chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Difficulty in range of motion and severe soreness in R arm after getting PNEUMOVAX 23 yesterday. Deltoid area swollen, red last night. Hot to touch. Advised pt this can sometimes occur with the vaccine. Advise icing the area to reduce inflammation. Ibuprofen as needed for pain. If it doesn't continue to get better, please have pt contact us and schedule an appt to be seen.
Age: 34.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Product administered at inappropriate site
Clinical narrative: Vaccines administered too close together - Rx includes mild swelling, redness, and tenderness in L deltoid.
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Back pain, Erythema, Local reaction, Pain in extremity, Pyrexia
Clinical narrative: Fever tmax 102.8 x 1 day. Local reaction to pneumococcal vaccine, local reaction to influenza redness swelling pain to left arm and back.
Age: 8.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Swelling
Clinical narrative: Fever tmax 102.8 x 1 day. Local reaction to pneumococcal vaccine, local reaction to influenza redness swelling pain to left arm and back.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: PT HAD SWELLING AND LIGHT REDNESS WITH SWELLING ON THE ARM. PT STATED THAT SHE TOOK TYLENOL AND MOTRIN TO HELP WITH THE PAIN BUT WAS STILL IN PAIN. WE CALLED HER PRIMARY DR AND DISCUSSED THE SITUATION WITH THEM. DR OFFICE SAID THAT WHAT WE TOLD HER IS WHAT THEY WOULD HAVE TOLD HER AND SHE SHOULD CONTINUE USING TYLENOL OR MOTRIN FOR PAIN AND ALSO SHOULD USE COLD PACK. IF SHE IS STILL CONCERNED ABOUT THE SAME THEN SHE COULD GO AND GET CHECKED BY THE DR. CALLED AND TOLD THE PT THE SAME AND SHE WAS OK WITH IT.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fatigue, severe headache, fever, aches; took ibuprofen which helped reduce fever but only dulled the severe headaches; lasted 12-14 hours; headache continued but lessened during next 6 hours.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site swelling, Rash
Clinical narrative: 1st shot, no reaction. Second shot, swelling and rash around shot site for about 2-3 weeks, fatigue, and about a month out, rash around abdomen that comes and goes. Still getting rashes intermittently.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Feeling abnormal, Muscular weakness, Vaccination site discomfort
Clinical narrative: Severe chills for several hours during the night; 3 degree temperature in the morning; soreness that spread from waist to feet over the course of several hours; discomfort at site of vaccine; weakness in arm where vaccine was administered; felt terrible for about 24 hours.
Age: 62.0
Sex: M
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 83.0
Sex: F
Vaccine: HEPA
Symptoms: Abdominal pain, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: PATIENT STATED SHE EXPERIENCED NAUSEA/VOMITING ALONG WITH PAIN IN ABDOMEN AND THROUGHOUT HER BODY. SHE ALSO STATED SHE EXPERIENCED A LOW GRADE FEVER OF ABOUT 99 DEGREE F.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Fall, Loss of consciousness, Scratch
Clinical narrative: This spontaneous report was received from a physician via company representative, referring to a 15 year old female patient. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were unknown by the reporter. On an unknown date, the patient was vaccinated with the first dose of regimen of GARDASIL 9 intramuscularly, for prevent human papilloma virus (HPV) (strength, dose, frequency, lot#, expiration date were not reported). In November 2018 (reported as "about two months ago"), the patient became unconscious and fell (loss of consciousness) after received a shot of GARDASIL 9. The physician reported that the patient was wearing glasses and the glasses broke and the patient received a scratch above her nose (scratch). The Physician also reported that on an unknown date, the patient was taken to an unspecified emergency room for treatment; it was unknown if diagnostic laboratories were performed. The Physician also reported that on an unknown date, they did follow up with the patient and the patient was fine, reported as recovered. The causality assessment was not provided. Upon internal review, loss of consciousness was determined to be a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was reported regarding concomitant medications, medical history of concurrent conditions. On 28-JAN-2019, the patient was vaccinated with an expired PROQUAD recombinant Human Albumin, lot # N020010 with expiration date on 13-JAN-2019 for prophylaxis (dose and route of administration were not reported).
