chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Dizziness, Fatigue, Headache, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of headache in a 74-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of headache (see case: US2018173656). On 19th September 2018, the patient received the 2nd dose of SHINGRIX. On 19th September 2018, less than a day after receiving SHINGRIX, the patient experienced headache, diarrhea and nausea. On 20th September 2018, the patient experienced dizziness and tiredness. On an unknown date, the outcome of the headache, dizziness, nausea and tiredness were not recovered/not resolved and the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the headache, dizziness, diarrhea, nausea and tiredness to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX into left arm. The headache and nausea presented the evening of vaccination. On 20th September 2018, 1 day after receiving SHINGRIX the patient experienced dizziness and she was tired. The patient had not been able to eat very much due to the nausea. The side effects were much more severe. This case has been linked to the US2018173656, reported by the same reporter.
Sex: U
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. An adolescent patient received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced a seizure following the vaccination and was seen in the emergency room (ER). Clinical outcome of the event was unknown at time of this report. The information on the lot number has been requested.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Contusion, Fall, Loss of consciousness, Syncope, Tremor
Clinical narrative: Patient was administered TDAP, MCV4 and HPV vaccine -within 15 minutes of the vaccines, she had a syncopal episode and fell forward from her chair on to the ground, then had shaking of limbs that lasted no more than 3 seconds. When picked up she was back to consciousness. She was allowed to remain in observation for another 15-20 minutes, after which she walked out of clinic unassisted. No serious injuries occurred except for a bruise of the forehead.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Fever.
Age: 38.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin, Human chorionic gonadotropin positive, Ultrasound scan normal, Vaginal haemorrhage
Clinical narrative: Patient was vaccinated on 10/1/18 and was possibly about 6 weeks pregnant, she had not been to OB/GYN yet, but home test was positive, vaccinator didn't realize. On 10/3/18 she was spotting and went to ER where they couldn't confirm or deny anything, ultrasound didn't show anything. Going to OB/GYN 10/5 for more detailed test. information from patient's friend/coworker.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Flushing, Heart rate increased
Clinical narrative: Facial flushing, rapid heartbeat, chest tightness.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Induration, Pain, Swelling, Urticaria
Clinical narrative: REDNESS, SWELLING AND HARD RAISED WHEEL (55 X 40 mm), SOARNESS. REACTION STILL PRESENT AT THIS TIME 3 DAYS AFTER RECIEVING VACCINE.
Age: 66.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Erythema, Pain in extremity, Pyrexia
Clinical narrative: Injection at 9:00 am on Oct 4. Everything fine until sudden onset of fever at 5:00 pm the same date. Fever throughout the night and pain as well as redness in the upper arm. It is now 24 hours later and there is still pain in the upper arm and redness in a radius of 4 inches as well as fever. The redness is a severe jagged bold red line. Fever and redness still continues as of 8:15 the next morning (0ct 5).
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea
Clinical narrative: Headache and nausea. Headache almost immediately afterwards nausea 14 hours afterwards.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood lactic acid, Chest X-ray, Metabolic function test, Pyrexia
Clinical narrative: Pt was seen at Emergency room later that evening for fever 105 degrees.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Nausea, Pyrexia
Clinical narrative: Received flu vaccine. Do not know any information about the manufacturer date or lot number. Nausea, light headed, fever.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Muscle tightness, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Flu Vaccine: Immediately had horrible pain when administered. Within 30 minutes, experienced stiff neck accompanied with extreme neck, shoulder and arm pain; could not reach or extend arm without pain. Continued to move arm in rotating and upward movements to ward off the pain and move the muscles. Didn't help. One day late, still experiencing same, but with less pain but tightness in shoulder and neck persist. Have NEVER experienced this before (usually just a low grade fever and soreness)
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Neck pain, Pain, Pain in extremity
Clinical narrative: Flu Vaccine: Immediately had horrible pain when administered. Within 30 minutes, experienced stiff neck accompanied with extreme neck, shoulder and arm pain; could not reach or extend arm without pain. Continued to move arm in rotating and upward movements to ward off the pain and move the muscles. Didn't help. One day late, still experiencing same, but with less pain but tightness in shoulder and neck persist. Have NEVER experienced this before (usually just a low grade fever and soreness)
Age: 22.0
Sex: M
Vaccine: UNK
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: I had a headache, was dizzy, and nausea and vomiting.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Cough, Fatigue, Headache, Myalgia
Clinical narrative: Fever, chills, severe nausea, severe fatigue, muscle aches, headaches, cough.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, chills, severe nausea, severe fatigue, muscle aches, headaches, cough.
