chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial information received on 14-Nov-2018 regarding an unsolicited valid serious case received from a non-health care professional (Manger of wellness center). This case involves a male patient (age unknown) who developed Gullian- Barre' Syndrome from receiving (flu shot) FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 09-Dec-2016, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI622AC, expiry date 30-jun-2017 via unknown route in unknown administration site. On an unknown date, the patient developed a serious Guillain-Barre syndrome with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. Lab data was not provided. Final diagnosis was diagnosis of Guillain-Barre syndrome. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for diagnosis of Guillain-Barre syndrome. List of documents held by sender- none. Sender's Comments: This case concerns an adult patient who presented with Guillain-Barre syndrome after vaccination with INFLUENZA QUADRIVAL A-B VACCINE. The time to onset is unknown. Moreover, there is no medical confirmation of the events, nor past history, clinical examination reports or lab tests reported that can rule out alternate etiologies. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Patient was given last years formula of flu vaccine. Upon discovery patient was notified and revaccinated with current vaccine per public Health recommendation. 2017-2018 formula was shipped to our store recently from another pharmacy med in with current 2018-2019 formula. This was not caught until after the vaccine was given in a chain of vaccinations.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event. Patient was inadvertently given 2017-2018 formula of AFLURIA. Upon discovery of the error patient was notified immediately and was then revaccinated with current formula. 2017-2018 AFLURIA was transferred to our store recently from another pharmacy along with current 2018-2019 formula and was not noticed until after vaccination had been given. Last years vaccine immediately taken out of inventory upon discovery.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Not an adverse event. Patient was given the 2017-2018 formula in error. We were able to contact him the following day and notified him of the error and that Public health recommended revaccination with the current vaccine. Patient will come in in the following weeks for revaccination, he states. 2017-2018 formula was transferred to our store in error along with current 2018-2019 formula, and this was not noticed until after several vaccinations were given around the same time. Last year's formula was immediately taken out of inventory.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Irritability
Clinical narrative: Red/swelling at injection site. Fussy/irritable.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: SHINGRIX was the shot that we got! felt tired, had muscle pain, a headache, shivering, fever, stomach pain, and nausea, tons of sweating.... had to leave work.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Myalgia, Nausea, Pyrexia
Clinical narrative: SHINGRIX was the shot that we got! felt tired, had muscle pain, a headache, shivering, fever, stomach pain, and nausea, tons of sweating.... had to leave work.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Urticaria
Clinical narrative: Hives, rash on face.
Age: 0.17
Sex: M
Vaccine: DTAP, DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Nurse administered Dtap and PENTACEL (DTAP/HIB/IPV) in left thigh of infant without realizing the double Dtap dose until documenting in computer after vaccinating child. Vaccine given approximately 10:40 AM on 11/20/18. No signs/symptoms noted at time of visit. Follow up call on 11/21/18 at 0845 with mom (via translator). No signs/symptoms noted. Mom thought increased temperature but confirmed temperature 97 F while on phone. Mom made aware of error. Mom reassured since no symptoms at this time, but mom is to monitor for fever, redness or swollen injection sites, fussiness. Mom to call Health department if symptoms arise to coordinate follow up care.
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Incoherent, Seizure, Syncope, Vomiting
Clinical narrative: Fainted, convulsed, woke up incoherent and threw up repeatedly. Occured approximately 15 minutes after receiving vaccine.
Age: 1.42
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Patient received 0.5 of FLUZONE and should have received 0.25 due to his age. Patient did not have any issues with the vaccine.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient experienced a "reflex response" when shot was given. Pain up and down her arm continued. She visited the Dr. on 11/13/2018 and was prescribed Gabapentin 600 mg at bedtime, but has not had any pain relief from the Gabapentin. She called today to report the incident.
