chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Dyspnoea, Headache
Clinical narrative: From note by ED attending Dr.: The patient was seen and examined in the Hospital Emergency Department on 09/11/2012. I have discussed the management with him. I have also seen the patient personally and reviewed the ED record. This is an addendum to the record. HISTORY OF PRESENT ILLNESS:  This is a 64-year-old, who received Zostavax vaccine, she had then a sense that her tongue was swelling and felt dizzy and short of breath.  EMS was called, gave her 50 IM Benadryl and had difficulty establishing an IV and she was sent to the Emergency Department where she said she had no difficulty breathing, but did have some sense of tongue swelling. PAST MEDICAL HISTORY: As indicated. PHYSICAL EXAMINATION: The patient appeared anxious. Her tongue appeared mildly swollen, but her ABCs were intact. She is normocephalic and atraumatic. Chest is clear without wheezing. Heart is regular. Abdomen is soft and nontender. Extremities are nontender.  Neurologic: A&O x4. Cranial nerves, sensory, motor exam are normal. ASSESSMENT AND PLAN: This is a woman, who came in after an acute allergic reaction to zoster vaccine. We are notifying the pharmacy so any reporting can be addressed appropriately with regard to her care.  The patient received IV Solu-Medrol 125 emergently and also had epinephrine ready should she need IV therapy. As we treated her over the next half hour or so, the patient's tongue swelling improved and it was not necessary to give further IV epinephrine. Because of the critical nature of this patient's presentation, she required 40 minutes of my personal involvement in critical care by the bedside preparing medications and generally in her treatment. The patient is admitted to Observation having symptoms essentially resolved, but to watch her airway to be sure that this was safe and that she would not require admission and she is admitted to Observation Unit in stable condition. As an addendum: The patient was monitored in the ED observation unit after receiving 50mg IM Benadryl in the field and 125mg IV Solu-medrol in the ED as described above. Her tongue swelling improved, and she had no further shortness of breath or concerns for airway obstruction. She felt well. She was discharged home in good condition, with a course of PO prednisone 60mg x 3 days, with instructions to follow-up with her PCP.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy
Clinical narrative: Pt. received Fluvirin vaccine on 9/4/12 and noticed reaction at 11:30, pain at site. On 9/6/12 Reported lymph node reaction - swollen, tender, sore and very painful. Sent to urgent care.
Age: 26.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Oedema peripheral, Pneumonia, Urticaria
Clinical narrative: Hives and bit of trouble breathing within 3 minutes of immunization; given BENADRYL. Medicine got rid of hives but 3-4 hours later had to take another dose. Next day, arm so swollen couldn't get arm through sleeve. Went to doctor who recommended over the counter MOTRIN. Has an appointment on 9/11 with pulmonologist because doctor thinks she has pneumonia now.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Inflammation, Pain
Clinical narrative: Pain, redness, inflammation.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Patient claimed he had a sore at injection sites then throbbing pain on his left arm & his left shoulder & his arm can't move so he went to emergency.
Age: 0.23
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Computerised tomogram head, Convulsion, Electroencephalogram, Full blood count, Metabolic function test
Clinical narrative: On July 11, 2012, patient had a 10 minute seizure 1 day after immunizations.
Age: 24.0
Sex: F
Vaccine: HPV4
Symptoms: Caesarean section, Human chorionic gonadotropin positive, Laboratory test, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: Information has been received from a registered nurse for GARDASIL, a Pregnancy Registry product, concerning a 24 year old female patient with drug allergies to "Quinolones" and a pertinent medical history of a spontaneous abortion (date unknown) who on 23-JUN-2011, 26-JUL-2011 and 20-DEC-2011 was vaccinated with her first, second and third dose of GARDASIL (third dose: lot number 671006/1291AA, expiration date 12-APR-2014) respectively. Concomitant therapy included omeprazole and prenatal vitamins. On 20-DEC-2011 after the patient received her third dose of GARDASIL it was determined she was pregnant. No adverse effect reported. The patient's LMP (last menstrual period) was 26-OCT-2011 and estimated delivery date was 01-AUG-2012. "Urine hCG after the vaccine was administered" and "a beta hCG was performed as well and the results have not be obtained yet". The patient had sought unspecified medical attention. At the time of the report, outcome of the event was unknown. Follow up information has been received from the registered nurse and a family nurse practitioner concerning the 24 year old female case worker above. The patient with (GERD) Gastrooesophageal reflux disease and a history of a spontaneous abortion 11 weeks from LMP (last menstrual period) (captured in WAES # 1201USA00571) on 06-OCT-2011 who on 23-JUN-2011, 26-JUL-2011 and 20-DEC-2011 was vaccinated with her first, second and third dose of GARDASIL (lot number: first dose 668229/1569Z, second dose 668229/1569Z and third dose 671006/1291AA) respectively. The patient's estimated conception date was also reported as "09-NOV-2011". Follow-up information has been received from a registered nurse and refers to a 24 years old female patient with blisters on the rear of the tongue, drug hypersensitivity, gastrooesophageal reflux disease and a history of surgery and abortion spontaneous (dates not specified). The patient has a history of 1 previous pregnancy. It was reported that the patient became pregnant with an LMP of 26-OCT-2011. Initial exposure to GARDASIL was at 0 week(s). It was reported that on 28-JUL-12 the patient delivered a female infant weighing 2862.71 gms or 6 lbs 5 ozs (infant's length was 20 inches) via cesarean delivery. The infant's APGAR scores are not available. Unspecified diagnostic tests were carried out at fourth, fifth and eighth month of pregnancy (approximately in February, March and June 2012, respectively. Outcomes unknown). Upon delivery, the infant was noted to be a normal, healthy newborn. Upon internal review, cesarean section was determined to be an other important medical event. Additional information is not expected.