Age: 1.0
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site infection, Injection site swelling
Clinical narrative: PARENTS NOTICED A RED BUMP AT INJECTION SITE WITHIN A DAY OF VACCINATION ADMINISTRATION. NEVER WENT AWAY THEN AROUND 09/22-23 THEY NOTICED IT WAS MUCH LARGER, REDDER. SEEN IN OFFICE AND IT WAS DETERMINED BY THE PROVIDER THAT PATIENT HAD AN INFECTION AT THE INJECTION SITE. HE WAS PUT ON A 10 DAY COURSE OF KEFLEX.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patients arm around injection site was red and the size of a baseball. It was raised in swelling around 1/8 of an inch and 3 inches in diameter. It was warm to the touch for the first 8 hours but not warm to the touch when she stopped by the pharmacy.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness and heat at injection site 9.22.18 to 9.25.18. Pain and soreness at injection site. Hard to raise arm. 9.21.18 to 9.25.18. Stomach pain (stabbing) 9.27.18 to 9.29.18. Headache and chills 9.28.18 to 9.29.18.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Mobility decreased
Clinical narrative: Redness and heat at injection site 9.22.18 to 9.25.18. Pain and soreness at injection site. Hard to raise arm. 9.21.18 to 9.25.18. Stomach pain (stabbing) 9.27.18 to 9.29.18. Headache and chills 9.28.18 to 9.29.18.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Injection site erythema, Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: 1:11 Wed 10/3/18 Received Vaccination. That evening ( Wed 10/3/18), noticed pain in axilla and palpated a swollen lymph node. On Thursday evening 7pm, she noted painful to touch round red rash at left deltoid injection site, NO itching, No drainage. On Friday morning 9:00 am she presented to Health Center to report reaction. She was examined by CRNP. Findings: Integumentary Other findings raised erythematous round area 40x35mm on left arm deltoid region, no drainage, cool to touch, non tender to touch. Lymphatics Left: no lymphadenopathy axillary. Continue her allergy medication, plus Benadryl.
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy
Clinical narrative: 1:11 Wed 10/3/18 Received Vaccination. That evening ( Wed 10/3/18), noticed pain in axilla and palpated a swollen lymph node. On Thursday evening 7pm, she noted painful to touch round red rash at left deltoid injection site, NO itching, No drainage. On Friday morning 9:00 am she presented to Health Center to report reaction. She was examined by CRNP. Findings: Integumentary Other findings raised erythematous round area 40x35mm on left arm deltoid region, no drainage, cool to touch, non tender to touch. Lymphatics Left: no lymphadenopathy axillary. Continue her allergy medication, plus Benadryl.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site discolouration, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Within two hours after injection, an area about 1 inch by 2 inches around the injection site was red, hot, swollen, and painful. Within two days, that area grew to 3-1/4" in diameter, red, hot, swollen and painful. The bright red color persisted for 10 days and took another week to fade to a dark area occupying the same area. Now, nearly four weeks later, the skin color has returned to normal, but the skin is peeling on that part of my arm, as if it had been sunburned.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin exfoliation
Clinical narrative: Within two hours after injection, an area about 1 inch by 2 inches around the injection site was red, hot, swollen, and painful. Within two days, that area grew to 3-1/4" in diameter, red, hot, swollen and painful. The bright red color persisted for 10 days and took another week to fade to a dark area occupying the same area. Now, nearly four weeks later, the skin color has returned to normal, but the skin is peeling on that part of my arm, as if it had been sunburned.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Neck pain, Pain in extremity
Clinical narrative: The side effects happened 3 days after receiving the vaccine. Severe pain at the back of both legs; pain in the back of my neck; headaches; extreme fatigue; shivering.
Age: 24.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Patient had fever and redness and swelling about 4 inches in diameter around the injection site.  PNEUMOVAX and FLUARIX were given in the same arm, unable to determine which vaccine cause the adverse event.
