chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Blood glucose, Cold sweat, Dizziness, Hypoglycaemia, Nausea
Clinical narrative: Nausea, cold sweats, dizziness, tinnitis, hypoglycemia (73 5min after event). Symptoms resolved quickly but then returned quickly as well. Took 4mg odt zofran which helped symptoms.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Tinnitus
Clinical narrative: Nausea, cold sweats, dizziness, tinnitis, hypoglycemia (73 5min after event). Symptoms resolved quickly but then returned quickly as well. Took 4mg odt zofran which helped symptoms.
Age: 19.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Dizziness
Clinical narrative: Dizziness-intermittently.
Age: 69.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Insomnia, Poor quality sleep, Pyrexia
Clinical narrative: Gradually started tried feeling and progressed to chills that become serious about 9:00 PM. Went to bed with to get rest and warm with numerous blankets. Did not take temperature but suspect high fever that lasted for about 2 to 3 hours. Continued to have a very restless night and hard to sleep. Took 2 aspirins prior to going to bed.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dysphonia, Dyspnoea, Ocular hyperaemia, Pyrexia
Clinical narrative: Difficulty breathing, hoarseness, red eyes, fever of 101.3, achy joints.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient was administered a flu dose for a child age 3 years and up (0.5mL) instead of a dose appropriate for her age (0.25mL).
Age: 0.33
Sex: M
Vaccine: PNC
Symptoms: Crying, Injection site erythema, Injection site induration, Injection site mass, Insomnia
Clinical narrative: My son received the PREVNAR vaccine at approximately 9:30 am on 10/22/2016.  That evening, patient was unable to sleep throughout the night which is unusual. On the morning of 10/12/2016 I noticed a red mark at the site of the injection and a large, hard lump under his skin approximately the size of a quarter - fifty cent piece. Each night since the vaccine was administered, my son is unable to sleep, and continues to wake up crying. Before the vaccine, my son was a good sleeper, and slept through the entire night (approximately 8-10 hours). I contacted the pediatrician office on 10/12/2016 and was told what type of side effects to look for but was not given an answer as to why he had a hard lump under his skin. The nurse on the phone said it may have been the result of pain. My son is scheduled to have the lump examined today at 3:50 pm.
Age: 11.0
Sex: M
Vaccine: HEP, HEPA, HPV9, IPV, MMR, TDAP
Symptoms: Axillary pain, Cellulitis
Clinical narrative: Cellulitis Right Axillary Fold and Pain. Patient started on a 10 day course of Bactrim.  And to return to see Pediatrician on October 13, 2016. At this time the plan was to continue and finish current treatment and to shower twice a day. And to return if no improvement or sxs worsen.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Cough, Defaecation urgency, Dyspnoea, Laboratory test, Lip swelling
Clinical narrative: Runny nose, coughing, difficulty breathing, need to defecate, lip swelling and chest rash.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Runny nose, coughing, difficulty breathing, need to defecate, lip swelling and chest rash.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Anaphylactic reaction, Cough, Dyspnoea, Pulmonary function test, Rash
Clinical narrative: Runny nose, coughing, difficulty breathing, need to defecate, lip swelling and chest rash.
Age: 6.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL, DTAP, HEPA, IPV, VARCEL
Symptoms: Rhinorrhoea, Swelling face, Wheezing
Clinical narrative: Runny nose, coughing, difficulty breathing, need to defecate, lip swelling and chest rash.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Back pain, Fatigue, Guillain-Barre syndrome, Headache
Clinical narrative: Runny nose, sore throat.  Admitted to hospital 10/7 with back pain, generalized weakness and myalgia, trouble moving hand. Diagnosed with Guillain-Barre.
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Myalgia, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Runny nose, sore throat.  Admitted to hospital 10/7 with back pain, generalized weakness and myalgia, trouble moving hand. Diagnosed with Guillain-Barre.
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Balance disorder, Gait disturbance, Vertigo
Clinical narrative: Vertigo symptom, could not walk straight.  Holding on to walls for balance.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Altered state of consciousness, Fall, Head injury, Syncope
Clinical narrative: Sycopal episode approximately 5 minutes after receiving vaccines. Pt fell backwards landing on floor, hit back of his head. Regained consciousness after approx 30 seconds, no apparent injury. Ice applied to back of head and legs elevated. Provide juice. Pt. complained of headache.Mother planned to take pt into the after hours clinic or call the emergency department if any further care should be given.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Eye discharge, Fatigue, Ocular hyperaemia, Pyrexia
Clinical narrative: Blood shot eyes with white puss coming out of the corner of my eyes.  low grade fever with the shakes.  Extreme fatigue with no appetite.  All activity very difficult - laid in bed.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Tremor
Clinical narrative: Blood shot eyes with white puss coming out of the corner of my eyes.  low grade fever with the shakes.  Extreme fatigue with no appetite.  All activity very difficult - laid in bed.
