chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: TENDER AREA AROUND VACCINATION SITE, WARM FEEL LIKE. UPON EXAMINATION, THERE IS A 2 INCHES RED AREA AROUND VACCINATION SITE, TENDER AND HARD.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fluid replacement, Headache, Nausea, Vomiting
Clinical narrative: Headache, shivering, nausea, vomiting. Replaced fluids. Patient feeling somewhat better today.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Site redness measuring 70mm, tenderness, swelling, and site warmth.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Cerebellar syndrome, Enterovirus test positive, Hemiparesis, Human rhinovirus test positive, Hyperreflexia
Clinical narrative: Noted onset of numbness/tingling to both feet on the weekend of Oct 11th. The altered sensation has been persistent since then and gradually progressing to now include the entirety of her body down from the mid-chest region. She also is reporting severe neck tightness and itching involving her upper chest area for the past two days. She was evaluated in Emergency Department yesterday and was given Valium 2 mg IV in addition to Ibuprofen 400 mg PO which provided some pain relief while she awaited MRI Cervical Spine and Brain. She was evaluated by pediatric neurology and the admitting team where it was determined that she also had increased reflexes on both sides involving her patellar tendon and Achilles in addition to subtle right sided weakness and diminished proprioception and dysmetria. The initial MRI read by neurology is consistent with transverse myelitis so she will be starting a course of Solumedrol 1 gm IV x3-5 days, IvIG 400 mg/kg/day x 5 days, Zantac and PT/OT evaluation.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Loss of proprioception, Muscle tightness, Myelitis transverse
Clinical narrative: Noted onset of numbness/tingling to both feet on the weekend of Oct 11th. The altered sensation has been persistent since then and gradually progressing to now include the entirety of her body down from the mid-chest region. She also is reporting severe neck tightness and itching involving her upper chest area for the past two days. She was evaluated in Emergency Department yesterday and was given Valium 2 mg IV in addition to Ibuprofen 400 mg PO which provided some pain relief while she awaited MRI Cervical Spine and Brain. She was evaluated by pediatric neurology and the admitting team where it was determined that she also had increased reflexes on both sides involving her patellar tendon and Achilles in addition to subtle right sided weakness and diminished proprioception and dysmetria. The initial MRI read by neurology is consistent with transverse myelitis so she will be starting a course of Solumedrol 1 gm IV x3-5 days, IvIG 400 mg/kg/day x 5 days, Zantac and PT/OT evaluation.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Nuclear magnetic resonance imaging thoracic, Paraesthesia, Polymerase chain reaction
Clinical narrative: Noted onset of numbness/tingling to both feet on the weekend of Oct 11th. The altered sensation has been persistent since then and gradually progressing to now include the entirety of her body down from the mid-chest region. She also is reporting severe neck tightness and itching involving her upper chest area for the past two days. She was evaluated in Emergency Department yesterday and was given Valium 2 mg IV in addition to Ibuprofen 400 mg PO which provided some pain relief while she awaited MRI Cervical Spine and Brain. She was evaluated by pediatric neurology and the admitting team where it was determined that she also had increased reflexes on both sides involving her patellar tendon and Achilles in addition to subtle right sided weakness and diminished proprioception and dysmetria. The initial MRI read by neurology is consistent with transverse myelitis so she will be starting a course of Solumedrol 1 gm IV x3-5 days, IvIG 400 mg/kg/day x 5 days, Zantac and PT/OT evaluation.