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Bedridden, Chills, Cough, Decreased appetite, Dehydration
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid serious case received from a Health Care Professional. This case involves a 55 years old female patient who experienced the patient tested positive for influenza A and there was a significant disruption of normal activity, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot LVJ005AF via intramuscular route in the left arm. On 11-Jan-2019, The patient developed a serious cough and sore throat 2 months 27 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On 12-Jan-2019, the patient developed a serious lethargy, fever of 103F, chills and rigor 2 months 28 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious anorexia, dehydration, laryngitis and nausea (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious the patient tested positive for influenza A (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On an unknown date, the patient developed a serious there was a significant disruption of normal activity (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. This was the case of lack of efficacy. The patient reported that she was bedridden for one week. Other relevant tests included the patient tested positive for influenza A on 14-Jan-2019. Final diagnosis was there was a significant disruption of normal activity and the patient tested positive for influenza A. The patient was treated with TAMIFLU for five days and was prescribed fluids. The patient was recovering at the time of report. List of document held: none. Sender's Comments: This case concerns an adult patient who presented with Influenza A infection after and despite vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, smoking history, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza, Influenza A virus test positive, Laryngitis, Lethargy, Loss of personal independence in daily activities
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid serious case received from a Health Care Professional. This case involves a 55 years old female patient who experienced the patient tested positive for influenza A and there was a significant disruption of normal activity, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot LVJ005AF via intramuscular route in the left arm. On 11-Jan-2019, The patient developed a serious cough and sore throat 2 months 27 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On 12-Jan-2019, the patient developed a serious lethargy, fever of 103F, chills and rigor 2 months 28 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious anorexia, dehydration, laryngitis and nausea (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious the patient tested positive for influenza A (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On an unknown date, the patient developed a serious there was a significant disruption of normal activity (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. This was the case of lack of efficacy. The patient reported that she was bedridden for one week. Other relevant tests included the patient tested positive for influenza A on 14-Jan-2019. Final diagnosis was there was a significant disruption of normal activity and the patient tested positive for influenza A. The patient was treated with TAMIFLU for five days and was prescribed fluids. The patient was recovering at the time of report. List of document held: none. Sender's Comments: This case concerns an adult patient who presented with Influenza A infection after and despite vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, smoking history, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal pain, Pyrexia, Vaccination failure
Clinical narrative: Initial information received on 21-Jan-2019 regarding an unsolicited valid serious case received from a Health Care Professional. This case involves a 55 years old female patient who experienced the patient tested positive for influenza A and there was a significant disruption of normal activity, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 15-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot LVJ005AF via intramuscular route in the left arm. On 11-Jan-2019, The patient developed a serious cough and sore throat 2 months 27 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On 12-Jan-2019, the patient developed a serious lethargy, fever of 103F, chills and rigor 2 months 28 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious anorexia, dehydration, laryngitis and nausea (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. These events were leading to disability. On an unknown date, the patient developed a serious the patient tested positive for influenza A (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. On an unknown date, the patient developed a serious there was a significant disruption of normal activity (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was leading to disability. This was the case of lack of efficacy. The patient reported that she was bedridden for one week. Other relevant tests included the patient tested positive for influenza A on 14-Jan-2019. Final diagnosis was there was a significant disruption of normal activity and the patient tested positive for influenza A. The patient was treated with TAMIFLU for five days and was prescribed fluids. The patient was recovering at the time of report. List of document held: none. Sender's Comments: This case concerns an adult patient who presented with Influenza A infection after and despite vaccination with FLUZONE QUADRIVALENT. The time to onset is compatible. However, there is no information regarding patient's condition at time of vaccination, immune status, smoking history, congenital predisposition to respiratory tract infections. Based upon the reported information, the role of the vaccine and a case of vaccination failure cannot be assessed.