Age: 36.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Severe redness/swelling/discomfort at injection site measuring > 4 cm at time of office visit 5 days later.
Age: 10.0
Sex: M
Vaccine: VARCEL
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Injection site vesicles, Vaccination complication
Clinical narrative: Parent stated - within 48 hr. developed a reaction to vaccine. At Health Dept. on 9-10-12 for PPD reading. Alerted another nurse to site of varicella vaccine administered on 9-7-12. Red, raised area with approximately 20 blisters - no fever; complained of discomfort.
Age: 0.18
Sex: F
Vaccine: RV5
Symptoms: Infrequent bowel movements
Clinical narrative: BM's decreased to 1 every 5 days after receiving ROTATEQ x 5-6 weeks.
Age: 18.0
Sex: F
Vaccine: HEP, MMR
Symptoms: Headache, Musculoskeletal stiffness, Pain, Pyrexia, Rash maculo-papular
Clinical narrative: Presented to office day 14 post MMR with resolving maculopapular rash chest, shoulders - stated she had fever, headache, body aches stiff neck 9/3 - 9/6 (day 10 - day 13), afebrile now.
Age: 1.91
Sex: M
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered
Clinical narrative: Records incomplete, vaccines were given as they were due. Discovered later an old record with all the vaccines given so patient had received duplicate vaccines.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Dyspnoea, Rash generalised, Rash maculo-papular, Swelling face, Wheezing
Clinical narrative: Pt rec'd KINRIX, MMR, PCV 13, VARIVAX on 8/21/2012 - child developed facial swelling, rash all over & difficulty breathing prior to leaving office. Swollen face, maculopapular rash & wheezing noted on exam. VSS treated with EPI, O2, BENADRYL, prednisone, albuterol (2 nebs). TX to ER for observation.
Age: 0.99
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Full blood count, Haematocrit normal, Haemoglobin normal, Influenza A virus test negative, Influenza B virus test
Clinical narrative: Fever 102 & vomiting 9/11/12. PE - slightly red posterior pharynx. CBC WBC - 9.7 Poly - 54 Mono - 11.9; Lymph 33.4 H/H 13/41 platelets 211 Rapid strep test (-) Flu A/B tests (-)
Age: 0.99
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Influenza virus test negative, Lymphocyte percentage, Monocyte percentage increased, Pharyngeal erythema, Platelet count normal
Clinical narrative: Fever 102 & vomiting 9/11/12. PE - slightly red posterior pharynx. CBC WBC - 9.7 Poly - 54 Mono - 11.9; Lymph 33.4 H/H 13/41 platelets 211 Rapid strep test (-) Flu A/B tests (-)
Age: 0.99
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR, PNC, VARCEL
Symptoms: Pyrexia, Streptococcus test negative, Vomiting, White blood cell count normal
Clinical narrative: Fever 102 & vomiting 9/11/12. PE - slightly red posterior pharynx. CBC WBC - 9.7 Poly - 54 Mono - 11.9; Lymph 33.4 H/H 13/41 platelets 211 Rapid strep test (-) Flu A/B tests (-)
Age: 39.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Pain, Vomiting
Clinical narrative: Body ache 9/1, vomited 9/1, diarrhea 9/2.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Abortion spontaneous, Haemorrhage, Maternal exposure during pregnancy, Muscle spasms
Clinical narrative: Patient called on Aug 26 2012 & stated that on 10/14/11 she received a flu shot while pregnant and the next day she had terrible cramping and bleeding and had a spontaneous abortion.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Chills, Rash pruritic
Clinical narrative: After a few minutes of vaccination, pt broke out with a rash around the wrist. Pt complained it was itchy & had chills. Pt took BENADRYL & ADVIL. Symptoms subsided after 1.5 hrs.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Mass, Neck pain, Pain
Clinical narrative: Red, swollen, sore hard raised lump 7 mm X 3 1/2 mm - felt a pain in arm & neck with initial vaccine. No treatment did not miss work.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Swelling
Clinical narrative: Red, swollen, sore hard raised lump 7 mm X 3 1/2 mm - felt a pain in arm & neck with initial vaccine. No treatment did not miss work.
