chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional  on 08 January 2014. This case is invalid as invalid as individual patient identifiers were not reported. Some patients had received ACTHIB on an unspecified date. The ACTHIB was reconstituted with sterile water instead of the diluent. The patient did not experienced any adverse event. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 21 February 2013. A dose of ActHIB was reconstituted with Merck diluent and administered to a patient. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 25 February 2013. ACTHIB was reconstituted with sterile water instead of ACTHIB diluent and dose was administered. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 08 February 2013. A patient received ACTHIB which was reconstituted with Merck diluent. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 05 March 2013. ACTHIB was Reconstituted with sterile water and administered. No information was provided regarding the patients. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Overdose
Clinical narrative: Initial overdose report received from a healthcare professional on 18 March 2013. A patient (No information was provided regarding the patient) had received ACT-HIB and PENTACEL so the patient received double ACT-HIB dosing. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 March 2013. Only diluent from the Acthib was administered to a patient without mixing the powder on it (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Underdose
Clinical narrative: Initial report received from a healthcare professional on 09 April 2013 and follow up information received from other company (Merck) on 24 April 2013. Other company reference number: 1-6856855155. A patient, whose age, gender, medical history and concomitant medications were not reported, had received a dose of ActHIB vaccine (lot number, dose number, route and site of vaccination were not reported) on an unspecified date. It was reported that the patient was administered ActHIB vaccine and some of the vaccine leaked out of the syringe. Thus the patient received a vaccine under dose. As of 09 April 2013, the patient had no adverse event. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 04 April 2013. A child was administered an expired dose of ADACEL. No more information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 12 April 2013. A dose of ACT-HIB that was reconstituted over 24 hours ago was administered to child. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 11 April 2013. A patient (No information was provided regarding the patient) had received a dose of Acthib that had been reconstituted with another diluent and not with the supplied diluent. It was reported that it may have been a Merck diluent. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 19 April 2013. ACTHIB reconstituted with sterile water was administered to a patient (no information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.3
Sex: U
Vaccine: DTAPIPVHIB, HIBV
Symptoms: No adverse event, Overdose
Clinical narrative: Initial misuse report received from a healthcare professional on 23 July 2013. A 04-month-old patient had received a dose of ACTHIB vaccine and also the ACTHIB in the dose of PENTACEL vaccine on 22 July 2013. No adverse event was reported. Documents held by sender: None.
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a non-healthcare professional on 22 July 2013. A female patient was administered two doses of ActHIB. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: U
Vaccine: HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 29 July 2013.  02-year-old patient received an extra dose of ACTHIB making a total of 5 doses. No adverse event was reported. List of documents held by sender: none
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Initial misuse report received from a healthcare professional on 16 July 2013. It was reported that the vaccine was too long in shipping and was being replaced, but one dose was given in error. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional  on 25 July 2013. A patient (no information was provided regarding the patient) received DTAP/IPV component of PENTACEL reconstituted with a separate ACTHIB instead of the ACTHIB component provided with the PENTACEL. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional  on 26 July 2013. During an inventory, it was found that the patient, who received ACTHIB on 24 July 2013, might have received ACTHIB that was reconstituted with sterile water. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a pharmacist on 06 November 2013. The patients had received ActHIB. It was reported that they used sterile water for reconstitution in a few cases. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Age: 0.55
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 20 November 2013. A patient whose gender, age, medical history and concomitant medications were not reported, had received a dose of ACTHIB vaccine, a dose of Pneumococcal vaccine from Wyeth batch number: G47423 and a dose of PEDIARIX vaccine from GlaxoSmithKline batch number: 5GS7L all vaccines on 26 August 2013 in the right thigh (route and dose number vaccines was not reported). On an unspecified date, the patient had fever, only once. The corrective treatments and laboratory investigations were not reported. The outcome of the event was not reported. List of documents held by sender is none. Additional information received on 06-Dec-2013: details were provided for immunization as follows. ACTHIB, lot # UH685AA was given on 4/18/13. ACTHIB, lot # UH738AA was given on 6/24/13. ACTHIB, lot # UH811AA was given on 8/26/13. Follow-up information received from healthcare professional on 16 January 2014. No new information was provided by reporter. Follow up information received from the healthcare professional on 28 January 2014. A 11-month-old female patient (birth weight was 3.3339 kg) had received a dose of ACTHIB (lot number was amended to UH811AA-UH782AB, previously was reported as: UH11AA-UH782AB), a dose of Pneumococcal vaccine and a dose of PEDIARIX vaccine on 26 August 2013. The number of brothers and sisters was reported as 3. It was reported that the patient and her brother and sister had no adverse event following prior vaccination. The vaccine was purchased with private funds and was vaccinated at private doctor's office or hospital. The patient did not receive any concomitant medications. The patient illness at time of vaccination was not reported and had no pre-existing physician diagnosed allergies, birth defects and medical conditions. No laboratory investigations were done. The patient was recovered on an unspecified date.