chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of nausea in a adult female patient who received FLUARIX (batch number AFLUA550AA, expiry date unknown). On an unknown date, the patient received FLUARIX. On an unknown date, an unknown time after receiving FLUARIX, the patient experienced nausea, vomiting and dizziness. On an unknown date, the outcome of the nausea, vomiting and dizziness were recovered/resolved. It was unknown if the reporter considered the nausea, vomiting and dizziness to be related to FLUARIX. Additional details were provided as follows: This case was reported by a physician, who herself was the patient. The age at vaccination was not reported. The patient received FLUARIX vaccine back in year 2010 and after vaccination she experienced nausea, vomiting and dizziness, which were lasted for about 1 to 2 months. No further information was reported regarding the event.
Sex: F
Vaccine: FLU4
Symptoms: Hypotension, Nausea, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a female patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 30th June 2017). On 8th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced nausea, vomiting and hypotension. On an unknown date, the outcome of the nausea, vomiting and hypotension were unknown. It was unknown if the reporter considered the nausea, vomiting and hypotension to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The age at vaccination was not reported for this report. The case was previously not reported. The other health professional stated that she would call back with details regarding the other two adverse events. This case has been linked with case US2016GSK149944 and US2016GSK149943 as reported by same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Hypotension, Nausea, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of nausea in a female patient who received FLUARIX QUADRIVALENT (batch number ZG3S5, expiry date 30th June 2017). On 8th October 2016, the patient received FLUARIX QUADRIVALENT. In October 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced nausea, vomiting and hypotension. On an unknown date, the outcome of the nausea, vomiting and hypotension were unknown. It was unknown if the reporter considered the nausea, vomiting and hypotension to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The other health professional stated that she would call back with details regarding the other two adverse events. This case has been linked with case US2016GSK149944 and US2016GSK149945.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on chest, bilateral arms, and small rash on right leg. I took 50mg BENADRYL PO due to symptoms. Symptoms lasted approx 3 hrs.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a 25-year-old female patient who received FLULALAVAL QUADRIVALENT (batch number Y9H77, expiry date April 2017). On 12th October 2016, the patient received the 1st dose of FLULAVAL QUADRIVALENT (intramuscular). On 12th October 2016, several hours after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site swelling, injection site warmth and injection site itching. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site itching were unchanged. The reporter considered the injection site swelling, injection site warmth and injection site itching to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. The patient experienced itching, swelling and feverish at injection site beginning evening of vaccination with FLULAVAL QUADRIVALENT (left deltoid) at 13:00. At the time of reporting the patient still had local swelling and itching and fever at injection site and the swollen area was the size of small apple.
Age: 71.0
Sex: M
Vaccine: FLU4
Symptoms: Arthropathy, Rash generalised, Respiratory disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a 71-year-old male patient who received FLUARIX QUADRIVALENT. Concomitant products included metformin, baby aspirin, and lisinopril. On 18th December 2015, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) 1 ml. On 19th December 2015, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced rash, respiratory system disorder and joint dysfunction. On an unknown date, the outcome of the rash, respiratory system disorder and joint dysfunction were recovered/resolved. The reporter considered the rash, respiratory system disorder and joint dysfunction to be probably related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient experienced a rash from face to his toes, a narrow breathing passage and severe joint malfunction of his knees, shoulders and hands after receiving flu vaccine. He had to wear leg braces for treatment.
