chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth, Pain
Clinical narrative: Onset noticed about 8 am on 9/13/12. On 9/14/12 reported pain in left upper arm 4 on a scale of 10. Worse when lifting. Area red, puffy, itchy, warm to touch. Denied fever. Area of inflammation marked. 11cm top to bottom x 7cm wide. Dr. aware. Monitor and use warm / cold compress. Completely resolved by 9/19/12.
Age: 18.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Approximately 2 minutes after receiving these vaccines the person fainted. She regained consciousness after 20-30 seconds and appeared to have no other problems afterwards.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Local reaction, Oedema peripheral, Tenderness
Clinical narrative: Left arm with swelling, mildly tender to palpation. MENVEO & GARDASIL were both given in this arm (left) localized reaction.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling/erythema 50 mm, warm to the touch, itchy.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: After 25 mins patient felt dizziness and lightheadedness. Patient asked to stay longer for observation. PCP aware.
Age: 23.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Approx. 70 mins. past receiving nasal FLUMIST client started with dizziness. B/P 102/60, P-80. Client reclined without additional symptoms until 3pm. At that time reports less dizziness but now has nausea/headache. 330p - B/P 110/64, P-78 & nausea. Client in touch on phone with primary doctor, arranged for ride home. Told to go to ER if any additional problems. Returned to work on 10/3/12 feeling fine.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Injection site rash
Clinical narrative: Rash near injection site on right thigh.
Age: 1.14
Sex: M
Vaccine: HEPA, MMR, VARCEL, HEPA, MMR, VARCEL
Symptoms: Incorrect route of drug administration, Injection site rash
Clinical narrative: Rash near injection site on right thigh.
Age: 25.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rubella antibody test
Clinical narrative: Titre drawn 9-25-12 to check immunity was "equivical" for Rubella.
Age: 25.0
Sex: F
Vaccine: MMR, MMR
Symptoms: Rubella antibody negative
Clinical narrative: Titre drawn 9-25-12 to check immunity was "equivical" for Rubella.
Age: 35.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Evening of vaccine had a headache. Next day severe body aches with fever much better after 24 hours.
Age: 16.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given an intradermal FLUZONE shot indicated in patients over 18 years old. No adverse event occurred, this is just a proactive report.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus generalised
Clinical narrative: Received flu vaccine 9/17/12. Developed generalized itchiness 9/19/12. Still scratching today. No complaint of respiratory distress. Has had flu vaccine without problems in the past. When questioned, has diarrhea when eating eggs.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Joint range of motion decreased, Pain, Swelling
Clinical narrative: On 10/2/12 received pneumococcal vaccine had swelling and pain afterwards for 6-8 hours then swelling spread, pain increased, had limited range of motion and temp 100.7 for 12 hours.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Computerised tomogram normal, Dizziness, Fall, Head injury, Lethargy
Clinical narrative: Pt sent to hospital by PCP after falling off exam table post vaccine administration. Patient fell & hit head, no loss of consciousness. Pt lethargic, dizzy, nauseous. Some vomiting. Pt received HPV, MCV4 & Tdap.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Nausea, Vomiting
Clinical narrative: Pt sent to hospital by PCP after falling off exam table post vaccine administration. Patient fell & hit head, no loss of consciousness. Pt lethargic, dizzy, nauseous. Some vomiting. Pt received HPV, MCV4 & Tdap.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Local reaction, Oedema peripheral
Clinical narrative: Severe (R) arm erythema & swelling. Suspect localized reaction no evidence of cellulitis.
Age: 6.0
Sex: M
Vaccine: FLUN3
Symptoms: Epistaxis
Clinical narrative: Bloody nose 1 hr after vaccine given.
Age: 1.19
Sex: F
Vaccine: FLU3
Symptoms: No adverse event
Clinical narrative: No adverse events observed.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Dizziness, Headache, Muscular weakness, Pain, Sjogren's syndrome
Clinical narrative: Has soreness, shivering, pain near armpit, headache, weakness and some dizziness in both arms.
Age: 41.0
Sex: F
Vaccine: TD
Symptoms: Injection site pain
Clinical narrative: "Severe arm pain" same arm as injection was given. Required two follow up office visits as well as Physical Therapy.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injections site red, swollen, tender to touch, hot...also same symptoms further down the arm and into the shoulder and arm pit.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Skin warm, Swelling, Tenderness
Clinical narrative: Injections site red, swollen, tender to touch, hot...also same symptoms further down the arm and into the shoulder and arm pit.
Age: 86.0
Sex: M
Vaccine: FLU3
Symptoms: Death
Clinical narrative: Per family pt had a good day and eve, no signs of allergic reaction or difficulty.  He failed to wake up the next morning. Time of death 10:37 AM.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Urticaria
Clinical narrative: Tightness in chest, cough and hives.  Awoke with symptoms in middle of night.  Did not seek treatment.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Grand mal convulsion
Clinical narrative: Patient got dizzy and had a tonic clonic seizure after about 10 mins. It lasted about 1 min and patient became alert again.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Burning sensation, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Sharp pain in all of left thigh. Bad burning, tingling, numbness can't sleep from burning pain.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Hyperaesthesia, Oedema peripheral
Clinical narrative: Severe swelling, tightness and pain of left upper limb; erythema of forearm with spread to arm.  Extreme pain to light touch. Took Benadryl.  Called physician and informed to not take flu shot again.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Eye irritation, Headache, Nasal congestion, Oropharyngeal pain
Clinical narrative: Symptoms started with a cough and then an itchy throat. Then throat became really sore, and developed a fever (eyes felt burning). Then a nasal congestion with runny nose and headache. This lasted overnight and the symptoms were almost completely gone by 10/10/2012 at 11:00 AM.
