chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Dry mouth, Dysgeusia, Hypoaesthesia, Pain in extremity, Paraesthesia oral
Clinical narrative: Based on follow up received on 4 February 2015 this case became medically confirmed. Initial unsolicited report received from Consumer on 01 December 2014. A 82-year-old male patient, had medical history of cancer in remission and he was on chemo treatments and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in the left deltoid on 17 November 2014. On 18 November 2014, the patient had experienced bad taste, dry mouth, arm pain, 24 hour after vaccination tingling on the tongue, outside of the mouth just below the lips and left side of the chin became numb. It was also reported that patient visited the dentist and no cause was found. The patient spoke to his oncologist who told him since he hasn't been on treatments for such a long time; it is unlikely caused by the chemo treatments. Laboratory investigations and corrective treatments were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects included no known drug allergy and cancer in remission were reported. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none. Followup information received from a health care professional on 4 February 2015. The batch number of the vaccine was reported as U5100AA and expiry date reported as 30 June 2015. Follow-up information received from a physician on 17 March 2015. No additional information to provide. Documents held by sender: none.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Initial report received from consumer on 13 OCTOBER 2014. A female patient (age was not reported), whose medical history and concomitant medications were not reported, had received a dose of INFLUENZA (batch number, expiry date, route, site of vaccination and dose number was not reported) in the past year that contained some kind of aspirin product on an unspecified date. The patient had experienced swelling of her whole arm with heat and pain on an unspecified date. The patient required emergency room or doctor visit. The lab investigation and corrective treatments were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were not reported. At the time of this report, the outcome of the event was resolved no an unspecified date. List of documents held by sender: none. Follow up information was received on 05 JANUARY 2015: No  new  information was reported.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 24 November 2014. A 70-year-old female patient, whose medical history and concomitant medication were not reported, had received a dose of FLUZONE HD, (batch number, dose, route and site of vaccination not reported), on an unspecified date. On an unspecified date, patient's injection site is still red with blue mottling, feels hot, almost looks like bruised. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Fatigue, Injection site pain, Myalgia
Clinical narrative: Initial report received from Consumer on 01 December 2014. A 67-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in the left deltoid on 02 October 2014. On 03 October 2014, the patient had experienced muscle soreness in left arm, constant pain from the shoulder to the wrist, tired, weak and increased pain with any arm movement, pain gets worse at night. The patient had no laboratory investigations and corrective were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects reported as none. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: Initial report received from Consumer on 01 December 2014. A 67-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date and dose number was not reported) in the left deltoid on 02 October 2014. On 03 October 2014, the patient had experienced muscle soreness in left arm, constant pain from the shoulder to the wrist, tired, weak and increased pain with any arm movement, pain gets worse at night. The patient had no laboratory investigations and corrective were not reported. The patient had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects reported as none. At the time of this report, the outcome of the event was not resolved. List of documents held by sender: none.
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Abnormal behaviour, Confusional state, Crying
Clinical narrative: Initial report received from a non-healthcare profession on 14 October 2014. A patient had received a dose of FLUZONE HD (batch number, dose in series, route and site of vaccination not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, after receiving the vaccine, the patient developed serious confusion and behavior changes (severe crying). Laboratory investigations and corrective treatments were not reported. The patient was sent to emergency room and then released. At the time of this report, the patient outcome was unknown. Documents held by sender: none. Follow-up information received from a non-healthcare professional on 30 December 2014. Patient initial and responsible physician information was updated. A 75-year-old patient has received FLUZONE HD (batch number U5017AA) in left arm on 03 October 2014 and event occurred on same day after vaccination i.e. on 03 October 2014. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Laceration, Product quality issue, Syringe issue