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described  the occurrence of febrile seizure in a adolescent male patient who received Flu Seasonal TIV Dresden. Concurrent medical conditions included seizure. On an unknown date, the patient received influenza vaccine. On an unknown date, 1 day after receiving Influenza vaccine, the patient experienced febrile seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the febrile seizure was recovered/resolved. The reporter considered the febrile seizure to be probably related to influenza vaccine. Additional details were reported as follows: the case was reported by the patient's parent. This case was previously reported to physician. the age at vaccination was not reported. The patient has denied permission to contact their physician. In 2015, the patient experienced fever and increased incidence of seizures after receiving flu vaccine.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Hypotension
Clinical narrative: Hypotension after 5 minutes of flu vaccine. Patient was observed in the next 15 minutes until the blood pressure normalized.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain
Clinical narrative: Complaint of immediate pain at injection site that has persisted for 3 weeks. Difficulty raising left arm more than 45 degrees. Seen by Primary Care Physician, on 10/10/2016 and prescribed ADVIL and shoulder exercises.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Asthenia, Feeling abnormal, Lacrimation increased, Nausea
Clinical narrative: By 9pm started feeling bad. Sat down on bed and got nauseous. Vomited violently for about 25 minutes to the point that had tears on eyes and stomach hurt above navel. Called poison control center in case there was something wrong with the vaccine. Did not take any medicine for problems. Next day, felt fine in the morning but was afraid to eat much. Had toast and omelette with  mushroom at night by 9pm the vomiting began again. Called pharmacy who verified that symptoms were on packet insert. Called triage nurse who advised pt to go to ER if violent vomiting continued. On Wednesday, did not feel like eating much. On Thursday felt fit as a fiddle but a little weak since had not eaten much the last couple of days. No fever during these days. No adverse events on arm. Was told by manufacturer that vax strain was sent of in August.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Vomiting
Clinical narrative: By 9pm started feeling bad. Sat down on bed and got nauseous. Vomited violently for about 25 minutes to the point that had tears on eyes and stomach hurt above navel. Called poison control center in case there was something wrong with the vaccine. Did not take any medicine for problems. Next day, felt fine in the morning but was afraid to eat much. Had toast and omelette with  mushroom at night by 9pm the vomiting began again. Called pharmacy who verified that symptoms were on packet insert. Called triage nurse who advised pt to go to ER if violent vomiting continued. On Wednesday, did not feel like eating much. On Thursday felt fit as a fiddle but a little weak since had not eaten much the last couple of days. No fever during these days. No adverse events on arm. Was told by manufacturer that vax strain was sent of in August.
Age: 69.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Abdominal pain upper, Feeding disorder, Injection site pain, Malaise, Nausea
Clinical narrative: By 9pm started feeling bad. Sat down on bed and got nauseous. Vomited violently for about 25 minutes to the point that had tears on eyes and stomach hurt above navel. Called poison control center in case there was something wrong with the vaccine. Did not take any medicine for problems. Next day, felt fine in the morning but was afraid to eat much. Had toast and omelette with  mushroom at night by 9pm the vomiting began again. Called pharmacy who verified that symptoms were on packet insert. Called triage nurse who advised pt to go to ER if violent vomiting continued. On Wednesday, did not feel like eating much. On Thursday felt fit as a fiddle but a little weak since had not eaten much the last couple of days. No fever during these days. No adverse events on arm. Was told by manufacturer that vax strain was sent of in August.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experiences local swelling and redness around the injection site. The swollen area is red, tender and a bit warm. It is not painful or itchy. The redness has faded a little since the day after the injection, but the area has moved down to her elbow and below.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Cerebrovascular accident, Dyskinesia, Facial paralysis, Facial paresis, Hypoaesthesia oral
Clinical narrative: 10/14/2016, The patient is a 58 year old female. Pt calls C/O "sideways smile" and right side of lip swollen. Pt thinks it is related to flu vac that was given on 10/11/16 because symptoms began on 10/12/16. I instructed pt to go to ER for eval. Pt plans to go tomorrow but I instructed pt to go today. 10/20/2016, 11:37 AM, The patient is a 58 year old female. See 10/14/16 phone encounter note pertaining to C/O facial weakness "sideways smile." Pt comes to pharmacy for refills and pharmacist directs her to me. Pt's smile is noticeably asymmetric. Pt states she is unable to control or move the right side of her mouth and it feels numb. Pt states she did not go to ER as instructed on 10/14/16 because she knows "it is Bells Palsy which is treated by steroids and I don't really want to take steroids." Pt has printed information from the internet RE: Bells Palsy and FLULAVAL immunization. Pt strongly instructed to go to ER although she voices several reasons for reluctancy. Pt given copy of general VIS for flu vaccines (not specifically for FLULAVAL). Pt requests this to be reported to VAERS. Pt given VAERS number and will report this on her own. Instructed pt to go to ER first but she is calling the VAERS number right now while still at pharmacy. 10/21/2016, 10:29 AM, I completed VAERS form and faxed to phone number provided. Copy in scanned documents. 10/20/16, Time seen by Doctor: 13:13. Chief Complaint, CVA/TIA Symptoms. Attending Note: I supervised the patient's care throughout the ED course. I have personally interviewed and examined the patient, reviewed and agree with the findings documented, unless otherwise addendumed. Patient is a 58 year-old F that states 10 days ago she noticed she had a right facial droop. This was shortly after receiving her flu shot. Patient also complains of full feeling of her right face and full sound of her hearing. Patient denies pain at time evaluation. No other modifying factors or associated symptoms.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Transient ischaemic attack