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 12 December 2013. The patient had received ACT-HIB. The vaccine was reconstituted with sterile water. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse reprot received from a healthcare professional on 04-Dec-2013: The patient had received ActHIB. ActHIB reconstituted with sterile water instead of ActHIB diluent and administered. (No information was provided regarding the patient). No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 10 December 2013. The patient had received ACT HIB and was reconstituted with sterile water instead of supplied diluent. (No information was provided regarding the patient). No adverse event ws reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Initial report received from healthcare professional on 15 December 2013. A patient whose age, gender, medical history and concomitant medications were not reported, received ACTHIB (lot number, expiration date, route and site of administration were unknown) on 04 December 2013. On 4 December 2013, patient received a dose of that was reconstituted with Merck's sterile diluent. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 06 January 2014. This is an invalid case as individual patient identifiers are missing. It was reported some patient had received ACTHIB vaccine that was reconstituted with sterile water. No information was provided regarding the patients. No adverse event was reported. Documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 10 September 2013. The patient (No information was provided regarding the patient) gave twins ACTHIB, only one got a reconstituted vaccine, they do not known which one received only diluents. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 04 September 2013. It was reported that, three child patients (No other information was provided regarding the patients) received ACTHIB with mixed sterile water diluents. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 13 September 2013. This is an invalid case as individual patient identifiers are missing. It was reported that sterile water was used to reconstitute ACT-HIB vaccine and was administered to the patients. No adverse event was reported. List of documents held by sender: none.
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: Initial misuse report received from a healthcare professional on 10 September 2013. This is an invalid case as individual patient identifiers are missing. It was reported that sterile water was used to reconstitute ACT-HIB and was administered to the patients. No adverse event was reported. List of documents held by sender: none.
Age: 2.0
Sex: M
Vaccine: TTOX
Symptoms: Peripheral swelling
Clinical narrative: This case is linked to case number 2013-08937 (same patient). Initial report received from non-healthcare professional (patient parent) on 19 August 2013. A 2-year-old male patient, whose medical history and concomitant medication were not reported, had received a dose of tetanus vaccine (manufacturer unknown, batch number, dose number, route and anatomical site of vaccination were not reported) on an unspecified date. On an unspecified date, after vaccination the patient developed swollen leg. The corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was not reported. Documents held by sender: none.
Age: 1.72
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 20 month old patient of an unknown age. Medical history and concurrent conditions were not reported. The physician informed that on 29-AUG-2008 the patient was vaccinated with the first dose of M-M-R II (strength, dosage, lot# and expiration date were not reported), the same day a dose of VARIVAX (Merck) (strength, dosage, lot# and expiration date were not reported), was administered concomitantly. The second dose of M-M-R II (strength, dosage, lot# and expiration date were not reported), and the second dose of VARIVAX (Merck) (strength, dosage, lot# and expiration date were not reported) were administered on 01-APR-2009. No adverse effects were reported. Additional information is not expected because the physician refused additional contact.
Age: 69.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Paraesthesia, Rash macular
Clinical narrative: This case was reported by a pharmacist and described the occurrence of tingling feet in a 69-year-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent medical conditions included asthma, ciprobay allergy, ivp dye allergy-hives, KEFLEX, sulfa drug allergy, LIPITOR allergy and MOBICOX allergy. Concurrent vaccination included typhoid  vaccine (Non-gsk, Sanofi; unknown route and injection site) given on 11 August 2014. On 11 August 2014 at 2:45 PM, the subject received unspecified dose of HAVRIX (1 ml, unknown route, right). On 11 August 2014, within hours of vaccination with HAVRIX, the subject experienced tingling in her foot and also blotching on her foot as well. The tingling went down from her leg all the way to her foot. The tingling was intermittent. At the time of reporting, the events were unresolved. The subject was seen by her doctor for these events.
