chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: FLU4
Symptoms: Exposure via skin contact, Underdose
Clinical narrative: attempted to inject it didn't go into the patients with no AE; he attempted to inject it didn't go into the patients but went all over his hand with no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an unknown age male patient for whom attempted to inject it didn't go into the patients but went all over his hand with no AE [Underdose] and [Exposure via skin contact], while he received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history was not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot UT 6686NA; Exp date: 30-Jun-2020] via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to vaccine underdose and Exposure via skin contact.  It was unknown if any adverse event occurred.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: nurse accidentally administered Flublok to a 17 year old patient, no AE; Initial information received on 22-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old patient of unknown age who had accidentally administered with a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number not reported) via unknown route in unknown administration site.  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.  At the time of reporting, no 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 holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: 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: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patients receiving Flublok Quadrivalent at age 16 and 17 years of age; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304580 and 2019SA304592.  This case involves Adult patient for whom receiving flublok quadrivalent at age 16 and 17 years of age (product administered to patient of inappropriate age) was reported, while he/she received vaccine influenza quadrivalent recombinant vaccine [Flublok Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose  dose of suspect influenza quadrivalent recombinant vaccine lot QFAA1938 via unknown route in unknown administration site for prophylactic vaccination.  It was a case of actual medication error due to product administered to patient of inappropriate age.   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.
Age: 17.0
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old patient received a dose of Flublok Quadrivalent, no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304580 (same reporter).  This case involves 17-year-old patient (gender not reported) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV](lot-QFAA1938 and Exp-30Jun2020) on an unknown date (reported as multiple patient's received a dose of FLUBLOK on 01-Oct-2019, 02-Oct-2019 and 03-Oct-2019 at the immunization fair).  Medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting the patient had no 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.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: fluzone high dose administered to 13 years old patient with no AE; fluzone high dose administered to 13 years old patient with no AE; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to case 2019SA311550 (same reporter).  This case involves a 13 years old male patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Lot no: UJ288AA, Expiry date: 02-Jun-2020) via intramuscular route in the left deltoid on 06-Nov-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 Inappropriate age at vaccine administration and overdose.  At the time of reporting, the patient had no 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.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Total time in excursion was 92 minutes and highest temp was 9.4 C/human error/no AE; one patient received Adacel after it underwent excursion/no AE; Initial information received on 07-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case was linked to 2019SA313263 (same reporter).  This case involves a patient of unknown demographics who received a dose of vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot U6378AA via unknown route in unknown administration site) on an unknown date after it underwent temperature excursion of 9.4 degree C for 92 minutes due to human error.  The patient's past medical history, concomitant therapy, medical treatment(s), vaccination(s) and family history were not provided.   It was of actual medication error case due to incorrect product storage and Poor quality vaccine administered.  It was unknown whether adverse event was experienced 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.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: The product reached room temperature for a cumulative time of 45 minutes. Caller states the excursion was due to a patient refusing the product after it had been prepared, no ae; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who was supposed to receive vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot number not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was potential medication error case due to incorrect product storage. The product reached room temperature for a cumulative time of 45 minutes. Caller states the excursion was due to a patient refusing the product after it had been prepared   No AE had been 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.  Information on the batch number was requested.
Age: 79.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: fluzone quadrivalent was inadvertently administered to 10 patients instead of fluzone HD, with no ae; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2019SA316262, 2019SA316289, 2019SA316290, 2019SA316263, 2019SA316286 and 2019SA316288 (same reporter).  This case involves a 79 year old female patient who received 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot no: UJ305AA, Expiry date: 30-Jun-2020) via intramuscular route in left deltoid on 07-Nov-2019 instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to wrong vaccine administered.  It was reported that Fluzone quadrivalent was inadvertently administered to 10 patients instead of Fluzone High dose.  At the time of reporting, the patient had no 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.
