chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash, Seizure like phenomena, Small fibre neuropathy, Tremor, Ultrasound scan
Clinical narrative: 3 weeks after vaccine was administered patient had joint pain in knees and back. Jan 2012 - increased back pain with muscle atrophy/weakness Feb/Mar 2012 - difficulty standing and walking. Truncated tremors 4/2012 Dx Allodynia. 6/2012 Dx Chronic Regional Pain Syndrome 8/2012 Large Fiber Neuropathy Dx 4/2013 Small Fiber Neuropathy Dx.
Age: 13.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: X-ray
Clinical narrative: 3 weeks after vaccine was administered patient had joint pain in knees and back. Jan 2012 - increased back pain with muscle atrophy/weakness Feb/Mar 2012 - difficulty standing and walking. Truncated tremors 4/2012 Dx Allodynia. 6/2012 Dx Chronic Regional Pain Syndrome 8/2012 Large Fiber Neuropathy Dx 4/2013 Small Fiber Neuropathy Dx.
Age: 84.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Culture throat, Erythema multiforme, Pruritus, Rash, Rash erythematous
Clinical narrative: Approximately 24 hrs after receiving FLUMIST (2013) intranasal, pt developed itchy red rash. No fever, no hives no lip swelling no SOB. Pt denies allergies to food or meds. Seen in office 10/15/13 AM - PE: significant for diffuse erythema multiforme minor rash on face, trunk/back, extremities. C/o pruritus. Appropriate dose of diphenhydramine 12.4 mg/5ml given, UA, rapid strep, tcx sent. Patient continues to have rash while in office.  Note: patient has has 2 previous doses of FLUMIST in 2011 and 2012, but not previously in 2013.
Age: 6.0
Sex: F
Vaccine: FLUN4
Symptoms: Rash pruritic, Streptococcus test negative, Urine analysis
Clinical narrative: Approximately 24 hrs after receiving FLUMIST (2013) intranasal, pt developed itchy red rash. No fever, no hives no lip swelling no SOB. Pt denies allergies to food or meds. Seen in office 10/15/13 AM - PE: significant for diffuse erythema multiforme minor rash on face, trunk/back, extremities. C/o pruritus. Appropriate dose of diphenhydramine 12.4 mg/5ml given, UA, rapid strep, tcx sent. Patient continues to have rash while in office.  Note: patient has has 2 previous doses of FLUMIST in 2011 and 2012, but not previously in 2013.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Fatigue, Local swelling
Clinical narrative: Swollen, redness around (R) arm, dizzy, fatigue.
Age: 71.0
Sex: U
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 76.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Patient experienced lightheadedness and shortness of breath. Pt was given 2 - 25 mg capsules of diphenhydramine. Paramedics also administered oxygen and pt was taken to hospital for observation. Pt released 2 hours later.
Age: 83.0
Sex: F
Vaccine: FLUX
Symptoms: Pain
Clinical narrative: Ached all over my body, especially left knee and left shoulder. No vomiting, no diarrhea. The aching was subsiding on - 9-15-13, by noon. I am healthy now!
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red, indurated softball size area to left deltoid. Warm and painful to touch.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Back pain, Chest pain, Erythema, Feeling abnormal, Rash
Clinical narrative: Patient complained of redness, swelling, bumpy/lumpy hot to touch and back and chest hurting. No fever just feeling really bad. Patient went to ER and given KEFLEX 500 mg and methocarbamol 150mg tab.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Swelling
Clinical narrative: Patient complained of redness, swelling, bumpy/lumpy hot to touch and back and chest hurting. No fever just feeling really bad. Patient went to ER and given KEFLEX 500 mg and methocarbamol 150mg tab.