Age: 1.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site pain, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 15 month old child patient (gender unspecified). The patient had no other medications and had no medical conditions. On 18-NOV-2014 at 09:48 hours, the patient was vaccinated with PEDVAXHIB, intramuscular in the left thigh. Other suspect therapies included PREVNAR 13 vaccinated in the left thigh on 18-NOV-2014 at 09:48 hours and PEDIARIX vaccinated in the right thigh on 18-NOV-2014 at 09:48 hours. Reporter stated that the patient received PEDVAXHIB in the left thigh approximately one inch from the PREVNAR 13. On 19-NOV-2014, around 09:50 hours (next day) the baby passed away. The patient was healthy without a lot of clinic visits. Reporter did not know the cause of death because an autopsy was currently being done. Action taken was not reported. The outcome of event was reported as fatal as the patient died on 19-NOV-2014. The cause of death was reported as unknown. Additional information has been requested.
Age: 1.3
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a 15 month old child patient (gender unspecified). The patient had no other medications and had no medical conditions. On 18-NOV-2014 at 09:48 hours, the patient was vaccinated with PEDVAXHIB, intramuscular in the left thigh. Other suspect therapies included PREVNAR 13 vaccinated in the left thigh on 18-NOV-2014 at 09:48 hours and PEDIARIX vaccinated in the right thigh on 18-NOV-2014 at 09:48 hours. Reporter stated that the patient received PEDVAXHIB in the left thigh approximately one inch from the PREVNAR 13. On 19-NOV-2014, around 09:50 hours (next day) the baby passed away. The patient was healthy without a lot of clinic visits. Reporter did not know the cause of death because an autopsy was currently being done. Action taken was not reported. The outcome of event was reported as fatal as the patient died on 19-NOV-2014. The cause of death was reported as unknown. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, myalgias.
Age: 23.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: Fever, chills, myalgias.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Blister, Post vaccination autoinoculation, Rash macular
Clinical narrative: PATIENT AWOKE AFTER SLEEPING NEAR SPACE HEATER WITH MACULAR RASH AND THREE VESICLES ON LEFT LATERAL ELBOW (SAME ARM AS SMALLPOX VACCINE), POSSIBLE AUTOINOCULATION VS THERMAL BURN, PATTERN OF RASH NOT CONSISTENT WITH MOST THERMAL BURN SO TREATING AS AN AUTOINOCULATION.
Age: 32.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Injection site reaction, Injection site vesicles, Post vaccination autoinoculation, Rash macular
Clinical narrative: PATIENT AWOKE AFTER SLEEPING NEAR SPACE HEATER WITH MACULAR RASH AND THREE VESICLES ON LEFT LATERAL ELBOW (SAME ARM AS SMALLPOX VACCINE), POSSIBLE AUTOINOCULATION VS THERMAL BURN, PATTERN OF RASH NOT CONSISTENT WITH MOST THERMAL BURN SO TREATING AS AN AUTOINOCULATION.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Eye movement disorder, Muscle injury, Strabismus
Clinical narrative: Eyes turning outwards after the MMR.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mild redness, swelling, and itching at injection site, approx 2". About 2100, the swelling and redness went from my elbow to shoulder and the itching increased.  I took Benadryl to combat the itching.  Throughout the night, the itching felt internal. I wanted to scratch, but I couldn't reach it.  I was unable to take Benadryl due to working.  After shift, I took Benadryl every 4 hours and called in for work, which I rarely do.  Monday, I started taking Prednisone for the redness and swelling.  Within a week my symptoms resolved.
Age: 1.54
Sex: M
Vaccine: HIBV, VARCEL
Symptoms: Abasia, Balance disorder, Cerebellar ataxia, Gait disturbance, Infection
Clinical narrative: Loss of balance, gait off, reverted back to crawling, mild clinical infection from vaccine, all occurring approx. 2 weeks after injection. Long term effects are neurological flare ups.  Neurologist diagnosed acute cerebellum ataxia from varicella zoster vaccination.
Age: 1.28
Sex: M
Vaccine: HEP, MMR
Symptoms: Malaise, Measles, Nervous system disorder, Pyrexia, Rash erythematous
Clinical narrative: Red spots all over body, fever, illness.
Age: 1.28
Sex: M
Vaccine: HEP, MMR
Symptoms: Rash generalised, Speech disorder developmental
Clinical narrative: Red spots all over body, fever, illness.