Age: 24.0
Sex: M
Vaccine: FLU4, HEPA, TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Muscle twitching, Pallor, Syncope
Clinical narrative: Client experienced syncopal episode immediately after receiving 3rd shot. Client slumped on exam table. He was lowered on exam table with feet elevated and fanned with file. Client appeared pale and non-responsive for approximately 4 to 5 seconds. 2 to 3 muscle twitches noted during time client was unresponsive. Client became responsive to voice and touch and remained in supine position on exam table for 15 to 20 minutes and then left the clinic unaided. Client was accompanied by girlfriend. Client states started feeling lightheaded during 1st shot, Hep A, and then immediately after 3rd shot, Tdap client was slumping and unresponsive. Client stated had fainted when receiving previous shots on 11-21-16.
Age: 24.0
Sex: M
Vaccine: FLU4, HEPA, TDAP
Symptoms: Unresponsive to stimuli
Clinical narrative: Client experienced syncopal episode immediately after receiving 3rd shot. Client slumped on exam table. He was lowered on exam table with feet elevated and fanned with file. Client appeared pale and non-responsive for approximately 4 to 5 seconds. 2 to 3 muscle twitches noted during time client was unresponsive. Client became responsive to voice and touch and remained in supine position on exam table for 15 to 20 minutes and then left the clinic unaided. Client was accompanied by girlfriend. Client states started feeling lightheaded during 1st shot, Hep A, and then immediately after 3rd shot, Tdap client was slumping and unresponsive. Client stated had fainted when receiving previous shots on 11-21-16.
Age: 64.0
Sex: F
Vaccine: SMALL
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Very tired. Slight headache. Some chills but do not know if I have a fever.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Pain when lifting arm up, pt reports usual soreness the day after receiving shot however the pain when lifting/raising his arm started the same day and hasn't gone away within the week.
Age: 0.17
Sex: F
Vaccine: BCG, DTP, OPV
Symptoms: Crying, Erythema, Injection site erythema, Injection site reaction, Injection site swelling
Clinical narrative: After the shot my baby's leg got red and swollen. After crying hard she turned so red and developed petechiae looking rashes on her legs.
Age: 0.17
Sex: F
Vaccine: BCG, DTP, OPV
Symptoms: Petechiae
Clinical narrative: After the shot my baby's leg got red and swollen. After crying hard she turned so red and developed petechiae looking rashes on her legs.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Malaise, Rhinorrhoea, Skin warm
Clinical narrative: Reports warm to touch, hard area under area with slight redness, runny nose and malaise.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient was given PNEUMOVAX 23 along with FLUZONE HIGH DOSE and came in 3 days later presenting with red itchy reaction at the site of injection.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Peripheral swelling
Clinical narrative: Right arm swelling, redness, warmth from injection site to wrist.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Right arm swelling, redness, warmth from injection site to wrist.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Exfoliative rash, Pityriasis rosea, Rash, Rash erythematous
Clinical narrative: This spontaneous report was received from the office administrator referring to a 14 year old male patient. No information regarding the patient's medical history and concomitant medication were reported. The patient's concurrent conditions included drug reactions and allergies to amoxicillin. On 31-JUL-2018, the patient was vaccinated with his first dose of GARDASIL 9 intramuscular route, lot # N025429 and expiration date 27-JUL-2020 (strength, dose and anatomical location were not reported) indicated for prophylaxis also reported as "recommended for male patients his age ". The office administrator reported that the patient's mother notified on 02-OCT-2018, that her son developed an oval, pink and scaly rash (exfoliative rash) on his torso and upper inner thighs within a day or two after vaccine administration which was evaluated subsequently by an unspecified allergist on an unspecified date, who thought that it looked like pityriasis rosea (pityriasis rosea). On 02-OCT-2018, the patient's mother brought the patient to the physician office for evaluation and the patient still had the oval, pink and scaly rash on his torso and upper inner thighs. It was unknown if the patient sought medical attention or if diagnostic laboratory test were performed. The patient would see an unspecified immunologist on 05-OCT-2018. The outcome of exfoliative rash and pityriasis rosea was reported as not resolved. The causal relationship between exfoliative rash and pityriasis rosea with GARDASIL 9 was not reported.
