chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Blood glucose decreased, Diabetic coma, Hyperhidrosis, Hypoglycaemia, Impaired driving ability
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case is linked to cases 2018SA290307 and 2018SA292920 (same reporter). This case involves a two patients of unknown age and gender who experienced sweating profusely, diabetic coma and hypoglycemia (reported as experienced same symptoms at different levels) while received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines and medications not given. On an unknown date, two patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via unknown route in unknown administration site. On an unknown date, patients developed a serious sweating profusely, diabetic coma and hypoglycemia following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These patients were hospitalized for these event (duration unknown). Lab tests not reported. Final diagnosis was diabetic coma. Corrective treatment not reported. The outcome of all event was unknown at the time of reporting. List of documents held by sender: none. Sender's Comments: This case concerns two patients who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding individual patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patients had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Road traffic accident, Vision blurred
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case is linked to cases 2018SA290307 and 2018SA292920 (same reporter). This case involves a two patients of unknown age and gender who experienced sweating profusely, diabetic coma and hypoglycemia (reported as experienced same symptoms at different levels) while received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines and medications not given. On an unknown date, two patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via unknown route in unknown administration site. On an unknown date, patients developed a serious sweating profusely, diabetic coma and hypoglycemia following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These patients were hospitalized for these event (duration unknown). Lab tests not reported. Final diagnosis was diabetic coma. Corrective treatment not reported. The outcome of all event was unknown at the time of reporting. List of documents held by sender: none. Sender's Comments: This case concerns two patients who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding individual patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patients had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: FLU4, FLU4, FLU4, FLU4
Symptoms: Diabetic coma, Hyperhidrosis, Hypoglycaemia
Clinical narrative: Initial information received on 17-Oct-2018 regarding an unsolicited valid serious case received from a consumer/non-hcp. This case is linked to cases 2018SA290307 and 2018SA292920 (same reporter). This case involves a two patients of unknown age and gender who experienced sweating profusely, diabetic coma and hypoglycemia (reported as experienced same symptoms at different levels) while received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant vaccines and medications not given. On an unknown date, two patients received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via unknown route in unknown administration site. On an unknown date, patients developed a serious sweating profusely, diabetic coma and hypoglycemia following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These patients were hospitalized for these event (duration unknown). Lab tests not reported. Final diagnosis was diabetic coma. Corrective treatment not reported. The outcome of all event was unknown at the time of reporting. List of documents held by sender: none. Sender's Comments: This case concerns two patients who developed diabetic coma, hypoglycemia and sweating profusely after vaccination with FLUZONE QUAD vaccine. The time to onset is unknown. However, there is no information regarding individual patient's past history, medical condition at time of vaccination and lab tests ruling out alternate etiologies. There was no information whether patients had a history of diabetes or not. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Asthenia, Fatigue, Somnolence
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 53 years old female patient who was delirious, confused, passed out a few times, incoherent/had a hard time talking, no memory of what she ate the night before, sweaty, sick and felt like she was going to die, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via intramuscular route in the right arm. On an unknown date, the patient developed a serious event of delirious, passed out a few times, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious confused, incoherent/had a hard time talking, no memory of what she ate the night before, sweaty, sick and she felt like she was going to die, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Relevant tests were not reported. Final diagnosis was sick, sweaty, no memory of what she ate the night before, incoherent/had a hard time talking, passed out a few times, confused, she felt like she was going to die and she was delirious. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: This case involves a 53 years old patient who experienced delirium, passed out, incoherent, amnesia, hyperhidrosis and malaise post vaccination with FLUZONE. Time to onset is unknown. Further information including patient's medical history, condition at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Amnesia, Confusional state, Delirium, Feeling abnormal, Hyperhidrosis