Age: 2.0
Sex: F
Vaccine: IPV
Symptoms: Feeling hot, Musculoskeletal stiffness, Pyrexia, Staring, Unresponsive to stimuli
Clinical narrative: The childcare called me with emergency as patient had developed a very high fever. When I arrived at the facility she was very hot and was staring at a point on the wall. Two months before patient had a febrile seizure and even though she was not experiencing one at day care, her body was very stiff and she was not very responsive. Her fever when measured was 104.3. I gave her Advil and alternates with Tylenol to bring her fever down and when I couldn't I gave her a warm bath and applied compresses to her head and ankles. She continued to have a very high fever for the next 24 hours.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Bacterial test, Blood bilirubin increased, Cellulitis, Extensive swelling of vaccinated limb, Injection site erythema
Clinical narrative: Arm starting hurting, became red and swollen beyond injection site, ran fever of 102 degrees; on 1/29/15, called primary physician and described symptoms (arm was now swollen from shoulder to elbow, hot and red), was told to go to ER; went to ER, diagnosed with having celluitis in arm, given Keflex antibiotic; on 1/30/2015, arm swollen from shoulder to tip of finger, went to primary physician, suspected blood clot and had an ultrasound of arm to rule out clot; given a different antibiotic, both orally and intramuscular; swelling would subside for a few hours and then return until another intramuscular injection; returned to physician on 2/2/2015 and was given another intramuscular antibiotic along with prednisone with directions to continue oral antibiotics (Bactrim); as of today's date (2/6/2015) the redness, swelling and fever are gone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Pain in extremity, Pyrexia, Ultrasound scan normal
Clinical narrative: Arm starting hurting, became red and swollen beyond injection site, ran fever of 102 degrees; on 1/29/15, called primary physician and described symptoms (arm was now swollen from shoulder to elbow, hot and red), was told to go to ER; went to ER, diagnosed with having celluitis in arm, given Keflex antibiotic; on 1/30/2015, arm swollen from shoulder to tip of finger, went to primary physician, suspected blood clot and had an ultrasound of arm to rule out clot; given a different antibiotic, both orally and intramuscular; swelling would subside for a few hours and then return until another intramuscular injection; returned to physician on 2/2/2015 and was given another intramuscular antibiotic along with prednisone with directions to continue oral antibiotics (Bactrim); as of today's date (2/6/2015) the redness, swelling and fever are gone.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: Arm starting hurting, became red and swollen beyond injection site, ran fever of 102 degrees; on 1/29/15, called primary physician and described symptoms (arm was now swollen from shoulder to elbow, hot and red), was told to go to ER; went to ER, diagnosed with having celluitis in arm, given Keflex antibiotic; on 1/30/2015, arm swollen from shoulder to tip of finger, went to primary physician, suspected blood clot and had an ultrasound of arm to rule out clot; given a different antibiotic, both orally and intramuscular; swelling would subside for a few hours and then return until another intramuscular injection; returned to physician on 2/2/2015 and was given another intramuscular antibiotic along with prednisone with directions to continue oral antibiotics (Bactrim); as of today's date (2/6/2015) the redness, swelling and fever are gone.
Age: 60.0
Sex: F
Vaccine: HEP, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, induration & pain at injection site.
Age: 8.0
Sex: F
Vaccine: VARCEL
Symptoms: Eyelid rash, Herpes zoster, Rash
Clinical narrative: Herpes zoster diagnosis in two-dose varicella vaccine recipient at ED around 9/23/14. Painful rash on right side of face and eyelid. Treated with acyclovir x 7 days.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Chest discomfort, Hypoaesthesia, Injection site discomfort, Injection site hypoaesthesia
Clinical narrative: For the past week I have had much discomfort in my upper arms, back and chest. I am currently experiencing a numbing sensation and weakness in those areas, too. I cannot sleep without taking analgesics before heading to bed because of the discomfort.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Insomnia, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: For the past week I have had much discomfort in my upper arms, back and chest. I am currently experiencing a numbing sensation and weakness in those areas, too. I cannot sleep without taking analgesics before heading to bed because of the discomfort.
Age: 1.53
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Acute sinusitis, Otitis media, Pyrexia, Rash generalised, Rash papular
Clinical narrative: Varicella diagnosis at hospital on 6/27/14. Generalized rash with reported >500 papular lesions with fever. Lasted 14 days. Did not scab. Also had acute sinusitis and otitis media. Received varicella vaccine dose 1 on 6/18/2014. Reported fever as high at 104.8 degrees F.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Hypoaesthesia
Clinical narrative: Woke up in the am and whole face "felt numb"; diarrhea x 1 day.
