chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 51.0
Sex: F
Vaccine: IPV, TDAP, VARCEL
Symptoms: Injection site pain, Pain
Clinical narrative: Left shoulder joint pain with movement and occasional intense stabbing pain lasting 10 seconds.
Age: 39.0
Sex: F
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Hypoaesthesia, Lymphadenitis, Mobility decreased, Pain
Clinical narrative: Big lump on arm.  Extreme pain, cannot lift arm at all and pain is going up left side of shoulder and the left side of my neck. Forearm is numb, and the pain even seems to be in my shoulder bone (proper). This is the 3rd Anthrax shot I have had, and I do not remember ever feeling this.  The pain is the worst pain I have ever had with any immunization. Due to this, if I still feel the same in the a.m., I will have to miss work because I cannot even take my clothes off.  After immunization I did ensure that I maximized movement of my arm because the pain started within 20 seconds after immunization (burning and pain).  I thought movement would help disperse the shot.  This is 100 times worse than a Tetanus shot!
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting, Vomiting projectile
Clinical narrative: Per mother, baby vomited X3.  Two times in small amounts, one time with a cup and a half of projectile vomitus.  Per mother, infant isn't having difficulty breathing (no rattling to chest), no rash or fever at this time.
Age: 1.03
Sex: F
Vaccine: HEPA, MMR
Symptoms: Pyrexia, Rash erythematous, Rash generalised, Streptococcus test negative
Clinical narrative: Fever began Saturday night 5/29, 102 degrees, would only come down a degree with infant Motrin.  Fever lasted 3 days (Saturday, Sunday, Monday) Tuesday morning (6/1), fever broke and woke up with a rash, head to toe of little red spots.  Spots were all over face, arms, hands, torso, legs and feet.  Took her to doctor's office.
Age: 38.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient states she developed redness, diffuse swelling and itching in the area she received a tetanus vaccine ~36hrs prior.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Computerised tomogram, Convulsion, Local reaction, Malaise
Clinical narrative: Felt ill for 7 days, large local reaction where KINRIX given. KINIRIX and Hep A given in left thigh. PROQUAD in right thigh. Felt ill then sz on day #8. Seems better after seizure. No meds given at hosp.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMRV
Symptoms: Urticaria
Clinical narrative: Pt. received vaccines at clinic about 45 minutes later developed hives - mom called clinic informed to give 2 tsp BENADRYL and brought back to clinic.  Taken to ER in a wheelchair.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Idiopathic thrombocytopenic purpura, Platelet count decreased
Clinical narrative: Initial report received from a consumer (patient's relative) on 21 May 2010: This patient was vaccinated with S-OIV FLUVIRIN (influenza virus vaccine monovalent, batch number 10073803), 0.5 ml, intramuscular, on 21 Nov 2009. After vaccination, platelet level of the patient decreased to 35, 36 (unit and reference value unknown) on 29 Dec 2009. it was diagnosed as idiopathic thrombocytopenic purpura. Final outcome of the event was reported as condition unchanged.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Bruxism, Crying, Cyanosis, Feeling abnormal, Musculoskeletal stiffness
Clinical narrative: Information has been received from a physician and a registered nurse concerning an eighteen year old female patient who on 12-MAY-2010, 18-JUL-2008 and 20-MAY-2010 was vaccinated with the first, second and third doses of GARDASIL (Lot # 659962/1740U, Lot # 659182/1757U and Lot # 663451/0216Y 0.5 ML, respectively) into the right arm. On 20-MAY-2010, the patient also received a dose of ADACEL (Lot # UF486DA) into the left arm. About 5 minutes after the third dose of GARDASIL had been administered, the patient sat down in the waiting room. The patient developed a "little" seizure. The nurse reported that the patient lost consciousness, became stiff in the legs and had clinched hands. The patient had cyanosis and was incontinent of urine. The registered nurse was  not sure how long the seizure had lasted. The patient regained consciousness and recovered. The patient's mother stated that on the evening of 20-MAY-2010 the patient had seemed a little "off" (not specified). The patient was referred to two different Neurologist physicians but the patient's mother had stated that the patient had not made an appointment with either Neurologist at that time. The patient was also advised to contact the Pediatric Cardiologist office to schedule an electrocardiogram ECG. On 24-MAY-2010, the registered nurse stated that the patient's mother was contacted via a telephone call. The patient's mother stated that the patient was "doing fine". On 25-MAY-2010, the nurse stated that the patient's father had told the physician that the patient had surgery in 2009. The patient received IV therapy and passed out. The patient's father thought that at that time the patient had a seizure. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Information has been received from a physician and a registered nurse concerning an eighteen year old female patient who on 12-MAY-2010, 18-JUL-2008 and 20-MAY-2010 was vaccinated with the first, second and third doses of GARDASIL (Lot # 659962/1740U, Lot # 659182/1757U and Lot # 663451/0216Y 0.5 ML, respectively) into the right arm. On 20-MAY-2010, the patient also received a dose of ADACEL (Lot # UF486DA) into the left arm. About 5 minutes after the third dose of GARDASIL had been administered, the patient sat down in the waiting room. The patient developed a "little" seizure. The nurse reported that the patient lost consciousness, became stiff in the legs and had clinched hands. The patient had cyanosis and was incontinent of urine. The registered nurse was  not sure how long the seizure had lasted. The patient regained consciousness and recovered. The patient's mother stated that on the evening of 20-MAY-2010 the patient had seemed a little "off" (not specified). The patient was referred to two different Neurologist physicians but the patient's mother had stated that the patient had not made an appointment with either Neurologist at that time. The patient was also advised to contact the Pediatric Cardiologist office to schedule an electrocardiogram ECG. On 24-MAY-2010, the registered nurse stated that the patient's mother was contacted via a telephone call. The patient's mother stated that the patient was "doing fine". On 25-MAY-2010, the nurse stated that the patient's father had told the physician that the patient had surgery in 2009. The patient received IV therapy and passed out. The patient's father thought that at that time the patient had a seizure. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Convulsion, Cyanosis, Loss of consciousness, Malaise, Muscle tightness
Clinical narrative: Information has been received from a physician and a registered nurse concerning an eighteen year old female patient who on 12-MAY-2010, 18-JUL-2008 and 20-MAY-2010 was vaccinated with the first, second and third doses of GARDASIL (Lot # 659962/1740U, Lot # 659182/1757U and Lot # 663451/0216Y 0.5 ML, respectively) into the right arm. On 20-MAY-2010, the patient also received a dose of ADACEL (Lot # UF486DA) into the left arm. About 5 minutes after the third dose of GARDASIL had been administered, the patient sat down in the waiting room. The patient developed a "little" seizure. The nurse reported that the patient lost consciousness, became stiff in the legs and had clinched hands. The patient had cyanosis and was incontinent of urine. The registered nurse was  not sure how long the seizure had lasted. The patient regained consciousness and recovered. The patient's mother stated that on the evening of 20-MAY-2010 the patient had seemed a little "off" (not specified). The patient was referred to two different Neurologist physicians but the patient's mother had stated that the patient had not made an appointment with either Neurologist at that time. The patient was also advised to contact the Pediatric Cardiologist office to schedule an electrocardiogram ECG. On 24-MAY-2010, the registered nurse stated that the patient's mother was contacted via a telephone call. The patient's mother stated that the patient was "doing fine". On 25-MAY-2010, the nurse stated that the patient's father had told the physician that the patient had surgery in 2009. The patient received IV therapy and passed out. The patient's father thought that at that time the patient had a seizure. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HPV4, TDAP, HPV4, TDAP
Symptoms: Musculoskeletal stiffness, Surgery, Urinary incontinence
Clinical narrative: Information has been received from a physician and a registered nurse concerning an eighteen year old female patient who on 12-MAY-2010, 18-JUL-2008 and 20-MAY-2010 was vaccinated with the first, second and third doses of GARDASIL (Lot # 659962/1740U, Lot # 659182/1757U and Lot # 663451/0216Y 0.5 ML, respectively) into the right arm. On 20-MAY-2010, the patient also received a dose of ADACEL (Lot # UF486DA) into the left arm. About 5 minutes after the third dose of GARDASIL had been administered, the patient sat down in the waiting room. The patient developed a "little" seizure. The nurse reported that the patient lost consciousness, became stiff in the legs and had clinched hands. The patient had cyanosis and was incontinent of urine. The registered nurse was  not sure how long the seizure had lasted. The patient regained consciousness and recovered. The patient's mother stated that on the evening of 20-MAY-2010 the patient had seemed a little "off" (not specified). The patient was referred to two different Neurologist physicians but the patient's mother had stated that the patient had not made an appointment with either Neurologist at that time. The patient was also advised to contact the Pediatric Cardiologist office to schedule an electrocardiogram ECG. On 24-MAY-2010, the registered nurse stated that the patient's mother was contacted via a telephone call. The patient's mother stated that the patient was "doing fine". On 25-MAY-2010, the nurse stated that the patient's father had told the physician that the patient had surgery in 2009. The patient received IV therapy and passed out. The patient's father thought that at that time the patient had a seizure. Upon internal review, seizure was considered to be an other important medical event. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: FLU3
Symptoms: Aneurysm, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Aneurysm 6 hrs after injection.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Anxiety, Asthenia, Chest X-ray, Chest discomfort, Dizziness
Clinical narrative: Shortness of breath, felt like something was sitting on my chest. Heart rate was 120bpm at rest. Felt very anxious was having problems breathing. Shaky and weakness all over body. Faint feeling and anxiety feeling.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Dyspnoea, Electrocardiogram, Heart rate increased, Tremor
Clinical narrative: Shortness of breath, felt like something was sitting on my chest. Heart rate was 120bpm at rest. Felt very anxious was having problems breathing. Shaky and weakness all over body. Faint feeling and anxiety feeling.