Age: 74.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient was inadvertently administered with Fluzone Quadrivalent instead of Fluzone HD, no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a Other Health Professional.  This case is linked to cases 2019SA316262, 2019SA316289, 2019SA316290, 2019SA316263, 2019SA316286 and 2019SA316288.  This case involves a 74 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UJ305AA, expiry date: 30-Jun-2020), via intramuscular route in the Right Deltoid, on 07-Nov-2019 instead of Fluzone HD (INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE).  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the wrong vaccine administered. It was reported that the Fluzone Quadrivalent was inadvertently administered to the patients instead of Fluzone HD.  At the time of reporting, the patient had no 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
Age: 75.0
Sex: F
Vaccine: FLU3, FLU4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Fluzone Quadrivalent was inadvertently administered to 72 year old patient instead of Fluzone HD/ no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to cases 2019SA316262, 2019SA316255, 2019SA316259, 2019SA316260, 2019SA316288, 2019SA316261, 2019SA316286 and 2019SA316263 (same reporter).  This case involves a 72 years old male patient who was inadvertently administered INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] instead of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 07-Nov-2019 the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ305AA, (Expiry date 30-JUN-2020)  via intramuscular route in the right deltoid.  It was actual medication error case due to wrong product administration.  No AE had been 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.
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising
Clinical narrative: black and blue from her  left elbow to her shoulder; Initial and live follow up information regarding this unsolicited valid non-serious case received from a pharmacist on 12-Nov-2019.  This case involves a 67 years old female patient who experienced black and blue from her  left elbow to her shoulder (Vaccination site discolouration), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On 30-Oct-2019, the patient received a dose  dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ288AA, Expiration date 30-JUN-2020 via intramuscular route in the left deltoid.  On an unknown date (unknown latency period) the patient experienced black and blue from her  left elbow to her shoulder (Vaccination site discolouration) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE.   It was not reported if the patient received a corrective treatment.  The outcome is reported as Unknown.
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Incorrect route of product administration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Injection site swelling, warm to touch erythema to the lower lateral third of upper left arm; Injection site swelling; Injection site tissue being warm to touch; Injection site skin with erythema to the lower lateral third of upper left arm; Injection site skin with induration; vaccine was administered Subcutaneous instated of intramuscular; pregnant woman (week 31 of pregnancy ) received ADACEL vaccine; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 34 years old pregnant female patient who experienced injection site swelling, warm to touch and erythema to the lower lateral third of upper left arm (vaccination site inflammation), (vaccination site swelling), (vaccination site warmth), (vaccination site erythema) and injection site skin with induration (vaccination site induration), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   Data regarding this pregnancy were received prospectively.   Events occurred at 31 weeks of pregnancy.  The date of last menstrual period was not reported.  Estimated date was reported as 09-Jan-2020.  The medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Influenza Vaccine for Immunization.  On 08-Nov-2019, the patient received a dose 0.5 mL of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6518AA via subcutaneous route in the left deltoid.  On unknown date, the patient developed a non-serious injection site swelling, warm to touch and erythema to the lower lateral third of upper left arm (vaccination site inflammation), (vaccination site swelling), (vaccination site warmth), (vaccination site erythema) and injection site skin with induration (vaccination site induration) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also the case of vaccine exposure during pregnancy and actual medication error due to inappropriate route of vaccination. The patient was 31 weeks pregnant when she received vaccine via subcutaneous route.  Treatment: the consumer came back to the clinic; that cold compress was applied to the area, and the clinic calling the manufacturer.  Pregnancy outcome was unknown at the time of report.  Outcome of the other events was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: TDAP
Symptoms: Injection site warmth
