chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 20-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011753: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 20-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011754: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a nurse referring to a patient of unknown age and gender. Concomitant therapies included sterile diluent. Information about concurrent condition, drug reactions/allergies and medical history was not provided. On 31-AUG-2018, the patient received one dose of improperly stored (-9 Celsius (C) degree to 8 C degree for 68 minutes; previous temperature excursion: -9 C degree to 8 C degree for 76 minutes) VARIVAX (lot # N029634, expiration date 23-OCT-2019; strength and route were not reported) for prophylaxis; reconstituted with properly stored sterile diluent (as reported lot# R002715, expiration date 20-FEB-2020). No adverse effects reported. The reporter called because of a data logger. Sender's Comments: US-009507513-1809USA005628: US-009507513-1809USA011283: US-009507513-1809USA011743: US-009507513-1809USA011744: US-009507513-1809USA011745: US-009507513-1809USA011746: US-009507513-1809USA011747: US-009507513-1809USA011748: US-009507513-1809USA011749: US-009507513-1809USA011750: US-009507513-1809USA011751: US-009507513-1809USA011752: US-009507513-1809USA011753: US-009507513-1809USA011755: US-009507513-1809USA011756: US-009507513-1809USA011757: US-009507513-1809USA011758: US-009507513-1809USA011759.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site infection, Injection site rash
Clinical narrative: Patient had rash at injection site which was diagnosed as infection.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Axillary pain, Chills, Headache, Injection site pain, Muscular weakness
Clinical narrative: Headache, muscle aches, muscle weakness, chills, nausea, arm where shot was given very sore and armpit of left arm was extremely tender and painful as though I had shingles in that area. 48 hours? treatment was over the counter ibuprofen and rest.
Age: 53.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Myalgia, Nausea, Tenderness
Clinical narrative: Headache, muscle aches, muscle weakness, chills, nausea, arm where shot was given very sore and armpit of left arm was extremely tender and painful as though I had shingles in that area. 48 hours? treatment was over the counter ibuprofen and rest.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Redness and edema on left upper arm few hours after receiving vaccine, no shortness of breath, no fever or chill. Axilla not affected.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Skin warm
Clinical narrative: On Monday 9/24/18 child received immunization for flu at recheck appointment. As documented and recalled by person who administered, it was given in left thigh intramuscularly. Mom called triage nurse on 9/25/18 with concerns regarding redness, heat to right upper thigh. Mom stated this was the site of injection. Child brought into provider on 9/16/18. Redness and heat to right upper thigh. No injection site notable at visit.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea, Fatigue, Myalgia
Clinical narrative: For two days after the shot, I experienced fatigue and myalgia (known effects) and then developed loose to watery stool for another few days. I self-medicated the diarrhea with a single 500 mg dose of azithromycin, treating it as a traveller's diarrhea (though my last travel was in May) and by this morning I'm back to having formed stool. The fatigue has ceased. I don't know if you subscribe to the adverse effects reporting system, but, if you do, this is one to mention.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Erythema, Fatigue, Headache
Clinical narrative: Severe swelling from shoulder to elbow; red, tight, hot skin; severe headache; weakness/tiredness; aches in muscles and joints; pain at injection site/upper arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Peripheral swelling, Skin tightness, Skin warm
Clinical narrative: Severe swelling from shoulder to elbow; red, tight, hot skin; severe headache; weakness/tiredness; aches in muscles and joints; pain at injection site/upper arm.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Fever, achiness, nausea, sore throat.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was to office with mom 9/24/2018, received FLULAVAL vaccine at that time, signed consent. 9/26/2018, patient returned to office for recheck with grandmother, she asked for flu vaccine and signed consent. Flu vaccine give two days apart. No side effects reported by mom at this time. GSK company made aware, information reviewed with mom.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood culture negative, Blood lactate dehydrogenase, Blood thyroid stimulating hormone, Chest X-ray abnormal, Computerised tomogram head normal
