chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Peripheral swelling, Skin warm
Clinical narrative: Swelling of Right arm into Right breast along with neck and ear pain. Redness and extremely hot to the touch. Unable to move arm. Went to Dr. on 11/09/16 and was given Amoxicillin.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Crying, Disturbance in attention, Dyskinesia, Enuresis, Feeling hot
Clinical narrative: Mom and Dad reported child woke up crying, hot, acted like he couldn't focus on them. Bed was wet. Child was stiff and jerking a little bit.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Musculoskeletal stiffness
Clinical narrative: Mom and Dad reported child woke up crying, hot, acted like he couldn't focus on them. Bed was wet. Child was stiff and jerking a little bit.
Age: 1.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Dyskinesia
Clinical narrative: Child developed some episodes of opening his mouth wide like trying to scream but no sound came out lasting for few second within 24 hours of vaccination, total of 5 episodes witnessed by family, lasted with 28 hours of immunization. Reported awake and alert during these episodes.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site swelling, Mental status changes, Pain, Peripheral swelling
Clinical narrative: Son called the morning of 11-9-2016 and reported that patient had redness and swelling of right arm. She also had AMS and was playing in food; when pt was brought into office she did have swelling of Rt arm (upper) and was complaining of all over body pain, slight fever, after evaluation she was sent to ER later was admitted and Dx with UTI.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia, Urinary tract infection
Clinical narrative: Son called the morning of 11-9-2016 and reported that patient had redness and swelling of right arm. She also had AMS and was playing in food; when pt was brought into office she did have swelling of Rt arm (upper) and was complaining of all over body pain, slight fever, after evaluation she was sent to ER later was admitted and Dx with UTI.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Blood creatinine normal, Blood potassium increased, Blood sodium normal, Blood urea normal, Echocardiogram
Clinical narrative: Following vaccine, went to store, noticed vision went "while" looked down, lights seemed bright. Next he knew, paramedics were there. Wife received call from "nurse" at store stating he had grand mal seizure lasting 2-3 min. Pt with no previous history of seizure. This occurred within 20-30 min of vaccine.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Generalised tonic-clonic seizure, Haemoglobin normal, Photophobia, Visual impairment, White blood cell count normal
Clinical narrative: Following vaccine, went to store, noticed vision went "while" looked down, lights seemed bright. Next he knew, paramedics were there. Wife received call from "nurse" at store stating he had grand mal seizure lasting 2-3 min. Pt with no previous history of seizure. This occurred within 20-30 min of vaccine.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Pain in extremity
Clinical narrative: PATIENT STATES ENTIRE ARM PAIN, BURNING.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Cold sweat, Fatigue, Tenderness
Clinical narrative: Patient states the evening of the vaccination she noticed symptoms such as cold sweats, fatigue. Patient reported to the pharmacy today (11/10/2016) that she is still experiencing "tenderness" in her left arm that she received the Pneumovax-23 vaccine in. Patient states she thinks it has improved since she received the vaccine ~2 weeks ago, and does not affect her daily tasks.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Patient received expired Zostavax, expired 10/6/2016.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: Right arm swelling, redness, and warmth.
Age: 15.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Syncope
Clinical narrative: Syncope Severe headache.
Age: 56.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Blister, Cellulitis, Injected limb mobility decreased, Injection site induration, Injection site nodule
Clinical narrative: Left arm began swelling and was becoming hot to the touch on the evening of 10/28/16. Pt applied ice. On 10/29/16, the swelling increased and blisters began to appear. Pt went to the ER was given antibiotics and sent home.  On 10/30/16, condition worsened with swelling from shoulder to the wrist and pt was unable to bend elbow and blisters worsening.  Pt went back to the ER, BP was 206/109 and her temperature was 103 degrees.  She was diagnosed with Cellulitis and placed on more antibiotics.  She was seen on 10/31/16 by her private physician who did an ultrasound on a hard knot that was present at the injection site, to r/o infection. By 11/1/16, the swelling was decreasing and the blisters were healing.
Age: 56.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site swelling, Peripheral swelling, Skin warm, Ultrasound scan
Clinical narrative: Left arm began swelling and was becoming hot to the touch on the evening of 10/28/16. Pt applied ice. On 10/29/16, the swelling increased and blisters began to appear. Pt went to the ER was given antibiotics and sent home.  On 10/30/16, condition worsened with swelling from shoulder to the wrist and pt was unable to bend elbow and blisters worsening.  Pt went back to the ER, BP was 206/109 and her temperature was 103 degrees.  She was diagnosed with Cellulitis and placed on more antibiotics.  She was seen on 10/31/16 by her private physician who did an ultrasound on a hard knot that was present at the injection site, to r/o infection. By 11/1/16, the swelling was decreasing and the blisters were healing.
