chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: This medically confirmed report (initial receipt 16-Jan-2013) concerns a 20-year-old female patient. The patient had no pertinent medical history or drug reactions/allergies. On 14-Jan-2013, the patient received AFLURIA (batch no: 07149221A) intramuscularly in the left arm. On 15-Jan-2013 (the day following vaccination), the patient developed a 3 inch injection site reaction including an irregular red welt, itching, pain and a low grade fever. The patient was seen by her physician who diagnosed cellulitis. The patient was treated with cephalexin. The outcome was reported as recovering.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an approximately 27-year-old female patient. The patient was vaccinated with dose 1 RECOMBIVAX HB (lot#, expiration date and route not reported) on 24-FEB-2012. On 05-NOV-2012 the patient was vaccinated with dose 2 RECOMBIVAX HB (lot#, expiration date and route not reported). No concomitant medications were reported. No adverse effect was observed or reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: Patient received intradermal FLUZONE on 1/15/13 6 days post vaccination patient has a large knot under the skin at injection site w/ redness and itching.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning a patient of unknown age and gender. On 07-JAN-2013, the patient was vaccinated with 0.65 milliliter (ml) live ZOSTAVAX (lot number reported as 671451/1193AA), subcutaneously that had expired on 25-OCT-2012. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Asthenia, Back pain, Blood creatine phosphokinase normal, Myalgia, Nausea
Clinical narrative: Fever within 24 hr, nausea & vomiting 3 days, rash within 3 days, tingling in fingers -> hands -> arms, muscle aches & weakness 3 days, back ache 5-7 days.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Paraesthesia, Pyrexia, Rash, Vomiting
Clinical narrative: Fever within 24 hr, nausea & vomiting 3 days, rash within 3 days, tingling in fingers -> hands -> arms, muscle aches & weakness 3 days, back ache 5-7 days.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Nausea, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: 10 hours after injection developed redness down Lt arm & tingling Lt. hand - this resolved later at home. The next morning awoke with nausea & vomiting & fever of 101 degrees oral. Parent is giving pt TYLENOL. Dr advised BENADRYL 25 mg Q 6 hr x 24 hrs. Symptoms resolved 1-17-13.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Nausea, Pyrexia, Vomiting projectile
Clinical narrative: About 3-4 hours after administration, pt got chills, fever temp=102 degrees F, nausea, projectile vomiting.
Age: 0.08
Sex: U
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: This spontaneous report as received from a Doctor of pharmacy refers to a 2 days old patient of unknown gender. The patient was vaccinated accidentally with 2 doses of RECOMBIVAX HB (route and lot # not reported) instead of 1 dose, on 20-JAN-2013. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Accidental exposure to product, Drug administration error, Rash
Clinical narrative: This spontaneous report was received from a registered nurse concerning a female medical assistant of unknown age. On 21-JAN-2013, the medical assistant started administered a dose of ZOSTAVAX lot reported as H016737, exp date: 07-SEP-2014 (dose not reported) to a patient but some of the vaccine leaked out because she had not completely attached the needle to the syringe. Some of the ZOSTAVAX splashed onto the medical assistant's cheek. The medical assistant rinsed her cheek with water and she developed a rash on the same cheek. However, the rash had already disappeared and there were no symptoms at the time of the report. No other co-suspects were reported. No concomitant medications were reported. The relatedness for the event was unknown for ZOSTAVAX. This is one report of several reports from the same source (MARRS#1301USA012572). Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to 8 patients (age and gender unknown). Between 01-DEC-2012 and 23-JAN-2013 (also reported as 23-JAN-2012), the patients were vaccinated with GARDASIL injection (route, dose and frequency not reported) (lot #H011350; expiration date on 21-FEB-2015). No other co-suspects were reported. No concomitant medications were reported. It was reported that the patients may have received GARDASIL exposed to 24 F for an unspecified period of time. No adverse symptoms reported. The outcome of patients received GARDASIL exposed to 24 F for an unspecified period of time was unknown. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient experienced arm pain after shot and is still having the pain on 1/21/13. Her doctor is on leave so she has not gone to a doctor for the pain.
Age: 1.02
Sex: F
Vaccine: MMRV
Symptoms: Cough, Eye irritation, Influenza virus test, Lethargy, Ocular hyperaemia
Clinical narrative: She began with high fevers (102.9F). Fevers lasted approx 4 days during which time she had a runny nose, cough, red/irritated eyes, she was lethargic. Then when the fever began to subside she started with the rash. The rash was severe and lasted 3 days.