Clinical narrative: 10/14/2016, The patient is a 58 year old female. Pt calls C/O "sideways smile" and right side of lip swollen. Pt thinks it is related to flu vac that was given on 10/11/16 because symptoms began on 10/12/16. I instructed pt to go to ER for eval. Pt plans to go tomorrow but I instructed pt to go today. 10/20/2016, 11:37 AM, The patient is a 58 year old female. See 10/14/16 phone encounter note pertaining to C/O facial weakness "sideways smile." Pt comes to pharmacy for refills and pharmacist directs her to me. Pt's smile is noticeably asymmetric. Pt states she is unable to control or move the right side of her mouth and it feels numb. Pt states she did not go to ER as instructed on 10/14/16 because she knows "it is Bells Palsy which is treated by steroids and I don't really want to take steroids." Pt has printed information from the internet RE: Bells Palsy and FLULAVAL immunization. Pt strongly instructed to go to ER although she voices several reasons for reluctancy. Pt given copy of general VIS for flu vaccines (not specifically for FLULAVAL). Pt requests this to be reported to VAERS. Pt given VAERS number and will report this on her own. Instructed pt to go to ER first but she is calling the VAERS number right now while still at pharmacy. 10/21/2016, 10:29 AM, I completed VAERS form and faxed to phone number provided. Copy in scanned documents. 10/20/16, Time seen by Doctor: 13:13. Chief Complaint, CVA/TIA Symptoms. Attending Note: I supervised the patient's care throughout the ED course. I have personally interviewed and examined the patient, reviewed and agree with the findings documented, unless otherwise addendumed. Patient is a 58 year-old F that states 10 days ago she noticed she had a right facial droop. This was shortly after receiving her flu shot. Patient also complains of full feeling of her right face and full sound of her hearing. Patient denies pain at time evaluation. No other modifying factors or associated symptoms.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Disorientation, Erythema, Facial bones fracture, Fall, Head injury
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 77 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient was given PREVENAR a "year ago", in approximately 2015. On an unspecified date in approximately October 2016 (reported as "within the last week"), the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiration date were not reported) intramuscularly. A couple hours later, the patient developed redness and swelling in the arm she got vaccine in. A day later, the patient became disoriented and fell. She hit her head and broke her nose. The patient went back the pharmacy "72 hours later" and she still had swelling. The patient used BENADRYL and a cold compress to treat the swelling. The pharmacist did not specify if the patient sought medical for her broken nose. The patient outcome was not reported. Action taken was not applicable. The causality between the events and PNEUMOVAX 23 was not provided. Upon internal review the event of facial bones fracture was considered to be medically significant. Additional information has been requested.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 77 year old female patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The patient was given PREVENAR a "year ago", in approximately 2015. On an unspecified date in approximately October 2016 (reported as "within the last week"), the patient was vaccinated with PNEUMOVAX 23 (dose, lot # and expiration date were not reported) intramuscularly. A couple hours later, the patient developed redness and swelling in the arm she got vaccine in. A day later, the patient became disoriented and fell. She hit her head and broke her nose. The patient went back the pharmacy "72 hours later" and she still had swelling. The patient used BENADRYL and a cold compress to treat the swelling. The pharmacist did not specify if the patient sought medical for her broken nose. The patient outcome was not reported. Action taken was not applicable. The causality between the events and PNEUMOVAX 23 was not provided. Upon internal review the event of facial bones fracture was considered to be medically significant. Additional information has been requested.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Food allergy, Local reaction
Clinical narrative: Large local reaction measuring several inches (7x5). Post Influenza vaccinations lasting 3-4 days.
Age: 78.0
Sex: M
Vaccine: FLU4
Symptoms: Eye swelling, Lip swelling, Urticaria
Clinical narrative: 10/19/16 This 78 year old male presents for evaluation of the following problem(s): Hives x 6 days. Patient had the high dose flu injection on 10/11/16. A few days later he started to develop hives. The hives are located on the arms and legs. He also has some mild swelling around his eyes and lips. The hives are non-pruritic. He did see Cardio 2 days ago who advised that he take some ZYRTEC which he did start ZYRTEC-D then. He thinks that the hives have subsided some on the arms. Besides the flu injection he cannot think of any other thing that would have caused this reaction. No new medications, foods, or soaps/detergents. High Dose lot # UI679AA exp: 4/9/16.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Bump on arm at injection site and pain (mild) after 1 week.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Myalgia, Nasal congestion, Pyrexia
Clinical narrative: 6hr post inj.=headache nasal congestion muscle aches fatigue low grade fever. Next am-severe vertigo persistent vertigo at times-PVCS-2 days post (10/19/16).
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: 6hr post inj.=headache nasal congestion muscle aches fatigue low grade fever. Next am-severe vertigo persistent vertigo at times-PVCS-2 days post (10/19/16).