Age: 50.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site coldness, Injection site pain, Musculoskeletal discomfort, Pain
Clinical narrative: She stated that she experienced some numbness to the tips of her fingers on her left hand. She stated she felt a dull pain and coldness to the deltoid area down to her elbow area on her left arm. She stated she had discomfort to the left side of her neck at her shoulder area. Ice pack applied.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain, Peripheral swelling
Clinical narrative: Arm got red and very swollen. Redness extended to back and top of chest. Also got painful.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Areflexia, Chest X-ray abnormal, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture abnormal
Clinical narrative: Lower extremity weakness, associated with areflexia in an ascending pattern - admitted to  Hospital on 11/6/16 with diagnosis of Guillain-Barre Syndrome and being with treated with IVIG, Neurontin and Motrin Remains inpatient to date.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging spinal abnormal, Nuclear magnetic resonance imaging thoracic abnormal
Clinical narrative: Lower extremity weakness, associated with areflexia in an ascending pattern - admitted to  Hospital on 11/6/16 with diagnosis of Guillain-Barre Syndrome and being with treated with IVIG, Neurontin and Motrin Remains inpatient to date.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Patient complained of Nausea after influenza vaccine was given.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Headache, Presyncope
Clinical narrative: Near syncopal episode with generalized weakness and c/o headache.
Age: 15.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMR, TD, VARCEL
Symptoms: Adverse reaction
Clinical narrative: I was only the MA who administer vaccines. PSR informed RN's of pt reactions. The RN's took over, so I don't know what was the reactions of the PT.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling
Clinical narrative: Swelling and pruritis.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Injection site rash, Pain, Peripheral swelling
Clinical narrative: Chills, body aches on Friday then Wednesday evening arm swelled and had 6 cm red, hot bump at injection site.
Age: 58.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Blood pressure increased, Head discomfort, Limb discomfort, Mobility decreased, Pallor
Clinical narrative: 5 minutes post Hep B vaccination arm felt heavy, fingers tingled, and head didn't feel right.  Patient called a co-worker to her office who called nurses to assess patient. Nurses said her face was pale white and her arm was shaking.  Nurse took blood pressure every couple of minutes.  It went as high as 190/110.  Patient fainted and slid from chair onto the floor with assistance from the nurse.  EMS was called.  Patient does not recall regaining consciousness until EMS arrived and was rubbing her sternum.  EMS transported patient to the Emergency Room for further treatment.  Patient reported that she was not given any medication at ED but was observed.  While she was there she reported that she couldn't move her legs for several hours. Finally when she was able to move her legs, she was discharged home.  ED recommended rest and plenty of fluids. Patient reported that she feels pretty good today (1 day post vaccination).
Age: 58.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Paraesthesia, Syncope, Tremor
Clinical narrative: 5 minutes post Hep B vaccination arm felt heavy, fingers tingled, and head didn't feel right.  Patient called a co-worker to her office who called nurses to assess patient. Nurses said her face was pale white and her arm was shaking.  Nurse took blood pressure every couple of minutes.  It went as high as 190/110.  Patient fainted and slid from chair onto the floor with assistance from the nurse.  EMS was called.  Patient does not recall regaining consciousness until EMS arrived and was rubbing her sternum.  EMS transported patient to the Emergency Room for further treatment.  Patient reported that she was not given any medication at ED but was observed.  While she was there she reported that she couldn't move her legs for several hours. Finally when she was able to move her legs, she was discharged home.  ED recommended rest and plenty of fluids. Patient reported that she feels pretty good today (1 day post vaccination).
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging, Periarthritis
Clinical narrative: Evaluated on 9/29/2016. Woke up with Shooting, Severe Shoulder pain. Took Ibuprofen 600 mg for pain control. Seen again on 10/28/16, Over 4 weeks developed decreased range of motion, worsening pain, adhesive capsulitis symptoms. Sent for MRI, results pending.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Full body rash (still evident 6 days later).
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Hyperhidrosis, Malaise, Pain
Clinical narrative: I suddenly became very ill with a respiratory infection. Symptoms include coughing, fevers, chills, sweats, body aches, and a rash.
Age: 22.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rash, Respiratory tract infection
Clinical narrative: I suddenly became very ill with a respiratory infection. Symptoms include coughing, fevers, chills, sweats, body aches, and a rash.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Nausea
Clinical narrative: Participant became nauseated and blood pressure increased 147/96 "stated eggs cause her to be nauseated".