Age: 49.0
Sex: F
Vaccine: UNK
Symptoms: Adverse reaction, Guillain-Barre syndrome
Clinical narrative: Pt. received the Influenza Vaccine in October. I am unaware of which kind. She was a patient in our ambulance. She relays symptoms related to Guillain-Barre Syndrome which I know is an adverse reaction.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Epistaxis, Tonsillar hypertrophy, Urticaria
Clinical narrative: Hives on face, arms and legs. Acute epistaxis where it has never existed. Swollen R tonsil.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received this second PREVNAR after receiving one the year prior on 09/25/2016. Patient was due to receive PNEUMOVAX 23 but was given PREVNAR 13 in error.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Computerised tomogram normal, Febrile convulsion, Influenza virus test negative, Postictal state
Clinical narrative: Patient had a febrile seizure the evening following vaccination. He had full body seizure activity for approximately 1 minute followed by a postictal state. He was taken by ambulance to the emergency room where a head CT, flu test, and strep test were all found to be normal. He had a documented temperature of 101 en route to the hospital.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Streptococcus test negative
Clinical narrative: Patient had a febrile seizure the evening following vaccination. He had full body seizure activity for approximately 1 minute followed by a postictal state. He was taken by ambulance to the emergency room where a head CT, flu test, and strep test were all found to be normal. He had a documented temperature of 101 en route to the hospital.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives over entire body.
Age: 40.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: 10/29/18, two weeks after vaccination, patient contacted us to say that his arm was still sore and hurting. He noted that the injection was given towards the middle of the bicep, it was not higher or lower than others. Stating Bicep and shoulder soreness and he had visited his primary care. Name of physician not given to us.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Body temperature increased, Headache, Neuralgia
Clinical narrative: All joints aching, headache, temp escalating to 101.7 by 11 PM, gout like nerve pain in hands, feet, ear, back pain at both kidneys. No treatment-rest and fluids.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Renal pain
Clinical narrative: All joints aching, headache, temp escalating to 101.7 by 11 PM, gout like nerve pain in hands, feet, ear, back pain at both kidneys. No treatment-rest and fluids.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse, concerning a female patient of unknown age. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with a fourth dose of RECOMBIVAX HB lot # N011851 with expiration date of 19-DEC-2019, intramuscularly (anatomical location was not reported) for prophylaxis. No adverse effect was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Conjunctivitis, Ophthalmic herpes zoster, Optic neuritis, Pneumoconiosis
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 16-SEP-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered a severe herpetic rash over the left side of his face and left eyelid and was diagnosed with herpes zoster ophthalmicus with conjunctivitis in the left eye. The patient additionally suffered from and was diagnosed with optic neuritis, which caused severe loss of vision in the left eye and was also diagnosed with pneumoconiosis. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to receiving the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, herpes zoster ophthalmicus, optic neuritis, and pneumoconiosis were determined to be medically significant. Herpes zoster ophthalmicus, optic neuritis, conjunctivitis, and pneumoconiosis was considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around 16-SEP-2016, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving ZOSTAVAX, the patient suffered a severe herpetic rash over the left side of his face and left eyelid and was diagnosed with herpes zoster ophthalmicus with conjunctivitis in the left eye. The patient additionally suffered from and was diagnosed with optic neuritis, which caused severe loss of vision in the left eye and was also diagnosed with pneumoconiosis. As a direct and proximate result of the defective ZOSTAVAX vaccine, the patient's symptoms have resulted in physical limitations not present prior to receiving the ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of patient's condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. Upon internal review, herpes zoster ophthalmicus, optic neuritis, and pneumoconiosis were determined to be medically significant. Herpes zoster ophthalmicus, optic neuritis, conjunctivitis, and pneumoconiosis was considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Erythema, Feeling abnormal, Oropharyngeal pain, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 36-year-old female patient received first single dose of PREVNAR 13 (could have been administered, but unsure) and flu vaccine on an unknown date in 2018 (reported as recently) both for immunization. Medical history and concomitant medications were not reported. On 14Nov2018, she felt her throat was closing, had a reddening from neck to head and for 1 minute felt like I was dying. At the time of the report, patient felt better but her throat still hurt. Final outcome of the event throat was closing and reddening from neck to head was unknown, throat pain was not recovered. Patient wanted to know if this situation could be caused by the vaccines. Information on the batch number has been requested. Pfizer is a marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the country of reporter. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Cardiac failure, Pneumonia
