chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product quality issue, Product reconstitution issue, Underdose
Clinical narrative: This spontaneous report was received from a pharmacist refers to a patient of unknown age and gender. No medical  history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with ZOSTAVAX, 1 vial of 1, (lot # K000328; Exp. date: 06-MAR-2014) (dose and strength not provided). No co-suspect or concomitant therapies provided. The sterile water diluent lot number was reported as H021469. The reporter stated that sterile water diluent vials (NDC 0006-430901) were under filled and when reconstituted with ZOSTAVAX did not produce the required 0.65 ml of medication. The unit was under filled and was given to the patient. The ZOSTAVAX lyo cake and vial appeared normal. No AE (adverse event) symptoms reported.  The patient did not seek medical attention. Product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: This spontaneous report as received from a pharmacist refers to a approximately 61 year old female patient with no drug allergies. The patient's pertinent medical history was none. On 07-JUL-2014 the patient was vaccinated with ZOSTAVAX (Dose/Frequency: 0.65 ml, route: subcutaneously in the left arm) (lot # J014810, expiry date: 21-FEB-2015). On an unknown date in July 2014, the patient developed a reaction slightly above the injection site that consisted of a raised red rash that was hard and hot to the touch. The patient called her physician who prescribed an antibiotic which possibly was clindamycin (manufacturer unknown). The patient was not seen by the patient's primary physician but the physician suspected she might have cellulitis The pharmacist was not sure if that was the physician who prescribed the antibiotic. The outcome of raised red rash that was hard and hot to the touch and cellulitis was reported as not recovered.  No product quality complaint was reported for ZOSTAVAX. Pharmacist stated that the patient stopped by at his pharmacy to let him know about the adverse event however, she had her antibiotic prescription filled at a different unspecified pharmacy. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 4 year old patient of unknown gender. On 02-JUL-2014 the patient was inadvertently administered a dose of PROQUAD (Merck) (dose: 0.5 ml, subcutaneously, lot # H020851) that had expired on 26-MAY-2014. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Eye allergy
Clinical narrative: This spontaneous report as received from a Pharmacist via Company Representative refers to a male patient of unknown age. On 05-NOV-2013 the patient was vaccinated with a dose of GARDASIL (dose and route not reported) Lot # H020901 with expiry date: 05-JUL-02015 or J006236 with expiry date: 25-FEB-2016. It was unable to be determined which lot number the patient was administered. It was unknown if that was patient's first dose of GARDASIL. On an unknown date the patient experienced allergic reaction in his eyes. The patient sought medical attention by visiting physician and the reaction was treated with unspecified medication. There was no intervention to prevent serious criteria. The outcome of allergic reaction in his eyes was unknown. Relatedness between the event and GARDASIL was not specified. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient of about 75 year old information about concurrent medical conditions, concomitant medication and pertinent medical history was not provided. On an unknown date the patient was vaccinated with a standard dose of ZOSTAVAX (lot # and route were not provided). On an unknown date the patient developed mild case of shingles after receipt of ZOSTAVAX. The outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient of approximately 24 years of age at the time of report. The patient's pertinent medical history included exercise induced asthma. The patient had no drug reactions or allergies. On an unknown date in July 1994 the patient was vaccinated with M-M-R II HSA. Another dose of M-M-R II was administered on an unknown date in April 1998. The concomitant medications were none. On an unknown date a lab test for the antibody titers were performed and was determined to have negative antibody titers to MMR. The patient sought medical attention by visiting the office. No treatment was provided. The outcome of negative antibody titers was not resolved. The causality was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to an unspecified patient of unknown gender and age. On 14-JUL-2014, the patient was vaccinated with an expired dose of M-M-R II lot # H012569, exp date reported as 29-JUN-2014 (dose number, route and indication not reported). No adverse effects were reported. No product quality complaint (PQC) involved. Additional information has been requested.