Age: 12.0
Sex: F
Vaccine: FLUN4
Symptoms: Pruritus, Sensory disturbance, Spinal X-ray
Clinical narrative: Noted onset of numbness/tingling to both feet on the weekend of Oct 11th. The altered sensation has been persistent since then and gradually progressing to now include the entirety of her body down from the mid-chest region. She also is reporting severe neck tightness and itching involving her upper chest area for the past two days. She was evaluated in Emergency Department yesterday and was given Valium 2 mg IV in addition to Ibuprofen 400 mg PO which provided some pain relief while she awaited MRI Cervical Spine and Brain. She was evaluated by pediatric neurology and the admitting team where it was determined that she also had increased reflexes on both sides involving her patellar tendon and Achilles in addition to subtle right sided weakness and diminished proprioception and dysmetria. The initial MRI read by neurology is consistent with transverse myelitis so she will be starting a course of Solumedrol 1 gm IV x3-5 days, IvIG 400 mg/kg/day x 5 days, Zantac and PT/OT evaluation.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Asthenia, Decreased appetite, Headache, Injection site pain, Metrorrhagia
Clinical narrative: Headache, moderate pain at injection site. Following 3 days:  spotting (period not due for 2 wks), nausea, loss of appetite, sleepiness, lack of energy. Today: spotting for 3 months in between periods.  This NEVER occurred prior to the vaccination.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Somnolence
Clinical narrative: Headache, moderate pain at injection site. Following 3 days:  spotting (period not due for 2 wks), nausea, loss of appetite, sleepiness, lack of energy. Today: spotting for 3 months in between periods.  This NEVER occurred prior to the vaccination.
Age: 19.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 11 x 12 cm size of redness, swelling to injection site, R deltoid.
Age: 11.0
Sex: M
Vaccine: FLUN4
Symptoms: Abdominal pain upper, Body temperature increased, Muscle twitching
Clinical narrative: Bilateral involuntary shoulder twitching, stomach ache, temperature of 99.1.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash, Secretion discharge
Clinical narrative: Began as rash on scalp, right ear, right side of neck, chest, back.   Lead to very weeping, very painful sores in this area.  Diagnosed as shingles by a physician, and treated with Valtrex and prednisone as of 10/10/2014.  Rash/blisters remain painful, have dried and hardened.
Age: 60.0
Sex: M
Vaccine: FLUX, VARZOS, VARZOS
Symptoms: Discomfort, Rash
Clinical narrative: Began as rash on scalp, right ear, right side of neck, chest, back.   Lead to very weeping, very painful sores in this area.  Diagnosed as shingles by a physician, and treated with Valtrex and prednisone as of 10/10/2014.  Rash/blisters remain painful, have dried and hardened.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient came in on 10/8/14 in the evening complaining of a sore red left arm after receiving her flu shot in that arm 2 days previously.  Her arm was red to the touch and swollen down to the elbow. Unfortunately, those were all of the details that were given.  Time of onset was not discussed.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Activities of daily living impaired, Asthenia, Diarrhoea, Myalgia
Clinical narrative: Blurred vision, muscle pain, stomach cramps and diarrhea. Last for weeks. I took Airborne and vitamins. I missed one day from work. I refrain from exercising I was too weak.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Vision blurred
Clinical narrative: Blurred vision, muscle pain, stomach cramps and diarrhea. Last for weeks. I took Airborne and vitamins. I missed one day from work. I refrain from exercising I was too weak.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Patient came in on 10/8/14 in the evening complaining of a sore red left arm after receiving her flu shot in that arm 2 days previously.  Her arm was red to the touch and swollen down to the elbow. Unfortunately, those were all of the details that were given.  Time of onset was not discussed.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Mobility decreased
Clinical narrative: Patient came in complaining of a red, swollen left arm.  Arm is visibly swollen and red on the outside and underside of his arm.  He also indicated that his arm is hard to move.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Within approximately 15 min of recieving the vaccination the patient displayed hives, swollen tongue and was immediately taken to the emergency department for evaluation.  She was given Decadron, Benadryl and a prednisone taper pack.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Injection reaction and cellulitis;  about 5 inches by 3 inches and dropped off vaccine by about 2-3 inches.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Eye pruritus, Feeling cold, Hot flush
Clinical narrative: Coughing, red itchy eyes, shortness of breath, swollen throat, cold/hot flashes.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Ocular hyperaemia, Pharyngeal oedema
Clinical narrative: Coughing, red itchy eyes, shortness of breath, swollen throat, cold/hot flashes.