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Lip pruritus, Swelling face
Clinical narrative: Flu shot sit swollen approx. 2hrs after administered, however subsided w/massage of area. Several hours after that, lip started to itch, followed by swelling of (R) cheek and bottom lip. Went to urgent care, Re'd steroid dose pack.
Age: 55.0
Sex: F
Vaccine: FLUR3
Symptoms: Chest discomfort, Cough, Dysphonia, Throat tightness, Urticaria
Clinical narrative: Hives on chest, itchy rash - BENADRYL 25 PO at pm. Mild wheezing, cough, hoarseness, tight throat and chest. IV BENADRYL 25 mg 10:15am, PEPSID 20mg IV 10:17am. Prednisone PO 20mg 10:10am. Discharged from ED 1:10p with Rx oral Prednisone 60mg daily x 4 days.
Age: 55.0
Sex: F
Vaccine: FLUR3
Symptoms: Wheezing
Clinical narrative: Hives on chest, itchy rash - BENADRYL 25 PO at pm. Mild wheezing, cough, hoarseness, tight throat and chest. IV BENADRYL 25 mg 10:15am, PEPSID 20mg IV 10:17am. Prednisone PO 20mg 10:10am. Discharged from ED 1:10p with Rx oral Prednisone 60mg daily x 4 days.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Discomfort, Limb discomfort, Pain in extremity
Clinical narrative: C/o pain, ache in upper arm began 10/11/16 feeling uncomfortable to move arm. Pain in the location of admin. of flu vaccine 13 day's prior. No issues at time of vaccine. MD states tx like tendonitis with gentle ROM, ice/heat. Increase ADVIL to 800mg q 6 hours.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Muscle twitching, Scleral discolouration
Clinical narrative: Within 3 hrs of receiving the flu shot I noticed twitching of (R) side of upper lip and red discoloration of sclera. This lasted for 12 hours then symptoms subsided, Red color of sclera disappeared - occasional twitch of lip noticeable 48 hrs.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: The pt was vaccinated w/ three vaccine into the Right deltoid on 10/17/16. Erythema, swelling began yesterday 10/19/16. Better today (was eval today). Afebrile.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Dysphonia, Increased upper airway secretion, Palpitations
Clinical narrative: Patient developed tightness in throat and chest; mucous production in throat; cough; change in voice; and palpitations. All symptoms started 10 minutes after influenza vaccine. Patient noted symptoms felt similar to reactions with bee stings/venom. Patient had been feeling well prior to event. On exam: Lungs clear, heart tachy; no oropharyngeal edema or stridor; no hives.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Tachycardia, Throat tightness
Clinical narrative: Patient developed tightness in throat and chest; mucous production in throat; cough; change in voice; and palpitations. All symptoms started 10 minutes after influenza vaccine. Patient noted symptoms felt similar to reactions with bee stings/venom. Patient had been feeling well prior to event. On exam: Lungs clear, heart tachy; no oropharyngeal edema or stridor; no hives.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Blood creatine phosphokinase normal, Burning sensation, Full blood count normal, Headache, Metabolic function test normal
Clinical narrative: Saw PCP 10/18/16 for Headaches/muscle pain that began one day after flu shot. Progressive pain and weakness in legs and arms since then. Now pain with walking and difficulty rising from chair. No documented fevers. Vomiting. Burning sensation in arms and legs. Was seen by neurologist on 10/19/16, who started Gabapentin.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Muscular weakness, Myalgia, Pain, Pain in extremity, Vomiting
Clinical narrative: Saw PCP 10/18/16 for Headaches/muscle pain that began one day after flu shot. Progressive pain and weakness in legs and arms since then. Now pain with walking and difficulty rising from chair. No documented fevers. Vomiting. Burning sensation in arms and legs. Was seen by neurologist on 10/19/16, who started Gabapentin.
Age: 25.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, pain an injection site since got a flu shot. Pt. filled KEFLEX antibiotic from her primary physician.
Age: 25.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Skin disorder
Clinical narrative: Swelling, redness, pain an injection site since got a flu shot. Pt. filled KEFLEX antibiotic from her primary physician.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Swelling, Vaccination site pain, Vaccination site warmth
Clinical narrative: 9cm x 7cm area of warmth, redness and tenderness extending from vaccine site. Given 11mg oral dexamethasone for swelling.
Age: 0.2
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was given the KINRIX pt's mother informed and was unhappy but had not further questions. Spoke with the pt's PCP and he stated there was no need for concern.
Age: 7.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Physician ordered a 7 year old male patient to be given tetanus booster, patient was given DtaP but should have been given TdaP due to his age, (over 7 years of age).
