chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLUN3, TDAP, FLUN3, TDAP
Symptoms: Dysphagia, Erythema, Hypersensitivity, Obstructive airways disorder, Pruritus
Clinical narrative: 12-20-2010 8:12 AM client called clinic to report possible side effects. 12-16-2010 client was seen at Immunization clinic and received A TDAP and FLUMIST. 12-16-2010 Client stated that she had difficulty swallowing and her hands and feet were itchy, and her foot had hives. Client states she has been taking BENADRYL. By 12-20-2010 8:12AM she reports that her hands were so swollen that she could not take her ring off, and that she felt as her hands would burst. Client was advised to be evaluated by a doctor. 12-20-2010 9:30AM Client went to be evaluated at Clinic, client states that she was advised to go to ER if swelling gets worse or comes back. 12-20-2010 2:30 pm Nurse at clinic spoke with client and she stated that the swelling has gone down in her hands and feet and that she was able to get her ring off, but that she still has hives all over arms and legs and compared them to a razor burn.
Age: 28.0
Sex: F
Vaccine: FLUN3, TDAP, FLUN3, TDAP
Symptoms: Rash
Clinical narrative: 12-20-2010 8:12 AM client called clinic to report possible side effects. 12-16-2010 client was seen at Immunization clinic and received A TDAP and FLUMIST. 12-16-2010 Client stated that she had difficulty swallowing and her hands and feet were itchy, and her foot had hives. Client states she has been taking BENADRYL. By 12-20-2010 8:12AM she reports that her hands were so swollen that she could not take her ring off, and that she felt as her hands would burst. Client was advised to be evaluated by a doctor. 12-20-2010 9:30AM Client went to be evaluated at Clinic, client states that she was advised to go to ER if swelling gets worse or comes back. 12-20-2010 2:30 pm Nurse at clinic spoke with client and she stated that the swelling has gone down in her hands and feet and that she was able to get her ring off, but that she still has hives all over arms and legs and compared them to a razor burn.
Age: 28.0
Sex: F
Vaccine: FLUN3, TDAP, FLUN3, TDAP
Symptoms: Dysphagia, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: 12-20-2010 8:12 AM client called clinic to report possible side effects. 12-16-2010 client was seen at Immunization clinic and received A TDAP and FLUMIST. 12-16-2010 Client stated that she had difficulty swallowing and her hands and feet were itchy, and her foot had hives. Client states she has been taking BENADRYL. By 12-20-2010 8:12AM she reports that her hands were so swollen that she could not take her ring off, and that she felt as her hands would burst. Client was advised to be evaluated by a doctor. 12-20-2010 9:30AM Client went to be evaluated at Clinic, client states that she was advised to go to ER if swelling gets worse or comes back. 12-20-2010 2:30 pm Nurse at clinic spoke with client and she stated that the swelling has gone down in her hands and feet and that she was able to get her ring off, but that she still has hives all over arms and legs and compared them to a razor burn.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Blindness cortical, Cerebral palsy, Drug exposure during pregnancy, Herpes virus infection, Microcephaly
Clinical narrative: After vaccine, began to have high protein in urine & decreased fetal movement.  Baby born with multiple medical problems.  Refer to VAERS ID# 413224.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Nuclear magnetic resonance imaging, Scan brain, Toxoplasmosis
Clinical narrative: After vaccine, began to have high protein in urine & decreased fetal movement.  Baby born with multiple medical problems.  Refer to VAERS ID# 413224.
Age: 17.0
Sex: F
Vaccine: FLU(H1N1), FLU3, FLU(H1N1), FLU3
Symptoms: Delivery, Drug exposure during pregnancy, Foetal hypokinesia, Protein urine
Clinical narrative: After vaccine, began to have high protein in urine & decreased fetal movement.  Baby born with multiple medical problems.  Refer to VAERS ID# 413224.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Left arm is red, on side of arm; some swelling & pain pt received injection in afternoon and came back the next day with the symptoms.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Arthralgia, Erythema, Injected limb mobility decreased, Injection site pain
Clinical narrative: 50 y/o female who received TDAP in her RUE; does not recall anything unusual regarding site administration or technique. Noted soreness, some redness and swelling with onset a few hours post-vaccination, but by 48 hours post-vaccination, she was experiencing significant pain. Area of redness and swelling was about the diameter of a golf-ball; swelling and redness gradually improved and resolved within 1 week post-vaccination. Denies significant systemic symptoms such as fever, generalized body pain, fatigue or headaches. Reports feeling well on day vaccine receipt. Pain at its peak was 10+/10 on pain scale; pain primarily limited to R) shoulder area and upper arm; pain significantly increased with AROM. Patient self treated with CELEBREX with minimal-moderate relief. Pain significantly limited ROM and patient was unable to carry out ADLs. Denies numbness and tingling. No R)UE weakness. No prior history of R)UE injury or trauma; no previous history of R)UE pain. Has had rotator cuff surgery on her left shoulder and does not feel current pain in R)UE is similar to that pain. Exam on 12/23 notes: R)UE - tenderness on palpation of deltoid muscle. Pain elicited by motion of the shoulder with a painful shoulder arc. Shoulders appeared normal; no muscle spasms. No instability of shoulders noted. No shoulder weakness. Pain on active ROM (+ Hawkins) and right bicipital tenderness. Dx - joint pain, localized in R) shoulder - biceps tendonitis vs rotator cuff tendonitis with referral to PT (pending) and CELEBREX prescribed.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Musculoskeletal pain, Myalgia, Pain, Rotator cuff syndrome