Age: 1.03
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Body temperature increased, Crying, Vaccination complication
Clinical narrative: Upon receiving second dose of DTaP that evening pt continued to cry for 6 hours straight and had a temp of 102F. She was seen at Urgent Care but no physical cause of distress could be determined except for vaccines received.  Upon receiving third dose of DTaP mom pre-medicated pt with Tylenol and continued this @ the clock following vaccines however, pt continued with inconsolable crying for 4 straight hours and ran a low grade temperature.  Person contacted and agreed this was an adverse effect listed on CDC vaccine website.  Mother instructed to continue with vaccine series and pre-medicate with Tylenol and hopefully pt will outgrow this reaction.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Limb discomfort, Pain in extremity, Pulse absent
Clinical narrative: Pt presented to ER with erythema of right upper extremity including discomfort (pain=8/10) and what appeared to be cellulitis on exam. She had a syncopal episode at home and was found on the floor with no pulse (PEA) and CPR was administered briefly before the pt regained consciousness.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Resuscitation, Syncope, White blood cell count normal
Clinical narrative: Pt presented to ER with erythema of right upper extremity including discomfort (pain=8/10) and what appeared to be cellulitis on exam. She had a syncopal episode at home and was found on the floor with no pulse (PEA) and CPR was administered briefly before the pt regained consciousness.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Extra dose administered
Clinical narrative: Extra dose of Rotavirus given to pt, pt is to recieved 2 doses and pt recieved 3.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abnormal behaviour, Autism, Childhood disintegrative disorder, Full blood count, Lethargy
Clinical narrative: Came home with patient and he slept 4 hours which is unusual and especially given that he was energetic in the AM. When he finally awoke he had thrown up and had a high fever. We gave him Motrin and he threw up again. We were not sure if he had gotten any Motrin in his system and started to burn up. We took him to ER a he clocked in at 103.5 fever and was listless. He was sleeping on me and lethargic. Clinged to me and was burning up. I had him down to only primary clothes and was blowing on his neck and head to keep him cool while we were waiting to get seen. In the following days, he seemed different...not as engaging, not as vibrant.
Age: 1.0
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Listless, Pyrexia, Urine analysis, Vomiting
Clinical narrative: Came home with patient and he slept 4 hours which is unusual and especially given that he was energetic in the AM. When he finally awoke he had thrown up and had a high fever. We gave him Motrin and he threw up again. We were not sure if he had gotten any Motrin in his system and started to burn up. We took him to ER a he clocked in at 103.5 fever and was listless. He was sleeping on me and lethargic. Clinged to me and was burning up. I had him down to only primary clothes and was blowing on his neck and head to keep him cool while we were waiting to get seen. In the following days, he seemed different...not as engaging, not as vibrant.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, and pain located 5 inches above left arm elbow.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Exposure during pregnancy, Foetal growth restriction, Incorrect route of drug administration, Induced labour, Inflammation
Clinical narrative: Swelling, redness, and pain located 5 inches above left arm elbow.
Age: 28.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema
Clinical narrative: Swelling, redness, and pain located 5 inches above left arm elbow.
Age: 53.0
Sex: F
Vaccine: HEPA
Symptoms: Dysgeusia, Dyspnoea, Pruritus
Clinical narrative: Metallic taste in mouth, shortness of breath, itching. Patient called into Public Health office to report symptoms and also that she is allergic to vaccine preservatives. (unreported during office visit) Advised to seek medical treatment. Patient reports that she will try Benadryl, and report back to Public Health if adverse response worsens.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Asthma, Condition aggravated, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Shortness of breath, fever, dizziness, fatigue, diaphoretic.
Age: 44.0
Sex: F
Vaccine: VARCEL
Symptoms: Hyperhidrosis, Influenza virus test negative, Pyrexia
Clinical narrative: Shortness of breath, fever, dizziness, fatigue, diaphoretic.