Clinical narrative: Initial misuse report received from a healthcare professional on 09 OCTOBER 2014. A female patient had received a dose of FLUZONE QIV (batch number UT171AB, dose in series, route and site of vaccination not reported) on unspecified date. It was reported that the patient received a laceration on her thumb when plunger fell out of FLUZONE QIV prefilled syringe barrel. The patient had administered vaccine and when she went to discard the prefilled syringe, the plunger "fell out" of the syringe barrel and cut her thumb of  her right hand. Reported that the part of the plunger that cut her thumb was the area around the plunger end that is inside the syringe barrel next to the barrel stopper. Stated her thumb did bleed, but cleansed the area and was put on a band aid and bleeding had stopped. Product complaint no 268663 was completed for the FLUZONE QIV prefilled syringe. List of documents held by sender: none.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site joint movement impairment, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 02 December 2014. A 72-year-old male patient, whose medical history and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD, (dose and batch number not reported) in left deltoid on 16-OCT-2014. On 16-Oct-2014, patient experienced left arm soreness and limited range of motion of his left arm. Reporter denied illness at time of vaccination and pre-existing physician diagnosed allergies. Patient was evaluated by a physician and under went an MRI of the left shoulder. Reporter did not have test results. Corrective treatment was not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow up information was received from a pharmacist on 03 February 2015: No new information was reported.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dizziness, Palpitations, Somnolence, Vomiting
Clinical narrative: Initial report received from healthcare professional on 02 DEC 2014. A 41-year-old female patient, whose concomitant medications were not reported, had received an intramuscular dose of FLUZONE (batch number: UT188AD, expiry: 30 JUN 2015, dose, dose number not reported) in left deltoid, on 30 SEP 2014. The patient had previously vaccinated with influenza vaccine two times and post vaccination experienced adverse reactions dizziness, heart palpitations, vomiting and elevated blood pressure. The patient had a medical history of allergies to latex, augmentin, environmental allergy and history of elevated blood pressure. It was reported that one hour after vaccination (vaccination on 30 SEP 2014), the patient experienced dizziness, heart palpitations, vomiting and elevated blood pressure. Lab details and corrective treatments were not reported. It was reported that dizziness resolved the next day and she felt draggy and later all symptoms resolved on unspecified date. The outcome of the event was reported as resolved. Documents held by sender: none.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from healthcare professional on 14 October 2014. A 29-year-old female patient, whose medical history was reported as unknown and concomitant medication were not reported, had received intradermal a dose of FLUZONE ID, (batch number: UT4993AA, expiry date: not reported) (dose in series not reported) in left arm on 13-Oct-2014. On 13-Oct-2014, patient experienced, swollen in left hand. Illness at the time of vaccination was reported as unknown. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender: none.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Paraesthesia, Pruritus, Skin warm
Clinical narrative: Initial report received from a non-healthcare professional on 14 OCTOBER 2014. A 65-year-old female patient, whose medical history was reported as unknown and concomitant medication were not reported, had received intramuscularly a dose of FLUZONE QIV, (batch number: UT158AA, expiry date unknown and cycle in series not reported) in left deltoid on 08-OCT-2014. On 08-OCT-2014, patient experienced tingling, red/thick and hot to touch and itchy. All symptoms are gone. Illness at the time of vaccination was reported as unknown. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as recovered. Documents held by sender: none.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Initial spontaneous report received from a healthcare professional on 13 NOVEMBER 2014. A 49-year-old female patients, whose medical history was not reported and concomitant medication was reported as vitamins, had received intramuscular a dose of FLUZONE (batch number: UI207AA), expiry date of vaccine and number of dose was not reported) in right deltoid on 26-OCT-2014. On 03-NOV-2014, patient experienced trouble picking arm up and soreness. Illness at the time of vaccination was reported as none. Pre-existing condition and illness at the time of vaccination was reported as none. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.  Follow up report received from a healthcare professional on 24 FEBRUARY 2015: The vaccine was confirmed to be Influenza Quadrival A-B vaccine and hence had been changed from FLUZONE to Influenza Quadrival A-B vaccine. Follow up report received from a healthcare professional on 10  MARCH 2015: No new information was reported.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: Initial report received from healthcare professional on 17 NOVEMBER 2014. A 54-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number UI207AA, Expiry date 30-JUN-2015, intramuscular in left deltoid) on 12 NOVEMBER 2014. The patient's  illness at the time of vaccination and medical history were unknown. The patient received many doses of FLUZONE QIV. It was reported that on 12 NOVEMBER 2014, 5 hours after receiving FLUZONE QIV, the patient could not move her left arm. On the next day she had 25% improvement, 2 days later she had 80% improvement and 2.5 days later she had 100% improvement but there was minimal pain. The patient's corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome was recovering. Documents held by sender: none.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Initial report received from a consumer (the patient) on 19 NOVEMBER 2014. A male patient had received a dose of INFLUENZA, (batch number, dose number, route and site of vaccination not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient was not feeling well. Corrective treatment and laboratory test was not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Limb discomfort, Pain in extremity, Peripheral swelling, Skin reaction