Clinical narrative: Injection site swelling, warm to touch erythema to the lower lateral third of upper left arm; Injection site swelling; Injection site tissue being warm to touch; Injection site skin with erythema to the lower lateral third of upper left arm; Injection site skin with induration; vaccine was administered Subcutaneous instated of intramuscular; pregnant woman (week 31 of pregnancy ) received ADACEL vaccine; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 34 years old pregnant female patient who experienced injection site swelling, warm to touch and erythema to the lower lateral third of upper left arm (vaccination site inflammation), (vaccination site swelling), (vaccination site warmth), (vaccination site erythema) and injection site skin with induration (vaccination site induration), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].   Data regarding this pregnancy were received prospectively.   Events occurred at 31 weeks of pregnancy.  The date of last menstrual period was not reported.  Estimated date was reported as 09-Jan-2020.  The medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Influenza Vaccine for Immunization.  On 08-Nov-2019, the patient received a dose 0.5 mL of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] lot U6518AA via subcutaneous route in the left deltoid.  On unknown date, the patient developed a non-serious injection site swelling, warm to touch and erythema to the lower lateral third of upper left arm (vaccination site inflammation), (vaccination site swelling), (vaccination site warmth), (vaccination site erythema) and injection site skin with induration (vaccination site induration) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  It was also the case of vaccine exposure during pregnancy and actual medication error due to inappropriate route of vaccination. The patient was 31 weeks pregnant when she received vaccine via subcutaneous route.  Treatment: the consumer came back to the clinic; that cold compress was applied to the area, and the clinic calling the manufacturer.  Pregnancy outcome was unknown at the time of report.  Outcome of the other events was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: FLU3
Symptoms: Insomnia, Mobility decreased, Muscle swelling, Myalgia
Clinical narrative: sleeping; abduction upper right bicep swelling; muscle pain- trouble with raising spoon to eat; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves Adult male patient who experienced abduction upper right bicep swelling (Muscle swelling), muscle pain- trouble with raising spoon to eat (Myalgia) and sleeping (Insomnia), while he received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number unknown).  On an unknown date, (latency: unknown) after receiving INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE patient experienced abduction upper right bicep swelling (Muscle swelling), muscle pain- trouble with raising spoon to eat (Myalgia) and sleeping (Insomnia).  It was not reported if the patient received a corrective treatment.  Outcome is reported as Not Recovered for all events.  Information about batch number is requested.
Sex: M
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Temperature that product was out of range: 27.5 F; Initial information received on 13-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 12 months old male patient who received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE and it was reported temperature that product was out of range: 27.5 f (Product storage error).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 13-Nov-2019, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE Suspension for injection in pre-filled syringe (batch number UT6656NA; expiration date 30-JUN-2020) via intramuscular route in the left vastus lateralis for prophylactic vaccination. Time Exposed: at least 7 hours below 32 F.   It was reported the patient received an invalid Fluzone Quadrivalent. Inactivated vaccines should be repeated as soon as possible.  It was a case of actual medication error due to incorrect product storage.   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 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.  No other information was reported.
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: has experienced persistent arm pain to the right arm described as occurring with any movement and the pain being severe; Initial information regarding an unsolicited valid non-serious case received from a nurse on 14-Nov-2019.  This case involves a 60 years old female patient who has experienced persistent arm pain to the right arm described as occurring with any movement and the pain being severe (Vaccination site pain), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.    On 07-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ256AB, Expiration date 30-JUN-2020) via intramuscular route in the right deltoid.  On an unknown date (unknown latency) the patient experienced persistent arm pain to the right arm described as occurring with any movement and the pain being severe (Vaccination site pain), following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome is reported as Not Recovered.
Age: 0.33
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 months old female during a well baby visit was administered Fluzone Quadrivalent; Initial information regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff) on 14-Nov-2019.  This case involves a 4 months old female patient for whom it was reported that 4 months old female during a well baby visit was administered fluzone quadrivalent (PT: Product administered to patient of inappropriate age), while she received vaccine INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  The patient's past medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included Prevnar 13, Pentacel and Rotavirus.  On 13-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED (lot number: UJ270AA) via intramuscular route in the left thigh for immunizations.  It was an actual medication error due to Inappropriate age at vaccine administration (PT: Product administered to patient of inappropriate age).  It was unknown whether any adverse event was 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."