Clinical narrative: Fever around 101 began on 6/27/18. Office visit on 7/5/18. CBC, urinalysis, blood culture all WNL. Office visit 7/6/18. CBC WNL and Chest x-ray with subtle perihilar opacities but no respiratory symptoms. Office visit 7/8/19? baby looked good but continued unexplained fevers. Office visit 7/13/18 with normal CBC except for slightly elevated platelets. Sent to ED. Normal ESR/CRP/bag urine and echo in ED by Infectious Disease. Baby looked good and was afebrile in ED. ED. Recommended weekly follow up with PCP for monitoring. Office visit 7/17/18: Chest xray and abdominal ultrasound 7/19/18 WNL. Office visit 7/23/18 Baby looked good; Fevers continuing; CBC WNL except for elevated platelets; Infectious disease continues to recommend monitoring and no further testing. Office visit 7/30/18 Temps continuing to 101 but asymptomatic other than eye infection with this exam. Office visit 7/31/18 Baby vomiting; fevers continuing; sent for head CT to rule out neoplasm. Office visit 8/1/18 Bloody emesis; continued fever around 101; CBC normal; urine. Head CT 8/3/18 normal. Office visit 8/7/18 fever 101 continues, otherwise baby looks good with normal exam. Office visit 8/14/18 fever continues 101.5; CBC, LDH, TSH and Free T4. Seen at Diagnostic Clinic 8/23/18; empiric trial of Naproxen 75mg BID x 3 days. Baby afebrile within 24 hours of starting Naproxen and has remained fever free. According to Mom, Diagnostic Group felt that the vaccines triggered an immune system reaction. Plan to stagger vaccines and give Naproxen with each set going forward.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Eye infection, Full blood count normal, Haematemesis, Platelet count increased, Pyrexia
Clinical narrative: Fever around 101 began on 6/27/18. Office visit on 7/5/18. CBC, urinalysis, blood culture all WNL. Office visit 7/6/18. CBC WNL and Chest x-ray with subtle perihilar opacities but no respiratory symptoms. Office visit 7/8/19? baby looked good but continued unexplained fevers. Office visit 7/13/18 with normal CBC except for slightly elevated platelets. Sent to ED. Normal ESR/CRP/bag urine and echo in ED by Infectious Disease. Baby looked good and was afebrile in ED. ED. Recommended weekly follow up with PCP for monitoring. Office visit 7/17/18: Chest xray and abdominal ultrasound 7/19/18 WNL. Office visit 7/23/18 Baby looked good; Fevers continuing; CBC WNL except for elevated platelets; Infectious disease continues to recommend monitoring and no further testing. Office visit 7/30/18 Temps continuing to 101 but asymptomatic other than eye infection with this exam. Office visit 7/31/18 Baby vomiting; fevers continuing; sent for head CT to rule out neoplasm. Office visit 8/1/18 Bloody emesis; continued fever around 101; CBC normal; urine. Head CT 8/3/18 normal. Office visit 8/7/18 fever 101 continues, otherwise baby looks good with normal exam. Office visit 8/14/18 fever continues 101.5; CBC, LDH, TSH and Free T4. Seen at Diagnostic Clinic 8/23/18; empiric trial of Naproxen 75mg BID x 3 days. Baby afebrile within 24 hours of starting Naproxen and has remained fever free. According to Mom, Diagnostic Group felt that the vaccines triggered an immune system reaction. Plan to stagger vaccines and give Naproxen with each set going forward.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Thyroxine free, Ultrasound abdomen normal, Urine analysis normal, Vomiting
Clinical narrative: Fever around 101 began on 6/27/18. Office visit on 7/5/18. CBC, urinalysis, blood culture all WNL. Office visit 7/6/18. CBC WNL and Chest x-ray with subtle perihilar opacities but no respiratory symptoms. Office visit 7/8/19? baby looked good but continued unexplained fevers. Office visit 7/13/18 with normal CBC except for slightly elevated platelets. Sent to ED. Normal ESR/CRP/bag urine and echo in ED by Infectious Disease. Baby looked good and was afebrile in ED. ED. Recommended weekly follow up with PCP for monitoring. Office visit 7/17/18: Chest xray and abdominal ultrasound 7/19/18 WNL. Office visit 7/23/18 Baby looked good; Fevers continuing; CBC WNL except for elevated platelets; Infectious disease continues to recommend monitoring and no further testing. Office visit 7/30/18 Temps continuing to 101 but asymptomatic other than eye infection with this exam. Office visit 7/31/18 Baby vomiting; fevers continuing; sent for head CT to rule out neoplasm. Office visit 8/1/18 Bloody emesis; continued fever around 101; CBC normal; urine. Head CT 8/3/18 normal. Office visit 8/7/18 fever 101 continues, otherwise baby looks good with normal exam. Office visit 8/14/18 fever continues 101.5; CBC, LDH, TSH and Free T4. Seen at Diagnostic Clinic 8/23/18; empiric trial of Naproxen 75mg BID x 3 days. Baby afebrile within 24 hours of starting Naproxen and has remained fever free. According to Mom, Diagnostic Group felt that the vaccines triggered an immune system reaction. Plan to stagger vaccines and give Naproxen with each set going forward.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient recieved the flu vaccine at 715am on 9/24/2018, and about 230pm on 9/25/2018 he said that he got hives on neck, upper and lower extremities and trunk.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Pt was given the SHINGRIX vaccine Subcutaneously 9/21/2018 when it should have been given Intramuscularly. Over the course of a few days, they reported redness and swelling at the incorrect injection site. He did not seek medical treatment as they did not deem in necessary. Symptoms have resolved by 09/26/2018.