Clinical narrative: Initial report received from a health care professional on 18 NOVEMBER 2014. An adult female patient, whose medical history and concomitant medications were not reported had received a 0.5 ml syringe dose of FLUZONE QUADRIVALENT (0.5 syringe, lot number: UI231AB, expiry date-30 JUN 2015, dose number, route and site of administration was not reported) on an unspecified date. On an unknown date after vaccination patient had experienced very red, inflamed and hot to the touch swollen arm, size of reaction 4x4 inches and painful and radiated down the arm/arm felt heavy. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: none.  Follow-up information received from a health care professional on 10 MARCH 2015. It was reported that the vaccine was administered on 07 NOVEMBER 2014 and on the same day at 8 PM the events had occurred. It was also reported that patient had not received any other vaccine within four weeks prior to the date of vaccination and had no illness at the time of vaccination. On an unspecified date the patient had recovered from the events.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Initial report received from a health care professional on 18 NOVEMBER 2014. An adult female patient, whose medical history and concomitant medications were not reported had received a 0.5 ml syringe dose of FLUZONE QUADRIVALENT (0.5 syringe, lot number: UI231AB, expiry date-30 JUN 2015, dose number, route and site of administration was not reported) on an unspecified date. On an unknown date after vaccination patient had experienced very red, inflamed and hot to the touch swollen arm, size of reaction 4x4 inches and painful and radiated down the arm/arm felt heavy. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: none.  Follow-up information received from a health care professional on 10 MARCH 2015. It was reported that the vaccine was administered on 07 NOVEMBER 2014 and on the same day at 8 PM the events had occurred. It was also reported that patient had not received any other vaccine within four weeks prior to the date of vaccination and had no illness at the time of vaccination. On an unspecified date the patient had recovered from the events.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Initial report received from Healthcare professional on 10 OCTOBER 2014. A 63-year-old female patient, whose medical history and concomitant medications were not reported., had received a dose of FLUZONE QIV (batch number, expiry date, route, site of vaccination and dose number was not reported) on 07 OCTOBER 2014. The patient had experienced generalized rash over her body, generalized rash over her body that was slightly red, itchy and rash at injection site on 08 OCTOBER 2014. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination, and pre-existing  diagnosed allergies and birth defects were not reported. At the time of this report the outcome of the event was not resolved. List of documents held by sender: none. Follow up information received from a healthcare professional on 20 JAN 2015. The patient had received a first dose of FLUZONE (batch number U196AC, via intramuscular route, anatomical side of administration was not reported) on 07-OCT-2014. There were no laboratory investigations reported.  List of documents held by sender: none.
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Decreased appetite, Fatigue, Hypersomnia
Clinical narrative: Based on additional information on 22 DECEMBER 2014, this case became medically confirmed. Initial report received from consumer on 10 OCT 2014. A 51-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QUADRIVALENT (lot number: UI196AD, dose, dose number, route and site of vaccination not reported) on 07 OCT 2014. The patient had influenza vaccine previously three years and was normal post vaccination. On 07 OCT 2014, post vaccination, the patient developed pain in right arm and in the night the patient felt like not eating and was very tired and had weak body, a slight pain in the lower back. In the next morning the lower back pain was much stronger that he could not move, body was very tired and weak. The patient slept longer than normal. The pain in lower back got worse and he took one tablet of 600 mg ibuprofen and went to sleep., THen at occupational help center, the patient took 2 ALEVE pills and applied some bio freeze cold therapy for pain relief in lower back. Lab investigation details were not reported. The outcome of the event was reported as unknown. Documents held by sender: None. Follow up information received from health care professional on 22 DECEMBER 2014. IT was unknown whether patient received FLUZONE in previous year. On an unspecified date patient was recovered from the events without long term effects.