Age: 68.0
Sex: F
Vaccine: FLUR3
Symptoms: Throat irritation
Clinical narrative: This is an initial report of an AE, received on 11Oct2016, for Protein Sciences FLUBLOK. Subject a 68 year old female, received FLUBLOK Intramuscular on 02Oct2016. On 02Oct2016, approximately six to seven hours after receiving FLUBLOK, the subject developed a sudden onset of an itchy throat that lasted for approximately two to three days and then resolved. She had no difficulty breathing. Medical and surgical history for the subject included multiple allergies and lactose intolerance. Concomitant medications were not reported.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Injury, Paralysis
Clinical narrative: This spontaneous report was received from a patient's mother concerning her 13 years old daughter. The patient's pertinent medical history included urinary tract infection. On an unknown date in 2009, when the patient was taken to the physician's office for urinary tract infection, she was vaccinated with GARDASIL (lot # and expiry date, dosing regimen and frequency unknown). Though she was not brought to physician office for vaccination she was vaccinated and she was harmed. At the time of the report the patient was paralyzed in a hospital. The outcome of the events were reported as not recovered/not resolved. The reporter did not provide the relatedness of the events with GARDASIL. Upon internal review "paralysis" was determined to be medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mom reported onset of 4 inch circular red raised area at site of HPV vaccine. Lasted 1.5 weeks - resolved on its own with no action taken by parent. Reported to provider after resolution.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: The following day after receiving vaccine, developed L delt redness, swelling, tenderness. Used no remedies to relieve.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Papule, Pruritus, Varicella post vaccine
Clinical narrative: 10-15 pruritic erythematous papules, clinically consistent with mild varicella, over thighs, groin, buttocks, penis, scrotum.
Age: 39.0
Sex: F
Vaccine: FLUC4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: I received my flu shot from the company nurse, in my left shoulder. A few minutes after receiving the flu vaccine, my arm was in pain from my shoulder to the top of my hand. The pain radiated down my arm until the evening, and the pain continued until the next morning. As of 10:15 AM the pain seems to be going away, and is not as intense. Vaccine information: Mfg. Seqirus, Inc. Lot 185327 EXP date 4/30/2017 Dose 0.5 cc IM.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Insomnia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Since 10/10/16, I have had dull throbbing pain on my left arm which radiates down past my elbow.  The pain is not excruciating however it is constant and bothersome.  I have taken Advil (400mg-600mg) since Monday in hopes of easing the pain; however it does not do much to elevate the pain.  The discomfort has made sleeping rather difficult since Tuesday of this week.  The pain feels as though it is intramuscular in nature and light rubbing does not seem to help much.  I am unable to sleep on my left side as this will cause the pain to intensify.  Nor can I put weight on this arm (i.e. leaning) as this will irritate and the pain will intensify as well.  Very limited use of my left arm as constant usage of the arm will increase pain and discomfort.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site irritation, Peripheral swelling
Clinical narrative: Left (vaccination arm) underarm irritation that lead to swelling at the armpit. Took ibuprofen and used ice pack during the night. By morning of 10/14/16 (next day) the swelling had increased and the area of swelling was the size of a small tangerine.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Dyspnoea, Exposure during pregnancy, Fatigue, Hypersensitivity
Clinical narrative: Numbness spreading from fingertips to face. Tiredness, sense of difficulty breathing.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia
Clinical narrative: Numbness spreading from fingertips to face. Tiredness, sense of difficulty breathing.
Age: 66.0
Sex: M
Vaccine: PNC13
Symptoms: Alveolitis allergic, Condition aggravated
Clinical narrative: Worsening of hypersensitivity pneumonitis.
Age: 56.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Nausea, Vomiting
Clinical narrative: Patient experienced nausea, vomiting, and chills few hours after he received the influenza and pneumococcal vaccines. States he has had similar reaction in the past with the influenza vaccine. Patient only received one dose of ZOFRAN 4mg Iv and feel completely well the next day.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site urticaria, Vaccination site swelling
Clinical narrative: Site of the vaccine injection had redness, swelling and hives.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Site of the vaccine injection had redness, swelling and hives.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen lymph gland at left underarm. Pain in underarm. Swelling persisting 48 hours later.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Decreased mobility in arm immunization was administered.