Age: 55.0
Sex: F
Vaccine: UNK
Symptoms: Vomiting
Clinical narrative: Severe vomiting for 3 days, unable to keep anything down.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Dizziness
Clinical narrative: C/o dizziness. Noted pt color was normal. Nurse had pt lie down, and applied a cool compress to posterior neck and gave him water. Nurse notified MD. VS were taken and stable. Pt reported dizziness was gone. MD saw pt and gave him permission to leave.
Age: 74.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient stated her arm is really red today. I looked at it and it is. She got it on 9/18 same day as flu shot. She got flu in left and PREVNAR 13 in right. Her arm is red, shot was given IM. No discoloration or bruising. She said it is a little sore. Will call her PCP to let them know as well.
Age: 88.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Severe itching and hives over entire body within 45 minutes of dose. Benadryl and Solu-medrol administered IV.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Hypoaesthesia, Injection site erythema, Injection site swelling, Pharyngeal oedema
Clinical narrative: Swelling left side of throat, weakness, low grade fever (99 deg), redness, swelling below site in injection, numbness left side of face.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: Swelling left side of throat, weakness, low grade fever (99 deg), redness, swelling below site in injection, numbness left side of face.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Injection site erythema, Injection site swelling
Clinical narrative: Pt was given the SHINGRIX vaccine Subcutaneously 9/21/2018 when it should have been given Intramuscularly. Over the course of a few days, they reported redness and swelling at the incorrect injection site. She did not seek medical treatment as they did not deem in necessary. Symptoms have resolved by 09/26/2018.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Tingling and pain in fingertips and in toes.
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Crying, Eye movement disorder, Fatigue, Hypotonia
Clinical narrative: After vaccines pt was fatigued, took at nap. Mom heard pt whining, attempted to give a pacifier which did not help. Mom picked up patient to nurse, he was completely limp, skin pale, seemed unresponsive, eyes rolling back. Called 911. Improved alertness by the time paramedics arrived. Pt was warm to touch. Pt was seen in ER- pt febrile T 100.8 and tachycardia present (198 BPM).
Age: 0.25
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pallor, Skin warm, Tachycardia, Unresponsive to stimuli
Clinical narrative: After vaccines pt was fatigued, took at nap. Mom heard pt whining, attempted to give a pacifier which did not help. Mom picked up patient to nurse, he was completely limp, skin pale, seemed unresponsive, eyes rolling back. Called 911. Improved alertness by the time paramedics arrived. Pt was warm to touch. Pt was seen in ER- pt febrile T 100.8 and tachycardia present (198 BPM).
