chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient received shot on 10/2, came in a few weeks later saying her arm hurt and what could be done and I recommended OTC remedies. Patient called again on or around 11/7 and said her arm still hurt and so I recommended she contact her primary care physician.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Headache, Pain, Pyrexia, Rash macular
Clinical narrative: Blotchiness on arm. Fever, headache, upset stomach, soreness.
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of an unknown age and gender. The patient's pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On an unknown dates, the patient was vaccinated with 2 doses of M-M-R II (exact dose, frequency, site and route of administration, lot#, expiration date and albumin status were not reported) outside the recommended dosing schedule. No adverse effects were reported.
Age: 60.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Speech disorder
Clinical narrative: This spontaneous report has been received from a pharmacist via a company representative, concerning a 60-year-old (about to turn 61 years old) female patient. The patient's concurrent condition included asthma and chronic obstructive pulmonary disease. Medical history and concomitant medications were not provided. On an unknown date (for many years), the patient had been vaccinated each year with PNEUMOVAX 23 (doses, frequencies, routes, lot numbers, expirations dates and indications were not provided); furthermore, on 18-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 intramuscularly (dose, frequency, lot number and expiration date were not provided) for pneumococcal prevention. On 18-OCT-2018, the patient contacted pharmacist with complaints of trouble speaking and trouble breathing. The reporter stated that the patient did not received any treatment. The therapy with PNEUMOVAX 23 was reported as continued. The outcome of trouble speaking, and trouble breathing was reported as not recovered. The causal relationship between the adverse events and the therapy was not assessed.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a nurse refers to the patients of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date the patient was vaccinated with improperly stored PROQUAD (lot # R013575, expiry date: 10-NOV-2019) (dose, frequency and route were not reported) for prophylaxis. The vaccines were stored in temperature of 47 degree Fahrenheit (F) to 77 F for 1 hour. There was no previous temperature excursion reported. A digital data logger was involved. No adverse effects were reported. No product quality complaint was involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 09-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 lot # N003997, intramuscular for prophylaxis. On 09-NOV-2018, 1 day after onset of therapy the patient experienced expired product administered. On an unknown date the patient experienced no adverse event. The outcome of expired product administered and no adverse event is unknown. The reporter considered expired product administered and no adverse event to be not assessed to PNEUMOVAX 23.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Headache, Injection site erythema, Injection site mass, Malaise
Clinical narrative: This spontaneous report as received from a other health professional refers to a 72 year old female patient with type 2 diabetes mellitus and drug hypersensitivity. On 06-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 lot # R017900, intramuscular for prophylaxis. Concomitant therapies included LIPITOR, METFORMIN HYDROCHLORIDE, SYNTHROID and HYDROCHLOROTHIAZIDE plus LOSARTAN POTASSIUM. On 06-NOV-2018, 1 day after onset of therapy the patient experienced peripheral swelling, vomiting, chills, injection site mass, headache, pyrexia, malaise and injection site erythema. The outcome of peripheral swelling, vomiting, chills, injection site mass, headache, pyrexia, malaise and injection site erythema was reported as not recovered/not resolved.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: This spontaneous report as received from a other health professional refers to a 72 year old female patient with type 2 diabetes mellitus and drug hypersensitivity. On 06-NOV-2018 the patient was vaccinated with PNEUMOVAX 23 lot # R017900, intramuscular for prophylaxis. Concomitant therapies included LIPITOR, METFORMIN HYDROCHLORIDE, SYNTHROID and HYDROCHLOROTHIAZIDE plus LOSARTAN POTASSIUM. On 06-NOV-2018, 1 day after onset of therapy the patient experienced peripheral swelling, vomiting, chills, injection site mass, headache, pyrexia, malaise and injection site erythema. The outcome of peripheral swelling, vomiting, chills, injection site mass, headache, pyrexia, malaise and injection site erythema was reported as not recovered/not resolved.