Sex: U
Vaccine: FLU3, FLU4, FLUR4
Symptoms: Product storage error
Clinical narrative: exposed to 80 degrees F for 16 hours due to the refrigerator being; Initial information received on 14-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves a patient of unknown demographics who exposed to 80 degrees F for 16 hours due to the refrigerator being (PT: Product storage error), while he/she received vaccines INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient past medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE, INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot UJ285AA, expiration date 02-JUN-2020), INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot OFAA1926, (expiration date 30-JUN-2020) for prophylactic vaccination.  On an unknown date, it was reported that exposed to 80 degrees F for 16 hours due to the refrigerator being open a little bit. (PT: Product storage error).  Action taken, corrective treatment and event outcome was not applicable at the time of reporting.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Blood glucose normal, Eye movement disorder, Haemoglobin normal, Seizure
Clinical narrative: PATIENT GOT WEAK AND FAINTED AND HAD SEIZURE WITH EYES ROLLING BACK FOR ABOUT 10 SECONDS
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: PATIENT GOT WEAK AND FAINTED AND HAD SEIZURE WITH EYES ROLLING BACK FOR ABOUT 10 SECONDS
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Herpes zoster, Radial nerve injury, Urticaria
Clinical narrative: About 8.30pm, patient started feeling burning sensation on left arm near wrist down to fingers.    Next day sensation migrated to forearm and turned into pain. On 11/19 patient called Employee Health and sent to specialist in same facility.  Neurologist specified symptoms indicated radial nerve injury. Patient continued to work with Employee Health letting them know symptoms and progress. On 11/21 went to Dr., at same facility, and prescribed Gabapentin. Next day, 11/22, woke up in welts from shoulder blade to forearm. Patient went to Employee Health and sent to ER. At ER patient diagnosed with shingles and prescribed anti-viral.  There has been no improvement yet, shingles spread to wrist, palm and fingers.  Patient has appointment to see her personal PCP (Dr. or NP).   Last vaccine received was Flu shot last year with no problem.    On Sunday, patient was just laying down all day; Motrin is not helping much.
Age: 72.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Localized pain in the left arm. Rash that extends from injection size down to elbow. Rash is pink with a slightly red "crescent shaped" boarder on the outside of the arm. Swelling in the left arm (pt describes swelling to be about 1.5 times bigger than his right arm). Symptoms began yesterday evening and have continued this morning and are now slightly worse. He also complains that he is feeling "lousy". Doesn't think he has a fever. I have recommended that he apply a cool compress to the arm and alternate tylenol and ibuprofen for the swelling and pain. Pt suggested that he could take prednisone and I suggested that he should ask his doctor before doing that. Pt was worried that this is an infection, I assured him I do not believe that is what it is. I believe it is a common injection site reaction.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Malaise, Pain, Pyrexia
Clinical narrative: Broke out in shingles on left neck, chest area.  Symptoms started 72 hours after injection.  Low grade fever, body aches, malaise
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Rash macular
Clinical narrative: ABOUT 24HRS AFTER RECEIVING VACCINE PATIENT NOTICE THAT VACCINE SITE WAS SORE. UPON OBSERVATION IT WAS NOTED THAT IT WAS SWOLLEN, BLOTCHY RED, SHE ALSO C/O THAT IT WAS ITCHY AND WARM, SHE REPORTED THIS WHILE AT WORK TODAY 11/26/2019  NOON.
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: ABOUT 24HRS AFTER RECEIVING VACCINE PATIENT NOTICE THAT VACCINE SITE WAS SORE. UPON OBSERVATION IT WAS NOTED THAT IT WAS SWOLLEN, BLOTCHY RED, SHE ALSO C/O THAT IT WAS ITCHY AND WARM, SHE REPORTED THIS WHILE AT WORK TODAY 11/26/2019  NOON.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pyrexia, Rash
Clinical narrative: Fever, chills, rash, lethargy
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: inappropriate vaccine interval (from dose #3 to dose #4) early vaccination
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Influenza like illness
Clinical narrative: FLU LIKE SX
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Blood pressure increased, Chills, Fatigue
Clinical narrative: Pain, redness and bruising at the injection site on arm.  After 12 hours, headache began followed by severe shivering, then elevated blood pressure, muscle and joint pain and fever. Overall tired, loss of energy,  flu-like symptoms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Pain, redness and bruising at the injection site on arm.  After 12 hours, headache began followed by severe shivering, then elevated blood pressure, muscle and joint pain and fever. Overall tired, loss of energy,  flu-like symptoms.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Pain, redness and bruising at the injection site on arm.  After 12 hours, headache began followed by severe shivering, then elevated blood pressure, muscle and joint pain and fever. Overall tired, loss of energy,  flu-like symptoms.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Balance disorder, Decreased appetite, Hypersomnia, Pain, Pyrexia