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient's mother). A 20-year-old female patient received TRUMENBA, (lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date (reported as Apr) at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient received a dose of meningococcal group b rlp2086 on an unspecified date reported as 'Apr' on her sick doctor's visit, her physical was scheduled 2 days after her sick visit so instead of coming back 2 days later doctor has done a physical and one dose of meningococcal group b rlp2086 was administered to the patient at the time of the visit. However for unknown reason when the patient's mother reached out to the doctor's office few months later as her daughter needed some forms for college. She was told by doctor's office that they do not have a record of her daughter receiving meningococcal group b rlp2086 in Apr or having physical on that day. The consumer stated that her daughter remember it because she even had her arm hurting. The outcome of the event of arm hurting was unknown. No follow-up attempts are possible; information about batch number cannot be obtained.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: Initial information received on 04-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 39 years old female patient who was exposed to vaccine FLUZONE QUADRIVALENT in context of to report drug exposure during pregnancy. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. Drug exposure during pregnancy occurred at unknown gestation period. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had <<XX>> previous pregnancy/ies. On 02-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI980AB via intramuscular route in the left arm. Relevant prenatal testing after exposure included was not reported. No lab data reported. Additionally, at time of reporting, the outcome of the pregnancy is unknown. 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
Sex: F
Vaccine: RAB
Symptoms: Product dose omission
Clinical narrative: Initial information received on 14-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 19 years old female patient who was administered with doses of IMOVAX RABIES (lot number, expiry date, dose, dose in series, route and site of administration was not reported) 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 drug dose omission since the patient missed to vaccinate with the second dose of IMOVAX RABIES. It was unknown whether patient had adverse event related to 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: F
Vaccine: TTOX
Symptoms: Hypersensitivity
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP via a other company. This case involves an adult female patient (age was not reported) who experienced allergies, while she received vaccine TETANUS TOXOID. 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 TETANUS TOXOID produced by unknown manufacturer lot number not reported. On an unknown date the patient developed a non-serious allergies (hypersensitivity) following the administration of TETANUS TOXOID. No lab data reported. Final diagnosis was allergies. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergies.
Sex: U
Vaccine: DTAP, HIBV, PPV
Symptoms: Product preparation error
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional, nurse. This case involves a 16 months old patient who received vaccine ACTHIB. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DAPTACEL and PNEUMOCOCCAL VACCINE. On 17-Aug-2018, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UI945AA via intramuscular route in the left deltoid. It was a case of actual medication error due to inappropriate reconstitution technique. The vaccine was mixed with the wrong Diluent. 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.
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Initial information received on 19-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case is linked to case 2018SA266224.(same reporter). This case involves Elderly female patient who experienced unable to lift her left arm, redness at the injection site and soreness, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.5 ml dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via intramuscular route in the left deltoid. On an unknown date, The patient developed a non-serious unable to lift her left arm (hypokinesia)  following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious redness at the injection site (vaccination site erythema) one hour following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, The patient developed a non-serious soreness (pain) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. Final diagnosis was soreness, redness at the injection site and unable to lift her left arm. Lab test not reported. The patient was treated with ACRIVASTINE (BENADRYL [ACRIVASTINE]), CALAMINE (CALAMINE) and CLOPIDOGREL BISULFATE (PLAVIX). The patient outcome is reported as Unknown for redness at the injection site, as Unknown for soreness and as Unknown for unable to lift her left arm.
Age: 0.5
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional, Nurse. This case involves an unknown age patient who received vaccine PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 19-Sep-2018, the patient received a 0.5 ml dose of suspect PENTACEL VACCINE lot number not reported via intramuscular route in the left thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. PENTACEL was reconstituted with QUADRICEL instead of PENTACEL and then injected. No adverse event occurred. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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.