Age: 30.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Rhinorrhoea, Throat irritation
Clinical narrative: Symptoms started with a cough and then an itchy throat. Then throat became really sore, and developed a fever (eyes felt burning). Then a nasal congestion with runny nose and headache. This lasted overnight and the symptoms were almost completely gone by 10/10/2012 at 11:00 AM.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling on right upper arm where vaccine was administered.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Dry mouth, Gastrooesophageal reflux disease, Hypersensitivity, Rash, Swollen tongue
Clinical narrative: Rash (described as hives) to legs and back; dry mouth; reflux; tongue swelling;  Pt went to ED and treated.  Pt DX with "Generalized allergic reaction with skin rash secondary to drug."
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Rash (described as hives) to legs and back; dry mouth; reflux; tongue swelling;  Pt went to ED and treated.  Pt DX with "Generalized allergic reaction with skin rash secondary to drug."
Age: 6.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness at injection site, warmth and swelling at injection site.
Age: 11.0
Sex: F
Vaccine: FLU3, HEPA, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Syncope.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and warmth at injection site (left deltoid).
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chest pain, Chills, Hyperhidrosis, Respiratory disorder
Clinical narrative: Patient wants flu shot reported to VAERS. Had symptoms (mild) last year with flu shot. History of painting occupation. Concerned about preservative in vaccine. Respiratory problems, chest on "fire", chills, inhaler not helping. Thought about going to ER, but waited. Rested, became sweaty, no vomiting. Symptoms lasted unto 2AM-3AM. Feels back to normal today. Also, had a Pneumovax 10/09/2012.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Blood culture negative, Chills, Chromaturia, Dyspnoea, Erythema
Clinical narrative: Fever, chills, headache/ pain behind my eyes, fatigue. 8/22/12 erythema nodosum on both legs-redness, tenderness and swelling.  Saw employee health md 8/23 and he diagnosed erythema nodosum, temp at that time was 102.4-advised to see my family md. Saw family md at 3pm that day-said I had a reaction to chickenpox vaccine. Fever continued over 101 degrees for 3 more days plus extreme fatigue. Noticed change-darkening of urine and had labs drawn on 8/25-routine employee health orders. Elevated liver enzymes. Went to minor care on 8/26 and sent to ER. Fatigue, SOB. O2 Sat 95, and 92. Elevated d-dimer, liver enzymes, sl elevated wbc. urine normal. Blood cultures drawn-negative. Temp sl elevated. Had discontinued Lamisil on 8/24.  Had taken this medication several years ago with no problem. Fatigue continued for 3 more days. Follow-up visit with md. Had labs repeated-told all was back to normal. Supposed to have second shot, but I will not.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema nodosum, Eye pain, Fatigue, Fibrin D dimer increased, Headache
Clinical narrative: Fever, chills, headache/ pain behind my eyes, fatigue. 8/22/12 erythema nodosum on both legs-redness, tenderness and swelling.  Saw employee health md 8/23 and he diagnosed erythema nodosum, temp at that time was 102.4-advised to see my family md. Saw family md at 3pm that day-said I had a reaction to chickenpox vaccine. Fever continued over 101 degrees for 3 more days plus extreme fatigue. Noticed change-darkening of urine and had labs drawn on 8/25-routine employee health orders. Elevated liver enzymes. Went to minor care on 8/26 and sent to ER. Fatigue, SOB. O2 Sat 95, and 92. Elevated d-dimer, liver enzymes, sl elevated wbc. urine normal. Blood cultures drawn-negative. Temp sl elevated. Had discontinued Lamisil on 8/24.  Had taken this medication several years ago with no problem. Fatigue continued for 3 more days. Follow-up visit with md. Had labs repeated-told all was back to normal. Supposed to have second shot, but I will not.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Hepatic enzyme increased, Oedema peripheral, Pyrexia, Tenderness, Urine analysis normal
Clinical narrative: Fever, chills, headache/ pain behind my eyes, fatigue. 8/22/12 erythema nodosum on both legs-redness, tenderness and swelling.  Saw employee health md 8/23 and he diagnosed erythema nodosum, temp at that time was 102.4-advised to see my family md. Saw family md at 3pm that day-said I had a reaction to chickenpox vaccine. Fever continued over 101 degrees for 3 more days plus extreme fatigue. Noticed change-darkening of urine and had labs drawn on 8/25-routine employee health orders. Elevated liver enzymes. Went to minor care on 8/26 and sent to ER. Fatigue, SOB. O2 Sat 95, and 92. Elevated d-dimer, liver enzymes, sl elevated wbc. urine normal. Blood cultures drawn-negative. Temp sl elevated. Had discontinued Lamisil on 8/24.  Had taken this medication several years ago with no problem. Fatigue continued for 3 more days. Follow-up visit with md. Had labs repeated-told all was back to normal. Supposed to have second shot, but I will not.
