chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Central nervous system lesion, Hypoaesthesia, Laboratory test abnormal, Paraesthesia
Clinical narrative: patient had a lesion on spinal cord; tingling, widespread throughout the body; numbness, widespread throughout the body; Initial information regarding an unsolicited valid serious case was received from a consumer or an other non-professional (patient) via Global Medical Information (GMI) (Reference number- 00337905) and transmitted to Sanofi on 29-Oct-2020.   This case involves a 59-year-old female patient (age reported as: 60 year old) who experienced numbness (hypoaesthesia) and tingling (paraesthesia) which became widespread throughout the body and a lesion on spinal cord (spinal cord disorder), after patient received INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.    On 18-Nov-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot UJ244AA, expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.   It was reported that, patient was unsure that vaccine was not preserved (NP) or from Multi-dose vial (MDV).  On 18-Nov-2019, the patient had non-serious numbness (hypoaesthesia) and tingling (paraesthesia) which became widespread throughout the body, following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED.   On the same day patient had testing and found she had a lesion on spinal cord (spinal cord disorder) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. This event was assessed as medically significant as per important medical event list.   Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome was reported as unknown for the events.; Sender's Comments: This case involves a 59-year-old female patient (age reported as: 60 year old) who experienced hypoaesthesia, paraesthesia and was found to have spinal cord lesion (spinal cord disorder) after vaccination with FLUZONE QUADRIVALENT MULTIDOSE. The time to onset is compatible with role of vaccine. Patient had testing and found she had spinal cord lesion. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance and other alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Vomiting
Clinical narrative: Pt vomited instantly after administration
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Dizziness
Clinical narrative: Patient was fine after sitting for 15 minutes in the vaccination room. Upon standing up the patient had sudden dizziness and lightheadedness to which I had the patient sit down in the chair for an additional 10-15 minutes. The patient's pulse, and blood pressure seemed ok, didn't have any symptoms of low blood sugar as he is a diabetic. He was given cold water to which he drank about half a water bottle. The patient stated they were ready to get up and go home to which he had the same dizziness and unsteadiness on his feet and walked an additional 5-10 steps to which this reaction still occurred so I had the patient sit down for another additional 10-15 minutes. He had more water and then he was escorted to a cab to go home to which he had similar dizziness but that it was better than how he felt earlier. I told patient to notify me at the pharmacy when he was home and safe. HIs primary care doctor was notified of the situation to which they stated they would follow up with the patient as well.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Feeling abnormal, Gait inability, Nausea, Pyrexia
Clinical narrative: extreme dizziness, unable to walk, felt uneasy, nausea, low grade temp
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Body temperature increased, Chills, Fatigue, Headache
Clinical narrative: Right upper arm very sore at the injection site.  Nausea, headache, chills, shaking started Saturday night.  Work up Sunday,  November 8 with a temperature of 101.4,  extreme muscle aches, fatigue, weakness, headache, chills, nausea feeling.  Took aspirin and sudafed during the day every 4 to six hours.  Started to feel better at 9:00 pm Sunday night
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Nausea, Tremor
Clinical narrative: Right upper arm very sore at the injection site.  Nausea, headache, chills, shaking started Saturday night.  Work up Sunday,  November 8 with a temperature of 101.4,  extreme muscle aches, fatigue, weakness, headache, chills, nausea feeling.  Took aspirin and sudafed during the day every 4 to six hours.  Started to feel better at 9:00 pm Sunday night
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient called the pharmacy on 11/9 and reported that he may be experiencing an allergic reaction to the flu vaccine he recently received on 11/6. Symptoms reported started on 11/8 included rash, itchiness, and hives that started on his back and spreading towards the back of his shoulder and arms. No swelling, redness, or rash on site of injection. No flu-like symptoms such as fever or chills. Patient claimed he didn't perform any activities or ate anything out of the ordinary over the weekend that may have triggered the allergic reaction. Patient had the flu shot before in the past with no issues. Confirmed that patient is not allergic to eggs. Patient taken Benadryl with some relief. Recommended patient during the telephone encounter on 11/9 to continue taking Benadryl and to seek urgent care if rash is not improving/ going away.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Pyrexia, Urticaria
Clinical narrative: Approx 4" raised, red, welt around injection site.  Lasted for several days post injection.  Note:  I photographed the welt 2 days after the injection, so am happy to share if desired.  Also slight fever on day following injection (100 degrees).  Pharmacist asked me to share reaction with VAERS.