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 53 years old female patient who was delirious, confused, passed out a few times, incoherent/had a hard time talking, no memory of what she ate the night before, sweaty, sick and felt like she was going to die, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via intramuscular route in the right arm. On an unknown date, the patient developed a serious event of delirious, passed out a few times, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious confused, incoherent/had a hard time talking, no memory of what she ate the night before, sweaty, sick and she felt like she was going to die, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Relevant tests were not reported. Final diagnosis was sick, sweaty, no memory of what she ate the night before, incoherent/had a hard time talking, passed out a few times, confused, she felt like she was going to die and she was delirious. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: This case involves a 53 years old patient who experienced delirium, passed out, incoherent, amnesia, hyperhidrosis and malaise post vaccination with FLUZONE. Time to onset is unknown. Further information including patient's medical history, condition at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Incoherent, Loss of consciousness, Malaise, Speech disorder
Clinical narrative: Initial information received on 22-Oct-2018 regarding an unsolicited valid serious case received from a consumer. This case involves a 53 years old female patient who was delirious, confused, passed out a few times, incoherent/had a hard time talking, no memory of what she ate the night before, sweaty, sick and felt like she was going to die, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UJ009AA via intramuscular route in the right arm. On an unknown date, the patient developed a serious event of delirious, passed out a few times, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant. On an unknown date, the patient developed a non-serious confused, incoherent/had a hard time talking, no memory of what she ate the night before, sweaty, sick and she felt like she was going to die, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Relevant tests were not reported. Final diagnosis was sick, sweaty, no memory of what she ate the night before, incoherent/had a hard time talking, passed out a few times, confused, she felt like she was going to die and she was delirious. It was not reported if the patient received a corrective treatment. The outcome of the events was not reported. List of documents held by sender: none. Sender's Comments: This case involves a 53 years old patient who experienced delirium, passed out, incoherent, amnesia, hyperhidrosis and malaise post vaccination with FLUZONE. Time to onset is unknown. Further information including patient's medical history, condition at the time of vaccination, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Myalgia
Clinical narrative: It was not a comfortable injection and bled. After bandage applied, left pharmacy. I started having severe muscle pain five hours after the injection. For two days pain in arm (elbow to shoulder/neck). I could not lift my right arm. I called the pharmacy then. They listened but said that some adverse reactions normal. It's now 25 days later and I still have discomfort in my right arm, particularly at night when sleep is disturbed. Also still some issues with arm movement (brushing hair, pulling clothes over head). I am retired from the Army and have been a pincushion for injections and this is not normal for me. I will not get another flu vaccination. My doctor said to call pharmacy. My pharmacy said that they would also submit a form to you.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Discomfort, Haemorrhage, Injected limb mobility decreased, Limb discomfort, Loss of personal independence in daily activities
Clinical narrative: It was not a comfortable injection and bled. After bandage applied, left pharmacy. I started having severe muscle pain five hours after the injection. For two days pain in arm (elbow to shoulder/neck). I could not lift my right arm. I called the pharmacy then. They listened but said that some adverse reactions normal. It's now 25 days later and I still have discomfort in my right arm, particularly at night when sleep is disturbed. Also still some issues with arm movement (brushing hair, pulling clothes over head). I am retired from the Army and have been a pincushion for injections and this is not normal for me. I will not get another flu vaccination. My doctor said to call pharmacy. My pharmacy said that they would also submit a form to you.
Age: 69.0
Sex: F
Vaccine: FLUA3, FLUA3
Symptoms: Myalgia, Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: It was not a comfortable injection and bled. After bandage applied, left pharmacy. I started having severe muscle pain five hours after the injection. For two days pain in arm (elbow to shoulder/neck). I could not lift my right arm. I called the pharmacy then. They listened but said that some adverse reactions normal. It's now 25 days later and I still have discomfort in my right arm, particularly at night when sleep is disturbed. Also still some issues with arm movement (brushing hair, pulling clothes over head). I am retired from the Army and have been a pincushion for injections and this is not normal for me. I will not get another flu vaccination. My doctor said to call pharmacy. My pharmacy said that they would also submit a form to you.