Age: 1.02
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash, Rhinorrhoea, Streptococcus test
Clinical narrative: She began with high fevers (102.9F). Fevers lasted approx 4 days during which time she had a runny nose, cough, red/irritated eyes, she was lethargic. Then when the fever began to subside she started with the rash. The rash was severe and lasted 3 days.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blood cholesterol normal, Blood glucose normal, Borrelia test, Full blood count
Clinical narrative: Pain in left arm, left side of back and left leg all the way down, had a hard time getting out of bed.  Walked bent over "like an old man" from the pain.  He never had this before.  Mild headache.  Aleve helps completely, then pain comes back when it wears off.  Symptoms wax and wane, have persisted now for a month since the vaccine.  No joint swelling or redness.  No symptoms on right side at all. Never had these types of musculoskeletal symptoms before the vaccine.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Headache, Laboratory test, Mobility decreased, Pain in extremity
Clinical narrative: Pain in left arm, left side of back and left leg all the way down, had a hard time getting out of bed.  Walked bent over "like an old man" from the pain.  He never had this before.  Mild headache.  Aleve helps completely, then pain comes back when it wears off.  Symptoms wax and wane, have persisted now for a month since the vaccine.  No joint swelling or redness.  No symptoms on right side at all. Never had these types of musculoskeletal symptoms before the vaccine.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Prostatic specific antigen normal
Clinical narrative: Pain in left arm, left side of back and left leg all the way down, had a hard time getting out of bed.  Walked bent over "like an old man" from the pain.  He never had this before.  Mild headache.  Aleve helps completely, then pain comes back when it wears off.  Symptoms wax and wane, have persisted now for a month since the vaccine.  No joint swelling or redness.  No symptoms on right side at all. Never had these types of musculoskeletal symptoms before the vaccine.
Age: 78.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Pain
Clinical narrative: Approx 8 cm x 8 cm area of Rt deltoid redness, hardness, swelling pain noted by 1-8-13. Did not come to clinic or report until today 1-15-13.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling abnormal, Injection site pain
Clinical narrative: Pt called pharmacy 1/21/13 to report prolonged side effect from flu shot received on 1/11/13. Reported pain at injection site that would start slow become increased intensity. Radiates outward. Feels like something is trying to get out. Does not radiate down arm. Not tender to touch. No problems moving arm/shoulder. Rates pain 8/10 on pain scale.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Within days after receiving the new vaccine, my right big toe was numb and is still numb.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness 10 x 6 cm area around 1mm site (L) prox arm.
Age: 25.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling, redness, tenderness prox (R) arm around inj site 10 x 18 cm.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive, Influenza B virus test, Pyrexia
Clinical narrative: Fever x 36 hours up to 101 degrees; Flu A positive exposure/mom & brother. Positive Flu A/Bianax A-B test kit. Rx TAMILFU 60 mgm po BID x 5 days.
Age: 0.47
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Body temperature increased, Rash macular
Clinical narrative: Patient developed macular like rash over torso, back, neck, and face some 4-8 hrs after receiving his immunizations here at office see below for type 4 vaccines. Low grade temp of 99 degrees noted 24 hours later.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Influenza, Influenza A virus test positive, Influenza B virus test, Pyrexia
Clinical narrative: Coughing, mucus, fever x 12 hours exposed to Flu / Mom. Positive Flu A / Binax test kit. Rx TAMIFLU 75 mgm po BID x 5 days.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Rhinorrhoea
Clinical narrative: Coughing, mucus, fever x 12 hours exposed to Flu / Mom. Positive Flu A / Binax test kit. Rx TAMIFLU 75 mgm po BID x 5 days.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis - (L) deltoid post injection.
Age: 17.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Infection
Clinical narrative: Cellulitis - (L) deltoid post injection.
Age: 31.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Asthenia, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 1/16/13: 6 hours after administration pt got tired & weak & next day felt fine. Then 1/21/13 about 7pm with left upper arm pain & swelling & warmth. Negative fever, better since yesterday better 1/22/13.
Age: 0.19
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling & erythema to (R) thigh.
Age: 23.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Nausea, Vision blurred
Clinical narrative: Pt. complained of dizziness, nausea, sweating, blurry vision. No temp. BP was normal. He had an empty stomach when he got the shot. Paramedics were called. No treatment was needed. Pt. was sent home. He recovered within 20 minutes.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site irritation, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was sore, swollen, irritated, and hot to the touch (as described by patient). Patient stated she took Ibuprofen.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Feeling hot, Hypoaesthesia
Clinical narrative: Started noticing a "heat sensation" in distal right leg about 9-10 days after vaccination. Sensation would last anywhere between 3 seconds to 30 seconds, and occur from 5 x per hr to 15 x per hr. Two weeks after vaccination, intermittent numbness in toes and fingers of bilateral extremities appeared.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: Local reaction with redness, warmth to left deltoid. No fever, chills. Dr./nurse instructed pt use cool compress, BENADRYL. Pt. verbal understanding if symptoms worse notify physician or go to E.R. pt agreed.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: See attached.