Sex: U
Vaccine: MENB
Symptoms: Blindness
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of TRUMENBA, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced vision loss the day after being vaccinated. The event resolved completely within that day. Following the second dose of the vaccine and no events were reported. The information on the lot number has been requested. Sender's Comments: the patient experienced vision loss that resolved completely within that same day. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 04-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 24 months old patient who was vaccinated with a 0.5 ml dose of PENTACEL (lot C5428AA) via intramuscular route in the right thigh on 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medication includes PREVNAR 13 not produced by Sanofi Pasteur lot number not reported. It was a case of actual medication error due to inappropriate reconstitution technique. It was not provided any information confirming whether the patient experienced any adverse event. The patient had a clinic visit on 24-Sep-2018. 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: FLU3
Symptoms: Swelling, Vaccination site swelling
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 65 years old female patient who experienced localized swelling and localized swelling, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medication were not provided. On an unknown date, the patient received a  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. On an unknown date, The patient developed a non-serious localized swelling (localised oedema) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious localized swelling (vaccination site swelling) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was localized swelling and localized swelling. Lab test not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for localized swelling and as Unknown for localized swelling.
Sex: F
Vaccine: FLU3
Symptoms: Excessive eye blinking, Tic
Clinical narrative: Initial information received on 08-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves Child female patient who experienced tick with lots of eye blinking, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE lot UT6259NA via unknown route. On an unknown date, the patient developed a non-serious tick with lots of eye blinking (eye disorder) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION NO PRESERVATIVE VACCINE. (Other relevant tests included No lab data.) Final diagnosis was tick with lots of eye blinking. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for tick with lots of eye blinking. List of documents held by sender: none
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 09-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves five patients (from 27 to 64 years of age) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot: UJ023AB) instead of FLUZONE QUADRIVALENT on 28-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 inappropriate age at vaccine administration, wrong vaccine administered and overdose. No adverse event was reported. The doctor was not involved in the cases; so it was suggested to remove his name from the report. 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. Additional information was received on 09-Oct-2018 by  "the same reporter".
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product storage error
Clinical narrative: Based on additional information received on 02 Nov 2018, this case considered as valid case from non case. (event updated) Initial information received on 10-Oct-2018 (initial version was non case). Follow up received from nurse on 02 Nov 2018. This case is linked to cases 2018SA284510 and 2018SA284522. This case involves infant male patient for whom vaccines were given before they were known to be inactive due to temperature stability was reported, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 02-Oct-2018, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via intramuscular route in the left thigh. It was an actual medication error due to incorrect product storage as vaccine were given before they were known to be inactive due to temperature stability. No adverse event were not reported. 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: MNQ, TD, TDAP, TYP
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited non-valid and non-serious case received from a other health professional. This case involves an seven patient who were vaccines with TYPHIM VI, MENACTRA, TENIVAC and ADACEL and TUBERSOL that were stored outside the recommended temperature range. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to incorrect product storage. It was reported that the vaccines reached min temp of 29.0 F and max was temp of 50 F for 11 hours 30 min and in second reading temp excursion temp min was 32.0 F and temp max was 50 F for 11 hours 20 min. It was not reported whether the 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 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. Follow up received from other health professional on 16-Oct-2018. Case becomes valid as number of patient reported.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Pain in extremity
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 2 years old male patient who experienced sore leg, redness around the injection site and swelling from his groin to his knee, while he received vaccine FLUZONE QUADRIVALENT. The patient's past vaccination(s) included FLU VACCINE VII in 2016 and FLU VACCINE VII in 2017. The patient's past medical history, medical treatment(s) and family history were not provided. Details of concomitant medication was not provided. On 11-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI982AB via intramuscular route in the left thigh. On 11 October 2018, the patient developed a non-serious event of sore leg following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 12 October 2018, the patient developed a non-serious event of redness around the injection site 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 13 October 2018, the patient developed a non-serious swelling from his groin to his knee 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was sore leg, redness around the injection site and swelling from his groin to his knee. Details of lab date was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for swelling from his groin to his knee, sore leg and redness around the injection site.
Age: 15.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Expired product administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 15 years old male patient who received expired vaccine MENACTRA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLUARIX. On 19-Oct-2018, the patient received a single 0.5 ml dose of suspect MENACTRA lot U5712AA (expiry date: 11:Oct-2018) via intramuscular route in the left arm. It was a case of actual medication error due to expired vaccine used. 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.