Age: 11.0
Sex: M
Vaccine: DTAP, FLU4, MNQ
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Dtap was ordered and given to 11 year old patient by mistake.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Abdominal discomfort, Asthenia, Decreased appetite, Fatigue, Feeling abnormal
Clinical narrative: Extreme fatigue; lethargic; cannot wake up, in deep sleeps often; low energy; frequent headaches; body aches; weakness; stomach problems; nausea; cramps; cannot eat at times; low appetite; neck pain; muscle weakness; brain fog; she has not had blood tests to determine what state her physical health is in. I also read in reports that is vaccine causes infertility, she has not had testing to determine her state of what her fertility is in.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Headache, Lethargy, Muscle spasms, Nausea, Neck pain
Clinical narrative: Extreme fatigue; lethargic; cannot wake up, in deep sleeps often; low energy; frequent headaches; body aches; weakness; stomach problems; nausea; cramps; cannot eat at times; low appetite; neck pain; muscle weakness; brain fog; she has not had blood tests to determine what state her physical health is in. I also read in reports that is vaccine causes infertility, she has not had testing to determine her state of what her fertility is in.
Age: 11.0
Sex: F
Vaccine: HPVX
Symptoms: Pain, Somnolence
Clinical narrative: Extreme fatigue; lethargic; cannot wake up, in deep sleeps often; low energy; frequent headaches; body aches; weakness; stomach problems; nausea; cramps; cannot eat at times; low appetite; neck pain; muscle weakness; brain fog; she has not had blood tests to determine what state her physical health is in. I also read in reports that is vaccine causes infertility, she has not had testing to determine her state of what her fertility is in.
Age: 0.5
Sex: M
Vaccine: FLUX, HEP
Symptoms: Pyrexia, Rash macular
Clinical narrative: Fever and red blotches on skin. TYLENOL for treatment.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: The patient was fine the 1st day after administration of the flu shot. She developed left shoulder pain and consulted with her MD a week after the shot and she still has the pain.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Bladder pain, Bone pain, Hypoaesthesia, Muscular weakness, Neuropathy peripheral
Clinical narrative: Peripheral Neuropathy symptoms from chemo that had resolved suddenly returned: numbness and pins/needles in hands, feet. Weak legs, hands. Bladder pain. Random aches and pains. Sharp needle-like stabbing pains in bones.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Paraesthesia
Clinical narrative: Peripheral Neuropathy symptoms from chemo that had resolved suddenly returned: numbness and pins/needles in hands, feet. Weak legs, hands. Bladder pain. Random aches and pains. Sharp needle-like stabbing pains in bones.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of vaccines and biological substances, init on 2016-09-28.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-10-02.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia, Sensory disturbance
Clinical narrative: Complain of Dull sensation on Left Side of face and tingling in left hand. BP 130/94 130/88 HR 70 and 71; Good facial symmetry no facial weakness noted; Patient has history of cluster migraines that tend have those symptoms; patient checked in a 7:00 PM and was doing well he took two TYLENOL.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Back pain, Fatigue, Headache, Injection site erythema, Nausea
Clinical narrative: Nausea, headache, fatigue. Neck and lower back pain. Slight erythema around immunization site.
Age: 13.0
Sex: M
Vaccine: HPV9
Symptoms: Neck pain
Clinical narrative: Nausea, headache, fatigue. Neck and lower back pain. Slight erythema around immunization site.
Age: 59.0
Sex: M
Vaccine: FLUC4, PPV
Symptoms: Monoplegia, Pain
Clinical narrative: Pt stated that he had a severely painful reaction in which he felt like his arm was paralyzed.
Age: 0.08
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13, UNK
Symptoms: Pyrexia
Clinical narrative: Postvaccination fever on 2016-10-04.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Vaccination complication
Clinical narrative: Adverse effect of other viral vaccines, initial encounter on 2016-10-06.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV1
Symptoms: Incorrect route of drug administration
Clinical narrative: Patient was accidentally given the Rotarix vaccine IM instead of oral. The patient did not have an immediate reaction.
Age: 71.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site rash, Injection site warmth, Pyrexia
Clinical narrative: Fever, Warmth, Redness, Rash from injection site down to 2 inches above elbow.
Age: 60.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Pain in extremity
Clinical narrative: MD ordered Diphtheria-Tetanus-acellular Pertussis vaccine (Tdap) and CMA gave the vaccine in left deltoid at 1240 on 10/7/16 (# GSK Lot # EC9A9, expiration 1/22/2019). Patient developed pain and swelling at the left arm injection site and returned to office on 10/10/16 for acute visit. MD assessed the patient and found mild swelling around the area of injection site. Patient stated that the pain is radiating to her left hand. Patient denied any erythema, fever or chills. Patient was advised to apply topical compress to the area, take acetaminophen or NSAIDS as needed and to return to office in one week for follow-up.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Skin warm
Clinical narrative: Arm was red and swollen at injection site. Arm was warm to the touch and itchy.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: Patient's upper arm started to swell after injection was done. Patient stated that she did not have any shortness of breath and no rashes or hives were seen. Patient waited in pharmacy for 20 minutes and the swelling went down and patient did not show any signs of a reaction anymore.