Age: 23.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Myalgia, Pain
Clinical narrative: Muscle & joint pain not relieved with TYLENOL. Burning pain especially in head. Not had any fever. Pain has been continuous since Nov. 8th (now 78 days).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Infection, Swelling
Clinical narrative: Patient developed redness, swelling after 12-14 hrs after getting the shot and subsequently got an infection. Being treated with antibiotics.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Headache, Hyperacusis, Hyperaesthesia, Hyperhidrosis
Clinical narrative: 46 y/o female who received seasonal flu vaccine on 22 JAN 2013, around 0900. She usually receives annual flu vaccines, but reports receiving the nasal mist over the past 4 years, and denies any adverse events. This year, she delayed getting the FLUMIST because several times since OCT 2012, when she thought about getting the vaccine, she had the "sniffles". She decided to get the vaccine on Tuesday, 22 JAN, as she felt well and was coming off a long weekend. The FLUMIST was not in stock, so she received the IM injection. She denies anything unusual related to vaccination technique or placement of the vaccination. She noted a significant amount of pain during the injection, but no unusual bleeding, bruising or streaking. Later on the day of vaccine receipt, patient reported the onset of a migraine, which started at the back of her head and progressed forward, It was accompanied by nausea, light and sound sensitivity, so by 1300 (4 hours post-vaccine receipt) she went home. She took a MIDRIN and rested, but did not get complete headache relief. She denies any visual changes or mental status changes. She noted some vaccination site soreness that prevented her from lying on her left side (the side she usually sleeps on). She also reports alternating sweats and chills through the night. She was not able to sleep due to her migraine, as well as other symptoms, so she stayed home from work on WED. She rested and increased her fluids. Her intense migraine was gone, but she reports having a dull headache and increased sensitivity of her scalp. After she took a shower that afternoon, she noted that her vaccination site looked red and swollen and was tender to touch. On THUR, she teleworked from home; her vaccination site was still tender and swollen, and her neck was sore due to not sleeping on her usual side. She applied cool compresses to her left upper arm throughout the day and took some ALEVE, which was not effective in relieving her arm pain and swelling. She denies any numbness, tingling or weakness of her left upper extremity. No increased warmth at her vaccination site. She did not experience any dyspnea, wheezing, nasal symptoms, difficulty swallowing, angioedema or swelling of her tongue, itching or tightness of her throat, flushing or hives. She did note her vaccination site and eyes were itchy on Thursday (48 hours post-vaccination). Today, she reports her vaccination site is still tender, red and itchy, but the swelling has decreased a little. Patient denies any other known exposures on day of vaccine receipt or since. Of note, within the past couple of months, she has noted after she ate shrimp, her lips and tongue become "itchy". She is allergic to TCN ' rash, nausea and vomiting, and she experiences allergy symptoms, usually in the spring. She denies any allergic reactions to insect stings or latex. No prior vaccine reactions.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Impaired work ability, Injection site erythema, Injection site pain, Injection site pruritus, Insomnia
Clinical narrative: 46 y/o female who received seasonal flu vaccine on 22 JAN 2013, around 0900. She usually receives annual flu vaccines, but reports receiving the nasal mist over the past 4 years, and denies any adverse events. This year, she delayed getting the FLUMIST because several times since OCT 2012, when she thought about getting the vaccine, she had the "sniffles". She decided to get the vaccine on Tuesday, 22 JAN, as she felt well and was coming off a long weekend. The FLUMIST was not in stock, so she received the IM injection. She denies anything unusual related to vaccination technique or placement of the vaccination. She noted a significant amount of pain during the injection, but no unusual bleeding, bruising or streaking. Later on the day of vaccine receipt, patient reported the onset of a migraine, which started at the back of her head and progressed forward, It was accompanied by nausea, light and sound sensitivity, so by 1300 (4 hours post-vaccine receipt) she went home. She took a MIDRIN and rested, but did not get complete headache relief. She denies any visual changes or mental status changes. She noted some vaccination site soreness that prevented her from lying on her left side (the side she usually sleeps on). She also reports alternating sweats and chills through the night. She was not able to sleep due to her migraine, as well as other symptoms, so she stayed home from work on WED. She rested and increased her fluids. Her intense migraine was gone, but she reports having a dull headache and increased sensitivity of her scalp. After she took a shower that afternoon, she noted that her vaccination site looked red and swollen and was tender to touch. On THUR, she teleworked from home; her vaccination site was still tender and swollen, and her neck was sore due to not sleeping on her usual side. She applied cool compresses to her left upper arm throughout the day and took some ALEVE, which was not effective in relieving her arm pain and swelling. She denies any numbness, tingling or weakness of her left upper extremity. No increased warmth at her vaccination site. She did not experience any dyspnea, wheezing, nasal symptoms, difficulty swallowing, angioedema or swelling of her tongue, itching or tightness of her throat, flushing or hives. She did note her vaccination site and eyes were itchy on Thursday (48 hours post-vaccination). Today, she reports her vaccination site is still tender, red and itchy, but the swelling has decreased a little. Patient denies any other known exposures on day of vaccine receipt or since. Of note, within the past couple of months, she has noted after she ate shrimp, her lips and tongue become "itchy". She is allergic to TCN ' rash, nausea and vomiting, and she experiences allergy symptoms, usually in the spring. She denies any allergic reactions to insect stings or latex. No prior vaccine reactions.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Nausea, Neck pain, Pain in extremity, Photophobia