Age: 1.27
Sex: M
Vaccine: DTAP, HIBV, VARCEL
Symptoms: Full blood count, Pyrexia, Urine analysis
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 month old male patient who was born premature, at 36 weeks. On 24-JAN-2014, the patient was vaccinated with (Oka/Merck) VARIVAX lot # J004167, expiry date: 08-APR-2015) 1350 U (plaque forming units); dose: as directed (0.5ml) injection, subcutaneously. Other suspect therapies included liquid PEDVAX HIB (dose, route of administration, indication, lot#, expiry date unspecified) and INFANRIX, both given concomitantly on the same day with (Oka/Merck) VARIVAX. On 27-JAN-2014, the patient developed a 103F temperature after receipt of (Oka/Merck) VARIVAX. The patient sought medical attention by visiting the office and received the treatment: ibuprofen and acetaminophen. The patient had the urine analysis and complete blood count (CBC) testing performed (on an unspecified date with no results provided). The outcome of event was reported as recovered on 03-FEB-2014. The relatedness between event and (Oka/Merck) VARIVAX or liquid PEDVAXHIB was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (also reported as employee) regarding an unknown number of patients. The patients demographics were unknown. There was no pertinent medical history and drug reaction or allergies of the patients reported. On an unknown date, an unknown number of patients was vaccinated with GARDASIL (dose, route, product lot and expiry date was not reported) that had been improperly stored. No adverse effects reported. There was no product quality complaint involved. This is one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MEN
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from healthcare worker regarding few patients. The reporter stated that she had seen few patients aged between 12-16 years, faint after receiving meningococcal vaccine (manufacturer unknown) or TDaP. The outcome of the event was unknown. The causality of the event with meningococcal vaccine (manufacturer unknown) was not reported. The case is linked to #1407USA005329 via same reporter link. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This spontaneous report ws received from a pharmacist referring to a female patient of unknown age. Pertinent medical history and drug allergies were unspecified. On an unknown date the patient was vaccinated with ZOSTAVAX, 1 injection, subcutaneous (dose not reported). No other concomitant therapies reported. On an unknown date the patient reported that after receiving ZOSTAVAX, the patient was shaking. The physician told the patient to go to the Emergency Room. The patient attended the Emergency Room. No treatment was received for the adverse event. The suspect product was not reintroduced. The patient did recovered and was fine when she attended her follow up appointment with her physician.  The patient sought medical attention. The outcome of the event was reported as recovered/resolved. The causality of the event was unspecified. Additional information has been requested.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 57 year old male patient with allergy to codeine. The patient's historical drugs included AFLURIA received in the left deltoid on 23-OCT-2013. On 27-NOV-2013, the patient was vaccinated with a dose of ZOSTAVAX lot number J008433, expiration date 11-OCT-2014, 0.65 ml, subcutaneous in the left arm. Concomitant medications were not specified. In December 2013, the patient left a phone message and reported that he still had soreness at injection site, especially when lifting his arm, where he received a flu shot, one month earlier. The reporter questions the accuracy of which injection site ZOSTAVAX or AFLURIA the patient referred to in a phone message. On an unknown date, the patient experienced pain at the injection site, of the left upper extremity, after receiving ZOSTAVAX. Treatment was not given for the event. The patient did not seek medical attention. The outcome of pain at the injection site, of the left upper extremity, after receiving ZOSTAVAX was not recovered/resolved, reported as continued. The relatedness between pain at the injection site, of the left upper extremity, after receiving ZOSTAVAX was not reported. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Borrelia test, Diarrhoea, Eye movement disorder, Insomnia, Irritability
Clinical narrative: On Monday 7/21/14 Mother notice babe right eye would not move out ward. She made an appointment with Dr. today. She also notes she had vomited x1 and had diarrhea on Monday and Tuesday. Monday also notes last night 7/22/14 babe is more irritable and didn't want to sleep.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Lumbar puncture, Nuclear magnetic resonance imaging brain, Vomiting
Clinical narrative: On Monday 7/21/14 Mother notice babe right eye would not move out ward. She made an appointment with Dr. today. She also notes she had vomited x1 and had diarrhea on Monday and Tuesday. Monday also notes last night 7/22/14 babe is more irritable and didn't want to sleep.
Age: 1.15
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Impetigo, Injection site erythema, Injection site infection, Injection site irritation
Clinical narrative: Patient developed redness and irritation at site of MMR injection. Patient was scratching at site of injection which then became superficially infected. Treated for impetigo on 7/21/14.
Age: 0.6
Sex: F
Vaccine: DTAPIPV, IPV
Symptoms: Incorrect dose administered
Clinical narrative: Gave 2 doses same day.
Age: 19.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dyskinesia, Hypotonia
Clinical narrative: Havrix given and tolerated well. After Gardasil was given the patient went limp and was lowered to the floor.  Jerking movement noted.  Aware of her surroundings 5-10 seconds later.
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Pruritus, Tenderness
Clinical narrative: This spontaneous report as received from a physician refers to a male patient of unknown age. The patient had no medical history or drug allergy. On an unknown date the patient was vaccinated with a dose of (Oka/Merck) VARIVAX (lot # K001389, expired date: 29-JAN-2016), 0.5 ml , once, subcutaneous. There was no concomitant medication. On an unknown date "2 to 3 days after" the unspecified patient received (Oka/Merck) VARIVAX, he developed significant erythema, "from the shoulder to elbow", mild induration, tenderness and pruritis. The patient was taken to an unspecified Emergency Room where he received unspecified antibiotics, "for possible cellulitis", and BENADRYL. The physician stated the patient was still experiencing "some" of the reported symptoms. No lab diagnostics studies were performed. The outcome of the events was reported as not recovered. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed a reaction in the back of her left arm about the circumference of a pool ball. It was red, raised, hot to the touch, and tender. Dr told her to take Benadryl 25mg po every 6 hours (4 taken). Sat 07/19/14 reports lump doubled in size, painful adn hot. MD started her on Cephalexin 500mg BID which was started 7/20/14 AM. Ibuprofen and cold packs used for comfort. Low grade fever 7/19 of 99.3 x 24 hours. As of July 21, 2014, size had not decreased, warm to touch and tender, no fever.