Age: 44.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Pruritus generalised
Clinical narrative: Pt. was vaccinated in the (L) deltoid with Hep. B and in the (R) deltoid with Flu vaccine around 4 pm. At 4:30 pm pt. returned stating he had itching all-over his body. No hives, redness, or breathing problems noted received BENADRYL 50mg po liquid, only.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Rash, Rash macular
Clinical narrative: Pt. states felt hot, face rashy with red blotches that's moved throughout the day - chin red when in office - to report 10-9-13 4:15pm. VSs BP 130/70 P 70 T 97 ax PO 95% RA.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Pt reported itching at 5-6 pm on 10/10/13 which resolved. Pt reported red, warm, slightly elevated, swollen area size of palm on arm near injection on 10/11/13 (reported both on 10/11/13) and I counseled her to apply a cold compress and f/u w/ MD; I l/m w/ MD 10/11/13.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Heart rate irregular, Palpitations
Clinical narrative: Extreme irregular heartbeat approximately 4 hours following vaccination. Significant palpitations persisted thru the evening and night.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Rash erythematous, Skin warm
Clinical narrative: Wed, 10-2-13 noticed area was warm. Thurs, 10-3-13 noticed stripe (red rash) about 2/3 of way around the arm ~ 2.5 inches wide, below injection site. Sat, 10-5-13 reported to pharmacist - could still see rash.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Dizziness, Fatigue, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient states the evening of receiving the PNEUMOVAX vaccine she experienced Rt arm pain, stiffness, swelling, fever with chills, lightheaded, fatigue. PNEUMOVAX given 10/14/13 at 9:30 am.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Swelling
Clinical narrative: Patient states the evening of receiving the PNEUMOVAX vaccine she experienced Rt arm pain, stiffness, swelling, fever with chills, lightheaded, fatigue. PNEUMOVAX given 10/14/13 at 9:30 am.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Urticaria
Clinical narrative: Diffuse urticaria beginning 1/2 hr post vaccine administration treatment with corticosteroids, H1/H2 blockers - EPIPEN dispensed secondary tightness in chest.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Pain, redness, raised area.
Age: 9.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 10-9-13 Pt. seen because of swelling to left upper arm that began several hours after injection on 10-7-13. 8.5 cm x 14 cm have on left upper arm. Non tender. Mild erythema.
Age: 70.0
Sex: U
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Feeling cold, Headache
Clinical narrative: Received vaccine at 11 am 9/23/2013 at 3 pm started to feel cold at 5 pm temperature reach to 103 F felt chill, headache called Med Ctr was instructed to take TYLENOL.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Pt reported redness, warmth and pain at injection site. Pt reported this to MD and was told to call back if it doesn't get better. Pt called back and received a course of antibiotic, which pt finished and completely recovered.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Fatigue
Clinical narrative: Chills, advised to take ADVIL and checked with pt next day - feels tired, but fine now.
Age: 83.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Pt states she experienced pain and redness at the site of injection. Pt was referred to PCP for further evaluation. Pt went to urgent care and was recommended to take BENADRYL and ALEVE.
Age: 42.0
Sex: U
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot
Clinical narrative: Tired and feeling of hotness.
Age: 76.0
Sex: U
Vaccine: FLU3, PPV
Symptoms: Local swelling, Nausea, Pain, Pyrexia
Clinical narrative: Pt states she experienced local soreness and swelling as well as some nausea and maybe some fever after receiving flu shot and pneumonia shot. Pt was referred to PCP.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: 6 hours after shot in ER with 102+ degrees fever body aches vomiting.
Age: 54.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Condition aggravated, Fatigue, Myalgia
Clinical narrative: Patient has been feeling more fatigued and has muscle aches since getting the vaccinations.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Local reaction, Urticaria
Clinical narrative: Localized urticarial reaction.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Electrocardiogram normal, Fall, Increased upper airway secretion, Lip swelling, Loss of consciousness
Clinical narrative: Patient received his FLUMIST vaccine. He was standing by the sink and seemed OK. His mother went to wash his face and he resisted, made a growling noise and then fell against her and onto the floor. He had brief (less than 30 seconds) tonic clonic jerking and urinated. He then regained consciousness and tried to stand up. We laid him on the exam table. He was awake but pale. VSS were nl, with nl HR and oximetry 100%. He acted sleepy but did not go to sleep. He had a bump on his upper lip. He was not complaining of headache but felt queasy. He sat up but wanted to lay down again and seemed sleepy. Over the next 30" his color improved and he became more alert. He did not complain of headache or have any vomiting. Medics were called to transport him to hospital. At hospital ER he had a nl EKG. He felt much better and was observed for several hours. he had a nl neck xray per Dr. He was sent home to f/u with his PCP. Will need to discuss need for referral to seizure clinic.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: Nausea, Pallor, Somnolence, Tonic clonic movements, Urinary incontinence
Clinical narrative: Patient received his FLUMIST vaccine. He was standing by the sink and seemed OK. His mother went to wash his face and he resisted, made a growling noise and then fell against her and onto the floor. He had brief (less than 30 seconds) tonic clonic jerking and urinated. He then regained consciousness and tried to stand up. We laid him on the exam table. He was awake but pale. VSS were nl, with nl HR and oximetry 100%. He acted sleepy but did not go to sleep. He had a bump on his upper lip. He was not complaining of headache but felt queasy. He sat up but wanted to lay down again and seemed sleepy. Over the next 30" his color improved and he became more alert. He did not complain of headache or have any vomiting. Medics were called to transport him to hospital. At hospital ER he had a nl EKG. He felt much better and was observed for several hours. he had a nl neck xray per Dr. He was sent home to f/u with his PCP. Will need to discuss need for referral to seizure clinic.