Age: 58.0
Sex: F
Vaccine: VARCEL
Symptoms: Vaccination complication, White blood cell count increased
Clinical narrative: Fever, chills, headache/ pain behind my eyes, fatigue. 8/22/12 erythema nodosum on both legs-redness, tenderness and swelling.  Saw employee health md 8/23 and he diagnosed erythema nodosum, temp at that time was 102.4-advised to see my family md. Saw family md at 3pm that day-said I had a reaction to chickenpox vaccine. Fever continued over 101 degrees for 3 more days plus extreme fatigue. Noticed change-darkening of urine and had labs drawn on 8/25-routine employee health orders. Elevated liver enzymes. Went to minor care on 8/26 and sent to ER. Fatigue, SOB. O2 Sat 95, and 92. Elevated d-dimer, liver enzymes, sl elevated wbc. urine normal. Blood cultures drawn-negative. Temp sl elevated. Had discontinued Lamisil on 8/24.  Had taken this medication several years ago with no problem. Fatigue continued for 3 more days. Follow-up visit with md. Had labs repeated-told all was back to normal. Supposed to have second shot, but I will not.
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Mother stated that child complained of redness and swelling to left armin the morning.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site haematoma, Pain in extremity, Skin warm
Clinical narrative: On evening of 10/8 patient states right arm sore/hurting, no bruising, no redness, 10/9/12 upon awakening 6:30am on 10/9 patient notice bruising approx 1 in around injection site-she states bruising worsening as day progressed-not red but arm felt warm. On 10/10/12 upon awakening patient states bruise larger about 2 in, redness on arm below injection site, feels warm to touch, some redness on R arm. No fever on any day per pt. Upon examining pt arm on 10/10/12 4:10pm bruise approx 1-2 in, redness below shot on arm, pt states warm to touch. Told pt to ice site, Tylenol pain/fever, and for patient to call MD stat for eval. Benadryl if allergic reaction. Pt called MD not in office 10/10/12 pt says she will call MD 10/11/12. She will notify us of outcome.
Age: 5.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pruritus
Clinical narrative: Swollen left arm and very itchy.  Provider seen patient today in clinic. Provider wants patient to do the following:  Diphenhydramine (Benadryl) 12.5 mg/5ml 6.5 ml every 6 hours for 3 days. Ice 3-4 x a day. Recheck if the redness gets more than 15 mm past the edges of the marked border today or if she has troubles breathing or swallowing.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pharyngeal oedema, Rash erythematous, Urticaria
Clinical narrative: Left deltoid. No pain. + pruritus. No wheezing, throat swelling, hives. 5cm nontender erythematous.
Age: 77.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Dizziness
Clinical narrative: Dizziness, had it before shot, but know worse.  Started after getting shot and has happened intermittently since.
Age: 94.0
Sex: M
Vaccine: FLUX
Symptoms: Anticoagulation drug level above therapeutic
Clinical narrative: IR LEVEL JUMPED FROM 2.2 TO 4.4 AFTER VACCINE (on blood thinner).
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, warm to touch, and mild pain (3/10) at the injection site.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Pain, Pyrexia, Swelling
Clinical narrative: Swelling, fever, large area of redness, pain; returned to doctor, prescribed antibiotic and steroid for possible infection.
Age: 52.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Immediate post-injection reaction, Injection site pruritus, Skin warm
Clinical narrative: Site became itchy right away. Went home. Left arm was red and warm to the touch. Today 10/10/2012 it was reported that redness extended 6-7 inches long and about the width of the arm. Going to doctor today and will start on Benadryl if OK with MD.
Age: 69.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site pruritus, Injection site rash, Injection site reaction, Staphylococcal infection, Wound drainage
Clinical narrative: Rash w big, itchy bumps from shoulder to elbow and spreading to outer arm area. Went to urgent care, got cortisone injection and was told to use topical. On Sept 27, 2012 was diagnosed w MRSA in right arm where pneumonia shot was given. Got IV Vancomycin. Called on 10-2-2012 and said she is going to a wound care clinic where right arm was lanced and drained at injection site area. Stated the rash that started around the injection site was itchy and she scratched it opening up the skin where the MRSA started. On 10-8-2012 patient states the arm is beginning to heal. Still itchy but not as bad. Still going to wound clinic.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA, TDAP, YF
Symptoms: Dizziness, Loss of consciousness, Muscle twitching, Pallor, Posture abnormal
Clinical narrative: Patient said he felt like he was going to pass out, went to get him juice, when returned patient was leaning back in chair with his head flung back. Patients skin was pale and greenish, was non-responsive. Patient twitched once or twice, and then came to. Patient drank juice and ate some chocolate and said was feeling ok. Color came back and he said he felt fine before leaving the office.
Age: 30.0
Sex: M
Vaccine: HEP, HEPA, TDAP, YF
Symptoms: Skin discolouration, Unresponsive to stimuli
Clinical narrative: Patient said he felt like he was going to pass out, went to get him juice, when returned patient was leaning back in chair with his head flung back. Patients skin was pale and greenish, was non-responsive. Patient twitched once or twice, and then came to. Patient drank juice and ate some chocolate and said was feeling ok. Color came back and he said he felt fine before leaving the office.