Age: 19.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Unevaluable event
Clinical narrative: No adverse events. Vaccine given IM instead of subcutaneous.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Erythema, Injection site erythema, Injection site pain, Musculoskeletal pain
Clinical narrative: 2 days after vaccination redness and soreness appeared under left arm and in armpit.  States she talked with nurse and in 2 weeks the soreness went away.  In early January began having occ pain on top of left shoulder, on movement and eventually couldn't sleep on her left side because of the discomfort.  Tried heat packs, Icy Hot which relieves the pain some.  Say Dr. 4-26-10 and received a cortisone shot in the shoulder and meds for inflammation.  Advised to follow up with doctor and let HD what is happening. 5-20-10 Saw Dr. again for reocurring pain and received another shot and auto-inflamatory meds.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Sleep disorder
Clinical narrative: 2 days after vaccination redness and soreness appeared under left arm and in armpit.  States she talked with nurse and in 2 weeks the soreness went away.  In early January began having occ pain on top of left shoulder, on movement and eventually couldn't sleep on her left side because of the discomfort.  Tried heat packs, Icy Hot which relieves the pain some.  Say Dr. 4-26-10 and received a cortisone shot in the shoulder and meds for inflammation.  Advised to follow up with doctor and let HD what is happening. 5-20-10 Saw Dr. again for reocurring pain and received another shot and auto-inflamatory meds.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Erythema, Pruritus
Clinical narrative: Patient received HPV around 4:40 pm 5/24/10.  States she developed itching interior aspect of both thighs around 9:00 p.m. on 5/24 with raised reddened areas on interior thighs, posterior aspect right axilla and small area right forearm; larger area left forearm.  Used Benadryl itch cream.  Still demonstrating symptoms around 3:30 on 5/25 when came to health department.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Swelling, redness and pain of R thigh, at injection site.  Next day pt reported severe headaches & lymphadenopathy of head, neck, axilla, groin.
Age: 56.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Coronary artery bypass, Guillain-Barre syndrome
Clinical narrative: Rcvd. phone call 5/28/10 that she (pt) was diagnosed with GBS 1 1/2 mo. ago (Definite Dx) by neurologist. Symptom onset was 11-11-09 after CABG x 4. She stated it took so long to confirm Dx of GBS because they thought was due to CABG. Definite date of Sx onset reported by pt.
Age: 1.51
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: 18 mo well child visit PCV 13 inj (R) anterior lateral thigh 5cm X 7cm erythema, warm extended 1 cc beyond circle area drawn prev. noc. Symptoms started 5/24/10 in evening. Rx KEFLEX TID x 10days.
Age: 1.04
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pruritus, Rash, Rash morbilliform
Clinical narrative: "Measles like rash" tiny red raised rash on face, scalp, trunk, extremities itchy, no fever.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC, RV5
Symptoms: Pyrexia
Clinical narrative: Fever 101.5 - 2 days after vaccines.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Injection site pain, Injection site pruritus, Paraesthesia, Rash
Clinical narrative: Had a ZOSTAVAX injection approximately 48 hours ago. At 24 hours after injection, noticed extreme itching at injection site. Broke out in rash about the size of a tennis ball. Application of BENADRYL creme and ACYCLOVIR did not take away the itching. This morning, when fabric touches site it itches, but otherwise it seems to burn and I notice a numbness in the bend of my arm...feels tingly.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Rash, fever 2 weeks after MMR vaccine. Treatment fluids and TYLENOL.
Age: 20.0
Sex: F
Vaccine: FLU(H1N1), MNQ, TDAP, VARCEL
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis/Staph at injection sites. x 3 sites (+) on bilateral arms.
Age: 38.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Fever up to 103F night of injection. Symptoms resolved the following day.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR
Symptoms: Blister, Oedema peripheral
Clinical narrative: Pt was seen on 5/24/10 for physical given DTaP and HEP A in R arm. Started with a swelling yesterday and looks blistery in R arm today.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Decreased appetite, Feeling abnormal, Myalgia, Pyrexia
Clinical narrative: Patient's wife called to report that patient "sick all last night with chills, feels very warm with high fever, no appetite, body aches and cannot work today from feeling so bad." Patient told to schedule OV for 5-14-10 but refused stating feeling better, no fever, no hives, no swelling.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Skin warm
Clinical narrative: Patient's wife called to report that patient "sick all last night with chills, feels very warm with high fever, no appetite, body aches and cannot work today from feeling so bad." Patient told to schedule OV for 5-14-10 but refused stating feeling better, no fever, no hives, no swelling.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site lymphadenopathy, Injection site warmth
Clinical narrative: Left upper arm with erythema, warm, lymphadenopathy, firm.  Follow up - Patient last name needs to be correcte4d. Record updated.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Injection site haematoma, Injection site haemorrhage
Clinical narrative: Immediately when needle (vaccination) was removed from my arm, blood began gushing out. Bleeding eventually stopped, but severe bruising. Lasted 6 wks; pain at injection site continues 5 mos. later; also periodic numbness, tingling, weakness in arm continues, also joint pain.
Age: 42.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Injection site pain, Muscular weakness, Paraesthesia
Clinical narrative: Immediately when needle (vaccination) was removed from my arm, blood began gushing out. Bleeding eventually stopped, but severe bruising. Lasted 6 wks; pain at injection site continues 5 mos. later; also periodic numbness, tingling, weakness in arm continues, also joint pain.
