chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Muscle contractions involuntary, Muscle spasms, Pyrexia, Weight increased, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received PREVNAR 13 (lot number and expiration date were unknown), via an unspecified route of administration on 12Feb2018 15:30 at a single dose for immunisation. The patient's medical history included chronic obstructive pulmonary disease (COPD) from 2017 and ongoing, and ongoing allergies that the patient has had for a long time. The patient's concomitant medications were not reported. On an unspecified date in 2018, the patient experienced weight gain. On 13Feb2018, the patient experienced muscle spasms/contracting, redness at injection site, swelling at injection site, fever and hot at injection site, joint pain, and could not move and couldn't get out bed. The patient reported that she has been having symptoms since receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) vaccine. She added that she has been in therapy since Mar2018; she had to go to physical therapy after receiving vaccine since Mar2018. The patient also reported that she has also gained weight since getting the shot. She usually weighed 155 to 160 lbs. Currently (2018), her weight is 180 lbs. The patient also reported that she received the vaccine at a clinic, received the shot at 3:30 pm on 12Feb2018. The next morning (13Feb2018) when she got up at 7:00 am, she could not move and couldn't get out bed. She stated that she has taken the other kind of pneumonia shot before and it did not affect her. She has had x-rays (2018). The therapist said she was still having muscle contractions and spasms. She was told by the therapist to call and report symptoms. The outcome of the events weight gain, muscle spasms/contracting, and joint pain was not recovered. Outcome of the events redness at injection site, swelling at injection site, fever and hot at injection site was recovered on Feb2018. And outcome of the event "could not move and couldn't get out bed" was unknown. Information on the batch/lot number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Adverse reaction, Injection site reaction
Clinical narrative: This is a spontaneous report from a contactable physician. A female patient of an unspecified age received PREVNAR 13 via an unspecified route of administration on an unspecified date at single dose for immunization. The patient's concomitant medications were not reported. The physician reported that the patient had a severe injection site reaction very large on an unspecified date. Additionally the physician mentioned that it was actually more than that, which was just the first of many reactions the patient had. The outcome of the event was unknown. Information on the lot number has been requested.
Age: 87.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, swelling not at the site of injection, it was on the injected arm.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt. was given a Flu Shot by  RN on 9-25-18 during the Flu Clinic. Pt. called on  9-26-18 complaining about her arm hurting and being painful swollen and warm to touch and also not being able to raise her arm. Pt. instructed to come in and see the provider. Pt. came in to see the provider that morning. Provider saw pt. and wrote in plan reassurance pt. regarding common local side effects from IM injections along with life threating s/s of concern. Provider also wrote that the pt. may continue to get the Flu vaccine. Prescribed Motrin or Tylenol or Benadryl as needed.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Pt reports welt.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus generalised
Clinical narrative: Generalized itching about 90 minutes after receiving injection. I took Benadryl 25 mg PO. Symptoms resolved within an hour.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Influenza like illness, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Terrible pain and swelling at site. 8 hours later felt like I had the flu. Terrible pain in my entire body, muscular. Next morning a mucusy cough, by 12:30 pm had trouble stopping coughing and breathing. Went to allergist. She saw me by 1 pm. Put me on a nebulizer with Albuterol. Prescribed 2 inhalers and a home nebulizer. Today, 4 days out, I have a giant hive on the inside of my right arm elbow.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Productive cough, Urticaria
Clinical narrative: Terrible pain and swelling at site. 8 hours later felt like I had the flu. Terrible pain in my entire body, muscular. Next morning a mucusy cough, by 12:30 pm had trouble stopping coughing and breathing. Went to allergist. She saw me by 1 pm. Put me on a nebulizer with Albuterol. Prescribed 2 inhalers and a home nebulizer. Today, 4 days out, I have a giant hive on the inside of my right arm elbow.
Age: 62.0
Sex: M
Vaccine: FLUC4
Symptoms: Cold sweat, Dizziness, Myalgia, Vertigo
Clinical narrative: Two hours after injection, became extremely dizzy (vertigo) and had to go home. Cold sweats with a temp of 97 F. Muscular pain. Took 8 hours to feel better, temp returned to normal. Had flu shots for 25 yrs without any adverse event.