Age: 66.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Patient given expired TD vaccine.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Feeling abnormal, Nausea, Vertigo, Vomiting
Clinical narrative: When attempting to sit up in bed, I was overcome by vertigo/dizziness followed by nausea & vomiting.  Acute symptoms lasted about 60 minutes followed by several hours of sleep.  As of 1 pm, 02/06/2015, I still have an abnormal feeling in the back of my head toward the nape of my neck.  I am able to eat and drink without problem.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Fatigue, Influenza like illness, Injection site pain, Urticaria
Clinical narrative: Having flu like symptoms, developed hives, difficulty breathing, pain on injection site, tired.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Erythema, Hyperaesthesia, Pain, Swelling
Clinical narrative: REDNESS, SEVERE PAIN, SWELLING, SENSITIVITY, FELT WEAK FOR THE ENTIRE WEEK AFTERWARDS.
Sex: U
Vaccine: PNC13
Symptoms: Drug administered at inappropriate site, Vaccination site cellulitis
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age, ethnicity, and gender received PREVNAR 13 single dose via intramuscular route of administration on an unspecified date. Relevant medical history and concomitant medications were not reported. The patient developed cellulitis due to poor injection technique; dose was administered too low in the bicep on an unspecified date with outcome of unknown. The reporter did not think the adverse event of vaccination site cellulitis was related to PREVNAR 13.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Blood glucose increased, Cough, Dyspnoea, Hypersensitivity, Respiratory distress
Clinical narrative: Allergic reaction. Patient received 5y vaccines (DTaP, IPV, MMRV). Left office and mom noticed cough when got to their car. No new ingestions. She had given him insulin in preparation for eating a snack. He told mom he couldn't breathe and he was brought back in to office. When I entered room he was audibly wheezing with pulse ox 89% and moderate resp distress. No swelling or vomiting. Able to answer questions. Vital signs quickly obtained P 108, R 32, BP 98/52. Albuterol 2.5mg started via 10L oxygen and SATS quickly rose to 100%. Given 1.5 tsp BENADRYL. Cleaned area on (R) outer thigh and mom administered his AUVI-Q without complication. 911 notified. Continued to wheeze while on albuterol, maintained SATS. Repeat vitals 15 min later P 116, R 28, BP 108/60. Paramedics arrived and given report. Glucose obtained in low 300's. Taken off albuterol and SATS stable at 98% on room air. Taken via ambulance to hospital. Spoke to mom 2h later, no more epi was needed, hospital monitoring him in ER. Advised contacting Dr.'s office for input on possible trigger. Will report episode to VAERS.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Wheezing
Clinical narrative: Allergic reaction. Patient received 5y vaccines (DTaP, IPV, MMRV). Left office and mom noticed cough when got to their car. No new ingestions. She had given him insulin in preparation for eating a snack. He told mom he couldn't breathe and he was brought back in to office. When I entered room he was audibly wheezing with pulse ox 89% and moderate resp distress. No swelling or vomiting. Able to answer questions. Vital signs quickly obtained P 108, R 32, BP 98/52. Albuterol 2.5mg started via 10L oxygen and SATS quickly rose to 100%. Given 1.5 tsp BENADRYL. Cleaned area on (R) outer thigh and mom administered his AUVI-Q without complication. 911 notified. Continued to wheeze while on albuterol, maintained SATS. Repeat vitals 15 min later P 116, R 28, BP 108/60. Paramedics arrived and given report. Glucose obtained in low 300's. Taken off albuterol and SATS stable at 98% on room air. Taken via ambulance to hospital. Spoke to mom 2h later, no more epi was needed, hospital monitoring him in ER. Advised contacting Dr.'s office for input on possible trigger. Will report episode to VAERS.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pruritus, Skin lesion
Clinical narrative: The patient notice his left hand start itching which was follow by appearance of an elevated red skin lesion, this eruption continued until both arms and neck were affected. No treatment was giving at that time.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Inadvertently administerd DTAP-IPV, <7Y (KINRIX). Child is 2 years old.
Age: 49.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Itching and rashes started to appear on initial date.  This happened for three days and then huge bumps appeared and rash turned in hives.  Given Prednisone to take and Benadryl every four hours.
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Swelling and redness; cellulitis.
Age: 39.0
Sex: M
Vaccine: TYP, YF
Symptoms: Pallor, Pruritus, Rash
Clinical narrative: Patient developed abdominal itching and rash 01 FEB. Rash is somewhat confluent perhaps slightly blanching somehwat lacy in nature and wide spread across the abdomen and the foreamrs on to the neck. PT does not have any rash on the face. Patient was ordered a urinalysis and prescribed atarax as needed for pruritis. Patient was informed to return to the clinic 02/09 for a follow up.