Age: 0.18
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Injection site reaction, Rash, Rash erythematous, Urticaria
Clinical narrative: Rash/hives developed on both twins;  location included front chest & back;  there was also a group of red bumps surrounding near the injection site on thigh.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Intussusception
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 17 year old male patient with ZITHROMAX allergy and Ampicillin allergy. No other pertinent medical history was reported. The patient was vaccinated with dose 2 GARDASIL (lot number, dose, frequency and route was unspecified) on 09-SEP-2012. No other co-suspects were reported. No concomitant medications were reported. On 28-SEP-2012 the patient was diagnosed with intussusception. The patient sought medical attention and was admitted to the hospital on the same day. It was unspecified if the patient received treatment. The outcome of intussusception was reported as recovered on an unspecified date in 2012. The relatedness for intussusception is unknown for GARDASIL. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test, Cardiac enzymes, Chest discomfort, Dizziness, Dyspnoea
Clinical narrative: Day 1-3 6 hours s/p flu shot felt unwell, cold, shaking uncontrolled, lasting 6 hours. Fever 104.0, hot flashes, insomnia, vomiting, dizzy, unsteady gait. Day 4 9/24/12 referred to Dr. Mon & Wed. SOB, chest discomfort, EKG.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Electrocardiogram, Feeling cold, Gait disturbance, Hot flush, Insomnia
Clinical narrative: Day 1-3 6 hours s/p flu shot felt unwell, cold, shaking uncontrolled, lasting 6 hours. Fever 104.0, hot flashes, insomnia, vomiting, dizzy, unsteady gait. Day 4 9/24/12 referred to Dr. Mon & Wed. SOB, chest discomfort, EKG.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Malaise, Pyrexia, Tremor, Vomiting
Clinical narrative: Day 1-3 6 hours s/p flu shot felt unwell, cold, shaking uncontrolled, lasting 6 hours. Fever 104.0, hot flashes, insomnia, vomiting, dizzy, unsteady gait. Day 4 9/24/12 referred to Dr. Mon & Wed. SOB, chest discomfort, EKG.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Headache, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: This 26 year old female presents with: 1. vaccine reaction. The symptoms began 15 minutes ago. The symptoms are reported as being moderate. The location is physician office. Aggravating factors include reaction to intradermal flu vaccine. She states the symptoms are acute. Patient received the intradermal Flu vaccine at 12:00pm (given by Dr in left deltoid) and at 12:15pm patient's left deltoid at injection site was red and warm at injection site she became dizzy and nausea and then started vomiting, patient stated her head started hurting, and her throat felt tight patient's blood pressure was 141/80 with a pulse was 121 Dr check the patient and ordered 50mg of BENADRYL (given at 12:30pm Im Right Glute by Ma) patient was taken to a room and blood pressure was rechecked at 12:30 and it was 121/77 pulse of 100 O2 was 97%, at 12:34 patient began to shake and was unresponsive and Dr used smelling salt and patient became responsive right away blood pressure was 122/82, pulse was 93 and O2 99%. Dr ordered patient 1000ml of 0.9% sodium chloride (lot # 15-184-JT Exp 3-1-2014) IV, IV Fluid started at 1:05pm by Dr in patients right arm. Blood pressure was taken again at 12:45pm 109/72 pulse 87 and O2 was 98%, patient finished IV fluids at 1:48pm and blood pressure was 114/77 pulse was 81 and O2 was 98% and patient stated she was feeling better, and was helped up and walked around without dizziness or nausea. Before going home patient was informed per Dr to take 50mg of oral BENADRYL if symptoms of nausea, dizziness, vomiting return and if patient has any difficult breathing to either call 911 or go to the Er and has to have someone with her today to keep a watch on her, patient friend picked her up and her husband was going to be home with her the rest of the day. Patient left at 2:00pm. Called patient at 3:34pm to check to see how she was doing she stated she was sleepy and laying down and husband was home and stated she still has a little dizziness, reinforce if any trouble breathing to either call 911 or go to ER patient stated OK.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Somnolence, Throat tightness, Tremor, Unresponsive to stimuli, Vomiting
Clinical narrative: This 26 year old female presents with: 1. vaccine reaction. The symptoms began 15 minutes ago. The symptoms are reported as being moderate. The location is physician office. Aggravating factors include reaction to intradermal flu vaccine. She states the symptoms are acute. Patient received the intradermal Flu vaccine at 12:00pm (given by Dr in left deltoid) and at 12:15pm patient's left deltoid at injection site was red and warm at injection site she became dizzy and nausea and then started vomiting, patient stated her head started hurting, and her throat felt tight patient's blood pressure was 141/80 with a pulse was 121 Dr check the patient and ordered 50mg of BENADRYL (given at 12:30pm Im Right Glute by Ma) patient was taken to a room and blood pressure was rechecked at 12:30 and it was 121/77 pulse of 100 O2 was 97%, at 12:34 patient began to shake and was unresponsive and Dr used smelling salt and patient became responsive right away blood pressure was 122/82, pulse was 93 and O2 99%. Dr ordered patient 1000ml of 0.9% sodium chloride (lot # 15-184-JT Exp 3-1-2014) IV, IV Fluid started at 1:05pm by Dr in patients right arm. Blood pressure was taken again at 12:45pm 109/72 pulse 87 and O2 was 98%, patient finished IV fluids at 1:48pm and blood pressure was 114/77 pulse was 81 and O2 was 98% and patient stated she was feeling better, and was helped up and walked around without dizziness or nausea. Before going home patient was informed per Dr to take 50mg of oral BENADRYL if symptoms of nausea, dizziness, vomiting return and if patient has any difficult breathing to either call 911 or go to the Er and has to have someone with her today to keep a watch on her, patient friend picked her up and her husband was going to be home with her the rest of the day. Patient left at 2:00pm. Called patient at 3:34pm to check to see how she was doing she stated she was sleepy and laying down and husband was home and stated she still has a little dizziness, reinforce if any trouble breathing to either call 911 or go to ER patient stated OK.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Chest X-ray normal, Chest discomfort, Electrocardiogram normal, Flushing, Hyperhidrosis
Clinical narrative: Received vaccine at 1:55 pm, took nap, awoke at 5:00 pm nausea, chest tightness, diaphoresis, flushing throat felt swollen, face tingling. Took BENADRYL 25 mg PO without help. Taken to ER via rescue squad at 7:30 pm. CXR okay, EKG okay. Received IV steroid and BENADRYL.