Age: 53.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site mass, Injection site nodule, Injection site pain, Injection site pruritus, Injection site rash
Clinical narrative: Light rash at injection site, sore & itchy lump forming/muscle knot.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Erythema, Pruritus, Pyrexia, Skin warm
Clinical narrative: Got Tdap on 8/28/12 at 2pm reaction started 8/29/12 am redness - itching - warm to touch - dizzy - fever measured reaction at 3 x 2 1/4. Pt. was told could take BENADRYL/cool compress.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site vesicles
Clinical narrative: Blister with redness at site of injection.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Injection site pain, Pain, Pain in extremity
Clinical narrative: Patient experienced pain around inj site 9.5.12 around 5 pm 09.06.12 patient experienced shooting pain from injection site, thru elbow to wrist and last 2 fingers of left hand. Fingers are numb.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Excessive swelling & redness on arm of injection reported to pharmacy 2 days after immunization. Patient went to walk-in clinic 9/5/12 and was started on antibiotics.
Age: 17.0
Sex: M
Vaccine: HPV4
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives on (L) arm, upper and mid back, itchy. Given BENADRYL 50 mg by school nurse. VSS at school and in office.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Pain
Clinical narrative: 1) Pt developed shingles in (R) T9 dermatome 9/5/2012. He has pain & redness.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: (L) arm swelling & red & warm to touch. Advised guardian to take client to doctor. Received 2 shots to the (L) arm.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: Patient presented to pharmacy two days after receiving FLUZONE HD vaccine. Patient had red, warm rash on upper arm surrounding vaccination site extending from shoulder to elbow. Patient reported the rash did not itch or cause pain. Rash first noticed by patient on 8-31-12 in the evening. Patient was advised to take Ibu, diphenhydramine & ice area as needed for swelling, pain & itch & report back if any worsening.
Age: 33.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient reported no adverse event. Vaccine was expired and administered to patient. After speaking with health department vaccine specialist, it was determined patient would need a duplicate vaccine in date.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Eye infection, Eyelid oedema, Feeling cold, Lip swelling
Clinical narrative: Patient had red, puffy & puss filled eyes,swelled lips, bad cough & cold feeling. Was taking CLARITIN for reaction but was told to discontinue & take BENADRYL liquid 1 teaspoonful every 4 hours. Followed up on 9/3/12 and patient was feeling better. Puffy & red eyes and cough better after 24 hours on BENADRYL.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Patient had red, puffy & puss filled eyes,swelled lips, bad cough & cold feeling. Was taking CLARITIN for reaction but was told to discontinue & take BENADRYL liquid 1 teaspoonful every 4 hours. Followed up on 9/3/12 and patient was feeling better. Puffy & red eyes and cough better after 24 hours on BENADRYL.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pruritus, Rash generalised
Clinical narrative: Rash covering entire body starting morning after shot given, itchy. Treatment Prednisone & BENADRYL at night & SOLUMEDROL shot.
Age: 63.0
Sex: F
Vaccine: UNK
Symptoms: Erythema, Skin warm
Clinical narrative: Red area, hot 3 inches wide down back side of elbow.
Age: 49.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Muscular weakness, Musculoskeletal pain, Pain
Clinical narrative: Acute onset (R) shoulder pain describes as "burning" from (R) neck to (R) forearm. (R) upper arm muscle weakness. Pain aggravated by movement. Occurring over 3d & persisting x 3.5 wks. (R) upper arm strength & pain improving since Aug 15, 2012. Tx: SKELAXIN 800mg QID PRN. Ibuprofen 600-800mg PRN. (R) arm exercises.
Age: 11.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt. given PEDIARIX at age 11.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Injection site erythema, Injection site urticaria, Nausea, Tachycardia, Vomiting
Clinical narrative: Child received KINRIX & MMR in same arm. Developed nausea, vomiting, tachycardia and a 1 cm red welt over location of MMR.
