chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 4.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA284722, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a four years old patient who received vaccine FLUZONE QUADRIVALENT that was outside of the recommended temp range below 32 Fahrenheit. The patient's past medical history and concomitant medication were not provided. On 02-Oct-2018, the patient received a dose of suspect QUADRIVALENT INFLUENZA VACCINE (lot number U1997AA) via intramuscular route in the left deltoid. It was a case of actual medication error due to product storage error. It was not known 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information regarding an unsolicited valid non-serious case received on 10-Oct-2018 from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a three year old patient (gender was not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number U1997AA and expiry date 30-Jun-2019) via intramuscular route in the left thigh on 02-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage (patients were given vaccines that were outside of the recommended temp range (below 32F)). No information about any 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 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: 12.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754 (same reporter). This case involves a 12-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number UJ025AC and Exp. date 02-Oct-2018) via intramuscular route in the left deltoid on   02-Oct-2018, which was outside of the recommended temp range (below 32F).  The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any 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 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: 18.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves an eight year old  patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number and Exp. date not reported) via intramuscular route in the right deltoid on 03-Oct-2018, which was outside of the recommended temp range (below 32F). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any 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 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: 5.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a 5 years old patient (gender not reported) who received vaccine FLUZONE QUADRIVALENT lot U1997AA via intramuscular route in the left deltoid on 03-Oct-2018 (expiry date 30-Jun-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that patient was given vaccines that were outside of the recommended temp range (below 32F). It was unknown if any adverse event experienced. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284754, 2018SA284750 (same reporter). This case involves a three years old patient who received vaccine FLUZONE QUADRIVALENT lot U1997AA via intramuscular route in the left vastus lateralis on 03-Oct-2018 (expiry date 30-Jun-2019). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to Incorrect product storage. It was reported that patients were given vaccines that were outside of the recommended temp range (below 32F). It was unknown if 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 holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284755, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284750 (same reporter). This case involves an eight year old patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number U1997A and Exp. Date 30 Jun 2019) via intramuscular route in the left deltoid on 03-Oct-2018, which was outside of the recommended temp range (below 32F). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any 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: 6.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA284722, 2018SA284723, 2018SA284724, 2018SA284725, 2018SA284726, 2018SA284727, 2018SA284728, 2018SA284729, 2018SA284730, 2018SA284731, 2018SA284733, 2018SA284732, 2018SA284734, 2018SA284735, 2018SA284736, 2018SA277767, 2018SA284721, 2018SA284751, 2018SA284752, 2018SA284746, 2018SA284747, 2018SA284748, 2018SA284749, 2018SA284753, 2018SA284754, 2018SA284750 (same reporter). This case involves a six-year-old patient (gender not reported) who was vaccinated with a dose of FLUZONE QUADRIVALENT (lot number- U1997AA and Exp. date 30-Jun-2019) via intramuscular route in the left deltoid on 03-Oct-2018, which was outside of the recommended temp range (below 32F). The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No information about any 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.
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 51 years old male patient who still complains of pain in left arm, sore to touch and during movement, while he received vaccine ADACEL. The patients past medical history and family history were not provided. Concomitant medications included FLUARIX in left arm on unknown date (Batch number not provided). On an unknown date, the patient received a 0.5ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine, lot U5829AB, expiry date 24-Nov-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious complains of pain in left arm, sore to touch and during movement (pain in extremity) one week following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine. Lab data was not provided. Final diagnosis was complains of pain in left arm, sore to touch and during movement. No corrective treatment was received. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for complains of pain in left arm, sore to touch and during movement. List of documents held by sender- none.