Age: 19.0
Sex: M
Vaccine: SMALL
Symptoms: Drug hypersensitivity, Pruritus, Rash generalised, Rash papular, Vaccination complication
Clinical narrative: Patient with acute onset at 05:00 AM today. Scattered to upper back abdomen and bilateral upper extremities. Patient on 10 day course of Augmentin which he started on 10/18/2018. Hx of PCN shots with no allergic rxn. Exam: airway patent, no perioral or periorbital swelling, no urticarial. Diffuse papular erythematous rash on face, anterior neck, chest. No evidence of angioedema, anaphylaxis, erythema multiforme. No new detergents, lotions, creams, chemical exposure, food. A/P: DC Augmentin. Decadron and Claritin for rash and itching. Report Augmentin as allergy and report small pox adverse rxn on VAERS.
Age: 0.67
Sex: M
Vaccine: DTAPHEPBIP, RV1
Symptoms: Vomiting
Clinical narrative: Throwing up.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chills, Feeling cold, Headache, Injection site pain, Pain in extremity
Clinical narrative: Vaccinated at 10am. Started feeling cold around 8pm. Chills and fever lasted about 8 hours. Went away but develop low grade headache (successfully treated with TYLENOL). Injection site was sore. Most symptoms resolved within a couple days, arm still sore.
Age: 59.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia
Clinical narrative: Vaccinated at 10am. Started feeling cold around 8pm. Chills and fever lasted about 8 hours. Went away but develop low grade headache (successfully treated with TYLENOL). Injection site was sore. Most symptoms resolved within a couple days, arm still sore.
Age: 34.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Employee reports swelling and redness day after vaccination. Two days after vaccination, increase swelling, pain, redness and itching around injection site. Ice to area as needed.
Age: 0.42
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a certified medical assistant regarding a 6 months old patient of unknown gender. The patient's pertinent medical conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with improperly stored ROTATEQ lot # N004817, expiration date: 06-OCT-2018 (dose and route of administration were not reported) for prophylaxis. The vaccines were stored in a temperature of 2 degrees Celsius to 8 degrees Celsius for 4 hours and in 9 degrees Celsius to 25 degrees Celsius for 76 hours (multiple excursions were reported). No previous temperature excursion. Call was due to digital data logger. No adverse effect reported. This is one of the several reports received from same reporter.
Sex: M
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Based on the information received on 25-Oct-2018, the narrative of the case was amended in the analysis tab. Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA272314. (Same reporter). This case involves an 87 years old male patient who experienced pain in right arm, while he received vaccine INFLUENZA VACCINE. The patient's past medical history included Arthralgia, Blood calcium abnormal, Bone density abnormal with bone density issues in that arm and now that pain from the arthritic shoulder, and H2N2 influenza (Flu) with fever of 102 F in 1950's. The patient's past vaccination(s) included INFLUENZA VACCINE with "heavy dose" and they had arm pain. The patient's past medical treatment(s) and family history were not provided. Concomitant medication was none. Reported as No concomitant vaccines given. On an unknown date (reported as last week), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the right arm. On an unknown date, the patient developed a non-serious pain in right arm (pain in extremity) following the administration of INFLUENZA VACCINE. It was also reported that now that pain from the arthritic shoulder is "over ceded/overshadowed" from the pain from the vaccine. (Other relevant tests included No lab data.) Final diagnosis was pain in right arm. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for pain in right arm. List of documents held by sender: none.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 10-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 50 years old male patient who received vaccine FLUZONE QUADRIVALENT and while treated with TUBERCULIN TEST [TUBERSOL]. The patients past medical history, concomitant medication and family history were not provided. On 10-Oct-2018, the patient received TUBERSOL (TUBERCULIN TEST) 0.5 mL intramuscular (lot - C5476AA, expiry date 16-Nov-2020) instead of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported. It was an actual medication error due to wrong vaccine administered. It was reported that Nurse practitioner ordered FLUZONE QUADRIVALENT but Nurse inadvertently gave Tubersol 0.5 mL IM to a patient. 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: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves 47 year old male patient who received 0.5 ml dose of FLUZONE QUADRIVALENT (batch number UI997AA, expiry date 30 June 2019, route of administration were not reported) in right deltoid on 10 Oct 2018. It was a case of potential medication error due to Incorrect product storage as FLUZONE QUADRIVALENT, stored in temperature of (-4) C. 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: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves 80 year female who received 0.5 ml of FLUZONE HIGH DOSE (batch number UJ047AB, expiry date 28-MAY-2019, route of administration were not reported) in left deltoid on an unspecified date. It was a case of actual medication error as Syringe issue and Underdose due to she states that a little went in and then the rest "exploded" out both sides of the syringe. It was reported that pharmacist notes that there are 2 cracks in the syringe. She states that one crack is "right above white box with NDC number in it", the second is "to the left on the box that has the lot number and expiration date. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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: 9.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 9 years old male patient who received vaccine QUADRACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 02-Oct-2018, the patient received a  dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C54998A. It was a case of actual medication error due to Inappropriate age at vaccine administration. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Inflammation, Skin warm, Swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from Health Authorities, This case is linked to case 2018SA286240, 2018SA286241, 2018SA286243, 2018SA286244, 2018SA286233, 2018SA286242 (same reporter). This case involves Adult female patient who experienced local redness and swelling that warm to the touch, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On 09-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AA. On an unknown date, the patient developed a non-serious local redness and swelling that warm to the touch 48 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. It was also reported 7 of the 10 individuals who received the vaccine had significant local reactions of redness, swelling, warm to touch. 47% reported pain at injection site, however, redness is not reported, and we all had the redness below the injection site not directly at the injection site. Day 2 after injection seemed to be the most significant timeframe for peak reaction. (Other relevant tests included no lab data.) Final diagnosis was local redness and swelling that warm to the touch. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for local redness and swelling that warm to the touch. Reported as 3 days post vaccine all are showing signs of improvement. Follow up information was received from a Pharmacist on 12-Oct-2018. No new information was received.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an elderly patient (age was not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (lot number and expiry date was not reported). 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 vaccine underdose. It was also a case of syringe issue since part of the vaccine leaked out. It was unknown whether the patient experienced any adverse events. 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 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: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a 35 years old female patient who experienced leg numbness, tingling, altered gait and weakness, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Details of concomitant medication was not provided. On 07-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ005AC via unknown route in the no information. On 09 October 2018, The patient developed a non-serious event of leg numbness (Hypoaesthesia), tingling (paraesthesia), altered gait (gait disturbance) and weakness (asthenia), 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. It was mention that the patient reported to the ER on Wednesday for complaining of leg numbness, tingling, altered gait and weakness. Other relevant tests included no lab data was provided. Final diagnosis was complaining of leg numbness, tingling, altered gait and weakness. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown for complaining of leg numbness, tingling, altered gait and weakness. Documents held by the sender: none.
Sex: F
Vaccine: FLU3, PNC
Symptoms: Hypersensitivity, Injected limb mobility decreased, Pain in extremity, Throat tightness, Vomiting
Clinical narrative: Initial information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Elderly female patient who experienced vomiting, pain in right arm (reported as right arm could not lift up and in pain), throat tightness (reported as it felt like her throat was closing up) and diagnosed with an allergic reaction, while she received vaccines PREVNAR and FLUZONE HIGH DOSE. 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 patient received a dose of suspect PREVNAR not produced by Sanofi Pasteur lot number not reported. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in the right arm. On an unknown date, the patient developed a non-serious vomiting following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and following the administration of PREVNAR. On an unknown date ,the patient developed a non-serious right arm could not lift up and in pain (pain in extremity) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and following the administration of PREVNAR. On an unknown date, the patient developed a non-serious it felt like her throat was closing up (throat tightness) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and following the administration of PREVNAR. On an unknown date, the patient developed a non-serious diagnosed with an allergic reaction (hypersensitivity) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE and following the administration of PREVNAR. (Other relevant tests included No lab data.) Final diagnosis was diagnosed with an allergic reaction, it felt like her throat was closing up, right arm could not lift up and in pain and vomiting. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for vomiting, as Unknown for right arm could not lift up and in pain, as Unknown for it felt like her throat was closing up and as Unknown for diagnosed with an allergic reaction. Documents held by sender: none.