Age: 2.0
Sex: F
Vaccine: DTAP, HEPA, PNC, VARCEL
Symptoms: Bronchospasm, Cough, Pyrexia
Clinical narrative: 103 degrees fever started day after IZ's given. Cough & bronchospasm. Mom called 8-3-12 to report. Home treatment with ibuprofen, albuterol x 2 ABT's. Rx for ORAPRED.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Induration
Clinical narrative: Large erythematous area. Small area of induration resolving over 24 hours. Significant bruising.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: 11:13 HPV injection given (L) deltoid. 11:14 c/o n/v, syncope episode, BP 88/50 HR 40. 11:15 Dr at bedside. Trendelenberg pos. BP 85/44 HR 50 SpO2 98% RA. 11:18 Epipen injection (R) thigh. 11:20 HR 102 BP 128/71. 11:25 Ambulance here, transported to medical center.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Asthenia, Dizziness, Pallor, Wheezing
Clinical narrative: Paleness, wheezing, weakness, feeling of faintness.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Haematochezia, Irritability, Occult blood positive
Clinical narrative: Pt received routine 2 month vaccinations on 9/4/12. PEDIARIX, HIB, PREVNAR 13 & ROTATEQ. On 9/5, pt had one episode of mild hematochezia with fussiness.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blood creatine phosphokinase increased, Metabolic function test normal, Muscular weakness, Pain in extremity
Clinical narrative: GARDASIL vaccine administered and within 2 days right arm painful and weak. Pt did not have weakness or pain in any other extremities. No dark urine. Treated with OTC pain relievers, increased fluids.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Approximately 30 hours after administration of KINRIX vaccine pt developed redness, swelling and warmth to site of injection, 10 cm x 12 cm in size at time of examination 3 days after vaccine administration.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Asthma, Cough, Dyspnoea
Clinical narrative: Shortness of breath, coughing, asthma, history "small windpipe" no other prior history of asthma.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: Pt with (L) arm pain, paresthesia and pain with motion. No swelling.
Age: 52.0
Sex: M
Vaccine: HEPAB, TDAP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Patient reported no adverse event. Vaccine was expired and administered to patient. After speaking with Co State Health department vaccine specialist, it was determined patient would need a duplicate vaccine in date.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Immediate post-injection reaction, Muscle spasms, Nasopharyngitis
Clinical narrative: Lightheaded immediately. Severe muscle cramps in legs and back from 10pm to 5am. Cold like symptoms day after.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling on (L) shoulder.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Eye discharge, Fatigue, Headache, Ocular hyperaemia, Pain
Clinical narrative: Red eyes, soreness, fatigue, headache, discharge from eyes. Local soreness.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Diarrhoea, Headache, Urine output decreased, Urticaria
Clinical narrative: MOC reports pt developed "hives" over entire body, fever (to 103.2 before TYLENOL), headache and diarrhea 4 days after vaccination. States urine output also down on day 4, intake and output now reported per usual temp elevated to touch, hive reduced to trunk per MOC at time of this report.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Adverse reaction
Clinical narrative: Severe reactions near injection site on right arm.
Age: 60.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Headache, Neck pain
Clinical narrative: Pt called and said had FLUVIRIN and PNEUMOVAX on 9/1/12 and has "severe headache and neck and back pain". Has history of neck and back surgery but doesn't think he aggravated it.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Mobility decreased, Pain in extremity, X-ray
Clinical narrative: Pt received vaccine on 8/18/12 and on 8/29 called to say her arm was aching. She could not find a comfortable position to sleep and could hardly raise her arm. She saw MD 8/30/12.
Age: 73.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Limb discomfort, Pyrexia, Rash macular
Clinical narrative: Pt returned following day to report that her left arm has been giving her discomfort since yesterday soon after getting high dose flu and pneumonia vaccine together. It appeared red, blotchy, and several inches in diameter. Recommended HC cream and ice pack & BENADRYL crm and to contact per primary MD.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Rash
Clinical narrative: Developed rash next day - 2 PCP visits and 1 ER visit - steroid shot did not improve rash 2nd steroid shot helped - previously client has taken Tetanus Diphtheria only - no respiratory distress.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Injection site swelling, Pain in extremity, Pyrexia, Rash erythematous
Clinical narrative: 8-31-12 developed red rash at injection site & fever started approximately 100.0 degrees F. Fever persisted through Sunday, while rash & swelling extended laterally down her arm to take elbow. Arm painful through 9-2-12.
Age: 16.0
Sex: M
Vaccine: IPV
Symptoms: Nausea, Syncope
Clinical narrative: Fainted & nauseated after immunization.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Headache, Lacrimation increased, Nausea
Clinical narrative: Headache, red eyes, diarrhea, nausea, cough, watery eyes, myalgia.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Ocular hyperaemia
Clinical narrative: Headache, red eyes, diarrhea, nausea, cough, watery eyes, myalgia.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema
Clinical narrative: After immunization on Sat 8/25 arm became red and by Tuesday it was red down to elbow (Rt arm). MD was visited and patient was given steroid injection & PO and Amox-clav 875 mg BID x 14 days. Symptoms are improving dramatically since then per patient.