Sex: U
Vaccine: FLUR4
Symptoms: Erythema, Pain, Paraesthesia oral, Skin warm, Swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a patient (age and gender not reported) who had pain, large red raised area warm to touch and pins and needles to her lips, 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 an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number: QFAA1827 and 30-Jun-2019) (dose, dose in series, route and site of administration was not reported). On an unknown date, following the vaccination the patient experienced pain, large red raised area warm to touch and pins and needles to her lips. (Other relevant tests included no lab data.) Final diagnosis was pain, large red raised area warm to touch and paraesthesia oral. 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: F
Vaccine: FLU4
Symptoms: Incorrect route of product administration, Product administered at inappropriate site
Clinical narrative: Initial and live follow-up information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female (age reported as 36) patient who received 0.5 ml of vaccine FLUZONE QUADRIVALENT (lot number not reported) via subcutaneous route instead of intramuscular route in further back of right arm and not in Deltoid muscle (wrong location). 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 route of vaccination and vaccine administered at inappropriate site. The patient was not having any problems and has not been seeking any treatment. 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: 4.0
Sex: M
Vaccine: DTAPIPV, IPV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from Other Health Care Professional. This case involves a four-years old male patient who received 2 IPV doses; one with IPOL lot NIG511 via unknown route in unknown administration site and one as part of KINRIX not produced by Sanofi Pasteur lot number not reported via unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA ZOSTER VACCINE for Immunisation. It was a case of actual medication error due to extra dose administered. 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 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: Incorrect dose administered
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 a less than 3 years old male patient who received 0.5 ml of vaccine FLUZONE QUADRIVALENT (lot UJ025AC, exp date: 30-Jun-2019) via unknown route in right deltoid. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccine was given. It was a case of actual medication error due to overdose. (It was reported that FLUZONE QUAD 0.5 mL dose given to child under 3, patient received pre-filled syringe 0.5 mL dose instead of indicated 0.25 mL.). 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 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: FLU3
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 pharmacist. This case involves a 57 years old male patient who received vaccine FLUZONE HIGH DOSE. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. On 12-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AB, expiry date May-2019 via unknown route in the left arm. It was an actual medication error due overdose and inappropriate age at vaccine administration. It was reported that a male 57-year-old patient received the FLUZONE HD. The pharmacist states that it most likely occurred due to the similar sounding name of FLUZONE HD vs FLUZONE QUADRIVALENT. 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: F
Vaccine: RAB
Symptoms: Product administered at inappropriate site
Clinical narrative: Initial information received on 14-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient of an unknown age who received a dose of IMOVAX RABIES lot number not reported via unknown route in gluteal area on an unknown date. The patient's past medical history included bat attack on face. The patient's medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine administered at inappropriate site as the vaccine was administered into the gluteal area which was not supposed to be administered into the gluteal area. It was unknown whether the patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 88.0
Sex: M
Vaccine: FLUX
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an 88 years old male patient who received Influenza Vaccine twice. At the time of the event, the patient had ongoing Dementia. The patient's concomitant therapy was not reported. On an unknown date in September 2018, patient received a dose of suspect Influenza Vaccine (lot number and expiry date not reported) and on 12-Oct-2018, the patient received another dose of suspect Influenza Vaccine (lot number and expiry date not reported). It was a case of actual medication error due to extra dose administered. It was unknown if adverse event occurred 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.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Vaccination site inflammation
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA286240, 2018SA286241, 2018SA286245, 2018SA286243, 2018SA286244 (Same patient). This case is for patient number: 06. This case involves a female patient (age unknown) who experienced vaccination site inflammation, while she received vaccine FLUZONE. The patient's past medical history was not provided. No concomitant medications were taken. On 09-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AA. On an unknown date, 48 hours post vaccination, the patient developed significant local redness and swelling that warm to the touch and the location of reaction was right below the injection. (Other relevant tests included no lab data.) Final diagnosis was vaccination site inflammation. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for vaccination site inflammation.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to cases 2018SA286233, 2018SA286243, 2018SA286240, 2018SA286245, 2018SA286244 and 2018SA286242. This case involves a patient (age and gender were not reported) who experienced local redness and swelling that warm to the touch, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Details of concomitant medication was not provided. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (frequency once) lot U1982AA via unknown route and administration site. On an unknown date, 48 hours of post vaccination the patient developed a non-serious events of local redness and swelling that warm to the touch following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was also mention that the location of reaction is right below the injection. Details of lab date was not provided. Final diagnosis was local redness and swelling that warm to the touch. It was not reported if the patient received a corrective treatment. The patient outcome was reported as unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This was linked with Case ID 2018SA286240, 2018SA286241, 2018SA286245, 2018SA286243, 2018SA286244 and 2018SA286233. This case involves Adult female patient who experienced significant local redness and swelling that warm to the touch, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 09-Oct-2018, the patient received a dose of suspect Influenza Quadrival A-B Vaccine (frequency once), lot U1982AA via unknown route in unknown anatomical site. On 12-Oct-2018, 48-hours post vaccination the patient developed a non-serious significant local redness and swelling that warm to the touch (vaccination site inflammation) following the administration of Influenza Quadrival A-B Vaccine. (Other relevant tests included no lab data.) Final diagnosis was significant local redness and swelling that warm to the touch. No corrective treatment was received. The event outcome was reported as Unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This was linked with Case ID 2018SA286240, 2018SA286241, 2018SA286245, 2018SA286242, 2018SA286244 and 2018SA286233. This case involves a female patient (age not reported) who experienced redness and swelling that warm to the touch, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatments, vaccinations and family history were not provided. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U1982AA via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious significant local redness and swelling that warm to the touch three days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included No lab data.) Final diagnosis was redness and swelling that warm to the touch. No corrective treatment was received. The event outcome was reported as Unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site extravasation
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 75 years old female patient who received vaccine FLUZONE HIGH DOSE lot UJ030AB, expiry date:05-05-2019 via unknown route in the left deltoid on 03-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Vaccine underdose. It was reported that when removed the bandage it was saturated with liquid and not blood. She was concerned she didn't get the full vaccine 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.
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 involves a female patient (age not reported) who experienced swelling at the site about 10-15 cm in size with redness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and concomitant medications were not provided. On 11-Oct-2018, the patient received a single 0.5 ml dose of suspect Influenza Quadrival A-B Vaccine, lot UJ035AA via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious swelling at the site about 10-15 cm in size with redness following the administration of Influenza Quadrival A-B Vaccine. (Other relevant tests included no lab tests.) Final diagnosis was swelling at the site about 10-15 cm in size with redness. It was unknown if corrective treatment was received by the patient or not. 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: 70.0
Sex: M
Vaccine: FLU3
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 cross linked to case 2018SA286322 and 2018SA286331, 2018SA288492 and 2018SA288497 (same reporter). This case involves a 70 year old male patient who experienced right deltoid was swollen about 10-15 cm at the site with redness, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On 10-Oct-2018, the patient received a single dose of suspect FLUZONE HIGH DOSE (lot UJ037AB), expiry date 12 June 2019 in the right deltoid. On an unknown date, the patient developed a non-serious Right deltoid was swollen about 10-15 cm at the site with redness, following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was swelling at the site about 10-15 cm in size with redness. It was unknown if corrective treatment was received by the patient or not. The outcome of the event was not reported. List of documents held by sender- none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves female patient (age not reported) who experienced very hot to the touch, upper arm pain, upper arm itchy and whole upper arm swelling and redness, while she received vaccine FLUZONE QUADRIVALENT. The patients 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 not reported via unknown route in unknown administration site. On an unknown date, the patient experienced a non-serious very hot to the touch (sensation of heat), upper arm pain (painful arm), upper arm itchy (pruritus) and whole upper arm swelling and redness (vaccination site inflammation) (Unknown latency) following the administration of Influenza Quadrival A-B Vaccine. Other relevant tests included no lab data. Final diagnosis was whole upper arm swelling and redness, upper arm itchy, upper arm pain and very hot to the touch. It was not reported if the patient received a corrective treatment. The patient outcome is not reported for all the events. List of documents held by sender: none.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Paraesthesia
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 78 years old female patient who experienced terrible tingling- All over body and joint pain, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Paraesthesia. The patient's past vaccination(s) included FLUZONE HIGH DOSE. The patient's past medical treatment(s) and family history were not provided. On 02-Oct-2018, the patient received a 0.5 mL dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported (expiry date, route and site of administration were not reported). On an unknown date, the patient developed a non-serious terrible tingling- All over body (paraesthesia) and joint pain (arthralgia) following the administration of Influenza USP Trival A-B High Dose Subvirion Vaccine. Other relevant tests included No lab data. Final diagnosis was joint pain and terrible tingling- all over body. It was not reported if the patient received a corrective treatment. The outcome of the events not reported. Additional information downloaded from Regulatory Authority database (level 2B) was received from consumer on 15-Oct-2018. Patient's past medical history updated. Additional information downloaded from Regulatory Authority database (level 2B) was received from consumer on 15-Oct-2018. No new information received. List of documents held by sender- none.
