chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site was raised, bumpy, itchy red and painful. Patient took diphenhydramine.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, VARCEL
Symptoms: Abdominal pain, Decreased appetite, Faeces discoloured, Fatigue
Clinical narrative: Fatigue, pale stool, abdominal pain, loss of appetite.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain in extremity, Tendonitis
Clinical narrative: Unable to lift arm past waist high. Continued pain and restricted movement for 4 weeks+ (ongoing. Visit to PA 2 weeks post-injection, prescribed steroid, pain/anti-inflammatory and sleep aid. 4 Weeks post-injection, treatment at chiropractor for bicep tendonitis due to restricted movement of shoulder from pain.
Age: 44.0
Sex: F
Vaccine: FLUC3
Symptoms: Injection site pruritus, Injection site rash, Injection site reaction, Rash, Urticaria
Clinical narrative: Rash, itching and whelps across arm at injection site.  Within 2 hours bilateral upper extremity and chest.  Within 6 hours across abodomen, back, chest and arms. Within 12 hours across all as listed above, onto hips, neck and face.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphagia, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: FEVER, INCREASING TO 101.9. INJECTION SITE SWOLLEN, BRILLIANT RED, HOT TO TOUCH AND EXPANDING IN SIZE. PULSE 109. DIFFICULTY SWALLOWING. REACTION TIME FROM APP 4 PM TO MIDNIGHT OR SO.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Dizziness, Fatigue, Gastrointestinal disorder, Headache, Hypoaesthesia
Clinical narrative: I do not remember when it first started. The symptoms I have include GI issues, headaches, tingling/numbness in hands and legs, dizziness, memory problems, and chronic fatigue.
Age: 23.0
Sex: F
Vaccine: ANTH
Symptoms: Memory impairment, Paraesthesia
Clinical narrative: I do not remember when it first started. The symptoms I have include GI issues, headaches, tingling/numbness in hands and legs, dizziness, memory problems, and chronic fatigue.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Experiencing redness on left arm of vaccination as well as itching. Itching spread to mid-rib area as well as up arm, neck and left side of face. She took Benadryl, which did help symptoms. She has a call into her doctor and will receive call back in the morning. She will proceed to ER if any serious anaphylactic reactions occur.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test, Guillain-Barre syndrome
Clinical narrative: Patient believes that she has Guillain-Barre Syndrome from the Fluzone HD that she received from us.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at injection site, suggested pain reliever or ice to reduce inflammation.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient believes that he has Guillain-Barre Syndrome from the Fluzone HD that he received from us.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Intense soreness/pain in the shoulder (site of injection) that lasted greater than 2 weeks.
Age: 42.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pruritus, Rash
Clinical narrative: PT STATES HAD PAIN RIGHT AWAY X2 DAYS .  FOLLOWED BY RASH & ITCHING STARTING SUNDAY 11/15/15 UNTIL PRESENT DAY.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site mass, Injection site warmth, Nausea
Clinical narrative: Flu-like symptoms: body ache, fever nausea.  Later, redness at site with palpable lump.  Hot to the touch.
Age: 62.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain, Pyrexia, Vaccination site infection
Clinical narrative: Flu-like symptoms: body ache, fever nausea.  Later, redness at site with palpable lump.  Hot to the touch.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site reaction, Muscle fatigue
Clinical narrative: Excessive pain/soreness/muscle fatigue at the injection site (left shoulder), including a "lump".  Pain lasting for greater than 5 weeks.
Age: 40.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site pain
Clinical narrative: Extreme pain surrounding injection site. Unable to use my arm fully. The following day pain continued and flu like symptoms ensued.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count, Pain, Pain in extremity, X-ray limb normal
Clinical narrative: Patient states she has had a throbbing pain in arm since time of vaccine. Xray of the left humerus performed 11/19/15, result normal. Obtained CBC, results pending.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Body temperature increased, Electroencephalogram normal, Generalised tonic-clonic seizure, Specialist consultation
Clinical narrative: Unprovoked tonic-clonic seizure. Lasted approx 3 minutes. Full recovery, no subsequent neurologic deficits noted. Has not recurred (as of the time of this report). Tmax measured at 100.5 F axillary. Emergency room visit with pediatric neurology consult 10/17/15; discharged home same day. Pediatric neurologist visit 10/29/15: no neurologic deficits noted.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: PATIENT PRESENTED WITH SHORTNESS OF BREATH AT ABOUT 4:15.  SHE WAS GIVEN 50MG OF BENADRYL AND ONE DOSE OF EPI-PEN 0.3MG IM. PARAMEDICS WERE CALLED AND ARRIVED WITHIN ABOUT 5 MINUTES.  PATIENT WAS TAKEN TO HOSPITAL FOR OBSERVATION.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Had Varicella vaccine 11/16/15 in RUE - felt a little bit of pain during the night and it was worse in the morning. Noticed it was swollen, red, and more painful at injection site. No drainage or streaking. Taking Advil with some improvement in discomfort. Denies fever/chills. Denies lip swelling, hives, rash sob/doe, nausea, vomiting, diarrhea or other symptoms.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Vertigo
Clinical narrative: Patient reports dizziness and lightheadedness, room spinning.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site joint pain
Clinical narrative: Severe left shoulder joint pain and trouble lifting arm.
