chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU3
Symptoms: Contusion, Skin warm, Swelling
Clinical narrative: Initial information received on 11-October-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 71 years old patient who had bruising, hot to the touch and swelling, 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 10-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ037AA and expiry date: 12-May-2019) via intramuscular route in the left arm. On an unknown date, following the vaccination the patient experienced bruising, sensation of warmth and swelling. (Other relevant tests included no lab data). Final diagnosis was swelling, hot to the touch and bruising. 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: Contusion, Product storage error, Skin warm, Swelling
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 79 years old patient for whom vaccines may have gotten too cold and perhaps frozen in the refrigerator, blue/green bruising, swelling and hot to the touch was reported, while he/she received vaccine FLUZONE HIGH DOSE. This case is linked with 2018SA284987. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines was administered. On 10-Oct-2018, the patient received a 0.5 ml standard dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ037AA expire date: 12-May-2019 via intramuscular route in the left arm. On an unknown date, patient developed a non-serious blue/green bruising unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, patient developed a non-serious swelling, hot to the touch and blue/green bruising unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not reported. This case is actual medication error due to incorrect product storage (it was reported as vaccines may have gotten to cold and perhaps frozen in the refrigerator). Final diagnosis was hot to the touch, swelling, blue/green bruising. It was not reported if the patient received a corrective treatment. The outcome of event of outcome of other 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 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: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 11-October-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old female patient foe whom FLUZONE HD was given to a patient that was beyond the expiration date was reported, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. On 01-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI840AC via intramuscular route in unknown administration site. The patient developed a non-serious fluzone hd was given to a patient that was beyond the expiration date. (expired product administered) unknown latency following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. It was not reported whether patient experienced any adverse event or not. The case is actual medication error due to expired vaccine used. Final diagnosis was fluzone hd was given to a patient that was beyond the expiration date. It was unknown whether patient experienced any adverse reaction after vaccination. Outcome of the event was not applicable. 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 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: DTAPIPVHIB
Symptoms: Exposure via eye contact, No adverse event
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. (Patient herself- A healthcare worker) via other company (Merck). This case involves an unknown age female patient who accidently received vaccine PENTACEL in her eye. The patient's past medical history and concomitant medication were not provided. On 17-Sep-2018, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine lot number (Batch numbers: HIB: C5573AA and DtaP: C5427BA) expiry date: 13-Oct-2019) reported. It was a case of actual medication error due to Occupational exposure to product and exposure via eye contact. 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 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: FLU4
Symptoms: Contusion, Product storage error, Skin warm, Swelling
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case was linked to 2018SA285348 (same reporter). This case involves a 25 years old patient of unknown gender who experienced blue or green bruising, hot to the touch, swelling, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies taken. On 10-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA (expiry date: 30-Jun-2019) via unknown route in the right arm. On an unknown date, The patient experienced bruising, swelling, hot to the touch and blue or green bruising one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 11-Oct-2018, patient required visit to doctor. It was a case of actual medication error due to incorrect product storage. It was reported that there being a suspicion that the vaccines might have gotten to cold and perhaps frozen in the refrigerator. Final diagnosis was swelling, hot to the touch and blue or green bruising. Lab tests not reported. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for blue or green bruising, as Unknown for swelling, hot to the touch and blue/green bruising. 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 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: U
Vaccine: FLU4
Symptoms: Contusion, Product storage error, Skin warm, Swelling
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 11-Oct-2018 from a physician. This case was linked to 2018SA285341 (same reporter). This case involves a 46 years old patient of unknown gender who experienced blue or green bruising, hot to the touch, swelling, while he/she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapies taken. On 10-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA (expiry date: 30-Jun-2019) via unknown route in the left arm. On an unknown date, the patient experienced blue or green bruising, hot to the touch and swelling one day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On 11-Oct-2018, patient required visit to doctor. It was a case of actual medication error due to incorrect product storage. It was reported that there being a suspicion that the vaccines might have gotten to cold and perhaps frozen in the refrigerator. Final diagnosis was swelling, hot to the touch and blue or green bruising. Lab tests not reported. It was not reported if the patient received a corrective treatment. The patient outcome was 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: FLU3