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Redness, swelling 2 cm induration cephalexin 500mg QID x 7 d - recheck in 1 week - 1/22/15 - DNKA pt called to cancel - feeling better.
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of wrong vaccine administered in a 64-year-old female patient who received BOOSTRIX (batch number 4SY79, expiry date May 2016). On 3rd February 2015, the patient received BOOSTRIX. On 3rd February 2015, an unknown time after receiving BOOSTRIX, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered was unknown. Additional information: The pharmacist reported that BOOSTRIX was placed in the freezer and accidentally given to the patient instead of ZOSTAVAX. The pharmacist was not aware of any issues that were experienced by the patient.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Diarrhoea, Epstein-Barr virus antibody positive, Fatigue, Headache
Clinical narrative: Fatigue, hand shaking starting day of vaccine and ongoing. 1 week later fever, headache, joint pain, sore throat, tingling, diarrhea, hives.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza virus test negative, Oropharyngeal pain, Paraesthesia, Pyrexia, Streptococcus test negative
Clinical narrative: Fatigue, hand shaking starting day of vaccine and ongoing. 1 week later fever, headache, joint pain, sore throat, tingling, diarrhea, hives.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor, Urticaria
Clinical narrative: Fatigue, hand shaking starting day of vaccine and ongoing. 1 week later fever, headache, joint pain, sore throat, tingling, diarrhea, hives.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Both thighs with swelling, redness and warm to the touch. Patient was seen at the ER for eval and given prescription for Clindamycin. RT- 02/05/15 measured 9cm x 5cm/ 02/06/15 measured 8cm x 4cm. LT - 02/05/15 measured 9cm x 5.5cm/ 02/06/15 measured 8cm x 5cm.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Malaise, Vomiting projectile
Clinical narrative: Patient began to have projectile vomiting and un-well sick feeling for 3 days following vaccination.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Low back pain -> radiated to buttocks and down both legs, calf and to toes. 5-days of pain. Self-treated w/ Ketoprofen.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site warmth
Clinical narrative: Noticed on Weds that the site is hard, red and blotchy. This worsened, on thursday she noted a blotchy red rash that has extended down her arm from the injecction site.  This area is now about 2 inches across and 6 inches down her arm.  Is blotchy red, warm to touch and itchy.  Pt advised to take Benadryl OTC.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash macular
Clinical narrative: Noticed on Weds that the site is hard, red and blotchy. This worsened, on thursday she noted a blotchy red rash that has extended down her arm from the injecction site.  This area is now about 2 inches across and 6 inches down her arm.  Is blotchy red, warm to touch and itchy.  Pt advised to take Benadryl OTC.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Nausea, Paraesthesia, Pruritus, Vertigo
Clinical narrative: After receiving flu shot on 1/26/2015, patient experienced nausea, tingling, vertigo and weakness. She began feeling itchy. She went to the emergency room. She received prednisone and famotidine. She began taking BENADRYL.
Age: 16.0
Sex: F
Vaccine: FLU3, MNQ
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: Received intramuscular injection at (L) deltoid 2nd MCV4 and FLUZONE 1/8/15 and then developed 8 cm x 10.5 cm area of redness, swelling and itching 1/9/15. Seen 1/12/15. Txd reaction: Diphenhydramine 25mg and triamcinolone 0.1% oint x 2 days.
Age: 1.17
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash, Rash erythematous
Clinical narrative: Has had 2 days of fever and last night noted with a couple of red bumps on face and body and today with more on trunk.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Neck mass, Pain, Skin mass
Clinical narrative: Noticed painful small lumps in scalp and on back of neck, right side.  Also noticed a red lump on the front of neck, also right side.  Discomfort was not sufficient to warrant my concern until morning of 2/05/15 when I noticed lumps were very swollen, red, and painful.  Also referred pain in right ear.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Noticed painful small lumps in scalp and on back of neck, right side.  Also noticed a red lump on the front of neck, also right side.  Discomfort was not sufficient to warrant my concern until morning of 2/05/15 when I noticed lumps were very swollen, red, and painful.  Also referred pain in right ear.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Swelling Baseball Size, very red and firm.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Blood creatine phosphokinase, Blood thyroid stimulating hormone, Cataplexy, Epstein-Barr virus antibody, Fatigue
Clinical narrative: Excessive fatigue and narcolepsy/cateplexy started mid October after receiving 3rd HPV vaccine and have continued since then.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Full blood count, Lipids, Metabolic function test, Narcolepsy, Red blood cell sedimentation rate
Clinical narrative: Excessive fatigue and narcolepsy/cateplexy started mid October after receiving 3rd HPV vaccine and have continued since then.