Clinical narrative: 50 y/o female who received TDAP in her RUE; does not recall anything unusual regarding site administration or technique. Noted soreness, some redness and swelling with onset a few hours post-vaccination, but by 48 hours post-vaccination, she was experiencing significant pain. Area of redness and swelling was about the diameter of a golf-ball; swelling and redness gradually improved and resolved within 1 week post-vaccination. Denies significant systemic symptoms such as fever, generalized body pain, fatigue or headaches. Reports feeling well on day vaccine receipt. Pain at its peak was 10+/10 on pain scale; pain primarily limited to R) shoulder area and upper arm; pain significantly increased with AROM. Patient self treated with CELEBREX with minimal-moderate relief. Pain significantly limited ROM and patient was unable to carry out ADLs. Denies numbness and tingling. No R)UE weakness. No prior history of R)UE injury or trauma; no previous history of R)UE pain. Has had rotator cuff surgery on her left shoulder and does not feel current pain in R)UE is similar to that pain. Exam on 12/23 notes: R)UE - tenderness on palpation of deltoid muscle. Pain elicited by motion of the shoulder with a painful shoulder arc. Shoulders appeared normal; no muscle spasms. No instability of shoulders noted. No shoulder weakness. Pain on active ROM (+ Hawkins) and right bicipital tenderness. Dx - joint pain, localized in R) shoulder - biceps tendonitis vs rotator cuff tendonitis with referral to PT (pending) and CELEBREX prescribed.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Swelling, X-ray limb
Clinical narrative: 50 y/o female who received TDAP in her RUE; does not recall anything unusual regarding site administration or technique. Noted soreness, some redness and swelling with onset a few hours post-vaccination, but by 48 hours post-vaccination, she was experiencing significant pain. Area of redness and swelling was about the diameter of a golf-ball; swelling and redness gradually improved and resolved within 1 week post-vaccination. Denies significant systemic symptoms such as fever, generalized body pain, fatigue or headaches. Reports feeling well on day vaccine receipt. Pain at its peak was 10+/10 on pain scale; pain primarily limited to R) shoulder area and upper arm; pain significantly increased with AROM. Patient self treated with CELEBREX with minimal-moderate relief. Pain significantly limited ROM and patient was unable to carry out ADLs. Denies numbness and tingling. No R)UE weakness. No prior history of R)UE injury or trauma; no previous history of R)UE pain. Has had rotator cuff surgery on her left shoulder and does not feel current pain in R)UE is similar to that pain. Exam on 12/23 notes: R)UE - tenderness on palpation of deltoid muscle. Pain elicited by motion of the shoulder with a painful shoulder arc. Shoulders appeared normal; no muscle spasms. No instability of shoulders noted. No shoulder weakness. Pain on active ROM (+ Hawkins) and right bicipital tenderness. Dx - joint pain, localized in R) shoulder - biceps tendonitis vs rotator cuff tendonitis with referral to PT (pending) and CELEBREX prescribed.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: 2 doses TDAP given within 7 months.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site discharge, Injection site erythema, Injection site pain, Injection site scab, Injection site swelling
Clinical narrative: Right arm -> deltoid muscle at shot site of varicella became red, swollen painful with movement began 12/21 - on 12/22 notice clear discharge -> scabby, redness, sore no pain, no itch.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Pain
Clinical narrative: Right arm -> deltoid muscle at shot site of varicella became red, swollen painful with movement began 12/21 - on 12/22 notice clear discharge -> scabby, redness, sore no pain, no itch.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARZOS
Symptoms: Expired drug administered
Clinical narrative: Expired vaccine.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site warmth
Clinical narrative: Per father, pt diagnosed with bilateral cellulitis in arms on 12/9/10. Per father - both arms were red and warm to touch.
Age: 8.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: No adverse event. Child was 8 years of age and received KINRIX.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Shingles like rash not in area of vaccine given.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Slight redness in shoulder - left slight itching in shoulder - left at this time redness is going down.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Blood thyroid stimulating hormone normal, Diarrhoea, Differential white blood cell count abnormal, Pallor, Vomiting
Clinical narrative: 12-12-10 Vomited x6, diarrhea x1 - looked "grey" while vomiting, "pasty" looking after vomiting.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: White blood cell count normal
Clinical narrative: 12-12-10 Vomited x6, diarrhea x1 - looked "grey" while vomiting, "pasty" looking after vomiting.