Age: 7.0
Sex: M
Vaccine: FLUN4
Symptoms: X-ray normal
Clinical narrative: Patient received his FLUMIST vaccine. He was standing by the sink and seemed OK. His mother went to wash his face and he resisted, made a growling noise and then fell against her and onto the floor. He had brief (less than 30 seconds) tonic clonic jerking and urinated. He then regained consciousness and tried to stand up. We laid him on the exam table. He was awake but pale. VSS were nl, with nl HR and oximetry 100%. He acted sleepy but did not go to sleep. He had a bump on his upper lip. He was not complaining of headache but felt queasy. He sat up but wanted to lay down again and seemed sleepy. Over the next 30" his color improved and he became more alert. He did not complain of headache or have any vomiting. Medics were called to transport him to hospital. At hospital ER he had a nl EKG. He felt much better and was observed for several hours. he had a nl neck xray per Dr. He was sent home to f/u with his PCP. Will need to discuss need for referral to seizure clinic.
Age: 77.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Feeling hot, Hyperhidrosis
Clinical narrative: Faint feeling, sweating, diarrhea, swollen tongue, hot, and nauseas, shaking, pallor, upset stomach.
Age: 77.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Nausea, Pallor, Swollen tongue, Tremor
Clinical narrative: Faint feeling, sweating, diarrhea, swollen tongue, hot, and nauseas, shaking, pallor, upset stomach.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Middle insomnia, Pain in extremity
Clinical narrative: Arm was sore all day Wednesday, woke up about midnight with arm hurting. Put BIOFREEZE on it. Did not look at arm till Thursday night - after her bath - had a 1-1 1/2 inch band that was red and warm to the touch below injection site. When came into health dept to have it looked at redness was gone.
Age: 9.0
Sex: F
Vaccine: MNQ
Symptoms: Body temperature increased, Decreased appetite, Erythema, Local swelling, Malaise
Clinical narrative: 1. Local erythema/swellings/tenderness. 2. Malaise/anorexia. 3. Low grade temp.
Age: 9.0
Sex: F
Vaccine: MNQ
Symptoms: Tenderness
Clinical narrative: 1. Local erythema/swellings/tenderness. 2. Malaise/anorexia. 3. Low grade temp.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Diarrhoea, Lethargy, Migraine, Nausea
Clinical narrative: 10/14/2013 at approximately 12:30 received vaccination stating later that day in evening she had lethargy and low grade temp 100.3 (max) she reported headache (migraine) and lethargy she stated she continued to take TYLENOL and c/o of N and V and diarrhea 10/16.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: 10/14/2013 at approximately 12:30 received vaccination stating later that day in evening she had lethargy and low grade temp 100.3 (max) she reported headache (migraine) and lethargy she stated she continued to take TYLENOL and c/o of N and V and diarrhea 10/16.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Dyspnoea, Lacrimation increased, Local swelling, Tachycardia
Clinical narrative: I received the flu vaccine (FLUZONE. Sanofi Pasteur Inc. lot UH890AA ndc 49281-013-88) at 12:30 on 09/12/2013. At 16:30 I began to experience tightness in the chest, increased respiratory effort, swelling of the neck, tachycardia, and urticaria of skin and eyes. No new food, or other agent exposure took place during the space of time from injection to reaction. Diphenhydramine 50mg PO taken and SpO2 , and respiratory monitoring initiated and continued 12 hours. Post monitoring symptoms included urticaria of eyes and tearing only.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: I received the flu vaccine (FLUZONE. Sanofi Pasteur Inc. lot UH890AA ndc 49281-013-88) at 12:30 on 09/12/2013. At 16:30 I began to experience tightness in the chest, increased respiratory effort, swelling of the neck, tachycardia, and urticaria of skin and eyes. No new food, or other agent exposure took place during the space of time from injection to reaction. Diphenhydramine 50mg PO taken and SpO2 , and respiratory monitoring initiated and continued 12 hours. Post monitoring symptoms included urticaria of eyes and tearing only.
Age: 61.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Pain at injection site. Swollen 3x the size.