Sex: U
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case involves a 62 years old patient (gender not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiration date, dose, route and site of administration was not reported) on an unspecified 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 and vaccination overdose. No information about any 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.
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old patient (gender not reported) who was vaccinated with a 0.5 ml dose of QUADRACEL (lot C5447AA and Exp date 18 Oct 2019) via unknown route in the right deltoid on 28-Sep-2018 a component of the PENTACEL instead of having both vials reconstituted and administered together. The patients medical history and concomitant medications were not reported. Concomitant medications included MMR for Immunisation; and VARICELLA VACCINE for Immunisation. It was an actual medication error due to inappropriate reconstitution technique. No information about any 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.
Sex: U
Vaccine: FLU4
Symptoms: Syringe issue, 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 patient of an unknown demographics who received a dose of FLUZONE QUADRIVALENT (lot UJ041AA, expiry date: 30-Jun-2019) (dose, route and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine underdose. It was reported that the syringe was cracked by where the bar code would be and vaccine squirted from the side. Nurse was unsure if the consumer received any or just part of the vaccine. It was also case of syringe issue. It was unknown whether patient experienced any adverse reaction after vaccination. Product complaint number reported as CO2018-00337. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Injection site rash, Rash
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a non-healthcare professional. This case involves a 24 years old female patient who experienced rash around the injection site that had moved down her arm, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 01-Oct-2018, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI997AA via intramuscular route in the left deltoid. The patient developed a non-serious rash around the injection site that had moved down her arm (rash generalised), on the same day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was reported that she had experienced these symptoms for the past two weeks. Relevant tests were not reported. Final diagnosis was rash around the injection site that had moved down her arm. Medical care sought on 15-Oct-2018 and Cortisone Cream 1% prescribed to be used daily. The outcome of the event was not reported. Documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLU3
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 cross linked to case 2018SA286322 and 2018SA286331, 2018SA288492 and 2018SA288497 (same reporter). This case involves a 79 year old male patient who experienced swollen about 10-15 cm at the injection site with redness, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history and concomitant medications were not provided. On 10-Oct-2018, the patient received a single dose of suspect FLUZONE HIGH DOSE lot UI985AC, expiry date 22-MAR-2019. On an unknown date, the patient developed a non-serious swollen about 10-15 cm at the injection site with redness, following the administration of FLUZONE HIGH DOSE. (Other relevant tests included no lab tests.) Final diagnosis was swollen about 10-15 cm at the injection site with redness. Corrective treatment was reported as treat with ice and alcohol compresses. The outcome of the event was not reported. List of documents held by sender- none.