Symptoms: Erythema, Injection site erythema
Clinical narrative: Initial information received on 12-October-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult patient who had redness 2-3 inches below injection sites, 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 localised erythema. (Other relevant tests included no lab data.) Final diagnosis was redness 2-3 inches below injection sites. It was not reported if the patient received a corrective treatment. The outcome of event was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist with live follow-up. This case involves a 75 years old female patient and reported that consumer received one third of the dose the consumer jumped and the needle came out of the consumer, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s), and family history were not provided. No other vaccine given. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number: UJ042AA and expiry date: 19-May-2019) via intramuscular route in the left deltoid. It was a case of actual medication error due to underdose. (It was reported that the consumer received one third of the dose the consumer jumped and the needle came out of the consumer). 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: 61.0
Sex: F
Vaccine: FLUR4
Symptoms: Paraesthesia, Urticaria
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional. This case involves a 61 years old female patient who had hives and felt tingling on arms, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 11-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number, expiry date, dose in series, route and site of administration was not reported) in the left deltoid. On an unknown date, following the vaccination the patient experienced hives and paraesthesia. (Other relevant tests included no lab data.) Final diagnosis was felt tingling on arms and hives. The patient was treated with BENADRYL. The outcome of the events was reported as unknown. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves five-month-old female patient for whom medication error was reported, while she received vaccine PENTACEL. batch number: C5516AA, expiration date: 15-Sep-2019, (dose, was not reported for both vaccines) via intramuscular route in the left vastus lateralis on 25-Sep-2018. The patient's medical history was not reported. Concomitant medications included PNEUMOCOCCAL VACCINE 13V and ROTAVIRUS VACCINE. It was an actual medication error due to product preparation error. (It was reported that Medical Assistants gave a patient the PENTACEL without using the proper diluent provided and used sterile water for injection that we had out at room temperature instead here in the office by accident). The patient didn't get the solution part of the vaccine, only got powdered form. The patient didn't have an adverse event to anything. It was unknown whether 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: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 61 years old male patient who experienced received 0.5 ml vaccine FLUZONE HIGH DOSE lot UJ037AA via intramuscular route in right deltoid site on 12-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was reported that the patient had a poor health history and he normally gets the FLUZONE HIGH DOSE. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported if the patient experienced 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 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: Underdose
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 3 years old female (3 year 8 months old) patient who got the 0.25 ml dose, 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 0.25 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route. Nurse called to report that the patient got 0.25 mL dose and needs to see if second dose is indicated. It was a case of actual medication error due to vaccine under dose. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, FLU4, PNC
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 4 months old male patient who received vaccine FLUZONE QUADRIVALENT. The patients past medical history and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (PENTACEL) and PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) (Lot number, expiry date and dose not provided) on 11-Oct-2018. On 11-Oct-2018, the patient received a 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259NA, expiry date 30-Jun-2019 via intramuscular route in the right thigh. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that FLUZONE QUADRIVALENT 0.25mL prefilled syringewas administered to a 4 month old patient/ did not result in follow up visit/treatment. 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 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: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician (patient herself). This case is linked with case 2018SA285704, from same reporter. This case involves Adult female patient (age unknown) who experienced swelling at the site about 10-15 cm in size with redness, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 11-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On unknown date, the patient developed a non-serious swelling at the site about 10-15 cm in size with redness (extensive swelling of vaccinated limb) (erythema) and (vaccination site reaction) with Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was swelling at the site about 10-15 cm in size with redness. As a corrective treatment to apply ice and alcohol compress was adviced. The patient outcome is reported as Unknown for swelling at the site about 10-15 cm in size with redness. List of documents held by sender- none.