Sex: F
Vaccine: RAB, RAB
Symptoms: Epstein-Barr virus infection, Fibromyalgia, Hypoaesthesia, Lethargy, Memory impairment
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves Adult female patient of unknown age who experienced facial numbness, epstein-barr type symptoms, lethargy, fibromyalgia type symptoms and memory problems, while she received vaccines IMOGRAM RABIES AND IMOVAX RABIES. 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 patient received a dose of suspect RABIES (HDC) VACCINE lot number not reported via unknown route. On an unknown date, the patient received a dose of suspect IMOGAM RABIES not produced by Sanofi Pasteur lot number not reported. On an unknown date, The patient developed a non-serious facial numbness (hypoesthesia) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. On an unknown date, the patient developed a non-serious epstein-barr type symptoms (epstein-barr virus infection) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. On an unknown date, the patient developed a non-serious lethargy following the administration of RABIES (HDC) VACCINE and  following the administration of IMOGAM RABIES. On an unknown date , the patient developed a non-serious fibromyalgia type symptoms (fibromyalgia) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. On an unknown date , the patient developed a non-serious memory problems (memory impairment) following the administration of RABIES (HDC) VACCINE and following the administration of IMOGAM RABIES. (Other relevant tests included No lab data.) Final diagnosis was memory problems, fibromyalgia type symptoms, lethargy, epstein-barr type symptoms and facial numbness. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for facial numbness, as Unknown for epstein-barr type symptoms, as Unknown for lethargy, as Unknown for fibromyalgia type symptoms and as Unknown for memory problems. Documents held by sender: none.
Age: 1.08
Sex: U
Vaccine: HEPA, IPV, MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to case 2018SA290123 (same reporter). This case involves a 13 months old patient who received a 0.5 mL dose of IPOL lot P1A171M, expiry date: 30-Apr-2020 via intramuscular route in the right thigh on 11-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Immunisation; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was a case of actual medication error due to incorrect product storage. It was reported that excursion was 51.8 degrees F for 1 Hour. 101-hours worth of excursions since 18May - 15Oct. These excursions were not included on one vial of the Unopened and Opened IPOL. There were Two Injections given during the most recent Excursion of 51.8 degrees F. x 1 Hour of the Opened IPOL Vial. It was not reported if the patient experienced any administered 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. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 34 years old female patient who experienced numbness and tingling in her handwhile she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Details of concomitant medication was not provided. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT630JA via intramuscular route in the right arm. On 16 Oct-2018, The patient developed a non-serious event of numbness (paraesthesia) and tingling in her hand (hypoaesthesia) 1 day following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Final diagnosis was numbness and tingling in her hand and numbness and tingling in her hand. Details of lab date was not provided. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for numbness and tingling in her hand.
Sex: F
Vaccine: FLUR4
Symptoms: Pruritus, Urticaria
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a female patient of an unknown demographics who experienced feel itchy and broke out in hives, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history includes vaccination with FLUZONE. On 15-Oct-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA1801, expiry date: 29-May-2019 in the left deltoid. On an unknown date, the patient developed a non-serious feel itchy (pruritus) and broke out in hives (urticaria), three hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. It was reported that the hives were mostly on her face, with a few scattered over her body. There was no local reaction at the site (left deltoid), She did not receive any other vaccines at the same time. Relevant tests were not reported. Final diagnosis was broke out in hives and feel itchy. The patient was treated with BENADRYL 25 mg. The patient was recovered from the event of hives and outcome of the feel itchy was not reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU4, HPV4, MNQ, TDAP
Symptoms: Expired product administered
Clinical narrative: Initial information received on 16-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 11-year-old a patient who received an 0.5 ml expired vaccination with MENACTRA (batch number U5746AD, expiry date 14 Oct 2018, route and site of administration were not reported) on 15 Oct 2018. Concomitant medications included FLUZONE QUADRIVALENT for Immunisation; ADACEL for Immunisation; and GARDASIL for Immunisation, the same day as the MENACTRA. It was a case of actual medication error due Expired vaccine used. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Exposure via skin contact, Injection site extravasation