Sex: F
Vaccine: FLUX
Symptoms: Immediate post-injection reaction, Rash
Clinical narrative: Initial information received on 22-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (patient). This case involves female patient of 88 years old (age at the time of report) who experienced it was done as a local rash, while she received vaccine INFLUENZA VACCINE. The patient's past medical history included Cardiac disorder and Ill-defined disorder (The patient has heart problem and a lot of health problems). The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Lethargy (the patient has been hibernating since December because she is afraid to catch the flu, saying she will die if she gets it and said she will die if she gets it). On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious it was done as a local rash (rash) following the administration of INFLUENZA VACCINE. It was reported that doctor was training someone in the office and she was the first patient this person administered a flu shot to. She lifted the skin up and put the needle into the skin then went to the other side and put in a PNEUMOVAX vaccine. The needles didn't go into the skin very far since the person pinched up the skin and she immediately broke out in a rash after the needle was removed on each injection. The patient did not know the name of the flu shot. The patient mentioned she was 88 years old. No lab data was reported. Final diagnosis was it was done as a local rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as unknown for it was done as a local rash.
Age: 5.0
Sex: M
Vaccine: RAB
Symptoms: Body temperature increased, Eye movement disorder, Rash, Skin warm, Unresponsive to stimuli
Clinical narrative: Child received rabies IgG on 1/18/19 in addition to his first rabies vaccination. He received a second rabies vaccination on 1/21/19. Third vaccination received 1/25/19. He seemed in his usual state of health until the afternoon of 1/27/18 when he felt warm. At a approximately 1600 hrs. the patient had a 45-90  second no-responsive episode, associated with eye deviation and loss of bladder control. No tonic-clonic activity; no post ictal  behavior. He received ibuprofen then and temp 45 minutes later was 102. No other illness symptoms then or when seen in the office 1/28/19. Exam then noted no mental status change and no focus of infection, other than a mild lacy rash on the extremities and trunk. No facial rash noted at any time. 1/29/19 - afebrile and at baseline.
Age: 5.0
Sex: M
Vaccine: RAB
Symptoms: Urinary incontinence, Urine analysis normal
Clinical narrative: Child received rabies IgG on 1/18/19 in addition to his first rabies vaccination. He received a second rabies vaccination on 1/21/19. Third vaccination received 1/25/19. He seemed in his usual state of health until the afternoon of 1/27/18 when he felt warm. At a approximately 1600 hrs. the patient had a 45-90  second no-responsive episode, associated with eye deviation and loss of bladder control. No tonic-clonic activity; no post ictal  behavior. He received ibuprofen then and temp 45 minutes later was 102. No other illness symptoms then or when seen in the office 1/28/19. Exam then noted no mental status change and no focus of infection, other than a mild lacy rash on the extremities and trunk. No facial rash noted at any time. 1/29/19 - afebrile and at baseline.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain
Clinical narrative: The patient developed a classic shingles rash with burning and pain.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Burning sensation, Headache, Immediate post-injection reaction
Clinical narrative: At the time of the vaccine (immediately after) the patient stated to her mom that her "brain felt like it was on fire". Since the time of the vaccine, she has had chronic headaches. Her mom stated she had never had frequent headaches before and that it is unlike her to complain about pain of any kind.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal pain
Clinical narrative: The patient and Technician administering the vaccine notices it was hard to inject the vaccine into the deltoid. There was more than normal resistance in the elderly mans small deltoid. Almost one month later the patient is still complaining of pain in his shoulder. He mentioned that his physical therapist suggested that he may have recieved the vaccine in a tendon instead of a muscle. He is considering having a steriod shot in the area to help alleviate the pain.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dry mouth, Oral mucosal exfoliation, Oral pain, Swollen tongue
Clinical narrative: Patient experienced adrs relating to mouth pain, sloughing of skin in mouth, dryness in mouth as well as swelling of tongue.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: The patient has a little score in the arm and still feel itchy after almost a month of the injection.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Fatigue, nausea, chills.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Intense muscle pain to the point where she cannot move her arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Limb mass, Pain in extremity