Age: 43.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Nausea, Pain, Pyrexia
Clinical narrative: Within 48 hr of vaccine, developed body ache, nausea, fever then cough which still going on 9 days after vaccine.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Pyrexia
Clinical narrative: Fever 101, arm swelling, redness.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Cough, Diarrhoea, Dysphonia, Headache
Clinical narrative: (Taking ibuprofen) about 4 hours after shot started shaking then developed very high fever thru the nite w/ some nausea - next day very weak - sore throat - hoarse- coughing - diarrhea - muscle soreness - headache - stuffy nose - symptoms lasted 5 days except high fever. Still feel feverish on day 6. Now have pain and swelling right wrist don't know if connected, but received no injury to wrist.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Joint swelling, Myalgia, Nasal congestion, Nausea, Oropharyngeal pain
Clinical narrative: (Taking ibuprofen) about 4 hours after shot started shaking then developed very high fever thru the nite w/ some nausea - next day very weak - sore throat - hoarse- coughing - diarrhea - muscle soreness - headache - stuffy nose - symptoms lasted 5 days except high fever. Still feel feverish on day 6. Now have pain and swelling right wrist don't know if connected, but received no injury to wrist.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Tremor
Clinical narrative: (Taking ibuprofen) about 4 hours after shot started shaking then developed very high fever thru the nite w/ some nausea - next day very weak - sore throat - hoarse- coughing - diarrhea - muscle soreness - headache - stuffy nose - symptoms lasted 5 days except high fever. Still feel feverish on day 6. Now have pain and swelling right wrist don't know if connected, but received no injury to wrist.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia
Clinical narrative: Just reporting a few side effects from the FLUZONE HIGH DOSE Vaccine: A few hours after the injection, I started with really bad chills, then developed a fever. Lasted 3 days. Nothing life threatening, but worth reporting.
Age: 74.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Skin warm
Clinical narrative: Patient had noticeable swelling at the administration site. The area was also warm to the touch. No redness was present; there was only swelling.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Dizziness, Hyperhidrosis, Hypersomnia, Night sweats
Clinical narrative: 10/3/2013 evening - sweats, dizziness. 10/3-10/4 all night: sweats, very dizzy, severe joint pain legs and arms. 10/4 all day: very dizzy, headache, sweats, sleep most of day.
Age: 72.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Pain in extremity
Clinical narrative: 10/3/2013 evening - sweats, dizziness. 10/3-10/4 all night: sweats, very dizzy, severe joint pain legs and arms. 10/4 all day: very dizzy, headache, sweats, sleep most of day.
Age: 1.03
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Haematoma, Ultrasound scan
Clinical narrative: (R) leg with hematoma - large noted. US done. No further treatment other than heat applied.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Blister, Nausea
Clinical narrative: Pharmacy contacted 10/11 - Pt reported "4 or 5" blisters along arm and reported "sick at stomach" - Also reported blisters on palm of right hand and his armpit.
Age: 30.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Ocular hyperaemia, Throat tightness
Clinical narrative: 4 hours after shot eyes red and face red, throat felt tight. School nurse gave diphenhydramine unknown dose and called ambulance.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Injection site warmth, Pain
Clinical narrative: Arm swollen (R) arm from shoulder to elbow - warm to touch, (R) arm 1.5" larger than (L) arm. Started evening of administration very painful.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Tremor
Clinical narrative: Patient got flu and pneumonia shots on 10/15/13. On 10/16/13 he developed tremors. Patient has let doctor know.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling
Clinical narrative: Lip swelling - no throat noticed about 1 hr after - woke up from nap - was ever bigger.
Age: 0.52
Sex: M
Vaccine: DTAPIPV, FLU3, HIBV, PNC13, RV5, UNK
Symptoms: Wrong drug administered
Clinical narrative: KINRIX (Dtap and Polio) given instead of separate Dtap and Polio (IPV) vaccines.
Age: 0.52
Sex: M
Vaccine: DTAPIPV, FLU3, HIBV, PNC13, RV5, UNK
Symptoms: Unevaluable event
Clinical narrative: KINRIX (Dtap and Polio) given instead of separate Dtap and Polio (IPV) vaccines.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt with redness and hot (RD) per father started today. 5 inches x 5 inches instructed to place cool compresses on arm and give TYLENOL if pain. If not better to come back no fever.
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site inflammation, Injection site pain
Clinical narrative: Patient received influenza (right arm) and Pneumococcal (left arm) vaccines on 10/2/13 at pharmacy. Pt returned on 10/4/13 complaining of pain and inflammation on left arm from injection site to below the elbow. RPh on duty recommended physician visit and provided vaccine details to patient.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Local swelling, Pain in extremity, Pyrexia, Rash
Clinical narrative: Patient said her arm swelled to the size of a tennis ball, was swollen all around her arm with intense pain. She also had a rash and a fever of 100 degrees for at least 3 days. The pain was under her arm too.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Body temperature increased, Chills, Delirium, Nausea
Clinical narrative: Temperature of 104 degrees, chills, delerium, nausea.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Pt called pharmacy on 10-7-13 stating arm still sore from flu shot she received on 9-19-13. Rph explained muscle soreness normal, pt stated she may need to see her doctor.