Age: 32.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Patient returned to clinic and reported that left arm injection site is extremely sore after Tdap administration. Patient returned the next day and was seen by NP, patient stated that left arm is very painful, left upper arm deltoid area examination revealed no swelling or redness but patient stated that it is painful to touch and that ROM is restricted. Patient advised to follow-up with PCP. VAERS completed.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Developed typical severe shingles.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Patient indicated that injection site became itchy around approximately 8:30 PM on 10/16/2014. Patient relayed that she took 25 mg Benadryl at the time she first noticed symptoms.  Patient stated that the injection site was still itchy in the morning (on 10/17/2014) and that she experienced increasing itchiness that spread into her shoulder around 3:00 PM. Patient sought attention from medical staff at the facility around 4 PM at which time medical staff noted mild redness around the injection site approximately 1 inch in diameter. Medical staff also noted warmth at the site and on superior aspect of lateral shoulder on the ipsilateral side.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood pressure, Fall, Syncope
Clinical narrative: Patient received influenza Afluria and Pneumovax-23. Patient received both injections and showed no abnormal signs. While patient was checking out at pharmacy (approximately 5 minutes after being vaccinated) she developed syncope and fell. Patient was caught before falling and placed on bench for 15-20 minutes. Attempted to check blood pressure via automatic cuff but was unable to acquire accurate reading. Provided patient with cold pack/paper towels and instructed her to remain seated for 15 to 20 minutes. She then went to an urgent care for follow up from physician.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia, Pruritus, Urticaria
Clinical narrative: Patient experienced hives, tingling of skin, and itching of ears.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Blood culture, Chills, Full blood count, Malaise, Metabolic function test
Clinical narrative: Fever of 104, severe nausea, malaise, chills, body aches/pain.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pain, Pyrexia, Urine analysis
Clinical narrative: Fever of 104, severe nausea, malaise, chills, body aches/pain.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Throat tightness, Vision blurred
Clinical narrative: Throat closing up, dizzy, blurry eyes, returned to doctors office and was sent to Emergency Room.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given Fluzone vaccine for ages 65 and older.  Patient is only 64 years old. No adverse reactions occurred after injection.  Patient and her MD were made aware of the error. Patient was observed for greater than 30 minutes after vaccine administered.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Bacterial test negative, Electroencephalogram normal, Febrile convulsion, Pyrexia, Viral test negative
Clinical narrative: SUDDEN ONSET FEVER, RESULTING IN FEBRILE SEIZURE, LASTED ~ 40 MINUTES.
Age: 42.0
Sex: M
Vaccine: FLUN4
Symptoms: Fatigue, Oropharyngeal pain, Pain, Pyrexia, Vaccine positive rechallenge
Clinical narrative: Sore throat fatigue fever 99 on ibuprofen very sore in general.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Patient had a fever that peaked at 101.5 degrees about 13 hours after receiving the quadravalent flu shot. Patient also has redness around the injection site.
Age: 12.0
Sex: F
Vaccine: HPV4, IPV, MNQ, TDAP
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Left upper arm became hot to touch and swollen from left shoulder to left elbow.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Joint range of motion decreased, Pain in extremity
Clinical narrative: Pt arm became very sore. Lost range of motion. Seemed to improve some but still extremely sore and "fees' wrong.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Gingival erythema, Gingival inflammation, Injection site pain, Injection site urticaria
Clinical narrative: Not sure when it began but 24 hours later looked at arm because had ache at site of injection. It hurt like if vax went into armpit. Line of hives, size of a quarter, went from vax site to lymph node in armpit. It was swollen but not itchy. Put cold compress and took BENADRYL. On 10/9 went to doctor who asked her to come back if did not get better. Got better by Saturday, hives were gone but armpit still ached. Since then also has redness and inflammation of gums. Went to dentist but she was not sure if related. Her last Pneumonia vax was on 2008 with no problems.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Swelling, Urticaria
Clinical narrative: Not sure when it began but 24 hours later looked at arm because had ache at site of injection. It hurt like if vax went into armpit. Line of hives, size of a quarter, went from vax site to lymph node in armpit. It was swollen but not itchy. Put cold compress and took BENADRYL. On 10/9 went to doctor who asked her to come back if did not get better. Got better by Saturday, hives were gone but armpit still ached. Since then also has redness and inflammation of gums. Went to dentist but she was not sure if related. Her last Pneumonia vax was on 2008 with no problems.