Sex: U
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 15 months old patient who was vaccinated with a dose of DAPTACEL expiry date: 08-Oct-2018 (lot number not reported via intramuscular route in unknown administration site) on 19-Oct-2018. The patient's medical history and concomitant medications were not reported. It is an actual medication error case due to expired vaccine used. It was reported that a 15-month old received a dose of DAPTACEL on 19Oc2018 that expired on 10/8/2018. It was reported that the patient had no adverse event developed. 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.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA310096 (Same reporter). This case involves a 32 years old female patient who was unable to move her arm (after a few days) and her arm was sore at the injection site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. Reported as No other vaccines administered this day. On 19-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT626NA, expiry date 20-Jun-2019) 0.5 ml via intramuscular route in the left arm. On an unknown date, reported as after few days the patient developed a non-serious she was unable to move her arm following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown the patient developed a non-serious her harm is sore at the injection site following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was also reported that the patient was referred to healthcare professional who referred her to orthopedic doctor. No lab data was reported. Final diagnosis was her harm is sore at the injection site and after a few days she was unable to move her arm. The patient was treated with IBUPROFEN. The event outcome was reported as Unknown for her arm is sore at the injection site and for after a few days she was unable to move her arm. List of documents held by sender: none.
Sex: F
Vaccine: FLUR4
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited non-valid non-serious case received from a consumer. This case involves female patient of an unknown age who experienced sore arm, while she received vaccine FLUBLOK QIV. The patient's past medical history included Pain in extremity, Nausea and Pyrexia. The patient's past vaccination(s) included TDAP with about a year ago at her HCP's office, and the nurse hit her bursa. The patient's past medical treatment(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported. On an unknown date, the patient developed sore arm following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Final diagnosis was sore arm. No lab data reported. It was not reported if the patient received a corrective treatment. The outcome of the event was not reported. Additional information was received from consumer on 05-Nov-2018. Event was updated in field and narrative and case became non-valid to valid. List of documents held by sender - none.
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Injection site bruising
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves Adult female patient (age was not reported) who developed a large bruise, 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 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number, expiry date not reported) via intramuscular route in right arm. It was also reported that the pharmacist stated that the vaccine was injected into a vein and the dose is will not be effective. On an unknown date, post vaccination patient developed a non-serious developed a large bruise. It was a case of actual medication error due to incorrect route of product administration. Lab data not reported. Final diagnosis was the vaccine was injected into a vein and the dose is will not be effective and developed a large bruise. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for developed a large bruise. 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
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 30 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE (Batch number: UI831AB, expiration date: 30-Jun-2018, site of administration: left deltoid and route was unknown) on 05-Nov-2018. The patient medical history and concomitant medications were not reported. It was an actual medication error due to expired vaccine used (expired dose of FLUZONE QUADRIVALENT given to female patient). No adverse event reported. 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: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 8 months old female patient who was given 0.5 ml instead 0.25 ml, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 05-Nov-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U5028AB, expiry date- 30-Jun-2019 via unknown route in right thigh. It was a case of actual medication error due to overdose. It was unknown 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.
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308764, 2018SA308765, 2018SA308766 and 2018SA308767. This case involves a 43 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE Batch number: UJ029AB, expiration date: 02-May-2019, route: intramuscular and site of administration was not reported) on an unknown date instead of FLUZONE QUADRIVALENT (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to inappropriate age at vaccine administration (administered FLUZONE HD to 43 year old patient) and wrong vaccine administered (administered FLUZONE HD instead of FLUZONE QUAD). 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 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: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked with 2018SA308764, 2018SA308765, 2018SA308766, 2018SA308767 (same reporter). This case involves 16 year old patient (gender unknown) who was vaccinated with dose of FLUZONE HIGH DOSE (Batch number, Expiry date, dose in series and site of administration was not reported) on an unknown date instead of FLUZONE QUADRIVALENT. Patient medical history and concomitant medications were not reported. It was a case of actual medication error due to wrong vaccine administered, overdose and inappropriate age at vaccine administration. It was unknown if the patient experienced any adverse events. 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: U
Vaccine: FLU3, FLU4
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308762, 2018SA308765, 2018SA308764 and 2018SA308767. This case involves a 16 years old patient who received a dose of FLUZONE HD instead of FLUZONE QUADRIVALENT on an unknown date (batch number, exp date, dose, dose in series, route and site of administration was not reported). The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration and overdose accidental (It was reported that nurse accidentally opened a box of FLUZONE HD instead of FLUZONE QUAD, and administered 5 patients under the age of 65 a dose of FLUZONE HD inadvertently). 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 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: 40.0
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA308762, 2018SA308764, 2018SA308765, 2018SA308766 (same reporter). This case involves a 40 years old patient (unspecified gender) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE lot UJ029AB via intramuscular route instead of FLUZONE QUADRIVALENT on an unknown date. 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 wrong vaccine administered and inappropriate age at vaccine administration (It was reported that nurse accidentally opened a box of FLUZONE HD instead of FLUZONE QUAD, and administered 5 patients under the age of 65 a dose of FLUZONE HD inadvertently). It was a case of accidental overdose. It was not reported whether the patient experienced any adverse events or not. 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.