Age: 53.0
Sex: F
Vaccine: TD
Symptoms: Hypersensitivity
Clinical narrative: Patient called to notify clinic that she went to the ER three times and was told that she probably had an allergic reaction or a Staph infection from her vaccination.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Palpitations, Pyrexia
Clinical narrative: Racing heart, dizziness, fever, chills
Age: 69.0
Sex: F
Vaccine: UNK
Symptoms: Angioedema, Rhinorrhoea, Sneezing, Throat irritation
Clinical narrative: angiodema eyes and lips  and itchy throat for about 12 hours extreme repetitive sneezing extreme runny noise  took benadryl. Only eye swelling left by following morning which resolved by noon that day.  I slept with an Epipen handy but did not need to use it.
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Injection site pain
Clinical narrative: patient describes soreness in the deltoid upon injection and still continuing this long after
Age: 21.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood creatine phosphokinase, Full blood count, Myositis, Red blood cell sedimentation rate
Clinical narrative: Myositis of left triceps beginning on 11/8 ~ 11 days after vaccine given.  Appears to be a delayed hypersensitivity reaction
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Right arm pain, decreased range of motion in shoulder, starting 5 days after vaccine persisting 3 weeks after vaccine
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received an improperly stored vaccine; This spontaneous report was received from a nurse and refers to patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-OCT-2020, the patient was vaccinated with the first dose of improperly stored vaccine of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) therapy type rHa, lot# T009929 has been verified to be a valid lot number, expiration date 16-SEP-2021 (exact dose, route and site of administration were not provided) for prophylaxis. The temperature excursion was - 6.6 Celsius degrees (C) for 1 hour and 45 minutes. There were no previous temperature excursion. The digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010348: US-009507513-2010USA010299:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Patient received an improperly stored vaccine; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, allergies, drug reactions, concomitant therapies or medical history provided. On 19-OCT-2020, the patient was vaccinated with one dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # T009929, expiration date: 16-SEP-2021, albumin status: rHa) (exact dose, dose number, route of administration and anatomical location were not reported) for prophylaxis. The temperature to which the vaccine was exposed was -6.6 degrees of Celsius (C) and the time frame was reported as 1 hour and 45 minutes. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA010299: US-009507513-2010USA010348:
Sex: U
Vaccine: HIBV
Symptoms: Product storage error
Clinical narrative: patient received a dose of PEDV AX IIlB after it was stored outside of the recommended storage range; No other adverse event reported; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Information on patient's pertinent medical history, drug reactions or allergies and concomitant medications was not provided.      On an unknown date, the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) (lot # T000885, expiration date 29-MAY-2022) 1 dose (route of administration was not provided) for prophylaxis, after it was stored outside of the recommended storage range. The vaccine was stored in temperature of 8.6 Celsius degrees in time frame of 9 hours and 10 minutes. The data logger was involved. There was no previous temperature excursion. No other adverse event reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: no adverse effects reported; the patient was inadvertently administered a dose of VAQTA which expired on 10/20/2020; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 26-OCT-2020, the patient was inadvertently vaccinated with an expired dose (reported as a dose) of hepatitis A vaccine, inactivated (VAQTA) injection, lot # S023220 and expiration date: 20-OCT-2020 for prophylaxis (route of administration was not reported). No adverse effects were reported.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Condition aggravated, Injection site pain, Insomnia, Myalgia
Clinical narrative: Pain at the injection site; it wakes her up at night; Tinnitus; Muscle Soreness of entire body; Shivering; Muscle Soreness; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus.   On 6th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2020, less than a month after receiving Shingrix, the patient experienced tinnitus, general body pain, shivering and muscle soreness. On an unknown date, the patient experienced injection site pain and insomnia. On an unknown date, the outcome of the tinnitus, general body pain, shivering, muscle soreness, injection site pain and insomnia were unknown.   It was unknown if the reporter considered the tinnitus, general body pain, shivering, muscle soreness, injection site pain and insomnia to be related to Shingrix.  Additional details were provided as follows: The reported Muscle Soreness of entire body, Shivering, and Pain at the injection site. The patient stated that she was most concerned about Tinnitus which started the night of the vaccination. The patient described it as so loud that it wakes her up at night and was constant.  The patient continued to have Tinnitus. The reporter consented to follow up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Sleep disorder, Tinnitus