Age: 55.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case is linked with case 2018SA285692, from same reporter. This case involves a 55 years old female patient who experienced swelling at the site about 10-15 cm in size with redness, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On 11-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ035AA, expiry date 30-Jun-2019 via intramuscular route in the left deltoid. On unknown date, the patient developed a non-serious swelling at the site about 10-15 cm in size with redness (extensive swelling of vaccinated limb) (erythema) and (vaccination site reaction) with Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was swelling at the site about 10-15 cm in size with redness. As a corrective treatment to apply ice and alcohol compress was adviced. The patient outcome is reported as Unknown for swelling at the site about 10-15 cm in size with redness. List of documents held by sender- none.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff). This case involves a 3 months old patient (gender unknown) who received vaccine FLUZONE PEDIATRIC. The patients past medical history, concomitant medication and family history were not provided. The patient did not receive any other vaccine. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259JA, expiry date 30-Jun-2019 via intramuscular route in the left thigh. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that MA administer a FLUZONE Pediatric 0.25 ml to a 3-month child. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 61.0
Sex: U
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 61 years old patient (gender not reported) who received vaccine FLUZONE HIGH DOSE (lot UJOO6AB) via intramuscular route in the left deltoid on 11-Oct-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 and overdose. The patient did not have any adverse event at the time of reporting. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 16.0
Sex: F
Vaccine: IPV
Symptoms: Product storage error
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 16 years old female patient who received 0.5 ml of vaccine IPOL (lot N1K921M, 14-Nov-2019) via unknown route in unknown administration site on 10-Oct-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 incorrect product storage (temperature excursion). It was reported that the refrigerator was out of range for 2 hours and 57 minutes with a maximum temperature of 57.1 F. It was not reported if the patient experienced any adverse event or not. 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. This case is linked to AER# 2018SA285833 (same reporter) and AER# 2018SA286128 (same reporter).
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a seven-months old male patient who had the diluent of pentacel and did not mix the vaccine with water, while he received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunisation; and ROTAVIRUS VACCINE for Immunisation. On 18-Sep-2018, the patient received a once 0.5 ml third dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot N022173, expiry date- 07-Dec-2018 via intramuscular route in the right thigh. It was a case of actual medication error due to inappropriate reconstitution technique as the patient did not receive the (HIB) portion of PENTACEL. 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 the sender: none.
Sex: U
Vaccine: DTAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a non-health care professional (Office Staff). This case involves a 10 years old patient who received vaccine DAPTACEL. The patients past medical history, concomitant medication and family history were not provided. No other vaccines were given on 04-Oct-2018, the patient received a 0.5ml dose of suspect Diphtheria-15/Tetanus/5 AC Pertussis Vaccine lot number, expiry date not reported via intramuscular route in unknown administration site. It was an actual medication error due to inappropriate age at vaccine administration. It was reported that a nurse at the practice injected a 10-year-old patient with DAPTACEL. Medical assistant stated that there were two vaccines boxes sitting side by side and the MA grabbed the wrong box and administered the vaccine from the wrong box. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: M
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 5 month old patient who received 0.25 ml FLUZONE QUADRIVALENT (batch number UT6259NA, expiry date 30 june 2019, route and site of administration were not reported) on 09 Oct 2018. It was a case of actual medication error as Inappropriate age at vaccine administration. It was unknown if any adverse event was 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Influenza like illness, Myalgia, Nausea
Clinical narrative: Approximately 2 days after receiving the vaccination the patient reports feeling like "the flu came to her". Episodes of nausea. Muscle soreness in the arm and also in other areas of the body. She reports still feeling nauseous. Pt has taken advil to help with some of the muscle pain.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests abnormal, Deafness, Deafness neurosensory, Dizziness, Tinnitus
Clinical narrative: The day following the exposure the employee/patient reported hearing loss along with light headed, vertigo and some tinnitus. This was most noticeable around 12 hrs after exposure. She is an audiologist. She had her hearing tested in her Audiology clinic and a 30db shift was noted in Low Frequency range. She consulted an ENT but was going to see and outside provider. She then prescribed steroids which corrected the hearing loss. She notes when she stopped taking them her hearing loss returned so she is currently still taking them. Her treating ENT has explained the symptoms may be considered Meniere's Disease but can not be for certain at this time.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Vertigo
Clinical narrative: The day following the exposure the employee/patient reported hearing loss along with light headed, vertigo and some tinnitus. This was most noticeable around 12 hrs after exposure. She is an audiologist. She had her hearing tested in her Audiology clinic and a 30db shift was noted in Low Frequency range. She consulted an ENT but was going to see and outside provider. She then prescribed steroids which corrected the hearing loss. She notes when she stopped taking them her hearing loss returned so she is currently still taking them. Her treating ENT has explained the symptoms may be considered Meniere's Disease but can not be for certain at this time.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Asthenia, Back pain, Discomfort, Headache