Age: 10.0
Sex: F
Vaccine: FLUN3
Symptoms: Dizziness, Muscle spasms, Tremor
Clinical narrative: The child became dizzy, very shaky, and experienced spasms in her right leg.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pruritus
Clinical narrative: Varicella vaccine given Sub Q (R) thigh 2:05pm. Immediately patient c/o itching & pain. Redness began. MD notified & entered. Ice applied & BENADRYL liquid given at 2:10pm. 2:30 redness is decreasing. 2:40pm pt ok'd to leave with instructions.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Electromyogram abnormal, Gait disturbance, Guillain-Barre syndrome, Heart rate increased
Clinical narrative: 10/18/2010- rapid heart rate and elevated blood pressure required Emergency Room visit and admission to Cardiac Surgery Intensive Care Unit for two nights at Hospital.  Treated with blood pressure medications.  Discharged from hospital with medications on 10/20/2010.  Symptoms slowly progressed to numbness, tingling, and weakness in extremities and then progressed further to difficulty walking and total paralysis of left side of face.  Was diagnosed with Guillain-Barre Syndrome on Monday, November 22nd 2010.  Treated with four infusions of IV Immune Globulin.  Currently enrolled in physical therapy three times per week.  Slowly improving symptoms.  Still unable to work or drive.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Impaired driving ability, Intensive care, Laboratory test normal
Clinical narrative: 10/18/2010- rapid heart rate and elevated blood pressure required Emergency Room visit and admission to Cardiac Surgery Intensive Care Unit for two nights at Hospital.  Treated with blood pressure medications.  Discharged from hospital with medications on 10/20/2010.  Symptoms slowly progressed to numbness, tingling, and weakness in extremities and then progressed further to difficulty walking and total paralysis of left side of face.  Was diagnosed with Guillain-Barre Syndrome on Monday, November 22nd 2010.  Treated with four infusions of IV Immune Globulin.  Currently enrolled in physical therapy three times per week.  Slowly improving symptoms.  Still unable to work or drive.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Muscular weakness, Paraesthesia, VIIth nerve paralysis
Clinical narrative: 10/18/2010- rapid heart rate and elevated blood pressure required Emergency Room visit and admission to Cardiac Surgery Intensive Care Unit for two nights at Hospital.  Treated with blood pressure medications.  Discharged from hospital with medications on 10/20/2010.  Symptoms slowly progressed to numbness, tingling, and weakness in extremities and then progressed further to difficulty walking and total paralysis of left side of face.  Was diagnosed with Guillain-Barre Syndrome on Monday, November 22nd 2010.  Treated with four infusions of IV Immune Globulin.  Currently enrolled in physical therapy three times per week.  Slowly improving symptoms.  Still unable to work or drive.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Throat irritation
Clinical narrative: After the patient got home her eyes began to swell shut and then she felt a funny feeling in her throat and went to the emergency room
Age: 52.0
Sex: M
Vaccine: ANTH
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Administered expired vaccine - no adverse event LOT # FAV 241
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Expired drug administered
Clinical narrative: admin expired lot number
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Diet refusal, Vomiting
Clinical narrative: Pt. awoke vomiting and then vomited several times thereafter; refused breast. Went to ER, given ondansetron ODT; no more vomiting. Had 1 loose stool 3 hours later.
Age: 1.03
Sex: F
Vaccine: FLU3, MMR, PNC13, VARCEL
Symptoms: Insomnia, Lethargy, Pyrexia
Clinical narrative: Father called clinic at 1:00PM, 12/21/10 with c/o fever onset 4PM 12/20/10 103.9 & now 104.0. (+) lethargy (-) vomiting or seizures. Inability to sleep. Gave acetaminophen recommended dose q 4-6 hr. Instructed to go to ER/U/C. Dr notified.
Age: 6.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Injection site ulcer, Local swelling, Skin ulcer
Clinical narrative: Localized erythema and swelling and possible generalized pruritus and urticaria - 31 hrs after vaccine. Treated with antihistamines and Prelone. A 6 year male patient, with a history of chronic idiopathic urticaria and food allergies, received on 10 November 2010 a right deltoid intramuscular injection of FLUZONE No Preservative 2010-2011, lot number U3777BA. The patient had no concomitant medications and denied any illness at the time of vaccination. On 15 November 2010, 5 days after the vaccine, the patient reported that he had an area the size of a 25 cent piece at the injection site which was ulcerated and painful. The patient was evaluated by an infectious disease specialist. The outcome was unknown. Additional information was received from the health care professional on 16 and 19 November 2010. The patient was vaccinated from a single-dose vial and developed a skin ulcer within 1 to 2 days of vaccination (previously reported as 5 days post-vaccination). He had "multiple medical problems", and had received influenza vaccines in the past. At the time of the report, the ulcer was healing on its own.
Age: 12.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Red area approx 30cm x 30cm. Warm to touch pt. given 1 tsp. BENADRYL at 1620. Complains area itches.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Heart rate increased, Influenza like illness, Paraesthesia
Clinical narrative: One day after receiving the seasonal influenza vaccine - felt tingling in (L) arm, increased heart rate, "flu-like symptoms". Called in sick to work on 12/7/2010. Did not seek treatment; declined follow-up.