Age: 85.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration
Clinical narrative: Arm where injection was given is described as "looking like I have a tattoo" down to the elbow (black and blue bruising). No swelling or discomfort.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain
Clinical narrative: Shortly after receiving flu immunization patient experienced extreme pain in his back. He sat down and continued to have pain. He walked into an exam room to lay down. He was examined by a provider. After 10 minutes the back pain was no longer present.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Vaccination site reaction
Clinical narrative: Severe Headache, Shingles around area of vaccine, Shingles in usual area of previous breakouts.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, X-ray limb normal
Clinical narrative: Right shoulder became VERY painful, range of motion in right shoulder greatly decreased.
Age: 25.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Joint range of motion decreased, Localised oedema, Skin warm, Tenderness
Clinical narrative: Tenderness, localized edema/ erythema approx. 8cm, decreased ROM, warm to touch.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Achy, throbbing pain near insertion site radiating to elbow and up shoulder.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Rash, Rash vesicular, Urticaria
Clinical narrative: Initial itchiness at local injection site. Later that evening, spots were noticed on patient's face which later spread to both arms and face the next day. Spots became blister, hives and whelps also developed. The patient contacted her doctor, which he was out of town, but prescribed her steroid, which she did not take. She took BENADRYL and used CALADRYL lotion since the spots developed and it had helped. Symptoms have improved since then.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Peripheral swelling, Skin warm, Vaccination site mass
Clinical narrative: Patient said that her arm was black and blue/bruised. Said she had a lump the size of a golf ball where vaccine was administered. Also said arm was swollen and hot to the touch.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Chills, Dizziness, Headache, Hyperhidrosis, Nausea
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (Lot # M03211, Expiry Date Mar 2017, NDC number 0005-1971-01), via an unspecified route of administration at 0.5 ml, single in the right deltoid, FLUZONE (Lot UI703AA, expiration date 08May2017), intramuscular in left arm, ZOSTAVAX (Lot M024698, expiration date 27Jun2017), subcutaneous in left arm, all on 04Oct2016 for immunization. The patient medical history and concomitant medications were not reported. The patient previously took Fluzone for immunisation. On 05Oct2016 at 09.00, the patient experienced headache, nausea, a little dizzy, sweating, shivers, blister in mouth, fever. On an unspecified date in Oct2016 it hurts when she lifts her right arm, swollen right jaw, hurts when opens mouth. On 09Oct2016 she developed rash. The outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Oral mucosal blistering, Pain, Pain in extremity, Pain in jaw, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (Lot # M03211, Expiry Date Mar 2017, NDC number 0005-1971-01), via an unspecified route of administration at 0.5 ml, single in the right deltoid, FLUZONE (Lot UI703AA, expiration date 08May2017), intramuscular in left arm, ZOSTAVAX (Lot M024698, expiration date 27Jun2017), subcutaneous in left arm, all on 04Oct2016 for immunization. The patient medical history and concomitant medications were not reported. The patient previously took Fluzone for immunisation. On 05Oct2016 at 09.00, the patient experienced headache, nausea, a little dizzy, sweating, shivers, blister in mouth, fever. On an unspecified date in Oct2016 it hurts when she lifts her right arm, swollen right jaw, hurts when opens mouth. On 09Oct2016 she developed rash. The outcome of the events was not recovered.
Age: 70.0
Sex: F
Vaccine: FLU4, PNC13, VARZOS
Symptoms: Rash, Swelling face
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 70-year-old female patient received PREVNAR 13 (Lot # M03211, Expiry Date Mar 2017, NDC number 0005-1971-01), via an unspecified route of administration at 0.5 ml, single in the right deltoid, FLUZONE (Lot UI703AA, expiration date 08May2017), intramuscular in left arm, ZOSTAVAX (Lot M024698, expiration date 27Jun2017), subcutaneous in left arm, all on 04Oct2016 for immunization. The patient medical history and concomitant medications were not reported. The patient previously took Fluzone for immunisation. On 05Oct2016 at 09.00, the patient experienced headache, nausea, a little dizzy, sweating, shivers, blister in mouth, fever. On an unspecified date in Oct2016 it hurts when she lifts her right arm, swollen right jaw, hurts when opens mouth. On 09Oct2016 she developed rash. The outcome of the events was not recovered.
