chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Patient broke out in fine rash and hives, was having intense itching.  Itching lasted for 2 days.
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Paraesthesia oral, Sensation of foreign body, Swelling face, Throat irritation
Clinical narrative: Scratchy and lumpy throat, face swelling, lips tingling, breathing felt tighter.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Peripheral swelling, Pruritus, Skin reaction
Clinical narrative: Arm red, swollen, itchy, other parts of arms and legs itchy.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Employee states that she began to have hive and itching and took Benedryl (dose unknown). Employee then presents to Employee Health office to request medication to relieve itching. EE has visible hives and swelling to bilateral arms and legs and is in considerable discomfort. Provided antihistamine as well as hydrocortisone cream. Advised to employee to follow up with PCP.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Extra dose administered
Clinical narrative: None reported.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Decreased appetite, Dehydration, Dizziness, Fatigue, Headache
Clinical narrative: Headache, dizziness, throwing up, tired most of the time. High blood pressure and heartbeat about 140-150 beats per minute. Fever 103. No appetite and dehydration.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Heart rate increased, Hypertension, Pyrexia, Vomiting
Clinical narrative: Headache, dizziness, throwing up, tired most of the time. High blood pressure and heartbeat about 140-150 beats per minute. Fever 103. No appetite and dehydration.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Asthenia, Dizziness, Palpitations, Viral infection, Vomiting
Clinical narrative: Headache, dizziness, throwing up, tired most of the time. High blood pressure and heartbeat about 140-150 beats per minute. Fever 103. No appetite and dehydration.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Decreased appetite, Dehydration, Dizziness, Fatigue, Headache
Clinical narrative: 10/7/16 Telephone call from father. Reported 2 hrs after receiving vaccinations on 10/3/16, client reported to had experienced weakness, dizziness, vomiting and palpitations was taken to emergency department. Was in ER for 2 days. Had 103 degree temp. Father stated D/C DX: Viral illness.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Heart rate increased, Hypertension, Pyrexia, Vomiting
Clinical narrative: 10/7/16 Telephone call from father. Reported 2 hrs after receiving vaccinations on 10/3/16, client reported to had experienced weakness, dizziness, vomiting and palpitations was taken to emergency department. Was in ER for 2 days. Had 103 degree temp. Father stated D/C DX: Viral illness.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB, FLU4, MENB
Symptoms: Asthenia, Dizziness, Palpitations, Viral infection, Vomiting
Clinical narrative: 10/7/16 Telephone call from father. Reported 2 hrs after receiving vaccinations on 10/3/16, client reported to had experienced weakness, dizziness, vomiting and palpitations was taken to emergency department. Was in ER for 2 days. Had 103 degree temp. Father stated D/C DX: Viral illness.
Age: 34.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles from flu shot.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient got swollen , red area around injection site.
Age: 56.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Paraesthesia
Clinical narrative: Patient complained about numbness and tingling on the arm flu shot was given 9 days later she couldnt lift her arm.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Blister, Rash erythematous, Rash generalised, Rash morbilliform, Varicella post vaccine
Clinical narrative: Hundreds of thousands of raised red bumps over every square centimeter of her body which resembles the measles. Also, she has chicken pox blisters on her back and her fron right shin. She has BOTH diseases.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL, DTAP, IPV, MMR, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Hundreds of thousands of raised red bumps over every square centimeter of her body which resembles the measles. Also, she has chicken pox blisters on her back and her fron right shin. She has BOTH diseases.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site hypoaesthesia, Sensory disturbance
Clinical narrative: Patient states that she is having some numbness at the location of vaccination in the deltoid muscle.  She also states that the numbness or "feeling funny" extends to the back of her scapula when she is driving.  Patient states that these symptoms started soon after vaccination on 10/4/16 and are continuing through today, 10/7/16.