Age: 58.0
Sex: F
Vaccine: FLUC3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received ZOSTAVAX on 11-14-15. On 11-16-15 patient reported to pharmacy that her right upper arm was red and swollen. On 11-19-15 pharmacist called to check on her. Her arm is much better - swelling gone and redness improving.
Age: 73.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient received ZOSTAVAX on 8-19-15. On 11-9-15 patient reported to pharmacy that her left upper arm still hurt and she could not lift it above her shoulder level. RPh reported symptoms to PCP.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: About 10-15 minutes after the vaccine, patient passed out briefly. After she woke up all was fine. Paramedics called as precaution - she refused hospital transfer.
Age: 0.68
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: (L) medial thigh rash 8 cm x 5 cm with localized non joint swelling rash is on medial thigh in between hip and knee. Ice, ibuprofen (OTC) hydrocortisone 1% OTC, Childrens BENADRY (OTC).
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: On 1/18/15 customer came in and stated she got a rash and itching on whole upper arm around injection site. By this time it was improving with less redness but still visible.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injury associated with device, Limb injury
Clinical narrative: Initial unsolicited misuse report received from non-healthcare professional (patient's parent) on 27 Oct 2014. A 04-year-old male patient, whose concomitant medications were not reported, had accidentally exposed to an informational FLUZONE ID syringe on 25 Sep 2014. The patient had a reported medical history of sickle cell disease, asthma and anemia. On 25 Sep 2014, the patient punctured his left index finger with the needle from the informational syringe box. Band aid was placed on his finger and reported as resolved. However the outcome of the event was reported as unknown. Documents held by sender: None. Follow up information received from a consumer (patient's parent) on 23-Jun-2015. The patient did not receive any vaccines. It was reported that the syringe box was left on the table which was lower enough such that anyone could have messed with it. The informational box should not have been on the table with the syringe inside. It was not at a secure place. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Flushing, Hot flush
Clinical narrative: Initial report received from a healthcare professional (pharmacist) on 27 October 2014. A female patient of unspecified age had received a dose of FLUZONE HD, (batch number, dose number, route of site of vaccination not reported) on an unspecified date. The patient's illness at the time of vaccination was not reported. The patient was allergic to latex. On an unspecified date, after vaccination, the patient experienced flushing and reported felt like a "hot flash". The patient was monitored for several minutes and provided with glass of water. Corrective treatment and laboratory details were not reported. On an unspecified date, the patient had recovered. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Dizziness, Hyperacusis, Irritability, Nausea
Clinical narrative: Initial report received from a healthcare professional on 27 October 2014. A 60-year-old female patient had received a dose of FLUZONE QIV, batch number-UI196AA, intramuscularly in left arm (dose and dose in series was not reported) on 29 September 2014. It was reported that the patient had denied the illness at the time of vaccination and had allergies to PCN. Cipro and Tetracycline. The patient had yearly received the flu shots vaccine. On 30 September 2014, one day after vaccination the patient experienced fever 101, nausea, 'dizziness', 'achyness', increased sensitivity to noise, irritability and burning sensation down both forearms. Reporter initially did phone evaluation on 30 September 2014. Nausea was reported on 10 October 2014 and other symptoms on 15 October 2014 during routine visit. The patient was vaccinated. Complementary investigations were not reported. On an unspecified date TYLENOL and ibuprofen was prescribed for fever and aches. On an unspecified date the patient was recovered from the event. Documents held by sender: none.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Pyrexia