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Chest discomfort, Chest pain, Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A elderly female patient (over age of 65) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration in the arm, on an unspecified date in Oct2016, at 0.5 ml single, for immunisation and FLUZONE, via an unspecified route of administration in the arm, on an unspecified date in Oct2016, at a high dose, for immunisation. The vaccines were administered in different arms. The patient's medical history and concomitant medications were not reported. In Oct2016 the patient experienced pain injection site, muscle pain, chest pain and heaviness on her chest all with outcome of recovered in Oct2016. The patient presented to the emergency room and was later discharged. No follow-up attempts possible. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. A patient of unspecified age ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced swelling at the injection site week after the injection on an unspecified date with outcome of unknown.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is a spontaneous report from a non-contactable consumer.  A female patient of unspecified age and ethnicity received PREVNAR, via an unspecified route of administration, in Sep2016, as single dose for immunization. The patient's medical history and concomitant medications were not reported. In Sep2016, the patient developed a little pink raised area at the injection site and was itchy at the injection site. The details were reported as follows: the patient received the Prevnar vaccine a month ago and developed a little pink raised area at the injection site. The patient still has it although it is a month later; it is about 1/4 the size of a penny. It is itchy at the injection site, but not as severe as a hive or an allergic reaction. The action taken with pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) was not applicable.  The outcome of developed a little pink raised area at the injection site and itchy at the injection site was unknown. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Axillary pain, Chest pain, Dyspnoea, Hypopnoea, Pain in extremity
Clinical narrative: 2 hours after vaccine. C/o arm pain that spreads up arm and under armpit and covers chest. Feels like it is in lungs. Unable to breathe deep. Is feeling slightly better today but still having pain and difficulty breathing. Refused to go to ER or doctor's office.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Painful respiration
Clinical narrative: 2 hours after vaccine. C/o arm pain that spreads up arm and under armpit and covers chest. Feels like it is in lungs. Unable to breathe deep. Is feeling slightly better today but still having pain and difficulty breathing. Refused to go to ER or doctor's office.
Age: 1.58
Sex: M
Vaccine: FLU4
Symptoms: Crying
Clinical narrative: Inconsolable (loud crying) for 20 hours.
Age: 12.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Injection site oedema, Injection site pain, Oedema, Pain
Clinical narrative: Significant pain and edema to right arm, shoulder, and extending to clavicle. SOB. Fever. Required bronchodilator and pain medication. Xray of humerus as precaution. Treated in clinic 10/6/16 and ED 10/7/16.
Age: 12.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, X-ray limb normal
Clinical narrative: Significant pain and edema to right arm, shoulder, and extending to clavicle. SOB. Fever. Required bronchodilator and pain medication. Xray of humerus as precaution. Treated in clinic 10/6/16 and ED 10/7/16.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Deltoid muscle sore and swollen, red and hot surrounding injection site. Patient took TYLENOL (acetaminophen) to help with symptoms. Swelling persisted for approximately one week. Redness and mild bruising still persist over two weeks later.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Administration site pain, Contusion, Ear pain
Clinical narrative: Patient states that a few days after vaccine, administration site became very painful and pain radiated up to ear. On 10/14, patient said large black bruise developed mid-arm.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Joint swelling, Myalgia, Oropharyngeal pain, Respiratory tract congestion, Urticaria
Clinical narrative: Started breaking out in hives on 10/07/16; by the 8th had sore throat, swelling in ankles, chest congestion, and muscle aches.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pain, Facial paralysis
Clinical narrative: Symptom started with an pain below the left ear. Pain worsened over time. Developed into partial Paralysis of the left side of the face.
Age: 1.58
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave patient their first flu vaccine and administered 0.5ml instead of the 0.25ml.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site swelling, Rash
Clinical narrative: Rash on arms, chest and legs. Pain and swelling at the injection site.
Age: 64.0
Sex: M
Vaccine: FLUC4
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Stomach ache, nausea and vomiting a few hours after administration.
Age: 80.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site haematoma, Peripheral swelling
Clinical narrative: Swelling of right arm and large hematoma developed about 6 inches below injection site.
Age: 66.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Very stiff neck and back on side of injection. Extreme difficulty moving head up, down or turning head left or right.