Clinical narrative: Next morning, woke up and felt like out of balance and feverish.  Drank coffee and then slept for 22 hours.   When woke up, Fever continued, felt like hit over head, loss of appetite  and aching all over--felt dreadful.   Patient did not take any extra medicine than usual.   Symptoms lasted for 4 days.  A week later patient reported incident to the pharmacy.  Patient not sure if has received the Fluad vaccine before but has received Flu vaccine consistently in the past since she is a physician
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site movement impairment, Injection site pain
Clinical narrative: Vaccine was delivered IM on the upper region of the medial deltoid, near the acromion process. Approximately 2 hours after injection, loss of mobility in the shoulder was noted accompanied with pain. Possibility of the vaccine being delivered to the bursa due to location of injection
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Headache, Injection site pain, Myalgia, Nausea
Clinical narrative: Fever 101.5, pain at injection site, sore muscles in back and thighs, headache, nausea
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever 101.5, pain at injection site, sore muscles in back and thighs, headache, nausea
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site that spread across the arm, heat, swelling
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Influenza like illness
Clinical narrative: Dizziness, flu-like symptoms starting 9 hours after flushot and continuing until time of report (24 hours after incident); referred patient to primary care physician. Instructed patient to sit/stand slowly and use caution driving.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Pt reported severe redness and swelling at the injection site the day after receiving the vaccine that prompted her to go to the emergency room. She was diagnosed with cellulitis and given antibiotics. She reported the incident to us on 11/21 (received vaccine on 11/5) and was recovered by the time of the reporting.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: patient says action site got red, hot grown enlarged over the arm. She came back and pharmacist Dr. informed her that is the normal side effects and monitor for symptoms more than pain, redness, at the action site. Patient said she started having chest pain and went to see her PCP. They gave her an antibiotic and hydroxyzine. Spoke to patient 11/24 Monday, and she said redness, hotness, area of action site is gone. She says she has intermittent chest pain and will follow up with the dr. Last year she came here for the flu shot with no issues. Our procedure:with washed hands, we glove ourselves, alcohol the action site, use a sterile inject safe barrier, use sterile 1'' needle and inject through the inject barrier sticker. Patient saw us doing that and assumes it could be a fluke on her body where she was exposed somewhere after the shot.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Felt nausea's 5 minutes after administration. Patient vomited and felt dizzy. Monitored for 25 minutes.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Erythema, Headache, Injection site pain, Injection site pruritus
Clinical narrative: I had my 2nd Shingles vaccine on Thursday 11/21/19 and at first it just really hurt, but then I had some bad side effects from it. The brochure advised that I should inform you, so I'm letting you know. My shoulder was very red and a bit swollen, very painful, tylenol and aleve helped a bit, but I also got a bad headache and felt very weak and sick. This lasted for 2 days, then slowly improved. Now, 4 days out, my arm is slightly sore and I'm finally feeling back to normal. The injection site also itched a bit, but nothing major.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Malaise, Musculoskeletal pain, Pain in extremity, Swelling
Clinical narrative: I had my 2nd Shingles vaccine on Thursday 11/21/19 and at first it just really hurt, but then I had some bad side effects from it. The brochure advised that I should inform you, so I'm letting you know. My shoulder was very red and a bit swollen, very painful, tylenol and aleve helped a bit, but I also got a bad headache and felt very weak and sick. This lasted for 2 days, then slowly improved. Now, 4 days out, my arm is slightly sore and I'm finally feeling back to normal. The injection site also itched a bit, but nothing major.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Contusion, Injection site pain, Muscular weakness, Pain