Clinical narrative: Initial report received from a healthcare professional on 27 October 2014. A 60-year-old female patient had received a dose of FLUZONE QIV, batch number-UI196AA, intramuscularly in left arm (dose and dose in series was not reported) on 29 September 2014. It was reported that the patient had denied the illness at the time of vaccination and had allergies to PCN. Cipro and Tetracycline. The patient had yearly received the flu shots vaccine. On 30 September 2014, one day after vaccination the patient experienced fever 101, nausea, 'dizziness', 'achyness', increased sensitivity to noise, irritability and burning sensation down both forearms. Reporter initially did phone evaluation on 30 September 2014. Nausea was reported on 10 October 2014 and other symptoms on 15 October 2014 during routine visit. The patient was vaccinated. Complementary investigations were not reported. On an unspecified date TYLENOL and ibuprofen was prescribed for fever and aches. On an unspecified date the patient was recovered from the event. Documents held by sender: none.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Initial report received from a health care professional (patient) on 27 October 2014. An adult female patient, had received a 0.5 ml single dose syringe of FLUZONE QIV vaccine (lot number: UI207AA, expiry date- 30 Jun 2015, dose number, route and anatomical side of administration was not reported) on 22 October 2014. The patient medical history and concomitant medications were not reported. On unknown date after vaccination patient had experienced injection site was really hot and red and it felt like a knot for about 3 days. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was recovered on an unspecified date. Documents held by sender: None. Follow-up information received from a nurse (the patient) on 13 January 2015: On 22 October 2014, the patient aged 31 years, presented the events after administration of FLUZONE QIV intramuscularly. The patient had no illness at the time of vaccination and no pre-existing physician diagnosed allergies, birth defects and medical conditions. The patient did not receive any other medications. Laboratory data was reported as "observation".
Sex: U
Vaccine: FLU3
Symptoms: Cough, Dizziness, Headache, Pyrexia, Wheezing
Clinical narrative: Initial report received from a healthcare professional on 28 October 2014. A patient, whose gender, medical history was unknown and concomitant medications was not reported, had received a first dose of FLUZONE HD (batch number, route of administration and site of administration was unknown) on 22 October 2014. On 23 October 2014, one day after vaccination, the patient experienced fever for 24 hours. On 26 October 2014 the patient again experienced fever (100.5 to 101 F), coughing and wheezing, head ache and dizziness. Laboratory investigations and corrective treatment was not reported. At the time of this report the patient was not recovered from the events. Documents held by sender: none.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Insomnia
Clinical narrative: Initial unsolicited report received from non-healthcare professional on 3 November 2014. A 54-year-old female patient, who has no relevant medical history and concomitant medications were not reported, had received a dose of FLUZONE (batch number was not reported, intramuscular in left arm) on 14 October 2014. It was reported that, the patient received Flu shots previously for many years but no adverse events were reported. It was reported that on 14 October 2014, few hours after receiving FLUZONE vaccine, the patient experienced pain in arm which was subsided after 24 hours but after that pain in the left upper arm was continued to increase again. The patient's pain was affecting her ability to lift arm as well as ability to sleep as she was not able to found any comfortable position. The corrective treatment was not reported and has no laboratory investigations. At the time of this report, the outcome was not recovered. Relationship "yes" as per reporter. Documents held by sender: none. Follow-up information received from a non-healthcare professional on 18 February 2015. The patient had fully recovered from all the events. It was reported that the pain had slowly subsided within one month. Follow up information received from a non-healthcare professional on 10 April 2015. It was reported that patient had no medical records and she is fine. List of Documents held by sender: None.
