chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 43 years old patient (gender not reported) who received vaccine FLUZONE HIGH DOSE (batch number, expiry date, dose, route and site of administration were not reported) on 18-Sep-2018. 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. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Motion sickness, Nausea, Vomiting
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 72 years old female patient who experienced motion seems to make her feel worse so she has been lying down most of the day, dizzy, nauseous, and vomiting, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 24-Sep-2018, the patient received 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid, frequency = once (expiry date not reported). On 25-Sep-2018, one-day post-vaccination patient developed a non-serious motion seems to make her feel worse so she has been lying down most of the day, dizzy, nauseous, and vomiting following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was vomiting, nauseous, dizzy and motion seems to make her feel worse so she has been lying down most of the day. It was not reported if the patient received a corrective treatment. The outcome of the event reported as unknown. List of documents held by sender: none.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Malaise, Pyrexia
Clinical narrative: Headache,GI upset, Fever and Chills,general malaise. Neck rash appear on day #2 post injection.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Headache,GI upset, Fever and Chills,general malaise. Neck rash appear on day #2 post injection.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Borrelia test negative, Joint swelling, Peripheral swelling, Streptococcus test negative, Swelling face
Clinical narrative: Hives all over body, swelling in the face, hands, knees.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Hives all over body, swelling in the face, hands, knees.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Fatigue, Myalgia, Pyrexia
Clinical narrative: On Friday evening I started having fatigue,muscle aches, and fever. This continued through Saturday and Sunday, fever between 99.5 and 101.5. Sunday morning Istarted having severe and sudden onset diarrhea. Today is Monday and i am starting tofeel better, though continue to have some generalized fatigue.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Fatigue, Injection site pain, Malaise, Myalgia
Clinical narrative: Within 4 hours, fatigue, exhaustion, chills, night sweats, mild nausea, significant, all-over muscle pain. Rest and sleep mostly resolved fatigue. Persistent muscle pain and malaise the next morning.  Injection site hurt more than any other vaccination site, ever. Last year had NO side-effects from flu shot.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Night sweats
Clinical narrative: Within 4 hours, fatigue, exhaustion, chills, night sweats, mild nausea, significant, all-over muscle pain. Rest and sleep mostly resolved fatigue. Persistent muscle pain and malaise the next morning.  Injection site hurt more than any other vaccination site, ever. Last year had NO side-effects from flu shot.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Gave DTaP too soon.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Asthma, Condition aggravated, Respiratory disorder
Clinical narrative: Severe respiratory illness and worsening asthma within 24 hours of administration of the vaccine.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Pt developed a blanchable maculopapular rash on his abdomen about 15-20 minutes after receiving the Flu vaccine. Pt appears well and denies any itchiness associated with the rash. Pt has not had any difficulty breathing or any other acute symptoms. Pt has been given Orapred and Benadryl. After observation for 40 minutes the Pt appeared stable and well without any respiratory distress, although the Pt's rash is increasing in size and is spreading to his arms. I will refer the Pt over to the ED for further evaluation.
Age: 5.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant regarding unspecified patients of unknown age and gender. The patients' medical history and concurrent conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX lot # N021720 with expiration date: 10-AUG-2019 (dosing details and route of administration was not reported), for prophylaxis. The sterile diluent (lot# R002715 with expiration date: 20-FEB-2020), used for reconstitution of the VARIVAX, was stored at the proper temperatures. No adverse effects were reported. The storage temperature was minus (-) 9 degrees Centigrade (C) to 8 degrees C for 8 minutes (multiple excursion). There was no previous temperature excursion. Digital data logger was involved. This is a non-valid case due to lack of patient identifier. Follow up information was received on 26-SEP-2018. On 26-SEP-2018, a call was placed to the primary reporter. A receptionist answered the call and shared that the reporter no longer worked there. She transferred call to an other (unspecified reporter) and a request was made for patient identifiers and vaccination dates. Follow-up information was received was received from a non-healthcare professional concerning a 5 year old patient of unknown age. On 20-JUL-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021720 for prophylaxis. This is one of several reports received from the same reporter. Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to multiple patients of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were unknown. On unspecified dates in March 2018, the patients were vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N000175 and expiration date 20-SEP-2018), (lot # N013884 and expiration date 05-DEC-2018) and PNEUMOVAX 23 (dose, units and frequency unknown) (lot # N020688 and expiration date 09-MAR-2019). The temperature excursion was at 32 degree F to 35 degree F (35.1F) (degree Fahrenheit) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. This is a non-valid report due to lack of patient identifiers. As on 26-SEP-2018, all telephone attempts to obtain follow-up information have been unsuccessful. A request was made for patient identifiers and date of vaccination. Upon receipt of follow-up information it was determined that this case is now valid because patient identifiers was received. Follow up information has been received on 27-SEP-2018 referring to a patient of unknown gender, currently 38 year old. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, units and frequency unknown) (lot # N020688 and expiration date 09-MAR-2019) for prophylaxis. On 13-APR-2018, the PNEUMOVAX 23 underwent temperature excursion. It was also reported that, no doses of ROTATEQ (lot # N000175 and expiration date 20-SEP-2018) was administered. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1809USA013793: Original Case: 1804USA006915; US-009507513-1809USA013794: US-009507513-1809USA013795.
