chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298678, 2018SA298675 and 2018SA298674, same reporter. This case involves a 44 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, family history were not provided. No other vaccines were administered. On 25-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA, expiry date 15-May-2019 via intramuscular route in the left arm. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 44 years patient was inadvertently administered FLUZONE HIGH DOSE. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298674, 2018SA298672, 2018SA298677, 2018SA298679, 2018SA298676, 2018SA298678, 2018SA298675 and 2018SA298676, same reporter. This case involves a 46 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On 25-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA, expiry date 15-May-2019 via intramuscular route in the left deltoid. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 46 years patient was inadvertently administered FLUZONE HIGH DOSE. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298672, 2018SA298673, 2018SA298675, 2018SA298676, 2018SA298677, 2018SA298678 and 2018SA298679. This case involves a 59 years old female patient who was inadvertently administered a 0.5 ml dose of vaccine FLUZONE HIGH DOSE (lot UJ039AA and Exp. Date 15-MAY-2019) via intramuscular route in the left deltoid on 25-Oct-2018. The patients past medical history included Hysterectomy. It was an actual medication error due to inappropriate age at vaccine administration and accidental overdose. No any information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298674, 2018SA298672, 2018SA298676, 2018SA298673, 2018SA298677, 2018SA298679 and 2018SA298678, same reporter. This case involves a 51 years old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On 25-Oct-2018, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA, expiry date 15-May-2019 via intramuscular route in the left arm. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that 51 years patient was inadvertently administered FLUZONE HIGH DOSE. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298677, 2018SA298678, 2018SA298675 and 2018SA298672 (same reporter). This case involves a 32 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ039AA, expiry date: 15-May-2019 via intramuscular route in hip on 25-Oct-2018. The date of last menstrual period was 08-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to Overdose and Inappropriate age at vaccine administration. It was reported that inadvertently administered FLUZONE HIGH DOSE who was less than 65 years of age. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298674, 2018SA298672, 2018SA298676, 2018SA298673, 2018SA298676, 2018SA298678, 2018SA298675, 2018SA298672. This case involves female patient who experienced inadvertently administered FLUZONE HIGH DOSE to 32 year old patient, no adverse event, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history included Hysterectomy. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On 25-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA in the left arm, expiration date- 15-May-2019. It was also a case of actual medication error due Inappropriate age at vaccine administration and overdose. No reaction occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age, Product name confusion
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298676, 2018SA298677, 2018SA298675, 2018SA298672 (same reporter). This case involves a 58-yeart-old female patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history was not provided. No other vaccines were administered on that day. On 25-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ039AA via intramuscular route in the left arm. It was a case of actual medication error due to inappropriate age at vaccine administration, Overdose accidental and Product name confusion. It was reported that they had two different kinds of flu vaccine which caused the confusion. Patient had questions regarding having ulcerative colitis. The patient did not experience 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: 29.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA298667, 2018SA298673, 2018SA298674, 2018SA298679, 2018SA298677, 2018SA298678, 2018SA298675 and 2018SA298672 (same reporter). This case involves a 29 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ039AA, expiry date: 15-May-2019 via intramuscular route in left deltoid on 25-Oct-2018. The date of last menstrual period was 08-OCT-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were administered today. It was actual medication error due to overdose and inappropriate age at vaccine administration (administered inadvertently administered FLUZONE HIGH DOSE to 29 year old/No reaction). It was reported that inadvertently administered FLUZONE HIGH DOSE who were less than 65 years of age. None of the persons report any reaction at this time. 