Sex: U
Vaccine: FLU3
Symptoms: Injection site abscess, Injection site urticaria
Clinical narrative: Initial report received from Healthcare professional on 03 November 2014. A 9 adult patient, whose medical history and concomitant medications were not reported, had received an intradermal dose of FLUZONE (Batch number UT4993BA, expiry date and dose number was not reported) in the deltoid on 30 October 2014. The patient had developed red welt big as a silver dollar at the injection site on 30 October 2014. Lab investigations were not reported and advice to take BENADRYL, ADVIL. The reaction was lasted up to 72 Hour. The patient had no 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. List of documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Vaccination site discolouration
Clinical narrative: Initial misuse report received from Healthcare professional on 31 October 2014. A patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE HD (Batch number, expiry date, site of vaccination and dose number was not reported) on 30 September 2014. The patient had experienced yellow discoloration at vaccination site on an unspecified date. Lab investigations and corrective treatment were not reported. At the time of this report the outcome of the event was unknown. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site nodule, Injection site pain
Clinical narrative: Initial report received from Consumer on 23 September 2014. A female patient (age was not reported), whose medical history and concomitant medications were not reported, had received a dose of FLUZONE ID (Batch number, expiry date, dose number and route of vaccination was not reported) in the fore arm on an unspecified date. The patient had experienced hard knot at injection site and painful area at injection site on an unspecified date. Lab investigations and corrective treatment were not reported. The patient illness at the time of vaccination, pre-existing diagnosed allergies and birth defects was not reported. At the time of this report, the outcome of the event was resolved on an unspecified date. List of documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Asthenia, Dysphonia, Fatigue, Pruritus
Clinical narrative: Initial report received from Healthcare professional on 29 October 2014. A 71-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HIGH DOSE (Batch number U5019CA, expiry date and dose number was not reported) on 23 October 2014. The patient had experienced hoarse voice, joint pain, itching, weakness, fatigue and rash on tongue on an unspecified date. 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 not resolved. List of documents held by sender: none. Follow-up information received from a health-care professional on 03 April 2015. Patient had received an injection of FLUZONE HIGH DOSE. Concomitant medications included Acetaminophen w/codeine 300-30 mg, Amoxicillin 500 mg and Ventolin HFA aerosol. No additional information reported. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Initial report received from Healthcare professional on 29 October 2014. A 71-year-old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE HIGH DOSE (Batch number U5019CA, expiry date and dose number was not reported) on 23 October 2014. The patient had experienced hoarse voice, joint pain, itching, weakness, fatigue and rash on tongue on an unspecified date. 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 not resolved. List of documents held by sender: none. Follow-up information received from a health-care professional on 03 April 2015. Patient had received an injection of FLUZONE HIGH DOSE. Concomitant medications included Acetaminophen w/codeine 300-30 mg, Amoxicillin 500 mg and Ventolin HFA aerosol. No additional information reported. Documents held by sender: none.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Crying, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Initial report received from a health care professional on 29 October 2014. An 11-year-old female patient had received an intramuscular dose of FLUZONE TIV (lot number, dose number was not reported) in left deltoid on 29 October 2014, had received an intramuscular dose of MENACTRA (lot number, dose number was not reported) in left deltoid on 29 October 2014 and had received a dose of ADACEL (lot number, route and dose number was not reported) in right deltoid on 29 October 2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as none. On 29 October 2014 it was reported that same day after vaccination of MENACTRA patient started crying, has been crying "unconsolablly" for one hour. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: None. Follow-up report received from a health care professional (physician) on 26 January 2015. It was reported that batch no of FLUZONE TIV was U1189AE, MENACTRA: 914041 and ADACEL: U4963AA. It was also reported that the patient was vaccinated at private doctor's office/hospital. And vaccine was purchased with private funds. Followed by one week, the patient also experienced sore throat, headache and myalgia on unspecified date. Work up for other cause was negative. No follow-up
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Initial report received from a consumer on 17 October 2014. A 70-year-old female patient had received an intramuscular dose of FLUZONE HD vaccine (lot number and dose number not reported) in left arm on 13 October 2014. The patient had no illness at the time of vaccination. The patient pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as controlled asthma and nasal allergies. On 14 October 2014 i.e. one day after vaccination patient had experienced red, puffy, itchy area that has progressed from shoulder to elbow on her left arm. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was recovered on an unknown date. Documents held by sender: None. Follow up information received from consumer (patient) on 26 Jan 2015. The patient had received a CLARITIN 10 mg once and Triamcinolone 0.1 % twice as a corrective treatment. The patient had no laboratory investigations.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Initial report received from a healthcare professional on 21 October 2014. A female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE QIV Adult Pre-Filled Syringe) (Batch number UI172AA and expiry date not reported) route and site of vaccination was not reported, on an unspecified date. On an unspecified date after vaccination the patient had experienced Leg Weakness (Both Legs). Corrective treatment was not reported and Laboratory data were reported as none. At the time of this report the outcome of the adverse events was unknown. List of documents held by sender: none. Follow-up information received from a health care professional on 20-JAN-2015. An 8-years-old patient had received 0.5 ml intramuscular dose of FLUZONE QIV on 17 October 2014 at 3:00 PM. On 18 October 2014, i.e. one day after vaccination the patient had the event leg weakness (both legs). The patient had food allergy in the past. At the time of this report the patient was recovered. The patient required ER visit.