Age: 43.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Induration, Injected limb mobility decreased, Pain, Swelling
Clinical narrative: 1:30 appt. vaccine administered by staff MA. I felt pain and swelling around 4. Left work early. By 5:30 it was rock hard and losing ability to lift my left arm. All night and next day felt frozen and couldn't move (L) arm much w/out (Rt) arm lifting it.
Age: 58.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Cough, Herpes zoster, Pyrexia
Clinical narrative: Patient c/o fever 101 degrees to 104 degrees starting 2 days after vaccination and lasting 5 days. C/o herpetic outbreak from chin to inside nostrils covering chin, mouth and nose. Continues coughing today and verbalizes slight improvement with herpetic outbreak.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Convulsion, Musculoskeletal stiffness, Tremor, Unresponsive to stimuli
Clinical narrative: Taken to Emerg. Dept for afebrile seizure at home. Parent stated - child became stiff then shaky - observed by paramedic. Shaking continued for 30 mins - at 8mins - parent stated child would not respond "seemed to faint" breathing nl. heart rate nl still shaking. At ER (emergency dept) child responding.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Injection site reaction
Clinical narrative: Large local allergic reaction over each deltoid muscle. 7cm.
Age: 46.0
Sex: F
Vaccine: HEP
Symptoms: Unevaluable event
Clinical narrative: None stated.  This is in follow-up to report(s) previously submitted on 05/25/2010: This document was sent in error by the clinic. There was no adverse event. Please discard. Clinic has been retrained regarding adverse events and completion of VAERS. Per RN.
Age: 28.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Provider (NP) ordered a DTaP and a Tdap was given.  The pt is not having any adverse reactions. No adverse event.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Body temperature increased, Erythema, Feeling hot, Pain, Swelling
Clinical narrative: Client received 1 vaccine, DTAP. R arm. Mom reports he complained about pain that evening but she did not observe the arm. Next day school nurse called clinic stating redness, swelling and heat from elbow to top of shoulder. Temp 100.4. Mom brought patient to clinic. R arm had redness, heat and swelling elbow to shoulder size of baseball at top on thin arms. Applied ice packs, advised intermittent timing, TYLENOL or MOTRIN. If difficulty breathing or worse, take to ER.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site induration, Injection site oedema
Clinical narrative: Edema, erythema, induration of left deltoid seen 5-21-10, 2 days after injections.
Age: 1.01
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site cellulitis, Injection site induration, Injection site warmth
Clinical narrative: Cellulitis 3x2 cm indurated, increased warmth @ area of varicella vaccination.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Rash vesicular
Clinical narrative: Vesicular rash along C6 dermatome from thumb to shoulder; began 1 day after vaccine.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 2.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Decreased appetite, Diarrhoea, Pyrexia
Clinical narrative: In the afternoon following shots, pt developed diarrhea & fever of 101F. Mom reports fever got as high as 103F. Decreased appetite, as well, starting afternoon following shots. Diarrhea subsided. Day after shots still has low appetite & T 101 in am of 5/27/10 per mom.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Pyrexia, Sleep terror
Clinical narrative: Wed: PPD placed Thurs: Fever no other sx. Fri: Night terrors
Age: 5.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Left upper arm red, swollen, painful, itches. Started the evening of receiving the shot and was still red and swollen when patient came into office on 5-26-10.
Age: 2.0
Sex: F
Vaccine: HEPA, HIBV, PNC
Symptoms: Cellulitis, Immunisation reaction, Urticaria
Clinical narrative: Urticaria, Cellulitis - reaction to immunization given on 5/20/10. SEPTRA 6ml BID x 10 days. BENADRYL Q 4 hours PRN.
Age: 1.38
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: RASH AND FEVER
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Autopsy, Bacterial test positive, Blood culture positive, CSF culture, Death
Clinical narrative: This case involves a fatal event was considered medically important for the events of vomiting and fever. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting and died due to an overwhelming sepsis from Group A Streptococcus pyogenes. The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and the second dose of ROTATEQ (Merck & Co Inc). On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room. On an unspecified date in May-2010, a culture (reported as "a very early culture of unspecified origin) was performed that revealed Streptococcus pneumoniae, however a blood culture on 18-May-2010 revealed Group A Streptococcus pyogenes. On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes. The cause of death was reported as streptococcal sepsis. The autopsy cause of death was undetermined. No additional information was available at the time of this report.
Age: 0.37
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Pyrexia, Streptococcal sepsis, Streptococcus test positive, Vomiting
Clinical narrative: This case involves a fatal event was considered medically important for the events of vomiting and fever. Information regarding PREVNAR 13 was received from a healthcare professional regarding a 5-month-old male patient who experienced a positive bacterial culture, fever and vomiting and died due to an overwhelming sepsis from Group A Streptococcus pyogenes. The patient received the first dose on 26-Apr-2010 along with a second dose of PENTACEL (Aventis-Pasteur) and the second dose of ROTATEQ (Merck & Co Inc). On 18-May-2010 the patient experienced fever and vomiting and was evaluated in the emergency room. On an unspecified date in May-2010, a culture (reported as "a very early culture of unspecified origin) was performed that revealed Streptococcus pneumoniae, however a blood culture on 18-May-2010 revealed Group A Streptococcus pyogenes. On 19-May-2010 the patient died due overwhelming sepsis from Group A Streptococcus pyogenes. The cause of death was reported as streptococcal sepsis. The autopsy cause of death was undetermined. No additional information was available at the time of this report.