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Based on additional information on 22 DECEMBER 2014, this case became medically confirmed. Initial report received from consumer on 10 OCT 2014. A 51-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QUADRIVALENT (lot number: UI196AD, dose, dose number, route and site of vaccination not reported) on 07 OCT 2014. The patient had influenza vaccine previously three years and was normal post vaccination. On 07 OCT 2014, post vaccination, the patient developed pain in right arm and in the night the patient felt like not eating and was very tired and had weak body, a slight pain in the lower back. In the next morning the lower back pain was much stronger that he could not move, body was very tired and weak. The patient slept longer than normal. The pain in lower back got worse and he took one tablet of 600 mg ibuprofen and went to sleep., THen at occupational help center, the patient took 2 ALEVE pills and applied some bio freeze cold therapy for pain relief in lower back. Lab investigation details were not reported. The outcome of the event was reported as unknown. Documents held by sender: None. Follow up information received from health care professional on 22 DECEMBER 2014. IT was unknown whether patient received FLUZONE in previous year. On an unspecified date patient was recovered from the events without long term effects.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Caesarean section, Exposure during pregnancy, Pre-eclampsia, Premature labour, Shortened cervix
Clinical narrative: Initial unsolicited pregnancy report received from a health care professional on 14 OCTOBER 2014. A 36 years old female patient, whose medical history and concomitant medications were not reported, had received first intradermal dose of FLUZONE ID (batch number UT4992AA and expiry date 30-APR-2014) site of vaccination was not reported, on 14-OCT-2014. The patient had not experienced any adverse reaction after the first injection of FLUZONE ID. No information about prior exposure to vaccine was provided. Comments regarding the mother's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as none. The last menstrual period was not reported and estimated date of delivery was 10 JUNE 2015. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from a nurse on 03 JUN 2015. The patient's age at the time of pregnancy was reported as 37 years. The patient had no family history of congenital abnormality. Mother's age at the time of pregnancy was 37 years. Father's age was 40 years. The patient was treated for infertility (donor egg IVF cycle and premature ovarian failure). she had tow previous pregnancies. There was 1 live birth and no pre-term birth. She  had one elective abortion. There was no spontaneous abortion prior to 20 weeks gestation and no fetal deaths (greater than 20 weeks gestation). The patient had received the following drugs during exposure: Delestrogen (20 mg/ml) from 02-SEPT-2014 to 21-NOV-2014 and ASA f5rom 02-SEP-2014 to 22-OCT-2014. She received the following drugs prior to vaccination: Lupron (5 units) from 02-SEP-2014 to 16-SEP-2014, Dexamethasone (0.5 mg) from 02-SEP-2014 to 22-SEP-2014 and Doxycycline (100mg) from 02-SEP-2014 to 08-SEP-2014. On an unspecified date, she experienced pregnancy complications which included preeclampsia (week 25-36), shortened cervix, preterm labor (week 30-31). There was no prenatal testing. The date of last menstrual period was 02-SEP-2014. Her date of delivery was 14-MAY-2015. She delivered two children (one female and one male) via cesarean section (36 weeks gestation). The heights for the male and female children were 31 cm. Weight for the male and female children were 2.63 and 2.38 kg respectfully. There were no congenital abnormalities. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Twin pregnancy
Clinical narrative: Initial unsolicited pregnancy report received from a health care professional on 14 OCTOBER 2014. A 36 years old female patient, whose medical history and concomitant medications were not reported, had received first intradermal dose of FLUZONE ID (batch number UT4992AA and expiry date 30-APR-2014) site of vaccination was not reported, on 14-OCT-2014. The patient had not experienced any adverse reaction after the first injection of FLUZONE ID. No information about prior exposure to vaccine was provided. Comments regarding the mother's health during pregnancy and risk factors (e.g.: alcohol, tobacco or recreational drugs) were reported as none. The last menstrual period was not reported and estimated date of delivery was 10 JUNE 2015. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from a nurse on 03 JUN 2015. The patient's age at the time of pregnancy was reported as 37 years. The patient had no family history of congenital abnormality. Mother's age at the time of pregnancy was 37 years. Father's age was 40 years. The patient was treated for infertility (donor egg IVF cycle and premature ovarian failure). she had tow previous pregnancies. There was 1 live birth and no pre-term birth. She  had one elective abortion. There was no spontaneous abortion prior to 20 weeks gestation and no fetal deaths (greater than 20 weeks gestation). The patient had received the following drugs during exposure: Delestrogen (20 mg/ml) from 02-SEPT-2014 to 21-NOV-2014 and ASA f5rom 02-SEP-2014 to 22-OCT-2014. She received the following drugs prior to vaccination: Lupron (5 units) from 02-SEP-2014 to 16-SEP-2014, Dexamethasone (0.5 mg) from 02-SEP-2014 to 22-SEP-2014 and Doxycycline (100mg) from 02-SEP-2014 to 08-SEP-2014. On an unspecified date, she experienced pregnancy complications which included preeclampsia (week 25-36), shortened cervix, preterm labor (week 30-31). There was no prenatal testing. The date of last menstrual period was 02-SEP-2014. Her date of delivery was 14-MAY-2015. She delivered two children (one female and one male) via cesarean section (36 weeks gestation). The heights for the male and female children were 31 cm. Weight for the male and female children were 2.63 and 2.38 kg respectfully. There were no congenital abnormalities. Documents held by sender: none.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Initial report received from a healthcare professional on 14 OCTOBER 2014. A female patient, whose age, medical history and concomitant medications was not reported, had received a dose of FLUZONE QUADRIVALENT (batch number U1205AC, expiry date, route and site of vaccination were not reported), on an unspecified date. On an unspecified date, after vaccination the patient had extreme rash over chest, face and arms. Laboratory data and corrective treatment were not reported. At the time of this report, the outcome was unknown. List of documents held by sender: none. Follow-up information received from a healthcare professional on 30 DECMBER 2014. A 34-year-old female patient was vaccinated with FLUZONE QUADRIVALENT in her left arm on 08-OCT-2014. On 08-OCT-2014, patient had extreme rash over chest, face, arms. NDC number was reported as 49781-621-15. Documents held by sender: none.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Adverse reaction, Pruritus
Clinical narrative: Initial report received from a healthcare professional on 14 OCTOBER 2014. A 55-year-old female patient, whose medical history was, reported as shellfish none and concomitant medication were not reported, had received a dose of FLUZONE QIV (batch number, cycle in series and site of vaccination not reported) on 07-OCT-2014. On 17-OCT-2014, patient experienced a very significant reaction to a flu shot 15 years ago/she had a very significant reaction to testing for allergy with the FLUZONE QIV and itching. Illness at the time of vaccination was reported as none. Corrective treatment was not reported and laboratory investigations were reported as none. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Feeling cold, Hyperhidrosis
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 14 OCT 2014. A 71-year-old male patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HD (lot number, dose, dose number, route and site of vaccination not reported) on 13 OCT 2014. The patient had a medical history of MRSA and atherosclerosis. It was reported that patient had used bandages, adhesive tape and stents. It was reported that on 14 OCT 2014, the night of vaccination, the patient developed chills and sweating. In the morning he experienced stomach pain like tightness. Lab investigation details and corrective treatments were not reported. The outcome of the event was reported as unknown. Documents held by sender: None. Follow-up information received from a non-healthcare professional on 05 JUNE 2015. No new information was provided. List of documents held by sender: None
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Accidental exposure to product, No adverse event, Syringe issue, Wound haemorrhage
Clinical narrative: Initial report received from healthcare professional on 15 OCTOBER 2014. A 25-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (batch number U5018BA, expiry date 30 JUN 2015 and dose number was not reported) on 15 OCTOBER 2014. The patient index finger was bleeding and when she put the syringe down she had glass in her index finger. Index finger was bleeding on 15 OCTOBER 2014. The patient had no lab investigations were reported and corrective treatment included antibiotic and band aids. The patient had no illness at the time of vaccination, pre-existing diagnosed allergies and birth defects included Seasonal Pen. At the time of this report the outcome of the event was unknown. List of documents held by sender: none. Follow-up information received from a healthcare professional on 02 JANUARY 2015. Patient details are updated. No adverse event reported after vaccination. No vaccination was done with 4 weeks prior. Other medications, illness at the time of vaccination and pre-existing physician-diagnosed allergies were reported as none. At the time of this report, the outcome of the patient was reported as recovered on an unspecified date. Documents held by sender: none.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Drug administered at inappropriate site