Age: 3.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Excessive eye blinking, Headache, Vomiting
Clinical narrative: Approx 6 hour after vaccines, reported head pain, and eye blinking. Putting hand to head frequently. Vomited x 1 that evening. Seen 6 Dec 10 at clinic for continued eye blinking and touching forehead.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Injection site warmth
Clinical narrative: Edematous and erythematous area on external (R) arm tender & warm to touch mild induration area about 10 x 8cm, fever x 2 days pt was given KEFLEX & ORAPRED to cover.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Pyrexia
Clinical narrative: Edematous and erythematous area on external (R) arm tender & warm to touch mild induration area about 10 x 8cm, fever x 2 days pt was given KEFLEX & ORAPRED to cover.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash pruritic
Clinical narrative: Patient reports a rash develop 4-5 days later - itchy rash - no blister. Pain in side develop the following weekend. Patient called Dr & was prescribes Tramadol for pain. Dr said to take TYLENOL.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pyrexia, Rash generalised
Clinical narrative: Pt felt weak after vaccine and following day body was covered by rash. Patient tried BENADRYL & did not go away in the following day and then went to ER. Had high temp as well gave IV fluids.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: Body temperature increased, Chills, Fatigue, Hyperhidrosis, Nausea
Clinical narrative: Chills, sweating.  Temp 99 to 100 degrees beginning in early evening.  Achey, groggy, tired, nauseated.  Would feel fine during the daytime.  No redness or swelling at injection site.  The upper arm was a little sore the day of the shot but that disappeared.  Has never had a reaction to any other immunization.  12-13-10 patient is no longer running low grade temperatures at night.
Age: 37.0
Sex: M
Vaccine: TDAP
Symptoms: No reaction on previous exposure to drug, Pain, Pain in extremity, Somnolence
Clinical narrative: Chills, sweating.  Temp 99 to 100 degrees beginning in early evening.  Achey, groggy, tired, nauseated.  Would feel fine during the daytime.  No redness or swelling at injection site.  The upper arm was a little sore the day of the shot but that disappeared.  Has never had a reaction to any other immunization.  12-13-10 patient is no longer running low grade temperatures at night.
Age: 3.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Pyrexia
Clinical narrative: CELLULITIS/FEVER
Age: 0.93
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Lethargy, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: The formal illness began when he was seen in peds clinic with a fever, lethargy and all over BODY WEAKNESS, which started that morning.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Eosinophilic cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Vaccination given in left deltoid.  Patient developed eosinophilic cellulitis.  Fever, chills, pain in left arm, redness/swelling/warm to touch from left shoulder to left elbow.  Patient using ibuprofen for discomfort and applying ice.  Assessed in office 12/22/10 and will be doing daily phone check in with patient.
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Pain in extremity, Pyrexia
Clinical narrative: Vaccination given in left deltoid.  Patient developed eosinophilic cellulitis.  Fever, chills, pain in left arm, redness/swelling/warm to touch from left shoulder to left elbow.  Patient using ibuprofen for discomfort and applying ice.  Assessed in office 12/22/10 and will be doing daily phone check in with patient.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Tremor
Clinical narrative: Patient reports that she felt dizzy unless lying down; also fatigue and shakiness. These symptoms have lasted for 6 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Arm swollen, red, and warm to touch. Keflex prescribed.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Information has been received from a Post-Marketing Surveillance Study for PNEUMOVAX 23. A medical assistant reported a 56 year old female patient, who on 16-MAR-2010 the patient was vaccinated with a dose of PNEUMOVAX 23 (Lot # 663936/0508Y, expire date 17-JUN-2010, route not reported) as part of a study. On 02-OCT-2010 the patient was vaccinated with another dose of PNEUMOVAX 23 (Lot #, expire date and route not reported). No adverse effect known. On an unspecified date, the patient developed pneumonia and was hospitalized. At the time of the report the outcome of the patient was unknown. At this time, relationship of pneumonia to study therapy was unknown. Additional information has been requested.
Age: 13.0
Sex: M
Vaccine: FLU3
Symptoms: Cyanosis, Dyspnoea, Erythema, Throat irritation
Clinical narrative: Per mom by 5:30pm he c/o his throat feeling funny but no reap sx. Then a few minutes later his hands were bright red and then his chest. She gave him a dose of BENADRYL and Alb. inhaler he got worse then started gasping for air. Went to ER and when arrived his hands, arms, legs and lips were purple.