Age: 0.75
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: No adverse event, Product preparation error
Clinical narrative: PENTACEL was ordered. When drawing up the vaccine, I used standard diluent to mix the vaccine instead of the PENTACEL solution. Therefore, patient didn't receive all components of the PENTACEL vaccine. No adverse reactions noted.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site rash, Pruritus
Clinical narrative: On the morning of the 10th, patient complained that there was something on his arm that itched. Directly beneath the injection site, a bulls eye rash had developed, the central portion of which was approximately 2" in diameter. The outer portion was spreading. He was taken to the doctor and, by 9:30 AM, the rash had clearly spread. By evening, it covered most of his arm from the shoulder to the elbow. He did not complain of intense itching, pain, or stiffness. Administration of Benadryl reduced redness. He was given Benadryl every 4-6 hours. By the next evening, Oct 11, the rash had nearly disappeared. The rash may have appeared before the 10th, but the injection site was not observed prior to the 10th. Pictures of the rash are available if needed.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site haemorrhage, Injection site reaction, Injection site swelling, Skin discolouration
Clinical narrative: Within a few minutes after injection I noticed slight swelling of the injection site and asked to change the Band-Aid. When the Band-Aid was removed, there was blood (considerable amount but not too much). By the time I came home the skin around the site became pink-purple and the change became more striking and dark rather rapidly. I still have it (getting slightly better). It has striped/mottled appearance and does not look like a bruise. I am a retired physician and I can tell a bruise. The overall area measures roughly  4.5 x 2.5 cm. It is not painful. I took a picture of it. I can submit it if necessary.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Pain, Skin warm
Clinical narrative: Redness and swelling, warm to touch, painful sensation.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin warm
Clinical narrative: Left arm has redness, warmth, edema and pain throughout arm.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal discomfort, Dyspepsia, Flushing, Vomiting
Clinical narrative: Complained of systemic flushing, abdominal discomfort with vomiting, dyspepsia. States began occurring hours post vaccination, states relaxed, slept and woke up next morning with symptoms resolved.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Injection-site reaction increasing in size and pain.  Currently, about the size of a lemon, raised, burning, and painful to touch.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Chest discomfort, Pruritus, Rash, Urticaria
Clinical narrative: Within first 15 minutes patient experienced hives and rash on right side of neck and tightness in chest. Severe itching and burning. Was seen in ER was given diphenhydramine, hydroxyzine inj, solu-medrol, and famotadine. Was prescribed hydroxyzine, prednisone, and famotadine outpatient. Hives and rash continued and was given solu-medrol on 10/11/2016. Patient is still experiences rash and hives and continues to be treated with hydroxyzine and a titration of prednisone.
Age: 59.0
Sex: M
Vaccine: FLU4, FLUR3
Symptoms: Pain, Pain in extremity
Clinical narrative: Soreness and achy since day of shot. Painful when raising hand above  head.
Age: 59.0
Sex: M
Vaccine: FLU4, FLUR3
Symptoms: Mobility decreased, Musculoskeletal pain, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Soreness and achy since day of shot. Painful when raising hand above  head.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Loss of consciousness, Pallor
Clinical narrative: Approx 5 minutes after admin of vaccine pt stood and then lost consciousness, Dad was near and caught him. Patient was placed on exam table with legs elevated. Pt regained consciousness had 4oz of apple juice, pt requested to use the restroom and upon standing pt said his stomach hurt and turned pale. Pt was placed on exam table again. BP was checked several times and cool compress placed on his forehead. Approx 20 min after admin of vaccine pt states he's ready to stand. Pt went to the restroom accompanied by Dad, no further problems. Pt D/C'd home. Parents advised to call the clinic if further problems.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Body temperature increased, Ear pain, Impaired work ability, Injected limb mobility decreased, Lethargy
Clinical narrative: Awakened the next morning not feeling well. Took Advil and later took an Allegra. At 11 AM she still was not feeling well so she took some Tylenol. Temp at that time 101 and later on that evening her Temp rose to 103. She did not work the next day on Friday 10/7 as not feeling well in genera. She was lethargic and rested throughout the day with Temp of 101 and didn't feel like she could really use her left arm (site of vaccinations). On Saturday 10/8, progressively getting better, and was afebrile, Left arm continued sore and was a little swollen. Sunday evening was not feeling well and had left ear pain. she had taken an Allegra and about a half hour later she began having sensation of throat feeling tight. She was not sure if due to anxiety or progression of reaction, so client went to the ER where Dr observed, but did not give any additional meds due to having taken the Allegra. Contacted HD Thurs 10/13 to report the Adverse Event. States today is feeling better and can use left arm pretty well although it continues to be sore.
Age: 55.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Malaise, Pain in extremity, Peripheral swelling, Throat tightness
Clinical narrative: Awakened the next morning not feeling well. Took Advil and later took an Allegra. At 11 AM she still was not feeling well so she took some Tylenol. Temp at that time 101 and later on that evening her Temp rose to 103. She did not work the next day on Friday 10/7 as not feeling well in genera. She was lethargic and rested throughout the day with Temp of 101 and didn't feel like she could really use her left arm (site of vaccinations). On Saturday 10/8, progressively getting better, and was afebrile, Left arm continued sore and was a little swollen. Sunday evening was not feeling well and had left ear pain. she had taken an Allegra and about a half hour later she began having sensation of throat feeling tight. She was not sure if due to anxiety or progression of reaction, so client went to the ER where Dr observed, but did not give any additional meds due to having taken the Allegra. Contacted HD Thurs 10/13 to report the Adverse Event. States today is feeling better and can use left arm pretty well although it continues to be sore.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site warmth, Musculoskeletal stiffness
Clinical narrative: Redness and swelling around the left upper arm where the vaccine was administered. Muscle stiffness and itchiness in the above area. The entire left upper arm was warm to touch.
Age: 7.0
Sex: F
Vaccine: FLUX
Symptoms: Vaccination site swelling
Clinical narrative: Redness and swelling around the left upper arm where the vaccine was administered. Muscle stiffness and itchiness in the above area. The entire left upper arm was warm to touch.