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient went to pharmacy on 11/9/16 complaining of raised red area approx. 3" in diameter around injection site and a radiating pain in arm to scapular area. RPh on duty asked when it started and if she had been doing anything to treat symptoms. Patient stated she had been icing the area. RPh told patient to continue icing and take NSAIDS if not contraindicated. He then drew a circle around the perimeter and told her that if it got worse to seek medical attention.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chapped lips, Injection site erythema, Lip exfoliation, Lip swelling, Oral discomfort
Clinical narrative: A few hours after receiving her second GARDASIL injection, her arm became red from shoulder to elbow and her lips began to swell. She took Benadryl. The next morning 10/10/16, her swelling had decreased, but her lips now feel chapped/peeling and has a burning sensation inside of her mouth.
Age: 21.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chapped lips, Erythema, Lip swelling, Oral discomfort
Clinical narrative: A few hours after receiving her second GARDASIL injection, her arm became red from shoulder to elbow and her lips began to swell. She took Benadryl. The next morning 10/10/16, her swelling had decreased, but her lips now feel chapped/peeling and has a burning sensation inside of her mouth.
Age: 2.0
Sex: M
Vaccine: DTAPIPV, HEPA, PNC13
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received KINRIX for their Dtap and Polio at the age of 2.
Age: 19.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Dizziness, Presyncope
Clinical narrative: This is a spontaneous report from a contactable healthcare professional received via a sales representative. A 19-year-old male patient of an unspecified race received TRUMENBA)(Lot # M37316; Exp. date Apr2017) at 0.5 ml single and human papilloma vaccine (Lot # M003659, Exp. date 20Sep2017), both intramuscular on 12Jul2016 for immunisation.  The patient medical history and concomitant medications were not reported. The patient almost passed out on an unspecified date after vaccinations. He elevated his legs and felt better. The event was resolving at time of report. On 12Jul2016, the patient experienced vasovagal near syncope with outcome of recovered. Treatment was not required. Follow-up attempts completed. No further information expected. Follow-up (03Nov2016): New information obtained from a contactable other HCP includes: Patient's date of birth, vaccines details, additional event (Vasovagal near syncope), onset and outcome, no treatment. Follow-up attempts completed. No further information expected. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a contactable consumer. A 69-year-old female patient of unspecified ethnicity received pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) (TRADE NAME UNSPECIFIED; Lot number unknown), via an unspecified route of administration, in 2005, as single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pneumonia. The clinical course was reported as follows: a 69-year old patient received a "pneumonia shot" (brand name unknown) in 2005; then the patient got pneumonia on an unspecified date. The outcome of pneumonia was unknown. Pfizer is a marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Age: 73.0
Sex: M
Vaccine: PNC13
Symptoms: Cardiac arrest, Death
Clinical narrative: This is a spontaneous report from a contactable health care professional received via a Pfizer sales representative. A 73-year-old male patient received single dose of PREVNAR 13, via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced cardiac arrest 30 minutes after vaccination and died on an unspecified date.  It was not reported if an autopsy was performed. Sender's Comments: The information available in this report is limited and does not allow a medically meaningful assessment of the case. In particular, the following relevant information is not available: medical history and concomitant medications. This case will be reassessed when additional information becomes available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Reported Cause(s) of Death: Cardiac arrest.
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pyrexia
Clinical narrative: This is a spontaneous report from a non-contactable consumer reporting for her mother in law. This female patient of an unspecified age, race and ethnicity received a single dose of PREVNAR 13 via an unspecified route of administration on an unspecified date for immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date after the vaccination the patient was achy and she had fever. Outcome was unknown. The reporter considered these conditions as adverse events to the vaccine and she believed that they were know side effects from the vaccine. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Headache, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. A 75-year-old female patient received PREVNAR 13, via an unspecified route of administration in right shoulder up high, on 01Nov2016, at single dose, for immunisation. Medical history included ongoing dyspepsia, ongoing anxiety, ongoing blood pressure and neck injury. Concomitant medication included PROTONIX tablet, from a few years and ongoing, at 40 mg 2x/day (one in morning before she eats and one at night before she eats), for indigestion; atenolol tablet, from quite a long time and ongoing, at 25 mg 1x/day (1/2 tablet now, before a tablet), for blood pressure; XANAX 0.25 mg tablet, 1 DF (dosage form) 2x/day, as needed and vitamins (unspecified trade name), from an unspecified date and ongoing, daily. Patient's height was about 5-2 (unit not provided) and weight about 138 (unit not provided). The patient experienced arm hurt for couple of days on an unspecified date with outcome of unknown, headache in Nov2016 with outcome of recovering and red spot on arm on 06Nov2016 with outcome of recovering. Therapeutic measures were taken as a result of arm hurt for couple of days and red spot on arm and included treatment with BENADRYL and hot and cold compresses.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Biopsy, Injection site infection
Clinical narrative: This is a spontaneous report from a contactable lawyer. A 65 year old male patient received PREVENAR 13 in late Sep2016 at single dose in left shoulder for pneumonia immunization, and influenza vaccine (FLU VACCINE VII) in right shoulder. Medical history and concomitant medication were not reported. In Oct2016, two weeks after getting the shot, the patient experienced left shoulder at the injection site seriously infected. The patient was seen by a facility that is not primary care physicians, but at an urgent care facility. He saw several urgent care doctors at a facility and was prescribed the antibiotics that didn't work. Patient went to a dermatologist about 10 days ago and had a biopsy done on 31Oct2016 waiting to get results from a lab as to what antibiotics might best be used to fight this infection. The patient has tried numerous antibiotics that did not work. Stated the names of the antibiotics might not be the precise name, but the name as the patient gave. These were KEFLEX, BACTRIM, Amoxicillin, and two other shots which he doesn't know whether they were antibiotic shots or not. Caller has no information on any of these products. At the time of the report the outcome was not recovered but mildly worsened.