Clinical narrative: RUNNING NOSE LIKE ALLERGY OFF AND ON, ON DAILY BASIS. BASEBALL SIZE BRUISE FOR 2 WEEKS. CONSTANT RIGHT SHOULDER PAIN WHEN ARM IS LIFTED AND WEAKNESS IN ARM. WORSENED JOINT PAIN AND SWELLING.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Rhinorrhoea, Swelling
Clinical narrative: RUNNING NOSE LIKE ALLERGY OFF AND ON, ON DAILY BASIS. BASEBALL SIZE BRUISE FOR 2 WEEKS. CONSTANT RIGHT SHOULDER PAIN WHEN ARM IS LIFTED AND WEAKNESS IN ARM. WORSENED JOINT PAIN AND SWELLING.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: He got a flu shot and fainted. He fainted few mins after the shot was given, it happened when he was standing in line to sign out for the shot. 911 was called, but dad refused. He woke up right away, the pharmacist on duty gave him water and orange juice. He was told to sit and put his head between his legs. He said he was fine and he left with his dad.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure fluctuation, Dizziness, Dyspnoea, Fatigue, Injection site rash
Clinical narrative: Blood pressure up and down, difficult to breathe,  dizzy, tiredness,  injection site swelling and fever, small bumbs around injection aite
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pyrexia
Clinical narrative: Blood pressure up and down, difficult to breathe,  dizzy, tiredness,  injection site swelling and fever, small bumbs around injection aite
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site induration, Injection site reaction, Injection site swelling, Livedo reticularis
Clinical narrative: PATIENT INITIALLY EXPERIENCED MOTTLING OF THE SKIN SURROUNDING THE INJECTION SITE BY ABOUT 1-1.5 SQUARE INCHES. THE SKIN WAS BROWNED AND DISCOLORED, IN ADDITION TO THE NORMAL EXPECTED SWELLING AND HARDENING OF THE LOCAL TISSUE. SHE DID NOT EXPERIENCE BRUISING. SHE TOOK HERSELF TO THE EMERGENCY ROOM TO BE INSPECTED FOR A SKIN INFECTION AND WAS TOLD IT WAS CLEAR OF INFECTION. TODAY, 11/26/19, SHE CAME TO THE PHARMACY TO SHOW ME THE SKING. I CAN SEE SLIGHT SLOUGHING OF THE SKIN IN THE CENTER NEAR THE INJECTION SITE AND STILL NO ADDITIONAL SWELLING NOR SPREADING OF THE MOTTLING OF THE SKIN.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: PATIENT INITIALLY EXPERIENCED MOTTLING OF THE SKIN SURROUNDING THE INJECTION SITE BY ABOUT 1-1.5 SQUARE INCHES. THE SKIN WAS BROWNED AND DISCOLORED, IN ADDITION TO THE NORMAL EXPECTED SWELLING AND HARDENING OF THE LOCAL TISSUE. SHE DID NOT EXPERIENCE BRUISING. SHE TOOK HERSELF TO THE EMERGENCY ROOM TO BE INSPECTED FOR A SKIN INFECTION AND WAS TOLD IT WAS CLEAR OF INFECTION. TODAY, 11/26/19, SHE CAME TO THE PHARMACY TO SHOW ME THE SKING. I CAN SEE SLIGHT SLOUGHING OF THE SKIN IN THE CENTER NEAR THE INJECTION SITE AND STILL NO ADDITIONAL SWELLING NOR SPREADING OF THE MOTTLING OF THE SKIN.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Nausea, Peripheral swelling
Clinical narrative: Beginning the morning after the vaccination (November 23rd), the patient experienced extreme nausea and a very swollen left arm. These symptoms resolved about 24 hours after onset. The patient stated that she did not feel completely  "like herself" until November 25th.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Arm pain
Age: 1.08
Sex: F
Vaccine: FLU4, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: High fever on day zero - greater than 104 Fahrenheit; rash day 11
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Cough, Oropharyngeal blistering, Pharyngeal swelling, Urticaria
Clinical narrative: Blisters in throat Swelling/whelps  Coughing
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Confusional state, Diarrhoea, Headache
Clinical narrative: Stated that less that one hour after injection at approximately 4:15pm, employee experienced diarrhea, confusion, and a headache. Donor states that she no longer feels confused.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone densitometry, Chills
Clinical narrative: OT CAME IN STORE TODAY 11/26/19 AM AND STATES THAT SHE EXPERIENCED BONEACHE (ESPECIALLY ARMS AND CHILL SIDE AFFECTS ON THE DAY AND LAST APPROXIMATELY 36 HOURS). AND SHE ASKING ME TO DO A VAERS REPORT, SHE SAID SHE IS NOT SURE TO GET A 2ND DOSE OF THIS INJECTION TO COMPLETE THE SERIES WHEN ASKING.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea
Clinical narrative: Light-headed and nausea starting the evening it was administered - Was resolved by the morning
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Dry mouth, Dry throat, Heart rate increased, Nausea
Clinical narrative: Caregiver given Hepatitis B vaccine (engerix) this afternoon. Caregiver called and stated she was fine right after the vaccine administration, but started to have adverse symptoms soon after while going home. Reported increased heartrate, dizziness, dry mouth and throat, felt like she was going to "throw-up" and a "squeeze" feeling in her throat as if she may throw-up. Stated she is not short of breathe nor does she have chest pain. Caregiver is currently with her significant other. Encouraged to stay with someone during at this time and advised to seek care as needed.