Age: 35.0
Sex: F
Vaccine: FLU3, TYP
Symptoms: Dizziness, Muscular weakness, Pain, Pyrexia, Renal pain
Clinical narrative: Light headed, muscle weakness, achy all over. Kidney throbbing pain. Fever 101.6.
Age: 36.0
Sex: F
Vaccine: FLUC4
Symptoms: Muscle spasms, Pain in extremity, Rash
Clinical narrative: Rash on face and pain/cramping in legs began day after vaccine was administered.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Underdose
Clinical narrative: As I was admin the immunization in the Left arm the vaccine came out of the syringe and ran down the patient's arm. I retrieved a new vaccine and admin in the patient's right arm. Pt did not complain of any ill effect - but I had to give a second injection. I don't know if there was a defect in the pre-filled syringe or the needle.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Decreased appetite, Dizziness, Dyspnoea, Full blood count normal, Laboratory test normal
Clinical narrative: Shaking, dry heaving, nausea, feeling short of breath at times, dizzy, loss of appetite, sore throat.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Nausea, Oropharyngeal pain, Retching, Streptococcus test negative, Tremor
Clinical narrative: Shaking, dry heaving, nausea, feeling short of breath at times, dizzy, loss of appetite, sore throat.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Flushing, Panic reaction, Pruritus, Throat tightness
Clinical narrative: Tightness in throat, hives, itching, flushed, panic, cough. Epi 0.3mg administrered at 10:15 AM. Benadryl 50mg IM administered approx. 10:30AM. Nebulizer Albuterol treatment @ 10:45am. Transported to Medical Center via EMS.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Tightness in throat, hives, itching, flushed, panic, cough. Epi 0.3mg administrered at 10:15 AM. Benadryl 50mg IM administered approx. 10:30AM. Nebulizer Albuterol treatment @ 10:45am. Transported to Medical Center via EMS.
Age: 70.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Pain
Clinical narrative: Can't lift arm, horrid pain.
Age: 65.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Rash
Clinical narrative: Patient was given vaccines on 9/26/16 we were not notified of any reaction until 10/06/2016. He came in with what looked to be a rash (poison ivy) or bug bites on his arm and said it was a reaction to the vaccines he received.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Oropharyngeal pain, Painful respiration, Palpitations
Clinical narrative: Sore throat, Headache, Chills, Heart palpitations, Hurts to take a deep breath.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Aphasia, Fatigue, Mobility decreased
Clinical narrative: Patient felt the following morning (10/6/16) and rest of day on the day after the vaccinations that she was extremely fatigued and could not move or talk (she was unsure when the onset may have been because she stayed up late at night then fell asleep; her husband returned home from work on 10/6/16 at 4.30pm to find her laying down not able to move or talk to him; the effects gradually wore off and by the second day post-vaccination was feeling better and back to normal(10/7/16).
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Adult Hep A give to child age 13.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUX, MMRV
Symptoms: Incorrect product storage
Clinical narrative: KINRIX-DTaP and IPV administered on 3/28/16 and was non-viable due to exposure of out of range temperatures.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Swelling, Urticaria, Vomiting
Clinical narrative: Pt received high dose flu vaccine. Later that evening started progressively worsening hives.  Called PCP office 10/5.  Was advised to take Claritan and benadryl.  Some improvement. Then worsening hives over night.  Seen in PCP office 10/6/16.  Started on Prednisone 40 mg and Benadryl 25 my prn. Symptoms worsened that night w chest tightness, vomiting, more swelling and hives.  Pt went to ER - received IV Prednisone and antihistamine w some improvement.  Discharged home.  PCP office called and advised they complete VAERS.  Pharmacist stated did not know what VAERS was.
Age: 29.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Client c/o shortness of breath and generalized dizziness that lasted for a few hours.