Clinical narrative: Pain at the injection site; it wakes her up at night; Tinnitus; Muscle Soreness of entire body; Shivering; Muscle Soreness; This case was reported by a consumer via call center representative and described the occurrence of tinnitus in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included tinnitus.   On 6th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th October 2020, less than a month after receiving Shingrix, the patient experienced tinnitus, general body pain, shivering and muscle soreness. On an unknown date, the patient experienced injection site pain and insomnia. On an unknown date, the outcome of the tinnitus, general body pain, shivering, muscle soreness, injection site pain and insomnia were unknown.   It was unknown if the reporter considered the tinnitus, general body pain, shivering, muscle soreness, injection site pain and insomnia to be related to Shingrix.  Additional details were provided as follows: The reported Muscle Soreness of entire body, Shivering, and Pain at the injection site. The patient stated that she was most concerned about Tinnitus which started the night of the vaccination. The patient described it as so loud that it wakes her up at night and was constant.  The patient continued to have Tinnitus. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: feel crappy 24 hrs after my second Shingles injection/ to feel bad; This case was reported by a consumer via call center representative and described the occurrence of feeling bad in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, 24 hrs after receiving Shingles vaccine, the patient experienced feeling bad. On an unknown date, the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the feeling bad to be related to Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter asked was it normal to feel crappy 24 houses after my second Shingles Injection. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Lethargy, Lip swelling, Pain
Clinical narrative: flu like symptoms; Fever; chills; body aches; lethargy; lips swelled; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   On 3rd June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd June 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, general body pain, lethargy and lip swelling. On an unknown date, the patient experienced influenza-like symptoms. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the fever, chills, general body pain, lethargy and lip swelling were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, lethargy and lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm and a pneumonia vaccine. The patient reported that flu like symptoms presented that night. fever, chills, body aches and lethargy. She also said her lips swelled and she took Benadryl and it resolved. She was not sure if the swelling happened that first night or the second night.  The reporter did not consent to follow up. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, lethargy and lip swelling to be related to Pneumococcal vaccine
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: flu like symptoms; Fever; chills; body aches; lethargy; lips swelled; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE).   On 3rd June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 3rd June 2020, less than a day after receiving Shingrix, the patient experienced fever, chills, general body pain, lethargy and lip swelling. On an unknown date, the patient experienced influenza-like symptoms. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the influenza-like symptoms was unknown and the outcome of the fever, chills, general body pain, lethargy and lip swelling were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, lethargy and lip swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix in the left arm and a pneumonia vaccine. The patient reported that flu like symptoms presented that night. fever, chills, body aches and lethargy. She also said her lips swelled and she took Benadryl and it resolved. She was not sure if the swelling happened that first night or the second night.  The reporter did not consent to follow up. It was unknown if the reporter considered the influenza-like symptoms, fever, chills, general body pain, lethargy and lip swelling to be related to Pneumococcal vaccine
Sex: F
Vaccine: VARZOS
Symptoms: Bedridden, Cough, Fatigue, Headache, Influenza like illness
Clinical narrative: headache; cough; flu like symptoms; fatigue lasted for 5 days. She was in bed for 2 days.; This case was reported by a consumer via call center representative and described the occurrence of headache in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced headache, cough, influenza-like symptoms, fatigue and bedridden. On an unknown date, the outcome of the headache, cough, influenza-like symptoms and bedridden were unknown and the outcome of the fatigue was recovered/resolved.   It was unknown if the reporter considered the headache, cough, influenza-like symptoms, fatigue and bedridden to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine 2 weeks ago. The patient reported experiencing headache, flu like symptoms, fatigue and cough.  The fatigue lasted for 5 days. She was in bed for 2 days. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pyrexia
Clinical narrative: fever; headache; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th October 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced fever and headache. On an unknown date, the outcome of the fever and headache were recovered/resolved.   It was unknown if the reporter considered the fever and headache to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient suffered from headache and fever for 3 days. The reporter consented to follow-up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020220508:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever for 2 days following first dose of RZV; This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.  Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication. The reporter reported adverse event from first dose to second dose specifically fever for 2 days following first dose of RZV.  The reporter asked were there any studies that provide data on adverse events from febrile fever reaction after receiving the first dose. Upon clarification regarding whether this was an adverse event or not given the form said "Confirmed no adverse event reported. The reporter confirmed and stated via email back, "The HCP said there was no adverse event.  The HCP question was based on a patient he administered RZV and had this reaction, however he explicitly said there was no adverse event when asked. This question was submitted by reporter and email was sent for clarifying information. The reporter did not consent to follow-up.