Age: 12.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Sleep study, Thyroxine free, Vitamin D
Clinical narrative: Excessive fatigue and narcolepsy/cateplexy started mid October after receiving 3rd HPV vaccine and have continued since then.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13
Symptoms: Bronchiolitis, Influenza virus test negative, Respiratory syncytial virus test negative
Clinical narrative: Developed Bronchiolitis, nebulizer with albuterol, amoxicillin, prednisolone prescribed.
Age: 25.0
Sex: M
Vaccine: HPV9
Symptoms: Aplastic anaemia, Biopsy bone marrow abnormal, Blood product transfusion dependent, Injection site pain
Clinical narrative: Bone marrow biopsy 10/20/14. Severe aplastic anemia. Transfusion dependent since then. Hospital short stay 11/30/2014 and 01/03/2015.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal lymphadenopathy, Abdominal pain, Appendicectomy, Ascites, Endoscopy large bowel
Clinical narrative: This spontaneous report as received from a registered nurse refers to her 12 year old granddaughter with no pertinent medical history and no drug reactions or allergies. In July 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). There was no concomitant medication. The nurse reported that starting in August 2014, the patient experienced abdominal pain and bouts of nausea. The patient was hospitalized on an unspecified date and had MRI conducted which showed the patient had swollen abdominal lymph nodes. The nurse stated that the patient was hospitalized another unspecified time and had exploratory surgery and had her appendix removed in order to treat the symptoms but it did not do any good. The nurse reported that the patient went to emergency room 4 or 5 times and in and out of the hospital due to abdominal pain and a buildup of fluid in her abdomen. The nurse stated that the doctor did so many tests including an upper and lower scope (results not provided) but still it could not be determined what the cause was. The nurse stated that they were holding off on giving the patient the second and third doses of GARDASIL (also reported as therapy discontinued), just in case GARDASIL caused all these issues. At the time of the report, the patient had not recovered from the adverse events. Upon internal review appendectomy was considered to be medically significant. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Endoscopy upper gastrointestinal tract, Exploratory operation, Incomplete course of vaccination, Nausea, Nuclear magnetic resonance imaging abnormal
Clinical narrative: This spontaneous report as received from a registered nurse refers to her 12 year old granddaughter with no pertinent medical history and no drug reactions or allergies. In July 2014, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # not reported). There was no concomitant medication. The nurse reported that starting in August 2014, the patient experienced abdominal pain and bouts of nausea. The patient was hospitalized on an unspecified date and had MRI conducted which showed the patient had swollen abdominal lymph nodes. The nurse stated that the patient was hospitalized another unspecified time and had exploratory surgery and had her appendix removed in order to treat the symptoms but it did not do any good. The nurse reported that the patient went to emergency room 4 or 5 times and in and out of the hospital due to abdominal pain and a buildup of fluid in her abdomen. The nurse stated that the doctor did so many tests including an upper and lower scope (results not provided) but still it could not be determined what the cause was. The nurse stated that they were holding off on giving the patient the second and third doses of GARDASIL (also reported as therapy discontinued), just in case GARDASIL caused all these issues. At the time of the report, the patient had not recovered from the adverse events. Upon internal review appendectomy was considered to be medically significant. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from the healthcare worker (certified medical assistant) refers to a patient of unknown age and gender. On an unknown date an improperly stored ROTATEQ (oral, dose, frequency and lot # not reported) was administered to one patient on an unspecified date. No adverse effects reported. No additional information provided. Additional information is not expected as there is no consent to contact the reporter.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional (licensed practical nurse) refers to unspecified patients of unknown demographics. Since 08-OCT-2014 these patients were administered with improperly stored ROTATEQ. All these patients experienced incorrect product storage as all of them were administered with improperly stored ROTATEQ. No adverse effects were reported. No product quality complaint (PQC) was involved. Outcome of the event, incorrect product storage was unknown. Reporter considered the event, incorrect product storage to be not related to ROTATEQ. This is one of several reports received from the same source (MARRS # 1502USA002815 and MARRS # 1502USA002816). Additional information has been requested.