Age: 0.3
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: KINRIX inadvertently given to 4 month old who needed Dtap and IPV.
Age: 1.0
Sex: U
Vaccine: IPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Vaccine was given at incorrect interval.
Age: 1.5
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Medical assistant administered MMRV and varicella to a 17 month old patient. Parents contacted by Provider to explain risks and monitor child.
Age: 18.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: We had an 18 year old today on private insurance who needed his 2nd Hep A vaccine. The only pediatric dose we had was from State. Our provider stated that it was ok to use the Private Adult dose since he was 18 years of age.
Age: 18.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt came into clinic for catch up on immunizations was in need of Varicella and MMR along with many other vaccinations. Patient is to old for PROQUAD.
Age: 0.2
Sex: U
Vaccine: DTAPHEPBIP, IPV
Symptoms: Wrong drug administered
Clinical narrative: 2 month old got PEDIATIX and then the next day got a dose of IPV.
Age: 14.0
Sex: U
Vaccine: MENB
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: The first dose of MenB vaccine was administered to a healthy 14 year old.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong drug administered
Clinical narrative: PROQUAD and VARICELLA were administered at the same time instead of MMR and VARICELLA separately.
Age: 1.1
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Following vaccine inventory, it was discovered patient was given (1) dose of varicella antigen in addition to (1) dose of PROQUAD (instead of (1) dose of varicella and (1) dose of MMR). Thus, patient was likely given double dose of Varicella. We contacted CDC and the incident was reported to patient's father. Follow up appointment scheduled with patient.
Age: 38.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Adult vaccination received only 0.5 ml dose. Should have been 1 ml.
Age: 1.5
Sex: U
Vaccine: TDAP
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Pt was to receive the Dtap and was given the Tdap.
Age: 11.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Unknown - was not involved. KINRIX was given to an 11 year old. Only approved for 4-5 years olds.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site inflammation
Clinical narrative: Patient presented to pharmacy with large bruise at injection site with large area surrounding site red and inflamed.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Blindness, Echocardiogram normal, Tricuspid valve incompetence
Clinical narrative: Episodes of partial blindness at football practice that night. Taken to ER.
Age: 68.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Erythema, Inflammation, Peripheral swelling
Clinical narrative: Inner arm very inflamed, swollen and red. The area was approximately 12 inch long and 3-4 inches wide.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site
Clinical narrative: Patient came in stating a nurse told him shot was given too high. No reported symptoms or complaints.
Age: 78.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Monoplegia, Peripheral swelling
Clinical narrative: Pt. noted inject site to be red and warm with swelling and numbness from deltoid to head the morning after PNEUMOVAX given. Pt. decline f/u appt. at this time.
Age: 78.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Hypoaesthesia, Injection site erythema, Injection site hypoaesthesia, Injection site swelling, Injection site warmth
Clinical narrative: Pt. noted inject site to be red and warm with swelling and numbness from deltoid to head the morning after PNEUMOVAX given. Pt. decline f/u appt. at this time.
Age: 78.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Swelling
Clinical narrative: Pt. noted inject site to be red and warm with swelling and numbness from deltoid to head the morning after PNEUMOVAX given. Pt. decline f/u appt. at this time.
Age: 12.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Unknown-employee no longer here but KINRIX was given to 12 year old. Only good for 4-6 years. Wrong timing/interval (e.g., interval too short).
Age: 14.0
Sex: U
Vaccine: HIBV
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered correct vaccine, staff member collected, drew and administered incorrect vaccine. Age of patient at time of event: 14 years. Contributing Factors: Staff selected wrong immunization.
Age: 4.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered MMRV (PROQUAD), staff member administered MMR.
Age: 22.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Pt came in to get 2nd hep b, looking at his record I saw he was given a PROQUAD injection. I called Merck and reported it, Dr spoke with the pt and it was reported on this as well.
Age: 16.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult dose of Hepatitis A was administered to a 16 year old female. Age of patient at time of event: 16 years 5 months 20 days.
Age: 25.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Adult patient given single MMR vaccine via IM route instead of recommended SQ route. No harm noted to patient.
Age: 1.6
Sex: U
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: KINRIX vaccine was given to a pt whose date of birth did not match the manufacture guidelines of ages 4-6 years.
Age: 5.0
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered
Clinical narrative: Patient had received PEDIARIX in past so was going to get KINRIX. I saw it on the box Dtap and IPV, then I saw it on the bottle, but in my head it was registering as the Dtap being the same brand and that he still needed the IPV. Afterwards when we were doing our after checks it was picked up by the other nurse.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Drug administration error, Extra dose administered
Clinical narrative: 13 month old in for WCC. Was given both MMRV and Varicella vaccine. Age of patient at time of event: 1 years 1 months. Type of Event: Extra dose. Contributing factors: inattention to detail of vaccine prep and admin.