Clinical narrative: 46 y/o female who received seasonal flu vaccine on 22 JAN 2013, around 0900. She usually receives annual flu vaccines, but reports receiving the nasal mist over the past 4 years, and denies any adverse events. This year, she delayed getting the FLUMIST because several times since OCT 2012, when she thought about getting the vaccine, she had the "sniffles". She decided to get the vaccine on Tuesday, 22 JAN, as she felt well and was coming off a long weekend. The FLUMIST was not in stock, so she received the IM injection. She denies anything unusual related to vaccination technique or placement of the vaccination. She noted a significant amount of pain during the injection, but no unusual bleeding, bruising or streaking. Later on the day of vaccine receipt, patient reported the onset of a migraine, which started at the back of her head and progressed forward, It was accompanied by nausea, light and sound sensitivity, so by 1300 (4 hours post-vaccine receipt) she went home. She took a MIDRIN and rested, but did not get complete headache relief. She denies any visual changes or mental status changes. She noted some vaccination site soreness that prevented her from lying on her left side (the side she usually sleeps on). She also reports alternating sweats and chills through the night. She was not able to sleep due to her migraine, as well as other symptoms, so she stayed home from work on WED. She rested and increased her fluids. Her intense migraine was gone, but she reports having a dull headache and increased sensitivity of her scalp. After she took a shower that afternoon, she noted that her vaccination site looked red and swollen and was tender to touch. On THUR, she teleworked from home; her vaccination site was still tender and swollen, and her neck was sore due to not sleeping on her usual side. She applied cool compresses to her left upper arm throughout the day and took some ALEVE, which was not effective in relieving her arm pain and swelling. She denies any numbness, tingling or weakness of her left upper extremity. No increased warmth at her vaccination site. She did not experience any dyspnea, wheezing, nasal symptoms, difficulty swallowing, angioedema or swelling of her tongue, itching or tightness of her throat, flushing or hives. She did note her vaccination site and eyes were itchy on Thursday (48 hours post-vaccination). Today, she reports her vaccination site is still tender, red and itchy, but the swelling has decreased a little. Patient denies any other known exposures on day of vaccine receipt or since. Of note, within the past couple of months, she has noted after she ate shrimp, her lips and tongue become "itchy". She is allergic to TCN ' rash, nausea and vomiting, and she experiences allergy symptoms, usually in the spring. She denies any allergic reactions to insect stings or latex. No prior vaccine reactions.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: 46 y/o female who received seasonal flu vaccine on 22 JAN 2013, around 0900. She usually receives annual flu vaccines, but reports receiving the nasal mist over the past 4 years, and denies any adverse events. This year, she delayed getting the FLUMIST because several times since OCT 2012, when she thought about getting the vaccine, she had the "sniffles". She decided to get the vaccine on Tuesday, 22 JAN, as she felt well and was coming off a long weekend. The FLUMIST was not in stock, so she received the IM injection. She denies anything unusual related to vaccination technique or placement of the vaccination. She noted a significant amount of pain during the injection, but no unusual bleeding, bruising or streaking. Later on the day of vaccine receipt, patient reported the onset of a migraine, which started at the back of her head and progressed forward, It was accompanied by nausea, light and sound sensitivity, so by 1300 (4 hours post-vaccine receipt) she went home. She took a MIDRIN and rested, but did not get complete headache relief. She denies any visual changes or mental status changes. She noted some vaccination site soreness that prevented her from lying on her left side (the side she usually sleeps on). She also reports alternating sweats and chills through the night. She was not able to sleep due to her migraine, as well as other symptoms, so she stayed home from work on WED. She rested and increased her fluids. Her intense migraine was gone, but she reports having a dull headache and increased sensitivity of her scalp. After she took a shower that afternoon, she noted that her vaccination site looked red and swollen and was tender to touch. On THUR, she teleworked from home; her vaccination site was still tender and swollen, and her neck was sore due to not sleeping on her usual side. She applied cool compresses to her left upper arm throughout the day and took some ALEVE, which was not effective in relieving her arm pain and swelling. She denies any numbness, tingling or weakness of her left upper extremity. No increased warmth at her vaccination site. She did not experience any dyspnea, wheezing, nasal symptoms, difficulty swallowing, angioedema or swelling of her tongue, itching or tightness of her throat, flushing or hives. She did note her vaccination site and eyes were itchy on Thursday (48 hours post-vaccination). Today, she reports her vaccination site is still tender, red and itchy, but the swelling has decreased a little. Patient denies any other known exposures on day of vaccine receipt or since. Of note, within the past couple of months, she has noted after she ate shrimp, her lips and tongue become "itchy". She is allergic to TCN ' rash, nausea and vomiting, and she experiences allergy symptoms, usually in the spring. She denies any allergic reactions to insect stings or latex. No prior vaccine reactions.