Clinical narrative: Arm pain/lump, flu like symptoms for 2 days.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: C-reactive protein, Chest pain, Dyspnoea exertional, Echocardiogram normal, Exercise tolerance decreased
Clinical narrative: Patient admitted to the hospital with chest pain. Developed viral respiratory infection following vaccine administration that started to improve 3 weeks after vaccination. Then developed chest pain and dyspnea with exertion, deep breathing, sitting up, and laying on his stomach with certain movements. Due to pain, he is unable to maintain previous fitness standards. Patient was admitted to hospital and diagnosed with myopericarditis. He was treated with colchicine and ibuprofen.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Myocarditis, Pain, Painful respiration, Red blood cell sedimentation rate, Respiratory tract infection viral
Clinical narrative: Patient admitted to the hospital with chest pain. Developed viral respiratory infection following vaccine administration that started to improve 3 weeks after vaccination. Then developed chest pain and dyspnea with exertion, deep breathing, sitting up, and laying on his stomach with certain movements. Due to pain, he is unable to maintain previous fitness standards. Patient was admitted to hospital and diagnosed with myopericarditis. He was treated with colchicine and ibuprofen.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Troponin normal
Clinical narrative: Patient admitted to the hospital with chest pain. Developed viral respiratory infection following vaccine administration that started to improve 3 weeks after vaccination. Then developed chest pain and dyspnea with exertion, deep breathing, sitting up, and laying on his stomach with certain movements. Due to pain, he is unable to maintain previous fitness standards. Patient was admitted to hospital and diagnosed with myopericarditis. He was treated with colchicine and ibuprofen.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: VERY SORE ARM 12 HOURS AFTER SHOT: CHILLS AND FEVER OF 99.1; SENSITIVE SKIN RASH; ACHY JOINTS; TIRED.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: VERY SORE ARM 12 HOURS AFTER SHOT: CHILLS AND FEVER OF 99.1; SENSITIVE SKIN RASH; ACHY JOINTS; TIRED.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Headache, Nausea, Pain in extremity
Clinical narrative: Severe headache, nausea, leg aches, diarrhea, weakness - all intermittent in severity, persisting 72 hours at time of this writing.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy, Dysgraphia, Full blood count, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Bladder weakness noticed a week later, brought it up at her wellness visit beginning of October. The pediatrician wasn't sure if it was behavioral or maybe wasn't emptying bladder completely. She thought it most likely wasn't residual weakness from previous GBS because she had been fine the past year and a half. Parents noticed hand weakness and cramping in November. Parents noticed increase hand weakness and decline, requested OT referral from pediatrician. Over Christmas break, parents noticed leg weakness and this continued into January. Scheduled follow-up with neurologist at first available appointment. **Asked daughter if she started having trouble with her hands in school in October, she said yes. (We know it was October because her teacher quit first week of November and we used this as a reference. We asked her if her hands hurt or she was having trouble in writing when he was still her teacher or after he left which she responded when he was her teacher still). She was admitted the day of her neurology appointment for tests and treatment. She was given 4 days of IVIG treatment and officially diagnosed with CIDP.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle spasms, Muscular weakness, Nerve conduction studies, Nuclear magnetic resonance imaging spinal, Pain in extremity
Clinical narrative: Bladder weakness noticed a week later, brought it up at her wellness visit beginning of October. The pediatrician wasn't sure if it was behavioral or maybe wasn't emptying bladder completely. She thought it most likely wasn't residual weakness from previous GBS because she had been fine the past year and a half. Parents noticed hand weakness and cramping in November. Parents noticed increase hand weakness and decline, requested OT referral from pediatrician. Over Christmas break, parents noticed leg weakness and this continued into January. Scheduled follow-up with neurologist at first available appointment. **Asked daughter if she started having trouble with her hands in school in October, she said yes. (We know it was October because her teacher quit first week of November and we used this as a reference. We asked her if her hands hurt or she was having trouble in writing when he was still her teacher or after he left which she responded when he was her teacher still). She was admitted the day of her neurology appointment for tests and treatment. She was given 4 days of IVIG treatment and officially diagnosed with CIDP.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Urinary incontinence