Age: 14.0
Sex: F
Vaccine: HEP, HEPA, HPV4, VARCEL
Symptoms: Tenderness, Urticaria
Clinical narrative: Arm tender and whelp on arm reported 10-17-14 at 16:17 by mother. Mother to give BENADRYL-TYL/MOTRIN alternating q4hours.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt presents today with c/o redness and warmth to touch at injection site (upper left arm). Redness measures 19 cm across by 10 cm down. Pt does report pain as well. Injection administered on 10/15/14. Pt reports flu vaccine administered by pharmacy on 10/15/14 - TX: Ice to area; Keflex if swelling continues. Call Monday to update call if fever develops.
Age: 1.3
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No immediate affects noted. Patient lives in residential facility with mother and nursing staff, together they will continue to monitor patient.
Age: 72.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Pain in extremity
Clinical narrative: Patient and spouse say that the morning following the vaccination, patient's right arm was sore and red from deltoid past elbow to halfway down forearm. Came to pharmacy, then went to urgent care! Dr prescribed Augmentin 875 twice a day x 14 days. Slight improvement at 4 PM on 10/17/14.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema
Clinical narrative: Employee developed a 6 x 3 1/2 cm area of redness 4" below the site of her influenza vaccination 1 day after receiving the flu vaccination.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Pt called 10-17-14 to ask if certain side-effects were common w/HIGH DOSE flu shot. Pt states pain bicep which radiates to her neck. No irritation or pain at actual injection site. Pt states pain subsided for few days then came back.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: Redness and swollen in lower part of arm.
Age: 41.0
Sex: F
Vaccine: FLUX, MMR, VARCEL
Symptoms: Erythema, Pruritus
Clinical narrative: Patient had reaction to chicken pox vaccine. It was red and itchy about a 4" circle.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Cough, Delirium, Fatigue, Feeling cold
Clinical narrative: By night felt tired and cold. Shaking, freezing to death. Woke up at night with chest spasms and racking cough that was very hurtful. Felt like chest was going to explode. Couldn't move at all to call for help. At one point was sweating and felt delirious; not sure if had fever. By morning, came out of it with no problems since.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Hyperhidrosis, Mobility decreased, Muscle spasms, Tremor
Clinical narrative: By night felt tired and cold. Shaking, freezing to death. Woke up at night with chest spasms and racking cough that was very hurtful. Felt like chest was going to explode. Couldn't move at all to call for help. At one point was sweating and felt delirious; not sure if had fever. By morning, came out of it with no problems since.
Age: 25.0
Sex: M
Vaccine: FLUN4, HEPA
Symptoms: Cold sweat, Euphoric mood, Feeling drunk, Hot flush, Vertigo
Clinical narrative: Hot flashes, euphoria, vertigo, cold sweats, feeling intoxicated.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Pt received shot, came back a few days later with a red, inflamed arm. A bit warm to the touch.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Induration, Rash
Clinical narrative: 5.5 cm x 4.5 cm induration rash on stomach, back and chest not itchy. Started this am.
Age: 1.42
Sex: M
Vaccine: FLUN4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No immediate affects noted. Patient lives in residential facility with mother and nursing staff. Together, they will continue to monitor the patient.
Sex: U
Vaccine: FLU3, PPV, TDAP
Symptoms: Drug administered at inappropriate site, Pain, Pyrexia, Skin discolouration
Clinical narrative: Fevers, black and blue mark went to ER told vaccines were administer into wrong muscle very painful.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Body temperature increased, Chills, Fatigue, Judgement impaired
Clinical narrative: Tiredness (extreme); could not walk or sit up. Impaired judgement. Extreme chills. 104.4 degrees temperature hours later.
Sex: U
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis
Clinical narrative: Pt developed cellulitis required hospital stay for 3 days.
Sex: U
Vaccine: FLU3
Symptoms: Blood pressure increased, Hyperhidrosis, Vomiting
Clinical narrative: 10-15 minutes after receiving flu vaccine pt felt hot began sweating. Transported to ER had increased blood pressure. Also complained of vomiting.
Sex: U
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: Received flu vaccine at a clinic unaware of her complaints.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Pt received the FLUZONE HD Monday 10/13/14 morning. Monday evening she developed a rash about 3 inches below the injection site. The rash was raised, red, and itchy. It was still there and about 4 inches in diameter when she came into the pharmacy 10/16/14.