Age: 20.0
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report has been received from a physician referring to a 20 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were unknown. On 20-JUN-2018, the patient was vaccinated with the first dose of GARDASIL 9 (route, batch/lot# and expiration date unknown) for an unknown indication. On 15-AUG-2018, the patient was vaccinated with the second dose of GARDASIL 9 (route, batch/lot# and expiration date unknown). On 27-AUG-2018, the patient was inadvertently vaccinated with the third dose of GARDASIL 9 (route, batch/lot# and expiration date unknown) (inappropriate schedule of vaccine administration). No adverse effects reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions or medical history provided. Concomitant therapies were not provided. On 13-SEP-2018, the patient was vaccinated with improperly stored PROQUAD lot # R001543 with an expiration date 15-JUL-2019 (dose, route of administration, anatomical location and albumin status were not reported). Other suspect therapies included sterile diluent (MERCK STERILE DILUENT) lot# R002036 with an expiration date 03-AUG-2020 (dose, route of administration and anatomical location were not reported), which was stored appropriately. No adverse effect was reported. Administered vaccine experienced the temperature excursion from -14 to -10 degrees Celsius for 11 days. There was no previous temperature excursion. A digital data logger was involved. This is one of two reports received form the same reporter.; Sender's Comments: US-009507513-1809USA008626:
Age: 2.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a non-healthcare professional concerning a 2 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 18-APR-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021720 with expiration date: 10-AUG-2019 (dosing details and route of administration was not reported), for prophylaxis. The sterile diluent (lot# R002715 with expiration date: 20-FEB-2020), used for reconstitution of the VARIVAX, was stored at the proper temperatures. No adverse effects were reported. The storage temperature was minus (-) 9 degrees Centigrade (C) to 8 degrees C for 8 minutes (multiple excursion). There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter.
Age: 10.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a non-healthcare professional concerning a 10 year old patient of unknown gender. The patient's medical history and concurrent conditions were not reported. On 05-JUL-2018, the patient was vaccinated with improperly stored dose of VARIVAX lot # N021720 with expiration date: 10-AUG-2019 (dosing details and route of administration was not reported), for prophylaxis (Product storage error). The sterile diluent (lot# R002715 with expiration date: 20-FEB-2020), used for reconstitution of the VARIVAX, was stored at the proper temperatures. No adverse effects were reported. The storage temperature was minus (-) 9 degrees centigrade (C) to 8 degrees C for 8 minutes (multiple excursion). There was no previous temperature excursion. Digital data logger was involved. This is one of several reports received from the same reporter.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown gender, currently 11 month old. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N013884 and expiration date 05-DEC-2018) for prophylaxis. On 13-APR-2018, ROTATEQ underwent temperature excursion at 32 degree Fahrenheit (F) to 35F (35.1F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1804USA006915: Original Case : 1804USA006915 US-009507513-1809USA013794: Original Case : 1809USA013793 US-009507513-1809USA013795: Original Case : 1809USA013793.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown gender, currently 11 month old. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N013884 and expiration date 05-DEC-2018) for prophylaxis. On 13-APR-2018, ROTATEQ underwent temperature excursion at 32 degree Fahrenheit (F) to 35F (35.1F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1804USA006915: Original Case : 1804USA006915 US-009507513-1809USA013793: Original Case : 1809USA013793 US-009507513-1809USA013795: Original Case : 1809USA013793.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown gender, currently 2 month old. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant therapy were not reported. On an unknown date in 2018, the patient was vaccinated with improperly stored doses of ROTATEQ (dose, units and frequency unknown) (lot # N013884 and expiration date 05-DEC-2018) for prophylaxis. On 13-APR-2018, ROTATEQ underwent temperature excursion at 32 degree Fahrenheit (F) to 35F (35.1F) for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA006915: Original Case: 1804USA006915; US-009507513-1809USA013794: Original Case: 1809USA013793; US-009507513-1809USA013793: Original Case: 1809USA013793.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 58 years old male patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UI994AB, expiry date: 09-APR-2019 via intramuscular route in the left arm on 22-Sep-2018 (Frequency: once). 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. It was reported that they had an offsite flu clinic and a FLUZONE HIGH-DOSE injection was given to a Male patient, age 58 years. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Manufacturing product shipping issue, Product storage error