Age: 24.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Fatigue, Malaise, Pain, Polymerase chain reaction, Pyrexia
Clinical narrative: Pt developed a rash, body aches and fever & fatigue 17 days after varicella vaccine administration. Rash was < 50 pox - but pt felt "very sick" symptoms last for 5 days. Patient was given varicella one day postpartum prior to hospital discharge. Because she developed rash - her 3 week old baby received varicella gamma globulin as a precautionary measure.
Age: 24.0
Sex: F
Vaccine: MMR, TDAP, VARCEL
Symptoms: Rash, Varicella virus test positive
Clinical narrative: Pt developed a rash, body aches and fever & fatigue 17 days after varicella vaccine administration. Rash was < 50 pox - but pt felt "very sick" symptoms last for 5 days. Patient was given varicella one day postpartum prior to hospital discharge. Because she developed rash - her 3 week old baby received varicella gamma globulin as a precautionary measure.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Hyperhidrosis, Irritability, Pallor
Clinical narrative: 6:45 c/o pale, sweaty & lightheaded. BP 130/70 P. 60 Ice to neck, cool water, laid on table. BENADRYL 50 mg given. 6:55 BP 82/40 & 911 called. 6:55 BP 120/80 P 60. 7 pm feeling & looking better. BP 125/95 P 60. 7:05 pm sitting up & rescue arrived. Transferred to hosp,
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a consumer refers to a female patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 21-NOV-2008. Batch number, route of administration and anatomical location were not reported. No other co-suspects were reported. No concomitant medications were reported. On unknown dates, the patient received dose 2 and 3 of GARDASIL on 21-NOV-2008. Batch number, route of administration and anatomical location were not reported. There was a time lapse of two years between the second and third dose. No adverse event or treatment information was reported. Additional information has been requested.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Lymphadenopathy, Pyrexia
Clinical narrative: Redness, swelling and warmth at injection site. Low grade fever and axillary lymphadenopathy within 24 hrs of vaccine & continued x 1 wk treated with po prednisone & naproxen.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic
Clinical narrative: Patient states that 2 days post vaccine, he developed a red, itchy rash. No fever, no pain. Rash was at injection site about 1 1/2 in diameter.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blood culture, Chest X-ray, Diarrhoea, Febrile convulsion, Full blood count
Clinical narrative: Febrile Seizure. Only other symptom leading up was a rash and mild diarrhea. EMS took to ER. Pt discharged.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Influenza virus test, Rash, Respiratory syncytial virus test
Clinical narrative: Febrile Seizure. Only other symptom leading up was a rash and mild diarrhea. EMS took to ER. Pt discharged.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza like illness, Muscle spasms, Nuchal rigidity, Pain, Sinusitis
Clinical narrative: Recipient described diffuse aches and pain a few days after vaccine given, progressive to nuchal rigidity and cramps. Alleviated by care from her own provider. More = was sick with flu like symptoms along with bad symptoms of sinusitis, used nasal spray and OTC meds to manage symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Bacterial test, Ultrasound scan
Clinical narrative: Bact c/s x2 ultra-sound Already submitted in detail.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Flushing, Headache, Nausea, Pruritus generalised, Urticaria
Clinical narrative: Within 30 min. of receiving GARDASIL #3 patient became flushed, generalized itching. Hives on chest, headache, nausea taken to ER - required IV meds including steroids/antihistamines.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Patient described having a red, raised and itchy area the size of a baseball around the injection site. The patient contacted their primary provider and they recommended ADVIL 200 mg twice a day and ZYRTEC daily.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Pruritus
Clinical narrative: Red at the right arm in the part of injection (back) swollen from up to the upper arm. CLARITIN to decrease at time. Itch/no pain. Hydrocortisone to decrease itch. Patient given steroid to decrease itch.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: 24+ hr after admin of DTap had swelling about the size of deck of cards at injection site. Was red, warm, small blisters, tenderness, no fever or systemic reaction per mother. Was taken to Urgent Care. Dr prescribed Amox in case of infection.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site warmth
Clinical narrative: 24+ hr after admin of DTap had swelling about the size of deck of cards at injection site. Was red, warm, small blisters, tenderness, no fever or systemic reaction per mother. Was taken to Urgent Care. Dr prescribed Amox in case of infection.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Erythema, Induration, Injection site swelling, Pain
Clinical narrative: Patient stated that the swelling at the injection site became progressive worse by the second day post vaccine. She developed a 1.5 inch red wheal that was itching and throbbing. 3/4 of the wheal was very hard. She states that she also developed hoarseness. She states that she started taking Benadryl on the evening of 11/24/13 and has continued to take it each night. The swelling at the site and the hoarseness had decreased but has not completely resolved.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient stated that the swelling at the injection site became progressive worse by the second day post vaccine. She developed a 1.5 inch red wheal that was itching and throbbing. 3/4 of the wheal was very hard. She states that she also developed hoarseness. She states that she started taking Benadryl on the evening of 11/24/13 and has continued to take it each night. The swelling at the site and the hoarseness had decreased but has not completely resolved.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Hint of nausea for the past 3 weeks, every day.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Injection site discolouration, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Pain/itching at injection site; discoloration at injection site; headache; body aches.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis, Pyrexia, White blood cell count increased
Clinical narrative: Patient developed cellulitis at site of injection. Next day, spiked a fever with elevated white blood cell count.