Age: 4.0
Sex: M
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 20 min after receiving vaccines pt with red rash along (L) leg spreading up and 1 small area on (R) ankle. No wheezing, SOB, swelling. No rash noted elsewhere. No s/s RXN at site of inj. Started on PEDIAPRED and BENADRYL, GM to monitor for s/sx worsening
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Joint range of motion decreased
Clinical narrative: Redness and swelling at immunization site-found on 5/28/10 (day after vaccination). Symptoms worsening and on 5/29/10 pt presented with approximately 2.5 x 5 cm area of redness and swelling to right lateral deltoid. Positive ROM; warm but no pain.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Dysphonia, Fatigue
Clinical narrative: Fatigue, weakness hoarseness over pass over past 6 days since Tdap vaccine.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Asthenia, Dysphonia, Insomnia, Malaise, Skin warm
Clinical narrative: Fatigue, weakness hoarseness over pass over past 6 days since Tdap vaccine.
Age: 49.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Somnolence
Clinical narrative: Fatigue, weakness hoarseness over pass over past 6 days since Tdap vaccine.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Teen fainted, recovered, then fainted again in office after receiving her 3rd GARDASIL (HPV). Teen ate breakfast before office visit.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Axillary pain, Body temperature increased, Full blood count, Injury, Swelling
Clinical narrative: Received PPV on 5/26/10 in left deltoid- On 5/30/10 started having pain in left axilla with swelling and severe tenderness. C/O temperature on 5/31/10 up to 100.8 degrees F. Had been exercising and working out on 5/30 but not aware of trauma to arm until started hurting in evening. On observation in clinic 6/1/10 no visible swelling, redness or other local reaction noted in left deltoid area.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Tenderness
Clinical narrative: Received PPV on 5/26/10 in left deltoid- On 5/30/10 started having pain in left axilla with swelling and severe tenderness. C/O temperature on 5/31/10 up to 100.8 degrees F. Had been exercising and working out on 5/30 but not aware of trauma to arm until started hurting in evening. On observation in clinic 6/1/10 no visible swelling, redness or other local reaction noted in left deltoid area.
Age: 0.23
Sex: F
Vaccine: PNC, RV5
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area was warm, raised and red, where injection was given.
Age: 20.0
Sex: F
Vaccine: HEPA, TDAP
Symptoms: Dizziness, Feeling hot, Wheelchair user
Clinical narrative: Pt sitting in lobby after vaccine administered for 20 min - pt then got hot and lightheaded transported per Doctor request to the E.R. via wheelchair.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, RV5, VARCEL
Symptoms: Inappropriate schedule of drug administration, Unevaluable event
Clinical narrative: Patient was given a varicella immunization too early by accident.
Age: 24.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: CSF culture negative, CSF glucose normal, CSF protein normal, CSF virus no organisms observed, Encephalitis
Clinical narrative: 24 y/o patient admitted to ICU via ED with (?) Dx of smallpox vaccinia/encephalitis. SM received primary SPV (LUE), Typhoid VICPS and AVA (RUE) on 28APR10-no other vaccines in 30-day window. Symptoms: Headache (784.0), generalized Pain (780.96), rash, oth nonspecific skin eruption (782.1).
Age: 24.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Headache, Intensive care, Lumbar puncture normal, Pain, Polymerase chain reaction
Clinical narrative: 24 y/o patient admitted to ICU via ED with (?) Dx of smallpox vaccinia/encephalitis. SM received primary SPV (LUE), Typhoid VICPS and AVA (RUE) on 28APR10-no other vaccines in 30-day window. Symptoms: Headache (784.0), generalized Pain (780.96), rash, oth nonspecific skin eruption (782.1).
Age: 24.0
Sex: M
Vaccine: SMALL, TYP
Symptoms: Rash
Clinical narrative: 24 y/o patient admitted to ICU via ED with (?) Dx of smallpox vaccinia/encephalitis. SM received primary SPV (LUE), Typhoid VICPS and AVA (RUE) on 28APR10-no other vaccines in 30-day window. Symptoms: Headache (784.0), generalized Pain (780.96), rash, oth nonspecific skin eruption (782.1).
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Body temperature increased, Cyst, Headache, Injection site erythema, Injection site swelling
Clinical narrative: High temperature, redness and swelling at site of injection (behind left arm), followed by 5 more cysts and swelling in thigh, underarm area. Saw the doctor on 5/25/10 was diagnosed as chickenpox and antiviral was prescribed. Symptoms have continued till today 6/2/10 with numerous other lesions/cysts all over body and headaches and temperature.