Age: 15.0
Sex: M
Vaccine: MENB
Symptoms: Eczema, Eczema eyelids, Rash generalised
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of his son. A 15-year-old male patient of an unspecified race received TRUMENBA, first single dose on 05Apr2016, second single dose on 26Jul2016, each via an unspecified route of administration, for immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. After the first vaccination, sometime in May2016, he got a little bit of eczema around his eyes and on his arm. Then on 26Jul2016 he had the second vaccination and after a few weeks he got really bad eczema around both eyes, on his face, and arm. His body also had all these little bumps that came out. He went to see the family doctor who said it was eczema and gave him an unspecified ointment, but it did not help. Then they went to a dermatologist who gave him some ointment and it helped a little bit, but not much. Then he got a hormone shot to control the situation. At the time of report he had some eczema around his eyes. The reporter considered his son has some kind of allergy to the vaccine. It was on his eye lashes, arms and body, but most severe on his eyes and arms. It was now time for his third dose.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Skin warm, Swelling
Clinical narrative: Redness, swelling, some induration and warmth. Pneumococcal vaccine is worse than the shingles reaction.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose increased, Confusional state, Dizziness, Hyperhidrosis, Malaise
Clinical narrative: Stated one of the ladies wasn't feeling well so I had her bring back to me. Patient c/o right arm tingling, sweating, itching, dizzy, confused ashen in color b/p taken 145/92; 11:30 .5 ml (500 mg) epinephrine given by right thigh 911 called b/p 165/112 hr 86 ems arrived 11:50 b/p 145/92 hr 82 patient said she had not  taken her B/P metformin this am random bld sugar 225 (she had a biscuit and coffee at 6:00 am. Patient refused and signed AMA consent to be taken to ER.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Pallor, Paraesthesia, Pruritus
Clinical narrative: Stated one of the ladies wasn't feeling well so I had her bring back to me. Patient c/o right arm tingling, sweating, itching, dizzy, confused ashen in color b/p taken 145/92; 11:30 .5 ml (500 mg) epinephrine given by right thigh 911 called b/p 165/112 hr 86 ems arrived 11:50 b/p 145/92 hr 82 patient said she had not  taken her B/P metformin this am random bld sugar 225 (she had a biscuit and coffee at 6:00 am. Patient refused and signed AMA consent to be taken to ER.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Fatigue, Myalgia, Vaccine positive rechallenge
Clinical narrative: Weak, Dizzy, Fatigue, Muscle ache vomited X 1 this lasted for 4 days.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Weak, Dizzy, Fatigue, Muscle ache vomited X 1 this lasted for 4 days.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, fluid, very red, hot to touch. This was few inches below injection site extending to only to elbow.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTS PAIN/SWELLING/REDNESS AT INJECTION SITE. STILL HAS FULL RANGE OF MOTION IN ARM AND HANDS.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Dyspnoea, Vision blurred
Clinical narrative: At 11:55 am Pt began to feel dizziness. Pt was unsure if it was due to her not eating so she did not notify provider. At 1:30 pm Pt contacted clinic with c/o worsening dizziness and difficulty catching her breath. I spoke to Dr. and he recommended for Pt to come in to be evaluated. Upon arrive at around 1:45pm Pt began to complain of blurry vision. Pt then evaluated by Dr.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Rash
Clinical narrative: Patient c/o she felt funny and had a rash on her chest and shoulders.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Rash pruritic
Clinical narrative: ITCHY RASH ON RIGHT ARM.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Injection site erythema, Injection site pruritus
Clinical narrative: Red around injection site, chills, injection site itchy.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pain
Clinical narrative: Patient stated she felt achy and lightheaded.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Discomfort, Dysphagia, Dysphonia, Dyspnoea, Feeling hot
Clinical narrative: Throat swelling, pressure, heat, difficulty swallowing, raspy voice. Difficulty breathing when laying down. Lungs clear. Benadryl 50 mg. ER Solumedrol injection. Still taking Benadryl next day symptoms less but persisting.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Pharyngeal oedema
Clinical narrative: Throat swelling, pressure, heat, difficulty swallowing, raspy voice. Difficulty breathing when laying down. Lungs clear. Benadryl 50 mg. ER Solumedrol injection. Still taking Benadryl next day symptoms less but persisting.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Dry eye, Dyspepsia, Fatigue, Headache
Clinical narrative: Headache, fatigue, dry eyes, heartburn/sour stomach, fever and chills.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperchlorhydria, Pyrexia
Clinical narrative: Headache, fatigue, dry eyes, heartburn/sour stomach, fever and chills.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Induration, Injection site erythema, Injection site pain, Skin warm
Clinical narrative: Site reaction red, tender to touch, burning sensation, 3x3 margins, hard, warm to touch in right arm.