Sex: F
Vaccine: PNC13
Symptoms: Alopecia, Blindness, Deafness, Decreased appetite, Depression
Clinical narrative: thyroid storm cancer; lose her hearing, eyesight; lose her hearing; lost her appetite; gained over 75 pounds in 7 months; hair falling out; eye lashes gone; tongue got thick; would get lost; fatigue; constantly thirsty; depression; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included allergic to all antibiotics including penicillin. Concomitant medications were unknown. The patient stated "Even the brochures do not tell you how often to get it." The patient stated she was allergic to all antibiotics. She told them and they would write a prescription with penicillin or other things she was allergic to. She would take it to the pharmacy and they caught the mistake. Suddenly, she lost her appetite, gained over 75 pounds in 7 months, hair falling out, eye lashes gone, tongue got thick, would get lost, fatigue, she was constantly thirsty. She would lose her hearing, eyesight, potty on herself. She got depression. Finally figured out that she had thyroid storm cancer. Outcome of all events was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Disorientation, Fatigue, Incontinence, Madarosis, Thirst
Clinical narrative: thyroid storm cancer; lose her hearing, eyesight; lose her hearing; lost her appetite; gained over 75 pounds in 7 months; hair falling out; eye lashes gone; tongue got thick; would get lost; fatigue; constantly thirsty; depression; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included allergic to all antibiotics including penicillin. Concomitant medications were unknown. The patient stated "Even the brochures do not tell you how often to get it." The patient stated she was allergic to all antibiotics. She told them and they would write a prescription with penicillin or other things she was allergic to. She would take it to the pharmacy and they caught the mistake. Suddenly, she lost her appetite, gained over 75 pounds in 7 months, hair falling out, eye lashes gone, tongue got thick, would get lost, fatigue, she was constantly thirsty. She would lose her hearing, eyesight, potty on herself. She got depression. Finally figured out that she had thyroid storm cancer. Outcome of all events was unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Thyroid cancer, Thyrotoxic crisis, Tongue disorder, Weight increased
Clinical narrative: thyroid storm cancer; lose her hearing, eyesight; lose her hearing; lost her appetite; gained over 75 pounds in 7 months; hair falling out; eye lashes gone; tongue got thick; would get lost; fatigue; constantly thirsty; depression; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included allergic to all antibiotics including penicillin. Concomitant medications were unknown. The patient stated "Even the brochures do not tell you how often to get it." The patient stated she was allergic to all antibiotics. She told them and they would write a prescription with penicillin or other things she was allergic to. She would take it to the pharmacy and they caught the mistake. Suddenly, she lost her appetite, gained over 75 pounds in 7 months, hair falling out, eye lashes gone, tongue got thick, would get lost, fatigue, she was constantly thirsty. She would lose her hearing, eyesight, potty on herself. She got depression. Finally figured out that she had thyroid storm cancer. Outcome of all events was unknown.   Information on the batch/lot number has been requested.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA277871, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00303291) and transmitted on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310354, 2020SA277871, 2020SA310901, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770  (same reporter)  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number- 00303291) and transmitted on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA277871, 2020SA310460, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 06-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised. It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product distribution issue, Product storage error
Clinical narrative: The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; The shipment of vaccine was received outside 72 hour guideline and was potentially compromised, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Health Authority (Reference number- 00303291) and transmitted to Sanofi on 06-Oct-2020.  This case is linked to cases 2020SA310350, 2020SA310351, 2020SA310352, 2020SA310901, 2020SA310354, 2020SA277871, 2020SA310461, 2020SA310462, 2020SA310463, 2020SA310464, 2020SA310555, 2020SA310556, 2020SA310557, 2020SA310558, 2020SA310559, 2020SA310704, 2020SA310705, 2020SA310706, 2020SA310707, 2020SA310708, 2020SA310759, 2020SA310760, 2020SA310761, 2020SA310762, 2020SA310763, 2020SA310764, 2020SA310765, 2020SA310766, 2020SA310767, 2020SA310768, 2020SA310769 and 2020SA310770 (same reporter).  This case involves a patient (demographics unknown) who was administered a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (lot UJ505AA, expiry date: 30-Jun-2021, form: prefilled syringe) via unknown route in unknown administration site for prophylactic vaccination on 05-Oct-2020, whose shipment was received outside the 72 hour guideline and was potentially compromised (product storage error and product distribution issue)  It was a case of an actual medication error due to incorrect product storage.  It was also a case of product shipment delay.  The shipment of vaccines was received outside the 72 hour guideline for standard shipping. It was received in 76 hours. The practice was advised not to use any remaining stock as new stock will be replenished and to return the remaining stock. It was also advised to re-vaccinate the patients who had received a dose of the potentially compromised product. No thermometer was in packaging and product was cold when they received it.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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: 0.33
Sex: M