Age: 8.0
Sex: F
Vaccine: FLU3, HEP, HEPA, IPV, MMR, TDAP, VARCEL
Symptoms: Erythema, Injection site pain, Injection site pruritus, Oedema peripheral
Clinical narrative: Parent stated that he notice Pt's left arm was red and swollen.  Pt complained of itching at the injection site.  Tender to touch.  Measures Approx 3cm X 3cm.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Injection site mass, Mass
Clinical narrative: LARGE MASS DEVELOPED AND HAS SOLIDIFIED.  STILL EXISTS 6 MONTHS LATER.
Age: 49.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Lipoma excision, Skin lesion
Clinical narrative: LARGE MASS DEVELOPED AND HAS SOLIDIFIED.  STILL EXISTS 6 MONTHS LATER.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Chills, Headache, Injection site erythema, Injection site pain
Clinical narrative: Patient got a swollen, painful red bump at the injection site.  On 1/10/13 she called and was told to monitor it and take ibuprofen.  She came in on 1/11/13 to show us the site and there was a red area about 4 in in diameter that was hot and painful; suggested steroid cream and or ice pack and to seek attention if it continued to grow or if systemic symptoms develop.  Spoke again on 1/15/13; she says over the weekend (1/12/13-1/13/13) the bump got up to 6 in in diameter and she got a couple "chicken pox" like bumps on the front of her arm.  She also complained of some chest tightness, runny nose, heachache and chills.  As of 1/15/13, she said her symptoms were improving.  She did not seek medical attention because she was unable to get an appt with her doctor.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Rash vesicular, Rhinorrhoea
Clinical narrative: Patient got a swollen, painful red bump at the injection site.  On 1/10/13 she called and was told to monitor it and take ibuprofen.  She came in on 1/11/13 to show us the site and there was a red area about 4 in in diameter that was hot and painful; suggested steroid cream and or ice pack and to seek attention if it continued to grow or if systemic symptoms develop.  Spoke again on 1/15/13; she says over the weekend (1/12/13-1/13/13) the bump got up to 6 in in diameter and she got a couple "chicken pox" like bumps on the front of her arm.  She also complained of some chest tightness, runny nose, heachache and chills.  As of 1/15/13, she said her symptoms were improving.  She did not seek medical attention because she was unable to get an appt with her doctor.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Patient noticed a red line going from injection site down to the elbow. Over the course of 2 days it turned into a very large erythemous area from the shoulder to the elbow and around the arm. Checked area on 1/28 still red down to the elbow.
Age: 73.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site streaking
Clinical narrative: Red line from the injection site down to the elbow. Over the course of 2 days redness spread down the arm to the elbow and around the arm. Checked area on 1/28, redness has lightened but still very large area.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Neck pain, Pain in extremity, Paraesthesia, Urticaria
Clinical narrative: Large Red Raised Hives on Left arm, itching of injection site, Pain from neck down left arm to hand between thumb and index finger, tingling and numbness in hand.  SIRVA.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Symptoms started on 1/23/13, patient felt feet were swollen and itchy. Patient noticed hands were swollen and itchy 1/24/13, also with urticaria on neck, legs, and trunk treated with BENADRYL and ibuprofen at home prescribed prednisone 20 mg 1 tab BID x 5 days of visit on 1/25/13.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Biopsy skin abnormal, Lichen planus, Rash
Clinical narrative: About 2 weeks after receiving flu shot I developed a rash over my trunk (front & back) & underarm area which was diagnosed as "lichen planus".
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Cellulitis, erythema, swelling to left thigh s/p DTaP & IPV vaccinations administered 1/14/13. 1/17/13 Rx'd Cephalexin 250 mg/ml.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Contusion, Full blood count, Haemorrhage subcutaneous, Injection site bruising, Laboratory test
Clinical narrative: Pt called & said 1 wk ago got Tdap, 3 days later got mall bruise at site, said it has gradually gotten large like bleeding under skin. Now below elbow on inside of forearm. Told to go to her MD. Pt said she wanted to come here & let us look at it first. To come at 7 pm 1-7-13 did not come called MD appt tomorrow came in - has MD appt.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling, redness 1 1/2" x 1 1/2" Rt deltoid (1/22/2013.)