Age: 23.0
Sex: F
Vaccine: UNK
Symptoms: Oropharyngeal discomfort
Clinical narrative: Caregiver given Hepatitis B vaccine (engerix) this afternoon. Caregiver called and stated she was fine right after the vaccine administration, but started to have adverse symptoms soon after while going home. Reported increased heartrate, dizziness, dry mouth and throat, felt like she was going to "throw-up" and a "squeeze" feeling in her throat as if she may throw-up. Stated she is not short of breathe nor does she have chest pain. Caregiver is currently with her significant other. Encouraged to stay with someone during at this time and advised to seek care as needed.
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Hypersensitivity, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT RECEIVED BOTH FLUZONE QUAD AND PNEUMOVAX 23 ON SATURDAY NOVEMBER 23RD AND CALLED TODAY, TUESDAY NOVEMBER 26TH REPORTING A RASH, SWELLING, AND HEAT AT THE INJECTION SITE AS WELL AS OVERALL FEVER AND CHILLS.  I ADVISED HER TO GO TO HER PHYSICIAN OR AFTER HOURS TO BE CHECKED FOR AN INFECTION/CELLULITIS.  SHE WAS SEEN TODAY AND CALLED BACK THIS EVENING TO REPORT SHE DOES NOT HAVE AN INFECTION JUST AN ALLERGIC REACTION AND WAS GIVEN AN ANT-INFLAMMATORY SHOT BY THE DOCTOR'S OFFICE
Age: 36.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: PATIENT RECEIVED BOTH FLUZONE QUAD AND PNEUMOVAX 23 ON SATURDAY NOVEMBER 23RD AND CALLED TODAY, TUESDAY NOVEMBER 26TH REPORTING A RASH, SWELLING, AND HEAT AT THE INJECTION SITE AS WELL AS OVERALL FEVER AND CHILLS.  I ADVISED HER TO GO TO HER PHYSICIAN OR AFTER HOURS TO BE CHECKED FOR AN INFECTION/CELLULITIS.  SHE WAS SEEN TODAY AND CALLED BACK THIS EVENING TO REPORT SHE DOES NOT HAVE AN INFECTION JUST AN ALLERGIC REACTION AND WAS GIVEN AN ANT-INFLAMMATORY SHOT BY THE DOCTOR'S OFFICE
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: The patient fainted and was unconscious for about 30 seconds before waking up.  He rested for a few minutes and then felt better and left with his father.
Age: 30.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Injection site reaction, Rash erythematous
Clinical narrative: PATIENT STATES HE DEVEOLPED A RED RASH AROUND THE AREA THAT BECAME LARGE ENOUGH TO CAUSE CONCERN TO GO THE EMERGENCY ROOM TO HAVE IT LOOKED AT.  PATIENT STATES THE PHYSICIANS DIAGNOSED HIM WITH CELLULUITIS AND PUT HIM ON AN ANTIBIOTIC.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: pt reported itchiness, swelling, and redness at injection site bigger than 1in. returned to urgent care for recheck. prescribed Pepcid, Claritin, and triamcinolone cream
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash vesicular
Clinical narrative: Patient developed shingles like rash approx. 2 weeks post vaccination. Initial treatment is valacyclovir. Aditional information is unkown to the pharmacy