chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Overdose
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a non-Health care professional (Office staff). This case involves a 22 months old male patient received vaccine FLUZONE via intramuscular route in left thigh on 27 Sep 2018. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to overdose. It was reported that FLUZONE QUADRIVALENT vaccine was administered 0.5mL to a 22-month old patient yesterday. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old male patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, concomitant medication and family history were not provided. On 26-Sep-2018, the patient received a 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI983AA, expiry date 30 Jun 2019 via unknown route in the left deltoid. It was an actual medication error due to vaccine underdose. It was reported that 3-year-old who received 0.25 mL dose of FLUZONE QUAD instead of 0.5 mL dose. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 52 years old patient (gender unknown) who received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5937LA, expiry date 30 Jun 2018 via intramuscular route in the left deltoid. It was an actual medication error due to  Expired vaccine used. It was reported that expired dose of FLUZONE QUADRIVALENT was given to one of their employees. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: MNQ, TDAP
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA274230, 2018SA274229 and 2018SA274203 from same reporter. This case involves Adolescent male patient (age unknown) who received vaccines ADACEL and MENACTRA. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect MENACTRA lot number, expiry date not reported via unknown route in unknown administration site. On an unknown date, the patient received injection of suspect ADACEL lot number, expiry date not reported via unknown route in unknown administration site. It was an actual medication error due to incorrect product. It was reported that from 30 Jul 2018 to 03 Aug 2018, patient received doses of vaccines stored outside the recommended range. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling, Pruritus, Throat irritation
Clinical narrative: Employee received flu shot and developed facial and throat itching and swelling around the eyes within 15 minutes of receiving vaccine. Employee took BENADRYL and ZANTAC when symptoms started but was still having itching and swelling. Employee reports symptoms worsened about one hour later and she presented to the ED. Employee was given oral steroid in the ED. Symptoms improving.
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Asthenia, Paraesthesia
Clinical narrative: Patient complained of tingling sensation in bilateral wrist/hands with increase in symptoms of weakness 24 hours later. Also, began to have tingling in face and bilateral  feet. Patient was evaluated and transported to ED for further workup and consult with neurology.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea
Clinical narrative: Diarrhea started approximately around 4:30pm and continued throughout the night. 10/06/18 started the day with no diarrhea but nausea that lasted until about 11:30pm.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth noted at injection site the day after vaccine given.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Patient started with fever the day after receiving the vaccines. The rash developed 2 days after the vaccines were given. The rash appeared all over the body. Patient did not seem to be bothered by the rash. Patient does not go to daycare. there has been no sickness at home. No medications were given. patient is following up in a week with the provider.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Ear pruritus, Formication, Herpes zoster, Pruritus, Rash
Clinical narrative: Received the Flu vaccine on 9/30/13. Pt has had same doctor since 2013. In May 2018, after vaccination was itching in hair/face. Went to doctor and doctor diagnosed a shingles rash; prescribed antiviral medication for 7 days. The medication did help with the itchiness. Still has feeling of crawling/ itching on head/ears. Went back to doctor and doctor said that symptoms would last about 1-2 years. The itchiness is worst at night time. Symptoms remain the same--have not changed. Pt took Flu vaccine today.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Injection site swelling, Lacrimation increased, Limb mass, Mobility decreased
Clinical narrative: I don't have all the information above about the actual shot. We are required to have a flu Shot due to work in a healthcare facility. I have had a bad reaction to this flu shot. my left arm has had a lump in it for days now. It has swollen much more than normal with pain and swelling around the injection site and up into my neck and shoulder resulting in pain and stiffness in my neck making it difficult to move my neck. The swelling spread up through my arm shoulder and neck in a way that it was noticeable to my husband and coworker that my shoulder and neck were very knotted up and swollen. This is just a much more exaggerated response than I have had to any other shot. I also noticed that my left eye was bothering me as well but that is harder to define just kind of weepy and a little blurry it took me a while to realize that was all connected and started right at the injection site.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal stiffness, Neck pain, Swelling, Vaccination complication, Vision blurred
Clinical narrative: I don't have all the information above about the actual shot. We are required to have a flu Shot due to work in a healthcare facility. I have had a bad reaction to this flu shot. my left arm has had a lump in it for days now. It has swollen much more than normal with pain and swelling around the injection site and up into my neck and shoulder resulting in pain and stiffness in my neck making it difficult to move my neck. The swelling spread up through my arm shoulder and neck in a way that it was noticeable to my husband and coworker that my shoulder and neck were very knotted up and swollen. This is just a much more exaggerated response than I have had to any other shot. I also noticed that my left eye was bothering me as well but that is harder to define just kind of weepy and a little blurry it took me a while to realize that was all connected and started right at the injection site.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: Shivering began about 12 hours after injection. Continued for roughly 2 hours, accompanied by chills. Next morning tired, but no ill effects.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Immediate post-injection reaction, Joint range of motion decreased, Pain, Product administered at inappropriate site
Clinical narrative: Vaccine administered too high near acromion. ROM affected immediately and pain. ROM returned in a daybut still painful and bruised.