Age: 22.0
Sex: M
Vaccine: FLU3
Symptoms: Neurological examination normal, Vision blurred
Clinical narrative: 11:50: pt received flu vaccine, IM LD, patient had never received a flu vaccine before, waited 15 min in waiting room prior to DC. Pt returned to clinic at 1400 stating blurred vision, neuro exam WNL, at 1410 pt stated vision changes had resolved, pt sent home, instructed to go to ER if symptoms reoccur or other symptoms occur.
Age: 62.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Unevaluable event
Clinical narrative: 1 x 6 cm tricep region.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Pt. vaccinated on 9-25-13. Arm felt fine for 2 days. On 2nd day pt said arm was very stiff and difficult to move arm; Also painful. Follow up w/pt. on 10-16-13 arm still very sore has been using Ibuprofen and creams to help relieve pain. Very slowly getting better.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Bright red, itchy, swollen from below injection site down to elbow began day after injection.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMRV
Symptoms: Injection site erythema, Vomiting
Clinical narrative: 10/15 Administered at 4:00p 10/16 vomiting x 2 at 8:30 a, localized, erythema, LLE, 2 areas, Top about 1" diameter, bottom 4 cm x 6 cm.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site bruising, Injection site pain, Injection site swelling
Clinical narrative: Swelling, pain and bruising at injection site 2 weeks after injection.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Rash erythematous, Rash pruritic
Clinical narrative: Small rash at site of injection. Small red itchy bumps on upper arm starting day after vaccine was administered. No treatment.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Dyspnoea, Ocular hyperaemia, Oxygen saturation decreased
Clinical narrative: SOB, elevated blood pressure redness of eyes, oxygen dropped.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Depressed level of consciousness, Feeling hot, Gaze palsy, Hyperhidrosis, Muscular weakness
Clinical narrative: 10 mins post vaccine patient experienced syncope episode. Pale and diaphoretic. 10 mins post syncope event patient at baseline. Patient was in the bathroom with her mother after the family received flu shot and c/o feeling hot and legs feeling shaky, then eyes rolled back and her mom caught her she started to pass out. Mom states she was pale and sweaty. She did not completely pass out mom states. Mom had her walking down hall to find a nurse.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Pallor, Syncope
Clinical narrative: 10 mins post vaccine patient experienced syncope episode. Pale and diaphoretic. 10 mins post syncope event patient at baseline. Patient was in the bathroom with her mother after the family received flu shot and c/o feeling hot and legs feeling shaky, then eyes rolled back and her mom caught her she started to pass out. Mom states she was pale and sweaty. She did not completely pass out mom states. Mom had her walking down hall to find a nurse.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt reported feeling "intense pain" in (L) deltoid injection site with administration. Pt reported pain "like never before" when received flu vaccine. States pain in (L) arm limited ability to abduct LUE to dress self x 2-3 days. States pain in (L) arm remains painful with lifting after 6 days. But pain has lessened. Pt counseled to see primary MD for evaluation ASAP.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Dyskinesia, Gaze palsy, Lethargy, Seizure like phenomena
Clinical narrative: On 10-16-13 pt was given FLUZONE at approx 9:42 am. Shortly thereafter pt complained of his stomache hurting. He began having seizure like activity including jerking movements, loss of bladder control and eyes rolling to the back of the head that lasted about 15 sec. He then was lethargic but was able to answer questions appropriately. Vitals were monitored.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Urinary incontinence
Clinical narrative: On 10-16-13 pt was given FLUZONE at approx 9:42 am. Shortly thereafter pt complained of his stomache hurting. He began having seizure like activity including jerking movements, loss of bladder control and eyes rolling to the back of the head that lasted about 15 sec. He then was lethargic but was able to answer questions appropriately. Vitals were monitored.
Age: 9.0
Sex: M
Vaccine: FLUN4
Symptoms: Urticaria
Clinical narrative: Patient received FLUMIST at a wellness fair on Saturday 10/12/13 at 10:30 am and presented with hives that evening and again the following morning and evening.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pain in arm starting AM after administration (couldn't lift arm") lasting thru 10/14 when pt reported. Pt took tramadol she had at home to help with pan, stated it was slowly decreasing.