Age: 41.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Chills, Differential white blood cell count, Full blood count, Headache, Lipase
Clinical narrative: Chief Complaint: FEVER, CHILLS, MUSCLE ACHES, VOMITING and HEADACHE. (41 yo M, no significant PMH, presenting with concerns for fever, chills, muscle stiffness, fatigue, bitemporal headaches and vomiting one day s/p anthrax vaccination. Pt reports after having vaccination, his L arm felt stiff. He went playing water polo and upon waking this morning he felt fatigued. Endorsed some fever and chills. Reports about 6 episodes of non bloody emesis this evening after dinner with bitemporal headaches and photophobia. Pt denies any recent sick contacts, diarrhea or constipation, prior hx of headaches. Denied any itchiness, wheals or wheezing after having vaccine.).  This started yesterday and is still present. It was gradual in onset and has been constant. At its maximum, severity described as moderate. When seen in the E.D., severity described as moderate. Modifying factors. Not worsened by anything. Not relieved by anything. No loss of appetite or weight loss. He has had a headache, fatigue, muscle aches and generalized weakness. He has had visual disturbance (photosensitivity). No decreased urine output. Similar symptoms previously. None. Recent medical care: The patient was seen recently in the emergency department.
Age: 41.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Metabolic function test, Myalgia, Photophobia, Photosensitivity reaction, Pyrexia
Clinical narrative: Chief Complaint: FEVER, CHILLS, MUSCLE ACHES, VOMITING and HEADACHE. (41 yo M, no significant PMH, presenting with concerns for fever, chills, muscle stiffness, fatigue, bitemporal headaches and vomiting one day s/p anthrax vaccination. Pt reports after having vaccination, his L arm felt stiff. He went playing water polo and upon waking this morning he felt fatigued. Endorsed some fever and chills. Reports about 6 episodes of non bloody emesis this evening after dinner with bitemporal headaches and photophobia. Pt denies any recent sick contacts, diarrhea or constipation, prior hx of headaches. Denied any itchiness, wheals or wheezing after having vaccine.).  This started yesterday and is still present. It was gradual in onset and has been constant. At its maximum, severity described as moderate. When seen in the E.D., severity described as moderate. Modifying factors. Not worsened by anything. Not relieved by anything. No loss of appetite or weight loss. He has had a headache, fatigue, muscle aches and generalized weakness. He has had visual disturbance (photosensitivity). No decreased urine output. Similar symptoms previously. None. Recent medical care: The patient was seen recently in the emergency department.
Age: 41.0
Sex: M
Vaccine: ANTH, FLU4
Symptoms: Urine analysis, Visual impairment, Vomiting
Clinical narrative: Chief Complaint: FEVER, CHILLS, MUSCLE ACHES, VOMITING and HEADACHE. (41 yo M, no significant PMH, presenting with concerns for fever, chills, muscle stiffness, fatigue, bitemporal headaches and vomiting one day s/p anthrax vaccination. Pt reports after having vaccination, his L arm felt stiff. He went playing water polo and upon waking this morning he felt fatigued. Endorsed some fever and chills. Reports about 6 episodes of non bloody emesis this evening after dinner with bitemporal headaches and photophobia. Pt denies any recent sick contacts, diarrhea or constipation, prior hx of headaches. Denied any itchiness, wheals or wheezing after having vaccine.).  This started yesterday and is still present. It was gradual in onset and has been constant. At its maximum, severity described as moderate. When seen in the E.D., severity described as moderate. Modifying factors. Not worsened by anything. Not relieved by anything. No loss of appetite or weight loss. He has had a headache, fatigue, muscle aches and generalized weakness. He has had visual disturbance (photosensitivity). No decreased urine output. Similar symptoms previously. None. Recent medical care: The patient was seen recently in the emergency department.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Light pink round area about 1 inch in diameter around injection site. No pain, no itching, no swelling.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC
Symptoms: Asthenia, Feeling cold, Pyrexia
Clinical narrative: Fever, chills, weakness.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Cellulitis, Culture, Inflammation, Pyrexia
Clinical narrative: Much information is stated from patient and what was presented to pharmacist who administered the vaccination. Patient said they had gone to dermatologist on 11/07/2016 having fever and dermatologist diagnosed as cellulitis in right lower leg. Dermatologist told patient after counseling that could come from contaminated vial or technique. Patient stated that they visited the hospital. Patient showed injection site to pharmacist and no swelling or redness detected. Patient said had mild inflammation after injection. Upon visual inspection none noticed. Patient then saw dermatologist on 11/7/2016 for treatment and obtained 3 prescription medications which were filled at same location. Patient stated developed allergic reaction from one medication and contacted prescriber and was changed to another antibiotic on 11/08/2016.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Blepharospasm, Immediate post-injection reaction, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reports that immediately after injection her right eye "was twitching." She went home and within 2 hours both eyes were "severely twitching" the injection site was red, hot and swollen and very painful. She states symptoms lasted for about 3 days. She was in clinic today (11/10/16) and said she can still feel bump at injection site.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: Patient reports that immediately after injection her right eye "was twitching." She went home and within 2 hours both eyes were "severely twitching" the injection site was red, hot and swollen and very painful. She states symptoms lasted for about 3 days. She was in clinic today (11/10/16) and said she can still feel bump at injection site.