Age: 11.0
Sex: U
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Adult dose Hep A given to 11 year old patient.
Sex: U
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult dose of Hep. A was given to 9 year old. Age of patient at time of event: 9 years.
Age: 17.0
Sex: U
Vaccine: TDAP
Symptoms: Product selection error
Clinical narrative: Patient was given TDaP vaccine thru VFC even through patient has a private insurance which requires private vaccine supply. Clinician informed and verbalized that is fine as long as we chart and file report. RN supervisor reported medication error.
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Extra dose administered
Clinical narrative: Pt. was given an unneeded dose of varicella vaccine. Age of patient at time of event: 9 years 6 months 24 days.
Age: 1.0
Sex: U
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: Patient was given a PROQUAD (instead of MMR) and VARIVAX.
Age: 0.6
Sex: U
Vaccine: IPV
Symptoms: Expired product administered
Clinical narrative: A vaccine was given to patient without the vaccine expiration being check. Age of patient at time of event: 8 months 20 days.
Age: 12.0
Sex: U
Vaccine: MENB
Symptoms: Wrong drug administered
Clinical narrative: MENACTRA ordered, BEXSERO given.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: 66 year old male was supposed to get FLUZONE HD but got AFLURIA (regular strength) flu shot.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Vomiting
Clinical narrative: Vaccine administered at 9AM, about 9:15AM patient C/O felling light headed, bp 110/70 - no other Sx, then over next 15-20 min., became nauseous and vomited x3. No rash, without swelling, positive soreness at injection site - without visible redness, swelling. BP/pulse remained stable, dizziness and nausea subsided after 3 hrs. but she has headache. Temp - 99.0.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Within 30-60 minutes after receiving flu shot patient experienced hives and excessive itching no other symptom reported. Patient contacted primary care provider whom told her to visit ER. Patient was treated with BENADRYL at ER. DC home same day.
Age: 1.25
Sex: M
Vaccine: FLU4, MMR
Symptoms: Pyrexia, Rash
Clinical narrative: On 10-14-16 seen in our office with a history of fever and rash onset last week which was 6 days after receiving Varicella.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Shooting pain down (L) arm; arm red and sore. ADVIL, cool compress.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Hypoaesthesia oral, Pain, Pyrexia
Clinical narrative: 24 hrs after injection pt had local pain, redness, fever. Also numbness of tongue and lower extremities. No SOB. No anaphylaxis. Symptom lasted 48 hrs. Pt is seen today 10/14/16 Rx ice, ADVIL.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: C-reactive protein, Differential white blood cell count, Full blood count, Metabolic function test, Peripheral swelling
Clinical narrative: Hives all over, swelling of hands and feet. BENADRYL and DECADRON injections. Now oral BENADRYL and steroid.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Urticaria
Clinical narrative: Hives all over, swelling of hands and feet. BENADRYL and DECADRON injections. Now oral BENADRYL and steroid.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Arm where PNEUMOVAX 23 administered got red, hot, swollen and painful from shoulder to elbow. KEFLEX 500mg qid x 10 days.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Ear swelling, Loss of consciousness, Peripheral swelling, Pruritus, Rash
Clinical narrative: Patient started itching on 10/18/16, developed swelling of hands and right earlobe, she passed out on 10/18/16. She did not go to hospital and did not report to the office until 10/20/16 she developed rash on arms, neck, face, legs. Patient had appt. with Dr. and was given 40 mg DEPO-MEDROL on 10/21/16.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Cardiac flutter, Chills, Influenza like illness, Injection site paraesthesia, Nausea
Clinical narrative: I received a flu vaccine on 10/17/16, on 10/18 - 19/16 I had blurred vision, heart palpitations, chills, fever, flu-like symptoms. Tingling in both upper arm/shoulders. Fluttering in the chest area which I get when I have had previous flu shots. I got very nauseous for 2 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Palpitations, Paraesthesia, Pyrexia, Vision blurred
Clinical narrative: I received a flu vaccine on 10/17/16, on 10/18 - 19/16 I had blurred vision, heart palpitations, chills, fever, flu-like symptoms. Tingling in both upper arm/shoulders. Fluttering in the chest area which I get when I have had previous flu shots. I got very nauseous for 2 days.