Age: 91.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure increased, Pyrexia
Clinical narrative: Patient describes feeling weak and blood pressure was elevated. Patient also have a high fever.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Blood glucose normal, Dizziness, Syncope
Clinical narrative: Patient experienced dizziness and fainted. He was checked by EMT and recovered. Had not experienced (syncope) before. Patient is ok.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: 24 hours after immunization, pt experienced a raised red bump that itched and persisted for at least 12 hours.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Eyelid oedema, Fatigue, Lip swelling, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: On 10/13/14 9 am received flu shot. By noon experiencing scratchy throat, red eyes, fatigue. By 5 pm in evening felt face and lips swollen eyes puffy. This morning still with sore throat, face and lips swollen.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling face, Throat irritation
Clinical narrative: On 10/13/14 9 am received flu shot. By noon experiencing scratchy throat, red eyes, fatigue. By 5 pm in evening felt face and lips swollen eyes puffy. This morning still with sore throat, face and lips swollen.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site erythema, Injection site warmth
Clinical narrative: Pt states date of vaccine admin experienced generalized discomfort at site. Redness at site but not noticed until that evening, then noted heat at site then too. No limit to limb movt or ROM (inj to (L) tricep area). No improvement in s/s since. Denies need for further tx when offered.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received flu vax 10/13/14. Within 12-24h began to have redness and tenderness at injection site left deltoid. Drew a mark around it to monitor progression and on 10/15 noted progressed redness although tenderness and swelling have decreased. No other sx. No reaction to previous vaccines. Declines office for occ med follow up.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Painful after injection, red a lot after injection bruising appeared Sunday (10/13/).
Age: 45.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Hyperhidrosis, Syncope
Clinical narrative: Received 3 vaccines Flu, Tdap, PNEUMOVAX about 3 pm. Later that evening woke up sweating went to bathroom and fainted. Husband called 911 for ambulance.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Soreness, tenderness, pain, swelling extending down arm (to elbow) of left arm. Tx w/ IBU and ice.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Abscess, Herpes zoster, Incisional drainage
Clinical narrative: 3 abscesses all formed in (L) axilla 3 days after vaccine. Then shingles to forehead 10 days after abscess required incision, drainage and antibiotics.
Age: 61.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 43 hours after receiving vaccines pt developed tennis ball sized red area that was hot and tender to touch. Red area was at location of ZOSTAVAX shot.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Hives ten minutes after FLUZONE HD. Treated with BENADRYL 75 mg IM.
Age: 41.0
Sex: U
Vaccine: FLU4
Symptoms: Injection site reaction, Injection site swelling
Clinical narrative: Swollen deltoid region 1 day after injection area of skin around injection. Site looks "burned" as though a caustic substance applied. Gave bacitracin ointment and patient will call with follow-up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No pertinent medical history or drug reactions/allergies were provided. The nurse reported that unspecified number of ROTATEQ doses (dose and lot number not provided) had been administered to patients, orally. No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia, Neck pain
Clinical narrative: Pain at injection site, (Lt) deltoid, (Lt) trapezius and neck starting 24 hours after injection -> lasting > 2 weeks +.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site movement impairment, Pain in extremity
Clinical narrative: Right arm (injected with PNEUMOVAX 23) became very sore to the point patient had to make a sling to hold up arm. She tried ADVIL, heating pad and ice, but no help. Feels paralyzed from (R) shoulder to (R) elbow.
Age: 14.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Fluzone vaccine administered on the afternoon of 10-13-14. No Rxn noted - child awoke the next day with hives "all over". Symptoms only lasted a few days.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Pt. presented to pharmacy with rash on face and thought she may be allergic to flu vaccine.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Rash macular
Clinical narrative: "2-3" below where shot was given there is a blotchy red band (like a sunburn) but not raised, not hot and only slightly itchy this morning."