Age: 64.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Injection site pain, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: RIGHT ARM SORENESS FROM SHOULDER TO ELBOW TO HAND SWELLING AND PAIN. SEVERE ENOUGH TO REDUCE SLEEP.
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Mobility decreased
Clinical narrative: Patient says numbness in hands and could not move for a week.
Age: 32.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Cough, Decreased appetite, Nausea, Pyrexia
Clinical narrative: Minor cough starting around 8:00PM. Chills and minor fever (100F) developed by 11:00PM. By 1:00AM (10/20/2016) I had developed significant nausea but did not vomit. I was nauseous for approximately 3-4 hours. Over the course of the day after vaccination I had loss of appetite and some nausea, but never vomited.
Age: 71.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity
Clinical narrative: Patient said that he received 2 vaccinations on 10/27/16 and said his arm was sore afterwards and started to get better but is still sore.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Pain in extremity
Clinical narrative: Pt stated her arm started hurting the night after getting her flu shot and experienced intense pain for at least 3 days following. Treatment limited to OTC analgesics. Complained that the pain has been persistent and she experienced weakness in the affected arm.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient was administered vaccine 10/08/16, and came into pharmacy 11/10/16 complaining of pain at the injection site and throughout arm, despite it being over a month later.
Age: 77.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient described swollen, painful arm associated with redness a few hours after getting the vaccine. Received MEDROL Dose Pak and CIPRO from physician.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Burning sensation, Chills, Erythema, Headache
Clinical narrative: Lump raised and progressively spread, red warm painful, approximately 8pm consulted with a pharmacist took BENADRYL and ZYRTEC, burning sensation across chest stomach thighs redness continued to spread along with pain in forearm approximately 5pm visited urgent care on 11/5/16 6cm by 6cm reaction of redness in addition to swelling and pain prescribed PEPCID in addition to BENADRYL And ZYRTEC severe headache began 11/7/16 continued pain muscle ache weakness, chills  headache 11/9/16 followed up with Dr prescribed mobid and SUDAFED swelling still present but mild still pain and weakness in arm and fluid ears, chills.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Mass, Middle ear effusion, Muscular weakness, Myalgia, Pain
Clinical narrative: Lump raised and progressively spread, red warm painful, approximately 8pm consulted with a pharmacist took BENADRYL and ZYRTEC, burning sensation across chest stomach thighs redness continued to spread along with pain in forearm approximately 5pm visited urgent care on 11/5/16 6cm by 6cm reaction of redness in addition to swelling and pain prescribed PEPCID in addition to BENADRYL And ZYRTEC severe headache began 11/7/16 continued pain muscle ache weakness, chills  headache 11/9/16 followed up with Dr prescribed mobid and SUDAFED swelling still present but mild still pain and weakness in arm and fluid ears, chills.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Skin warm, Swelling
Clinical narrative: Lump raised and progressively spread, red warm painful, approximately 8pm consulted with a pharmacist took BENADRYL and ZYRTEC, burning sensation across chest stomach thighs redness continued to spread along with pain in forearm approximately 5pm visited urgent care on 11/5/16 6cm by 6cm reaction of redness in addition to swelling and pain prescribed PEPCID in addition to BENADRYL And ZYRTEC severe headache began 11/7/16 continued pain muscle ache weakness, chills  headache 11/9/16 followed up with Dr prescribed mobid and SUDAFED swelling still present but mild still pain and weakness in arm and fluid ears, chills.
Age: 16.0
Sex: F
Vaccine: MEN
Symptoms: Rash, Tenderness
Clinical narrative: Tenderness and rash.