Age: 76.0
Sex: F
Vaccine: TDAP
Symptoms: Hypoaesthesia, Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity, Skin warm
Clinical narrative: 8/28 immediately upon administration of Tdap Pt. expressed pain & arm felt numb, hot & full from shoulder to hand & into the muscle. Through out day her arm was sore but could move it, 8/29 arm more difficult to move in morning. On 8/30 & 8/31 arm was "so-so". On 9/1 it hurt and 9/2 had problem lifting arm & can't feel pressure on arm. 9/4 continues to be unable to lift arm. Has medical appt. 9/4/12 in afternoon.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling, and warmth at FLUZONE site injection 2 days after injection.
Age: 71.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Back pain, Pain in extremity
Clinical narrative: Wife arrives at clinic today to report after pneumonia vaccine 9-10-12 at noon, at 2 o'clock PM, pt had severe arm and upper right sided back pain that lasted 10 hours before going to E.R. Given IV pain med and kept for 4 hours then sent home with PO pain medication. Wife states Dr. said it was because of "the way it was injected".
Age: 0.18
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None - A/E. Pt given vaccine for children 4+ yrs old at 2 mos.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Cellulitis, pt received antibiotic.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Hypoaesthesia, Paraesthesia
Clinical narrative: Shoulder to fingertips numb and tingling - very painful in shoulder joint.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: On Thursday (1 day after vaccine was administered) pt. developed a red area near injection site 2-3" dia. and itches. It resolves as for Saturday but still itches. Pt took ALLERGR. She states no allergies to latex or other ingredient.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Tenderness, redness, warmth around the site. Ibuprofen instructed to apply ice to the area; take as needed.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Injection site pain, Pain, Pyrexia
Clinical narrative: Pain, redness 3" x 6". Feels feverish. (Pt. reported pain at time of injection). Rx KEFLEX 500mg QID x 10 days. Medrol Dose Pack.
Age: 44.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Headache, Pain in extremity, Pyrexia
Clinical narrative: Pt was given PNEUMOVAX 9/7/12. Pt stated arm became very sore and red and also got a headache on 9/9/12 as he's had ever since also ran a fever for 2 days. Prednisone 10 mg as directed. Cool compress or OTC pain medication.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Pharyngeal disorder
Clinical narrative: Shortly after receiving her first INFLUENZA vaccine, patient started feeling lightheaded. B/P 99/62 (supine) P-66 at 11am. 11:05 am: C/O thickness in throat. No itching or difficulty breathing. 11:07 am: B/P 102/63 P-59. 11:12 am: 129/82 P-79. BENADRYL 50 mg p.o. x 1 lungs clear. POX 99%. 11:25 AM: 99/65 P-73 lightheaded. Thick throat: to Emergency Room.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot, Pruritus, Swelling
Clinical narrative: Redness, swelling, hot feeling, itching. For 3 days following.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Injection site vesicles, Swelling, Tenderness
Clinical narrative: Red, hard and swollen -> on 9-8-12 was tender on 9-7-12. Still swollen and red, blisters at injection site on 9-11-12, but is resolving.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Injection site reaction, Tenderness
Clinical narrative: Possible allergic urticarial reaction just at site of injection. (Localized) redness/tenderness/warmth.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Chills, Nausea, Vomiting
Clinical narrative: Chills, NV, sore arms, burning sensation w/pneumonia shot, IV fluids.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Abasia, Aphagia, Arthralgia, Burning sensation, Chills
Clinical narrative: Fever (high), chills, couldn't walk, couldn't eat, vomiting, nausea. Gave IV fluids, & anti nausea meds, joint pain, double vision throat burning. Pneumonia shot left burning sensation, diarrhea.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Diarrhoea, Diplopia, Nausea, Pyrexia, Throat irritation
Clinical narrative: Fever (high), chills, couldn't walk, couldn't eat, vomiting, nausea. Gave IV fluids, & anti nausea meds, joint pain, double vision throat burning. Pneumonia shot left burning sensation, diarrhea.
Age: 52.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Fever (high), chills, couldn't walk, couldn't eat, vomiting, nausea. Gave IV fluids, & anti nausea meds, joint pain, double vision throat burning. Pneumonia shot left burning sensation, diarrhea.