Age: 30.0
Sex: M
Vaccine: TDAP
Symptoms: Erythema, Mass, Pain, Skin warm, Swelling
Clinical narrative: Redness which has progressively increased in size to 3" x 6". Warm to touch. Swollen and lump approx size of dime. Is now more sore. Applying Icy Hot at night. No fever. Today -MD recommended ZYRTEC 10 mg 1/day w/daily recheck.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Erythema, Local swelling
Clinical narrative: After vaccination patient got redness and swelling in left arm. Swelling and redness faded within a week but a small bump remained under the skin, first the size of a marble and now, 24 days later, size of a penny.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV, PPV
Symptoms: Injection site swelling
Clinical narrative: After vaccination patient got redness and swelling in left arm. Swelling and redness faded within a week but a small bump remained under the skin, first the size of a marble and now, 24 days later, size of a penny.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Nausea, Paraesthesia oral, Throat tightness
Clinical narrative: Started tingling lips, mouth, nasal cavity, then felt pressing on throat, nausea x 5 hrs after vaccination - recording to report by mother.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Injection site pain, Pain
Clinical narrative: Injection painful. Pain to deltoid area - pain increases with movement. No redness, swelling. Pain has increased and radiates to elbow - unable to take anti-inflammatory due to allergies. Only take Tylenol. No decrease in symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site warmth, Pyrexia
Clinical narrative: Welted and red around injection site, warmth to touch and painful low grade fever.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Welted and red around injection site, warmth to touch and painful low grade fever.
Age: 67.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site bruising, Injection site reaction, Rash erythematous
Clinical narrative: Information has been received from a pharmacist regarding a 67 year old female patient. The patient's medical history, drug reactions or allergies were not provided. On 16-SEP-2103, the patient was vaccinated with the second dose of PNEUMOVAX23 (subcutaneously in the right arm) (lot # J004747, expiration date 20-JUL-2014). On the same day, the patient received concomitantly a dose of Influenza virus vaccine (unspecified) (in left arm). On 16-SEP-2013, the patient developed an injection site reaction after vaccination with PNEUMOVAX 23. This may have been the patient's 2nd dose of PNEUMOVAX 23. The patient initially developed bruising at the PNEUMOVAX 23 injection site which has developed into a "reddish rash moving toward her elbow". At the time of the report, the patient was recovering from the adverse event. Additional information has been requested.
Age: 13.0
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 year old patient (gender unknown). On 30-SEP-2013, the patient was vaccinated subcutaneously with a 0.5 ml dose of PROQUAD. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unknown date, the patient was vaccinated in the pharmacy with PNEUMOVAX 23 (lot # J007786, expiration date: 25-SEP-2014). Route of administration and dose were not reported. Concomitant medications were not reported. On 29-SEP-2013 the patient experienced serious swelling at the injection site and complained of pain. These injection site reactions were larger than the pharmacy has ever seen before. The patient sought for medical attention and treatment was given for the events (not specified). The outcome of the adverse events was reported as recovering. The relationship between PNEUMOVAX and the adverse events was not reported. The pharmacist stated there have been 5 or 7 patients who have received this Lot and have not reported any reactions. A lot check was requested by pharmacist. This case is linked to case 1310USA003793 and 1310USA003792 via same reporter link. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Administration site pain, Injection site erythema, Injection site vesicles
Clinical narrative: Soreness, redness, blistering at administration site.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Lymphadenopathy, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history and no drug reactions/allergies. On 28-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H014561, expiration date: 21-MAR-2013, 0.5 ml, intramuscularly). It was reported that the patient was administered an unspecified pneumococcal vaccine on an unspecified date over 5 years ago. Concomitant therapies included valacyclovir hydrochloride, Seroquel, Klonopin and estrogens, conjugated Premarin. It was reported that after the patient was administered a dose of PNEUMOVAX23, on an unspecified dated in September 2013, the patient experienced nausea, swollen lymph nodes in the arm, fever, red spots going down the arm, vomiting, a swollen and hot arm and red ring around her biceps. The outcome of red ring around her biceps, nausea, swollen lymph nodes in the arm, fever, red spots going down the arm, vomiting and a swollen and hot arm was reported as not recovered/not resolved. The patient called the pharmacist. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Rash, Rash erythematous, Skin warm, Vomiting