Age: 33.0
Sex: F
Vaccine: FLU4, HEP, VARCEL
Symptoms: Burning sensation, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Redness at injection site to back side of left arm approximately 2in long and 1.5 in wide.  Injection site warm to touch.  Left upper arm swollen. Client states arm hurts and burns.  Clients also states that she applied ice to site for a few minutes while at work.
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis 3 inches below the injection site.
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Fatigue, Injection site pain
Clinical narrative: Sore injection site; arm gets fatigued easily within few days and lasting till today's visit (10-14-16); R shoulder sore anteriorly.
Age: 26.0
Sex: M
Vaccine: FLUC4
Symptoms: Headache, Pyrexia
Clinical narrative: Patient had mild headache and fever which has lasted longer than typical for a vaccine (going on 4 days now).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Swollen tongue
Clinical narrative: Pt reported AE to pharmacy 10/13/16. Some time later in the afternoon her tongue began to swell. She went to Urgent Care sometime after 5:00PM, was given Benadryl and began to feel better. Patient reported she felt fine the next day.
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Facial pain
Clinical narrative: R sided facial pain and redness.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: On 10/13/2016, patient called the pharmacy around 8:30pm, 10/13/2016, and described symptoms of swelling on upper left arm and pain (near injection site). No itching, fever, chills, or redness reported. Pharmacist called patient today around 3pm to follow-up and patient stated that around 3am she awoke to being in pain in her left arm and was sleeping on it. She then applied ice and took 1 tablet of Advil. She woke up at 5:30am and reported to her volunteer activity today. She stated that she took 1 tablet of Tylenol during the day. Today, patient reported no malaise, chills, fever, redness, and noted decreased swelling and pain. Pharmacist spoke with patient today and will follow up with Primary Care Doctor, and patient on Monday to check on patient.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Malaise, Nausea, Pyrexia
Clinical narrative: FEVER, HEADACHE, NAUSEA, SICK... PT HUSBAND WAS GOING TO TAKE HER TO THE HOSPITAL. SHE REFUSES TO TAKE MEDICATION (IE. TYLENOL OR IBUPROFEN). BUT SHE DIDN'T GO AND HUSBAND CAME IN TODAY (10/14/16) TO LET US KNOW ABOUT THE REACTION AND THAT HE WANTED US TO REPORT IT.
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Hypoaesthesia, Impaired driving ability, Injection site pain, Injection site swelling, Middle insomnia
Clinical narrative: I was awoken in the middle of the night by significant pain in my upper left arm at the injection site.  I switched sides and was able to go back to sleep, but when I got up in the morning I noticed my arm in that area was swollen and there was enough pain that it made it difficult to use that arm. I had trouble driving.  I called the office and was told to go to the emergency room to rule out infection and cyst.  Nothing was resolved, and I was sent home with instructions to use ice packs, motrin, and rest.  Over the next couple of weeks my arm was strange and painful, with swelling and tingling and numbness of my skin from the top of my shoulder down to the top of my hand.  During this time there was a strange symptom: my arm hairs, on that arm only, all stood straight up.  Eventually/gradually these symptoms have dissipated significantly.  I still have some numbness and tingling here and there, along with some slight tenderness, but the swelling at the injection site seems to be gone.
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Musculoskeletal disorder, Ophthalmological examination, Pain in extremity, Paraesthesia, Skin swelling
Clinical narrative: I was awoken in the middle of the night by significant pain in my upper left arm at the injection site.  I switched sides and was able to go back to sleep, but when I got up in the morning I noticed my arm in that area was swollen and there was enough pain that it made it difficult to use that arm. I had trouble driving.  I called the office and was told to go to the emergency room to rule out infection and cyst.  Nothing was resolved, and I was sent home with instructions to use ice packs, motrin, and rest.  Over the next couple of weeks my arm was strange and painful, with swelling and tingling and numbness of my skin from the top of my shoulder down to the top of my hand.  During this time there was a strange symptom: my arm hairs, on that arm only, all stood straight up.  Eventually/gradually these symptoms have dissipated significantly.  I still have some numbness and tingling here and there, along with some slight tenderness, but the swelling at the injection site seems to be gone.
Age: 50.0
Sex: F
Vaccine: TTOX
Symptoms: Tenderness
Clinical narrative: I was awoken in the middle of the night by significant pain in my upper left arm at the injection site.  I switched sides and was able to go back to sleep, but when I got up in the morning I noticed my arm in that area was swollen and there was enough pain that it made it difficult to use that arm. I had trouble driving.  I called the office and was told to go to the emergency room to rule out infection and cyst.  Nothing was resolved, and I was sent home with instructions to use ice packs, motrin, and rest.  Over the next couple of weeks my arm was strange and painful, with swelling and tingling and numbness of my skin from the top of my shoulder down to the top of my hand.  During this time there was a strange symptom: my arm hairs, on that arm only, all stood straight up.  Eventually/gradually these symptoms have dissipated significantly.  I still have some numbness and tingling here and there, along with some slight tenderness, but the swelling at the injection site seems to be gone.