Age: 4.0
Sex: M
Vaccine: DTAP, MMR
Symptoms: Extensive swelling of vaccinated limb, Injection site erythema, Injection site rash, Injection site swelling
Clinical narrative: Pt was seen 8/29 for 4 yo well visit.  Given DTaP and MMR. On 8/10 parents reported significant swelling of thigh at DTaP site, (+) erythema. No fever, given ibuprofen & BENADRYL. Seen in office 8/31. Thigh was still swollen and rash had spread to cover every entire circumference. Measurements of thigh: 0.4 cm left --> 28 cm on right. Lower thigh was (L) 27 cm, (R) 31 1/2 cm - Dx: Extensive limb swelling Rxn to DTaP.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Rash erythematous, Rash pruritic
Clinical narrative: Patient complained of sensitivity on head that started 2nd or 3rd day following ZOSTAVAX shot & quit couple of days ago. Also reported red rash on upper chest that only itched if he touched it, which started 2nd or 3rd day following the shot is still present.
Age: 9.0
Sex: M
Vaccine: VARCEL, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Confirmed varicella - 9/11/12 multiple pox over back, chest, thighs, groin, buttocks.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC, RV5
Symptoms: Irritability
Clinical narrative: Mom discuss at 4 m visit that pt was very fussy x 1 wk after 2 m vaccines no other specific sx.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site pain, Myalgia, Nausea
Clinical narrative: Chills, muscle aches, nausea, sick to stomach site soreness, pt said never vomited.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Muscular weakness
Clinical narrative: Numbness & weakness in arm (left) gave MEDROL & Dosepak and referred to Dr.
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Cough
Clinical narrative: Per mom, child coughed at night, nonstop sounded like a "whoop" when taking a breath.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Erythema, Feeling hot, Induration, Local swelling, Nausea
Clinical narrative: Large swollen, red, hard area (soft ball size) heat, nausea, fever.
Age: 73.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pyrexia
Clinical narrative: Large swollen, red, hard area (soft ball size) heat, nausea, fever.
Age: 1.37
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Received MMR, VZV, HAP 9/5/2012. Grandmom states "ran fever on the 9th and started breaking out on 10th that morning". Grandmom states "put aloe vera on it".
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Abdominal pain, Chills, Diarrhoea, Injection site pain, Nausea
Clinical narrative: Nausea, abdominal cramping, diarrhea, fever, chills, site tenderness.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia
Clinical narrative: Nausea, abdominal cramping, diarrhea, fever, chills, site tenderness.
Age: 13.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: 2 in redness and swelling at injection site no pustular areas at site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Computerised tomogram normal, Dyspnoea, Echocardiogram normal, Electrocardiogram normal
Clinical narrative: Patient called paramedics because she was experiencing shortness of breath. She also felt pain in the chest and could not lie down on it. After a full cardiac work-up (EKG, CT scan, echo) her heart is fine.
Age: 59.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cold sweat, Pain in extremity, Urticaria, Vomiting
Clinical narrative: 8-23-12 After shot had a welt - that lasted a couple of hours. Went to bed (welt gone). Woke up about 2 hours after bed with vomiting, then cold sweats for rest of night. 8-24-12 - Woke about 6am, no N/V, but arm sore between shoulder & elbow. 8-25-12 - Fine.
Age: 12.0
Sex: M
Vaccine: FLUN3, HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a 12 years old male patient with lithium allergy, headaches, unspecified hearing loss, allergic rhinitis, eczema and ADHD. The patient was vaccinated with lot # (670048/0963AA) dose 2 GARDASIL, right deltoid on 04-JAN-2012 at 05:47 PM. No other co-suspects were reported. Concomitant medications included: FLUMIST. It was reported that the patient was administered an immunization that was stored at invalid temperatures, the immunization was stored at a temperature of 32 degrees F or less. No adverse reaction occurred. This is one of several reports from the same source. Additional information is not expected.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Maternal exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report was received from a resident concerning to a 19 years old female patient with no pertinent medical history and no known drug reactions or allergies. The patient's history of previous pregnancies and live births was not provided. On 15-JUL-2008, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot # were not provided). No other co-suspects were reported. There was no concomitant medication. On 21-AUG-2012, the patient was vaccinated with the second dose of GARDASIL (dose, route and lot # were not provided). On 22-AUG-2012, the patient found to be pregnant with an LMP (Last menstrual period) of 16-JUL-2012 and an EDD (estimated delivery date) of 22-APR-2013. Initial exposure to GARDASIL was at 5 week(s). The patient was exposed to GARDASIL during trimester 1. Urine pregnancy test was performed on 22-AUG-2012. No adverse event reported (other than the pregnancy). The patient did not received treatment for the adverse event. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a female patient of unknown age who on 05-SEP-2012 was vaccinated with an 0.5 ml., intramuscular dose of GARDASIL that had expired on 25-JUN-2012, lot number 665607/1332Y. No adverse events were reported. Additional information has been requested.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity
Clinical narrative: This spontaneous report as received from a 63 years old male pharmacist refers to himself. The patient had none pertinent medical history. The patient had none drug allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) subcutaneously on 19-AUG-2012. Concomitant medications were reported as none. It was reported that the patient's arm was sore and he had a headache on 20-AUG-2012. The patient did not seek medical attention. No treatment was given. Lab diagnostics studies performed were reported as none. The patient was recovered on 22-AUG-2012. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: HEPA, TDAP, TYP, VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning a male patient of unknown age who on 27-AUG-2012 was vaccinated with an expired dose, 0.65 ml dose subcutaneous ZOSTAVAX, lot number 670547/0659AA, expiration date 04-AUG-2012. No adverse events were reported. This is one of several reports received from the same source (other MAARS number 1209USA002305). Additional information had been requested.
