006682: US-009507513-1711USA006683: US-009507513-1711USA006683: US-009507513-1711USA006084.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Extra dose administered, Gait disturbance, Injection site erythema, Injection site swelling
Clinical narrative: My son was double dosed/given extra of the HepA immunization and the PCV after the doctor was given an immunization record that stated his shots were UP TO DATE until 3/28/2019. His right thigh is now swollen, red and he isn?t able to put pressure on his leg. When he tries to walk he limps. He got these shots on 11/15/2017 at 11am and woke up from a nap later that day (2:30p) and had these symptoms. It has worsened today 11/16/2017.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Parosmia
Clinical narrative: Nausea, headache, sensitivity to smell starting approximately one hour after received vaccination, patient took an ondansetron and laid down and fell asleep for two hours, when awakened, patient states nausea had resolved and headache diminished as well as sensitivity to smell.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Pain at the region and his arm was beefy red and warm.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient developed redness on the right shoulder which is warm to touch and slightly painful. The site of reddened area is bigger than the size of patient's palm.
Age: 12.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: After administering vaccinations patient stated that she felt faint. RN and mother laid patient on the ground and elevated knees. RN gave patient a juice box. Patient was coherent and did not lose consciousness. After 10 minutes of laying on ground and drinking juice box patient sat in chair for several minutes and drank another juice box. Patient stated she felt well after 10 more minutes of observation. Mother and patient ambulated out of clinic without difficulty.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Asthenia, Dizziness, Fatigue, Gait disturbance, Wheelchair user
Clinical narrative: Pt reports that he began to feel dizzy, lightheaded, very tired, and weak about 30 minutes after receiving GARDASIL. Symptoms were persisting at 2 hours post-vaccination, when he returned to the office. Vital signs were stable, no signs of anaphylaxis. He appeared very weak and tired (required wheelchair for unsteady gait), but was responsive and oriented to person, time, place, and situation.  He was sent home to rest with instructions to take ibuprofen or TYLENOL. He returned to the office the following morning to report that he rested and took ibuprofen and is feeling much better.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Pain and decreased range of motion of left arm since flu shot, reported continued issues 11/16/17.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Limb discomfort, Pain in extremity
Clinical narrative: Discomfort and pain in left arm for weeks since injection, including limited range of motion.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: The pt was given an incorrect dose of FLUZONE 0.25 mL instead of FLUZONE 0.5 mL. Guardians notified and patient is scheduled to come in for corrected dose and then will need additional dose as this is the first time receiving the flu vaccine.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Ear discomfort, Eye movement disorder, Loss of consciousness, Pallor
Clinical narrative: Approximately 5 minutes after receiving vaccine, started complaining about feeling weak, ears "feeling weird", spots in visual field, pale. 1-2 minutes later while seated - head fell back, eyes rolled backwards, lost consciousness for ~ 2 - 3 seconds then came out of it quickly, felt better, conversing appropriately. BP 96/48 @ 4:30 pm, 98/72 @ 4:40 pm, pulse "in the 60s" per nurse's note. Other nurse nearby stated that she heard her say her throat felt funny when she was first complaining. Pt states "it was just for a minute then it went away".  Sent by ambulance to ER. Went to school the next day feeling fine. Has appt with allergist in January 2018 to evaluate for future flu vaccine.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Posture abnormal, Throat irritation, Visual impairment
Clinical narrative: Approximately 5 minutes after receiving vaccine, started complaining about feeling weak, ears "feeling weird", spots in visual field, pale. 1-2 minutes later while seated - head fell back, eyes rolled backwards, lost consciousness for ~ 2 - 3 seconds then came out of it quickly, felt better, conversing appropriately. BP 96/48 @ 4:30 pm, 98/72 @ 4:40 pm, pulse "in the 60s" per nurse's note. Other nurse nearby stated that she heard her say her throat felt funny when she was first complaining. Pt states "it was just for a minute then it went away".  Sent by ambulance to ER. Went to school the next day feeling fine. Has appt with allergist in January 2018 to evaluate for future flu vaccine.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, itching, and swelling around injection site 12-18 hours after vaccines given.