Age: 1.5
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional and additional information received on the same date. This case involves a 18 months old male patient (also reported as 14 months) who inadvertently received 0.5 ml dose instead of 0.25 ml dose of FLUZONE QUADRIVALENT from a multi-dose vial. The patient was not kept for observation. The patient's past medical history and concomitant medication were not provided. On 05-Nov-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UIB83AA, expiry date: 30-Jun-2019) via intramuscular route in the left thigh. It was a case of actual medication error due to accidental overdose. It was not reported, if the patient experienced any AE. 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: FLU3
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves an unknown age female patient who received vaccine FLUZONE HIGH DOSE (lot number not reported) via sublingual route in unknown administration site on an unknown date. The patient's past vaccination(s) included FLUZONE HIGH-DOSE sublingually for the past 3 years. The patient's past medical history, medical treatment(s) and family history were not provided. The patient has ongoing illness of MS. It was a case of actual medication error due to wrong route of product administration. It was reported that the patient has MS and cannot take any shots (IM). At the doctor's office they squirt the liquid under her tongue have her hold it there for a couple of minutes then swallow the liquid. It was reported that the patient never 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.
Age: 48.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 48 years old male patient who experienced was inadvertently given 0.5 ml vaccine MENACTRA (lot US5916AA and expiration date 27-Jun-2019) via subcutaneous route in the right deltoid on 31-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included FLULAVAL for Immunisation. It was a case of actual medication error due to inappropriate route of vaccination. It was not reported 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 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: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: Initial information received on 03-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 53 years old female patient who experienced chills, vomiting and fever at 100.7 and rising till 105.1, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Nov-2018 at 9:00 am, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On 03-Nov-2018 at 05:00 eight hours post vaccination the patient experienced a non-serious chills and fever at 100.7 and rising till 105.1 (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 04 Nov 2018, one day patient had vomiting. Other relevant tests included no lab data. Final diagnosis was fever at 100.7 and rising till 105.1, vomiting and chills. It was not reported if the patient received a corrective treatment. The event outcome was not reported. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Skin irritation
Clinical narrative: Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a non-health care professional. This case involves Elderly patient (age and gender was not reported) who had skin red and irritated, 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 an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION 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 skin red and irritation skin. Lab data not reported. Final diagnosis was skin red and irritated. It was not reported if the patient received a corrective treatment. The outcome of the events was reported as unknown. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a non health care professional. This case involves a 79 years old patient (gender unknown) received a dose of suspect FLUZONE HD, lot number not reported via unknown route in unknown administration site on 01 Oct 2018 and on 06-Nov-2018 (date of report) patient again received 0.5 ml single dose of the same vaccine lot UJ051AA, expiry date 01 June 2018 via unknown route in the left deltoid by mistake. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication was taken. It was a case of actual medication error due to extra dose administered. No adverse reaction 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: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased
Clinical narrative: Initial information received on 05-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 32 years old female patient who had unable to move her arm, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 19-Oct-2018, the patient received a dose of 0.5 ml suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number: UT626NA and expiry date: 20-Jun-2019) via intramuscular route in the left arm. On an unknown date, following the vaccination the patient had mobility decreased. (Other relevant tests included no lab data.) Final diagnosis was unable to move her arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for unable to move her arm. List of documents held by sender: none.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Nasal congestion, Oropharyngeal pain, Pyrexia
Clinical narrative: The morning after the vaccine was administered, I developed a severe sore throat, followed by nasal congestion and cough. I also developed a slight fever. I took ROBITUSSIN DM, cough drops, CLARITIN, and antibiotics over a time frame of several weeks. The cough and nasal congestion would not let up. It finally dissipated. On it's own.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Pyrexia, Rhinorrhoea