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Pleurisy
Clinical narrative: Initial report received from a non-healthcare professional on 12 November 2014. A female patient (age not reported) whose medical history and concomitant medication were not reported, received a dose of FLU SHOT (batch number, expiry date of vaccine, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, patient experienced pleurisy and soreness at the injection. 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.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Initial report received from a healthcare professional on 12 November 2014. A 76-year-old female patient had received a dose of FLUZONE HD batch number - U5023BA, Expire date - 27 April 2015, intramuscularly in left deltoid on 09 October 2014. The medical history was not known (denied by patient) and concomitant medication was not reported. On 09 October 2014, after vaccination, the patient experience pain at the injection site and cannot lift her arm over her head. Laboratory investigation was not reported. It was reported that the patient was not evaluated or treated by a physician. The patient states she takes TYLENOL and the symptoms resolve but come back when the TYLENOL wears off. At the time of this report the outcome of the event was unknown. Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Vaccination error
Clinical narrative: Initial report received from a healthcare professional on 10 November 2014. A female patient (age not reported) whose medical history and concomitant medication were not reported, received intramuscularly a dose of FLUZONE ID (batch number, expiry dose of vaccine and route of vaccination was not reported) in right arm on an unspecified date. On an unspecified date, patient experienced mark on arm at injections site. Patient stated that, she had personally administered 200 doses from the same lot number with no other c/o of injection site reaction. 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 received from a consumer on 04 February 2015. A 46-year-old female patient had received 0.1 ml of FLUZONE ID, Batch number: UT4982BA in right deltoid in October 2014. Patient had not received any vaccination prior to four weeks and had no illness at the time of vaccination. The vaccine was purchased at private fund. The patient had no pre-existing physical-diagnosed allergies, birth defects, medical condition. It was reported that the event was caused by an administration error. At the time of this report the patient was not recovered from event. Documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Dysgeusia, Feeling abnormal, Injection site haemorrhage
Clinical narrative: Initial report received from healthcare professional on 23 Oct 2014. A female patient, whose age, medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE (batch number: UI195AA, dose, dose number not reported) in left deltoid on 23 Oct 2014. It was reported that on 23 Oct 2014, the patient bled from injection site, stated she felt funny for a few minutes after the injection and had a strange taste in her mouth. Lab details and corrective treatments were not reported. The outcome of the event was reported as recovered. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Initial report received from a healthcare professional on 23 October 2014. A 58-year old female patient, whose medical history and concomitant medications were not reported, had received a dose of Flu vaccine via intramuscular route (dose, batch number, dose number and site of administration were not reported) on 14 Oct 2014. On an unspecified date, the patient experienced pain in her arm and described it as throbbing, stabbing with pins and needles. The patient consulted doctor on 15 Dec 2014 and the physician assessed the pain was probably from the flu shot. Laboratory investigations and corrective treatments were not reported. At the time of this report, the event outcome was unknown. Documents held by sender: none.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Incorrect route of drug administration, Pain
Clinical narrative: Initial unsolicited misuse report received from a Pharmacist On 27 January 2015. A 56-year-old female patient had received a dose of FLUZONE QIV vaccine (lot number: UI192AB, expiry date was 30 June 2015, route of administration reported as intravenous and dose number, site of administration was not reported) on 26 January 2015. The patient's concomitant medications were not reported. The patient was hospitalized for heart symptoms. The patient was reported as allergic to ace inhibitors. It was reported that the vaccine was administered intravenously instead of intramuscular route. On an unspecified date post vaccination, the patient experienced body aches and chills. Corrective treatment and laboratory details were not reported. At the time of this report, the patient was not recovered from adverse events. Documents held by sender: None.