Age: 2.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Blood test, Synovitis, Ultrasound scan abnormal, X-ray
Clinical narrative: Transient synovitis of the hip.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Mass, Skin warm
Clinical narrative: Lump, redness, warm to touch, patient concerned, affected area is larger than a 50 cent piece.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site rash
Clinical narrative: Rash on his left upper arm after receiving DTAP/IPV vaccine without fever, pain.
Age: 61.0
Sex: F
Vaccine: FLUX
Symptoms: Myalgia, Throat irritation
Clinical narrative: Started with myalgia and scratchy throat.
Age: 9.0
Sex: M
Vaccine: HPV4
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Swelling, pain, and redness to right arm, worsening the following day.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, skin irritation, redness, itching at injection site.
Age: 23.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Cardiac murmur, Immediate post-injection reaction, Loss of consciousness, Seizure, Syncope
Clinical narrative: Patient fainted then started seizure immediately after receiving 3rd shot in right deltoid. EPI pen was administered soon as patient started to regain consciousness from seizure.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site abscess, Injection site rash
Clinical narrative: Hard lump formed in the arm as well as red non-raised rash radiating from the injection site.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site nodule, Pyrexia
Clinical narrative: Fever, Chills, Knot at site of injection and under arm.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Painful respiration
Clinical narrative: Shoulder pain, Inspiratory pain.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Blood glucose increased, Depression
Clinical narrative: Occured about 12hrs after vaccinations  blood sugars over 500 which she handled with her humalog "heavy" depression lasting for over 36 hours  did not go to dr or hospital.
Age: 86.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Patient came into my pharmacy. Wednesday 10/5/2016 at 7pm. She is legally blind and asked me to look at her arm from a vaccine administered elsewhere. She has definite cellulitis. I marked the area. Called the doctor the next morning, got her into the office.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Erythema, Local swelling, Pain, Rash
Clinical narrative: Red, painful, and swollen rash like area in the armpit of the right arm.
Age: 7.0
Sex: M
Vaccine: FLUX, FLU4
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Red, painful, and swollen rash like area in the armpit of the right arm.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: lLrge raised red spot over injection area.
Age: 78.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Mobility decreased, Night sweats
Clinical narrative: Patient has redness, swelling, and tenderness along upper right arm.  Experienced difficulty raising arm and mild sweating during the night after receiving PNEUMOVAX.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Induration 3 x 2.5 inches, redness, erythema. Swollen.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Induration, Swelling
Clinical narrative: Induration, erythema, redness swollen.
Age: 94.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Left arm swelling and redness.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Patient received the Fluzone HD. Patient was under pharmacist supervision when patient stated that she felt like she was about to faint. She also stated that she has received flu shots in the past and this never happened before.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Fatigue, Headache, Pyrexia
Clinical narrative: Dizziness, fatigue, headache, low fever.
Age: 60.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site pain, Injection site rash
Clinical narrative: Patient reported having normal immunization site tenderness. Two immunizations administered into patients right arm approximately 1 and 1/2 inches apart on 10/5/16. Patient reported rash started in the evening on 10/6/16 directly over injection sites. Woke up 10/7/16 with a more prominent rash over injection site.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Bruxism, Dizziness, Dyspnoea, Loss of consciousness, Muscle rigidity