Clinical narrative: Violent shaking and chills that started at approximately 8:30 p.m., almost 4 hours after vaccine. That continued until  about 12:00 midnight  with a high fever that lasted until 9:00 - 10:00 the following morning. I used Ibuprofen to help with  fever. I did not feel capable of driving and did not seek medical care other than contact with an RN by phone during this time. During the next 2 days I developed a runny nose, occasional cough and was very tired.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Violent shaking and chills that started at approximately 8:30 p.m., almost 4 hours after vaccine. That continued until  about 12:00 midnight  with a high fever that lasted until 9:00 - 10:00 the following morning. I used Ibuprofen to help with  fever. I did not feel capable of driving and did not seek medical care other than contact with an RN by phone during this time. During the next 2 days I developed a runny nose, occasional cough and was very tired.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness
Clinical narrative: Dizziness upon movement of head which subsides when stops moving head. Denies nausea, vomiting, diarrhea or blurred vision.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Amenorrhoea, Back pain, Fatigue, Laboratory test normal
Clinical narrative: 2-3 days after the Td vaccine she had "fatigue" in her lower back which progressed to sharp pain. By the 3rd day of this pain she went to ER. Had many tests and nothing was found. Was given some Rx and it took 2-3 months for pain to go away. She never got her menses after this shot and still hasn't.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia, Somnolence
Clinical narrative: Fever, chills, achy, sleepy.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Impaired work ability, Throat tightness, Wheezing
Clinical narrative: Spoke with pt and he tells me that "I have a Hx of bronchial problems, but haven't had Sx's in a while." He tells me that he had "tightness in my throat, SOB, wheezing. It knocked me out for a whole day." He was using PRIMATENE mist and his roommate's inhaler which did help.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever/Chills and nausea, muscle aches.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Chest X-ray, Chest pain, Pain in extremity
Clinical narrative: This spontaneous case, initially received from other non-health professional on 30-Oct-2018, concerns a 52-year-old, adult female patient. The patient's concomitant medication included acid reflux medicine for an unknown indication. On 14-Sep-2018, the patient was administered AFLURIA QUADRIVALENT [dose: 0.5 ml, route of administration: intramuscular, anatomical location: left arm, batch number: 01144611A (reported as 02144611A), and expiry date: 30-May-2019]. On the same day, after vaccination, the patient experienced huge pain in her arm that went all the way down in the arm which had persisted. On 26-Oct-2018, the patient made an emergency room visit for worsening of symptoms and burning of her chest. The patient was given anti-inflammatory and some pain medications, but she did not want to take the pain medication. The patient had some x-rays on her chest as well. At the time of this report, the patient's symptoms were persisting and not improving (not recovered). The reporter assessed this case as serious (medically significant).
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Alpha 1 foetoprotein normal, Exposure during pregnancy, Prenatal screening test, Pyelocaliectasis, Ultrasound antenatal screen
Clinical narrative: This is an serious observational study case, initially received on 31-Oct-2018, concerning a 22-year-old, pregnant female, subject of Body mass index:  40.8, weight: 216 lbs and height: 61 inch, enrolled in a study. This was the subject's first pregnancy. The father did not receive any medications prior to conception. The subject did not have any paternal or maternal history with major congenital malformation. The subject didn't have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The subject's last menstrual period date was 01-Feb-2018. The gestational age of the subject was 37 weeks. The subject's current condition included hypothyroidism. The subject's concomitant medication included LEVOXYL [start date: 10-Apr-2018, dose:  200 mcg, frequency: four times a day (qid), route: oral] for hypothyroidism. On 10-Apr-2018, the subject underwent ultrasound test and no major congenital malformation was noted. On 08-May-2018, the subject underwent nuchal translucency test and no major congenital malformation was noted. On 08-May-2018, the subject underwent first trimester screening test and no major congenital malformation was noted.  On 05-Jun-2018, the subject underwent maternal serum alpha-fetoprotein screening (MSAFP)/serum markers test and no major congenital malformation was noted. On 23-Oct-2018, the pregnant subject was administered Flu Vaccine Egg Split QIV CSL (batch number: YF40208, dose, route of administration, anatomical location and expiry date: not reported). On an unknown date, after administration of suspect vaccine, the subject's pregnancy status was collected, and left pelviectasis was noted. The subject's estimated date of delivery was reported as 14-Nov-2018. At the time of this report, the outcome of the events left pelviectasis was not reported. This case was linked to the original case: 201805222.