Age: 1.0
Sex: F
Vaccine: DTAP, FLU4, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Patient came in with a localized reaction to the FLUZONE vaccine in his Right Deltoid. Patients Deltoid is warm to the touch and red. Red area is 7.5 cm x 5.5 cm on Right Deltoid.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 3" area at imm site red and warm to touch. No swelling or fever.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Guillain-Barre syndrome, Pain, Peripheral swelling
Clinical narrative: Body aches, symptoms of Guillain-Barre, swollen feet, still feeling symptoms.
Age: 51.0
Sex: F
Vaccine: FLUR3
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: Patient developed itching, redness, warmth and induration in (R) deltoid region, approximately 1 hour after receiving the FLUBLOK vaccine. Symptoms have continued up to 48 hrs after receiving vaccine. She has taken ALLEGRA and BENADRYL with some help. Also C/O headache and nausea.
Age: 51.0
Sex: F
Vaccine: FLUR3
Symptoms: Nausea
Clinical narrative: Patient developed itching, redness, warmth and induration in (R) deltoid region, approximately 1 hour after receiving the FLUBLOK vaccine. Symptoms have continued up to 48 hrs after receiving vaccine. She has taken ALLEGRA and BENADRYL with some help. Also C/O headache and nausea.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: FLUZONE QUAD. given approx. 0920 on 10/21/16. 40-45 min later, pt became nauseated and had lg. emesis x 3.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Mobility decreased, Neuritis
Clinical narrative: Unable to raise arm; numbness; diagnosed as inflamed nerve-prescribed MEDROL Dose pak.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Pruritus
Clinical narrative: Day 1 - Itching scalp (first night), ears, neck, fatigue. Day 2 - Red, demarcated bruise on left arm 3 inches below injection site. Additional soreness. Used cold compress.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Facial paralysis
Clinical narrative: 15 days after receiving FLUVAX got dx Bells Palsy. No prodromal virus infections, No other Imms, No h/o HSV.
Age: 15.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Syncope
Clinical narrative: Pt received flu shot, then HPV-9. Within 2 min. pt had syncopal event that lasted approx. 1 min.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Pt stating still a lot of arm pain several weeks after. 2 wks.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: Pt. rec. FLUZONE QUAD and 40-45 min later pt. had syncopal episode and when became responsive within a min - had lg. emesis.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received FLUARIX QUAD on 10/20/163 She came back into pharmacy on 10/21/16 stating her arm is sore and she's having trouble lifting her arm.
Age: 1.83
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None. No symptoms or reaction.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling softball size on muscle on arm pain/redness/warm, (Injection site reaction ZOSTAVAX). Back of left tricep. Patient treated for cellulitis post reaction).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Limited mobility in arm where vaccine was administered.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site atrophy, Scar
Clinical narrative: (R) deltoid (posterior) atrophy, (R) tricep atrophy. (R) arm immobile - scar tissue build up. Physician visit. Physical therapy.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Crying, Decreased eye contact, Depressed level of consciousness, Irritability, Lethargy
Clinical narrative: After vaccine started noticing twitching movements which were random. Very lethargic for 2-3 days. Difficult to arouse. Decreased neck control and eye contact. Cried for 8 hours - fussy/irritable.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Mobility decreased, Muscle twitching
Clinical narrative: After vaccine started noticing twitching movements which were random. Very lethargic for 2-3 days. Difficult to arouse. Decreased neck control and eye contact. Cried for 8 hours - fussy/irritable.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Swelling and tenderness of left upper arms, 11x11 cm.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Muscle swelling
Clinical narrative: Patient experienced redness down from injection site down towards elbow. Feels like muscle may be swelling. No pain.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Nausea, Pallor, Paraesthesia
Clinical narrative: Patient became light headed, nauseated, sweaty, and pale after receiving TDaP, MENACTRA, and HPV vaccine. Complained of tingling in his left arm after receiving MENACTRA. Doctor notified. Patient observed in office for 30 minutes. Symptoms subsided after 10-20 minutes.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: Our medical clinic is part of the VFC program and one of our VFC refrigerators malfunctioned and created a too low temperature for vaccines to be viable. Patient received vaccination due to human error in not pulling the non-viable vaccines from refrigerator when it was reported that all non-viable vaccines were pulled correctly and transferred correctly. After speaking with all pharmaceutical companies regarding patient receiving non-viable vaccines, patient have been recalled and will received vaccine as soon as possible. Age of patient at time of event: 11 years 6 months.
Age: 4.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Incorrect product storage
Clinical narrative: Our medical clinic is part of a program and one of our program refrigerators malfunctioned and created a too low temperature for vaccines to be viable. Patient received vaccination due to human error in not pulling the non-viable vaccines from refrigerator when it was reported that all non-viable vaccine were pulled correctly and transferred correctly. After speaking with all pharmaceutical companies regarding patient receiving non-viable vaccines, patient have been recalled and will receive vaccine as soon as possible. Age of patient at time of event: 4 years 7 months.