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received a PEDIARIX that was her second dose of DTAP, and Polio and her third Hepatitis B. The Hep B dose was too early to be her final dose.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Body temperature increased, Chills, Diarrhoea, Dry throat
Clinical narrative: Asthma-like breathing constriction, dry throat, puffy eyes, and chills from 4 PM through the night.  Temperature slightly elevated at 98.6 (my normal temp is 97.6). Some relief from constricted breathing following dose of 25mg benadryl PO. Diaharrea and mild body aches today. Breathing problem and chills were most worrisome, and I considered going to ER but did not go.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Eyelid oedema, Pain
Clinical narrative: Asthma-like breathing constriction, dry throat, puffy eyes, and chills from 4 PM through the night.  Temperature slightly elevated at 98.6 (my normal temp is 97.6). Some relief from constricted breathing following dose of 25mg benadryl PO. Diaharrea and mild body aches today. Breathing problem and chills were most worrisome, and I considered going to ER but did not go.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient complained of itching at the site of injection immediately after receiving the vaccine. She got swelling and redness at the site of injection. She placed an ice pack on the site for 20 minutes, said she was feeling better and left. 10 minutes later she returned complaining of itching on her chest and other arm. Upon inspection the patient was found to have hives on her neck, face, chest and redness on her chest, both arms and legs. School nurse administered 25mg of Benadryl and another 25mg of Benadryl 15 minutes later. The redness and hives completely resolved and the patient returned back to work.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient complained of itching at the site of injection immediately after receiving the vaccine. She got swelling and redness at the site of injection. She placed an ice pack on the site for 20 minutes, said she was feeling better and left. 10 minutes later she returned complaining of itching on her chest and other arm. Upon inspection the patient was found to have hives on her neck, face, chest and redness on her chest, both arms and legs. School nurse administered 25mg of Benadryl and another 25mg of Benadryl 15 minutes later. The redness and hives completely resolved and the patient returned back to work.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis
Clinical narrative: Patient was diagnosed with cellulitis on left arm following immunization.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness and swelling in arm, away from infection site. Pt went to urgent care where abx were prescribed for suspected cellulitis, however, pt stated cellulitis ruled out by physician in office visit next day. Prednisone ordered for reaction by physician.
Age: 1.17
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: 0.5ml dose given instead of 0.25ml dose, no adverse reaction at this time.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Act (ref# 747828) concerning a 18 year old female patient. On 26-APR-2018, the patient was vaccinated with GARDASIL 9 (lot # N022584), expiry date: 15-JUN-2020, dose 2, intramuscular in the right arm. It was reported that second dose was given too soon, and was supposed to be given 1-2 months from the first GARDASIL 9 shot which was administered on 12-APR-2018. Merck recommended giving the 2nd injection again at least 1 month after the last injection administered and was scheduled to re-administer the second GARDASIL 9 on 29-MAY-2018.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Swollen tongue
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 74 years old female patient who experienced tongue and body swelling, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 11-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot U1981AA. The patient developed a non-serious tongue and body swelling following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was tongue and body swelling. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for tongue and body swelling.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Elderly patient who received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported. It was a case of actual medication error due to improper product storage. The shipment had been flagged as having been too long in shipping transit. 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: 21.0
Sex: F
Vaccine: FLUR4
Symptoms: Influenza like illness, Muscular weakness, Paraesthesia, Peripheral swelling
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves 21-year-old female patient who experienced large swelling in arm for a week from shoulder to elbow, mild weakness in left arm, tingling in fingers and flu like symptoms, while she received vaccine FLUBLOK QIV. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was none. On 06-Sep-2018, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot 2FAA1810 expiry date: 30-Jun-2019 via intramuscular route in the left deltoid. On an unknown date, the patient developed a non-serious large swelling in arm for a week from shoulder to elbow 6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious mild weakness in left arm 6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious tingling in fingers 6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. On an unknown date, the patient developed a non-serious flu like symptoms6 hours following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab data.) Final diagnosis was flu like symptoms, tingling in fingers, and mild weakness in left arm and large swelling in arm for a week from shoulder to elbow. 600 mg of Ibuprofen was received as corrective treatment. The patient outcome is reported as Unknown for large swelling in arm for a week from shoulder to elbow, as Unknown for mild weakness in left arm, as Unknown for flu like symptoms and as recovered/resolved on an unknown date for tingling in fingers. Follow-up information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. Patient age and event outcome was updated. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Initial information received on 13-Sep-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves two adult patients who experienced feeling ill, fever, nausea and body ache, while he/she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE lot UI995AA. On an unknown date, the patient developed a non-serious feeling ill (malaise) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious fever (pyrexia) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious nausea within 24 hours following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. On an unknown date ¸the patient developed a non-serious body ache (pain) within 24 hours following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. No lab data reported. Final diagnosis was body ache, nausea, fever and feeling ill. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for all the events.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse via phone. This case involves a 69 years old female patient who experienced nausea, vomiting, fever and body ache, while she received vaccines PNEUMOVAX and FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had had the same flu shot last year without issues. On 12-Sep-2018, the patient received 0.5 mL dose of suspect FLUZONE HIGH DOSE lot U1995AA, expiry date 01-04-2019 via intramuscular route in the right deltoid. On 12-Sep-2018, the patient received a dose of suspect PNEUMOVAX not produced by Sanofi Pasteur (batch number, expiry date, route and site of administration were unknown). On an unspecified date, next day post-vaccination patient developed a non-serious nausea, vomiting, fever and body ache following the administration of FLUZONE HIGH DOSE. Relevant tests were not reported. Final diagnosis was body ache, fever, vomiting and nausea.  The patient was treated with TYLENOL for Product used for unknown indication. The outcome of the events reported as unknown. Documents held by sender: none.