Age: 13.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Hypoaesthesia, Presyncope
Clinical narrative: Patient was vaccinated at 2:45pm with Polio and Menactra in the right deltoid and Gardisil 9 in the left arm. When given the Gardasil last he immediately tensed up, and went into a vasovagal episode.  Another person and I lowered him to the ground safely placed an pillow under his head and gave him cold wash cloths for he forehead. We called for help immediately and Dr. came in to evaluate. Shortly after episode patient asked where he was and states he was tired, dizzy, sweating, his whole body felt numb, and felt as though he fell asleep for a quick nap. Dr. checked his blood pressure, and did a full body examination along with listening for bowel sounds, extremity movement, along with checking for level of consciousness. One he was improving we placed him back in a chair with a pillow behind his head, and we gave him some water and Gatorade. We monitored patient for at least 30 minutes post incident. Dr. evaluated and accompanied him out to his car. Parents and patient stated that this has never happened before but siblings and father has had this happen before to them.
Age: 13.0
Sex: M
Vaccine: HPV9, IPV, MNQ
Symptoms: Tension
Clinical narrative: Patient was vaccinated at 2:45pm with Polio and Menactra in the right deltoid and Gardisil 9 in the left arm. When given the Gardasil last he immediately tensed up, and went into a vasovagal episode.  Another person and I lowered him to the ground safely placed an pillow under his head and gave him cold wash cloths for he forehead. We called for help immediately and Dr. came in to evaluate. Shortly after episode patient asked where he was and states he was tired, dizzy, sweating, his whole body felt numb, and felt as though he fell asleep for a quick nap. Dr. checked his blood pressure, and did a full body examination along with listening for bowel sounds, extremity movement, along with checking for level of consciousness. One he was improving we placed him back in a chair with a pillow behind his head, and we gave him some water and Gatorade. We monitored patient for at least 30 minutes post incident. Dr. evaluated and accompanied him out to his car. Parents and patient stated that this has never happened before but siblings and father has had this happen before to them.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Tingiling in the left hand middle finger 20 minutes after the injection. Resolved in 10 munutes to a slight numbness.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Movement disorder, Muscle tightness, Nausea
Clinical narrative: Patient reported being at a Church meeting Saturday morning when she suddenly felt dizzy, her neck muscles tensed up and she couldn't turn her head. She felt nauseous and like she was going to pass out. This feeling lasted for 15-20 minutes before finally going away.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Body temperature increased, Dyspnoea, Erythema, Heart rate increased
Clinical narrative: Experienced itching, redness, and swelling of skin estimated at about 80% of body by ER nurse.  Experienced rapid heartbeat, increased blood pressure/heart rate, increased temperature and difficulty breathing.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling
Clinical narrative: Experienced itching, redness, and swelling of skin estimated at about 80% of body by ER nurse.  Experienced rapid heartbeat, increased blood pressure/heart rate, increased temperature and difficulty breathing.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: On Sunday 10/09/2016, patient noticed some swelling, redness and pain at the site of injection and it was getting larger.  She also experienced some fever and the site of injection is hot to touch.  She then saw her PCP on Monday, who prescribed her with Claritin, Prednisone, and Benadryl for possible allergic reaction.  She was also instructed to ice the area.  She then reported that the swelling and pain getting worse even though the redness and the fever had subsided.  She then saw her PCP again on Wednesday who had instructed her to continue the prescribed treatment, but suspected possible cellulitis!  However, the PCP did not prescribe any antibiotic.  On Thursday, the patient then self-treated her with some antibiotic that she had (she claimed) and felt better!
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Decreased appetite, Dizziness, Headache, Mobility decreased, Muscle spasms
Clinical narrative: Pounding headache, nausea, loss of appetite, weakness in extremities, light headed and faint, cervical and thoracic spine muscles very tight and spasms, limited mobility.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle tightness, Muscular weakness, Nausea, Syncope
Clinical narrative: Pounding headache, nausea, loss of appetite, weakness in extremities, light headed and faint, cervical and thoracic spine muscles very tight and spasms, limited mobility.
Age: 59.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Diarrhoea, Flank pain, Mobility decreased, Pain in extremity, Skin warm
Clinical narrative: Patient reported she could not raise her arm because it was painful.  Also reports the arm was warm to the touch, she was having diarrhea, and the pain stretched down her side near her ribs.  She took Ibuprofen 800 mg, but that did not help.  Patient went to urgent care for further treatment although she did not disclose further treatment.