Clinical narrative: Bladder weakness noticed a week later, brought it up at her wellness visit beginning of October. The pediatrician wasn't sure if it was behavioral or maybe wasn't emptying bladder completely. She thought it most likely wasn't residual weakness from previous GBS because she had been fine the past year and a half. Parents noticed hand weakness and cramping in November. Parents noticed increase hand weakness and decline, requested OT referral from pediatrician. Over Christmas break, parents noticed leg weakness and this continued into January. Scheduled follow-up with neurologist at first available appointment. **Asked daughter if she started having trouble with her hands in school in October, she said yes. (We know it was October because her teacher quit first week of November and we used this as a reference. We asked her if her hands hurt or she was having trouble in writing when he was still her teacher or after he left which she responded when he was her teacher still). She was admitted the day of her neurology appointment for tests and treatment. She was given 4 days of IVIG treatment and officially diagnosed with CIDP.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Electrocardiogram normal, Hypoaesthesia, Hypovitaminosis, Malaise
Clinical narrative: Patient reported being very sick for 1 week after 1st dose. The day of 2nd dose patient had numbness under right arm prior to dose, numbness has progressively gotten worse since 2nd dose. Numbness has spread to middle of chest, across right side, and down to upper right hip. Patient is unsure if symptoms are related to vaccine, but requested the event to be reported. Experiences tightness and sharp pain occasionally in the numb areas. Patient saw an urgent care facility about symptoms, which ordered an EKG to evaluate possibility of heart attack. Negative results. Patients primary care doctor did blood work and found some vitamin deficiencies.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Skin tightness
Clinical narrative: Patient reported being very sick for 1 week after 1st dose. The day of 2nd dose patient had numbness under right arm prior to dose, numbness has progressively gotten worse since 2nd dose. Numbness has spread to middle of chest, across right side, and down to upper right hip. Patient is unsure if symptoms are related to vaccine, but requested the event to be reported. Experiences tightness and sharp pain occasionally in the numb areas. Patient saw an urgent care facility about symptoms, which ordered an EKG to evaluate possibility of heart attack. Negative results. Patients primary care doctor did blood work and found some vitamin deficiencies.
Age: 14.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Brief syncope episode immediately after vaccination. No injury.
Age: 0.25
Sex: F
Vaccine: DTAP, IPV
Symptoms: Erythema, Skin warm
Clinical narrative: Day after shots patient started with flushed bright red cheeks. She does not have a fever. They come and go, sometimes just one cheek sometimes both. When red, they are hot to the touch. This has been going on for a week now.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Muscle spasms, Pain
Clinical narrative: Sharp pain as soon as needle was injected, high upon right arm. Was told I had a muscle spasm, when I thought she hit a nerve. She said arm would be sore for several days. I had severe pain, loss of motion that is still causing issues today. Saw a family doctor in October 2018. Doctor gave me muscle relaxer and some range of motion exercises. Continued to have severe pain when moving my arm Could not take off shirt alone, could not raise arm high at all and any moving of my arm caused sharp pain. Saw doctor again in November and started Physical therapy in December. Range of motion did get better and pain was/is not as bad now but I still have some pain and range of motion is still limited.
Age: 51.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain in extremity, X-ray limb
Clinical narrative: Sharp pain as soon as needle was injected, high upon right arm. Was told I had a muscle spasm, when I thought she hit a nerve. She said arm would be sore for several days. I had severe pain, loss of motion that is still causing issues today. Saw a family doctor in October 2018. Doctor gave me muscle relaxer and some range of motion exercises. Continued to have severe pain when moving my arm Could not take off shirt alone, could not raise arm high at all and any moving of my arm caused sharp pain. Saw doctor again in November and started Physical therapy in December. Range of motion did get better and pain was/is not as bad now but I still have some pain and range of motion is still limited.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness
Clinical narrative: Pt reported feeling dizzy and chest pain about 15 minutes after administration. Pt showed no external symptoms (change in color, sweating, etc). Upon report of chest pain, emergency services were contacted.