Age: 0.4
Sex: M
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning to a 16 weeks old male patient. On 21-AUG-2012, the patient was vaccinated with 2 mL of the first dose of ROTATEQ, oral. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of drug administration, Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered concerning a 4 years old male consumer who on 17-MAY-2012 was vaccinated with the first dose of VARIVAX 0.5 mL (route and lot # not provided) and on 07-AUG-2012 received the second dose of VARIVAX (merck) 0.5 mL (route and lot # not provided). The nurse stated that on 23-AUG-2012, the patient received the third dose of VARIVAX (merck) 0.5 mL (route and lot # not provided). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age who on 28-SEP-2010, was vaccinated with the first dose of GARDASIL and on 16-AUG-2011, was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). The third dose had not been administered at the time of the report. No adverse effects were reported. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Injection site pruritus
Clinical narrative: This spontaneous report as received from a physician refers to male patients of unknown age. The patients were vaccinated with GARDASIL (Lot #, dose/frequency, route and duration were unspecified) on an unknown date. The physician stated that "when GARDASIL was administered to boys they complained of itching at the injection site when girls had such complaint". It was unspecified whether the patients had sought medical attention or not. The outcome was unknown. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a physician refers to a 27 years old female patient. The patient was vaccinated with GARDASIL (lot number, expired date, dose, route and injection site were not reported) on 12-APR-2012. No other co-suspects were reported. No concomitant medications were reported. On 12-APR-2012 the patient experienced GARDASIL injection at the age of 27. It was unspecified whether the patient sought medical attention. Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 2 months old patient. On 29-AUG-2012, the patient was vaccinated with the first dose of 2 ml ROTATEQ oral (lot#unknown) that was expired. No other co-suspects were reported. No concomitant medications were reported. It was unknown that if the patient had sought medical attention. No adverse event had occurred. Additional information has been requested.
Age: 5.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 5 years old patient. On 18-AUG-2012 the patient was vaccinated with a dose of ZOSTAVAX in error. On 31-JUL-2012 the patient was vaccinated with a dose of VARIVAX (Merck). It was unknown if the patient sought medical attention or not. No adverse effect has been observed or reported. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 27 years old female patient. The patient was vaccinated with GARDASIL (lot number, dose, route not reported) on 07-JUL-2012 at the age of 27. No other co-suspects or concomitant medications were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 61 years old female patient with no pertinent medical history. The patient was vaccinated with ZOSTAVAX (lot number 0564AE, expiration date 21-MAR-2013) on 22-AUG-2012. There were no concomitant medications. The patient developed an injection site reaction about 3 days after vaccination approximately on 25-AUG-2012. The patient developed an injection site reaction described as a red (erythematous), swollen, itchy, painful and warm to touch area at the injection site that was about 3 inches in diameter and raised about a half inch. No treatment or laboratory diagnostics studies were performed. The injection site reaction resolved without treatment (unspecified time frame). The patient had sought unspecified medical attention on 07-SEP-2012. Additional information is not expected.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Dizziness, Headache, Herpes zoster, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a currently 72 years old female consumer with no drug allergies refers herself. The patient's medical history included spinal surgery in 2004 resulting in nerve damage. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) about 5 years ago (in approximately 2007). Concomitant medications included LYRICA and unspecified pain medication. The patient had had shingles twice since receiving ZOSTAVAX. She was not sure of the exact dates of the shingles, but thought that they were within the last three years (one case could have been two years ago (in approximately 2010) and the other case about three years ago (in approximately 2009)). She was treated for the two cases of shingles, treatment unspecified. About 2 months ago (in approximately June 2012) she developed a headache and currently the consumer was experiencing swollen glands, became dizzy and lightheaded, sick to the stomach with a low grade fever and had one vesicle on the inside of her elbow that was itchy (exact start date unspecified but within two months). No current treatment was noted. The headache was reported to have resolved (date of resolution unspecified). The outcome of swollen glands, became dizzy and lightheaded, sick to the stomach with a low grade fever and one itchy vesicle on the inside of her elbow was reported as not recovered. The patient sought medical attention by office contact. Additional information has been requested.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pruritus, Pyrexia