Sex: U
Vaccine: FLUR4
Symptoms: Malaise
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves an unknown age patient who experienced feeling sick, while he/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 not reported. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via unknown route. On an unknown date, the patient developed a non-serious feeling sick following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. (Other relevant tests included No lab data). Final diagnosis was feeling sick. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for feeling sick. Documents held by sender: none.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Initial unsolicited report received from nurse on 21-Sep-2018. This case is linked to cases 2018SA267265, 2018SA267283, 2018SA267295, 2018SA267294, 2018SA267293, 2018SA267304, 2018SA267305 and 2018SA267274. This case involves a [60 years old] male patient who was vaccinated with a single expired dose 0.5 ml dose of FLUZONE QUADRIVALENT 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. On 17-Sep-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UI997AB via unknown route in the left deltoid. 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.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Initial information received on 20-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an elderly patient who was vaccinated with a dose of FLUZONE HIGH DOSE lot UI994AA; expiry date: 09-Apr-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of syringe leak since few drops has been leaked while administering the vaccine from the tip where the needle connects. It was not reported whether the patient has been affected following the vaccination. This is reported to 13th complain of this type for this product for a year. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site mass
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 71 years old female patient who  had a red lump in her arm the diameter of a tennis ball about 1/2 to 1 inch below the injection site as she had a bruise there, 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 was none. it was reported that no other vaccine were used. On 20-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ006AA expiry date: 14-Apr-2018 via intramuscular route in the left deltoid. On an unknown date (reported as that appeared that evening or the next day) the patient developed a non-serious  red lump in her arm the diameter of a tennis ball about 1/2 to 1 inch below the injection site as she had a bruise there (swelling) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was had a red lump in her arm the diameter of a tennis ball about 1/2 to 1 inch below  the injection site as she had a bruise there. No corrective treatment was received. The patient outcome is reported as Unknown for had a red lump in her arm the diameter of a tennis ball about 1/2 to 1 inch below the injection site as she had a bruise there. List of documents held by sender: none.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Initial information received on 24-Sep-2018 regarding an unsolicited valid non-serious case received from a Non healthcare professional. This case involves a 68 years old female patient who experienced itching at that night and the next day hives, while she received vaccine FLUZONE HIGH DOSE. The patient's past vaccination(s) included FLUZONE HD for last 2 years and do not have any reaction. The patient's past medical history, medical treatment(s) and family history were not provided. Concomitant medications included PREVNAR 13 for Immunization. On 18-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UI993AB via unknown route. On an unknown date, the patient developed a non-serious that night she had itching (pruritus) that night following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious the next day hives next day following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included No lab data.) Final diagnosis was the next day hives and that night she had itching. The patient was treated with MEDROL and BENADRYL. The patient outcome is reported as Unknown for that night she had itching and as Not Recovered / Not Resolved on an unknown date for the next day hives. It was also reported that still has hives to her waist, back, abdomen, and chest. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Initial information received on 25-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional (physician's assistant). This case involves 25 patient(s) who was vaccinated with a 0.5 ml dose of FLUZONE HIGH DOSE (lot: uj006ab) via intramuscular route in the deltoid (not specified) from 14-Sep-2018 to 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to deteriorated drug administered because of cold chain management had been broken since shipping was delayed before receipt of product. It was not reported whether the patient experienced any adverse events following the vaccinations 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: 7.0
Sex: U
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 7 years old patient (gender not reported) who received 0.5 ml fourth dose of vaccine QUADRACEL (lot C5248AA, expiration date 21-AUG-2019) including IPOL and DAPTACEL instead of ADACEL via intramuscular route in the right deltoid on 22-May-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included MMR and VARICELLA VACCINE. It was a case of actual medication error due to wrong vaccine administered and inappropriate age at vaccine administration. No adverse event noted. 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: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves female patient who experienced FLUZONE QUADRIVALENT given to employee today subcutaneously, while she received vaccine FLUZONE QUADRIVALENT. 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 QUADRIVAL A-B VACCINE lot number not reported via subcutaneous route. It was a case of actual medication error due to Inappropriate route of vaccination. The patient outcome is reported as Not Applicable for fluzone quadrivalent given to employee today subcutaneously. 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: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Wrong drug administered