Age: 27.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: High temperature, redness and swelling at site of injection (behind left arm), followed by 5 more cysts and swelling in thigh, underarm area. Saw the doctor on 5/25/10 was diagnosed as chickenpox and antiviral was prescribed. Symptoms have continued till today 6/2/10 with numerous other lesions/cysts all over body and headaches and temperature.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Herpes zoster, Migraine, Pruritus
Clinical narrative: Itching on right rib area, a bit of a HA (has migraines).  Illness progressed and diagnosed with shingles on 5/11/2010.
Age: 27.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Dermatitis, Injection site infection, Injection site inflammation, Lymphadenitis, Skin infection
Clinical narrative: Inflammation/infection from shot area to armpit/chest.  Was given Bactrim/Septra DS to treat infection.
Age: 31.0
Sex: F
Vaccine: TTOX
Symptoms: Blood creatine phosphokinase increased, Electromyogram abnormal, Myositis
Clinical narrative: Administered 11/2009 after motor vehicle accident. Pt then developed myositis.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Arthritis, Asthenia, Dizziness, Erythema, Fatigue
Clinical narrative: Accidentally cut hand at work - they took me to Urgent Care. 12/30/08 - Light headed and nausea, head hurting real bad, extreme vomiting, arm hurting, red from shot, weak and tired (about 1 hr after shot). Sent home from work. (Daughter called to report to Urgent Care I was sick). Time went on then on 3/1/09, I woke up in excruciating pain. I was told it was (arthritis), (sprain), (rotator cuff muscle) (cervical). I now believe it was brachial neuritis from tetanus vaccine.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: Accidentally cut hand at work - they took me to Urgent Care. 12/30/08 - Light headed and nausea, head hurting real bad, extreme vomiting, arm hurting, red from shot, weak and tired (about 1 hr after shot). Sent home from work. (Daughter called to report to Urgent Care I was sick). Time went on then on 3/1/09, I woke up in excruciating pain. I was told it was (arthritis), (sprain), (rotator cuff muscle) (cervical). I now believe it was brachial neuritis from tetanus vaccine.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Skin laceration, Vomiting
Clinical narrative: Accidentally cut hand at work - they took me to Urgent Care. 12/30/08 - Light headed and nausea, head hurting real bad, extreme vomiting, arm hurting, red from shot, weak and tired (about 1 hr after shot). Sent home from work. (Daughter called to report to Urgent Care I was sick). Time went on then on 3/1/09, I woke up in excruciating pain. I was told it was (arthritis), (sprain), (rotator cuff muscle) (cervical). I now believe it was brachial neuritis from tetanus vaccine.
Age: 24.0
Sex: F
Vaccine: HEPA, YF
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: 4 days after receiving the vaccine she developed a red, itchy area with bumps at the injection site of YFVAX.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Rash erythematous, Rash macular, Skin tightness
Clinical narrative: Redness and swelling near injection site. Right arm 14 x 14 cm erythematous patch, warm, blanching and mildly tight.
Age: 5.0
Sex: M
Vaccine: DTAP, MMR, VARCEL
Symptoms: Skin warm
Clinical narrative: Redness and swelling near injection site. Right arm 14 x 14 cm erythematous patch, warm, blanching and mildly tight.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Emotional distress, Injection site erythema, Injection site swelling, Irritability, Screaming
Clinical narrative: Extreme irritability, redness and swelling of thighs. Mom stated patient woke up screaming and unable to calm down for several hours after shots. Mom had to give several doses of Tylenol.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Rash vesicular, Skin lesion, Varicella, Varicella post vaccine
Clinical narrative: Started with bumps on face and legs on 5/24 then progressed to vesicular lesions which crusted over. Diagnosed on 5/27/10 with chickenpox (<20 lesions in various stages).
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Chest pain, Dysphonia, Dyspnoea, Headache, Increased upper airway secretion
Clinical narrative: As administered Tdap on 5-27-10 at about 11:30. States about 2 hrs later she started with a HA. She went home her HA was worsening. She went to sleep when she woke up she was having difficulty breathing; as she went to blow her nose she felt phlegm coming up from chest area with a burning sensation. Her mucous was pinkish tinged. She took Motrin and drank fluids throughout the day, was hoarse and felt swelling to throat. Did not go to ER thought it was a cold. Today continues with symptoms. No fever sent to see her PCP.
Age: 59.0
Sex: F
Vaccine: TDAP
Symptoms: Pharyngeal oedema
Clinical narrative: As administered Tdap on 5-27-10 at about 11:30. States about 2 hrs later she started with a HA. She went home her HA was worsening. She went to sleep when she woke up she was having difficulty breathing; as she went to blow her nose she felt phlegm coming up from chest area with a burning sensation. Her mucous was pinkish tinged. She took Motrin and drank fluids throughout the day, was hoarse and felt swelling to throat. Did not go to ER thought it was a cold. Today continues with symptoms. No fever sent to see her PCP.