Age: 21.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Body temperature increased, Myalgia, Oropharyngeal pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a Nurse on 23-Jan-2015. A 21 years old female patient, had received a dose of MENACTRA via intramuscular route in the right deltoid (Batch number 44798AA, expiry date unknown), ADACEL via intramuscular route in the left deltoid (batch number 44971AA, expiry date unknown) and FLUZONE via intramuscular route in the right deltoid (batch number 41231AA, expiry date unknown) on 22-Jan-2015 at 07:30 p.m. There was no pre-existing physician diagnosed allergies, birth defects, medical conditions and no illness at the time of vaccination. The concomitant medications included antibiotics which were stopped on 21-Jan-2015. On 23-Jan-2015, at 11.30 a.m., the patient experienced sore throat, achy legs/arm muscle pain and body temperature of 101.5 degree Fahrenheit. There were no lab investigations and corrective treatment was not reported. 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  physician on 05-Mar-2015. It was reported that the patient had received the first dose of all three vaccines MENACTRA, ADACEL and FLUZONE. The patient had not received any other vaccination prior to these three vaccines and dose not have any illness at the time of vaccination. The patient's family had not experienced any adverse event after any vaccinations. The patient had received antibiotics as corrective treatment and stopped the treatment on 21 Jan 2015. At the time of this report the patient was recovered from adverse events. Documents held by sender: none.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Local swelling, Muscle tightness
Clinical narrative: Initial report received from a healthcare professional on 21 October 2014. This case is linked to the case 2014SA149860 for adverse event following ADACEL vaccine. A 59 year old female patient, whose medical history and concomitant medications were not reported, had received a dose of FLUZONE TIV (Batch number UI198AB and expiry date not reported) in the right deltoid, on 17-OCT-2014. It was reported that the patient had received an ADACEL injection about 6 weeks ago she had a similar reaction which occurred after FLUZONE vaccine. It was reported that on 18-OCT-2014 the patient had tightness and swelling on the right side of neck she described it as about twice the size of the noodle. The patient had a 3 half mm nodule on her subclavicular notch without lymph involvement. The patient had no illness at the time of vaccination, no known allergies, birth defects and medical conditions were not reported. Corrective treatment was not reported and Laboratory data were reported as none. At the time of this report the outcome of the event was unknown. List of documents held by sender: none.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: (R) anterior thigh 10 1/2 x 13 cm increase warm erythema region.
Age: 4.0
Sex: F
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: 9 x 9 1/2 erythematous rash area thigh (L) itchy increased warm.
Sex: F
Vaccine: FLUX
Symptoms: Blood pressure increased, Heart rate increased
Clinical narrative: Initial report received from a healthcare professional on 21 October 2014. A female patient, whose age, medical history and concomitant medication was not reported, had received a dose of INFLUENZA VACCINE (manufacturer unknown) (batch number, dose, dose in series, route of administration and site of administration was not reported) on unspecified date in 2008. On unspecified date in 2008, after vaccination, the patient experienced increased heart rate and BP. Laboratory investigation was not provided and corrective treatment was not reported. On an unspecified date the patient was recovered from event. Documents held by sender: none.
Age: 57.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site atrophy, Pain in extremity
Clinical narrative: Pain in arm,. Dimple at injection site x 2 weeks.
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration, Injection site vesicles
Clinical narrative: Initial report received from a health care professional on 17 October 2014. A female patient (age not reported), had received an intradermal dose of FLUZONE ID vaccine (lot number: unknown, dose number and site of administration was not reported) on 16 October 2014. The patient illness at the time of vaccination was unknown. The patient pre-existing physician diagnosed allergies, birth defects and medical conditions was unknown. On 17 October 2014 i.e. one day after vaccination patient had experienced Blistering, hardness and induration at injection site. It was reported that patient was evaluated at the hospital emergency room and intent of call was for treatment recommendations. Corrective treatment and laboratory investigations were not reported. At the time of this report, patient outcome was unknown. Documents held by sender: None. Follow-up information received from a non-health care professional on 11 March 2015. No new information was reported. Documents held by sender: none.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Muscular weakness, Pain in extremity, Peripheral swelling
Clinical narrative: Initial report received from a health care professional on 10 November 2014. A 41-year-old female patient, had received an intramuscular dose of FLUZONE vaccine (lot number: UI200AB, expiry date- 30 June 2015) in left deltoid on 10 October 2014. The patient illness at the time of vaccination was unknown. The patient pre-existing physician diagnosed allergies, birth defects and medical conditions was unknown. It was reported that patient had received flu shot yearly. On 10 October 20014 i.e. same day after vaccination patient had experienced Pain and swelling with soreness in left arm since vaccination and now hard to move arm without pain which increased from 2/3 at rest to 8/10 when moving. Has weakness in the left arm. Corrective treatment and laboratory details were not reported. At the time of this report, patient outcome was not recovered. Documents held by sender: None. Followup information received from a healthcare professional on 23 January 2015. It was reported that patient was seen once on 8 September 2013.