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 11 patients of an unknown demographics who received  a dose of FLUZONE HIGH DOSE which was might be unstable due to extended time in transit may be unstable due to extended time in transit time reported as 9-5. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ024AC expiry date: 29-Apr-2019 via unknown route. It was a case of actual medication error due to incorrect product storage. No known symptoms were reported for any patient. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 70 years old male patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant medication received. On 24-Sep-2018, the patient received a 0.5 ml single dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ022AB via intramuscular route in the left deltoid. It was a case of actual medication error due to Syringe issue, Exposure via skin contact and underdose. the nurse administering the vaccine to the patient said that when she pulled needle came of patient's skin the bulk of it leaked out. Caller said the leak was around hub where the needle was attached to syringe and also from the patient's arm when it was pulled out. She is not sure how much of the 0.5ml the patient actually got. She said it ran down his arm and she thinks he probably did not get much of the FLUZONE HD vaccine. They used a 1 inch needle. It was unknown whether 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.
Age: 17.0
Sex: M
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 17 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 24-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI995AA, expiry date 01 Apr 2018 via unknown route in the left deltoid. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 48 years old male patient who received vaccine FLUZONE HIGH DOSE who was less than 65 years old. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. It was reported no other vaccine were used. On 24-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI981AB expiry date: 16-Mar-2019 via intramuscular route at right upper extremity. It was a case of actual medication error due to inappropriate age at vaccine administration. No specific symptoms are being reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 11 number of elderly patient who was vaccinated with a dose of FLUZONE HIGH DOSE; lot UJ024AC and expiry date: 29-Apr-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to incorrect product storage. At this time no known reported symptoms from any patient. 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. List of documents held by sender: none.
Age: 3.0
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 38 months old patient who was vaccinated with 0.25 ml once dose of FLUZONE QUADRIVALENT (Batch number: UT6259LA and expiry date: 30-Jun-2019) via intramuscular route in the left thigh on 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported.  It was a case of actual medication error due to vaccine under dose because 0.25 ml (pediatric dose) was given to a 38 months old patient. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: None.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a ten- years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (carton Lot: UI985AC and Pre-filled syringe Lot: UI985AC) expiry date: 22-Mar-2019 via intramuscular route in the right deltoid on 13-Sep-2018 instead of vaccine FLULAVAL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient's concomitant medications included ACETAMINOPHEN for an unknown indication at a dose of 325 mg. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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 party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 32.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 32 years old male patient who received a 5 mL dose of vaccines FLUZONE HIGH DOSE lot UJ00AA, expiry date: 25-MAR-2019 via intramuscular route in the right arm on 19-Sep-2018, when he was supposed to have FLUZONE QUADRIVALENT. 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 wrong vaccine administered, overdose and Inappropriate age at vaccine administration. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown age of patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ024AA via intramuscular route in the right arm on 10-Sep-2018 and on 25 Sep 2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered. It was an actual medication error due to extra dose administered. It was reported that a patient may have received two doses of FLUZONE HD within 2 weeks on 10-Sep-2018 and on 25 Sep 2018. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 42 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE (batch number, expiry date, route and site of administration were unknown). 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. It was reported that a 42 years old female patient received FLUZONE HD. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Herpes pharyngitis
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 66 years old female patient who experienced herpes sore on her throat, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 04-Sep-2018, the patient received 0.5 mL dose of suspect FLUZONE HIGH DOSE lot UI993AB, expiry date: 18-MAR-2019 via intramuscular route in the left deltoid. On an unknown date, couple of days afterwards vaccination patient developed a non-serious herpes sore on her throat following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was a herpes sore on her throat. The patient was treated with VALTREX for Product used for unknown indication (1 Gram twice a day). The outcome of the event reported as unknown. List of documents held by sender: none.