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: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from an other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298631, 2018SA298611, 2018SA297575, 2018SA298603, 2018SA298695 and 2018SA298701. This case involves a patient (age and gender not reported) who was vaccinated with 5 ml dose of FLUZONE HIGH DOSE which was previously frozen, (lot U1995AB and Exp. Date 20 Jun 2018) via intramuscular route in the arm (either right or left) during the period lasting 01Oct2018 to 08Oct2018. The patients medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. No any information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from Other health professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298631, 2018SA298611, 2018SA298692, 2018SA297575, 2018SA298495 and 2018SA298603, same reporter. This case involves Elderly patient (gender unknown) who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received a 0.5ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1995AB, expiry date 20-Jun-2019 via intramuscular route in unknown administration site. It was an actual medication error due to incorrect product storage. It was reported that there was possible temperature excursion, the staff was unaware that the temperature report from the refrigerator showed that the FLUZONE HD was frozen at some time. 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.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 24-Oct-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case is linked to cases 2018SA298495, 2018SA298512, 2018SA298536, 2018SA298593, 2018SA298573, 2018SA298622, 2018SA298644, 2018SA298649, 2018SA298631, 2018SA298611, 2018SA298692, 2018SA298603, 2018SA297575 and 2018SA298695 (same reporter). This case involves a patient of an unknown demographics who received 5 ml dose of vaccine FLUZONE HIGH DOSE lot U1995AB, expiry date: 20-Jun-2019 via intramuscular route and site of administration arm nos on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to incorrect product storage (patients were injected with this previously frozen FLUZONE HD). It was reported that patients were injected with previously frozen FLUZONE HD. The caller stated that the staff were unaware that temperature reading from the refrigerator showed that the FLUZONE HD vaccines were frozen at some point in time. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299805 and 2018SA299809 (same reporter). This case involves 83 years old male patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, 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 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: 68.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked to 2018SA299806, 2018SA299807, 2018SA299808, 2018SA299815, 2018SA299810, 2018SA299811, 2018SA299812, 2018SA299813, 2018SA299814, 2018SA299794 and 2018SA299809 (same reporter). This case involves 68 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage as flu vaccines were in shipment for too long. It was reported that, 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 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: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Acupuncture, Chiropractic, Injection site pain, Pain
Clinical narrative: Received vaccination on 10/9/2018. Immediately after injection no abnormal symptoms. On 10/20/18 deep pain occurred in right deltoid. Constant progressive. Exacerbated by movement.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Blood creatine phosphokinase, Diarrhoea, Heart rate increased, Metabolic function test, Pyrexia
Clinical narrative: Vomiting, diarrhea, increased heart rate, fever.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Vomiting, diarrhea, increased heart rate, fever.
Age: 2.0
Sex: M
Vaccine: FLUA3
Symptoms: Body temperature increased, Dysstasia, Gait disturbance, Injection site pain
Clinical narrative: 3 hrs post inj severe pain in thigh of inj. 9 hrs post 99.4 temp and 18hrs post inj severe pain to area with pt refusing to walk or stand.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site pain, Rash
Clinical narrative: From the parent: "She broke out in a rash, her muscles were still sore from the injection even though she has been moving her arm. Excessive tiredness more than her normal routine. We were given a steroid medication to help."
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site bruising, Pain in extremity
Clinical narrative: BRUISING OF UPPER LEFT ARM, SEVERE PAIN IN LEFT ARM, AND RANGE OF MOTION OF LEFT ARM GREATLY DECREASED, WITH NUMBNESS.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Grip strength decreased, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Woke the day after injection with muscle weakness and soreness to all extremities, hands swollen and decreased grip strength. Was assessed at an Urgent Care 10/25 and saw primary care MD 10/26. Ibuprofen recommended for symptom relief.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: She received the vaccination on 10/30 at 1 pm. Around Wednesday she had a swollen and red upper left arm. She came in to the pharmacy on Thursday and the swelling had moved down her arm to her elbow area. The swelling covers around 8 inches down her arm. She does not state any pain/itchiness.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site joint pain, Injection site pain, Joint noise, Pain
Clinical narrative: Vaccine site appeared higher on the left arm than the location of previous vaccines. More painful injection than previous flu vaccines. Soreness of the arm increased over the course of the day and by evening the arm was painful to lift. Started taking ibuprofen daily with a heating pad on the injection site at bedtime, after 4 days the arm cannot be lifted higher than the chest and impossible to lift overhead. The shoulder joint continues to be very painful and a popping sound in the joint can be heard when trying to move the arm.