Age: 60.0
Sex: F
Vaccine: FLUR4
Symptoms: Wrong technique in product usage process
Clinical narrative: Vaccine administered into bone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Chills, Feeling abnormal, Headache, Immediate post-injection reaction
Clinical narrative: Received shot in left arm--it seemed high as per patient. Patient indicated that it was pulled immediately and hard and she felt pain right away and she did bleed (soaked a cotton ball)--the arm was very sore that evening--raised swollen and hard area. Next morning patient felt chills, shakes, body aches, headache, and a fever (100.9--taken 1.5 hours after taking Acetaminophen 500 mg--1 tablet). Came home after work, still feeling terrible. Called Urgent Care and she was seen. Now are is bruised. She was diagnosed with cellulitis--cephalexin 500 mg TID X 7 D.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site haemorrhage, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Received shot in left arm--it seemed high as per patient. Patient indicated that it was pulled immediately and hard and she felt pain right away and she did bleed (soaked a cotton ball)--the arm was very sore that evening--raised swollen and hard area. Next morning patient felt chills, shakes, body aches, headache, and a fever (100.9--taken 1.5 hours after taking Acetaminophen 500 mg--1 tablet). Came home after work, still feeling terrible. Called Urgent Care and she was seen. Now are is bruised. She was diagnosed with cellulitis--cephalexin 500 mg TID X 7 D.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: Received shot in left arm--it seemed high as per patient. Patient indicated that it was pulled immediately and hard and she felt pain right away and she did bleed (soaked a cotton ball)--the arm was very sore that evening--raised swollen and hard area. Next morning patient felt chills, shakes, body aches, headache, and a fever (100.9--taken 1.5 hours after taking Acetaminophen 500 mg--1 tablet). Came home after work, still feeling terrible. Called Urgent Care and she was seen. Now are is bruised. She was diagnosed with cellulitis--cephalexin 500 mg TID X 7 D.
Age: 85.0
Sex: F
Vaccine: FLUX
Symptoms: Dyspnoea, Foaming at mouth, Pupil fixed, Tongue discolouration
Clinical narrative: Went home and about 35 minutes later started having breathing problems. Patient was grasping for air, tongue turning blue, foaming in the mouth, eyes started getting fixed. Taken to hospital in ambulance and on the way patient kept saying that she was short of breath. She was admitted and still is there in stable condition.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Malaise, Pain, Tachycardia, Vomiting
Clinical narrative: Patient stated several hours after receiving vaccine she felt ill and had symptoms of chills, vomiting, tachycardia and achiness.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Patient has been experiencing stomach pain and diarrhea since a few days after receiving vaccine. Patient has a doctor appointment today to discuss with doctor to determine whether some other issue is occurring.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Anxiety, Blood test, Blood test normal, Cerebral disorder, Delusion
Clinical narrative: Patient began presenting with extreme psychological adverse reactions to the flu shot in November 2017. She has not recovered to date. Her symptoms are cyclical and are not improving. She presented at the height of this reaction with hallucinations, delusions, paranoid thoughts, lethargy, anxiety and depression. She was admitted to the hospital about November 27, 2017 and was discharged with unknown brain condition. She was then recalled to the hospital when doctors suggested she had autoimmune encephalitis. All tests resulted in negative outcomes. It was suggested she had dementia and depression; however doctors cannot agree as to the  correct diagnosis. She is once again in the hospital for indeterminate amount of time at psychiatric unit due to worsening conditions once again. I (daughter) have corresponded with at least two other individuals with similar conditions that appear to be related to flu shot. At least two doctors have expressed concern over flu shot and the timing of when patient's symptoms started coinciding with flu shot.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Dementia, Depression, Hallucination, Lethargy, Lumbar puncture
Clinical narrative: Patient began presenting with extreme psychological adverse reactions to the flu shot in November 2017. She has not recovered to date. Her symptoms are cyclical and are not improving. She presented at the height of this reaction with hallucinations, delusions, paranoid thoughts, lethargy, anxiety and depression. She was admitted to the hospital about November 27, 2017 and was discharged with unknown brain condition. She was then recalled to the hospital when doctors suggested she had autoimmune encephalitis. All tests resulted in negative outcomes. It was suggested she had dementia and depression; however doctors cannot agree as to the  correct diagnosis. She is once again in the hospital for indeterminate amount of time at psychiatric unit due to worsening conditions once again. I (daughter) have corresponded with at least two other individuals with similar conditions that appear to be related to flu shot. At least two doctors have expressed concern over flu shot and the timing of when patient's symptoms started coinciding with flu shot.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Lumbar puncture normal, Mental disorder, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging normal, Paranoia