Clinical narrative: Muscle aches and joint pain all over body. Achy legs and lower back. Headache. Nausea, started around dinner time same day of flu shot. Woke up this morning with same symptoms to include weakness, uncomfortable feeling, extreme lower back pain, joint pain in hands and wrists. I did not feel like this prior to the vaccine. Still ongoing because it has not even been 24 hours. Not positive if Influenza type is correct***
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Nausea, Pain in extremity
Clinical narrative: Muscle aches and joint pain all over body. Achy legs and lower back. Headache. Nausea, started around dinner time same day of flu shot. Woke up this morning with same symptoms to include weakness, uncomfortable feeling, extreme lower back pain, joint pain in hands and wrists. I did not feel like this prior to the vaccine. Still ongoing because it has not even been 24 hours. Not positive if Influenza type is correct***
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling, Scab, Skin irritation
Clinical narrative: Pt stated that her arm was red and slightly swollen from the flu vaccine, when pt came into office on 10/16/2018, spot was a small scab and arm was minimally red and swollen.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Diplopia
Clinical narrative: Developed double vision. Confirmed by opthomologist following day. Follow up 5 days later demonstrated reduction in side effect but significant degree of double vision persists today.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age an gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster or shingles (date unspecified). On an unknown date in 2015, the patient was treated by the same physician for a vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered the events to be related to the ZOSTAVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unknown date in 2007, the patient was vaccinated with ZOSTAVAX as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, anatomical location, lot#, expiration date were unknown). The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles (onset date was not provided). On an unknown date in 2015, the patient was treated by the physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter determined the events to be related to the ZOSTAVAX.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation involving a male patient, age and medical history not provided. In 2012 the patient was inoculated with ZOSTAVAX vaccine by a physician for routine adult health maintenance and the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 10-JUL-2016 the patient was treated by a physician for onset of a blistering vesicular rash, which was diagnosed as severe herpes zoster or shingles The patient was prescribed VALTREX and tramadol for management of his painful symptoms and chronic pain. As a direct and proximate result of ZOSTAVAX or despite receiving ZOSTAVAX for prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering and other damages. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse via referring to a 11 years old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 11-OCT-2018, the patient was received one dose of improperly stored GARDASIL 9 (lot # R003557 with expiration date 20-DEC-2020; strength, dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. Temperature/Time frame: 47 degrees Fahrenheit (F) to 77F for 9 minutes and below 0 F for 24 hours. No previous temperature excursion was reported. Digital data logger was involved. This is one of two reports received from the same reporter (linked case # 1810USA007667).; Sender's Comments: US-009507513-1810USA007667:
Age: 0.58
Sex: M
Vaccine: HEP
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse via referring to a 7 months old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 11-OCT-2018, the patient was received one dose of improperly stored RECOMBIVAX HB (lot # R004185 with expiration date 06-NOV-2020; strength, dose, frequency and route were not reported) for prophylaxis. No adverse effects were reported. Temperature/Time frame: 47 degrees Fahrenheit (F) to 77F for 9 minutes and below 0 F for 24 hour. No previous temperature excursion was reported. Digital data logger was involved. This is one of two reports received from the same reporter (linked case # 1810USA007439). Sender's Comments: US-009507513-1810USA007439.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Pain in extremity
Clinical narrative: This spontaneous report was received from a pharmacist referring to an 84-year old male patient. The patient had no medical history, concurrent condition, drug allergies/reactions and concomitant medication. On 14-OCT-2018, the patient was vaccinated with PNEUMOVAX 23 (dosing details not provided) lot# R021048, expiry date: 14-APR-2020, intramuscularly to prevent pneumonia. On 16-OCT-2018, the patient called the pharmacy to report that he had redness at the injection site (injection site erythema) and his arm was extremely sore and he could barely use the arm (pain in extremity). The patient self-medicated with trolamine salicylate (ASPERCREME) to the arm and Ibuprofen (also reported as treatment: No). It was not known if the trolamine salicylate (ASPERCREME) or ibuprofen have provided any relief. The outcome of the events was reported as not recovered. Causality assessment for the events was not reported. The reporter considered the event of pain in extremity to be serious due to disability. Lot number R021048 has been verified to be valid for PNEUMOVAX 23.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Arthritis, Back pain, Condition aggravated, Fatigue
Clinical narrative: I asked for a preservative free vial. Late Monday and worse on Tuesday, Wed, I had very bad back pain and very bad right knee pain and aches all over. I already have dysfunction in the above areas, but did not have a flare up until I had the shot. It was as if all my arthritis conditions came flying out much worse than ever. I could barely walk. I felt shaky as well. I was just about to go to the doctor on Thursday when the pains subsided mostly (still in back somewhat), but I am left with fatigue which isn't like me. I am cautiously optimistic that I am mostly recovered, but really scared and scared about the future.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Fear, Gait disturbance, Nervousness, Pain
Clinical narrative: I asked for a preservative free vial. Late Monday and worse on Tuesday, Wed, I had very bad back pain and very bad right knee pain and aches all over. I already have dysfunction in the above areas, but did not have a flare up until I had the shot. It was as if all my arthritis conditions came flying out much worse than ever. I could barely walk. I felt shaky as well. I was just about to go to the doctor on Thursday when the pains subsided mostly (still in back somewhat), but I am left with fatigue which isn't like me. I am cautiously optimistic that I am mostly recovered, but really scared and scared about the future.