Age: 20.0
Sex: F
Vaccine: RAB
Symptoms: Nausea, Paraesthesia, Pharyngeal oedema
Clinical narrative: Received vaccine at 1:55 pm, took nap, awoke at 5:00 pm nausea, chest tightness, diaphoresis, flushing throat felt swollen, face tingling. Took BENADRYL 25 mg PO without help. Taken to ER via rescue squad at 7:30 pm. CXR okay, EKG okay. Received IV steroid and BENADRYL.
Age: 86.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphoma
Clinical narrative: Information has been received from a registered pharmacist (R.Ph.) concerning an 86 year old female patient. On an unspecified date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route and frequency, and lot number were not reported). On an unknown date the patient was diagnosed with lymphoma. It was reported that the patient was not taking any immunosuppressive medication and there had been no hospitalization. At the time of the report, the patient's outcome unknown. It was unspecified if the patient sought medical attention. The relatedness for lymphoma was unknown for ZOSTAVAX. As per internal procedure, lymphoma has been considered to be an other important medical event. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: GlaxoSmithKline - FLUARIX given 9/27/12 (Thurs. afternoon). Woke up Friday morning with rash to back, extremities, groin area. No difficulty breathing, rash and itching. Seen in Urgent Care on 10/1/12, given Medrol 4 mg pak x 6 days and will f/u with PMD.
Age: 47.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Cellulitis, Erythema, Oedema peripheral
Clinical narrative: RUE edema & erythema the evening after receiving vaccines; Dx is cellulitis at this time. Tx Doxycycline hyclate 100 mg 1 tab BID for 10 days.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity
Clinical narrative: Pt has normal swelling on the right arm. Pt also has pain (severe) radiating throughout the whole right arm for 3-5 days. The pain subsided and patient is well after 1 week.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm hot, swollen, & red from elbow to shoulder.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Blood electrolytes, Cardiac enzymes, Computerised tomogram, Full blood count, Hyperhidrosis
Clinical narrative: Rec'd vaccine Friday, Sunday body aches with mild vertigo. Monday same symptoms, still mild. Tues night into Wed exp. severe vertigo, nausea, sweating, went to Emergency Room. Given ANTIVERT & ZOFRAN. Discharged to home.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Vertigo
Clinical narrative: Rec'd vaccine Friday, Sunday body aches with mild vertigo. Monday same symptoms, still mild. Tues night into Wed exp. severe vertigo, nausea, sweating, went to Emergency Room. Given ANTIVERT & ZOFRAN. Discharged to home.
Age: 9.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Abdominal pain upper, Cyanosis, Fall, Hypokinesia, Unresponsive to stimuli
Clinical narrative: Patient received vaccines Hep A & Influenza in office in am without problems. Mom called approx 2 hrs. later and reported patient c/o stomach ache, fell to the floor, unresponsive, no movement & turning purple. Lasted approx 5 min & resolved. Looked well in office afterward.
Age: 7.0
Sex: F
Vaccine: FLU3
Symptoms: Urticaria
Clinical narrative: Broke out in hives.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema, Induration, Pruritus, Rash, Swelling
Clinical narrative: Redness, itching very bad and small bumps, hardness, swollen. Got the flu shot on a Monday. Started on Wednesday till Sunday. 5 days.
Age: 1.01
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Rash
Clinical narrative: Rash developed around shot site after 2 days increased after 3-4 days to red lesion with small bump. Pt now has small spots on torso/arms & legs - started on 9/30/12.
Sex: M
Vaccine: VARCEL
Symptoms: Rash generalised, Rash maculovesicular, Scab
Clinical narrative: 10/1/12 scattered maculovesicles - drying on upper back, scalp, arms, and trunk. Approximately 20 spots.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster
Clinical narrative: Shingles. Diagnosed 5 days after the flu vaccine injection.