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 59 year old female patient with no pertinent medical history and no drug reactions/allergies. On 28-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H014561, expiration date: 21-MAR-2013, 0.5 ml, intramuscularly). It was reported that the patient was administered an unspecified pneumococcal vaccine on an unspecified date over 5 years ago. Concomitant therapies included valacyclovir hydrochloride, Seroquel, Klonopin and estrogens, conjugated Premarin. It was reported that after the patient was administered a dose of PNEUMOVAX23, on an unspecified dated in September 2013, the patient experienced nausea, swollen lymph nodes in the arm, fever, red spots going down the arm, vomiting, a swollen and hot arm and red ring around her biceps. The outcome of red ring around her biceps, nausea, swollen lymph nodes in the arm, fever, red spots going down the arm, vomiting and a swollen and hot arm was reported as not recovered/not resolved. The patient called the pharmacist. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician refers to a 61 year old female patient. On 27-APR-2013 the patient was vaccinated with ZOSTAVAX, subcutaneous as shingles vaccinations. On 28-Apr-2013, the patient experienced shingles after receiving ZOSTAVAX. The outcome of shingles after receiving ZOSTAVAX is unknown. This is one of two reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a physician refers to a 11 year old male patient. On 20-AUG-2013 the patient was vaccinated with the second dose of GARDASIL (dose, route and lot number were not reported), and on 04-OCT-2013, patient was inadvertently given the third dose of GARDASIL (lot number was not reported) 0.5 ml, intramuscular, early. Concomitant medications were not reported. Additional information has been requested.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Headache, Nodule, Pain, Pruritus
Clinical narrative: Day 1 Large red spot, stinging, fevered. Day 2 Soreness and knot. Day 3 More redness, soreness, larger red spot. Headache. Still have small red spot and itching.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Pyrexia
Clinical narrative: Day 1 Large red spot, stinging, fevered. Day 2 Soreness and knot. Day 3 More redness, soreness, larger red spot. Headache. Still have small red spot and itching.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Reaction started about 90 min post immunization. Started with pain at injection site, patient had low grade fever an could not move arm. Redness noticed 10/7 and has spread down to elbow by 10/8. Area is hot, hard and red.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pyrexia
Clinical narrative: Reaction started about 90 min post immunization. Started with pain at injection site, patient had low grade fever an could not move arm. Redness noticed 10/7 and has spread down to elbow by 10/8. Area is hot, hard and red.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 20 year old female patient. No medical history or concomitant conditions were reported. On 04-SEP-2013 the patient was vaccinated with GARDASIL dose 1. No lot number or expiration date was reported. As soon as the patient arrive home (on 04-SEP-2013), she experienced swelling and injection site pain. The injection site was also reported to be red. The pain was reported to be severe enough to "keep her up at night". The patient returned to the physician on 25-SEP-2013. The physician observed the injection site arm and reported that the arm was no longer swollen, but visibly red and still sore. Since an unspecified date, the events were treated with ADVIL. To date only the first dose of GARDASIL has been administered. The reporter did not provide a causality statement. No further information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash vesicular, Tenderness
Clinical narrative: Shingles like rash luin incubation of vaccine, red and tender area as congealed pre vaccine.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Rash, Skin discolouration
Clinical narrative: Patient developed rash on arm at injection site and on her leg 3 days after Zostavax injection. She also reported a dark spot on affected leg in a different spot than the rash.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Mobility decreased, Pain in extremity, Rash erythematous
Clinical narrative: Patient received vaccine and that evening her arm was swollen and there was a raised red rash that covered about 6 inches around her upper arm. Patient said she could not raise her arm and it was very painful. Doctor recommended Ibuprofen and ice and by the next day patient said she was better.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin mass, Swelling
Clinical narrative: Had swelling and redness 2 days after shot then small nodule formed under skin.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Nausea, Pyrexia, Swelling
Clinical narrative: Redness, swelling, fever, h/a, nausea.
Age: 11.0
Sex: M
Vaccine: DTAP
Symptoms: Wrong drug administered
Clinical narrative: None noted. Child was inadvertently administered DTap instead of TDap. Unable to verify responsible party by phone. Sent letter to known address.
Age: 17.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 69.0
Sex: M
Vaccine: HEPAB
Symptoms: Urticaria
Clinical narrative: Hepatitis A and B 3 courses. 1st no effect; 2nd extenstive bruising. 3rd Hives all over body for a week. Self treated/BENADRYL.
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: TDap 10-12-13. Returned 10-14-13 for re-eval site. 8 x 6 cm area of Erythema and warmth. No induration.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site vesicles
Clinical narrative: Multiple vesicles at injection site, redness, swelling lasting 3 - 4 wks. Itching also. Size approximately 2".
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to 4 patients of unknown age and gender. Relevant medical history and concomitant medication were not provided. On an unknown date the patients were vaccinated with ZOSTAVAX. Lot number, dose, route and frequency were not provided. On an unknown date the patients experienced shingles after receiving ZOSTAVAX. All four unspecified patients received the ZOSTAVAX from the same unspecified retail pharmacy. The representative also reported that she was unsure if this was just a "venting" physician about that particular unspecified retail pharmacy. The outcome of shingles was unknown. The reported causality was unknown. Additional information has been requested.