Clinical narrative: Patient began presenting with extreme psychological adverse reactions to the flu shot in November 2017. She has not recovered to date. Her symptoms are cyclical and are not improving. She presented at the height of this reaction with hallucinations, delusions, paranoid thoughts, lethargy, anxiety and depression. She was admitted to the hospital about November 27, 2017 and was discharged with unknown brain condition. She was then recalled to the hospital when doctors suggested she had autoimmune encephalitis. All tests resulted in negative outcomes. It was suggested she had dementia and depression; however doctors cannot agree as to the  correct diagnosis. She is once again in the hospital for indeterminate amount of time at psychiatric unit due to worsening conditions once again. I (daughter) have corresponded with at least two other individuals with similar conditions that appear to be related to flu shot. At least two doctors have expressed concern over flu shot and the timing of when patient's symptoms started coinciding with flu shot.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Positron emission tomogram, Positron emission tomogram normal
Clinical narrative: Patient began presenting with extreme psychological adverse reactions to the flu shot in November 2017. She has not recovered to date. Her symptoms are cyclical and are not improving. She presented at the height of this reaction with hallucinations, delusions, paranoid thoughts, lethargy, anxiety and depression. She was admitted to the hospital about November 27, 2017 and was discharged with unknown brain condition. She was then recalled to the hospital when doctors suggested she had autoimmune encephalitis. All tests resulted in negative outcomes. It was suggested she had dementia and depression; however doctors cannot agree as to the  correct diagnosis. She is once again in the hospital for indeterminate amount of time at psychiatric unit due to worsening conditions once again. I (daughter) have corresponded with at least two other individuals with similar conditions that appear to be related to flu shot. At least two doctors have expressed concern over flu shot and the timing of when patient's symptoms started coinciding with flu shot.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Swelling, Urticaria
Clinical narrative: Pain. Swelling (over most of upper, outer arm). Redness. What appeared to be hives. Itching.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: As per patient "Noticed an itchy rash on the trunk of my body. Got worse overnight and increased to lower stomach & back."
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of an unknown age and gender. Patient's concurrent conditions, medical history and concomitant therapies were not reported. On 24-SEP-2018, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 for prophylaxis (lot # N001007, expiration date 19-SEP-2018, dosage and route of administration were not reported). No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to 10 patients from 11 to 17 years of age. The patients' medical history was not provided. On 04-SEP-2018 (4 doses), 06-SEP-2018 (1 dose), 07-SEP-2018 (1 dose), 11-SEP-2018 (3 doses) and 12-SEP-2018 (1 dose) the patients were vaccinated with improperly stored doses of VARIVAX lot # N034556, expiration date 05-DEC-2019 for prophylaxis. Sterile diluent (manufacturer unknown) was properly stored. The doses underwent a temperature excursion of 47 to 77 degrees Fahrenheit for 15 hours. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative and refers to a 16-year-old male patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 06-AUG-2016, the patient was vaccinated with GARDASIL lot# M003659 with expiration date on 20-SEP-2017 (dose, route and site of administration were not reported) for prophylaxis. When leaving the office, the patient fainted in the elevator. No treatment was given for the event. The outcome of the was reported as recovered on an unknown date. Causality assessment between the event and GARDASIL was not reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Ophthalmic herpes simplex