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, received from a contactable consumer reported for herself. A 63-year-old female patient received PREVNAR 13, via an unspecified route of administration this past year (2017) (could not recall when) at single dose for immunisation. The patient medical history and concomitant medications were not reported. Patient got pneumonia about 5 weeks ago (Oct2018). She was not aware the type of pneumonia. Also she was taken to the hospital by ambulance so she did not know the name/information of the physician. She was hospitalized for about 5 days and had just now started to feel better. She had other comorbidities such as heart failure during this time. The outcome of pneumonia was recovering, of heart failure was unknown.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 07-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA311665 and 2018SA314176. This case involves a six patient who received an expired dose of 0.25 ml of vaccine FLUZONE QUADRIVALENT Suspension for injection (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patients medical history and concomitant medications were not reported. It was a actual medication error due to expired vaccine used. Eight doses outdated influenza vaccine being administered, before they realized they were expired. It was unknown whether patient experienced any adverse event following 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: TDAP
Symptoms: Hypersensitivity
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves Adult patient who had mild reaction, while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date, dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced reaction allergic (NOS). (Other relevant tests included no lab data). Final diagnosis was mild reaction. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for mild reaction. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA317803 (same reporter). This case involves a 57 years old female patient who experienced broke out in a rash, while she received vaccine FLUZONE QUADRIVALENT. 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 INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. On an unknown date, the patient developed a non-serious broke out in a rash unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included no lab test). Final diagnosis was broke out in a rash. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for broke out in a rash. The reporter assessed the causal relationship with suspect vaccine as possible. List of documents held by sender: none.
Age: 79.0
Sex: U
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Rash
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 79 years old patient and reported that patient's arm became painful, swollen and a rash developed, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 13-Nov-2018, the patient received a dose of 0.5 ml suspect FLUZONE HIGH DOSE (lot number: UJ042AB and expiry date: 19-May-2019) via unknown route in the left deltoid. On an unknown date, following the vaccination the patient experienced swollen arm, rash and painful arm. Lab data not reported. Final diagnosis was the patient's arm became painful, swollen and a rash. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown for all events. List of documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information and additional information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Office manager) via phone. This case involves a 61 year old male patient who received a 0.5 ml dose of FLUZONE HIGH DOSE, [Suspension for injection in pre-filled syringe] (Batch number: UJ024AC, site of administration: left deltoid, expiration date and route was not reported) on 28-Sep-2018. The patient's past medical history, medical treatments, vaccinations and family history were not provided. Patient did not receive concomitant vaccination. It is an actual medication case error due to inappropriate age at vaccine administration. A 61 year old male received a FLUZONE HD. The patient had no adverse reactions. 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: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 11 years old female patient who accidently received an expired dose of 0.5 ml of vaccine MENACTRA (batch number: U5751AB, expiry date: 12-Nov-2018) via intramuscular route in the right deltoid on 16-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication were FLULAVAL and TDAP. It was case of actual medication error due to Expired vaccine used. No adverse event was experienced. 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 EC 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: 15.0
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 years old male patient who received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was received. On 14-Oct-2018, the patient received prefilled syringe of 0.5 ml single dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1818 (expiry date: 30-Jun-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. Patient did not have any adverse reaction. 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.