Age: 2.0
Sex: F
Vaccine: FLUC4
Symptoms: Wrong drug administered
Clinical narrative: The patient was given FLUCELVAX 0.5 mL rather than the appropriate dose of FLUZONE 0.25 mL.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 20 plus year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/allergies were not reported. Approximately in March 2017 (reported as 7 months ago), the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 mcrg/ml injection (dose, lot # and expiration date were not reported) for prophylaxis. Approximately in September 2017 (reported as 6 months later), the patient was vaccinated with the second dose of RECOMBIVAX HB. At the time of this report (4 months after the second dose), the patient did not have the third dose of the vaccine. No adverse effects were reported.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: About 3 hours after injection patient started to notice symptoms she has swelling at injection site, area is warm and painful. Swelling lump measured to be 9.5cm X 9.5cm at 1:20 PM. She was given TYLENOL 1,000 gm and Loratadine 10 mg. She was given an ice pack to apply to site. It is 2 PM and still in our office not much improvement has been seen at this time.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Arm is red - potentially infected, wants to be careful, a little swollen, painful, feels like someone punched in the arm.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Redness at the site of injection along with pain, also chills and fever, suggested advil for pain
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Redness at the site of injection along with pain, also chills and fever, suggested advil for pain
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Bronchitis, Lymph gland infection, Lymphadenopathy, Mobility decreased, Neck pain
Clinical narrative: Arm was sore and got progressively worse to the point of not being able to move in certain directions. Severe pain when moving arm. I still have pain but not as severe. I also have pain in my neck. I took ibuprofen which helped a bit but did not take away the pain. My shot was on 8/31 and I still have some pain with movement. During this time I had a sinus infection upper respiratory and swollen glands right after that I had bronchitis and an infected lymph node behind my ear. Do not know if this was related to the shot.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity, Sinusitis, Tenderness, Upper respiratory tract infection
Clinical narrative: Arm was sore and got progressively worse to the point of not being able to move in certain directions. Severe pain when moving arm. I still have pain but not as severe. I also have pain in my neck. I took ibuprofen which helped a bit but did not take away the pain. My shot was on 8/31 and I still have some pain with movement. During this time I had a sinus infection upper respiratory and swollen glands right after that I had bronchitis and an infected lymph node behind my ear. Do not know if this was related to the shot.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling, Skin warm, Ultrasound scan normal
Clinical narrative: Swelling, heat and pain in right arm increasing from 11-7-17 in afternoon to 11-10-2017 afternoon. Notified provider. Started on doxycycline and CIPRO on 11-10 after texting a picture of her swollen arm to her provider (patient was in out of town and could not get to the clinic until later that evening.) Dr ordered a sonogram to check for a clot, which was done and it was negative for clot. Then antibiotics were started. Swelling & pain decreased and were mostly gone on 11-13-17. No problems now.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity
Clinical narrative: Patient said she thought it was immediately more painful when getting the vaccination. She said her pain has persisted since she received the vaccination two and a half weeks ago. She said it hurts to lift her arms and the pain is pretty severe.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Child diagnosed with intussusception as per ultrasound. Child was sent to hospital. The intussusception spontaneously improved without the need for enema.
Age: 75.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: WIFE REPORTS APPROXIMATELY ONE HOUR AFTER RECEIVING VACCINE, PATIENT'S LEFT ARM BECAME SWOLLEN AND PAINFUL AT INJECTION SITE. NO TREATMENT WAS GIVEN. WIFE CALLED OFFICE THE NEXT DAY AND REPORTED SYMPTOMS. SYMPTOMS BY THEN HAD DECREASED AND PATIENT STATED HIS ARM WAS "BETTER". WIFE WAS ADVISED TO APPLY ICE, ELEVATE PATIENT'S ARM AND GIVE OTC PAIN MED (ACETAMINOPHEN OR IBUPROFEN) IF NEEDED AND TO CALL OFFICE IF SYMPTOMS DID NOT RESOLVE OR CONDITION WORSENED.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Adverse reaction, Mobility decreased, Nausea, Nerve injury, Pain in extremity
Clinical narrative: Patient came to the pharmacy stating she had severe reaction about 7pm when she got home. Her arm was hurting, she couldn't move it, and also was nauseated. The nauseating feeling went away that night but the pain in her arm persisted. She contacted her PCP for advice and they instructed her to go to the ER. She then made an appointment and saw her doctor on 11/16/17. He said from physical examination it seemed like nerve damage. He gave her a prednisone shot and a PERCOCET rx.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity, Skin warm
Clinical narrative: Pain in the arm, especially with raising the arm. Upper arm/shoulder area is warm to touch. Took ibuprofen, advised to continue ibuprofen and ice the area alternating 15 minutes on/off.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Neck pain, Pain in extremity
Clinical narrative: Arm pain that influenced sleep (had to take sleeping pills), extended to neck. Ibuprofen and cold compresses helped pain. Pain has lasted 6 weeks from date of injection. Not influencing range of motion.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, hot, swollen at the injection site.