Age: 42.0
Sex: M
Vaccine: FLUC4
Symptoms: Pain in extremity
Clinical narrative: Vaccine site appeared higher on the left arm than the location of previous vaccines. More painful injection than previous flu vaccines. Soreness of the arm increased over the course of the day and by evening the arm was painful to lift. Started taking ibuprofen daily with a heating pad on the injection site at bedtime, after 4 days the arm cannot be lifted higher than the chest and impossible to lift overhead. The shoulder joint continues to be very painful and a popping sound in the joint can be heard when trying to move the arm.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Severe chills began 12 hours after vaccination. Also body aches, fatigue. Body aches and fatigue continued the next day.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Vomiting
Clinical narrative: As I finished washing dishes by hand, I felt light headed, sat down and then vomited, possibly my dinner that day. Sat there, not knowing if it was best to drink water or other liquids at that time. Tried to clean my top with paper towel, removed vomit from carpet and went to bed. I called my clinic the next day or so and was told to drink liquids to avoid de-hydration. Person said I didn't need to report this reaction cause it wasn't that serious. The vaccine info. statement I was given after I had it says Flu Vaccine (Inactivated or recombinant) and is dated 8/07/2015.
Age: 10.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Induration, Peripheral swelling, Skin warm
Clinical narrative: Flu shot was administered at school and within the hour a huge red hard feverish bulge in the upper arm formed.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Injection site induration, Injection site warmth, Malaise, Pain
Clinical narrative: Patient was given the vaccination. About 30 minutes later she noticed a small, blister like bump that she thought looked kind of like a blister. Over time the injection site reaction grew. Finally 6 hours later the site was hard to the touch, hot, and about 3 inches in diameter. Also, at this time pt reported feeling achy and not well. She was advised by her boss to go to the ER. At the ER, pt was given a shot of prednisone and told to take Benadryl and Zyrtec at home before being released. The patient felt achy and "rough" throughout the night but does report improvement this morning.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia
Clinical narrative: Confirmed case of Shingles beginning 3 days after receiving vaccine. Open vesicle and nerve pain on back of head. Pt was started on Acyclovir 800mg five times a day beginning 10/26/2018 and symptoms are improving.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, FLUN4, MMRV
Symptoms: Erythema, Swelling
Clinical narrative: Pt seen in office of 4-5 inch area of mild swelling and erythema. Not tender to touch, full range of motion and strength. Advised cold compresses and BENADRYL with follow up if no improvement in 3-5 days.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Chills, Injection site pain, Pain
Clinical narrative: On 10/29 I had the flu shot in my left arm, and the PNEUMOVAX 23 in my right arm. Some soreness at injection sites the next day. But about 24 hours later, 2pm 10/30 I started having moderate pain in my right armpit a few inches from the injection site. By 8pm that night, 10/30 I could not even lift my right arm without a good amount of pain. I also started having chills that night, that persisted thru about 11am Wed 10/31. The pain in my armpit lessened 10/31, and is still a bit there 11/1. As of Nov 1 there is still some residual pain in my right armpit, but no chills. I also did not have any fever at all during this time. I took 2 TYLENOL (325mg) and 2 ADVIL (200 mg each) Tuesday night 10/30 for the pain. I called both my pharmacist at pharmacy and my primary health care provider at Family Pracitice (spoke to a nurse), and both said they have had no reports of side effects from this vaccine. I was told by my Primary care physician to come in the next day, but the pain was very much less, so I did not go to the doctor.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Prednisone, Hydrocortisone.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: 9cm in diameter area of redness and swelling with warmth at injection site.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 19-MAY-2015, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 26-OCT-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 14-NOV-"2018" (after the date of this report), a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 23-FEB-2015, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the zoster vaccine live (ZOSTAVAX) vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about March 2016, a pharmacist administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about September 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 2013, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 2016, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked to case 2018SA297839 and 2018SA297828 (same reporter). This case involves a nine years old male patient who was inadvertently vaccinated with a dose of FLUZONE HIGH DOSE lot UJ030AB expiry date 05-May-2019 via intramuscular route in the left thigh on 22-Oct-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error case due to drug administered to patient of inappropriate age and overdose. It was not reported whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from other healthcare professional. This case is linked to cases 2018SA297838 and 2018SA297828 (same reporter). This case involves a 31-years old female patient who was inadvertently administered 0.5 ml once dose of FLUZONE HIGH DOSE (Batch number: UJ030AB and expiration date: 05-May-2019) via intramuscularly in the right deltoid on 22-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration and overdose because the vaccine was inadvertently given to a 31 year old patient. It was unknown if any adverse event occurred or not following the administration of 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: 5.