Clinical narrative: The patient came into the pharmacy and received a flu shot. After giving the shot, I turned to place the syringe in the sharps conainer. When I turned back around the patient looked faint, so I called out to her to see if she was ok. The patient was not responsive and then proceeded to pass out slouching onto her right shoulder in the chair. I called to the patient with no response. Shortly after passing out the patient began to have a tonic seizure-like reaction. She became rigid and stiff, clinching her teeth and struggling to breath. I immediately told my technician to call 911. The seizure lasted about 30 seconds to a minute. While seizing, I stabilized the patients head and neck and tried to maintin their airway. Breathing was taxed, however, the patient never stopped breathing. During the seizure the patient also urinated involuntarily. The patient regained consciousness and I ask her if she knew what happened and if she was feeling ok. The patient felt pale, faint, and nauseous. She was very out of it, but was responsive and able to answer questions correctly. Her blood pressure was 103/55 mmHg and heart rate was 72. EMS arrived and were briefed on the situation and the patient was taken to the hospital.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Nausea, Pallor, Seizure like phenomena, Tonic convulsion
Clinical narrative: The patient came into the pharmacy and received a flu shot. After giving the shot, I turned to place the syringe in the sharps conainer. When I turned back around the patient looked faint, so I called out to her to see if she was ok. The patient was not responsive and then proceeded to pass out slouching onto her right shoulder in the chair. I called to the patient with no response. Shortly after passing out the patient began to have a tonic seizure-like reaction. She became rigid and stiff, clinching her teeth and struggling to breath. I immediately told my technician to call 911. The seizure lasted about 30 seconds to a minute. While seizing, I stabilized the patients head and neck and tried to maintin their airway. Breathing was taxed, however, the patient never stopped breathing. During the seizure the patient also urinated involuntarily. The patient regained consciousness and I ask her if she knew what happened and if she was feeling ok. The patient felt pale, faint, and nauseous. She was very out of it, but was responsive and able to answer questions correctly. Her blood pressure was 103/55 mmHg and heart rate was 72. EMS arrived and were briefed on the situation and the patient was taken to the hospital.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli, Urinary incontinence
Clinical narrative: The patient came into the pharmacy and received a flu shot. After giving the shot, I turned to place the syringe in the sharps conainer. When I turned back around the patient looked faint, so I called out to her to see if she was ok. The patient was not responsive and then proceeded to pass out slouching onto her right shoulder in the chair. I called to the patient with no response. Shortly after passing out the patient began to have a tonic seizure-like reaction. She became rigid and stiff, clinching her teeth and struggling to breath. I immediately told my technician to call 911. The seizure lasted about 30 seconds to a minute. While seizing, I stabilized the patients head and neck and tried to maintin their airway. Breathing was taxed, however, the patient never stopped breathing. During the seizure the patient also urinated involuntarily. The patient regained consciousness and I ask her if she knew what happened and if she was feeling ok. The patient felt pale, faint, and nauseous. She was very out of it, but was responsive and able to answer questions correctly. Her blood pressure was 103/55 mmHg and heart rate was 72. EMS arrived and were briefed on the situation and the patient was taken to the hospital.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Chest X-ray abnormal, Chills, Hypotension, Lung infiltration, Nausea
Clinical narrative: Pt took nap woke up with chills, nausea, vomiting, and low blood pressure, went to ER. Treated for reaction with decadron, Benadryl, Epi Pen, started throwing PVC did chest x-ray and inflitrates found. Has been in hospital for 48 hours.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Ventricular extrasystoles, Vomiting
Clinical narrative: Pt took nap woke up with chills, nausea, vomiting, and low blood pressure, went to ER. Treated for reaction with decadron, Benadryl, Epi Pen, started throwing PVC did chest x-ray and inflitrates found. Has been in hospital for 48 hours.
Age: 30.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Chills, Diarrhoea, Inflammation, Myalgia, Pain
Clinical narrative: Muscle pain, diarrhea, chills, body aches and fever.
Age: 30.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Pyrexia
Clinical narrative: Muscle pain, diarrhea, chills, body aches and fever.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Rash, Secretion discharge
Clinical narrative: Patient came into pharmacy with rash on his left arm that was seeping and red. He received the shingles shot on 9/26/16. Patient may have the shingles.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Nausea, Pruritus, Rash, Urticaria
Clinical narrative: Developed nausea, hives, itching, and rash about 2 hours after injection. Went to urgent care for tx on 10/1/16 in the AM. They gave steroid injection/cream. Patient has been on BENADRYL every day since until today 10/7/16. Symptoms have been waxing and waning since injection. Patient had previously had same injection (FLUZONE HD) in 2015 with no problems.