Age: 1.42
Sex: F
Vaccine: HIBV, MMR, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a 17 months old female patient who accidently received vaccine ADACEL instead of DAPTACEL (formulation: Suspension for injection for both vaccines). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR VACCINE for Immunisation; and ACTHIB for Immunisation. On 14-Nov-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot U6043BA (expiry date: 22-Aug-2020) via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate age at vaccine administration and Wrong vaccine administered. It was reported that no 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.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 12 years old male patient who received 0.5 ml dose of expired vaccine FLUZONE QUADRIVALENT (lot UT5954NA and expiration date 30-Jun-2018) via unknown route in unknown administration site on 15-Nov-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 expired vaccine used. It was not reported if patients 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 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: F
Vaccine: FLU3
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a Pharmacy intern. This case involves a 77-years old female patient who received vaccine FLUZONE HIGH DOSE lot UJ051AB, expiry date: 05-Jun-2019 via intramuscular route in the left arm on 16-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HAVRIX for Immunisation. It was actual medication error due to exposure via skin contact and vaccine underdose. It was reported that administered the FLUZONE HIGH DOSE vaccine, however some of the vaccine ran down her arm. It was reported that No A/E. 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: Wrong product administered
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient of an unknown demographics who received vaccines FLUZONE QUADRIVALENT (lot number, expiry date, dose, expiry date, route and site of administration were not reported) but was supposed to receive FLUZONE HIGH DOSE (lot number, expiry date, dose, expiry date, 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. It was actual medication error due to wrong vaccine administered. It was reported that administered FLUZONE QUAD to a patient but was supposed to be FLUZONE HD. It was unknown if any adverse event was 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. Documents held by sender: none.
Sex: F
Vaccine: HEPAB, TD, TYP
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 15-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves adult female patient (age reported as mid 60s), who was vaccinated with first and second dose of TYPHIM VI (lot number: N1K801M and expiry date: 15-Oct-2019) via intramuscular route in the deltoid NOS on 15-Nov-2018 (in morning). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included TD VACCINE for Immunisation; and TWINRIX for Immunisation on an unknown date. It was a case of syringe issue because some drops of the vaccine leaked out of the syringe, where the Luer-Lok attached to the syringe itself. It was also a case of actual medication error due to vaccine under dose because patient did not get enough of the TYPHIM VI dose. 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 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: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 8 years old male patient who received vaccine DAPTACEL. The patients past medical history, concomitant medication and family history were not provided. On 31-Jan-2011, the patient received a First dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection lot number not reported via unknown route in unknown administration site. On 01-Mar-2011 he also received a second dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 02-Mar-2012 he also received a third dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 19-Oct-2018 he also received a fourth dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. It was an actual medication error due to inappropriate schedule of vaccine administered. It was reported that eight year old child received his fourth DAPTACEL at age 2, he missed his fifth 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.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Received Flu vaccine 10/17/2018 - No redness/swelling/bruising/soreness experienced initially for the first week but on 10/24/2018 developed soreness of the left anterior deltoid and bicep. He stated that he did pick of firewood and has blown leaves at the time the soreness developed. Client stated, "Unsure if it is related to straining a muscle or the flu vaccine so he wanted to report it." Has not seen a physician and has treated with over the counter medication - TYLENOL - Ibuprofen and creams without relief. Symptoms have been present for 4 weeks. 11/21/2018 - Referred to Physician for exam / Follow-up.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Nausea
Clinical narrative: Chills, stomach discomfort, mild nausea, headache.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain Barre Syndrome.
Age: 63.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Syncope
Clinical narrative: Pt had a syncope on the way out of the facility.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Muscle swelling
Clinical narrative: A little more than 24 hours after getting vaccine, my left arm pit began to hurt. The pain increased and about two hours later my arm pit and muscle were swollen and the muscle area was red.   Thought I might have infection so went to urgent care. Doctor had me take Ibuprofen 4x/day and gave me a prescription for Sulfamethoxazole-Trime800-160 every 12 hours for 7 days.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Gait disturbance, Guillain-Barre syndrome, Hypoaesthesia, Neurological examination abnormal