Age: 1.08
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC
Symptoms: Blood test normal, Body temperature increased, Febrile convulsion
Clinical narrative: Diagnosed with febrile seizure. Temperature 104 degrees.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Crying, Diarrhoea, Diet refusal, Irritability, Poor quality sleep
Clinical narrative: December 18, 19, 20 fever 37.7C little vomit. December 21, 22, 23 rush (still today rush) started on head chest back and slowly took over all body. All these days poor appetite, refuses to eat mostly milk only.  Diarrhea.  Sleeping bad in night wakes up crying. Day time more sleepy, fussy.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Somnolence, Vomiting
Clinical narrative: December 18, 19, 20 fever 37.7C little vomit. December 21, 22, 23 rush (still today rush) started on head chest back and slowly took over all body. All these days poor appetite, refuses to eat mostly milk only.  Diarrhea.  Sleeping bad in night wakes up crying. Day time more sleepy, fussy.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Incorrect drug dosage form administered
Clinical narrative: The Menveo liquid conjugate dose was not diluted into the powder.  Pt received the "Liquid Conjugate Component" only.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Feeling abnormal, Headache, Pain
Clinical narrative: I got dizzy after the shot, head felt odd, body odd, and stayed at the pharmacy, since they were not concerned I stay 15 mins and left. Shortly after that I got body aches, and a small headache. This progressed all day and night. Woke up feeling lots of body aches and headache. Drank lots of water before and after the immunization. Took nothing for it. At 3pm on the 22 I called and they said I could take aspirin, which I did. I will report when I feel better.
Age: 24.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Cardiac function test normal, Computerised tomogram normal, Convulsion, Electroencephalogram normal, Nuclear magnetic resonance imaging normal
Clinical narrative: First time Seizure/Fainting. Went to see Doctor and tests came back normal. On 12/22/2010 around 9:30am had another seizure/fainting episode. Required Hospitalization.
Age: 24.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Syncope
Clinical narrative: First time Seizure/Fainting. Went to see Doctor and tests came back normal. On 12/22/2010 around 9:30am had another seizure/fainting episode. Required Hospitalization.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain upper, Headache, Pyrexia
Clinical narrative: Patient report to ER for fever, stomach ache, and headache within 12 hours of immunization
Age: 1.05
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Full blood count normal, Pyrexia, Rash generalised
Clinical narrative: Erupted with rash am of 12/23/10 - worsening over 24hrs to cover entire body. Fever with max 101. Treated with TYLENOL, Ibuprofen, and BENADRYL.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Erythema, Respiratory tract congestion, Swelling
Clinical narrative: Swelling & redness of entire shoulder bone aching congestion > overnight - pt felt better 24 hr after injection.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Product outer packaging issue, Wrong drug administered
Clinical narrative: Pt was given the influenza vaccine with preservative. Box from the manufacturer was mislabeled.
Age: 1.26
Sex: M
Vaccine: DTAPIPVHIB, FLU3
Symptoms: Product label issue, Wrong drug administered
Clinical narrative: Pt was given influenza vaccine with preservative - the box was mislabeled by the manufacturer.
Age: 0.57
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Product outer packaging issue, Wrong drug administered
Clinical narrative: Pt was given Influenza vaccine with preservative in it. Box stated vaccine for 6 mos - 18 yrs.
Age: 0.53
Sex: F
Vaccine: DTAPIPVHIB, FLU3, HEP, PNC13, RV5
Symptoms: Product outer packaging issue, Wrong drug administered
Clinical narrative: Pt was given influenza vaccine with preservative in it - box mislabeled by the manufacturer.
Age: 1.55
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Product outer packaging issue, Wrong drug administered
Clinical narrative: Pt was given influenza vaccine with preservative - the box was mislabeled by the manufacturer.
Age: 1.52
Sex: F
Vaccine: FLU3, HEPA
Symptoms: Product outer packaging issue, Wrong drug administered
Clinical narrative: Pt given flu vaccine with preservative in it - box mislabeled by the manufacturer.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Musculoskeletal pain
Clinical narrative: Patient reported erythema and pain to right shoulder after getting PNEUMOVAX 23. Had seasonal influenza in left arm same day. No fever or spread. Tx with MOTRIN & ice.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Asthenia, Headache, Influenza, Sluggishness
Clinical narrative: Patient claims he experienced a mild "flu" for 2 days after administration. Headache, sluggishness and generalized weakness. Denies temperature & GI effects.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Pain in extremity
Clinical narrative: Patient complains of sore arm, which leads to difficulty showering, after receiving FLUZONE High Dose vaccine.
Age: 28.0
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Joint swelling, Musculoskeletal pain
Clinical narrative: (All by Hx) 12/4 swelling & pain L knee 12/7 swelling & pain R knee & pain R knee & pain L shoulder. Symptoms are resolving.
Age: 26.0
Sex: M
Vaccine: MMR
Symptoms: Axillary pain, Joint stiffness, Joint swelling, Pain in extremity
Clinical narrative: By history: 11/14 swelling & stiffness L knee 11/18 swelling & stiffness Rt knee 11/24 aching L axilla 11/26 pain in fingers. All symptoms have resolved.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Vomiting
Clinical narrative: Symptoms: Vomiting, body aches, chills Time course: 10-12 hrs after vaccination Treatment: None.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site nodule, Injection site swelling
Clinical narrative: Mother called and stated that the site where pt. has received his PREVNAR 13 vaccination was swollen last night and there is a hard nodule. Mother noticed the swelling last night and the swelling appears to be going down today and there are no other symptoms. Mother requested to have a VAERS form filled out.