Age: 22.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia
Clinical narrative: Developed a reaction in the back of her left arm about the circumference of a pool ball. It was red, raised, hot to the touch, and tender. Dr told her to take Benadryl 25mg po every 6 hours (4 taken). Sat 07/19/14 reports lump doubled in size, painful adn hot. MD started her on Cephalexin 500mg BID which was started 7/20/14 AM. Ibuprofen and cold packs used for comfort. Low grade fever 7/19 of 99.3 x 24 hours. As of July 21, 2014, size had not decreased, warm to touch and tender, no fever.
Age: 12.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Cold sweat, Dyskinesia, Pallor
Clinical narrative: Patient given Tdap, Menactra, Havrix and Gardasil-last to be given.  After given the patient laid back on the table, jerking movement witnessed.  Skin was pale and clammy  After a few seconds she was able to be aware of her surroundings. Checked by provider and given juice to drink.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Wheezing
Clinical narrative: Wheezing.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Irritability
Clinical narrative: Child exhibted fussiness and had diarrhea starting with in one hour of the vaccine through today (07/23/2014).  Parent told to take child to doctor today.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature decreased, Immediate post-injection reaction, Pruritus generalised, Throat tightness
Clinical narrative: Patient experienced immediate "throat closing" and generalized itching. Rash not seen. 25mg IV Benadryl given at 9:33 AM and Solumedrol 100mg IV given at 12:20pm.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Local reaction, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Patient was vaccinated w/ INFANRIX DTaP in the left thigh on 7/21/14, came in 2 days later w/ redness, swelling, hot to touch local reaction at site of vaccine. She was treated w/ cephalexin 250mg/5mL 1 tsp tid x 10 days along w/ BENADRYL.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The reporter stated that on 21-JUL-2014, an unspecified patient was vaccinated with a dose of ROTATEQ (lot # H020558, expiry date: 17-APR-2014, oral) that was expired. Pertinent medical history and concomitant medications were not reported. No adverse effect reported. The outcome of the events was unknown. No further information provided. Additional information has been requested.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site swelling, Pain
Clinical narrative: Swelling from injection site to elbow. Redness. Pain.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Muscle contractions involuntary, Musculoskeletal stiffness, Tremor, Unresponsive to stimuli
Clinical narrative: He felt lightheaded, laid back in car, head tilted to the side his body clenched up, arm curled up and wrist and hands curled up and legs stuck straight out stiff like, then body began shaking, he was non responsive to me shouting at him to 10 sec. He does not remember it happening.
Age: 10.0
Sex: F
Vaccine: MMR
Symptoms: Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Per client's mother, client experience itchiness at injection site and red bumps. Client's mother reports she is treating with over-the-counter BENADRYL and cold-compress applied to injection site.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor
Clinical narrative: MENACTRA, Tdap and HPV administered in that order. Immediately after HPV given, pt stated he felt dizzy. He then temporarily closed his eyes and "passed out" for about 5 seconds, then woke up and said he fell asleep. He was nauseous and pale for about 5 minutes afterward. Drank some water and ate some fruit snacks and felt better. He left in good condition. VSS during the incident.
Age: 8.0
Sex: F
Vaccine: HEP
Symptoms: Bilirubin conjugated normal, Blood bilirubin normal, Diarrhoea, Pyrexia, Vomiting
Clinical narrative: Fever of 100.8 F, 24 hrs after Hepatitis B #1 vaccine given, then onset of vomiting 36 hrs later, watery diarrhea for 4 days after received vaccination. No jaundice.
Age: 76.0
Sex: U
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Fall, Rash, Tremor
Clinical narrative: Rash, chills, shakes, temp 101, fall. Urgent care on 6/25/14 - dexamethasone sodium phosphate 10mg and Hydroxyzine HCl 25mg oral tablet.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 16-JUL-2014 the patient was vaccinated inadvertently with an improperly stored (Oka/Merck) VARIVAX, subcutaneous, 0.5 ml (lot number and expiration date not reported). No adverse effects reported. This is one of two reports from the same reporter (1407USA008036). Additional information has been requested.
Age: 1.7
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Duplicate order entered. Unclear if this was an IT glitch or provider error. During 1 month return visit duplicate order showed as "Pending" (not given). RN administered vaccine.