Age: 20.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Erythema, Exposure during pregnancy, Feeling hot, Rash, Rash pruritic
Clinical narrative: Patient called in on 10/16 and stated that she had received both the flu shot and Tdap yesterday at her appointment and last night her face was red and hot. States this morning it was red, hot, with a rash on both side of her face that was very itchy. Patient recommended to take BENADRYL as directed on box until rash went away. Recommended to go to ER if she started to have trouble breathing. Patient is G1P0, 29 weeks gestation with EDD 12/27/18.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: A child ages 2 year 11 months received FLUZONE QUADRIVALENT .5ml instead of the FLUZONE QUADRIVALENT .25 ml.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Bursitis, Injected limb mobility decreased, Laboratory test, Loss of personal independence in daily activities
Clinical narrative: I had flu shot on Oct 1, shot was given very high on shoulder-later that day could not move arm up and out-pain began and mobility/strength decreased (unable to get shirt off and on/comb hair, etc)-let Dr. know and saw office Oct 4-impression bursitis and advised to take anti-inflammatory, warm/cold compress, light movement w/ no weight workouts for two weeks; did not resolve so visited Orthopedic on Thursday 10/18-diagnosed w/ rotator cuff tendon injury "tendinitis"-PT, anti-inflammatory shot and home exercises ordered to try to resolve this injury.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered at inappropriate site, Rotator cuff syndrome, Tendonitis, X-ray
Clinical narrative: I had flu shot on Oct 1, shot was given very high on shoulder-later that day could not move arm up and out-pain began and mobility/strength decreased (unable to get shirt off and on/comb hair, etc)-let Dr. know and saw office Oct 4-impression bursitis and advised to take anti-inflammatory, warm/cold compress, light movement w/ no weight workouts for two weeks; did not resolve so visited Orthopedic on Thursday 10/18-diagnosed w/ rotator cuff tendon injury "tendinitis"-PT, anti-inflammatory shot and home exercises ordered to try to resolve this injury.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema
Clinical narrative: Red area appeared. Skin intact Ice applied.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Influenza like illness, Injection site swelling, Ocular discomfort
Clinical narrative: Pressure behind the eyes, achy joints, swollen injection site, mild fever, chills, flue-like symptoms.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Pressure behind the eyes, achy joints, swollen injection site, mild fever, chills, flue-like symptoms.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Palpitations
Clinical narrative: Heart palpitations, headache, shortness of breath continue at this time per pt. for palpitations, pt. made appt. with cardiology for evaluation.
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient had a 4in by 4in red 2 inches under the injection site of the vaccine.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Dyskinesia, Nausea, Pallor, Posture abnormal, Vomiting
Clinical narrative: As MA pulling out needle from Right deltoid, patient exhibited jerky movements, head tilted back, eyes open, no loss of consciousness, became pale, complained of nausea, vomited.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram normal, Intensive care, Laboratory test, Loss of consciousness, Pyrexia
Clinical narrative: Patient developed a fever around midnight of 8/21. At 4:30 AM his wife found him having a seizure, 3 in a row, without gaining consciousness in between. He was transferred via ambulance to Hospital. He was then transferred on 8/21 to another Hospital. He was treated with sedation, then started on KEPPRA and VIMPAT. It was 10 days before he regained consciousness, and he was in the neurological ICU the whole time. He was subsequently transferred to the stroke floor, then discharged to a rehabilitation facility on 9/19/18.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Seizure
Clinical narrative: Patient developed a fever around midnight of 8/21. At 4:30 AM his wife found him having a seizure, 3 in a row, without gaining consciousness in between. He was transferred via ambulance to Hospital. He was then transferred on 8/21 to another Hospital. He was treated with sedation, then started on KEPPRA and VIMPAT. It was 10 days before he regained consciousness, and he was in the neurological ICU the whole time. He was subsequently transferred to the stroke floor, then discharged to a rehabilitation facility on 9/19/18.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling
Clinical narrative: REDNESS DESCENDING DOWN ARM TOWARD ELBOW, SWELLING, HARDNESS, AND PAIN. BEGAN THE EVENING OF 10/15/18.
Age: 56.0
Sex: F
Vaccine: FLUR4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Within 10 min of injection of the egg free flu vaccine. I experienced swelling, pain and redness below the injection site that has continued into the second day.
Age: 64.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Client reported that 6 days after vaccine she developed a quarter size red mark on her arm that then developed to the size of a cupcake. Denies pain, just redness and itching.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Administration site swelling, Injection site erythema, Injection site pruritus
Clinical narrative: Redness, swelling and itching at the site of administration.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Mass, Pruritus, Skin warm
Clinical narrative: 10/4/18-hard lump, surrounding area warm, swollen, red, and itchy. Continues as such until today 10/19/18.