Age: 0.58
Sex: M
Vaccine: DTAP
Symptoms: Dyspnoea, Eyelid function disorder, Loss of consciousness
Clinical narrative: My 7 month old eyes were flickering he had trouble breathing and kept falling out. The event lasted about 3 minutes. I called 911 to get help. He was taken to hospital. Doctors believe he may have had a seizure but were unsure because they didn't see it. He has to follow up with a neurologist.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: Patient received flu shot in right deltoid at 12:10 PM. He returned at 3:00 PM with his right arm shaking at rest. He had no injection site symptoms, no arm soreness, and still had full range of motion. However, whenever he stopped moving his arm and it was at rest it was trembling uncontrollably. The patient was instructed to wait 24 hours and if no improvement, go see a doctor to be evaluated.
Age: 79.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: The morning after patient received his vaccinations his right arm, the arm he received his SHINGRIX was swollen, red, itchy, and warm to touch from about mid upper arm above his elbow up to his shoulder. It was a localized reaction. It is not getting any worse and patient is taking BENADRYL and contacting his doctor if symptoms get worse.
Age: 49.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness unilateral
Clinical narrative: Marked decrease in hearing loss on the side of vaccination.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Fatigue, Vision blurred, Visual field defect
Clinical narrative: Pt complained of tiredness, peripheral vision loss, and hazy peripheral vision shortly after receiving influenza vaccination at a flu shot clinic held at hospital provided by pharmacists from Drug Store. She is an employee of the hospital and was monitored by medical personell until symptom resolution around 6:00. She denied being treated at the emergency room. Vitals and blood glucose remained normal and no other symptoms occurred.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral haemorrhage, Headache, Intensive care, Laboratory test, Loss of consciousness
Clinical narrative: On 9/11/18 felt feverish, body and muscle aches, headache. Passed out in floor causing brain bleed and resulting in a 8 day stay in hospital, 4 of those days in the neuro ICU.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: On 9/11/18 felt feverish, body and muscle aches, headache. Passed out in floor causing brain bleed and resulting in a 8 day stay in hospital, 4 of those days in the neuro ICU.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Fall, Head injury, Impaired work ability, Pyrexia
Clinical narrative: On 9/11/18 felt feverish, body and muscle aches, headache. Passed out in floor causing brain bleed and resulting in a 8 day stay in hospital, 4 of those days in the neuro ICU.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral haemorrhage, Headache, Intensive care, Laboratory test, Loss of consciousness
Clinical narrative: Patient's wife stated that husband may have had an adverse reaction he got feverish on 9/11 and called out of work then he sat in a chair and lost balance and fell due to fever and cracked his head open.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Patient's wife stated that husband may have had an adverse reaction he got feverish on 9/11 and called out of work then he sat in a chair and lost balance and fell due to fever and cracked his head open.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Balance disorder, Fall, Head injury, Impaired work ability, Pyrexia
Clinical narrative: Patient's wife stated that husband may have had an adverse reaction he got feverish on 9/11 and called out of work then he sat in a chair and lost balance and fell due to fever and cracked his head open.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: The injection itself was painful and done with a bit roughly. Shortly after I began experiencing pain at the site of injection. I was not concerned as I knew it was normal. However, the pain continued for days, till this day 9/27/2018. It is difficult to raise my left arm without any pain. Something as simple as taking off my shirt causes pain.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Skin reaction
Clinical narrative: Localized skin/tissue reaction. 3.5 inches wide by 4 inches in length. Use BENADRYL 1 capsule PO every 6 hours for the next 24-48 hours. Ice pack to site 20 minutes on, 40 minutes off. Return to clinic if any worsening of symptoms, if any shortness of breath or trouble swallowing, go directly to the ER. No change in areas at this time.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Pt described itching 2 days post vaccination and now hives to MD. MD called us on 9/27/18. 15 days post vaccination.
Age: 13.0
Sex: M
Vaccine: FLU4, HEPA, IPV, MNQ, TDAP, VARCEL
Symptoms: Blister, Erythema, Eye swelling
Clinical narrative: At time of visit for vaccine administration, client's mother reported client as a healthy adolescent with no acute or chronic illnesses. Mother denied any reaction to previous vaccines. Only reported allergy at the time of vaccination was to penicillin. Client appeared healthy at time of visit and in no emotional or physical distress. Within 1 1/2 hrs of vaccination, mother contacted clinic reporting client having a reaction to the vaccines. 30 minutes later client presented to clinic with bilateral periorbital swelling and redness, blisters noted to upper checks below bilateral periorbital sockets.  Client denied any headaches, or pain to face or eyes; client denied any pressure to eyes. Client remained calm and cooperative throughout process, showing no signs of emotional or physical distress (including respiratory distress).