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Adverse event
Clinical narrative: Initial unsolicited report received from healthcare professional on 12 December 2014. A male patient, whose medical history, age, gender, and concomitant medications were not reported, had received a dose of FLUZONE HD batch number- U5042AA, Expire date- 14-MAY-2015 (dose number, dose in series, route of administration, site of administration were not reported) also ADACEL batch number-U4963AA, Expire date- 30-Jan-2017 (dose number, dose in series, route of administration, site of administration were not reported) and PNEUMOVAX  (manufacturer-Merck, batch number, dose number, dose in series, route of administration, site of administration were not reported ) on unspecified date in December 2014. On unspecified date in December 2014 after vaccination the patient experienced a reaction which is not specific. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event is unknown. Documents held by sender: none. Follow-up report received from a health care professional on 1 July 2015. No new additional information was reported. Documents held by sender: none.
Sex: U
Vaccine: FLU3
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Initial unsolicited report received from a healthcare professional on 06-Jul-2015. This case is linked with 2014SA151239, 2015SA105624, 2015SA015628, 2015SA105631. A patient (age and gender was not reported) whose medical history and concomitant medications were not reported had received a dose of FLUZONE ID (batch number UT4993BA, dose, route, site of administration were not reported) on 30 Oct 2014. Pre-existing physician diagnosed allergies, birth defects, medical conditions and illness at the time of vaccination were reported as none. On 30 October 2015, same day after vaccination, patient experienced that injection site was very sore which lasted almost a week, area around the injection shot was about a circumference of a highlighter, and patient also had fever. Laboratory investigations and corrective treatments were not reported. At the time of this report the patient outcome from the reported events was unknown. Documents held by sender: none.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Initial report received from healthcare professional on 24 October 2014. A 58-year-old female patient, whose medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number UI173AA, expiry date 30 June 2015, and dose number was not reported) in to the left deltoid on 02 October 2014. The patient had experienced sore arm when lifts arm to a 90 degree angle and soreness at the injection site on an unspecified date after vaccination. Lab investigation and corrective treatment were not reported. The patient had no illness at the time of vaccination, pre-existing diagnosed allergies and birth defects were reported as unknown. The outcome of the event was unknown at the time of this report. List of documents held by sender: none. Follow up unsolicited report received from a health care professional on 15 January 2015. It was reported that the patient had received 0.5 ml dose of FLUZONE QIV.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Red, itching, rash at shot area (R) deltoid).
Age: 11.0
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Chest discomfort, Emotional distress, Head discomfort, Irritability, Paranoia
Clinical narrative: Initial unsolicited report received form a Consumer on 23 January 2015. An 11-years-old patient, whose gender, medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number U5101FA and expiry date 30-JUN-2015) in the left deltoid and also received an intramuscular dose of ADACEL (batch number C4666AA and expiry date 15-JAN-2015) in the left deltoid on 15-JAN-2015. On 15-JAN-2015 i.e. 15 minutes post vaccination the patient was tired, irritable, went into a sleep like state for 3 min and awoke with head heaviness, tightness in chest, increased irritability and became inconsolable and paranoid. The patient also had periods of being her normal self and paranoia which took 2 hours to resolve. Laboratory investigations were not reported and the physician prescribed MOTRIN to the patient. Illness at time of vaccination was denied. The patient had allergy to tree nuts. The patient's birth defects and medical conditions were not reported. Other vaccination within 4 weeks of FLUZONE QIV and ADACEL vaccinations was not reported. At the time of this report the patient was recovered. Documents held by sender: none. Addendum on 30 Mar 2015: Upon second medical examination of case at time of internal review a significant correction was performed to create an additional event record for 'went into a sleep like state for 3 min and awoke,' to delete event 'became inconsolable', modify event to 'chest tightness' and modify listed ness of event 'irritability' from listed to unlisted.