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Burning sensation, Eczema, Nail matrix biopsy, Pain, Pruritus
Clinical narrative: Vesicular rash starting in hands and spreading to whole body with itching, burning, body aches, fever. Hospitalized 9/20/16-9/23/16.  Biopsy of rash "spongiotic dermatitis with frequent eosinophils."
Age: 65.0
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Rash generalised, Rash vesicular, Red blood cell sedimentation rate increased
Clinical narrative: Vesicular rash starting in hands and spreading to whole body with itching, burning, body aches, fever. Hospitalized 9/20/16-9/23/16.  Biopsy of rash "spongiotic dermatitis with frequent eosinophils."
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Blindness, Guillain-Barre syndrome, Hypoaesthesia, Immunoglobulin therapy, Lumbar puncture
Clinical narrative: Approximately 2 weeks after vaccine I experienced numbness in extremities, severe pain, loss of vision. I was diagnosed with GBS at 3 weeks after vaccine. I received IVIG.
Age: 41.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pain
Clinical narrative: Approximately 2 weeks after vaccine I experienced numbness in extremities, severe pain, loss of vision. I was diagnosed with GBS at 3 weeks after vaccine. I received IVIG.
Age: 13.0
Sex: M
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Wrong patient received medication
Clinical narrative: Patient was given PENTACEL vaccine by mistake, it was intended for his nephew. Child was severe static encephalopathy Ex preemie 24 weeks.
Age: 69.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient called office on 11-3-16 in AM stating she has swelling in the arm in which she received her flu shot. Arm also red. Pt. denies visit to see the doctor recommended warm compress, TYLENOL. patient to call office for fever, increase in swelling, redness, pain.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Vomiting
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of abdominal pain in a 28-year-old female patient who received FLUARIX QUADRIVALENT. On an unknown date, less than a year after receiving FLUARIX QUADRIVALENT, the patient experienced abdominal pain and vomiting. On an unknown date, the outcome of the abdominal pain and vomiting were recovered/resolved. It was unknown if the reporter considered the abdominal pain and vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not associated with a QA complaint. The registered nurse (RN) reported that the patient (an employee) had an adverse event to last year's FLUARIX QUADRIVALENT. The patient claimed that she had abdominal pain and vomiting for 3 months after vaccination. The nurse reported that the patient did not want to received FLUARIX vaccine of the reporting year due to her last year's reaction. The reported batch number (32TN) of FLUARIX QUADRIVALENT did not exist and was updated to 329TN as per sales database).
Age: 81.0
Sex: M
Vaccine: FLUX, PPV
Symptoms: Joint swelling, Musculoskeletal pain
Clinical narrative: This initial report was received from a 81 year old male patient with drug allergy to morphine (manufacturer unknown), codeine derivatives, penicillin, lisinopril (manufacturer unknown), clindamycin HCL, hydrochlorothiazide and LIPITOR. The patient's concomitant therapies included an unspecified medication and an unspecified flu vaccine applied in his right arm. The patient did not have pertinent medical history. On 04-NOV-2016, the patient was vaccinated with PNEUMOVAX 23, 0.5 ml dose, intramuscular route, expiration date 03-NOV-2017 (strength and lot number were not reported). On 07-NOV-2016, also reported as 3 days after vaccination, the patient experienced swelling on his left elbow and soreness in his left shoulder. The patient did not seek medical attention, received treatment for the events and no laboratory test were performed. At the reporting time, the patient was recovering from joint swelling and musculoskeletal pain. The reporter did not assess the causal relationship between the reported events and therapy with PNEUMOVAX 23. This is one of several reports for the same patient (1611USA004990 and 1611USA004989). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Phone call from Mom, reporting that patient's arm is red, hot to touch and swollen from shoulder to elbow. Advised ice to arm, MOTRIN or TYLENOL and to monitor.
Age: 41.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Dizziness, Hypoaesthesia, Immediate post-injection reaction, Injection site pruritus, Skin warm
Clinical narrative: Following Hep A vaccination pt immediately reported that her chin felt warm and numb, she stated that she felt dizzy, and localized itching at site. Cold compresses pack was placed at the injection site, Pt was monitored and assessed for about 24 minutes and instructed to call us if symptoms persist.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Flu shot received in (L) arm on Monday 10/24/16. On Tuesday morning above individual had severe pain in left hip area. Pain has lessened each day but still exists on day 5. Recovered by day 7.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Rash, Swelling
Clinical narrative: Rash down side of arm; red and raised.