Age: 0.48
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Crying, Decreased appetite, Irritability, Pain, Screaming
Clinical narrative: DTAP-HIB-IPV, PCV 13, ROTAVIRUS - fussy ever since, decrease appetite, no fever, painful screaming crying. At office visit 5/27 consolable with mom holding. Dr. reeducated re TYLENOL use & increase dose to 120 mg.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Fatigue, Headache, Injection site erythema, Malaise
Clinical narrative: Patient had onset of malaise then tired, aches, headaches. On 5/31/10 she noted a small red splotch on left arm at injection site and red area on back.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Pain, Rash macular
Clinical narrative: Patient had onset of malaise then tired, aches, headaches. On 5/31/10 she noted a small red splotch on left arm at injection site and red area on back.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Tenderness
Clinical narrative: Growing redness which led mom to ED 1st night. No meds given by doctor. Continued to grow/tender. Seen by ED doc following night; started on Keflex. Mom reports response.
Age: 80.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site pruritus, Oedema peripheral
Clinical narrative: Phone call patient stated that her arm became quite swollen all the way to elbow and had redness also. Patient stated site of injection very itchy. Patient treated self with Gold Bond-was having no problems today. Clinic was closed or she would have come in to be seen.
Age: 21.0
Sex: M
Vaccine: TTOX
Symptoms: Hypoaesthesia, Loss of consciousness
Clinical narrative: Donor states one hour after receiving immunization body went numb loc time unknown transported to ER. IV therapy given in ER and released.
Age: 53.0
Sex: F
Vaccine: TYP
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Uticarial rash covering extremites, swollen face, erythematous face and neck. Treatment Benadryl 50mg every 4 hours X 24 hours, then Benadrly 25mg every 6 hours X 3 days.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, PNC13
Symptoms: Pyrexia, Vomiting
Clinical narrative: FEVER OF 104 AND VOMITING
Age: 1.45
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Gait disturbance, Skin warm, Somnolence, Unresponsive to stimuli, Vomiting
Clinical narrative: Mother said child vomited x 5 throughout night seemed "a little warm" was not responding normally to stimuli - seemed sleepy and after 4 oz of Pediasure slept until 1 pm next day. Seemed a little unsteady on feet but by time seen in office at 2:14 pm on 6-2-10 seemed alert active and well coordinated.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain, Antinuclear antibody, Borrelia test, Burning sensation, Depression
Clinical narrative: Severe pain extremeties- numbness tingling, burning fatigue, developed allergies gluten, sugar, casein, fatigue, irritability, depression, abdominal pain.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Electromyogram, Fatigue, Full blood count, Hypoaesthesia, Irritability
Clinical narrative: Severe pain extremeties- numbness tingling, burning fatigue, developed allergies gluten, sugar, casein, fatigue, irritability, depression, abdominal pain.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Multiple allergies, Nuclear magnetic resonance imaging, Nuclear magnetic resonance imaging brain, Pain in extremity, Paraesthesia
Clinical narrative: Severe pain extremeties- numbness tingling, burning fatigue, developed allergies gluten, sugar, casein, fatigue, irritability, depression, abdominal pain.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash and swelling at injection site thru June 1.
Age: 57.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Urticaria
Clinical narrative: Hives and treated with Benadryl started 5-26, resolved 6-1.
Age: 46.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Arthralgia, Blood creatine phosphokinase increased, Blood urea increased, Headache, Pyrexia
Clinical narrative: Headache. Fever. Joint pain - polyarthralgia.
Age: 46.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: White blood cell count increased
Clinical narrative: Headache. Fever. Joint pain - polyarthralgia.
Age: 16.0
Sex: F
Vaccine: HEPA, HPV4
Symptoms: Dizziness
Clinical narrative: Lightheadedness.
Age: 55.0
Sex: F
Vaccine: FLU(H1N1)
Symptoms: Back pain, Hypoaesthesia
Clinical narrative: Patient says that about a week after receiving the vaccine she experienced a radiating pain down her back that turned into numbness.
Age: 49.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Neuralgia
Clinical narrative: Fingers / tongue / feet neuropathic pain starting Dec 2008 - with continual pains past 7 months.
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Pyrexia, Rash, Varicella
Clinical narrative: Bumps on belly, back, low grade temp, and headache. Dx with Atypical chicken pox.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Induration, Mass, Skin warm, Swelling
Clinical narrative: Shot given 6/1/10. On 6/2/10 large, raised, hard lump which was hot to the touch.
Age: 27.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Oedema peripheral, Pruritus, Urticaria
Clinical narrative: Nurses' right arm became reddened, swollen, itchy, and had several welt formations.
Age: 26.0
Sex: M
Vaccine: TTOX
Symptoms: Axillary pain, Injection site pain, Injection site swelling, Oedema peripheral
Clinical narrative: Area where shot administered as well as entire upper arm region swollen and very sore. The following day, June 3rd, as soon as I woke up felt stinging pain in armpit region. This area has become extremely swollen and large, and very sore.