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mass
Clinical narrative: Given vaccine 1/14/2013 - returned 1/15/2013 slight redness cool soaks & tropical prednisone. Returned again ordered KEFLEX as redness increased and lump. x bid x 10 days. Went to her MD 1/18 - returned 1/19 no vesicles on arm. Returned 1/22 arm less erythema.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Headache, Herpes zoster, Injection site erythema, Injection site mass
Clinical narrative: Given vaccine 1/14/2013 - returned 1/15/2013 slight redness cool soaks & tropical prednisone. Returned again ordered KEFLEX as redness increased and lump. x bid x 10 days. Went to her MD 1/18 - returned 1/19 no vesicles on arm. Returned 1/22 arm less erythema.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Malaise
Clinical narrative: Given vaccine 1/14/2013 - returned 1/15/2013 slight redness cool soaks & tropical prednisone. Returned again ordered KEFLEX as redness increased and lump. x bid x 10 days. Went to her MD 1/18 - returned 1/19 no vesicles on arm. Returned 1/22 arm less erythema.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Oedema peripheral, Pyrexia
Clinical narrative: Swollen red upper arm w/fever KEFLEX QID at ER cellulitis.
Age: 0.16
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV1
Symptoms: Depressed level of consciousness, Unresponsive to stimuli, Vomiting
Clinical narrative: Unresponsiveness 6 hours after immunizations given. Patient had a frightening period of unresponsiveness last night but is completely back to normal this am. Chronological Hx: 12.27 - 3:00 PM: immunizations given here - 5:00 PM: fed normally and put to bed - 9:00 AM: mom tried to awaken because he never sleeps that long. She couldn't arouse him even when wetting his face with cold wet rag. 11:00 AM: Triage phone nurse rec'd a trip to ER with my rec & my approval to do so also. Parents didn't go monitored at home for 4 hrs. 12.28 1:00 AM: fed, vomited once then returned to normal reassuring activity & demeanor. He's been fine since. He's eaten, returned the feed, has normal muscle tone, color a strong vigorous cry, good eye contact. Pulses OK cap. refill < 2 sec.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Cough, Dysphonia, Throat irritation
Clinical narrative: Pt rec'd vaccine on 1/22/13. He called pharmacy on 1/27/13 reporting symptoms of coughing, scratchy throat (hoarseness) since 1/23/13. He reports no treatment.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physicians assistant concerning a female patient of unknown age who on an unspecified date after one year of receiving the first dose of GARDASIL was vaccinated with dose 2 of 0.5 ml GARDASIL, IM, (lot # not provided). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a 69 years old female patient with chronic obstructive pulmonary disease (COPD), sulfa allergy, KEFLEX allergy and penicillin allergy. The patient who had a prior episode of shingles was vaccinated with live ZOSTAVAX (dose, route and lot not reported) on 14-MAR-2011 on the recommendation of her physician. No other co-suspects were reported. Concomitant medications included: steroids (unspecified). The patient developed a second case of shingles on 21-JAN-2013. The patient exhibited a red burning rash on her left butt cheek. The patient felt it may be triggered from all the medications especially the steroids. The patient was treated with valcyclovir 3 times daily. The outcome of the event was reported as not recovered/not resolved. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 12 years old patient (unknown age and gender), who on 19-APR-2011 was vaccinated with a dose of GARDASIL (dose, route and lot number were not reported) and on 22-AUG-2011, was vaccinated with a dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect had been observed or reported. At the time of the report, the patient's outcome for the adverse event was unknown. This is one of two reports from the same report. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Erythema, Hyperhidrosis, Injection site erythema, Injection site induration
Clinical narrative: Daughter was injected with flu shot AFLURIA vial 0112 at the pharmacy. That night went to take bandaid off and noticed a huge red-big bump on arm right below site and she felt like vomiting that morning and dizzy and ran a 99.9 temp and sweating the next day the same. Was told by her doc. and pharmacist to put cool pack on it and BENADRYL. She slept most the day. 3 days later bump is starting to go down, and she's feeling better.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pyrexia, Swelling
Clinical narrative: Daughter was injected with flu shot AFLURIA vial 0112 at the pharmacy. That night went to take bandaid off and noticed a huge red-big bump on arm right below site and she felt like vomiting that morning and dizzy and ran a 99.9 temp and sweating the next day the same. Was told by her doc. and pharmacist to put cool pack on it and BENADRYL. She slept most the day. 3 days later bump is starting to go down, and she's feeling better.
Age: 20.0
Sex: M
Vaccine: HEPAB, HPV4
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse symptoms or event. Pt while receiving GARDASIL series, was administered CERVARIX for 2nd shot instead of GARDASIL. This was noted when pt. presented for 3rd shot. Pt. was told to follow up 1 month to rec'v 3rd GARDASIL.