Age: 21.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Pt states her arm starting hurting around 3 pm - took some Ibuprofen - didn't help much - in pain throughout the night - woke up this morning could not move arm.
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Headache, Hyperhidrosis
Clinical narrative: Joint & muscle pain; headache, fever; sweating, diarrhea; stomach pain 24 hours after vaccine - continued for 7 days - treated with BRAT diet; over the counter pain reliever (TYLENOL - ibuprofen).
Age: 63.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza virus test, Myalgia, Pyrexia
Clinical narrative: Joint & muscle pain; headache, fever; sweating, diarrhea; stomach pain 24 hours after vaccine - continued for 7 days - treated with BRAT diet; over the counter pain reliever (TYLENOL - ibuprofen).
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Middle insomnia, Musculoskeletal pain
Clinical narrative: Patient reported pain in upper arm, 'all over' and under shoulder of right arm where she had the injection. Pain was intolerable and would wake her up at night. No redness, heat, or swelling at the site. Reported taking IBU & FLEXERIL to no avail.
Age: 26.0
Sex: F
Vaccine: FLU3, MMR, PPV
Symptoms: Cellulitis
Clinical narrative: Cellulitis - 2 days after. BACTRIM DS 800/160 mg oral tab NORCO 5/325.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injected limb mobility decreased, Injection site pain
Clinical narrative: Headache, tenderness/pain (L) upper arm. Persists despite use of ALEVE. Pain with elevation/internal rotation & abduction (L) shoulder at least 1 week later. Unable to elevate above shoulder level.
Age: 1.97
Sex: M
Vaccine: VARCEL
Symptoms: Erythema, Induration, Vaccination site warmth
Clinical narrative: Erythema, induration, warmth on area of vaccine site. BENADRYL ointment on area. Did not take antibiotics orally.
Age: 52.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Rash, Vaccine positive rechallenge
Clinical narrative: 10/10/2012 No reaction to eggs but rash reaction after flu 1-3 days for last 2 years.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Monoplegia, Pyrexia
Clinical narrative: 27 Aug 12 5:00 PM shot administered. 28 Aug 12 3:00 AM awoke with 104.7 fever, legs were paralyzed for a few minutes. 103 fever most of the day. 6:00 PM uncontrollable diarrhea, no notice, no pain. 29 Aug 12 Fever 101, diarrhea ended about 6:00 PM. 30 Aug 12 Better.
Age: 16.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness
Clinical narrative: After receiving immunization, pt temporarily lost consciousness upon standing.
Age: 67.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Chills, Pyrexia, Visual impairment
Clinical narrative: Knee pain, fever, chills, vision changes.
Age: 1.29
Sex: F
Vaccine: DTAP, FLU3, HEPA
Symptoms: Rash
Clinical narrative: Rash developed five hours later. Treatment: BENADRYL OTC and ZYRTEC.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Nausea, Pallor, Tremor
Clinical narrative: Student states that at 10:00 PM she became very pale and started to shake. She was nauseated & dizzy. Her heart rate went to 130. This morning she had slight nausea and a heart rate 100. By 1000 she was feeling better & her heart rate was 85.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Client reported to Health Unit Oct. 10, 2012, reported, "I received a Flu shot here on Oct 4, 2012 to my right arm and yesterday Oct. 9, 2012, I began experiencing, chest discomfort with breathing/dry cough/sore throat/multiple blistered red raised areas with severe itching and swelling to and around injection site". Cortisone ointment applied to site/throat lozenges given/cold compress given for self application. Referred to Primary Health Care Team for further evaluation.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site vesicles, Oropharyngeal pain
Clinical narrative: Client reported to Health Unit Oct. 10, 2012, reported, "I received a Flu shot here on Oct 4, 2012 to my right arm and yesterday Oct. 9, 2012, I began experiencing, chest discomfort with breathing/dry cough/sore throat/multiple blistered red raised areas with severe itching and swelling to and around injection site". Cortisone ointment applied to site/throat lozenges given/cold compress given for self application. Referred to Primary Health Care Team for further evaluation.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC
Symptoms: Injection site erythema, Injection site haematoma, Injection site papule
Clinical narrative: Erythematous, multiple papular lesions on both ant-lat thighs with small bruise on injection sites. Adv. local ice, HC cream 1%.
Age: 70.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Muscular weakness
Clinical narrative: Patient states he is experiencing muscle weakness from the waist down starting a few hours after vaccination.
Age: 57.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pt started to get red swelling on (R) deltoid yesterday. Positive warm, positive pain, positive red & swelling.
Age: 4.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Client brought to Health Dept. by parents who reports when client woke up this morning, he had complaints of right leg itching. parents observed red, hard area to (Rt) outer thigh - area warm to the touch, hard, very swollen - approx. 2 inches by 2 inches - Seen by M.D. - diagnosis of cellulitis.