Age: 1.17
Sex: M
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: Initial unsolicited report received from a nurse via phone on 14-SEP-2018. This case involves a 14 month patient who was vaccinated with 0.5 ml dose of DAPTACEL (batch number C5190AA, expiry date 24 April 2019), intramuscularly in left thigh on 14 Sep 2018. It was reported that, patient also received Daptacel on an unspecified date in June 2018. Concomitant medication involved Prevnar, Varicella and HIB. It was a case of actual medication error as Extra dose administered. It was unknown if any adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU4, HIBV, PPV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a four years old patient (gender not reported) who was vaccinated with 0.5 ml fourth dose of ADACEL (batch number U5770AA and expiration date 15-SEP-2019) via intramuscular route in the left deltoid on an unspecified date instead of DAPTACEL. The patients medical history was not reported. Concomitant medications included FLUZONE QUADRIVALENT for Immunization; ACTHIB for Immunization; and Pneumococcal Conjugate Vaccine for Immunization. It was an actual medication error due to wrong vaccine was administered (patient received Tdap instead of DTap) and inappropriate age at vaccine administration (ADACEL administered to 4 years old). It was reported that, on 18 Sep 2018 patient visited to physician. 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: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Incorrect product formulation administered, Product preparation issue
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a two- months old male patient who received 0.5 mL first dose of DTAP-IPV component only from the vaccine PENTACEL (lot number of DTAP-IPV C5324AC; Lot number on box is C5507AA that matches HIB component), expiry date- 05-Sep-2019 via intramuscular route in the thigh (not specified) on 20-Sep-2018. On an unknown date, the patient also received a dose of suspect PREVNAR 13, HEPATITIS B VACCINE and ROTAVIRUS VACCINE not produced by Sanofi Pasteur (batch number, expiry date, route and site of administration were unknown). The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to inappropriate reconstitution technique. It was unknown whether patient experienced any adverse reaction after the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 20-Sep-2018 and additional information was received on same day regarding a non-valid unsolicited valid non-serious case received from a nurse. This case involves an unknown age patient who received expired vaccine FLUZONE HIGH DOSE lot UI869AA, expiry date 05-May- 2018 (route, dose and site of administration were not reported). 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 expired vaccine used. It was reported that caller updated adverse event information saying the expired product given was Fluzone High Dose and not Quadrivalent. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Local reaction, Vaccination site swelling
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case involves a five-years old female patient who experienced localized reaction of large swelling, while she received vaccine FLUZONE QUADRIVALENT. The patients past medical history, concomitant medication and family history were not provided. On an unknown date in 2015, the patient received a 0.5ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI440AD, expiry date 30-Jun-2016 via intramuscular route in the deltoid NOS. On an unknown date, patient developed a non-serious localized reaction of large swelling with unknown latency following the administration of FLUZONE QUADRIVALENT. For this reason, the flu vaccine was omitted for the patient in 2016. It was reported as in 2017, at a different site not affiliated with this case, patient received another flu vaccination (unknown Brand) in the thigh and the father reports another localized reaction (football sized). Relevant tests were not reported. Final diagnosis was localized reaction of large swelling. It was not reported if the patient received a corrective treatment. On an unknown date the patient was recovered from the event. Documents held by sender- none.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial unsolicited valid non-serious case received from a nurse on 20-Sep-2018. This case is linked to 2018SA266205 (same reporter). This case involves a 60 years old female patient who was vaccinated with a dose of FLUZONE HIGH DOSE (lot UJ004AB via unknown route in the left deltoid) instead of FLUZONE QUADRIVALENT on 15-Sep-2018 instead of FLUZONE QUADRIVALENT vaccine. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose (it was reported that a 60 year old patient was vaccinated with FLUZONE HD). It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Initial unsolicited valid non-serious case received from a nurse on 20-Sep-2018. This case is linked to 2018SA266203 (same reporter). This case involves a 61 years old female patient who was vaccinated with 0.5 ml first dose of FLUZONE HIGH DOSE (lot UJ004AB, expiry date: 30 Mar 2019 via unknown route in the left deltoid) instead of FLUZONE QUADRIVALENT on 15-Sep-2018. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to wrong vaccine administered, inappropriate age at vaccine administration and overdose as it was reported that a 61-year-old patient was accidently vaccinated with FLUZONE HD. This is trivalent. They should have gotten Quadravalent. It was not known whether the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with related case 2018SA266212 for other patient under 65. This case involves patient (age under 65 years, gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that patient under 65 was accidentally injected with Fluzone High dose. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Sex: U