Age: 81.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood glucose increased, Rash erythematous, Rash generalised, Rash pruritic, Rash vesicular
Clinical narrative: Developed nausea, hives, itching, and rash about 2 hours after injection. Went to urgent care for tx on 10/1/16 in the AM. They gave steroid injection/cream. Patient has been on BENADRYL every day since until today 10/7/16. Symptoms have been waxing and waning since injection. Patient had previously had same injection (FLUZONE HD) in 2015 with no problems.
Age: 19.0
Sex: F
Vaccine: FLU4, HPV9
Symptoms: Blood pressure immeasurable, Hyperhidrosis, Nausea, Pulse absent, Syncope
Clinical narrative: The patient became diaphoretic, nauseated and fainted. Her pulse and BP were undetectable by manual and mechanical means for 10 minutes, though she was alert the entire time. She was alert within seconds of fainting and was back to normal condition within 20 minutes of onset of symptoms.
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Anaphylactic shock, Dyspnoea, Panic reaction, Pharyngeal disorder, Respiratory arrest
Clinical narrative: My daughter was having trouble breathing at about 745 pm and after 15 minutes on a nebulizer it was not helping her breathe better.  She panicked and began to point to her neck repeating "it's not working,  something is wrong". 911 was called at 807pm and before they arrived she stopped breathing . After arrival at about 815 pm, they carted her into the ambulance where they injected her with an epi pen where then she gained consciousness. She was rushed to the ER for further treatment at about 9Pm.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pneumonia, Sepsis
Clinical narrative: Hospital visit, sepsis, pneumonia. All 2 days after vaccines - hospitalized and given antibiotics.
Sex: U
Vaccine: PNC13
Symptoms: Diabetes mellitus, Dyslipidaemia, Extra dose administered
Clinical narrative: This spontaneous report was received from a pharmacy student regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and drug reactions/allergies were unknown. Approximately in 2004 (reported as "12 years ago") the patient was vaccinated with PNEUMOVAX 23 (dose, frequency, expiry, route and batch/lot# were not reported). The patient had received two doses of PREVNAR 13 one dose of on an unspecified date in January 2015 and then a second dose on an unspecified date in January 2016 (extra dose administered). Approximately in 2016 (reported as "currently"), the patient was diagnosed with diabetes and dyslipidemia and it could not be determined that if the patient experienced these conditions before or after receiving the dose of PNEUMOVAX 23. The outcome of diabetes mellitus and dyslipidaemia was unknown. The reporter did not provide the relatedness of the events with PNEUMOVAX 23. There was no product quality complaint involved. Upon internal review "diabetes" was determined to be medically significant. Additional information is not expected as the reporter did not wish to be contacted.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site bruising in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number 9D325, expiry date June 2017). On 15th September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. In September 2016, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced injection site bruising. On an unknown date, the outcome of the injection site bruising was recovering/resolving. The reporter considered the injection site bruising to be almost certainly related to FLUARIX QUADRIVALENT. Additional details were received as follows: The patient experienced bruising at injection site lasting over 12 days after vaccination. The start date of bruising was unknown.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were reported. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QUADRIVALENT had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were reported. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were reported. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 94.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Throat tightness
Clinical narrative: Patient presented for flu shot. Approximately 5-10 minutes after injection pt stated having tightness of throat and chin numbness. Was seen by Dr., given 25 mg BENADRYL IM. No improvement given 25 mg BENADRYL IM again. Pt not improved - sent by EMS to ER.