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 5 years old male patient who received fifth dose of vaccine IPOL (Batch number, expiry date, dose, route and site of administration were not reported). The patient's past vaccination(s) included IPOL with series of 3 plus a booster dose in his school. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to incorrect product storage because the product was administered to a patient after the temperature excursion (the refrigerator reached a low of 32 degrees Fahrenheit for 20 minutes). That 5th dose was from the opened IPOL MDV that had reached a temperature < 35F. No other effects were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a seven years old female patient who received 0.5 mL dose of vaccine FLUZONE QUADRIVALENT lot UJ034AB, expiry date: 30-Jun-2019 via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was actual medication error due to vaccine underdose and exposure via skin contact. It was also case of syringe issue. It was reported that administered fluid was all over the arm of patient. She was unsure if the patient received a complete dose because it looked like most of it was on the patient's arm. Nurse did not note any cracks in the syringes and was unsure if the patient received a complete dose because it looked like most of it was on the patients arm. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLUR4
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a Non-health care professional (Office staff). This case involves a patient of an unknown age and gender who received vaccine FLUBLOK QIV twice in error. The patient's past medical history, concomitant medication and family history were not provided. On 24-Sep-2018, the patient received a first 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number and expiry date not reported via unknown route in the right arm. On 24-Oct-2018, the patient received a second 0.5ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QSAA1804, expiry date 01-Jun-2019 via unknown route in the left arm. It was an actual medication error due to wrong vaccine administered and extra dose administered. It was reported that Patient received FLUBLOK QUADRIVALENT twice on 24-Oct-2018 and 24-Sep-2018. The patient was scheduled for different vaccines yesterday and was given FLUBLOK QUADRIVALENT in error. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Sex: M
Vaccine: IPV, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 15-year-old male patient who was vaccinated inadvertently with 0.5 ml expired dose of IPOL (Batch number: M1477, expiration date: 09 Sep 2018, dose, route was not reported) in left deltoid on 25 Oct 2018. The patients medical history were not reported. Concomitant medication includes ADACEL. It was an actual medication error due to expired vaccine used. It was unknown if patient had adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Injection site rash
Clinical narrative: Initial information received on 25-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient (older than 65 years old) who experienced rash around the injection site and a "hard lump"., rash around the injection site and a "hard lump"., my shoulder "hurt badly, when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., cuff injury and upper arm for the pain, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included Rubber sensitivity. The patient's past medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT lot number, expiry date not reported. On an unknown date, post vaccination patient developed a non-serious rash around the injection site and a "hard lump", rash around the injection site and a "hard lump". (vaccination site induration), my shoulder "hurt badly (musculoskeletal discomfort), when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been. (vaccination site erythema), cuff injury (rotator cuff syndrome), upper arm for the pain. Lab data not reported. Final diagnosis was upper arm for the pain, cuff injury, when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., my shoulder "hurt badly, rash around the injection site and a "hard lump". and rash around the injection site and a "hard lump". It was not reported if the patient received a corrective treatment. The event outcome was reported as Unknown for rash around the injection site and a "hard lump"., as Unknown for rash around the injection site and a "hard lump"., as Unknown for my shoulder "hurt badly, as Unknown for when a band aid was put on the injection site of a flu immunization, he had a red area where the band aid had been., as Unknown for cuff injury and as Unknown for upper arm for the pain.