Age: 43.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Aura, Diarrhoea, Headache, Pain, Photophobia
Clinical narrative: "I had a monster headache Wednesday from that shot. And I had loose bowels... well... still. Just behind the crest of my forehead, about halfway between crown and hairline. In the middle. Pain level 5 on 1-10, unignorable.  I was quite light sensitive. (0 = no noticible effect, 10=unbearable -- 6.). I did not try any NSAIDS or anything. Started with aura-y stuff (just out of sorts, everything seemed bright) Weds AM, 12-14 hours after the shot, by the time I got to work 30-60 later, it hurt, and I came pretty much straight home and put my head under a blanket and slept. It was mostly resolved 12-16 hours later."
Age: 43.0
Sex: M
Vaccine: HPV4, HPV4
Symptoms: Aura, Diarrhoea, Headache, Photophobia
Clinical narrative: "I had a monster headache Wednesday from that shot. And I had loose bowels... well... still. Just behind the crest of my forehead, about halfway between crown and hairline. In the middle. Pain level 5 on 1-10, unignorable.  I was quite light sensitive. (0 = no noticible effect, 10=unbearable -- 6.). I did not try any NSAIDS or anything. Started with aura-y stuff (just out of sorts, everything seemed bright) Weds AM, 12-14 hours after the shot, by the time I got to work 30-60 later, it hurt, and I came pretty much straight home and put my head under a blanket and slept. It was mostly resolved 12-16 hours later."
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Asthenia, Guillain-Barre syndrome, Immunoglobulin therapy, Lumbar puncture, Neurological examination
Clinical narrative: 2 days after vaccine given, severe leg pains started. Within 2 days, increased in severity -> admitted - diagnosed with Guillain-Barre Synd (reflexes & weakness ensued). Improved quickly with IVIG.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity, Reflexes abnormal
Clinical narrative: 2 days after vaccine given, severe leg pains started. Within 2 days, increased in severity -> admitted - diagnosed with Guillain-Barre Synd (reflexes & weakness ensued). Improved quickly with IVIG.
Age: 0.54
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HEP, RV5
Symptoms: Wrong drug administered
Clinical narrative: Pt was administered Pediarix and a separate dose of Hepatitis B vaccine, he should of received Hib vaccine with Pediarix not Hep B.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site scab, Pain in extremity
Clinical narrative: 2 INCH ACROSS RED BULLSEYE FORMED UNDER BANDAGE.  ARM HURT.  WAS NOT ITCHY AND THERE WAS NO TEMPERATURE.  TODAY, 1/28/13 IT APPEARS AS A SCAB OVER INJECTION SITE AND REDNESS HAS DISAPPEARED.
Age: 44.0
Sex: F
Vaccine: YF
Symptoms: Dizziness, Hypoacusis, Nausea
Clinical narrative: Patient into clinic 1/28/13 to receive Typhoid vaccine. Reports continued episodes of dizziness & nausea since receiving Yellow Fever 1/25/13. Dizziness happens with rising and decreases as day progresses. Dizziness only affects the left side of patient's body. Nausea is continuous throughout the day. Reports muffled Left ear at this time.  No medications or Treatment given at this time. Advised patient to follow up with PMD for muffled left ear. Does not report pain or fever.  Patient's vital signs are WNL, afebrile, injection site is WNL.
Age: 2.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Induration, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: Urticarial rash at site of injection, itchy.  Pruritis improved with Benadryl, but erythema and induration lasted several days.
Age: 16.0
Sex: F
Vaccine: FLU3, HPV4, MNQ
Symptoms: Expired drug administered, No adverse event
Clinical narrative: NO ADVERSE EVENTS, PATIENT GIVEN EXPIRED VACCINE (TDAP) EXPIRED 12/2012.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: REDNESS, SWELLING.
Age: 61.0
Sex: F
Vaccine: HEPAB, IPV, TDAP, VARZOS
Symptoms: Blood pressure increased, Tinnitus
Clinical narrative: Elevated BP of 166/110 from norm of 128/78.  Also ringing in ears.
Age: 21.0
Sex: M
Vaccine: HEPA, TYP, YF
Symptoms: Chills, Influenza like illness, Mental disorder, Pyrexia
Clinical narrative: High fever, chills, flu-like symptoms, altered mental state. Symptoms abated in ~24-48 hours.
Age: 6.0
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Approximately a 3-inch wide circle surrounding the injection site became red, splotchy, bumpy, hard, raised, hot and very itchy.  Child was taken to urgent care where the doctor stated that it was in fact a reaction to the injection.  A steroid cream was prescribed and is being used twice daily.  After three days of using the cream the spot is beginning to dissipate.  It is still hot, red, raised and itchy, but not as badly as it was a few days ago.