Age: 1.02
Sex: M
Vaccine: HEPA, PNC13, VARCEL
Symptoms: Rash generalised
Clinical narrative: Mother noticed pt. had rash all over body on morning of 12/23/10.
Age: 0.35
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Febrile convulsion, Postictal state
Clinical narrative: Given vaccines on 12/17/10. Parents gave TYLENOL after vaccines. Normal routine afterwards. Put patient to bed, mom awakened later by noises, found patient seizing in crib. Lasted approx 1 min, postictal for 3 min. Transport by EMS to ER. No documented fever per parents or told to them by EMSA or ER. Tmax 99. Discharged home with dx of febrile seizure. No recurrences since then per parents.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient first noticed arm red and swollen 12/20/10 in the evening after inj. given the next day 12/21/10 pt mom - noticed and stated entire back of pt (L) upper arm red, swollen and warm to touch on 12/22/10 pt mom contacted clinic arm assessed and red, swollen, warm to touch area approx 3" long and 1" wide mom instructed to give pt BENADRYL & monitor 12/23/10 pt mom contacted she stated area cont. to decrease in size. No SOB or other adverse reactions ever noticed on pt. No fever noted either.
Age: 27.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site pain, Pain, Pain in extremity
Clinical narrative: Pt reports pain from the top of her rt shoulder down the arm and is unable to move her arm and when she does, it is very painful and difficult to move. Shot location doesn't look swollen or red but is painful to the touch.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Midnight arm pain, soft tissue swelling area is warm and red.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Pain
Clinical narrative: Pain radiating from injection site up through shoulder and down arm, welt about 3cm X 3 cm appeared.  Next morning welt much larger and pain in arm/shoulder more intense.  Saw Dr. at 2:30 in afternoon and welt was 9.5 cm X 3.5 cm.  Pain being treated with Tylenol and ice being applied to welt.  Slight reduction in welt size and redness, and reduction in pain after Tylenol, and then back to previous level when Tylenol wears off.  Today a new symptom has appeared:  tenderness and slight swelling of the right arm pit (injection site is right arm).
Age: 53.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Arthralgia, Back pain, Chills, Dysgeusia, Fatigue
Clinical narrative: Chills, fever of 101.5 to 101.9 x 2 days, headache, back ache, diffuse muscle and joint pain from head to feet, fatigue, excessive thirst, abnormal taste, slight nausea.  No vomiting or diarrhea, no upper respiratory symptoms, congestion, rhinorrhea or cough.  Slept approximately 20 of 24 hours.  Unable to work as scheduled on 12/22/2010.  In addition, there has been localized muscle soreness, tenderness, and erythematous patches and streaks over left upper arm from shoulder to elbow, with point tenderness and redness over site of Tdap vaccination x 5 days.  MMR was given SC at the same time in the same upper extremity, but there was no tenderness in that area.  PLEASE NOTE:  I am a health care provider; the RN who gave the vaccines had flawless technique and the Tdap was given IM in the deltoid.
Age: 53.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site reaction, Injection site streaking
Clinical narrative: Chills, fever of 101.5 to 101.9 x 2 days, headache, back ache, diffuse muscle and joint pain from head to feet, fatigue, excessive thirst, abnormal taste, slight nausea.  No vomiting or diarrhea, no upper respiratory symptoms, congestion, rhinorrhea or cough.  Slept approximately 20 of 24 hours.  Unable to work as scheduled on 12/22/2010.  In addition, there has been localized muscle soreness, tenderness, and erythematous patches and streaks over left upper arm from shoulder to elbow, with point tenderness and redness over site of Tdap vaccination x 5 days.  MMR was given SC at the same time in the same upper extremity, but there was no tenderness in that area.  PLEASE NOTE:  I am a health care provider; the RN who gave the vaccines had flawless technique and the Tdap was given IM in the deltoid.