Age: 4.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Injection site warmth, Pharyngitis streptococcal
Clinical narrative: Client brought to Health Dept. by parents who reports when client woke up this morning, he had complaints of right leg itching. parents observed red, hard area to (Rt) outer thigh - area warm to the touch, hard, very swollen - approx. 2 inches by 2 inches - Seen by M.D. - diagnosis of cellulitis.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling at site next day, increased swelling & redness for 2 days after that. Redness & swelling continued for 5 more days - pt applied ice for 3-4 days.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Erythema, Induration, Malaise, Nausea
Clinical narrative: Rcd 2012-13 Influenza vaccine on 10/2/12. Felt pain to elbow within 30 minutes of IZ. Slowly feeling N/general malaise. Came to Occ Health 10/4/12. Has 10cm x 3cm area of erythema/induration & itch.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Rcd 2012-13 Influenza vaccine on 10/2/12. Felt pain to elbow within 30 minutes of IZ. Slowly feeling N/general malaise. Came to Occ Health 10/4/12. Has 10cm x 3cm area of erythema/induration & itch.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Immediate post-injection reaction, Injection site warmth, Local reaction, Lymphadenopathy
Clinical narrative: Immediate local reaction - spread to upper arm, hot to touch, glands swollen under arm where received shot - reaction on right arm where received PPSV - no reaction to Flu.
Age: 1.31
Sex: M
Vaccine: DTAPIPVHIB, FLU3, MMR, VARCEL
Symptoms: Erythema, Induration
Clinical narrative: Local rxn 8cm x 6cm erythema and induration.
Age: 63.0
Sex: F
Vaccine: RAB
Symptoms: Dizziness, Oxygen saturation decreased, Pallor
Clinical narrative: I felt lightheaded. Nurse said I turned pale. Asked me to take a juice box, eat crackers. Meanwhile a nurse took my blood pressure: Started at 170/90, 5 min later 150/80 & when I left. 120/60. My oxygen had dropped to 75 - back to 93 ", pulse 88 to 80. Took about 45 min to feel ok.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Pt. said her arm was red and swollen (R arm). She took BENADRYL and an NSAID and it is getting better.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Pt. starting itching approximately 5-10 minutes after receiving FLUZONE .5cc injection. Given BENADRYL 25mg at 11:30 AM. Itching still present at 11:55 AM given second BENADRYL 25 mg.
Age: 82.0
Sex: M
Vaccine: FLU3
Symptoms: Bronchospasm, Dyspnoea, Electrocardiogram normal, Syncope
Clinical narrative: Patient was given FLUZONE-HD at 2:21 PM on 9/28/12, appeared normal after 20 minutes, and was sent home. The patient entered the Emergency Dept. around 7:30 that evening experiencing shortness of breath and subjective bronchospasms. The patient then experienced syncope. EKG and vital signs appeared normal and patient was discharged after a couple of hours.
Age: 53.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Large localized reaction with redness on (L) arm at ADACEL injection site and below.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: Rash (itchy, sore, welt about 4x4"). Appeared 2 days after injection. Pt applied BENADRYL cream.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Feeling hot, Pyrexia, Swelling
Clinical narrative: Egg shaped swelling (1 1/4 in x 2), redness, heat on 10/2; swelling increased to (1 1/2 x 3") on 10/3; swelling elongated to 5 inches on 10/4 with low grade fever; pt saw her MD on 10/4 when 3 vesicles on one side & 1 vesicle on other side of body appeared.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Feeling hot, Hypoaesthesia, Lip swelling, Pain in extremity, Paraesthesia
Clinical narrative: Stabbing/throbbing pain to upper arm (left). Numbness & tingling to entire arm/head (left). Hives (face neck) - swelling lip tongue - sudden warmth over most of body.
Age: 58.0
Sex: F
Vaccine: UNK
Symptoms: Swollen tongue, Urticaria
Clinical narrative: Stabbing/throbbing pain to upper arm (left). Numbness & tingling to entire arm/head (left). Hives (face neck) - swelling lip tongue - sudden warmth over most of body.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Hallucination, Injection site haematoma
Clinical narrative: Hallucination, bruising on area (at site).
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Headache, Nausea, Vomiting
Clinical narrative: Developed nausea, headache, dizziness, emesis x 2 1.5 hrs after Tdap immunization. Resolved with 48 hrs.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Computerised tomogram normal, Occipital neuralgia
Clinical narrative: Acute (R) Occipital Neuritis one week following ZOSTAVAX.
Age: 1.12
Sex: M
Vaccine: DTAPIPVHIB, HIBV, MMR, PNC, VARCEL
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Gave a PENTACEL and HIB.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Inflammation
Clinical narrative: MD diagnosed with extreme inflammatory response.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Chills, Dyspnoea, Feeling hot
Clinical narrative: 2012-13 Flu vaccination at 130pm on 10/2/12 - OK until approximately 530-6pm, felt weak/shaky, pain to lower back, SOB, hot/chills, next day still felt weak, chills decreased - now feels better (10/4/12).
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Nervousness
Clinical narrative: 2012-13 Flu vaccination at 130pm on 10/2/12 - OK until approximately 530-6pm, felt weak/shaky, pain to lower back, SOB, hot/chills, next day still felt weak, chills decreased - now feels better (10/4/12).