Age: 11.0
Sex: M
Vaccine: FLUN(H1N1)
Symptoms: Allergy to vaccine, Body temperature fluctuation, Depressed level of consciousness, Pyrexia
Clinical narrative: Mother reports fever of 105 F to 106 F and was to hospital.  Complained of decreased level of consciousness and unable to control temperature. Mother states physician diagnosed child with allergic reaction to H1N1 nasal mist.  Mother states was sent home once temperature decreased. ON 10/15/2009 client was taken to urgent care for same complaints.  Per Mother client was given a steroid and antihistamine injection and sent home. Mother states child had complete recovery after receiving medications.
Age: 14.0
Sex: F
Vaccine: TDAP
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Seizure approximately 7:30AM the day after Tdap, approximately 17 hours later. Child has known seizure disorder and takes meds plus diastat PR at home. Recovered fully.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Joint range of motion decreased
Clinical narrative: A PNEUMOVAX 23 vaccine adm'd on 5/27/10 without problem. By late afternoon, patient experiencing intense pain over entire right deltoid region. Limiting rang of motion above shoulder. By 9pm, patient had fever of 100.8 with chills and erythema at deltoid, extending to right bicep. Due to fever of 99.8 and bicep erythema and induration 5/30/10, Cipro 500mg OD x 3d resolved symptoms.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: A PNEUMOVAX 23 vaccine adm'd on 5/27/10 without problem. By late afternoon, patient experiencing intense pain over entire right deltoid region. Limiting rang of motion above shoulder. By 9pm, patient had fever of 100.8 with chills and erythema at deltoid, extending to right bicep. Due to fever of 99.8 and bicep erythema and induration 5/30/10, Cipro 500mg OD x 3d resolved symptoms.
Age: 17.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea
Clinical narrative: Patient woke up and felt nauseated for about one hour then went back to bed. She denied any other symptoms, woke up a few hours later and ate breakfast.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Back pain, Hypokinesia, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: The first evening with problem, (6/1/10), arm with injection became very sore and somewhat painful to move. By that night around 10:15PM arm pain was very severe. Next day (6/2/10), I could not move my arm because of severe pain. I could not do any of the following: lift my arm, move arm in any direction, hold something that weighed more than 2 pounds or even make any quick movement without feeling robust severe pain in that arm. The pain at times when trying to dress was so severe, I cried out. I got little sleep because lying down caused pain which moved from my arm to my neck and back shoulder. This pain has lasted so far four days. Today is day four and I am finally feeling less pain. I can finally touch my face without pain but, I still can not raise my arm without feeling pain.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Neck pain, Pain in extremity, Poor quality sleep
Clinical narrative: The first evening with problem, (6/1/10), arm with injection became very sore and somewhat painful to move. By that night around 10:15PM arm pain was very severe. Next day (6/2/10), I could not move my arm because of severe pain. I could not do any of the following: lift my arm, move arm in any direction, hold something that weighed more than 2 pounds or even make any quick movement without feeling robust severe pain in that arm. The pain at times when trying to dress was so severe, I cried out. I got little sleep because lying down caused pain which moved from my arm to my neck and back shoulder. This pain has lasted so far four days. Today is day four and I am finally feeling less pain. I can finally touch my face without pain but, I still can not raise my arm without feeling pain.
Age: 11.0
Sex: F
Vaccine: TDAP
Symptoms: Pain in extremity
Clinical narrative: 4/28/10 2PM vaccine administered. On 4/29/10 around 9AM - Pain in right side of body, including arm and leg. At 4PM noticed could not move her arm. Went to Emergency Room. Stated B/P elevated. Pulse increased. States was told may have been allergic reaction to vaccine.
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Joint swelling, Lip swelling, Oedema peripheral
Clinical narrative: Information has been received from a licensed practical nurse concerning an 18 year old female patient with red dye and penicillin allergy who on 17-MAR-2010 and 19-MAY-2010 was vaccinated with a first and second dose of GARDASIL (Lot # 662724/0313Y for both doses), 0.5 mL, IM. Concomitant therapy included LOESTRIN 24 FE. The nurse reported that on 20-MAY-2010 the patient had experienced swollen bottom lip, heel, hip, and wrist after receiving the second dose of GARDASIL. She had been taking BENADRYL. The patient called the office. At the time of this report, the patient was recovering. The licensed practical nurse considered "swollen bottom lip, heel, hip, and wrist" to be other important medical events. It was also stated that the patient had similar reaction when she was little with an unknown medication. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Bronchospasm, Cognitive disorder, Fatigue, Hypersensitivity
Clinical narrative: Information has been received from a physician concerning a 19 year old female who in July 2009 and December 2009, was vaccinated with the first and second doses of GARDASIL, respectively. The patient experienced one week of feeling exhausted and brain fog after receiving her first dose of vaccine. She experienced severe brain fog and profound fatigue after the second dose. She was not able to attend spring semester of college as a result. Prior to receiving GARDASIL she was an athlete who excelled at track and excelled as a student and did not have an allergy to citrates prior to receiving GARDASIL. The patient was also experiencing a severe hypersensitivity to citrates and seemed to be more prone to Streptococcus infections. The physician also reported the patient just recently experienced intense bronchospasm for 1 hour after taking a lactobacillus mixture. It was discovered after the patient's reaction that the mixture contained an extremely small amount of citrate. At the time of report the patient had not recovered. No further information is available.