Clinical narrative: Initial solicited report received from non  healthcare professional (consumer) on 15 OCT 2014. A 36-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV (lot number: UI200AB, dose, dose number, route of vaccination not reported) in deltoid, on 14 OCT 2014. It was reported that nurse might have given too high in deltoid and on 15 OCT 2014, the patient developed bruising. Lab investigation details and corrective treatments were not reported. The outcome of the event was reported as resolved. Documents held by sender: None. Follow up information received from non healthcare professional on 30 DEC 2014. No new information reported. Follow up information received from non healthcare professional on 30 JAN 2015. It was reported that this unknown report was not filled by the health center. The event is not reported by patient to the health center. No other information provided.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Full blood count, Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Initial report received from a healthcare professional on 16 OCTOBER 2014. This case is lined to the case 2014SA157396 and 2014SA157397. A female patient, whose medical history and concomitant medications was not reported, had received an intramuscular 0.5 ml dose of FLUZONE QIV (batch number UI190AC and expiry date 16-JUN-2015, site of vaccination not reported), on an unspecified date. On an unspecified date, after vaccination the patient had large injection site swelling, greater than 2 inches. They have redness and itching immediately after injection. The patient also presented with 10 inch welt on her thigh and had a low grade fever. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The child was positive for strep and is receiving antibiotics. The patient required ER visit. At the time of this report the outcome was unknown. List of documents held by sender: none. Follow up information received from Physician on 14 JANUARY 2015.  A 5 year old female patient had developed elevated boy temperature of 100.4 several hours after receiving FLUZONE QIV on 13 OCTOBER 2014. On 14 OCTOBER 2014, patient developed swelling and redness at the site of injection (area of erythema was: 8 inches x 10 inches). The lesion rapidly increased in size and the patient was seen on 15 OCTOBER 2014. It was also reported that prior to 4 weeks no vaccine was administered. The patient had no illness at the time of vaccination, no pre-existing diagnosed seasonal allergies and birth defect, medical condition. The details of laboratory investigations included the rapid strep test was positive on an unspecified date and CBC done on 17 OCTOBER 2014. The corrective treatment included Augmentin (dose: 600 mg, frequency: twice a day). At the time of this report, the patient was recovered from the event of swelling and redness on 17 OCTOBER 2014, while outcome for low grade fever was unknown. Note: The available source document was in handwritten format hence document is not legible. Addendum: 05-MARCH-2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the product code from 450 to 477.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Pyrexia, Streptococcus test
Clinical narrative: Initial report received from a healthcare professional on 16 OCTOBER 2014. This case is lined to the case 2014SA157396 and 2014SA157397. A female patient, whose medical history and concomitant medications was not reported, had received an intramuscular 0.5 ml dose of FLUZONE QIV (batch number UI190AC and expiry date 16-JUN-2015, site of vaccination not reported), on an unspecified date. On an unspecified date, after vaccination the patient had large injection site swelling, greater than 2 inches. They have redness and itching immediately after injection. The patient also presented with 10 inch welt on her thigh and had a low grade fever. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The child was positive for strep and is receiving antibiotics. The patient required ER visit. At the time of this report the outcome was unknown. List of documents held by sender: none. Follow up information received from Physician on 14 JANUARY 2015.  