Age: 93.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: No adverse events experienced. Flu shot may have been given SQ and shingles vaccine may have been given IM. Merck stated shingles vaccine ok and no need for re-vaccination. CDC states no need for flu shot re-vaccination.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Rash, Rash generalised
Clinical narrative: Pt was given a flu shot on 9/19/12. Pt complained that she broke out with a rash along her neck on Saturday night & all over her body by Sunday. BENADRYL & hydrocortisone was used for treatment.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4
Symptoms: Face injury, Loss of consciousness, Suture insertion
Clinical narrative: Pt. passed out while checking out. When she passed out she hit her chin on the counter. Pt. had to go to the ER for stitches.
Age: 42.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Fatigue, Pruritus, Skin warm, Swelling
Clinical narrative: Swelling, redness, area was warm and itchy (4 days). Very tired for 2 days.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Decreased appetite, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, decreased appetite.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Oedema peripheral, Rash
Clinical narrative: Patient developed rash, swollen arm. She saw her doctor, he gave Doxycycline 100mg for 14 days.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site anaesthesia
Clinical narrative: Pt came for 2012 flu vaccine & reported site of last years flu (2011) (Left deltoid) was numb and radiates up into (L) shoulder. Numbness intermittent. Pt. did allow 2012 flu vaccine to be given and would report any new findings.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Syncope, Urticaria
Clinical narrative: Patient fainted about 5 minutes after the administration of the flu shot. He was taken to the hospital where he was treated. The next day (about 24 hrs later) he broke out in hives and was given a MEDROL dose pak.
Age: 16.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Loss of consciousness
Clinical narrative: Patient fainted about 5 minutes after the administration of the flu shot. He was taken to the hospital where he was treated. The next day (about 24 hrs later) he broke out in hives and was given a MEDROL dose pak.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient had red & tender arm from the injection site at the deltoid to her elbow.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Myalgia, Neck pain, Pyrexia
Clinical narrative: Fever/chills overnight. Muscle and neck pain. Felt better in AM.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Musculoskeletal pain, Tendonitis
Clinical narrative: Received flu shot on September 17th. Pt concerned about SIRVA. Very sore shoulder by 6 hrs after shot progressed to shoulder pain that pt's dr. thinks may be tendonitis/bursitis. Soreness fluctuates, but is still ongoing. Pt. has been trying different NSAIDs for pain relief. Been to Dr. twice now on diclofenac -> feeling better. Seeing shoulder specialists in 2 weeks.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle mass, Myosclerosis
Clinical narrative: Hardened mass in muscle. Significant pain. No redness.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Dizziness, Dry mouth, Dyspnoea, Electrocardiogram normal, Paraesthesia oral
Clinical narrative: Patient reported dizziness after vaccines. Patient reported tingling in face (one side). Also had tingling on tongue and in throat. Mild SOB. Dryness in mouth. Given Prednisone and BENADRYL.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Headache
Clinical narrative: Patient came in next month (23 days) and told us if we needed to report side effect, we said yes - that night of the shot patient experienced strong headache, temp > 103.5, and chills -> all symptoms gone by morning -> except chills also next day.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Nausea, Swelling
Clinical narrative: Nausea. Bruise - bruising lasted several weeks. Swelling. Patient requested we send this info in to let company know.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Local reaction
Clinical narrative: Red area where vaccine was administered. Itchy, somewhat swollen, happen a day later after injection - MD Called deemed local reaction. Suggested by MD BENADRYL.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Arthralgia, Fatigue, Laboratory test normal, Pyrexia, White blood cell count decreased
Clinical narrative: Prolonged fever 99.5 - 100.6 joint & aches fatigue. Note: exposed to varicella 1 week prior to immunization. I.D. MD says not related.
Age: 0.51
Sex: F
Vaccine: FLU3, HEP, HIBV, IPV, PNC, RV5
Symptoms: Incorrect dose administered
Clinical narrative: Gave .5ml instead of .25.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Injection site warmth
Clinical narrative: 10-5-12 patient presents with fever at site of injection and rash. Patient said started 10-4-12.
Age: 84.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity, Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: It looks like patient had an allergic rxn to PNEUMOVAX vaccine. He (R) upper arm was red / blue and swollen. Recommended that pt. takes ADVIL for inflammation.
Sex: U
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a health care worker refers to unspecified number of patients of unknown age. The patients were vaccinated with GARDASIL in 2008. No other co-suspects were reported. No concomitant medications were reported. The patients experienced fainting after receiving GARDASIL in 2008. These events happened at an unspecified facility where the healthcare worker was employed at that time. The outcome of the patients was unknown. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker regarding an approximately 13-year-old female patient. On 31-AUG-2012, the patient was vaccinated with dose 1, 0.5 milliliter (ml) GARDASIL (lot# not reported) intramuscularly. No concomitant medications were reported. On 14-SEP-2012 the patient was vaccinated with her second dose of 0.5 ml GARDASIL (lot # not reported) intramuscularly. No adverse effects reported. No other information provided. Additional information is not expected.
Sex: F
Vaccine: HPV4
Symptoms: Migraine
Clinical narrative: This spontaneous report was received from a physician via a company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated intramuscularly with dose 3 GARDASIL. No concomitant medications were reported. On 10-SEP-2012 and 11-SEP-2012, the patient experienced migraine headaches. No treatment information was reported. The outcome of migraine headache was unknown. The relatedness for migraine headache was unknown for GARDASIL. Additional information has been requested.