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: The patient was due for a DTaP and an IPV. I administered the KINRIX, not realizing that it is only administered to patients who are 4-6 years of age, and as one of the booster doses.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that she gave Hepatitis A adult dose when a pediatric/adolescent dose should have been given.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that she gave a Hepatitis A adult dose when a pediatric/adolescent dose should have been given.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that a Hepatitis A adult dose was given when a pediatric/adolescent dose should have been administered.
Age: 0.2
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Incorrect dose administered
Clinical narrative: Two nurses checked vaccine record and identified vaccines due. Initially planned to give IPV and PEDIARIX (charge), then realized PENTACEL indicated instead (VFC). IPV already planned and subsequently given. Client received PENTACEL and IPV.
Age: 88.0
Sex: U
Vaccine: TD
Symptoms: Expired drug administered
Clinical narrative: An expired vaccine was dispensed and administered to a patient in the ED. The pharmacist examined the product prior to dispensing and the nurse examined it prior to administration. The vaccine expiration date of "18APR14", written in the format of DD/MM/YY, was misinterpreted as April 14, 2018. The date format is commonly written as MM/DD/YY. Upon surveying multiple medications in the pharmacy, it is apparent that expiration date format is not consistent amongst products. Although bar coded medication administration (BCMA) is widely utilized in hospital systems to reduce error of medications being administered, expiration dates are not captured in the bar code of the medication. Hence, visual check of the expiration date by the healthcare providers remains the only method to ensure medications to be given are in good condition. Variations of expiration date format create a barrier in accurate and straightforward interpretation, especially in the acute care hospital setting where efficiency and multi-tasking are expected. In the industry where safe and reliable patient care is paramount, presentation of medication information should be made as simple as possible. Standardization of expiration date format would be beneficial to the safe provision of patient care.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Nurse documented that a Hepatitis A adult formulation was administered when a pediatric/adolescent dose should have been given.
Age: 16.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that Hepatitis A Adult formulation was administered when a pediatric/adolescent dose should have been given.
Age: 15.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that Hepatitis A adult dose was given when a pediatric/adolescent dose should have been administered.
Age: 9.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that Hepatitis A adult dose was administered when a pediatric/adolescent dose should have been given.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that Hepatitis A adult dose was given when pediatric/adolescent dose should have been administered.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Cough, Dyspnoea, Erythema, Pruritus, Throat irritation
Clinical narrative: At 3:45 I started to experience tingle sensation in my throat along with a cough. A few minutes later I started having difficulty breathing and itchiness on my torso/chest and face. After that I began to turn red and break out in hives on my face, back, arms, and chest. I was seen by a Doctor. At 4:00 pm I was given a dose of oral Benadryl, my vitals were taken and I was monitored. My symptoms began to dissipate after I took the medication. I was discharged with an Adult Epi Pen for home use if a secondary reaction occurred.
Age: 26.0
Sex: M
Vaccine: TYP, YF
Symptoms: Urticaria
Clinical narrative: At 3:45 I started to experience tingle sensation in my throat along with a cough. A few minutes later I started having difficulty breathing and itchiness on my torso/chest and face. After that I began to turn red and break out in hives on my face, back, arms, and chest. I was seen by a Doctor. At 4:00 pm I was given a dose of oral Benadryl, my vitals were taken and I was monitored. My symptoms began to dissipate after I took the medication. I was discharged with an Adult Epi Pen for home use if a secondary reaction occurred.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Anxiety, Crying, Depressed mood, Depression, Feeling of despair
Clinical narrative: CHILD WAS AT CAMP AND SUDDENLY DEVELOPED OVERWHELMING SADNESS AND DEPRESSION. DEPRESSION, CRYING PROGRESSED OVER THE NEXT 4 DAYS. THIS LED CHILD TO QUESTION SUICIDE. SHE WAS TAKEN TO LOCAL ER AND ADMITTED TO AN INPATIENT MENTAL HEALTH HOSPITAL. SHE EXPERIENCED SEVERE DEPRESSION, DESPARATION, RACING THOUGHTS THAT WOULD NOT TURN OFF AND ANXIETY. SHE HAD TO BE PUT ON LEXAPRO AND SEROQUEL AND WAS DISCHARGED TO HOME 5 DAYS LATER. SHE IS NOW IN OUTPATIENT THERAPY.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Suicidal ideation, Tachyphrenia
Clinical narrative: CHILD WAS AT CAMP AND SUDDENLY DEVELOPED OVERWHELMING SADNESS AND DEPRESSION. DEPRESSION, CRYING PROGRESSED OVER THE NEXT 4 DAYS. THIS LED CHILD TO QUESTION SUICIDE. SHE WAS TAKEN TO LOCAL ER AND ADMITTED TO AN INPATIENT MENTAL HEALTH HOSPITAL. SHE EXPERIENCED SEVERE DEPRESSION, DESPARATION, RACING THOUGHTS THAT WOULD NOT TURN OFF AND ANXIETY. SHE HAD TO BE PUT ON LEXAPRO AND SEROQUEL AND WAS DISCHARGED TO HOME 5 DAYS LATER. SHE IS NOW IN OUTPATIENT THERAPY.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site mass, Injection site pain, Injection site urticaria