Age: 52.0
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Injection site pain
Clinical narrative: Administration cause her pain, and went to ER. She is saying physical therapy is now required.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Feeling abnormal, Flushing
Clinical narrative: Patient received Flu shot and within a few minutes he state he felt "off" and had trouble breathing. Patient appeared flushed and sat down and started to feel better. We called 911 and patient was taken by ambulance to hospital.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Rash macular, Soft tissue swelling
Clinical narrative: 11/3 flu vaccine (L) arm. 11/5 required emergency visit for marked soft tissue swelling with splotchy areas of erythema extending up over the shoulder and down to the AC joint.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Flushing, Headache, Influenza like illness, Pain
Clinical narrative: C/O flu like symptoms about 4 hours after receiving flu vaccine. 3 days of body aches. No documented fever, felt flushed, HA top of head.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Redness, fever on the arm where the injection was.
Age: 11.0
Sex: F
Vaccine: FLU4, HEPA, HPV9, MNQ
Symptoms: Asthenia
Clinical narrative: The patient began to feel weak after she received vaccines. No syncope. Patient lied down and recovered well.
Age: 10.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Erythema, Skin warm
Clinical narrative: Mom states deltoid warm to touch with redness after receiving vaccines. Redness extended from elbow to shoulder. No treatment needed.
Age: 69.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Body temperature increased, Fatigue, Feeling cold, Tremor
Clinical narrative: "Four hours after getting vaccinated he started to feel really cold and began shaking. At 6 hours he was very cold, violently shaking and had a temperature of 102.3. I got his temperature down to normal 6 hours later. He was exhausted the next day, but is fine now."
Age: 11.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site swelling
Clinical narrative: Swelling of (L) upper arm at site of injection. No redness, no fever, no resp. S/S, feels fine otherwise - just "huge swelling" of arm.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Crying, Immediate post-injection reaction, Lethargy, Loss of consciousness
Clinical narrative: Pt. received 2 vaccines (HEP A and FLU 6-35 mos) in right thigh, pt. immediately became lethargic, mom observed "blackout". Pt eyes open; after stimulating by touch showed some responsiveness, Dr retrieved, pt. became lethargic again. After approx. 10 sec., crying and responsiveness. Pt. had cried through both vaccines, determined lack of breath was or most likely cause.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site bruising, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt. received FLUZONE QUAD 0.5 ml IM LD on 10/9/16 a.m. Pt. called HD 110716 with C/O (L) shoulder pain and numbness to fingers intermittently - beginning approximately 1 1/2 wks after flu shot. States diff. getting comfortable at rest. Hadn't taken anything for pain until 110716 pm (TYLENOL) that helped some. MD apt 110816 pm.
Age: 80.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site haemorrhage
Clinical narrative: Pt. noticed this a.m. an irregular ecchymotic area distal and anterior on upper left arm approx. 7 cm. No redness or swelling noted at injection site. Encourage warms soaks QID.
Age: 79.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Dizziness, Erythema, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Redness, tenderness, soreness (had to left arm) fever, dizziness. Problem start about 30-40 mins after shot. Medical doctor put patient on antibiotic.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm
Clinical narrative: Pt had itchy and warm to touch on (L) arm on 11-8-16. Pt didn't have redness until today 11-10-16.
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Pain in hand/radiating down arm (using Ibuprofen and heat).
Age: 57.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Drug administered at inappropriate site, Pain in extremity
Clinical narrative: Pain in hand/radiating down arm (using Ibuprofen and heat).
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Gait disturbance
Clinical narrative: Both hip joints were very achy. Employee had trouble walking. She had to lift her foot with her hands in order to dress. Day 2 50% better. Day 3 100% better.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus generalised, Rash
Clinical narrative: Severe allergic reaction Rash and itching over entire body.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Erythema, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Pt developed (L) arm redness, swelling, and stiffness.
Age: 61.0
Sex: F
Vaccine: FLU4, PPV, FLU4, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt developed (L) arm redness, swelling, and stiffness.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Herpes zoster, Laboratory test abnormal
Clinical narrative: Onset of shingles started 24 hrs after administration of flu shot. patient had prev. had shingles and shingles vaccine. Patient was healthy/on a wellness routine (exercise, eating healthy) and active/high energy until 1 day after flu shot.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, PNC13
Symptoms: Croup infectious, Pyrexia
Clinical narrative: Fever to 103.7 post imms 11-7-16. Temp continued and was 100.7 11-9-16.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Light redness on arms/back. No swelling or itching. Does not appear to have gotten any worse since appearing 11/4/16 morning.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site rash, Injection site swelling, Peripheral swelling, Rash
Clinical narrative: FLUZONE HD and PNEUMOVAX 23 were administered on the same day, but in different arms. Patients left arm started swelling the day after administration and a rash was present. Swelling and rash went from upper arm past the elbow.
Age: 72.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site nodule, Injection site pruritus
Clinical narrative: Pt stated developed 2 nodules around injection site and had itching - developed 1 day following injection. Reaction developed in R arm near PREVNAR injection site.