Age: 0.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong patient received medication
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid serious case received from a pharmacist. This case involves one-day old female patient who accidentally received a 0.5 ml dose of FLUZONE QUADRIVALENT (batch number, expiry date, route and site of administration were not reported) which was ordered for her mother on an unspecified dose. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. No known reported symptoms. 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: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Asthma, Dyspnoea, Headache, Migraine
Clinical narrative: Within one hour of receiving the vaccine I began to have a headache, which has progressed into a migraine and continues to persist. This is day 6. Prescribed Maxalt, OTC Exedrin Migraine, and Ibuprofen have not been effective to relieve. I have taken more migraine medication in the past 6 days than I have in the past 6 months. I woke up on 9/27/18 having some difficulty breathing, feeling almost asthmatic, although I am not. That has since resolved. This is the first flu shot I recall getting.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: All symptoms occurred in right arm with the Pneumo Vaccination - Beginning pain in arm and shoulder at 7:00 pm - Pain became extreme in shoulder by midnight and throughout night - Could not lift the arm - By next morning arm was very swollen in shoulder and bicep and had a fever in the area - By 6:00 pm developed a rash on arm from injection site that radiated outward in all directions - Called pharmacy and advised to take Benadryl- Consulted with local pharmacist and was told that the amount of swelling was excessive- Pharmacist drew a line around rash and advised that if it spread to seek treatment at urgent care - Pain in arm still extreme- Took Benadryl at 7:00pm and slept for next 12 hours- Pain, rash and swelling began to subside slowly the next day- Fever at site took 2 more days to disappear- 4 days after vac, and symptoms had subsided- Both vacs were given at apex of shoulder directly into the rotator cuff and not in the correct lower position.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Product administered at inappropriate site
Clinical narrative: All symptoms occurred in right arm with the Pneumo Vaccination - Beginning pain in arm and shoulder at 7:00 pm - Pain became extreme in shoulder by midnight and throughout night - Could not lift the arm - By next morning arm was very swollen in shoulder and bicep and had a fever in the area - By 6:00 pm developed a rash on arm from injection site that radiated outward in all directions - Called pharmacy and advised to take Benadryl- Consulted with local pharmacist and was told that the amount of swelling was excessive- Pharmacist drew a line around rash and advised that if it spread to seek treatment at urgent care - Pain in arm still extreme- Took Benadryl at 7:00pm and slept for next 12 hours- Pain, rash and swelling began to subside slowly the next day- Fever at site took 2 more days to disappear- 4 days after vac, and symptoms had subsided- Both vacs were given at apex of shoulder directly into the rotator cuff and not in the correct lower position.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Herpes zoster, Pruritus, Rash papular, Secondary transmission
Clinical narrative: Classic shingles rash developed in L1-L2 dermatomes on right three days after immunization on the left (first dose of varicella given in right thigh in 2014). Rash was not vesicular but otherwise had classic red, bumpy appearance in clusters along dermatome distribution. Child complained of itching but not pain. 18 days after this child's shingles rash erupted her father (normal immune system, wild-type chicken pox in childhood) erupted in his first ever outbreak of shingles.
Age: 4.0
Sex: F
Vaccine: HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed to receive KINRIX, but received a 3rd HEP A in error.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Exposure via skin contact, Skin burning sensation
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional (Practice manager). This case involves a 25 years old female patient who experienced an accidental skin exposure, dysgeusia and burning skin, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history and family history were not provided. The patient did not receive any concomitant medication. On 26-Sep-2018, the patient exposed to a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot U6263CA, expiry date 30-Jun-2019 via skin contact. On 26-Sep-2018, it was reported that Medical assistant was drawing up a dose from single dose vial and when she was pushing out the air a small drop of vaccine landed on her left index finger and burning started immediately on that skin and she had a metallic taste in her mouth. The event outcome was reported as not applicable for an accidental skin exposure and as unknown for burning skin and dysgeusia. List of documents held by sender- none.