Clinical narrative: Large red, hot hive: 3 x 5"; large, painful lump the size of an egg at injection sight; flu like symptoms; was sick for 10 days. It took about 12 days for the redness and lump to dissipate. I do have reaction to flu shots, but not this severe.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Malaise
Clinical narrative: Large red, hot hive: 3 x 5"; large, painful lump the size of an egg at injection sight; flu like symptoms; was sick for 10 days. It took about 12 days for the redness and lump to dissipate. I do have reaction to flu shots, but not this severe.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that Hepatitis A adult dose was given when a pediatric/adolescent dose should have been administered.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Medication error
Clinical narrative: Hib Vaccine given using Sterile H2O diluent instead of diluent that accompanies Hib Vaccine.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented Hepatitis A Adult formulation given when a pediatric/adolescent dose should have been administered.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that she gave an Hepatitis A adult dose when a pediatric/adolescent dose should have been given.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that a Hepatitis A adult dose was given when a pediatric/adolescent dose should have been administered.
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Off label use
Clinical narrative: Nurse administered an Adult Hepatitis B vaccine when a pediatric/adolescent dose should have been given.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that Hepatitis A adult dose was given when a pediatric/adolescent dose should have been administered.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that she gave a Hepatitis A adult dose when she should have administered a pediatric/adolescent dose.
Age: 13.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that she gave a Hepatitis A adult dose when a pediatric/adolescent dose should have been given.
Age: 18.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that a Hepatitis A adult dose was given, when a pediatric/adolescent dose should have been administered.
Age: 8.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that a Hepatitis A adult dose was given when a pediatric/adolescent dose should have been administered.
Age: 12.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that a Hepatitis A adult dose was administered when a pediatric/adolescent dose should have been given.
Age: 19.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Nurse documented that a pediatric/adolescent dose was administered when an Adult dose should have been given.
Age: 10.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Nurse documented that she gave a Hepatitis A adult dose when a pediatric/adolescent dose should have been given.
Age: 24.0
Sex: U
Vaccine: MNQ
Symptoms: Expired drug administered
Clinical narrative: Patient given vaccine before realizing that vaccine had expired.
Age: 12.0
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient was given Tdap last year 6/17/13, and then given Tdap again this year on 6/17/14.
Age: 0.7
Sex: U
Vaccine: IPV
Symptoms: Incorrect dose administered
Clinical narrative: Patient got double dose on polio vaccine.
Age: 24.0
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered
Clinical narrative: Date on vaccine was not legible enough and was not verified before administration.
Age: 0.6
Sex: U
Vaccine: MNQ, PPV
Symptoms: Wrong drug administered
Clinical narrative: Pt was given PCV 23 instead of MENVEO vaccine.
Age: 0.5
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Patient was ordered KINRIX by Doctor but was given PEDIARIX by Medical Assistant. Patient was two months early for Hepatitis B dose.
Age: 0.3
Sex: U
Vaccine: HIBV
Symptoms: Wrong technique in drug usage process
Clinical narrative: Wrong diluent used with this vaccine. I used sterile water diluent instead of the one that was provided in the package.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: MMR PROQUAD given with a .05 dose of varicella.
Age: 17.0
Sex: U
Vaccine: HEPA
Symptoms: Off label use, Wrong drug administered
Clinical narrative: Patient was seen in our clinic and provider ordered Adult Hep A to be given. Information was not verified and patient was given wrong vaccine. Patient received adult dose was given. Should have been Ped/adol dose.
Age: 20.0
Sex: M
Vaccine: YF
Symptoms: Wrong technique in drug usage process
Clinical narrative: I am Triage RN and work with 4 LVNs in our clinic. On 6/9/14 one of our patients received the yellow fever vaccine, but the wrong diluent was used for the vaccine. Rather than using NaCl, the LVN used sterile water. Each yellow fever vaccine vial should correspond with a bottle of diluent. They each come in packages of 5. Theoretically, when we have to open a new package of vaccines, we should have to open a package of diluents as they correspond 1:1. Upon review, it was noted that in addition to this incident there were 2 extra vials of diluent in our med room. It is unclear why-whether two other patients received the vaccine with the incorrect diluent, or two vaccines were misplaced, etc., and there was no way to find out. We have tried to track this, look back at patient records, etc., to no avail. For the patient that we are sure did receive the vaccine with the incorrect diluent this writer called both the CDC as well as the manufacturer to determine whether there could be any adverse reactions and to ensure that the vaccine would still be effective. Ultimately the Manufacturer stated there has been no studies or data on this, but that they believe that the vaccine would still be immunogenic as the diluent that was used was without preservatives. We attempted to check the titers for this pt to ensure the vaccine was effective, but despite our efforts we were unable to accomplish this prior to his trip.