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of ophthalmic herpes simplex in a 64-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received the 1st dose of SHINGRIX. On 7th September 2018, 31 days after receiving SHINGRIX, the patient experienced ophthalmic herpes simplex (serious criteria GSK medically significant). On an unknown date, the outcome of the ophthalmic herpes simplex was unknown. It was unknown if the reporter considered the ophthalmic herpes simplex to be related to SHINGRIX.  Additional details were reported as follows: On 7th September 2018, the patient went to her eye physician and was diagnosed with herpes simplex virus (HSV) in the right eye. On 28th September 2018, the reporting physician became aware of her right eye HSV diagnosis. The reporter agreed to be follow up. No additional information was provided.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited non-serious case received from other health professional (physician's assistant). This case is related to case- 2018SA274507, 2018SA274519, 2018SA274520, 2018SA274521, 2018SA274522, 2018SA274523, 2018SA274524, 2018SA274525. This case involves 66 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot number: UI993AB), expiry date 18 Mar 2019 via intramuscular route that were not considered valid due to prolonged shipping and unknown temperatures on 21 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to deteriorated drug administered because of prolonged shipping. It was reported that Vaxserve delivered FLUZONE HD 0.5mL the week of 09 Aug 2018 and it took 3 days to deliver, was told by Vaxserve that doses were viable at that time and temp indicator in shipping container did not show a change in temp, then received call from Vaxserve on 25 Sep 2018 stating that doses were not viable from shipping excursion, doses were given to nine patients. It was not reported whether the patient experienced any adverse event following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. Follow up information received from other health professional (physician's assistant) on 27-Sep-2018. Individual patients were identified. Narrative updated accordingly. List of documents held by sender- none.
Sex: U
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked to case 2018SA272032 and 2018SA271978 (same reporter). This case involves unknown age of 24 patients who received vaccine IPOL (lot N1G511M and N1D451M) via unknown route (expiry date and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that three temperature excursions on 2/14/18, 3/8/18, 4/11/18 of 1-degree C. for approx 14 hours. Vaccines included two open MDV of IPOL, and unopened other products. States that 24 children received IPOL after the temp excursion. It was not reported if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from non-health professional. This case involves 82 years old patient of an unknown gender who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ004AA via intramuscular route in the left deltoid (frequency-once, expiry date not reported) on 25-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to underdose. It was also case of syringe issue. It was reported that RN was giving the vaccine to a patient and liquid leaked out the compartment between the needle and the part of the syringe where the vaccine is and patient received the majority of dose. It was unknown whether the patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves male patient of an unknown age who received vaccine FLUZONE HIGH DOSE lot UJ000AB via unknown route (expiry date, dose and site of administration were unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to underdose. It was also the case of syringe issue. It was reported that when nurse attached the needle to the prefilled syringe there was no leaking but when she went to inject and started pressing, it squirted out from where the hub or leur lock attaches barrel portion of syringe and was leaking down his arm. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Antibody test abnormal
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult female patient who experienced received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants (antibody test abnormal) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. No Lab data was reported. Final diagnosis was received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for received a single flu shot in the past that caused her to develop antibodies that will not let her donate blood to babies/infants. Documents held by the sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Anaphylactic reaction, Hypersensitivity
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves a patient (age and gender not reported) who experienced allergic reaction/ anaphylactic, while he/she received vaccine FLUZONE QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient developed a serious allergic reaction/ anaphylactic (anaphylactic reaction), following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. Relevant tests were not reported. Final diagnosis was allergic reaction/ anaphylactic. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Documents held by the sender: none.; Sender's Comments: Patient developed anaphylaxis after vaccination. Exact time to onset is unknown. Anaphylaxis is listed with the vaccine. Additional information including but not limited to the patient's immunization history (i.e., previous immunizations and any adverse events following immunization), allergic history, previous similar episodes as well as allergy testing to identify the culprit allergen are needed to further assess this case. Based on the information available, a role of the vaccine cannot be assessed.