Sex: U
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were provided. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Inflammation, Swelling, Tenderness
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inflammation in a adult patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). In September 2016, the patient received FLUARIX QUADRIVALENT. In September 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced inflammation, tenderness and swelling. On an unknown date, the outcome of the inflammation, tenderness and swelling were unknown. It was unknown if the reporter considered the inflammation, tenderness and swelling to be related to FLUARIX QUADRIVALENT. Additional details were reported as follows: The reporter explained that several staff, about 8, who received the FLUARIX QIV vaccine had developed large amounts of inflammation, swelling and tenderness. On the date of reporting, it was the day 4 after injection. No further details were reported. On 30th September 2016 at 3:14 hours, the reporter's office was contacted and got voicemail that they contacted GlaxoSmithKline GMS Quality and found FLUARIX in Lot Locator system. This was one of the 8 cases reported by the same reporter.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Formication, Product quality issue, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of urticaria generalized in a 44-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7KK33, expiry date 30th April 2017). This case was associated with a product complaint. Previously administered products included Flu vaccine (the patient did not experience any adverse event after Flu vaccination). On 29th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On 29th September 2016, 10 min after receiving FLULAVAL QUADRIVALENT, the patient experienced urticaria generalized and formication. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the urticaria generalized, formication and pharmaceutical product complaint were unknown. The reporter considered the urticaria generalized and formication to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case was previously not reported to anyone. This case was reported by a registered nurse. The patient experienced urticaria which was present all over her body but began behind the patient's knees and back, then spread and formication after vaccination with FLULAVAL QUADRIVALENT on left deltoid. The reporter stated that a multidose vial of FLULAVAL might be suspect. It caused various adverse drug events in several patients with similar adverse drug event pattern. The suspect vial was available for return. Replacement or credit was not requested by reporter. This case is 1 of the 3 cases reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Dry mouth, Formication, Product quality issue, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of urticaria in a adult female patient who received FLULAVAL QUADRIVALENT (batch number 7KK33, expiry date 30th April 2017). This case was associated with a product complaint. On 29th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On 29th September 2016, 20 min after receiving FLULAVAL QUADRIVALENT, the patient experienced urticaria, formication and dry mouth. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the urticaria, formication, dry mouth and pharmaceutical product complaint were unknown. The reporter considered the urticaria to be almost certainly related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the formication and dry mouth to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that that a female patient experienced urticaria, dry mouth and hives. She also reported formication. The reporter stated that a multi dose vial of FLULAVAL might be suspect. It had caused various adverse events in several patients with a similar adverse event pattern. The suspect vial was available for return. Replacement or credit was not requested by reporter. This case is 1 of the 3 cases reported by the same reporter.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Diarrhoea, Flushing, Lacrimation increased, Ocular hyperaemia, Pruritus generalised
Clinical narrative: At 18-20 minutes after vaccination, patient developed full body itching, facial flushing, increased throat clearing, injected sclera, and water eyes. Patient given 10 ml of CLARITIN. Symptoms resolved after 90 mins.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Throat irritation
Clinical narrative: At 18-20 minutes after vaccination, patient developed full body itching, facial flushing, increased throat clearing, injected sclera, and water eyes. Patient given 10 ml of CLARITIN. Symptoms resolved after 90 mins.
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site swelling in a female patient who received FLUARIX QUADRIVALENT. On an unknown date, the patient received FLUARIX QUADRIVALENT at an unknown dose. On an unknown date, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced injection site swelling and injection site pain. On an unknown date, the outcome of the injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site swelling and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: the age at vaccination was not reported. the nurse stated that the patient got FLUARIX QIV from last season and experienced the events. No further information was provided.