Sex: M
Vaccine: PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated on pharmacy with PNEUMOVAX23 (lot # J007786, expiration date: 25-SEP-2014). Route of administration and dose were not reported. Concomitant medications were not reported. On 27-SEP-2013 the patient experienced serious swelling at the injection site and complained of pain. These injection site reactions were larger than the pharmacy has ever seen before. The patient sought for medical attention and treatment was given for the events (not specified). The outcome of the adverse events was reported as recovering. The relationship between PNEUMOVAX23 and the adverse events was not reported. The pharmacist stated there have been 5 or 7 patient who have received this Lot and have not reported any reactions. A lot check was requested by pharmacist. This case is linked to case 1310USA003793 and 1310USA002354 via same reporter link. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site haemorrhage, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Onset swelling, ecchymosis, heat, tender to palpation - 3 cm area at injection site tx - seen at clinic. Follow up calls.
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 multiple unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with a dose of PROQUAD lot # J002933, expiring  12-SEP-2014 (dose and route not provided) that went through an unsupported temperature excursion. No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. Pertinent medical history, drug reactions or allergies were not reported. On an unspecified date, the patient was vaccinated with PNEUMOVAX23 (lot # J007786, expiration date: 25-SEP-2014). Route of administration and dose were not reported. Concomitant medications were not reported. On 27-SEP-2013 the patient experienced serious swelling at the injection site and complained of pain. These injection site reactions were larger than the pharmacy has ever seen before. The patient sought for medical attention and treatment was given for the events (not specified). The outcome of the adverse events was reported as recovering. The relationship between PNEUMOVAX23 and the adverse events was not reported. The pharmacist stated there have been 5 or 7 patient who have received this Lot and have not reported any reactions. A lot check was requested by pharmacist. This case is linked to case 1310USA003793 and 1310USA002354 via same reporter link. Additional information has been requested.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site reaction, Myalgia, Pain
Clinical narrative: Vaccine was injected in left arm near shoulder. It's been 3 weeks and I still feel where injection was and have has throbbing pain in area and down to my elbow. Also will feel pain in shoulder muscle. It's sharp pain when I bend my arm or use neck muscles.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report was received from certified medical assistant concerning a patient of unknown age and gender. On 15-SEP-2007, the patient was vaccinated with the first dose of Hepatitis B vaccine (Recombinant) (manufacturer unknown) (lot number, expiry date, dose and route unspecified). On 11-OCT-2007, the patient was vaccinated with the second dose of Hepatitis B vaccine (Recombinant) (manufacturer unknown) (lot number, expiry date, dose and route unspecified) which was too early. On 10-Apr-2008, the patient was vaccinated with the third dose of Hepatitis B vaccine (Recombinant) (manufacturer unknown) (lot number, expiry date were reported as 655149/0006U and 09-MAY-2009 respectively, dose and route unspecified) which was too late. No concomitant therapy was reported. On an unspecified date, Hepatitis antibody testing was performed which showed that the patient had low immunity to hepatitis B. The outcome of the event was unknown. The relatedness for the event was unknown for Hepatitis B vaccine (Recombinant) (manufacturer unknown). Additional information has been requested.
Age: 42.0
Sex: M
Vaccine: MMR
Symptoms: Measles, Measles antibody negative, Mumps antibody test negative, Pyrexia, Rubella antibody negative
Clinical narrative: This spontaneous report was received from a physician assistant via a company representative concerning 42 year old male patient. Approximately on an unknown date in April 2013 (reported as about 6 months ago), the patient was vaccinated with a dose of MMR II (lot number, expiry date, dose and route unspecified). No concomitant therapy was reported. Approximately on an unknown date in 2013, after the vaccination, the patient developed a measles rash with koplik spots and a fever. On an unknown date prior to vaccination, titers were performed that showed the patient did not have immunity against measles, mumps and rubella. The patient sought medical attention (called physician office). It was unspecified if any treatment was given or if any lab test were performed after the vaccination. The outcome of the events was unknown. The relatedness for a measles rash with koplik spots and a fever was unknown for MMR II. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a treating pharmacist vial a field employee refers to a male patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX for prevention of shingles (dose, frequency, lot#, expiration date unknown, injections as reported route). On an unknown date, the following day of receiving ZOSTAVAX, the patient called to report a rash had developed on his leg. Action taken with therapy and outcome of the event were unknown. Additional information has been requested.