Age: 12.0
Sex: U
Vaccine: MNQ, TDAP
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 12 years old patient who was vaccinated with the vaccine MENACTRA (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Hypersensitivity
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a Office Staff. This case involves a patient (age and gender not reported), who experienced allergic reaction, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported (expiry date, dose, dose in series, route and site of administration were not reported). On an unknown date, the patient developed a non-serious allergic reaction (hypersensitivity), following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was also a case of actual medication error due to inappropriate age at vaccine administration because patient under 65 years old was vaccinated. No Lab data was reported. Final diagnosis was allergic reaction. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 44 years old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UJ006AA and expiry date: 14-Apr-2019) in the left deltoid (dose in series and route of administration were not reported) on an unknown date. The patient's past medical history included Female sterilization on an unspecified date of 2004. The patient's past medical treatment(s), vaccination(s) and family history were not provided. No concomitant vaccines given. It was a case of actual medication error due to inappropriate age at vaccine administration. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Overdose
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 18 years old patient who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were unknown) on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Inappropriate age at vaccine administration and overdose. It was reported that one of their staff pharmacists injected FLUZONE HD into an 18 years old patient. Caller did not have information to provide regarding the event or the lot number of the vaccine that the patient received. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site discolouration, Injection site rash, Product administered at inappropriate site
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 71 years old female patient who experienced developed a huge brown, purple rash or cellulitis and received FLUZONE HD given in middle of arm. Nurse reported it was not given in the deltoid and was about 3-4 inches below the deltoid, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. It was also a case of an actual medication error due to vaccine administered at inappropriate site as patient received FLUZONE HD given in middle of arm. Nurse reported it was not given in the deltoid and was about 3-4 inches below the deltoid. On 10-Sep-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U19778C, expiry date not provided via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious developed a huge brown, purple rash or cellulitis (vaccination site rash & vaccination site cellulitis) with Unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was developed a huge brown, purple rash or cellulitis. No corrective treatment was received. The patient outcome is reported as Recovering / Resolving for developed a huge brown, purple rash or cellulitis. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial unsolicited report received from a pharmacist on 27-Sep-2018. This case involves a 44-year old female patient who was vaccinated with a dose of 0.5 ml FLUZONE HIGH DOSE on (Batch number: 250785, exp: 30-Apr-2019) via unknown route in the left deltoid) on 25-Sep-2018. The patient's medical history and concomitant medications were not reported. No concomitant vaccines given. It was an actual medication error due to inappropriate age at vaccine administration. It was not reported if any adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: MENB, MNQ
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information regarding an unsolicited pregnancy valid non-serious case received on 27-Sep-2018 from a nurse. This case involves a 16 years old female patient who was exposed to vaccine MENACTRA while she was pregnant. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported pregnant occurred at unknown gestation period. The patient was in her first trimester. The date of last menstrual period was reported as 20-Jul-2018. The estimated due date is 28-Apr-2019. The patient's concomitant medication vaccination included TRUMENBA. The patient had an unknown previous pregnancies. On an unknown date, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5989AA via unknown route in the left deltoid. On an unknown date, the patient received a dose of suspect TRUMENBA not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site. It was a case of Vaccine exposure during pregnancy. Additionally, at time of reporting, the outcome of the pregnancy is unknown. List of documents held by sender: none.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional (office staff). This case involves a 13 months old female patient and reported that ACT-HIB mixed with sterile water given to a patient, while she received vaccines ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 18-Sep-2018, the patient received a 0.5 ml once dose of suspect ACT-HIB (lot number: UI817AAA and expiry date:14-Nov-2018) (dose in series and route was not reported) in the left deltoid. On 18-Sep-2018, the patient received a dose of suspect HEPATITIS A VACCINE produced by unknown manufacturer (lot number, expiry date, dose, dose in series and route of administration was not reported) in the right deltoid. It was a case of actual medication error due to inappropriate reconstitution technique (reported that ACTHIB mixed with Merck sterile water diluent (Lot# N014021, Exp 04-Aug-2019). It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Incorrect route of drug administration
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 65 years old male patient who had vaccine that started out as intramuscular but the patient pulled away and the rest may have been injected subcutaneously, while he received vaccine FLUZONE HD. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Patient did not receive any other injections or concomitant medications. On 27-Sep-2018, the patient received a  0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ023AB, expiry date- 25-Apr-2019 via subcutaneous route in the right arm. It was a case of actual medication error due to inappropriate route of vaccination. It was unknown whether adverse events occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site pruritus, Injection site rash, Mobility decreased
Clinical narrative: Initial information received on 28-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 65 years old female patient who experienced tired and couldn't get out of bed through the weekend, some itching at site and rash at injection site 4 inches wide, flat while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect 0.5 ml INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ000AB via intramuscular route in the left arm. On an unknown date, the patient developed a non-serious tired and couldn't get out of bed through the weekend, some itching at site and rash at injection site 4 inches wide, flat, following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Relevant tests were not reported. Final diagnosis was rash at injection site 4 inches wide, flat, some itching at site and tired and couldn't get out of bed through the weekend. The patient was recommended Hydrocortisone cream as corrective treatment. The outcome of the events was not reported. List of documents held by sender: none.