Age: 90.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Inflammation, Pruritus, Rash
Clinical narrative: Red, inflamed rash on arm of immunization. Was itchy but painless and non-itching.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Pruritus, Skin warm, Tenderness
Clinical narrative: Pt indicated it was warm to touch, itches, slightly tender and feels like a big bruise.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Erythema, Skin warm
Clinical narrative: Temp went up to 103 degrees / 3 days arm hot and red 5 days.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy to metals, Lymphadenopathy, Oropharyngeal pain, Paraesthesia oral, Snoring
Clinical narrative: Pt states having an allergy to mercury. States in the past she has received flu shots that didn't have mercury in it. States symptoms started approx 10 minutes after receiving the flu shot in L deltoid. No noticeable redness or rash localized to area of injection. Pt states her lips, tongue and lower jaw feels tingly. States that she feels like the lymph nodes in her neck feel swollen. Pt denies any problems swallowing. States her throat is a little sore from snoring last night. Speaking in full sentences, denies any trouble breathing. In no noticeable respiratory distress. Lung sounds CTA. SpO2 97% RA. Diphenhydramine 25 mg once, ranitidine 50 mg once, methylprednisolone 125 mg once.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site pain, Mobility decreased
Clinical narrative: Pt. states vaccine site very painful with increasing pain starting with discomfort up after shot with very painful about 2 days later. Site is painful to the touch but not warm, swollen or red. Pt states it is very painful to raise arm in certain positions and cannot remove shirt without assistance. No report of fever.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Child received FLUMIST, about 25 min after receiveing FLUMIST child broke out hives on face and neck, Guardian gave BENADRYL - oral, Rash did not get better, Guardian took child to ER - monitored for about 6 hours. Child to have appointment with Allergy MD.
Age: 35.0
Sex: F
Vaccine: FLUR3
Symptoms: Dysphagia, Dyspnoea, Flushing, Immediate post-injection reaction, Rash
Clinical narrative: Immediate reaction of rash, facial flushing. SOB. Tightness of throat and difficulty swallowing.
Age: 35.0
Sex: F
Vaccine: FLUR3
Symptoms: Throat tightness
Clinical narrative: Immediate reaction of rash, facial flushing. SOB. Tightness of throat and difficulty swallowing.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity, Injection site swelling
Clinical narrative: Pt came in and talked with RPh after receiving flu shot. Large bump appeared over flu shot area. Went to ER where diagnosis was allergic reaction.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Local swelling, Night sweats, Pain
Clinical narrative: 2 hrs after receiving vaccine, pt. experienced swelling and redness in right arm, swelling went to elbow, very sore, swollen, took diphenhydramine that night, had extreme night sweats that night. Went to urgent care next day was told she had cellulitis and given Abx. Went to reg. doc that same day was told not to take Abx unless fever went to 100.5. Fever only went to 99.9, never took Abx. spoke to pt on Friday, still slight redness towards elbow, sore, swelling gone, still taking BENADRYL and ZYRTEC. Feels much better.
Age: 54.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: 2 hrs after receiving vaccine, pt. experienced swelling and redness in right arm, swelling went to elbow, very sore, swollen, took diphenhydramine that night, had extreme night sweats that night. Went to urgent care next day was told she had cellulitis and given Abx. Went to reg. doc that same day was told not to take Abx unless fever went to 100.5. Fever only went to 99.9, never took Abx. spoke to pt on Friday, still slight redness towards elbow, sore, swelling gone, still taking BENADRYL and ZYRTEC. Feels much better.
Age: 17.0
Sex: F
Vaccine: FLUN4, VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a Licensed Practical Nurse refers to a 17 year old female with none drug reactions/allergies. None pertinent medical history was reported. On 10-OCT-2014 the patient was vaccinated with VARIVAX, lot# reported as K002918, expiry date 26-FEB-2016, 0.5 ml, subcutaneous. The patient also received FLUMIST on the same day (10-OCT-2014), (dose and route not reported). The nurse reported that the patient who was pregnant received a dose of VARIVAX. She stated that at the time the VARIVAX was administered, it was not known that the patient was pregnant. She reported that the patient arrived to the clinic three days after receiving VARIVAX on 13-OCT-2014 and asked to have a pregnancy test done which resulted positive. At time of reporting (15-OCT-2014), the patient had 4 weeks and 5 days pregnancy. The LMP (Last Menstrual Period) was 12-SEP-2014 and EDD (Estimated date of delivery) was 19-JUN-2015. The pregnancy outcome was outcome pending. No adverse effect reported. No treatment was given. None lab diagnostics studies was performed. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Patient came in 3 days post ZOSTAVAX inject with 4 inch diameter rash at injection site. Told her that was normal but will follow for a few days.