Age: 7.0
Sex: U
Vaccine: HEP
Symptoms: Off label use
Clinical narrative: Nurse administered Adult dose of Hep B instead of Ped dose of Hep B.
Age: 0.8
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered
Clinical narrative: Patient was given a third dose of 6-36 month flu vaccine. Patient had already had two doses prior.
Age: 7.0
Sex: U
Vaccine: FLU3, HPV4, TD
Symptoms: Drug dispensing error
Clinical narrative: At public immunization clinic vaccines prepared for client (child 1). Name of client (first and last name) was called but another child client (child 2) and mother responded and came to the vaccination area. Child 1 never responded or heard name called. Both clients speak little of the language. Names were not that similar but mistaken nevertheless by client 2 (7 years old) and his mother. Did not verify again as client 2 entered room crying and clinging to mother.
Age: 0.2
Sex: U
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Baby in for first set of vaccines. Pulled out a single dose of Hep B pediatrics and should have set up and given ACT-HIB vaccine instead. Parent of baby called and she will bring baby back to clinic this AM to get her first dose of HIB vaccine.
Age: 0.3
Sex: U
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: HAVRIX given to 3 month 24 day old client should have received ENGERIX B.
Sex: U
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a Hepatitis A, instead of a Hepatitis B that was needed.
Age: 0.8
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Accidentally administered KINRIX as a 3rd DTaP and IPV.
Age: 0.8
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered to an infant over 8 months of age. Was confused about the timing restrictions of ROTATEQ.
Age: 5.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: On 05/30/2014 a medical asst gave a dose of TDAP instead of a DTAP 5th dose.
Age: 1.6
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Daughter had a Hep A first dose at 3/18/2014. Then on 6/05/2014, was given another shot of it which was less than the 6 month interval. They were given the daughter's shot record (hand carried by father) at the start of the appointment which listed the prior vaccine on 3/18/2014.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered
Clinical narrative: PROQUAD and VARIVAX was given to a 12 month child.
Age: 0.7
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: KINRIX vaccine was administered to an 8 month old patient, when PEDIARIX was intended.
Age: 59.0
Sex: U
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient had already had 2 doses of TDAP, last one was in 2011. Patient received another TDAP on 6/6/14. After discussing the MA involved, she stated "doctor told me to".
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received the 2013-2014 flu vaccine in August 2013 and another one was received 6/6/14.
Age: 15.0
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Kudos on your vaccine error report. Appreciate it. I'm not sure if monitoring errors are within the scope of your article, but wanted to share none-the-less. I don't have specifics to provide, but just want to mention a trend that we have seen related to HPV vaccines. We have had instances (due to demands on speedy room turn over) in our physician offices where patients are asked to sit in the waiting room for 15 minutes following their injection. They are handed a timer and directions are provided to the waiting room, but they faint en route. We have instructed staff to escort the patient to the waiting room chair, arm in arm. Patients may feel that we are over cautious, but we have seen patients exhibit no problem with the first 2 injections, but somehow faint with the 3rd.
Age: 18.0
Sex: F
Vaccine: HEPA
Symptoms: Off label use
Clinical narrative: Patient received adult dose HAVRIX Hepatitis A vaccine when she should have received a pediatric dose through the age of 18.
Age: 1.0
Sex: U
Vaccine: DTAP
Symptoms: Expired drug administered
Clinical narrative: Medical Assistant didn't follow appropriate steps to check vaccine expiration and double check with Licensed Provider before giving an expired vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Received immun 7/21/14 at 14:30. 1 hr later pain developed. Then noted redness developed, redness, swelling of the arm distal to the shot and now 36 hrs into this, redness spread to entire upper arm.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain. Diagnosed w/ cellulitis at urgent care and given antibiotic.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient called at 7:20 am on 07/23/14 indicating the injection site was red, warm, raised and itchy. The injection side was 2 inches wide and 3 inches long. Her eyes were also itchy. Symptoms were resolving within 24 hours of onset.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Angiogram, Blindness, Bordetella test negative, Laboratory test normal, Nuclear magnetic resonance imaging
Clinical narrative: Bilateral vision loss. Bilateral optic neuritis. Initially dx 6/25/14. Remissions and exacerbations until the present time. Improvement with steroids.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Optic neuritis, Treponema test negative
Clinical narrative: Bilateral vision loss. Bilateral optic neuritis. Initially dx 6/25/14. Remissions and exacerbations until the present time. Improvement with steroids.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Pain, Polymerase chain reaction
Clinical narrative: Two-dose varicella vaccine recipient diagnosed with herpes zoster at the hospital on 04/06/2014. Painful rash on right arm - back/arm pit crease, spread to hand. Rash onset 4/1/14. Not hospitalized. No history of varicella. Lasted <4 weeks. Also reported slight fever and vomiting. Treated with antivirals- name of meds is unknown.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Pyrexia, Rash, Varicella virus test positive, Vomiting
Clinical narrative: Two-dose varicella vaccine recipient diagnosed with herpes zoster at the hospital on 04/06/2014. Painful rash on right arm - back/arm pit crease, spread to hand. Rash onset 4/1/14. Not hospitalized. No history of varicella. Lasted <4 weeks. Also reported slight fever and vomiting. Treated with antivirals- name of meds is unknown.