A 5 year old female patient had developed elevated boy temperature of 100.4 several hours after receiving FLUZONE QIV on 13 OCTOBER 2014. On 14 OCTOBER 2014, patient developed swelling and redness at the site of injection (area of erythema was: 8 inches x 10 inches). The lesion rapidly increased in size and the patient was seen on 15 OCTOBER 2014. It was also reported that prior to 4 weeks no vaccine was administered. The patient had no illness at the time of vaccination, no pre-existing diagnosed seasonal allergies and birth defect, medical condition. The details of laboratory investigations included the rapid strep test was positive on an unspecified date and CBC done on 17 OCTOBER 2014. The corrective treatment included Augmentin (dose: 600 mg, frequency: twice a day). At the time of this report, the patient was recovered from the event of swelling and redness on 17 OCTOBER 2014, while outcome for low grade fever was unknown. Note: The available source document was in handwritten format hence document is not legible. Addendum: 05-MARCH-2015. Upon second medical examination of case at time of internal review the following has been modified in this case. Significant correction was done to correct the product code from 450 to 477.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haemorrhage, Injection site induration, Syringe issue
Clinical narrative: Initial report received from healthcare professional on 9 OCTOBER 2014. A 68-year-old female patient, whose concomitant medications were not reported, had received a dose of FLUZONE HD (batch number: U5044AA, intramuscular in left deltoid) having expiry date 20 MAY 2015 on 9 OCTOBER 2014. The patient is possible pre diabetic and she denied any illness at the time of vaccination. It was reported that, the syringe was malfunctioned and dose was not administered. Upon removing the needle the patient had significant bleeding at the injection site with know formation. The patient's corrective treatments and laboratory investigations were not reported.  At the time of this report, the outcome was unknown. Documents held by sender: none. Follow-up information received from health care professional on 29 DEC-2014. At the time of this report, the symptoms were resolved.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 09 OCTOBER 2014.  An 88-year-old female patient, had received a dose of FLUZONE HD, (batch number U5044AA, dose in series, route and site of vaccination were not reported) on 03 OCTOBER 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. The patient's concomitant medications were not reported. On 08 OCTOBER 2014,  5 days after vaccination, the patient's "blood pressure was up" and felt like she was "going to have a heart attack". The patient was taken to hospital emergency room but "nothing was found".  Corrective treatment and laboratory details were not reported. At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 08 OCTOBER 2014. This case is part of cluster of two cases and is linked to case number 2014SA154599. 4 patients had received a dose of FLUZONE QIV (batch number UI188AA, dose in series and site of vaccination not reported) intramuscularly on an unspecified date. The patient had no illness at time of vaccination and had no known allergies. On an unspecified date, after receiving the vaccine, the patients developed site reactions with swelling, redness and heat. The patient also experienced dizziness, nausea, vomiting and chills within 12 hours. Laboratory investigations were not performed. The patient was advised to apply ice and take BENADRYL prn (as needed). At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: Initial report received from a healthcare professional on 08 OCTOBER 2014. This case is part of cluster of two cases and is linked to case number 2014SA154599. 4 patients had received a dose of FLUZONE QIV (batch number UI188AA, dose in series and site of vaccination not reported) intramuscularly on an unspecified date. The patient had no illness at time of vaccination and had no known allergies. On an unspecified date, after receiving the vaccine, the patients developed site reactions with swelling, redness and heat. The patient also experienced dizziness, nausea, vomiting and chills within 12 hours. Laboratory investigations were not performed. The patient was advised to apply ice and take BENADRYL prn (as needed). At the time of this report, the patient outcome was unknown. Documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Initial report received from a healthcare professional on 08 OCTOBER 2014. A 69-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (batch number U5023BA, expiration date, dose in series not reported) in to the deltoid left on 06 OCTOBER 2014. The patient had experienced swelling about a 5 inch diameter, 6-8 inches below the injection site, redness about 5 inch diameter, 6-8 inches below the injection site, warm to touch and bruising at the injection site on 07 OCTOBER 2014. The patient's had no illness at the time of vaccination, and pre-existing diagnosed allergies and birth defects were no known drug allergy. The patient had no laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the events was not resolved. List of documents held by sender: none. Follow-up information received from a healthcare professional on 23 JAN 2015. Expiry date of vaccine FLUZONE HD was reported as 27-APR-2015. Any other vaccination within 4 weeks prior was reported as none. Documents held by sender: none.