Clinical narrative: This spontaneous report as received from a currently 72 years old female consumer with no drug allergies refers herself. The patient's medical history included spinal surgery in 2004 resulting in nerve damage. The patient was vaccinated with a dose of ZOSTAVAX (lot # not reported) about 5 years ago (in approximately 2007). Concomitant medications included LYRICA and unspecified pain medication. The patient had had shingles twice since receiving ZOSTAVAX. She was not sure of the exact dates of the shingles, but thought that they were within the last three years (one case could have been two years ago (in approximately 2010) and the other case about three years ago (in approximately 2009)). She was treated for the two cases of shingles, treatment unspecified. About 2 months ago (in approximately June 2012) she developed a headache and currently the consumer was experiencing swollen glands, became dizzy and lightheaded, sick to the stomach with a low grade fever and had one vesicle on the inside of her elbow that was itchy (exact start date unspecified but within two months). No current treatment was noted. The headache was reported to have resolved (date of resolution unspecified). The outcome of swollen glands, became dizzy and lightheaded, sick to the stomach with a low grade fever and one itchy vesicle on the inside of her elbow was reported as not recovered. The patient sought medical attention by office contact. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 years old female patient with no known allergies. The patient was vaccinated SC into back of unspecified arm with 0.65 ml ZOSTAVAX (lot # not reported) on 27-AUG-2012. Concomitant medications included hydroxychloroquine sulfate and low dose prednisone. In August 2012 the patient experienced adverse reaction. The patient came to the pharmacy on 29-AUG-2012 with a large red bump, size of a plum, warm to touch, at the injection site of unspecified arm. No treatment was given. No laboratory test was done. At the time of reporting, the patient had not recovered for the events. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect route of drug administration, Incorrect storage of drug, No adverse event
Clinical narrative: Initial information has been received from a registered pharmacist concerning 38 unspecified patients of unknown age. The patient's pertinent medical history and drug reactions or allergies were unspecified. On an unspecified date, the patient's were vaccinated subcutaneously instead of intramuscularly with a 0.5 ml dose of RECOMBIVAX HB, (lot # 1740AA, Expiration date: 07-JUN-2014) (lot number is an invalid lot number for hepatitis b vaccine), that was stored at -5 degrees to 10 degrees C from 11-JUN-2012 to 13-JUN-2012. It was reported that the patients did  not had any adverse effects. This is one of several reports from the same source. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a 74 year old male consumer with no drug reactions or allergies reporting on himself. The patient's medical history included heart stent. The patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (Lot # not reported) SQ on 09-JUL-2012. No other co-suspects were reported. Concomitant medications included EFFIENT, ZOCOR and lisinopril (manufacturer unknown). The consumer reported that on 16-JUL-2012, about one week after getting the vaccine, he got a rash on his right arm above his elbow and on his wrist. He also had a small rash on his right leg below the knee and also at the ankle, in the back of his leg. The rush itched but there was no pain associated with this rash. The consumer thought the rash was a case of shingles. The patient did not receive treatment for the adverse event. There were no Lab diagnosis or studies performed. The consumer stated that the rash disappeared in early August. Additional information has been requested.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with MMR II (Lot number not provided) subcutaneously into anterior lateral thigh and VARIVAX (Merck) (vaccination site, route and strength unknown) (Lot number not provided) at the same time on 17-AUG-2012 (reported as "one week ago"). No concomitant medications were reported. On an unknown date in August 2012 the patient experienced rash after receiving MMR II and VARIVAX (Merck) at the same time. No treatment information was reported. The outcome of rash was unknown. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Eyelid oedema, Flushing, Hyperhidrosis, Lymph node pain
Clinical narrative: Difficulty breathing, flushed skin, profuse sweating, swollen/painful glands in his neck, swelling of the eyes.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymphadenopathy, Pyrexia, Vision blurred
Clinical narrative: Difficulty breathing, flushed skin, profuse sweating, swollen/painful glands in his neck, swelling of the eyes.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Dyspnoea, Eye swelling, Flushing, Hyperhidrosis, Impaired driving ability
Clinical narrative: Difficulty breathing, flushed skin, profuse sweating, swollen/painful glands in his neck, swelling of the eyes.
Age: 50.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Difficulty breathing, flushed skin, profuse sweating, swollen/painful glands in his neck, swelling of the eyes.