Age: 81.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 81-year-old female patient who received Flu seasonal TIV Dresden. On an unknown date, the patient received seasonal influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to Seasonal Influenza vaccine. Additional details were provided as follows: the age at vaccination was not reported. the patient received the flu vaccine several times in past and did not have any other adverse event other than soreness in arm. This case has been linked with case US2016143211 as reported by same reporter.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Dysgeusia, Formication, Paraesthesia oral, Product quality issue, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of urticarial in a 34-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 7KK33, expiry date 30th April 2017). Previously administered products included influenza vaccine (never experienced event). On 29th September 2016, the patient received FLULAVAL QUADRIVALENT (intramuscular). On 29th September 2016, 5 min after receiving FLULAVAL QUADRIVALENT, the patient experienced urticarial, paresthesia lips, formication and taste altered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the urticaria, paresthesia lips, formication, taste altered and pharmaceutical product complaint were unknown. The reporter considered the urticarial, formication and taste altered to be almost certainly related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the paresthesia lips and pharmaceutical product complaint to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: This case not previously reported to anyone. This case was reported by a registered nurse. the reporter stated that a multidose vial of FLULAVAL may be suspect. the patient received Flu Seasonal QIV on right deltoid and experienced funny taste in her mouth, paresthesia around the lips. It caused various adverse drug events in several patients with similar adverse drug event pattern. The suspect vial was available for return. Replacement or credit was not requested by reporter. This case is 1 of the 3 cases reported by the same reporter.
Age: 84.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 84-year-old female patient who received Flu Seasonal QIV Dresden. On 26th September 2016, the patient received influenza vaccine Quadrivalent. On 27th September 2016, 1 days after receiving Influenza vaccine quadrivalent, the patient experienced nausea. On an unknown date, the outcome of the nausea was unknown. the reporter considered the nausea to be possibly related to influenza vaccine quadrivalent. Additional details were provided as follows: This case was not previously reported to anyone. the patient did not receive any other medications. the patient was given a quadrivalent flu shot but the brand was not known. the patient developed nausea in the next morning after her breakfast at 9:30.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rash erythematous, Rash pruritic, Skin warm
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of itchy rash in a 39-year-old female patient who received FLUARIX QUADRIVALENT. On 22nd September 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On 22nd September 2016, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced itchy rash, rash erythematous and skin warm. On an unknown date, the outcome of the itchy rash, rash erythematous and skin warm were not recovered/not resolved. The reporter considered the itchy rash, rash erythematous and skin warm to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced rash which was on the neck, under the arm, groin area and breast, the rash was not raised but red, warm to the touch, webbed looking and itchy after vaccination with FLUARIX QUADRIVALENT on an unknown arm. The patient might follow up with her healthcare professional, but had not sought medical attention at this time. The patient did mention that she had the same rash reaction whenever she is used to get sick. The representative was going to try to contact the patient to get permission from her asking for her demographics.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal stiffness
Clinical narrative: Starting evening 9/22/16 stiff neck (and range of motion backward) continuing through 10-3-16 (date of report). No fever, no other SXS. Tried naproxen, little relief, tried heat and cold, short term relief. Advised physician visit to patient.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Injection site redness. Stayed almost 4-5 days. Patient is ok.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Myalgia, Pain in extremity
Clinical narrative: Very sore arm, below injection site, around muscle and tightness and throbbing, tried ibuprofen and used ice, no welt on injection but warmness.
Age: 57.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Hot flush, Mobility decreased, Pain in extremity
Clinical narrative: Monday received shot, woke up with chills, hot flashes, arm really sore could barely lift it. Getting better now.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Balance disorder, Nausea, Vertigo
Clinical narrative: About 12 hours after receiving vaccine he reports sudden onset vertigo. Some nausea. Felt off-balance.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Chest pain, Headache, Injection site swelling, Insomnia, Lip swelling
Clinical narrative: PNEUMOVAX was injected rapidly into my right arm, and almost immediately my arm swelled from the elbow up (3x the normal size). In addition, it has affected my breathing, and led to chest pain, severe headaches, and swelling of my lips. It was also very painful. I was up all night and got no rest. The pharmacy was overloaded (1 pharmacist) and no after care/supportive care was offered by the pharmacist.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Respiration abnormal
Clinical narrative: PNEUMOVAX was injected rapidly into my right arm, and almost immediately my arm swelled from the elbow up (3x the normal size). In addition, it has affected my breathing, and led to chest pain, severe headaches, and swelling of my lips. It was also very painful. I was up all night and got no rest. The pharmacy was overloaded (1 pharmacist) and no after care/supportive care was offered by the pharmacist.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: (L) upper arm, redness, cellulitis; minimal tenderness; ROM good. Warm compresses x oral antibiotics.