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 67 years old female patient who was vaccinated with 0.5 ml once dose of FLUZONE QUADRIVALENT (Batch number: UT6310KA and expiry date: 30-Jun-2019) in the right deltoid on 27-Sep-2018 instead of FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOVAX 23 for Immunisation. It was a case of actual medication error due to wrong vaccine administered because patient was vaccinated with FLUZONE QUADRIVALENT and inappropriate age at vaccine administration because a 67 years old patient mistakenly received the following vaccine. No known reported symptoms. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pain, Pruritus, Rash pruritic, Skin warm
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 69 years old male patient who developed an itchy rash on both arms and fingers on both hands and pruritus in the groin area, his left arm became red, warm and aches and pain, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing FLUZONE HD. Concomitant medication was not reported. On 17-Sep-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot LUI994AA via unknown route in the left deltoid. On an unknown date, the patient developed a non-serious developed an itchy rash on both arms and fingers on both hands and  pruritus in the groin area (rash generalized) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious his left arm became red, warm (vaccination site inflammation) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. On an unknown date, the patient developed a non-serious aches and pain (pain) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. (Other relevant tests included no lab data.) Final diagnosis was aches and pain, his left arm became red, warm and developed an itchy rash on both arms and fingers on both hands and pruritus in the groin area. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Recovered / Not Resolved on an unknown date for his left arm became red, warm, as Unknown for developed an itchy rash on both arms and fingers on both hands/ pruritus in the groin area and as Unknown for aches and pain.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU4
Symptoms: Drug administered to patient of inappropriate age, Extra dose administered, Wrong drug administered
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 61 years old male patient who was vaccinated with a 0.5 ml once a dose of FLUZONE HIGH DOSE (Batch number: UJ006AA and expiry date: 14-Apr-2019) via intramuscular route instead of TDAP and also received a dose of 0.5 ml dose of FLUARIX not produced by Sanofi Pasteur (lot number: 794A3 and expiry date: 30-Jun-2019) via intramuscular route. Site: IM Right and Left Arm (received FLUZONE HIGH DOSE and FLUARIX but it is undertermined which arm each vaccine was given in) on 24-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. It was a case of actual medication error due to inappropriate age at vaccine administration because a 61 year old patient received the following vaccine; extra dose administered because received two doses on the same day and wrong vaccine administered because not received TDAP. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Syringe issue, Underdose
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional. This case involves a 79 years old female patient who received 0.5 mL dose of vaccine FLUZONE HIGH DOSE lot UJ02980D, expiry date: 02-MAY-2019 via intramuscular route in the right deltoid on 26-Sep-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included a dose of shingles vaccine (VARICELLA ZOSTER VACCINE) in left arm  for Immunisation. It was an actual medication error due to underdose. It was also the case of syringe issue. It was reported that when she was giving a pre-filled syringe of Fluzone HD it started to leak where the hub of the needle meets the syringe barrell when the .5 ml, IM, into the right deltoid was being injected. She stated that it leaked a little bit and that she saw 90% of the medication go into the patient. It was unknown whether patient experienced any adverse reaction after vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Initial unsolicited report received from a Pharmacist on 27-SEP-2018. This case involves a adult patient (reported as 40 something year old patient) who was vaccinated with a dose of FLUZONE HIGH DOSE (Batch number, expiration date, dose, route and site of administration was not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual Medication error due to inappropriate age at vaccine administration and overdose (as it was reported that a 40 something year old patient got the FLUZONE HD vaccine). Caller did not have any of the other details on patient or lot number. No information on adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: U
Vaccine: DTAPIPVHIB, PNC13, RVX
Symptoms: No adverse event, Product preparation error
Clinical narrative: Initial unsolicited report received from a pharmacist on 27-Sep-2018. This case involves a two-month-old patient (gender not reported) who was vaccinated with a dose of 0.5 ml PENTACEL lot number not reported via unknown route in the left thigh on 26-Sep-2018. The patient's medical history was not reported. Concomitant medications included PREVNAR 13, and ROTAVIRUS VACCINE for Immunisation. It was an actual medication error due to wrong solution used in drug reconstitution (it was reported that the ACTHIB (lot number: C5515AA, expiry date: 15-Sep-2019) portion had been reconstituted with sterile water rather than IPV (lot number: C5422AA, expiry date: 15-Sep-2019)). No information on adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 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: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case is linked to case 2018SA272311 (same reporter). This case involves 87 years old female patient who was vaccinated with dose of INFLUENZA VACCINE (batch number, expiration date and dose was not reported) via unknown route in the right arm  on an unspecified date. The patients past vaccination(s) included INFLUENZA VACCINE  n NOV-2017 with Pain in extremity as it was heavy dose. The patients past medical history, medical treatment(s) and family history were not provided. On 26-SEP-2018, the patient developed a non-serious pain in right arm (pain in extremity) following the administration of INFLUENZA VACCINE. No information about a corrective treatment reported for pain in arm. The patient outcome was unknown for pain in right arm. List of documents held by sender: none.