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Arm has hurt ever since. Pain constant but worse when raising arm or lifting. Pain around injection  site and up into shoulder. Primary care are writing this off as my body reacting oddly but 2 months of this is ridiculous. Pain is achy and becomes more noticeable on use.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure immeasurable, Dizziness, Feeling hot, Flushing, Hyperhidrosis
Clinical narrative: Patient awoke complaining of numerous muscle aches and pains. About 10 minutes later felt dizzy and flushed. Sat down, perspiring profusely and experienced full syncope. Placed patient in reclined position with feet up. Pulse faint but regular. Patient awoke in about 2 minutes complaining of feeling hot. Temperature was 97.1 F. Blood pressure could not be read during syncope, - instrument error on 2 readings. Blood pressure on waking was 110 over 50 mm Hg. Patient requested TYLENOL for aches. Recovery was uneventful.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pulse abnormal, Syncope
Clinical narrative: Patient awoke complaining of numerous muscle aches and pains. About 10 minutes later felt dizzy and flushed. Sat down, perspiring profusely and experienced full syncope. Placed patient in reclined position with feet up. Pulse faint but regular. Patient awoke in about 2 minutes complaining of feeling hot. Temperature was 97.1 F. Blood pressure could not be read during syncope, - instrument error on 2 readings. Blood pressure on waking was 110 over 50 mm Hg. Patient requested TYLENOL for aches. Recovery was uneventful.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt presented today complaining of red, swollen area around injection site. Area warm (not hot) to touch. Area of involvement is approx 4 inches in diameter. I recommended cold compress and antihistamine. I called the patient's PCP and arranged for patient to be seen today (11:45 appt).
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Pain, Rash, Swelling
Clinical narrative: Soreness, rash, swelling. Soreness started 2 days after injection and rash started 5 days after injection.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site infection
Clinical narrative: Injection site infection.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling down my arm all the way to my fingers.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Blood glucose, Confusional state, Fall, Lethargy
Clinical narrative: Patient presented as highly anxious during the administration of the flu shot. Flu shot was given. Patient subsequently stood from the chair and walked toward the front of the room. Staff and writer heard a noise and observed the patient on the ground toward the front of the room. No witness fully observed the action. Patient was conscious when writer intervened. Patient reported he "blacked out". Patient was pallor, lethargic, and somewhat confused about the events that had transpired. Patient became more alert as writer probed several health assessment questions. Writer lifted the patients legs up in the air for several moments and patient was educated about the intervention. The school nurse was called and further assessment was completed. After some time, patient stood on his own accord and care was fully transferred to the school nurse where he remained for some time. After the clinic had concluded, writer observed the patient in the school nurse's office without being in distress.
Age: 17.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Pallor
Clinical narrative: Patient presented as highly anxious during the administration of the flu shot. Flu shot was given. Patient subsequently stood from the chair and walked toward the front of the room. Staff and writer heard a noise and observed the patient on the ground toward the front of the room. No witness fully observed the action. Patient was conscious when writer intervened. Patient reported he "blacked out". Patient was pallor, lethargic, and somewhat confused about the events that had transpired. Patient became more alert as writer probed several health assessment questions. Writer lifted the patients legs up in the air for several moments and patient was educated about the intervention. The school nurse was called and further assessment was completed. After some time, patient stood on his own accord and care was fully transferred to the school nurse where he remained for some time. After the clinic had concluded, writer observed the patient in the school nurse's office without being in distress.