Sex: U
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Initial report received from a non-healthcare professional on 10 OCTOBER 2014. This case is linked to case Id 2014SA140266. A patient (age and gender not reported), whose medical history and concomitant medication were not reported had received a dose of FLUZONE QIV, (batch number: UI192AA, expiry date: 30-JUN-2015) route and site of vaccination not reported, on an unspecified date. On an unspecified date, patient experienced swelling from shoulder to elbow. Corrective treatment and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 05 NOVEMBER 2014: The patient did not seek any medical treatment and the final outcome was unknown. Addendum 3-FEB-2015: Upon second medical examination of case at time of internal review the following had been modified in this case: Core unlisted was captured as Y, reaction site was modified as shoulder to elbow. Expiry date of vaccine was taken as 30-JUN-2015 in Product screen and narrative, reported type was taken as non-HCP and CSD was corrected as 10-OCT-2014. The case is for one patient. Reporter screen has been corrected.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Initial report received from a consumer on 10 OCTOBER 2014. A 69-year-old female patient, whose concomitant medication was not reported and had no medical history, had received a dose of FLUZONE HD (batch number, dose, dose in series was not reported intramuscularly in left arm on 21 SEPTEMBER 2014. On 21 SEPTEMBER 2014, after vaccination, the patient presented pain at injection site immediately and has gotten worse since vaccination, left arm was very painful, can't lift her arm more than 6 inches. The patient experienced difficulty in sleeping due to the painful arm. Laboratory investigation was not reported.  Patient was treated with TYLENOL and CELEBREX with no relief. At the time of this report the outcome of event was unknown. Documents held by sender: none. Follow-up information received from a non-health professional (Medical assistant) on 26 FEBRUARY 2015: It was reported that the patient did not receive flu vaccine at their office and they did not have any additional information. Documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Ear pain, Feeling abnormal, Headache, Pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 24 OCTOBER 2014. A 63-year-old male patient, whose medical history was reported as unknown and concomitant medication were not reported, had received intramuscularly a dose FLUZONE QIV, (batch number: UI192AA, expiry date: 30-JUN-2015) and cycle in series not reported, in left deltoid on an unspecified date. On an unspecified date, patient experienced earache, headache, body aches and arm was painful and has also experienced "not feeling right". Illness at the time of vaccination was not reported. Corrective treatment and laboratory investigations were not reported.  At the time of this report, the outcome of the event was reported as not recovered. Documents held by sender; none. Follow up information received from a health care professional on 6 FEBRUARY 2015. It was reported that patient had no concomitant medications and his medical history was reported as none, it was also reported that patient had not received any previous dose of FLUZONE QIV. The patient had received the vaccine on 15 OCTOBER 2014. Onset date of events was reported as 16 OCTOBER 2014. The patient had recovered on an unspecified date.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Tic
Clinical narrative: Initial report received from a non-healthcare professional on 23 OCTOBER 2014. A 7-years-old male patient, whose concomitant medication was not reported, had received a dose of FLUZONE (batch number U4694CA, expiry date, site and route of vaccination were not reported), on 23-SEP-2013. The patient has two mutations for cystic fibrosis, being monitored for this, does not have cystic fibrosis. On 26-SEPTEMPBER-2013, 3 days after vaccination developed audible and head  jerk type tic. Illness at the time of vaccination. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not provided. Corrective treatment and laboratory data were not reported. The patient required ER visit. At the time of this report the patient was recovered. List of documents held by sender: none.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Eye pruritus, Headache, Ocular hyperaemia, Throat irritation
Clinical narrative: Initial report received from a healthcare professional on 22 OCTOBER 2014. A 74-year-old female patient, whose concomitant medication were not reported, had received intramuscularly a dose of FLUZONE HD, (batch number and cycle in series not reported) in left deltoid on 18-OCT-2014. On 19-OCT-2014, patient experienced red itchy eyes, tickle in throat, shortness of breath and headache. Patient denied illness at the time of vaccination and medical history. Corrective treatment was reported as BENADRYL (50 mg) and TYLENOL. Laboratory investigations were  not reported.  At the time of t his report, the outcome of the event was reported as recovered. Documents held by sender: none
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Fatigue, Hypersomnia, Injection site pain
Clinical narrative: Initial report received from a consumer (the patient) on 22 OCTOBER 2014. A 75-year-old female patient had received an intramuscular dose of FLUZONE HD, (batch number and dose in series not reported) in right deltoid on 20  OCTOBER 2014. The patient was feeling tired on the day of vaccination from over activity and pre-existing physician diagnosed allergies, birth defects and medical conditions incudes allergy to shellfish, seasonal rhinitis for which patient received ZYRTEC and cough due to acid reflux. The patient's concomitant medications were not reported. The patient had been receiving yearly flu shot.  On 02 OCTOBER 2014, same day after vaccination, the patient developed weakness, dizziness, low grade fever of 99.6-100.6 degree Celsius. The patient slept the entire day and also experienced soreness at the injection site. IT was reported that the reaction was due to a week immune system but the patient states that she does not have a week immune system. Patient did not seek physician evaluation and treatment. Complimentary investigations were not reported. On 22 OCTOBER 2014, the patient had recovered from the symptoms. Documents held by sender: none.