Age: 11.0
Sex: U
Vaccine: FLU4, TDAP
Symptoms: Somnolence
Clinical narrative: Initial unsolicited report received form a Consumer on 23 January 2015. An 11-years-old patient, whose gender, medical history and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (batch number U5101FA and expiry date 30-JUN-2015) in the left deltoid and also received an intramuscular dose of ADACEL (batch number C4666AA and expiry date 15-JAN-2015) in the left deltoid on 15-JAN-2015. On 15-JAN-2015 i.e. 15 minutes post vaccination the patient was tired, irritable, went into a sleep like state for 3 min and awoke with head heaviness, tightness in chest, increased irritability and became inconsolable and paranoid. The patient also had periods of being her normal self and paranoia which took 2 hours to resolve. Laboratory investigations were not reported and the physician prescribed MOTRIN to the patient. Illness at time of vaccination was denied. The patient had allergy to tree nuts. The patient's birth defects and medical conditions were not reported. Other vaccination within 4 weeks of FLUZONE QIV and ADACEL vaccinations was not reported. At the time of this report the patient was recovered. Documents held by sender: none. Addendum on 30 Mar 2015: Upon second medical examination of case at time of internal review a significant correction was performed to create an additional event record for 'went into a sleep like state for 3 min and awoke,' to delete event 'became inconsolable', modify event to 'chest tightness' and modify listed ness of event 'irritability' from listed to unlisted.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Injection site rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 47-year-old female patient who received FLUARIX (batch number 7HZ73, expiry date 30th June 2016). Concomitant products included CEFTIN, WELLBUTRIN SR and Levothyroxine. On 9th November 2015, the patient received FLUARIX (intramuscular). On 11th November 2015, 2 days after receiving FLUARIX, the patient experienced itchy rash. On an unknown date, the outcome of the itchy rash was not recovered/not resolved. The reporter considered the itchy rash to be possibly related to FLUARIX. Additional details were received as follows: The reporter stated that, the patient notified the pharmacy that, 48 hours after receiving FLUARIX, she experienced an itchy rash. The itchy rash was not localized around injection site. The reporter stated that, the rash was continuing to get worse.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Initial report received from a Consumer (the patient) on 05 November 2014. A 63-year-old male patient had received a dose of FLUZONE QIV, (batch number U1190AA, dose in series, route and site of vaccination not reported) on 31 October 2014. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 31 October 2014, same day after vaccination, the patient experienced "not feeling well" and next morning had fever to 101F, chills, myalgia, joint pain and lethargy On 05 November 2014, the patient was still having chills, myalgia, lethargy. Also stated that the patient had swelling, redness, soreness at area around injection site. Corrective treatment and laboratory data was not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Lethargy, Malaise, Myalgia
Clinical narrative: Initial report received from a Consumer (the patient) on 05 November 2014. A 63-year-old male patient had received a dose of FLUZONE QIV, (batch number U1190AA, dose in series, route and site of vaccination not reported) on 31 October 2014. The patient had no illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions were not reported. On 31 October 2014, same day after vaccination, the patient experienced "not feeling well" and next morning had fever to 101F, chills, myalgia, joint pain and lethargy On 05 November 2014, the patient was still having chills, myalgia, lethargy. Also stated that the patient had swelling, redness, soreness at area around injection site. Corrective treatment and laboratory data was not reported. At the time of this report, the patient had not recovered. Documents held by sender: none.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Respiratory tract congestion, Sinus congestion
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 05 November 2014. This case is a cluster of 2 cases and is linked to 2014SA155735 (Same reporter, vaccine and vaccine lot number). A 67-year-old female patient, whose concomitant medication was not reported, had received a dose of FLUZONE HD, (batch number, expiry date of vaccine, cycle in series and route of vaccination was not reported) in deltoid on 18-Oct-2014. On 18-Oct-2014, patient experienced chest congestion, sinus congestion, erythema at injection site and fatigue (patient was unable to go out of her house in over 1 week due to the extreme fatigue). Corrective treatment and lab investigations were not reported. Illness at the time of vaccination was not reported. Medical history was reported as; patient had allergies to numerous antibiotics, narcotics and aspirin. Corrective treatment and lab 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 report received from a Consumer (the patient) on 29 January 2015. Lot number of vaccine was J5041BA and expiry date was 12 May 2015. The vaccine was administered intramuscularly in left arm.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a Physician on 16 October 2014. A 5-year-old female patient, who had medical history of seasonal allergy and allergy to cat and dog, and concomitant medications were not reported, had received an intramuscular dose of FLUZONE QIV (Batch number, expiry date and site of vaccination not reported), on 06-NOV-2014. On an unspecified date, after vaccination the patient had swelling at the injection site, induration, and hot to touch at the injection site. The patient had no illness at the time of vaccination were unknown. Laboratory data were not reported and patient had received FLUMIST as corrective treatment. At the time of this report, the patient was not recovered. List of documents held by sender: none. Follow up information received from a physician on 06 March 2015. It was reported that the lab tests were not performed. The patient did not receive any concomitant vaccines. List of documents held by sender: none.