Age: 45.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site swelling, Pain
Clinical narrative: 24  hours after injection was given, his left arm, where TDaP injection was given, is painful to move and swelling around injection site with pain worsening. No signs and symptoms were present the day of injection.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pain in (L) shoulder, weakness and limited range of motion to (L) shoulder has been present since receiving vaccine in October 2018.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Decreased appetite, Fatigue, Full blood count, Hallucination, Lethargy
Clinical narrative: Hallucinations, lethargy, fatigue, paleness, loss of appetite.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Metabolic function test, Pallor, Red blood cell sedimentation rate
Clinical narrative: Hallucinations, lethargy, fatigue, paleness, loss of appetite.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Diarrhoea, Headache, Injection site erythema, Injection site pain
Clinical narrative: Red, pain and warm at site of injection. Feel weak, cold on her feet -> took TYLENOL -> helped. Headache. Diarrhea -> took IMMODIUM -> helped.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Peripheral coldness
Clinical narrative: Red, pain and warm at site of injection. Feel weak, cold on her feet -> took TYLENOL -> helped. Headache. Diarrhea -> took IMMODIUM -> helped.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Pyrexia
Clinical narrative: Localized area of redness, induration and tenderness (5-6 cm in diameter) at site of MMRV in (R) thigh. Otherwise well - no other rash, fever - developed 24 hours after injection and unchanged at 48 hours.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Spoiled vaccine administered to patient after being labeled do not use/administer due to not receiving vaccine within shipping/receiving period.
Age: 5.0
Sex: U
Vaccine: FLUN4
Symptoms: Extra dose administered
Clinical narrative: Patient received an extra dose of the flu vaccine.
Age: 2.8
Sex: U
Vaccine: FLUC4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Gave 2 year 8mos old flu vaccine IM Lt thigh. Our previous vaccine was 6 months and up. This vaccine was for age 4years and up.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: MMR immunization was ordered along with a Varicella immunization. However, a VARIVAX and a PROQUAD was given instead.
Age: 32.0
Sex: U
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Member received wrong vaccine due to missing question in 6 rights of administration. Patient came in for 'I'd during a flu clinic where all other patients were given the flu vaccine. Tech did not verify "right vaccine."
Age: 1.66
Sex: U
Vaccine: HEPA, HIBV
Symptoms: Wrong product administered
Clinical narrative: During vaccination the MA pulled HIB instead of Hep A and administered vaccine.
Age: 36.0
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong product administered
Clinical narrative: While working in Incident Command for Hepatitis A outbreak, often nurses are recruited from different clinical areas to assist with vaccination efforts. As a result, expert knowledge of vaccine brands/components is not always guaranteed. At two separate clinics, one on 11/7/2018 and one on 12/5/2018, a nurse had been told (incorrectly) that VAQTA would be an option for latex-free vaccine, when the single dose, latex-free vials of HAVRIX ran out. 3 total patients with known latex allergies received VAQTA, believing it to not be made with latex. None of the patients had a reaction. One of the immunization nurses in the department caught the error. I worked with immunizations and the nurses in Incident Command to add vaccine lists to their outreach kits that included vaccine name, vaccine components and whether latex-free or not. This information will be added to training for nurses assisting Incident Command. Additionally, we chose to add bright stickers next to the "made without latex" statement on the packaging as a double check for all nurses. We feel that the "made without latex" statement is small and does not stand out, and it would be helpful to have it more prominently displayed on the packaging.
Age: 1.8
Sex: U
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: My 20 month old recently received the Tdap instead of the DTaP. We had to reschedule due inability to have doctors order for it the first visit. Then on the revisit they ended up going the wrong vaccination.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: MMR and VZV were ordered for child. Patient was given PROQUAD combo to a 13 y/o child.
Age: 0.5
Sex: U
Vaccine: HIBV
Symptoms: Product prescribing error
Clinical narrative: Wrong vaccine ordered on chart and given. Physician notified parents and correct vaccine administered.
Age: 11.0
Sex: U
Vaccine: HPV9
Symptoms: Product administered at inappropriate site
Clinical narrative: 11 year old pt came into office at urgent care and received GARDASIL 9 vaccine IM in buttocks. Wrong administration site (e.g. gluteus maximus rather than the deltoid).
Age: 18.0
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient, who is 18 y.o.a. was given an adult dose of Hepatitis B when pediatric dose is indicated until 19 y.o.a. No adverse reactions or side effects were noted. Incident was reported to facility as well.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Incorrect route of product administration
Clinical narrative: Began to give the vaccine nasally then realized error and stopped. A new vaccine was opened and administered orally.
Age: 2.3
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Wrong product administered
Clinical narrative: Patient was given KINRIX rather than Dtap, staff member did not pay attention and grab KINRIX administrated the vaccine and did not report to supervisor.
Age: 72.0
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Pharmacist failed to mix adjuvant with antigen. Adjuvant component alone injected.