Age: 72.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Patient calling with c/o rash on chest that he noticed after shingles shot. Rash.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Pruritus
Clinical narrative: First of all could not answer all the above as I do not have that information. As I said received the Flu shot on Friday September 14, 2018 Was not sure of the exact time I had written. I would think between 12:30 & 1:00. My husband had it also. We went to the diner for breakfast and my LEFT ARM STARTED ITCHING. Then I saw the whole area get SUNBURN RED. This redness was about 3 inches long and 2 inches wide. TOOK A PHOTO OF IT AND IT IS STILL IN MY CAMERA IF YOU WISH TO SEE IT! Went in to see DOCTOR and he was surprised to see it. He did put me on CLARTIN in the morning, prescribed FLUOCINONIDE CREAM to put on the REDNESS & BENADRYL at night. We stayed in touch. The redness as of SEPTEMBER 26, has faded but I can still see it. No more itching either. BTW: I have a  GREAT CARING DOCTOR.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Influenza like illness, Injection site pain, Muscular weakness
Clinical narrative: Starting Friday patient experienced extremely painful area around administration site in the arm. The later she started to experience achy joints described as flu-like symptoms and extreme fatigue. On day 4 she reports about being 80% well with aches being gone but still muscle weakness.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site irritation, Injection site pain, Injection site warmth
Clinical narrative: Site of PNEUMOVAX shot is red, warm, and irritated. Pt says it hurts but is not itchy. Warm to touch. Has been taking Tylenol. She will let us know if it gets worse and we will call to follow up regardless.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: No unusual discomfort at the vaccine site at the time of administration. Later that day, the patient started noticing significant pain radiating down her arm. The pain spread to her forearm. She could not easily move the arm due to pain but was able to perform activities of daily living with great effort. The injection was administered on Wednesday. The patient approached me on Sunday stating that the pain was still significant but was improving. She stated that there was no visible sign of reaction at the injection site (redness, swelling, heat, or streaking). She could not take her jacket off to show me the site because of discomfort.
Age: 72.0
Sex: F
Vaccine: FLUA3, TDAP
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site haemorrhage, Injection site nodule, Injection site pain
Clinical narrative: RIGHT AFTER INJECTION; BLEEDING OCCURRED AND HUGE BRUISING AND A KNOT A ND SWELLING. I TOLD PT TO TAKE A ANTIHISTAMINE WHEN SHE GOT HOME AND APPLY A WARM WET WASHCLOTH AND ICE. I CALLED HER ON SATURDAY TO CHECK UP ON HER AND SHE SAID HER ARM WAS STILL HURTING BUT BETTER TODAY 9-29-18.
Age: 72.0
Sex: F
Vaccine: FLUA3, TDAP
Symptoms: Injection site swelling
Clinical narrative: RIGHT AFTER INJECTION; BLEEDING OCCURRED AND HUGE BRUISING AND A KNOT A ND SWELLING. I TOLD PT TO TAKE A ANTIHISTAMINE WHEN SHE GOT HOME AND APPLY A WARM WET WASHCLOTH AND ICE. I CALLED HER ON SATURDAY TO CHECK UP ON HER AND SHE SAID HER ARM WAS STILL HURTING BUT BETTER TODAY 9-29-18.
Age: 1.0
Sex: M
Vaccine: HIBV, MMRV, PNC13
Symptoms: Injection site erythema
Clinical narrative: Redness at injection site, temp of 100.2.
Age: 83.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Confusional state, Disorientation, Dizziness, Pain in extremity, Visual impairment
Clinical narrative: Patient received both vaccines in separate arms on Weds, 9/26. She reports feeling alright on Thursday with mild arm soreness, but waking up on Friday 9/28 with significant arm soreness (we told her it was possible), but more so concerning is that she reported significant disorientation, dizziness, and confusion that she is attributing to the vaccines. Spoke with the patient for the first time on 10/1 and she reports that she is forgetting dates and is still experiencing confusion and changes in vision. I suggested she call her physician to report her symptoms, and that they may do further testing to rule out other causes and that they may not be attributable to vaccine but that the doctor should be contacted regardless. She is concerned that the combination of the two vaccines has resulted in these symptoms.