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. The patient's medical history included asthma (current condition), patient has a history of having asthma flare-ups "from time to time" and was treated with Prednisone each time. On 03-OCT-2014 the patient was vaccinated with ZOSTAVAX (lot #, dose, route not reported)). Concomitant medications were unspecified inhalers. On an unknown date in October 2014 the patient who received ZOSTAVAX brought a prescription for Prednisone to the pharmacy on 07-OCT-2014 to treat an asthma "flare up". The patient sought medical attention by contacting the physician. There was not product quality complaint. The outcome is unknown. The pharmacist says the patient's flare-up has "nothing to do with ZOSTAVAX" (assessed as causality not related). Additional information is not expected as the pharmacist did not want to provide further details.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 10-SEP-2014, the patient was vaccinated with a dose of improperly stored PROQUAD injection (lot# K007798, expiration date 29-NOV-2015 (strength, dose and route not reported). No adverse effects reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a male patient of unknown age. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX vial 19400 PFU for unknown indication (route, dose and frequency unknown). Concomitant medications were not reported. On an unknown date, the patient experienced a patient received ZOSTAVA and alter developed shingles. The outcome of shingles was unknown. Causality assessment was not reported. VZVIIP packed faxed. Product quality complaint was not reported. Additional information has been requested.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: This spontaneous report as received from a 73 year old female patient regarding herself. The patient's medical history included shingles in 2011. On an unknown date in 2012, the patient was vaccinated with ZOSTAVAX  (dose and route were not reported). Concomitant medications were not reported. On 07-OCT-2014, the patient has shingles again and painful at all like the first time. The outcome of now she has shingle again and painful was unknown. Causality assessment was not reported. Patient sought unspecified medical attention. Product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No concurrent information or medical history was provided. On 07-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot # J013345 with expiry date: 11-JAN-2015; strength, dose, route of administration and indication  unspecified in the arm. No concomitant medications were reported. The pharmacist (who also administered the vaccine) reported that ht patient experienced swelling from injection site down to their elbow. In October 2014 (exact date unknown), after being administered PNEUMOVAX23). The pharmacist participated in a Flu Clinic. No treatment was given. The outcome of swelling was reported as recovering. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a nurse refers to a 77 year old male patient. Pertinent medical history, drug reactions/allergies and lab diagnostics studies were not reported. On 14-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 (lot # K004148, expiration date 10-MAY-2015),  0.5 ml, intramuscularly. Concomitant medication was not reported. On 14-OCT-2014, after receiving PNEUMOVAX23, the patient experienced pain at the injection site that radiated into the shoulder. The adverse event was treated with orally codeine. The outcome of the event was unknown. The patient sought medical attention by saw nurse. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a other health professional refers to a patient of unknown age. On 25-AUG-2014 the patient was vaccinated with ROTATEQ vial, lot # K001935; expiry: 08-DEC-2014 (dose, dose # and route unspecified). No concomitant medications were reported. On 26-AUG-2014, it was reported that the patient was exposed to temperatures outside of the proper storage range. No adverse effect reported. The outcome of were exposed to temperatures outside of the proper storage range and no adverse effect reported is unknown. There was no product quality complaint (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The nurse called and reported that an unknown number of patients additionally were administered PROQUAD (Merck) which were improperly stored. The PROQUAD (Merck) exposed to -12.1 degrees Celsius for 21 hours (20 hours and 45 minutes). The excursion was supported. The nurse believed at least one or two individuals had received these various vaccines but did not have specific data. She had not received any reports of adverse effects to patients post vaccination (No adverse effects reported). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with penicillin allergy. On 13-OCT-2104, the patient was vaccinated with ZOSTAVAX vial, lot # K007548, expiry date 23-AUG-2015, 0.65 milliliter, subcutaneous in the left arm. Concomitant medications were not reported. ON an unknown date approximately in October 2014, the patient experienced redness, swelling, pain and warmth on her left arm at the injection site after receiving ZOSTAVAX. On an unknown date approximately in October 2014, vesicles started to develop at the injection site. No treatment was given for the events. No lab diagnostics were performed. The outcome of vesicles starting to develop at the injection site and redness, swelling , pain and warmth on her left arm at the injection was reported as not recovered. Causality assessment was not reported. Patient sought medical attention and came back to pharmacy. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. Current conditions and medical history was not reported. On 15-OCT-2014, the patient was vaccinated with ZOSTAVAX vial (dose, route and frequency not reported). Concomitant medications were not reported. On 15-OCT-2014, expired dose of ZOSTAVAX (expiry date: 14-SEP-2014, Lot number-J0006830) was administe4red and no adverse effects were reported. Product quality complaint was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA) refers to a patient of unknown age. On 01-OCT-2014 the patient was vaccinated with an expired dose of ZOSTAVAX (dose, lot # and route were unknown, expiration date 28-SEP-2014). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On 30-SEP-2014, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) injection, (lot # K007798, expiration date 29-NOV-2015) (strength, dose and route not reported). No adverse effects reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69  year old male patient. There was no pertinent medical history or drug reactions. On 17-SEP-2014 the patient was vaccinated with the second dose of PNEUMOVAX23 (strength was not reported), lot # J009833, expiration date: 25-JAN-2014, 0.5 ml, intramuscularly in right deltoid muscle. There was no concomitant therapy. On 18-SEP-2014, the patient experienced redness, soreness, and swelling of the right biceps muscle. The injection site was not affected. No treatment was given. No labs were performed. The patient sought medical attention by pharmacy visit.  The outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. On an unkonwn date, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) injection, (lot # K007798, expiration date 29-NOV-2015) (strength, dose and route not reported). No adverse effects reported for the patient. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of GARDASIL injection (strength, dose, route of administration, indication, lot# and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of ROTATEQ injection, route of administration not reported, defaulted to oral (strength, dose, indication, lot # and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of VAQTA injection 9strength, dose, route of administration, indication, lot # and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of ZOSTAVAX injection (strength, dose, route of administration, indication, lot # and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of M-M-R II injection (strength, dose, route of administration, indication, lot # and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patient of unknown demographics. No concurrent conditions or medical history were provided. On an unknown date, those patients were vaccinated with doses of (Oka/Merck) VARIVAX injection (strength, dose, route od administration, indication, lot # and expiry date unspecified), that were improperly stored. No concomitant medications were reported. No adverse effects were reported.  Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 09-SEP-2014 the patient was vaccinated with (Oka/Merck) VARIVAX 0.5 ml dose, subcutaneously (lot number and expiration date were not provided) that underwent a supported temperature excursion. No adverse event was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse refers to a 16 year old female patient. No information about medical history, concurrent conditions was reported. On 28-AUG-2014 the patient was vaccinated with GARDASIL (lot # K005083, expiry date 04-NOV-2016 (also reported as 05-NOV-2016) dose# 1 in the series, dose, unit and route not reported)). No concomitant medications were reported. The patient was pregnant at the time of administration with an estimated date of last menstrual period (LMP) of 10-MAY-2014 and an estimated date of conception of 24-MAY-2014 (both dates calculated from the estimated due date (EDD) of 15-FEB-2015 that was reported). Initial exposure to GARDASIL was at 15 week(s). No adverse effects reported. The pregnancy outcome was unknown. There was no product quality complaint. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. No concurrent conditions or medical history were provided. On 07-OCT-2014, the patient was vaccinated with a dose of PNEUMOVAX23 injection (lot # J013345) with expiry date: 11-JAN-2015; strength, dose, route of administration and indication unspecified) in the arm. No concomitant medications were reported. The pharmacist (who also administered the vaccine) reported that the patient experienced swelling from injection site down to their elbow, on 07-OCT-2014, after being administered PNEUMOVAX23. The pharmacist participated in a Flu Clinic. No treatment was given. The outcome of swelling was reported as recovering. The relatedness between the event and PNEUMOVAX23 was not reported. Additional information has been requested.