Age: 12.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: 12 year old given INFANRIX, should have gotten BOOSTRIX.
Age: 11.0
Sex: U
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: Medical assistant incorrectly administered INFANRIX to patient instead of BOOSTRIX. The correct vaccine was ordered in EMR by physician. The correct vaccine was discussed with medical assistant, parent and patient.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient stated that she had swelling and erythema extending the whole area of the left upper arm and some itching.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pain in right leg that started the same day she received the immunization. She describes the pain as "shooting". Also complained of tingling of her right leg. Pain lasted for several days.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Influenza virus test
Clinical narrative: Patient had systemic reactions to the vaccine. Patient suffer from flu like symptoms. She had fever, chills, headaches, muscle aches, nausea and diarrhea.
Age: 69.0
Sex: F
Vaccine: HEPAB
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Patient had systemic reactions to the vaccine. Patient suffer from flu like symptoms. She had fever, chills, headaches, muscle aches, nausea and diarrhea.
Age: 1.3
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: I reviewed patient's child profiled and noticed after shot was given that patient was not due until 10/2016 for the vaccine since she had the first dose in April and second dose was on Oct 2016. Second dose was given too soon.
Age: 15.0
Sex: M
Vaccine: HPV9
Symptoms: Eyelid ptosis, Visual acuity reduced
Clinical narrative: Pt. stated (L) eye vision problems after receiving vaccine. Vaccine adm. approximately 935am. Pt returned to office approximately 11am. Pt was assessed both eyes responsive to light, could read fingers in front and peripheral. Pt has (L) eye drooping and focuses to (L). Mom reports child has glasses to correct his vision and droopy eye, but he will not wear his glasses. Mom reports pt is "slow and not all there". Reports pt ran into door this morning because of poor vision. BP 103/63, HR-74 R-16.
Age: 17.0
Sex: U
Vaccine: MNQ
Symptoms: Product reconstitution issue
Clinical narrative: Pt was given the diluent only, was not mixed with component.
Age: 0.5
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: A 6 month old patient was given PPV23 dose #3 instead of PCV13. Age of patient at time of event: 6 months. Type of event: wrong vaccine. Contributing Factors: Similar vaccine abbreviations.
Age: 1.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Extra dose administered, Product name confusion, Product packaging confusion
Clinical narrative: Grabbed the MMRV rather than the MMR alone. Gave the MMRV and Varicella. Age of patient at time of event: 12 months. Type of Event: Wrong vaccine. Contributing Factors: Similar brand names; Similar generic names; Similar vaccine abbreviations; Similar vaccine container labels/packaging; Products stored near one another; Not familiar with products.
Age: 6.0
Sex: U
Vaccine: HPV9
Symptoms: Wrong drug administered
Clinical narrative: 6 year old patient was supposed to receive Hep A. HPV syringe was being prepared simultaneously for another patient and HPV was given instead of Hep A.
Age: 20.0
Sex: U
Vaccine: DTAP
Symptoms: Underdose
Clinical narrative: On July 25, 2016 the patient was seen in the office for a routine physical for college. His vaccines needed to be updated for his school, specifically for DTaP. The vaccine was drawn and given to the patient. It wasn't until the following day that it was discovered that he was given the pediatric DTaP as opposed to getting the adult booster. An attempt was made to call the patient and a message was left. The patient returned the call on July 28th, three days later. He was informed of the vaccine error and informed that he was in no physical danger. He was further informed not to get any DTaP boosters for the next ten years - to inform anyone wanting to give him a booster of the fact he got a pediatric dose. Patient said he understood and would follow instructions.
Age: 62.0
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient given Zoster vaccine 11/23/15. Patient received an extra dose of Zoster vaccine 8/2/16.
Age: 18.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong drug administered
Clinical narrative: 18 year old patient received PROQUAD as her first dose instead of receiving MMR and VZV separately.
Age: 5.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: Patient given expired dose. Patient called, returned to clinic, and immunized with non expired vaccine. Age of patient at time of event: 5 years 5 months 29 days.
Age: 72.0
Sex: U
Vaccine: PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: An adult patient was given the pediatric dose of the PCV-13.
Age: 3.0
Sex: U
Vaccine: DTAPIPV
Symptoms: Wrong drug administered
Clinical narrative: Order was for INFANRIX. KINRIX was given to pt. instead. Age of patient at time of event: 3 years.