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pruritus, Injection site reaction
Clinical narrative: Patient received on 9/24/2018. Presented to clinic 9/26/18 stating "I went to Clinic and a NP told me to come here for you to fill out a VAERS report for my arm." Patient states she did not have formal exam at clinic. Left deltoid local reaction not warm to the touch, no fever. RN recommended that patient use warm compresses and or ice on and off for comfort. Patient reports slight itching. Hydrocortisone or BENADRYL recommended. RN provided s/sx to report to PCP. Patient reports that she feels run down and tired since receiving the SHINGRIX vaccine. Patient notified that sx should resolve within 2-3 days. Patient states that she is "feeling better."
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Loss of consciousness, Nausea, Pallor
Clinical narrative: Patient given MENACTRA and FLUARIX in Right arm. Then HPV in left arm. Immediately after giving HPV patient began to sway to right and had a loss of color in her face. MA grabbed arm of patient and positioned her to a Supine position. Patient was not conscious for 4-5 seconds and then regained consciousness. Patient was given ice pack and water. Patient described "blacking out" and not knowing what happened. She still felt nausea after 10 minutes of lying done and sitting in exam room. Patient sat in exam room for 15 minutes until she felt better and her facial color returned. Provider examined spoke to patient and then patient was released.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Irritability, Musculoskeletal stiffness
Clinical narrative: Patient developed swelling, redness and warmth to touch at injection site the following evening Wednesday 9/26/18. Irritable, and is walking stiff-legged. Seen in Urgent Care and are treating with TYLENOL and BENADRYL. Still determining what next step in care will be.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Feeling abnormal, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: Chills and fever night of injection, nauseated, felt poorly x 3 days, swelling/sore right arm.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Chills and fever night of injection, nauseated, felt poorly x 3 days, swelling/sore right arm.
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid rash, Herpes zoster, Ophthalmic herpes zoster, Pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 17-SEP-2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Ten days after receiving ZOSTAVAX, the patient developed an intermittent, sharp throbbing pain and red raised bumps on her eye and face. Thereafter, the patient was diagnosed with herpes zoster opthalmicus.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review herpes zoster ophthalmicus was considered a medically significant event. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On 17-SEP-2007, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Ten days after receiving ZOSTAVAX, the patient developed an intermittent, sharp throbbing pain and red raised bumps on her eye and face. Thereafter, the patient was diagnosed with herpes zoster opthalmicus.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Upon internal review herpes zoster ophthalmicus was considered a medically significant event. Additional information has been requested.
Sex: M
Vaccine: FLU3
Symptoms: Injection site extravasation, Underdose
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional, Pharmacist. This case involves a 71 years old male patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No Concomitant medication received. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number UJ006AB in left arm intramuscularly. It was a case of actual medication error due to vaccine underdose. Patient didn't get an adequate dose of the FLUZONE HD because there was leakage after the injection. No reaction 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: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Paraesthesia oral
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a 16 years old male patient who felt light headed, dizzy and his tongue felt funny, while he received vaccine MENACTRA. The patient's past vaccination(s) included MENACTRA on 06-AUG-2013 with no other information available regarding his first injection. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medication was not reported. It was also reported that No other vaccines were given this same day. On 11-Sep-2018, the patient received a second dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5841AA via intramuscular route in the right deltoid. On 11-Sep-2018, the patient developed a non-serious he felt light headed (dizziness) 15 minute following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 11-Sep-2018, the patient developed a non-serious dizzy (dizziness) 15 minute following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. On 11-Sep-2018, the patient developed a non-serious his tongue felt funny (paresthesia oral) 15 minute following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. It was also reported that Patient reports eating a small sandwich 6.5 hours prior to this 2nd injection. (Other relevant tests included No lab data.) Final diagnosis was his tongue felt funny, dizzy and he felt light headed. An unknown corrective treatment was received. It was also reported that Patient was then given orange juice, took vitals, observed for one hour by physician. The patient outcome is reported as Unknown for he felt light headed, as Unknown for dizzy and as Unknown for his tongue felt funny. List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked to case 2018SA262407 from same reporter. This case involves an unknown age male patient who experienced pain, shivering and fever, while he received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date, the patient received injection of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number, expiry date and dose not reported via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious pain with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious shivering with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. On an unknown date, the patient developed a non-serious fever with unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data was not provided. Final diagnosis was fever, shivering and pain. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for fever, as Unknown for shivering and as Unknown for pain. List of documents held by sender - none.