Age: 46.0
Sex: M
Vaccine: FLUX
Symptoms: Grip strength decreased, Guillain-Barre syndrome, Muscular weakness, Vaccination complication
Clinical narrative: Patient received influenza vaccine 9/30/16 and developed decreased grip strength in left arm starting the following morning. Later in the day on 10/1/16, patient developed decreased right arm grip strength. Patient was hospitalized and on 10/2/16, patient noticed weakness in left quadricep. Patient was ultimately diagnosed and treated for Guillain-Barre Syndrome that was thought likely secondary to the influenza vaccine.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Back pain, Dyspnoea, Injection site erythema, Nausea, Throat tightness
Clinical narrative: Patient seen in Emergency department for sensation of throat tightness. Mild shortness of breath. Nausea and back pain starting 4 hours after receiving flu shot. Similar reaction last year after vaccine. Mild erythema around shot injection site. ED diagnosis: Reaction to influenza immunization.
Age: 29.0
Sex: F
Vaccine: FLU4, TDAP
Symptoms: Vaccination complication
Clinical narrative: Patient seen in Emergency department for sensation of throat tightness. Mild shortness of breath. Nausea and back pain starting 4 hours after receiving flu shot. Similar reaction last year after vaccine. Mild erythema around shot injection site. ED diagnosis: Reaction to influenza immunization.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash
Clinical narrative: Rash across forehead, buttocks, elbows, knees, palms of hands, soles of feet; itching.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Arthralgia, Hypoaesthesia, Pain in extremity, Pruritus, Rash
Clinical narrative: Rash across forehead, buttocks, elbows, knees, palms of hands, soles of feet; itching.
Age: 64.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Rash pruritic
Clinical narrative: Rash across forehead, buttocks, elbows, knees, palms of hands, soles of feet; itching.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Skin discolouration
Clinical narrative: Customer received Flu vaccination on 9/27/2016. Broke out in painful rash 9/28/2016 on right shoulder and neck, 9/30 rash spreading to other extremities. Painful darkening rash.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient came in 10/7/16. Had reaction to FLUZONE-HD. Arm got red and itchy at injection site.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Right deltoid arm/3 cm erythema/tender on 9/29-9/30/16.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large, red swollen bump around injection site starting the day after admin in the morning. Patient received KEFLEX as treatment.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Syncope
Clinical narrative: Patient received FLUARIX PFS flu shot in left arm. After vaccine patient felt light headed and fainted. Stated she had not eaten in the morning. BP was taken 136/93, 132/92, 126/82. Gave orange soda, chocolate and peanut butter cracker to help increase blood sugars.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLUC4, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Right anterior thigh with a 6-7 cm area of erythema, slight warmth to touch, and slightly indurated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLUC4, MMR, VARCEL
Symptoms: Local swelling, Swelling face
Clinical narrative: Mother called our office on 9/30/16 stating that patient was having facial/neck swelling. They were sent to the ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMR, VARCEL
Symptoms: Presyncope, Vomiting
Clinical narrative: Vomiting and vasovagal reaction.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen and warm to touch at injection site. Swelling size about the size of baseball shadow. Advised to use BENADRYL and cool packs.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling, Rash, Skin warm, Tenderness
Clinical narrative: Left arm red, warm rash, swelling, tenderness.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Flu vaccine given Tues 10/4/16. Thursday AM area of injection red, warm and painful to touch. At examination, area approximately 3-4 in in diameter with erythema, swelling and pain. No fever. Treated with Cephalexin. NP.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient stated that her arm was sore for over two weeks and that she could not reach her arm behind her back because it was too sore.