Age: 87.0
Sex: F
Vaccine: FLUA3
Symptoms: Swelling face
Clinical narrative: Cheeks started swelling, no sign of difficulty breathing, patient coming in-and-out of it, PROAIR used, BENADRYL given, 911 called and taken to the hospital, no other signs of anaphylaxis, EPIPEN offered and refused.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Patient states that she has a bump or a knot in her arm around the injection site since the vaccine was administered which flares up from time to time.
Age: 79.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Swelling
Clinical narrative: She had redness, swelling, and a nurse at the local health center thought maybe a cellulitis.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient stated arm had been sore for a month and consulted Dr. who said it was given in bursa sac by patients description of vaccination.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site vesicles
Clinical narrative: A blister developed at the site of injection the day after the injection. The blister is approximately 7 mm and slightly raised. It apparently contains fluid. The blister has decreased in size but is still apparent on 11/16/2017. There are no other symptoms.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, IPV, TDAP
Symptoms: Incorrect dose administered
Clinical narrative: Inappropriate dose for patient's age, should have been 0.5 mL for pediatric dose.
Age: 12.0
Sex: M
Vaccine: HEP, HEP, IPV, TDAP
Symptoms: Drug administered to patient of inappropriate age, Headache, Overdose, Pain in extremity
Clinical narrative: Inappropriate dose for patient's age, should have been 0.5 mL for pediatric dose.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Patient reported on 11/16/2017 that she has had and has a hard bump at the immunization site since 10/2/2017. Patient was not able to pull up sleeve to show me. Patient stated it was and is not hot, is not itchy and is not swollen. Just a hard bump. A friend told her to put heat instead of ice so she was putting heat on it.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchospasm, Dyspnoea, Malaise
Clinical narrative: Patient received vaccine at 5 PM, went home and started feeling ill at 9 PM. Drove himself to hospital experiencing shortness of breath. Was given "breathing treatment" at the hospital and felt better after. Was discharged at 5 AM with diagnosis of acute bronchial spasm.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Paraesthesia oral, Pharyngeal oedema, Urticaria
Clinical narrative: Patient had hives, difficulty breathing, lip tingling, throat swelling.
Age: 67.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Swelling
Clinical narrative: Patient came in today to report local swelling, sore arm, warm red skin around vaccinated area which appeared day following immunization.
Age: 61.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: Patient said she had frequent vomiting.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Myalgia, Skin warm
Clinical narrative: Skin feels hot, muscle aches and pains, dizzy.
Age: 82.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient complained of waking up in night following vaccination with fever and chills and the following morning having a redness and swelling on injection site on left arm.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: It locked up my chest or lungs and I couldn't suck in air to breathe. I called 911 and all my vitals checked out fine and after a while, I was able to breathe normal again.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Balance disorder, C-reactive protein normal, CSF culture negative, CSF test normal
Clinical narrative: Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when "your feet fall asleep," though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a "cold" sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Cytomegalovirus test negative, Cytomegalovirus test positive, Dysphagia, Dysphemia
Clinical narrative: Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when "your feet fall asleep," though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a "cold" sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Dysstasia, Endotracheal intubation, Fall, Feeling cold
Clinical narrative: Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when "your feet fall asleep," though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a "cold" sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Headache, Hypoaesthesia, Hypoaesthesia oral, Immunoglobulin therapy
Clinical narrative: Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when "your feet fall asleep," though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a "cold" sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of control of legs, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal abnormal, Nuclear magnetic resonance imaging thoracic abnormal, Respiratory failure
Clinical narrative: Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when "your feet fall asleep," though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a "cold" sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Sensation of foreign body, Speech disorder, Urinary retention, Vomiting, West Nile virus test