Age: 2.0
Sex: U
Vaccine: IPV
Symptoms: Wrong product administered
Clinical narrative: 0.5 mL of IPV was drawn up and injected into the pt. instead of PCV 13.
Age: 19.0
Sex: U
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Got PCV13 instead of HPV vaccine.
Age: 3.0
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: I, MA looked over immunization record to determine what vaccines needed to be administered to 3 year old patient. I checked multiple times for the age and thought age was 4 years of age. I then thought PEDIARIX was what needed to be administered. I administered PEDIARIX instead of the KINRIX. Patient was not of age to receive any of those doses. Next dose should have been KINRIX at age 4 years.
Age: 0.33
Sex: U
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Medical assistant administered expired ROTARIX vaccine to a child. Medication expired on 10/26/2018 and was administered on 11/27/2018.
Age: 0.17
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Nurse gave Tdap instead of PENTACEL. Parent was requesting the shots be given as individual shots and nurse mistakenly gave the wrong shot.
Age: 2.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong product administered
Clinical narrative: Nurse gave TDaP instead of PENTACEL.
Age: 56.0
Sex: U
Vaccine: TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Majority or all of vaccine volume exited between the needle and syringe and did not make it to the patient. Device failure likely due to typhoid syringe geometry.
Age: 0.58
Sex: U
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Hepatitis A vaccine was inadvertently ordered on a 7 month old instead of Hepatitis B. The error was not caught by nursing the the vaccine was administered.
Age: 0.75
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: PEDIARIX ordered, PENTACEL given.
Age: 1.0
Sex: U
Vaccine: VARZOS
Symptoms: Wrong product administered
Clinical narrative: VARIVAX ordered, ZOSTAVAX GIVEN.
Age: 62.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric VAQTA given to 62 y/o.
Age: 29.0
Sex: U
Vaccine: HEPA
Symptoms: Underdose
Clinical narrative: Pediatric dose of VAQTA given to 29 y/o.
Age: 55.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: 2nd flu shot given in same flu season to 5 y/o.
Age: 3.0
Sex: U
Vaccine: HEPA
Symptoms: Wrong patient received product
Clinical narrative: Patient received Hep A vaccine in error. Mom placed wrong child on table.
Age: 1.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Intercepted product prescribing error
Clinical narrative: DAPTACEL ordered incorrectly, patient needed PENTACEL RN caught order error and spoke with physician. Correct vaccine given.
Age: 1.33
Sex: U
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Patient was given an IM shot of DTap (4th dose too early). No symptoms at time of vaccine administration. Was seen an hour after vaccine was given and remained asymptomatic.
Age: 87.0
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient came to the window and there was a communication barrier. They claimed they needed a flu vaccine and presented a paper for the flu. We gave him the form to fill out and he returned. When we did pre-vaccine counseling he said he needed the flu vaccine. We administered the vaccine and he started discussing the pneumonia vaccine. When we checked his profile we searched by name and found he had 2 profiles with 2 different date of births and he had a flu vaccine at the beginning of the month.
Age: 0.75
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Wrong product administered
Clinical narrative: Provider wrote down the vaccine for the MA to give. The provider wrote the wrong shot to be given.
Age: 15.0
Sex: U
Vaccine: HPV9, MENB
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient came in to clinic for Nurse visit for 2nd dose of BEXSERO, I gave HPV GARDASIL 9 also. Patient already has 3 doses of HPV. Notified Dr. of incident and advised patient another dose of HPV does not have harmful effects. Patient was informed of vaccine error. BEXSERO was the only vaccine initially that was only suppose to be given. HPV GARDASIL 9 is the extra dose). No adverse reaction 15 min after injection.