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 43 years old female patient who received vaccine FLUZONE QUADRIVALENT lot UJ040AA, expiry date: 30-JUN-2019 via unknown route in the left deltoid on 19-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitants medications were given. It was actual medication error due to vaccine underdose and exposure via skin contact. It was reported that some of the vaccine leaked from the patients arm. 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: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves a two-years old patient of an unknown gender who received a first dose of 0.5 ml instead of 0.25 ml FLUZONE QUADRIVALENT (lot number, expiry date, dose, route and site of administration were not reported) on 20-Sep-2018. The patient's past medical history included iron deficiency anemia. The patient's medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to overdose and extra dose administered. It was reported that patient came in for the first time to get a flu shot and the child was administered 0.5 ml instead of 0.25 ml of FLUZONE QUADRIVALENT. Later on an unknown date, when the child came back to the medical office to check/monitor for iron deficiency anemia, the nurse misread the chart and the child was administered another 0.25 ml of the vaccine. The pediatric patient received 0.75 ml total dose. It was not reported if the patient experienced any adverse event following the vaccination or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 1.67
Sex: M
Vaccine: DTAP, FLU4, HEPA
Symptoms: Incorrect dose administered
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 20 months old male patient who was vaccinated with 0.5 ml dose of vaccine FLUZONE QUADRIVALENT (lot number: UJ012AD and expiry date: 30-Jun-2019) via intramuscular route in left thigh "left vastus lateralis" on 17-Oct-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included patient received DAPTACEL and HAVRIX on an unknown date. It was a case of actual medication error due to overdose because the patient received 0.5 ml dose of the FLUZONE QUADRIVALENT vaccine. 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 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: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 years old male patient who experienced swelling, redness and heat coming from the arm at injection site, while he received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a  0.5 ml once dose of suspect FLUZONE lot UI983AA, expiry date- 30-Jun-2019 via intramuscular route in the left deltoid at 06:00 PM. On an unknown date, patient developed a non-serious swelling, redness and heat coming from the arm at injection site (vaccination site inflammation) following the administration of FLUZONE. (Other relevant tests included No lab test.) Final diagnosis was swelling, redness and heat coming from the arm at injection site. The patient was treated with BENADRYL ALLERGY and PREDNISONE. The patient outcome is reported as Unknown for swelling, redness and heat coming from the arm at injection site.
Sex: F
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a female patient (age not reported) who had a reaction and mother thinks that her daughter may be allergic to Formaldehyde in the FLUZONE, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history included flu like symptoms and lots of allergies (ongoing). The patient's past vaccination included flu mist (influenza vaccine). The patient's past medical treatment(s), and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site. On an unknown date, the patient had a reaction and mother thinks that her daughter may be allergic to Formaldehyde in the FLUZONE (hypersensitivity) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE. (Other relevant tests included no lab data.) Final diagnosis was had a reaction. It was not reported if the patient received a corrective treatment. The patient outcome was reported as Unknown. List of documents held by sender: none.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site urticaria, Pain, Pain in extremity
Clinical narrative: Initial information received on 19-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 72 years old female patient who experienced raised wheal at the site of injection, bruising at the site of injection, severe pain and difficulty raising her left arm, 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 08-Oct-2018, the patient received a 0.5 ml once dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ0308A, expiry date- 05-May-2019 in the left arm. On 08-OCT-2018, in the evening the patient developed a non-serious raised wheal at the site of injection following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 08-OCT-2018, in the evening patient developed a non-serious bruising at the site of injection following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date patient developed a non-serious severe pain following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date patient developed a non-serious difficulty raising her left arm following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab test.) Final diagnosis was difficulty raising her left arm, severe pain, bruising at the site of injection and raised wheal at the site of injection. No lab data reported. Patient received CELEBREX as corrective treatment. The patient outcome is reported as Unknown for raised wheal at the site of injection, as Unknown for bruising at the site of injection, as Unknown for severe pain and as Unknown for difficulty raising her left arm.