Age: 18.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: NAUSEA, LIGHT HEADED, BLURRED VISION.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site rash
Clinical narrative: Patient woke up with rash at injection site, throughout day rash increased.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 72.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Dysgeusia, Stomatitis
Clinical narrative: Sore in mouth, with strong salty taste in mouth. Metallic flavor in mouth with certain acidic foods and water. The metallic flavor has persisted for over 6 months.
Age: 73.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Feeling hot, Headache, Swelling face, Urticaria
Clinical narrative: Headaches, swollen face, hives on her neck, thigh, low back and feeling warm.
Age: 0.18
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Enema administration, Intussusception, Ultrasound abdomen abnormal
Clinical narrative: Intussusception.
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Blood pressure increased, Muscle spasms
Clinical narrative: Patient had neck spasms which progressed to lower back spasms with blood pressure elevating to 190/90.  After approximately 10 minutes of resting, spasms ceased and blood pressure decreased to 160s.  Follow up with patient at 8pm and patient stated that she had no symptoms and the blood pressure had returned to 120s as tested on home blood pressure monitor.
Age: 0.51
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Cyanosis, Eye movement disorder, Respiratory arrest, Syncope, Unresponsive to stimuli
Clinical narrative: Last night pt was making some noises like complaining (mom was eating, she thought he wanted to eat too), then when he was standing he started to collapse, was caught before he fell, eyes rolled back, didn't close but pt was not focusing or responding to his name, looks like he stopped breathing and his lips started to turn blue, mom slapped him a couple of times, he recovered and returned to normal.  Had temp of 38 when checked.  Has been fine since, did well overnight and acting normally today.
Age: 34.0
Sex: M
Vaccine: TTOX
Symptoms: Arthralgia, Mobility decreased, Muscular weakness
Clinical narrative: Extreme joint pain in left shoulder. Unable to move arm past 10 degrees in any direction. 3rd tetanus shot in 34 years and I have never felt this much pain before. Muscles seem extremely weak and even without the extreme joint pain not sure I would be able to lift arm without difficulty. Stepped on nail late Sunday (07/19/2014) and tetanus booster was administered on Tuesday (07/22/14). Starting to feel nauseous as of 9:30 pm 07/23/2014.
Age: 24.0
Sex: F
Vaccine: HEPA, TDAP, TYP, YF
Symptoms: Convulsion, Loss of consciousness
Clinical narrative: Patient passed out about 1 minute after shot, she did convulse slightly but regained consciousness after 10-15 seconds.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Pt received IZ on 7/18 on (R) thigh. Mother reports site swollen to softball size on 7/19. Denies, fever, rash or redness. On 7/20 site swollen to size of golf ball. No leg impairment, no change in energy level. On 7/23 swollen to size of a quarter. Will continue to follow.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Vomiting
Clinical narrative: Patient felt light headed and was vomiting. Patient was advised to lay down and given cold water.
Age: 5.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Decreased appetite, Dizziness, Eye pain, Fall, Headache
Clinical narrative: Dizziness, fell down. Won't eat or drink, headache, eye pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Pyrexia, Vomiting
Clinical narrative: Fever, vomiting.