Age: 64.0
Sex: M
Vaccine: YF
Symptoms: Asthenia, Dysstasia, General physical health deterioration, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: On March 25th I started to feel weakness in my thigh. On March 26th I started to feel progressive weakness to the extent that on March 28th I could not stand on my own and went to the ER. The diagnosis was Guillain-Barre Syndrome and was treated with plasma exchange. I was discharged to rehab on April 5 but had to return to the hospital due to further weakening after approx. one week. There I was treated with IVIG and then discharged once again to rehab. My condition continued to deteriorate to the point that I was essentially quadriplegic. In mid-May I was admitted back to hospital where steroid treatment commenced consistent with CIBD. This turned the corner for me and I have seen steady improvement over the past few months.
Age: 64.0
Sex: M
Vaccine: YF
Symptoms: Inflammatory bowel disease, Laboratory test, Muscular weakness, Plasmapheresis, Quadriplegia
Clinical narrative: On March 25th I started to feel weakness in my thigh. On March 26th I started to feel progressive weakness to the extent that on March 28th I could not stand on my own and went to the ER. The diagnosis was Guillain-Barre Syndrome and was treated with plasma exchange. I was discharged to rehab on April 5 but had to return to the hospital due to further weakening after approx. one week. There I was treated with IVIG and then discharged once again to rehab. My condition continued to deteriorate to the point that I was essentially quadriplegic. In mid-May I was admitted back to hospital where steroid treatment commenced consistent with CIBD. This turned the corner for me and I have seen steady improvement over the past few months.
Age: 44.0
Sex: M
Vaccine: TD
Symptoms: Local reaction, Pain in extremity, Peripheral swelling
Clinical narrative: Localized swelling of L arm. No redness/warmth. Pain and swelling better 10/1/18 when patient reported event to writer.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Loss of consciousness
Clinical narrative: Patient was given vaccine on 9/25/18 and called on 9/27/18 stating after she got the vaccine on 9/25/18 that she felt dizzy and kept passing out and this last 3 hours and didn't seek emergency services.
Age: 59.0
Sex: M
Vaccine: FLU4
Symptoms: Neuralgia, Night sweats
Clinical narrative: AFTER FLU SHOT WAS GIVEN PATIENTS REPORTS NERVE PAIN IN HIS ARM AND OVER THE WEEKEND THE NERVE PAIN TRAVELED TO HIS LOWER LEGS AND FEET. HE ALSO REPORTED NIGHT SWEATS FOR TWO NIGHTS.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Mental status changes, Pyrexia
Clinical narrative: Fever, and change of mental status.
Age: 67.0
Sex: F
Vaccine: FLUA3, PPV, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Right arm deltoid spreading to bicep redness, slight induration, itchiness (pruritus) erythema.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Nausea, Pain, Peripheral swelling
Clinical narrative: BAD RASH EXTENDED 4 INCHES BY 2 INCHES, SWELLING, COULD NOT LIFT ARM AFTER TWO DAYS, EXTREME FEVER AND CHILLS, NAUSEA, SWELLING ON ARM - RASH, SWELLING, PAIN HAS LASTED 5 DAYS SO FAR .
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash, Swelling
Clinical narrative: BAD RASH EXTENDED 4 INCHES BY 2 INCHES, SWELLING, COULD NOT LIFT ARM AFTER TWO DAYS, EXTREME FEVER AND CHILLS, NAUSEA, SWELLING ON ARM - RASH, SWELLING, PAIN HAS LASTED 5 DAYS SO FAR .
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Contusion, Dizziness, Headache, Peripheral swelling
Clinical narrative: Swollen upper arm, bruise (lasted 5 weeks), weak, dizziness, headache - would go away, bruises under fingernails.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: Redness and swelling of arm that was extremely painful and itchy.
Age: 49.0
Sex: F
Vaccine: VARCEL
Symptoms: Tongue ulceration
Clinical narrative: Sore on tongue.
Age: 12.0
Sex: F
Vaccine: FLUC4
Symptoms: Blood pressure abnormal, Loss of consciousness, Pulse abnormal
Clinical narrative: About 3-5 minutes after receiving the injection the patient passed out for about 20 seconds before coming to. This happened two more times over the next 10-15 minutes.
Age: 32.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, induration and tenderness at injection site (left arm).