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 18-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional (pharmacy student). This case involves a 33 years old female patient who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot: UJ006AA; expiry date: 14-Apr-2019) in the right deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate age at vaccine administration. It was not reported whether the patient had experienced any adverse events 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. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Rhinorrhoea, Sneezing
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA266204 (same reporter). This case involves a 75 years old male patient who experienced naggy, runny nose and coughing, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 14-Sep-2018, the patient received a 0.5 mL dose of suspect FLUZONE HIGH DOSE lot number not reported via intramuscular route (expiry date and site of administration were not reported). On an unknown date, on same day of post-vaccination patient developed a non-serious coughing of an unknown latency following the administration of FLUZONE HIGH DOSE. On an unknown date, next day post-vaccination patient developed a non-serious naggy (sneezing) and runny nose (rhinorrhoea) following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was runny nose, naggy and coughing. It was not reported if the patient received a corrective treatment. The outcome of the event not reported.
Sex: U
Vaccine: TDAP
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves Adult patient (age and gender was not reported) and reported that the temperature excursion was to 0.2 degree Celsius but later discovered it was actually negative 0.3 degree Celsius while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a booster dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date and site of administration was not reported) via intramuscular route. It was a case of actual medication error due to product storage error temperature too low. 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. List of documents held by sender: none.
Age: 1.58
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Overdose
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a health professional, Nurse. This case involves a 19 months old female patient who received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL (lot number: C5254AB) for Immunisation; and HEPATITIS A VACCINE (HEPATITIS A VACCINE) for Immunisation, both in right thigh. On 21-Sep-2018 at 09 AM, the patient received a 0.5 ml single first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT5899MA via intramuscular route in the right thigh. It was a case of actual medication error due to overdose. It was unknown whether adverse event occurred or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267253, 2018SA267274, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293, 2018SA267304 and 2018SA267305. This case involves a [53 years old] female patient who was vaccinated with a single expired dose 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI815AA, expiration date: 30-Jun-2018, site of administration: left deltoid and route was not reported) on 17-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267265, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293, 2018SA267304 and 2018SA267305. This case involves a [55 years old] female patient who was vaccinated with a single 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI815AA, expiration date: 30-Jun-2018, site of administration: right deltoid and route was not reported) on 17-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267253, 2018SA267283, 2018SA267295, 2018SA267293, 2018SA267304 and 2018SA267294. This case involves a [36 years old] female patient who was vaccinated with a single dose of 0.5 ml FLUZONE QUADRIVALENT (Batch number: UI815AA, expiration date: 30-Jun-2018, site of administration: right deltoid and route was not reported) on 17-Sep-2018. The patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to expired vaccine used. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267282, 2018SA267253, 2018SA267293, 2018SA267295, 2018SA267304, 2018SA267274, 2018SA267294 and 2018SA267305 (same reporter). This case involves a 56 years old female patient who was vaccinated with an expired dose of 0.5 mL vaccine FLUZONE QUADRIVALENT lot UI815AA, expiry date:30-Jun-2018 via unknown route in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expire vaccine used. It was reported that 9 doses of expired FLUZONE QUADRIVALENT single dose vials exp. date: 30-Jun-2018 given inadvertently to employees for routine vaccination with no adverse reaction 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 and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves a three years old patient (gender not reported) who was vaccinated with a 0.25 ml of FLUZONE QUADRIVALENT (lot UT62259KA and expiration date not reported) via unknown route in the left deltoid on 13-Sep-2018. No other vaccines were given. The patients medical history and concomitant medications were not reported. It was an actual medication error due vaccine underdose (as the patient vaccinated with a 0.25 ml instead of 0.5ml). No information about adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267282, 2018SA267253, 2018SA267283, 2018SA267295, 2018SA267304, 2018SA267274, 2018SA267294 and 2018SA267305 (same reporter). This case involves a 56 years old female patient who was vaccinated with an expired dose of 0.5 mL vaccine FLUZONE QUADRIVALENT lot UI815AA, expiry date: 30-Jun-2018 via unknown route in the left deltoid on 17- Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to expire vaccine used. It was reported that 9 doses of expired FLUZONE QUADRIVALENT single dose vials exp. date: 30-Jun-2018 given inadvertently to employees for routine vaccination with no reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267293 and 2018SA267304 same reporter. This case involves a 30 years old female patient who received a 0.5ml dose of suspect vaccine FLUZONE QUADRIVALENT, lot UI815AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid on 17-Sep-2018. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired vaccine used. It was reported that patient was administered FLUZONE QUADRIVALENT vaccine on 17-Sep-2018, which was expired on 30-Jun-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267294, 2018SA267282, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267294, 2018SA267293 and 2018SA267304 same reporter. This case involves a 60 years old male patient who received a 0.5 ml dose of suspect vaccine FLUZONE QUADRIVALENT, lot UI815AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid on 17-Sep-2018. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired vaccine used. It was reported that patient was administered FLUZONE QUADRIVALENT vaccine on 17-Sep-2018, which was expired on 30-Jun-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267305, 2018SA267294, 2018SA267282, 2018SA267295, 2018SA267293, 2018SA267253 and 2018SA267283 same reporter. This case involves a 57 years old female patient who received a 0.5ml dose of suspect vaccine FLUZONE QUADRIVALENT, lot UI815AA, expiry date 30-Jun-2018 via intramuscular route in the left deltoid on 17-Sep-2018. The patients past medical history and family history were not provided. The patient did not receive any concomitant medication. It was an actual medication error due to expired vaccine used. It was reported that patient was administered FLUZONE QUADRIVALENT vaccine on 17-Sep-2018, which was expired on 30-Jun-2018. The patient did not experience any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender - none.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA267265, 2018SA267274, 2018SA267253, 2018SA267282, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293 and 2018SA267304 (Same reporter). This case involves Adult female patient (age not reported), who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UI815AA and expiry date: 30-Jun-2018) (dose in series and route not reported) in the left deltoid on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No concomitant reported. It was a case of actual medication error due to expired vaccine used. No reaction reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 60.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 60 years old female patient who had DAPTACEL that was given to an adult, while she received vaccine DAPTACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On 20-Sep-2018, the patient received a booster dose of 0.5 ml suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot number: C5148AA and expiry date: 09-Feb-2019) via intramuscular route in the right deltoid. It was a case of actual medication error due to inappropriate age at vaccine administration. 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. List of documents held by sender: none.
Sex: U
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves adult patient (age and gender not reported) who was vaccinated with a 0.5 ml dose of MENACTRA via intramuscular route (Batch number, expiry date, dose in series and site of administration were not reported) on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included GARDASIL 9 for Immunisation on an unknown date. It was a case of actual medication error due to incorrect product storage (it was reported that moved their vaccines due to the hurricane and initially thought the temp excursion was to 0.2C but later discovered it was actually negative 0.3 degree Celsius). It was reported that no treatment as no symptoms 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 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 the sender: none.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 6 months old male patient who was vaccinated with a 0.5 ml third dose of PENTACEL (lot number: C5541AA and expiry date not reported) via intramuscular route in the right thigh on 13-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included ENGERIX B, FLUZONE QUADRIVALENT, PREVENAR 13 and ROTATEQ for Immunisation on an unknown date. It was a case of actual medication error due to inappropriate reconstitution technique because only the TDaP-IPV portion of PENTACEL was given and not the ACTHIB. 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 the sender: none.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves female patient (age unknown) who received 0.5 ml dose of vaccine FLUZONE HIGH DOSE, lot number, expiry date not reported via unknown route in unknown administration site. The patients past medical history and family history were not provided. Concomitant medications included VACCINE SHINGRIX on unknown date, lot number not reported via unknown route in unknown administration site. It was an actual medication error due to vaccine underdose and syringe issue. It was reported that received only part of her FLUZONE HD dose after noticing a drop fall down her arm. It leaked because the needle wasnt completely attached to the syringe. But caller said it was screwed on tightly with the luer lock. The leaking occurred during injection but did not seep from the injection site. 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.