Age: 18.0
Sex: U
Vaccine: HPV4
Symptoms: Arthralgia, Myalgia
Clinical narrative: Approx. 13 hrs after administration of vaccination pt experienced severe joint and muscle pain. Lasted to a lesser degree x48 hrs. Responded to MOTRIN.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: On 7/22 pt reported pain, itching, swelling, and slight redness and heat at injection site. 7/23, pt had extreme swelling and red from shoulder to elbow, pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Large redness at KINRIX injection site, itchy but not painful.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Condition aggravated, Confusional state, Convulsion, Cough, Depressed level of consciousness
Clinical narrative: Seizure at school on 1-9-13 and had first HPV (GARDASIL) on 11-26-12. Dad got a call at 1045 today that she had a seizure; teacher with her said she had a grand mal seizure; lasted 6 minutes. Had a few more minutes of incoherent confusion; not recognizing anyone. Teacher who witnessed this has a child with seizures; had difficulty breathing at the time; no cyanosis; coughing and breathing erratically, thought she bit her tongue; blood flowing from mouth that stopped at end of seizure. Leaned on desk, fell onto floor, didn't hit head but spasms caused head to bounce. Gets migraines and had one yesterday, lots of stress yesterday and more than average in the last couple of months. School didn't call 911. No incontinence. Dad took her home, she was still "kind of out of it" (like when she has 'bad migraine'). She can't remember much until she got to bed at 1145; could walk on own but not stable. Slept 3 1/2 hours. Feels tired now; no headache. Migraines have been present since age 3; sees Dr. Has her on RELPAX, ibuprofen and BENAGRYL/REGLAN. No chest pain. Usually ibuprofen at onset of HA works.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Electroencephalogram normal, Fall, Fatigue, Gait disturbance
Clinical narrative: Seizure at school on 1-9-13 and had first HPV (GARDASIL) on 11-26-12. Dad got a call at 1045 today that she had a seizure; teacher with her said she had a grand mal seizure; lasted 6 minutes. Had a few more minutes of incoherent confusion; not recognizing anyone. Teacher who witnessed this has a child with seizures; had difficulty breathing at the time; no cyanosis; coughing and breathing erratically, thought she bit her tongue; blood flowing from mouth that stopped at end of seizure. Leaned on desk, fell onto floor, didn't hit head but spasms caused head to bounce. Gets migraines and had one yesterday, lots of stress yesterday and more than average in the last couple of months. School didn't call 911. No incontinence. Dad took her home, she was still "kind of out of it" (like when she has 'bad migraine'). She can't remember much until she got to bed at 1145; could walk on own but not stable. Slept 3 1/2 hours. Feels tired now; no headache. Migraines have been present since age 3; sees Dr. Has her on RELPAX, ibuprofen and BENAGRYL/REGLAN. No chest pain. Usually ibuprofen at onset of HA works.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Grand mal convulsion, Incoherent, Migraine, Mouth haemorrhage, Muscle spasms
Clinical narrative: Seizure at school on 1-9-13 and had first HPV (GARDASIL) on 11-26-12. Dad got a call at 1045 today that she had a seizure; teacher with her said she had a grand mal seizure; lasted 6 minutes. Had a few more minutes of incoherent confusion; not recognizing anyone. Teacher who witnessed this has a child with seizures; had difficulty breathing at the time; no cyanosis; coughing and breathing erratically, thought she bit her tongue; blood flowing from mouth that stopped at end of seizure. Leaned on desk, fell onto floor, didn't hit head but spasms caused head to bounce. Gets migraines and had one yesterday, lots of stress yesterday and more than average in the last couple of months. School didn't call 911. No incontinence. Dad took her home, she was still "kind of out of it" (like when she has 'bad migraine'). She can't remember much until she got to bed at 1145; could walk on own but not stable. Slept 3 1/2 hours. Feels tired now; no headache. Migraines have been present since age 3; sees Dr. Has her on RELPAX, ibuprofen and BENAGRYL/REGLAN. No chest pain. Usually ibuprofen at onset of HA works.
Age: 17.0
Sex: F
Vaccine: HPV4
Symptoms: Nuclear magnetic resonance imaging, Respiration abnormal, Tongue biting
Clinical narrative: Seizure at school on 1-9-13 and had first HPV (GARDASIL) on 11-26-12. Dad got a call at 1045 today that she had a seizure; teacher with her said she had a grand mal seizure; lasted 6 minutes. Had a few more minutes of incoherent confusion; not recognizing anyone. Teacher who witnessed this has a child with seizures; had difficulty breathing at the time; no cyanosis; coughing and breathing erratically, thought she bit her tongue; blood flowing from mouth that stopped at end of seizure. Leaned on desk, fell onto floor, didn't hit head but spasms caused head to bounce. Gets migraines and had one yesterday, lots of stress yesterday and more than average in the last couple of months. School didn't call 911. No incontinence. Dad took her home, she was still "kind of out of it" (like when she has 'bad migraine'). She can't remember much until she got to bed at 1145; could walk on own but not stable. Slept 3 1/2 hours. Feels tired now; no headache. Migraines have been present since age 3; sees Dr. Has her on RELPAX, ibuprofen and BENAGRYL/REGLAN. No chest pain. Usually ibuprofen at onset of HA works.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an health care worker refers to an unspecified number of patients of unknown age and gender might have received GARDASIL (Lot# unspecified) dose, frequency and location unspecified, which were stored improperly on an unspecified date. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.