Clinical narrative: He initially felt numbness on his entire left leg and a small amount on his right leg. He then felt weak and had trouble walking, but was able to walk. He felt that he could not feel his feet so it made it harder to walk. His neuro exam was negative except for an unsteady gait. He had normal sensation to pinprick, light touch and proprioception. He had an MRI of his LS spine and it was unremarkable. The following day, he was numb from his buttock down both legs. He could not effectively push out a bowel movement and was more unsteady on his feet. He was admitted to the hospital and had an LS spine and thoracic spine MRI with gadolinium that were negative. Of note, his B12 level was 249 and he received a B12 shot. His symptoms started to improve slightly. He had less of a sensation of numbness and his gait improved slightly. He went home against medical advice because he felt that this was likely GBS from the flu shot and since his case was mild, he did not want further treatment. He is able to walk without a cane, but is someone unsteady. His breathing is fine and I will follow him weekly.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Nuclear magnetic resonance imaging normal, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: He initially felt numbness on his entire left leg and a small amount on his right leg. He then felt weak and had trouble walking, but was able to walk. He felt that he could not feel his feet so it made it harder to walk. His neuro exam was negative except for an unsteady gait. He had normal sensation to pinprick, light touch and proprioception. He had an MRI of his LS spine and it was unremarkable. The following day, he was numb from his buttock down both legs. He could not effectively push out a bowel movement and was more unsteady on his feet. He was admitted to the hospital and had an LS spine and thoracic spine MRI with gadolinium that were negative. Of note, his B12 level was 249 and he received a B12 shot. His symptoms started to improve slightly. He had less of a sensation of numbness and his gait improved slightly. He went home against medical advice because he felt that this was likely GBS from the flu shot and since his case was mild, he did not want further treatment. He is able to walk without a cane, but is someone unsteady. His breathing is fine and I will follow him weekly.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Diarrhoea, Nasal congestion, Nausea, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Information was received from a consumer via a medical inquiry on 14SEP2018. A 22 year old female experienced sore throat, stuffy nose, drainage, vomiting, diarrhea and nausea following immunization with smallpox vaccine. Medical history: 'bad hip' but otherwise healthy. On 11SEP2018 the consumer received immunization with smallpox vaccine in the left arm (lot number unknown). The following day, she developed a 'really bad sore throat, stuffy nose and a lot of drainage. On 13SEP2018, while in the field, she developed nausea with vomiting and diarrhea. She reported concern related to returning to the field the following day due to the severity of her symptoms. On 01OCT2018, follow up with the consumer revealed that she was treated with an unspecified nausea medication; all symptoms resolved within a week. No further information is expected.
Age: 22.0
Sex: F
Vaccine: SMALL
Symptoms: Vomiting
Clinical narrative: Information was received from a consumer via a medical inquiry on 14SEP2018. A 22 year old female experienced sore throat, stuffy nose, drainage, vomiting, diarrhea and nausea following immunization with smallpox vaccine. Medical history: 'bad hip' but otherwise healthy. On 11SEP2018 the consumer received immunization with smallpox vaccine in the left arm (lot number unknown). The following day, she developed a 'really bad sore throat, stuffy nose and a lot of drainage. On 13SEP2018, while in the field, she developed nausea with vomiting and diarrhea. She reported concern related to returning to the field the following day due to the severity of her symptoms. On 01OCT2018, follow up with the consumer revealed that she was treated with an unspecified nausea medication; all symptoms resolved within a week. No further information is expected.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 85-year-old male patient who received SHINGRIX for prophylaxis. Co-suspect products included triamcinolone acetonide unknown for an unknown indication and triamcinolone acetonide cream for an unknown indication. The patient's past medical history included bruising of leg (Prior to getting the 2nd dose he had fallen several days before). Concurrent medical conditions included sulfonamide allergy. Concomitant products included liquid paraffin + wool fat (Lubriderm). On 10th October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) and triamcinolone acetonide at an unknown dose and frequency. In October 2018, the patient started triamcinolone acetonide at an unknown dose and frequency. On 11th October 2018, 1 days after receiving SHINGRIX and triamcinolone acetonide, 1 day after starting SHINGRIX and triamcinolone acetonide and not applicable after starting triamcinolone acetonide, the patient experienced erythema and pruritus. In October 2018, the patient experienced pruritus aggravated. The patient was treated with benadryl (nos) (Benadryl). Triamcinolone acetonide was discontinued (Dechallenge was unknown). Rechallenge with triamcinolone acetonide was unknown. Triamcinolone acetonide was discontinued (Dechallenge was unknown). Rechallenge with triamcinolone acetonide was unknown. On an unknown date, the outcome of the erythema, pruritus and pruritus aggravated were not recovered/not resolved.  