Vaccine: FLU3
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case is linked with related case 2018SA266210 for other patient under 65. This case involves patient (age under 65 years, gender unknown) who received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. It was an actual medication error due to overdose and inappropriate age at vaccine administration. It was reported that patient under 65 was accidentally injected with Fluzone High dose. It was unknown whether patient experienced any adverse reaction after the injection. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chest discomfort, Cough, Ocular hyperaemia, Pain
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 68 years old female patient who experienced body aches, very red blood shot eyes, deep cough, pressure on her chest, and a temperature of more than 99, while she received vaccine FLUZONE HIGH DOSE. The patients past medical history, concomitant medication and family history were not provided. On 19-Sep-2018, in the evening the patient received injection of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ010AC, expiry date 22-Apr-2019 via unknown route in unknown administration site. On 20-Sep-2018, the patient developed a non-serious body aches one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, the patient developed a non-serious very red blood shot eyes one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, the patient developed a non-serious deep cough one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, the patient developed a non-serious pressure on her chest, 1 day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On 20-Sep-2018, patient developed a non-serious a temperature of more than 99 one day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Lab data was not provided. Final diagnosis was a temperature of more than 99, pressure on her chest, deep cough, very red blood shot eyes and body aches. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for deep cough, as Unknown for pressure on her chest, as Recovering / Resolving for body aches, as Recovering / Resolving for a temperature of more than 99 and as Unknown for very red blood shot eyes. List of documents held by sender- none.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 83 years old female patient who was vaccinated once with an 0.5 ml expired dose of FLUZONE HIGH DOSE (lot UI890AB; expiry date: 05-Jun-2018 via intramuscular route in the left deltoid. 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 expired vaccine used. It was not reported whether the patient experienced any adverse events following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 63 years old female patient who was vaccinated with a 0.5 ml once dose of FLUZONE HIGH DOSE (batch number UJ006AB and expiration date 14-Apr-2019) (route and site of administration was not reported) on 20-SEP-2018. The patients medical history and concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration. No specific adverse event symptoms reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: Product preparation issue
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an patient (age and gender was not reported) who was vaccinated with a dose of PENTACEL (Lot number for box:C5449AA; expiry date: 07-Dec-2018; lot number for DTaP-IPV component: C5288AA; expiry date: 07-Dec-2018) on an unknown date. The patients 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 reconstitution technique since nurse at the hospital gave the PENTACEL vaccine but instead of giving the 2 components together she only gave the powder-ActHIB part and not the liquid part-DTaP-IPV component. It was not reported whether the patient experienced any adverse events following the reaction. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 5.0
Sex: U
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional. This case involves a 5 years old patient who was vaccinated with 0.5 ml dose of PENTACEL (Batch number: C5464AA and expiry date: 26-Jul-2019) via intramuscular route in the left deltoid instead of DAPTACEL and IPV on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR for Immunisation; and VARICELLA VACCINE for Immunisation on an unknown date. It was a case of actual medication error due to wrong vaccine administered. No adverse events reported at this time. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by the sender: none.