Age: 53.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Myalgia, Nausea, Pyrexia, Rash erythematous, Thirst
Clinical narrative: Chills, fever of 101.5 to 101.9 x 2 days, headache, back ache, diffuse muscle and joint pain from head to feet, fatigue, excessive thirst, abnormal taste, slight nausea.  No vomiting or diarrhea, no upper respiratory symptoms, congestion, rhinorrhea or cough.  Slept approximately 20 of 24 hours.  Unable to work as scheduled on 12/22/2010.  In addition, there has been localized muscle soreness, tenderness, and erythematous patches and streaks over left upper arm from shoulder to elbow, with point tenderness and redness over site of Tdap vaccination x 5 days.  MMR was given SC at the same time in the same upper extremity, but there was no tenderness in that area.  PLEASE NOTE:  I am a health care provider; the RN who gave the vaccines had flawless technique and the Tdap was given IM in the deltoid.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Influenza, No reaction on previous exposure to drug, Pain, Pyrexia
Clinical narrative: Woke up with sharp pain in lower part of rt lung.  Pain continued for the remainder of day.  Patient considered going to emergency room because of sharp pain.  Fever and body aches began approx. 12:30 pm of same day.  The pain in the lungs subsided and patient experienced common flu symptoms which required 3 separate doctors visits and went on breathing treatments Dec. 6 for 1 week.  2nd round of antibiotics were also given.  Subsequent to this illness patient had received flu shot every year for past 10 years and had not had respiratory flu for 3 years.  Never had breathing treatments.  As of this date patient is still coughing periodically.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Haemorrhage, Pruritus, Rash erythematous, Rash generalised
Clinical narrative: Initial consumer (patient's daughter) on 10 Dec 2010: This patient with an unknown medical history was vaccinated with FLUVIRIN (batch number: unknown) 0.5 ml intramuscularly on 06 Nov 2010. The patient developed red, raised rashes all over her body on 11 Nov 2010. She also complained of persistent itching and bleeding. The outcome was reported as condition ongoing.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Productive cough, Wheezing
Clinical narrative: Dry cough until December 15, then, cough with mucus.  To date am coughing up and wheezing.  Taking otc cold and cough syrup. I am on second bottle. At times I feel fine, then, relapse and cough and wheeze. The mucus is thick, it started out clear, then, yellow, now white and clear.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Pain, Pruritus
Clinical narrative: Swelling, pain and rash at injection site; itching and slight pain at various points on trunk.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Back pain, Bacterial infection, Bacterial test positive, Blood test abnormal
Clinical narrative: Severe pain in lower left back, started earlier in the day and increased quickly throughout the evening.  I couldn't stand, walk or move.  Ambulance took me to the hospital.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Dysstasia, Urinary tract infection
Clinical narrative: Severe pain in lower left back, started earlier in the day and increased quickly throughout the evening.  I couldn't stand, walk or move.  Ambulance took me to the hospital.
Age: 2.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: SEIZURE
Age: 60.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Inflammation, Injection site pain, Muscular weakness
Clinical narrative: General muscle weakness and mild inflammation of right neck, with mild headache upon waking up in the morning.  Soreness at injection site first noticed on 12/25/2010 upon waking up in the morning.  The symptoms are continuing and still present with the exception of the injection site soreness, at the time this report was filed at approx. 2 PM on 12/26/2010.
Age: 41.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Pain in deltoid where injection took place.  Patient went to an Urgent Care.  The Dr. diagnosed her with a hematoma.  No medicinal treatment prescribed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: my arm was quite red and swollen and has remained this way for 5 days
Age: 59.0
Sex: M
Vaccine: JEV
Symptoms: Ataxia, Paraesthesia
Clinical narrative: Initial information retrieved via the scientific literature on 20 December 2010.  Adverse event reports following Japanese encephalitis vaccination.  A 59-year-old male patient had received a second dose of JE-VAX and 25 days post-vaccination developed ataxia and paresthesias in his extremities.  The patient was hospitalized one night and discharged with outpatient physical and occupational therapy.  Per the reporter, no follow-up information was available.  The reporter for this case is the same as for cases 2005-00286, U1999-00204, 2010-07083, 07084, 07085, and -07087.  Documents held by sender: None.
Age: 3.0
Sex: F
Vaccine: JEV
Symptoms: Pruritus, Urticaria
Clinical narrative: Initial information retrieved via the scientific literature on 20 December 2010. Adverse event reports following JE-VAX. A 3-year-old female patient had received a second dose of JE-VAX (lot not reported) on an unspecified date, and 5 days later was hospitalized for 4 days with urticaria and pruritus. Recovery status was not reported. The reporter for the case is the same as for cases 2005-00286, U1999-00204, and 2010-07083, -07084, 07086, and -07087.