It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX and triamcinolone acetonide. It was unknown if the reporter considered the pruritus aggravated to be related to triamcinolone acetonide. Additional details were provided as follows: On 9th October 2018, the patient saw his dermatologist and was prescribed a triamcinolone ointment. On 10th October 2018, in the morning, the patient applied the ointment then later that day he received SHINGRIX. Next morning, the patient experienced redness and itching all over his chest, stomach, back and arms. Some time later the patient saw his dermatologist again for a previously scheduled appointment and he was this time prescribed triamcinolone cream to treat the itching he was experiencing. Less than a month after using the triamcinolone cream the really broke out and the itching was continuous. The patient received Benedryl to get some sleep. The patient's dermatologist thought that the itching was caused by SHINGRIX. The patient's pharmacist thought it might be caused by the triamcinolone. The patient had stopped taking both triamcinolone formulations, but still had the itching. The patient was going to a quick clinic on the reporting date to see a doctor. The physician details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash papular, Rash pruritic
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of erythropapular rash in a elderly patient who received SHINGRIX (batch number L7F7E, expiry date 22nd November 2020) for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythropapular rash, itchy rash, pain and shingles. On an unknown date, the outcome of the erythropapular rash, itchy rash, pain and shingles were unknown. It was unknown if the reporter considered the erythropapular rash, itchy rash, pain and shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The health care professional reported red bumpy itchy rash on back of neck towards left side was vaccinated on right arm.  No confirmation of shingles by physician.
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Nausea, Peripheral swelling, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema of extremities in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities, swelling arm, nausea, vomiting and discomfort. On an unknown date, the outcome of the erythema of extremities, swelling arm, nausea and vomiting were unknown and the outcome of the discomfort was recovered/resolved. It was unknown if the reporter considered the erythema of extremities, swelling arm, nausea, vomiting and discomfort to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that after the SHINGRIX shot her arm swelled up and turned red. The patient stated that she was throwing up and nausea for the first day. The patient stated she was uncomfortable for about a week. The patient had denied permission to contact their physician.
Sex: F
Vaccine: FLU4
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of unwell in a female patient who received Flu Seasonal QIV Dresden for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced unwell. On an unknown date, the outcome of the unwell was unknown. It was unknown if the reporter considered the unwell to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. After receiving the flu shot the patient got ill.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site pain, Pain, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 1st dose of SHINGRIX. On 1st November 2018, immediately after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced injection site pain, sluggishness, general body pain, fever and chills. On an unknown date, the outcome of the injection site pain, sluggishness, influenza-like symptoms, general body pain, fever and chills were recovered/resolved. The reporter considered the injection site pain, sluggishness, influenza-like symptoms, general body pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's shot was painful enough to cuss the nurse who administered it. Onset was nearly immediate of sluggish, flu like symptoms which included body aches, low grade fever. About 2 days later, the patient was enough to put in bed with chills despite 100 degree F temperature outside. The patient's side effects subsided finally about 6 days later. The reporter knew a 2nd dose would be needed to complete the series but would hold off until past flu season. The reporter knew full well event related to shot because she was a physician. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Sluggishness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in a 55-year-old female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included immunocompromised. On an unknown date, the patient received the 1st dose of SHINGRIX. On 1st November 2018, immediately after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the patient experienced injection site pain, sluggishness, general body pain, fever and chills. On an unknown date, the outcome of the injection site pain, sluggishness, influenza-like symptoms, general body pain, fever and chills were recovered/resolved. The reporter considered the injection site pain, sluggishness, influenza-like symptoms, general body pain, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's shot was painful enough to cuss the nurse who administered it. Onset was nearly immediate of sluggish, flu like symptoms which included body aches, low grade fever. About 2 days later, the patient was enough to put in bed with chills despite 100 degree F temperature outside. The patient's side effects subsided finally about 6 days later. The reporter knew a 2nd dose would be needed to complete the series but would hold off until past flu season. The reporter knew full well event related to shot because she was a physician. The reporter did not consent to follow up.