Clinical narrative: Patient was diagnosed with progressive Guillain-Barre. Symptoms started on 11/11 with sensation of numbness in the bottom of his feet. On 11/12, the patient reports progressing sensation of numbness to include his entire feet and legs below the level of the knee. He describes the numbness as similar to when "your feet fall asleep," though persisting in duration. On 11/13, the patient had an episode of emesis after experiencing difficulty swallowing. He reports sensation of food getting stuck in his throat when swallowing. He also reports sensation of tongue numbness that he describes as a "cold" sensation. The patient reports having fallen this morning in his bathroom after losing balance. He describes losing control over his lower extremities. Dad reports the patient not being able to stand from a laying position this afternoon, and had to be carried to the car in transporting to the ED. The patient denies recent illness, nasal congestion, cough or fever. He does endorse a headache that he describes as dull and aching sensation in the frontal region without radiation of pain elsewhere. He reports a vague aching sensation in his low back that is not made worse with positional changes. He also reports sensation of incomplete voiding with urination. He describes sensation of difficulty in taking a deep breath though denies shortness of breath. The patient has a history of stuttering and feels as though his stutter has gotten worse in the past few days. He denies recent rash or skin changes. He denies joint pain or aching sensation in his extremities. The patient had his influenza vaccination on 11/2. On 11/15 his symptoms worsened and had a harder time speaking with increasing lower extremity numbness. IVIG 1g/kg (80g) IV q24h was initiated on 11/15. He was intubated on the AM of 11/16 for respiratory failure.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Myalgia, Pain
Clinical narrative: Pt experienced pain/redness in shoulder extending from shoulder to distal bicep. Woke up in middle of night with some pain and discovered that it was red and sore. Pt given some BENADRYL next day to see if redness would go down. Pt will call back next week if hasn't gotten better.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Chills, Dysstasia, Fatigue, Gait disturbance
Clinical narrative: Sudden extreme weakness, exhaustion, chills, blurred vision, difficulty standing and walking. Went home to bath tub to get warm and then to bed. Took TYLENOL 1000 mg and ATIVAN 0.5 mg. Body aches continued for another day, though much less severe.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Vision blurred
Clinical narrative: Sudden extreme weakness, exhaustion, chills, blurred vision, difficulty standing and walking. Went home to bath tub to get warm and then to bed. Took TYLENOL 1000 mg and ATIVAN 0.5 mg. Body aches continued for another day, though much less severe.
Age: 70.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site warmth, Pyrexia
Clinical narrative: Chills, fever, redness, hardness and hot to touch at site of injection.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Cough, Erythema, Injection site induration, Injection site warmth
Clinical narrative: Fever, chills, coughing, redness and swelling in left arm, hotness and hard around injection site. Got an upper respiratory infection.
Age: 61.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Upper respiratory tract infection
Clinical narrative: Fever, chills, coughing, redness and swelling in left arm, hotness and hard around injection site. Got an upper respiratory infection.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fatigue, Nausea, Vomiting
Clinical narrative: Soon after the injection the patient noted fatigue and lightheadedness. She went home and immediately went to sleep. Symptoms continued the next day. Day 2 post vaccination the patient developed nausea and vomited once. Her symptoms are slowly improving at this point.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Confusional state, Headache, Hyperammonaemia, Metabolic encephalopathy
Clinical narrative: Vomiting, fever, headache, confusion, on the morning of 11/4/2017 continuous low blood sugar even after glucose and juice was given to the patient.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Vomiting, fever, headache, confusion, on the morning of 11/4/2017 continuous low blood sugar even after glucose and juice was given to the patient.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Patient came into pharmacy day after immunization (11/16/17) to report that her arm had swollen and was hot to the touch approximately 5 hours after receiving the immunization. Patient took some ADVIL afterwards. Discussed with patient to see provider if worsens or could take some BENADRYL for symptom relief.
Age: 0.92
Sex: F
Vaccine: PNC13
Symptoms: Intensive care, Status epilepticus
Clinical narrative: 11 mo with Wolf-Hirschhorn syndrome had PREVNAR on 11/15. Went to ED in Status epilepticus. Required an IO to be placed. Transferred to ICU on 11/16.
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 18-month-old female patient who received FLULAVAL QUADRIVALENT (batch number 7PL77, expiry date 31st May 2018). On 31st October 2017 10:52, the patient received FLULAVAL QUADRIVALENT .5 ml. In November 2017, 20 hrs after receiving FLULAVAL QUADRIVALENT, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site tenderness. On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving and the outcome of the injection site erythema and injection site tenderness were recovered/resolved. The reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site tenderness to be related to FLULAVAL QUADRIVALENT. Rerun narrative: Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT on the left thigh and about "20 to 24 hours" after receiving FLULAVAL QUADRIVALENT, the patient experienced redness, swelling and tenderness of entire left thigh. The patient was taken to the emergency room and a follow-up physician's office visit was conducted; no further treatment was performed at either facility. On 3rd November 2017, a follow-up phone call was placed by the healthcare professional office to the patient and that time the patient's mother reported the symptoms of redness and tenderness had completely resolved, patient was up and walking around normal, however there was still some mild swelling. The healthcare professional reported no other vaccines were administered that day and believe the symptoms were a direct result of the FLULAVAL QIV vaccine. No further information was reported at this time regarding the event.