Age: 22.0
Sex: M
Vaccine: JEV
Symptoms: Convulsion
Clinical narrative: Initial information retrieved via the scientific literature on 20 December 2010.  Adverse event reports following Japanese encephalitis vaccination.  A 22-year-old male patient had received a first dose of JE-VAX (lot not reported) administered alone on an unspecified date, and 5 minutes post-vaccination he had an apparent brief seizure.  After the event he was alert and oriented with normal vital signs and no other symptoms.  He was observed for 90 minutes and then released home (hospitalization was not mentioned).  No further seizure activity was reported.  The reporter for the case is the same as for cases 2005-00286, U1999-00204, and 2010-07083, -07084, 07085, and -07086.  Documents held by sender: None.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Blood test normal, Chest X-ray normal, Chills, Culture throat negative, Dizziness
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 27-SEP-2010, a 11 year old male patient with history of obesity, spinal cord tumor, left sided weakness and pre-existing illness of wound open in his hand was vaccinated IM with the first dose of GARDASIL (Lot # 666121/1778Y) into his right arm. Concomitant vaccinations included: the fifth dose of FLUZONE (lot # U3571AA) given IM into his left arm, the first dose of ADACEL (Lot # C3475AA) given IM into his right arm and the first dose of MENACTRA (Lot # U3463AA) given IM into his right arm. Concomitant medications included: DUODERM, nystatin, MSD, AQUAPHOR. It was reported that on 29-SEP-2010, 2 days after the vaccination, the patient developed fever. He was seen in the ER and he had a positive blood culture. The patient was admitted because he still had fever. Subsequently, he was diagnosed with left humerus osteomyelitis and with a subperiosteal abscess left humerus also. The patient was taken to surgery to drain the abscess. A PICC line was placed for antibiotics. The reported events extended the patient's hospital stay. Labs, MRI, CxR and an Echocardiogram were performed on an unspecified date (results not provided). The patient's outcome was not reported. The original reporting source was not provided. The VAERS ID # was 401591. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Fatigue, Headache, Influenza virus test negative, Injection site erythema, Injection site swelling
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 27-SEP-2010, a 11 year old male patient with history of obesity, spinal cord tumor, left sided weakness and pre-existing illness of wound open in his hand was vaccinated IM with the first dose of GARDASIL (Lot # 666121/1778Y) into his right arm. Concomitant vaccinations included: the fifth dose of FLUZONE (lot # U3571AA) given IM into his left arm, the first dose of ADACEL (Lot # C3475AA) given IM into his right arm and the first dose of MENACTRA (Lot # U3463AA) given IM into his right arm. Concomitant medications included: DUODERM, nystatin, MSD, AQUAPHOR. It was reported that on 29-SEP-2010, 2 days after the vaccination, the patient developed fever. He was seen in the ER and he had a positive blood culture. The patient was admitted because he still had fever. Subsequently, he was diagnosed with left humerus osteomyelitis and with a subperiosteal abscess left humerus also. The patient was taken to surgery to drain the abscess. A PICC line was placed for antibiotics. The reported events extended the patient's hospital stay. Labs, MRI, CxR and an Echocardiogram were performed on an unspecified date (results not provided). The patient's outcome was not reported. The original reporting source was not provided. The VAERS ID # was 401591. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Nausea, Pain in extremity, Pyrexia, Urine analysis normal
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 27-SEP-2010, a 11 year old male patient with history of obesity, spinal cord tumor, left sided weakness and pre-existing illness of wound open in his hand was vaccinated IM with the first dose of GARDASIL (Lot # 666121/1778Y) into his right arm. Concomitant vaccinations included: the fifth dose of FLUZONE (lot # U3571AA) given IM into his left arm, the first dose of ADACEL (Lot # C3475AA) given IM into his right arm and the first dose of MENACTRA (Lot # U3463AA) given IM into his right arm. Concomitant medications included: DUODERM, nystatin, MSD, AQUAPHOR. It was reported that on 29-SEP-2010, 2 days after the vaccination, the patient developed fever. He was seen in the ER and he had a positive blood culture. The patient was admitted because he still had fever. Subsequently, he was diagnosed with left humerus osteomyelitis and with a subperiosteal abscess left humerus also. The patient was taken to surgery to drain the abscess. A PICC line was placed for antibiotics. The reported events extended the patient's hospital stay. Labs, MRI, CxR and an Echocardiogram were performed on an unspecified date (results not provided). The patient's outcome was not reported. The original reporting source was not provided. The VAERS ID # was 401591. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.
Age: 11.0
Sex: M
Vaccine: FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP, FLU3, HPV4, MNQ, TDAP
Symptoms: Blood culture positive, Bone abscess, Chest X-ray, Echocardiogram, Incisional drainage
Clinical narrative: This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act. On 27-SEP-2010, a 11 year old male patient with history of obesity, spinal cord tumor, left sided weakness and pre-existing illness of wound open in his hand was vaccinated IM with the first dose of GARDASIL (Lot # 666121/1778Y) into his right arm. Concomitant vaccinations included: the fifth dose of FLUZONE (lot # U3571AA) given IM into his left arm, the first dose of ADACEL (Lot # C3475AA) given IM into his right arm and the first dose of MENACTRA (Lot # U3463AA) given IM into his right arm. Concomitant medications included: DUODERM, nystatin, MSD, AQUAPHOR. It was reported that on 29-SEP-2010, 2 days after the vaccination, the patient developed fever. He was seen in the ER and he had a positive blood culture. The patient was admitted because he still had fever. Subsequently, he was diagnosed with left humerus osteomyelitis and with a subperiosteal abscess left humerus also. The patient was taken to surgery to drain the abscess. A PICC line was placed for antibiotics. The reported events extended the patient's hospital stay. Labs, MRI, CxR and an Echocardiogram were performed on an unspecified date (results not provided). The patient's outcome was not reported. The original reporting source was not provided. The VAERS ID # was 401591. This is one of several reports received from the same source. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. In addition, an expanded lot check investigation was performed. The testing performed on the batch prior to release met all release specifications. The lot met the requirements of the Center and was released. No further information is available.