Age: 18.0
Sex: U
Vaccine: MMR, MMRV
Symptoms: Product appearance confusion
Clinical narrative: While being trained, someone grabbed the wrong vaccine to prepare for a patient. I noticed they grabbed the wrong thing because I work in immunizations frequently and know where everything is by placement. The trainee, didn't realize they grabbed the wrong thing and still didn't notice after I informed them. I brought the box in closer to them to show them the fine print of where one says Varicella and the other does not. I never thought it was an issue until they made me realize how easily the two can be confused, even through they are on different shelves.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given first dose of rota vaccine inadvertently at 6 months if age.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Paralysis
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of paralysis legs in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ms (Multiple sclerosis) and allergy to animal. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th January 2019, 1 days after receiving SHINGRIX, the patient experienced paralysis legs (serious criteria GSK medically significant), fever and urinary incontinence. On 17th January 2019, the outcome of the paralysis legs, fever and urinary incontinence were recovered/resolved. It was unknown if the reporter considered the paralysis legs, fever and urinary incontinence to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving multiple sclerosis medication concomitantly. On 15th January 2015, the patient received SHINGRIX late in the day in left deltoid. The patient stated that she was allergic to animal products and thought that the reaction to SHINGRIX occurred because the antigen was grown in hamster ovary cells. The patient had a fever of 101.4 degree F and her legs were paralyzed and felt like spaghetti. The patient also experienced urinary incontinence. This lasted for about 10 hours. By 17th January 2019, all symptoms were resolved. The reporter was not sure about providing physician's information. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diplegia, Pyrexia, Urinary incontinence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of paralysis legs in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ms (Multiple sclerosis) and allergy to animal. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th January 2019, 1 days after receiving SHINGRIX, the patient experienced paralysis legs (serious criteria GSK medically significant), fever and urinary incontinence. On 17th January 2019, the outcome of the paralysis legs, fever and urinary incontinence were recovered/resolved. It was unknown if the reporter considered the paralysis legs, fever and urinary incontinence to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving multiple sclerosis medication concomitantly. On 15th January 2015, the patient received SHINGRIX late in the day in left deltoid. The patient stated that she was allergic to animal products and thought that the reaction to SHINGRIX occurred because the antigen was grown in hamster ovary cells. The patient had a fever of 101.4 degree F and her legs were paralyzed and felt like spaghetti. The patient also experienced urinary incontinence. This lasted for about 10 hours. By 17th January 2019, all symptoms were resolved. The reporter was not sure about providing physician's information. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diplegia, Incontinence, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of paralysis legs in a 63-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included ms (Multiple sclerosis) and allergy to animal. On 15th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 16th January 2019, 1 days after receiving SHINGRIX, the patient experienced paralysis legs (serious criteria GSK medically significant), fever and urinary incontinence. On 17th January 2019, the outcome of the paralysis legs, fever and urinary incontinence were recovered/resolved. It was unknown if the reporter considered the paralysis legs, fever and urinary incontinence to be related to SHINGRIX. Additional details were provided as follows: The patient was receiving multiple sclerosis medication concomitantly. On 15th January 2015, the patient received SHINGRIX late in the day in left deltoid. The patient stated that she was allergic to animal products and thought that the reaction to SHINGRIX occurred because the antigen was grown in hamster ovary cells. The patient had a fever of 101.4 degree F and her legs were paralyzed and felt like spaghetti. The patient also experienced urinary incontinence. This lasted for about 10 hours. By 17th January 2019, all symptoms were resolved. The reporter was not sure about providing physician's information. The reporter consented to follow up.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The pertinent medical history of the patient was not reported. On 17-OCT-2018, the patient was administered with VARIVAX (lot # R002509, expiration data is 25-JAN-2020)(Dose and frequency are unspecified) subcutaneously for prophylaxis. The unspecified doses of VARIVAX were improperly stored with a temperature of 28 Fahrenheit (F) and storage time less than 1 hour. The temperature excursion occurred as a result of a reading from a digital data logger. There was no occurrence for previous temperature excursion. The concomitant therapy sterile diluent(STERILE DILUENT)(lot#M015992, expiration date is 26-NOV-2018) was not reported to be improperly stored by the reporter. No adverse effects were reported. The outcome of events was unknown. This Is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA001564: US-009507513-1901USA001565:
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Information about the patient's concomitant medication, pertinent medical history and drug reactions was not provided. On 31-DEC-2018, the patient was administered a dose of ZOSTAVAX (19400 PFU, lot # N026817 and expiration date 25-DEC-2018; frequency was unknown) with sterile diluent subcutaneously for prophylaxis (expired product administered). No adverse effects were reported.