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4-month-old patient was inadvertently administered the Fluzone Quadrivalent with no adverse event; Initial information regarding this unsolicited valid non-serious case received from a consumer/ non-health care professional on 12-Oct-2020.  This case involved a 4-month-old male patient who inadvertently received a 0.5 ml dose of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Lot number- UT7065LA, expiration date: 30-Jun-2021, prefilled syringe) via intramuscular route in the left thigh (Product administered to patient of inappropriate age) for prophylactic vaccination on 09-Oct-2020.  The patient's medical history, medical treatments, vaccinations and family history were not provided.   It was a case of actual medication error due to Inappropriate age at vaccine administration. (Latency: Same day).  At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 40-year old received Fluzone High-Dose Quadrivalent in error/no AE; 40-year old received Fluzone High-Dose Quadrivalent in error/no AE; 40-year old received Fluzone High-Dose Quadrivalent in error/no AE; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 40-years-old female patient who received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) in error (product administered to patient of inappropriate age, medication error and overdose).   The patient's past medical history and family history were not provided.  Concomitant medication of the patient included sodium (NA).   On 12-Oct-2020, the patient received quadrivalent influenza vaccine (Fluzone high-dose quadrivalent) at a dose of 0.7 mL (frequency: once) at untranslated region (UTR) for prophylactic vaccination.   On 12-Oct-2020, same day after initiation of quadrivalent influenza vaccine, the nurse administered quadrivalent influenza vaccine to a 40-year-old patient in error with no AE (adverse event) was reported (product administered to patient of inappropriate age, medication error and overdose).   Disclaimer: 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.  It was a case of overdose and also a case of actual medication error due to inappropriate age at vaccine administration (latency was on same day).  No other relevant information was reported.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 63 years old male patient was given Fluzone High Dose Quadrivalent by mistake because he looks older than he is/ no adverse event; 63 years old male patient was given Fluzone High Dose Quadrivalent by mistake because he looks older than he is/ no adverse event; Initial information received on 14-Oct-2020 regarding an unsolicited valid non-serious case received from a nurse manager via Health Authority (Reference number- 00316083).  This case involved a 63 years old male patient who was vaccinated with 0.7 ml single dose vial of QUADRIVALENT INFLUENZA VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (batch number UJ500AA and expiry date: 30-Jun-2021) via intramuscular route in left deltoid administration site on 14-Oct-2020 for prophylactic vaccination (product administered to patient of inappropriate age and overdose).  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 (latency was on same day).   At the time of reporting, patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Injection site itchy; Injection site was hot and red; Injection site was red; Injection site was hot; Initial information regarding an unsolicited valid non-serious case was received from pharmacist (reference number-00321543) and transmitted to Sanofi on 19-OCT-2020.  This case involves 65-year old female patient who had injection site was hot itchy and red (Vaccination site pruritus, Vaccination site inflammation, Vaccination site erythema and vaccination site warmth) while she received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Medical history, medical treatment, concomitant medication and family history were not provided.  The patient's past vaccination(s) included flu shots in the past.  On 16-Oct-2020, the patient received dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number: UJ536AA and expiry date: 30-JUN-2021] via an unknown route at left deltoid site for prophylactic vaccination. It was reported that the this was the first time the patient taking HD.  On an unknown date, the patient developed a non-serious reaction which was hot itchy and red (Vaccination site pruritus, Vaccination site inflammation, Vaccination site erythema and vaccination site warmth), (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome for reported events was unknown.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: administered expired doses of ACTHIB with no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- US-SANOFI-00341596) and transmitted to Sanofi on 02-Nov-2020.  This case involves a 1 years old male patient who received first 0.5 ml expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ112AAB, expiry date: 21-Jun-2020) via intramuscular route in the left outer thigh on 02-Nov-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included INFLUENZA VACCINE.  It was an actual medication error due to the expired vaccine used (latency-same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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: 0.58
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: they had an expired ActHib given to a patient/No AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Medical Information (Reference number- US-SANOFI-00342350) and transmitted to Sanofi on 02-Nov-2020.  This case involves a 7 months old male patient who received second 0.5 ml expired dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ081AAA, expiry date: 02-Oct-2020) via intramuscular route in the left leg on 08-Oct-2020 for prophylactic vaccination (expired product administered).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX) and PNEUMOCOCCAL VACCINE 13V (PNEUMOCOCCAL VACCINE 13V).  It was an actual medication error due to the expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: Within 3 hours..very swollen..sore, red and hot to the touch.(for 5 days), shoulder socket extremely sore...spread across base of neck and into opposite shoulder socket.  Could not lift arms above my head for six days.  Very bad headache...Unable to carry on with normal activity for four days (in bed).  Overwhelming tiredness, teariness, loss of appetite, body aches, shivers...  NO FEVER.  Lost one week at work...  Used ibreprophen, tylenol, ice,         ********   I had a severe case of shingles at the age of four!!!!!  It doesn't ask this anywhere on the questionnaire but it is certainly worth noting.