chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: M
Vaccine: HEP
Symptoms: Swelling face, Tremor
Clinical narrative: Swelling of his face, face was red, fever, tremors.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red, swollen and warm to the touch area.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Blood test, Dyspnoea, Tremor
Clinical narrative: Started to tremor alot more than usual and having breathing problems.  Ended up at the ER.
Age: 0.45
Sex: F
Vaccine: DTAP, HPV4, IPV, PNC13, RV1
Symptoms: Wrong drug administered
Clinical narrative: HPV was administered instead of HIB.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Paraesthesia
Clinical narrative: Tdap administered in left deltoid at 5:10 pm. 20 minutes after injection patient complained of mild lightheaded and mild tingling to volar aspect of left hand.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with PROQUAD (Merck) (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No adverse effect was reported. The outcome of administered doses that were outside the original box and exposed to light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient with unknown age and gender. The patient's medical history was not reported. On 21-MAR-2014 the patient was vaccinated with an expired dose of PROQUAD (lot # H015638, expiration date: 23-FEB-2014) 0.5 ml, subcutaneous. Concomitant therapy was not reported. No adverse events were reported. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients, also reported as less than 10 patients if any (nurse was unable to say for sure if PNEUMOVAX 23 was administered), of unknown age and gender. No patient information was available. On an unknown date, the patients might have been vaccinated with a dose of PNEUMOVAX 23 (lot # J004747, expiry date 20-JUL-2014, dose, frequency, route and site of administration not specified), which was out of temperature range and not supported by in house stability data, also reported as exposed to unknown temperatures for 17 days in an unmonitored refrigerator that did not have a power failure. No adverse effects were reported. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test, Herpes zoster, Urine analysis
Clinical narrative: This spontaneous report as received from a 62 year old female patient refers on herself. The patient's current conditions included thyroid, migraines, depression and shingles - described by the patient as "on and off for years". There was none drug reactions/allergies in patient's medical history. On 06-DEC-2011, reported also as "6 months after last shingles occurred" the patient was vaccinated with a dose of ZOSTAVAX (one time vaccine) (Dose, Route, Lot number and Expiration Date not provided). Concomitant therapies included amitriptyline hydrochloride, SYNTHROID, IMITREX and trazodone hydrochloride (reported as TRANZIDONE). In November 2012 reported also as "a year later" after vaccination the patient "broke out with shingles". The patient sought medical attention and was prescribed acyclovir by her doctor. Blood and urine test were done "6 months ago" (in approximately September 2013)-no results were provided. The outcome of shingles and relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Case number PHHY2014US037836, is an initial literature report received on 21 Mar 2014. In this article, the author mentioned about the events after influenza vaccination for a 04-year-old girl. She had a known history of peanut, tree nut and shellfish allergy. She had pollen-food allergy syndrome from melons and bananas. She avoided gummy candies and other foods containing gelatin because she disliked them. Her vaccination history included vaccination with influenza vaccine at 03 years of her age and experienced shortness of breath and tightness of the chest (see case: PHHY2014US035991). She was vaccinated with influenza vaccine (not specified seasonal or pandemic, manufacturer and batch number: not reported, so conservatively coded as Influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination she experienced shortness of breath and tightness of the chest. The outcome and seriousness of the events were not reported.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to an unknown number of patients with unknown age. The patients' medical history and drug allergies were not reported. On an unknown date, patients were vaccinated with M-M-R II, 0.5 ml, (lot # and expired date were not reported). Concomitant therapy was not reported. Nurse mentioned that M-M-R II that was received by the patients was improperly stored in the fridge by being exposed to light for about 3 months. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with GARDASIL (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light and no adverse effect was unkonwn. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with ZOSTAVAX (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No adverse effect. The outcome of administered doses that were outside the original box and expsoed to light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: FLUX
Symptoms: Chest discomfort, Dyspnoea, Immediate post-injection reaction
Clinical narrative: Case number PHHY2014US035991, is an initial literature report received on 21 Mar 2014. In this article, the author mentioned about the events after influenza vaccination for a 03-year-old girl. She had a known history of peanut, tree nut and shellfish allergy. She had pollen-food allergy syndrome from melons and bananas. She avoided gummy candies and other foods containing gelatin because she disliked them. She was vaccinated with influenza vaccine (not specified seasonal or pandemic, manufacturer and batch number: not reported, so conservatively coded as Influenza vaccine INN) on an unknown date. On an unknown date, immediately after vaccination she experienced shortness of breath and tightness of the chest. The outcome and seriousness of the events were not reported. The patient again received influenza vaccine next year and experienced the same events (see case: PHHY2014US037836).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age. On 29-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot # H019034; expired date 17-JAN-2014) (dose, route and injection site were not reported). On unknown dates the patient developed two cases of shingles (dates of shingles cases unspecified, but patient had a current case at the time of the call) following vaccination with ZOSTAVAX. Action taken was not provided. The patient present status was reported as not recovered/not resolved at the time of report. The patient's had contacted pharmacist for medical attention. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with VARIVAX (Merck) (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No adverse effect was reported. The outcome of administered doses that were outside the original box and exposed to light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with M-M-R II (strength, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No concomitant medications were not reported. No adverse effect. The outcome of administered doses that were outside the original box and exposed to light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a 4 year old (reported as 4 years 7 months old) female patient. Number of siblings was reported as 3. On 10-MAR-2014 at 13:00 hr, the patient was vaccinated with VARIVAX (Merck) dose 2, lot # J008170 in the right thigh. On 10-MAR-2014 at 16:30 hr, 3 hrs 30 min after onset of therapy the patient experienced right thigh hot hard large area of thigh (1/3) swollen, itchy. The patient was administered BENADRYL and ibuprofen. On 13-MAR-2014, the patient was reported have recovered from the events. The causality was not reported. It was reported that the patient was vaccinated at a private doctor's office/hospital and the vaccine was purchased with public funds. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to unspecified number of patients of unknown age and gender. On an unknown date, unspecified number of patients may have been vaccinated with ROTATEQ (strength, dose number, dose, route, lot number and expired date unknown) that was stored outside of the original box and exposed to light. No adverse effect was light and no adverse effect was unknown. No further information was provided. This is one of several reports received from same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age (gender not reported). On 24-MAR-2014 the patient inadvertently administered with 1 single dose of ROTATEQ (lot # H015682), orally, that has expired on 18-MAR-2014. No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse reporting a 49 year old female patient. The patient was allergic to morphine. On 24-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #3H021941, expiration date 11-JUL-2014), 0.5 ml, intramuscularly in left arm. Concomitant therapy was not reported. The patient developed redness, warmth, and swelling extending from the injection site towards her elbow a few hours after administration of PNEUMOVAX 23 on 24-SEP-2013. The patient also developed fever and increased sweating. The patient was evaluated in the office on 30-SEP-2013 by a doctor and was prescribed AUGMENTIN and prednisone for cellulitis. The patient was seen in her office again on 02-OCT-2013 and 04-OCT-2013. The symptoms were improving but the injection site was still warm and tender. On 11-MAR-2014, the patient was evaluated by physician assistant, who was with another doctor's dermatology practice, and was diagnosed with lipodystrophy at the injection site. She was recommended to massage the area and take MOTRIN. The patient was again seen by the doctor on 14-MAR-2014. She was diagnosed with a possible abscess at the injection site and had been referred to an unspecified infectious disease practice for evaluation. At the time of the report the patient was recovering from the events. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth, Lipodystrophy acquired, Pyrexia
Clinical narrative: This spontaneous report as received from a nurse reporting a 49 year old female patient. The patient was allergic to morphine. On 24-SEP-2013, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #3H021941, expiration date 11-JUL-2014), 0.5 ml, intramuscularly in left arm. Concomitant therapy was not reported. The patient developed redness, warmth, and swelling extending from the injection site towards her elbow a few hours after administration of PNEUMOVAX 23 on 24-SEP-2013. The patient also developed fever and increased sweating. The patient was evaluated in the office on 30-SEP-2013 by a doctor and was prescribed AUGMENTIN and prednisone for cellulitis. The patient was seen in her office again on 02-OCT-2013 and 04-OCT-2013. The symptoms were improving but the injection site was still warm and tender. On 11-MAR-2014, the patient was evaluated by physician assistant, who was with another doctor's dermatology practice, and was diagnosed with lipodystrophy at the injection site. She was recommended to massage the area and take MOTRIN. The patient was again seen by the doctor on 14-MAR-2014. She was diagnosed with a possible abscess at the injection site and had been referred to an unspecified infectious disease practice for evaluation. At the time of the report the patient was recovering from the events. The relationship between the events and PNEUMOVAX 23 was not reported. Additional information has been requested.
Sex: M
Vaccine: HEPA, MNQ, TDAP, VARCEL
Symptoms: Erythema, Local swelling, Pruritus, Skin warm, Tenderness
Clinical narrative: (L) arm lateral area 2 1/2 circular red, raised, warm to touch - c/o itching slight pain when touched. Seen by MD - private - 3/27/14 - Rx BENADRYL. F/U as needed.
Age: 0.9
Sex: M
Vaccine: FLU4, HEP
Symptoms: Febrile convulsion, Gaze palsy, Tonic clonic movements
Clinical narrative: Febrile seizure - tonic clonic episode lasting 5 -> 10 min with eyes rolled up.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer who refers on his 70 year old grandmother. On an unknown dates the patient received two doses of pneumonia vaccine (manufacturer unknown) (dose, route, site of administration and lot # not reported) in two months and she did not have any side effects. Additional information is not expected.
Age: 1.05
Sex: F
Vaccine: FLU3, HEPA, MMR
Symptoms: Body temperature increased, Rash erythematous, Rash pruritic
Clinical narrative: Red raised itchy rash to entire body. Temp of 101-102.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Mom reported the next day pt had soreness around the injection site, headache, body aches, and fatigue. Ibuprofen administered by parents who report some relief.
Age: 1.18
Sex: F
Vaccine: DTAPHEPBIP, MMR, PNC
Symptoms: Cough, Pyrexia
Clinical narrative: Mom states patient fine yesterday 3/27 - Developed cough which is worse lying down. States fever but not taken.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Immediate post-injection reaction, Injection site pruritus, Injection site swelling, Injection site warmth, Rhinorrhoea
Clinical narrative: Pt states she immediately felt the injection site begin to itch. She states the itching increased and the area is now raised, swollen and warm to the touch (pt has dark skin so no redness is apparent). She exhibits nasal discharge, sneezing but no temperature.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Sneezing
Clinical narrative: Pt states she immediately felt the injection site begin to itch. She states the itching increased and the area is now raised, swollen and warm to the touch (pt has dark skin so no redness is apparent). She exhibits nasal discharge, sneezing but no temperature.
Age: 1.29
Sex: F
Vaccine: DTAP, MMR
Symptoms: Pyrexia
Clinical narrative: Fever Tmax 103.1 degrees F x 1 day.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date in 2009 (unknown date 5 years ago), the patient was vaccinated with ZOSTAVAX vial, (lot number and expiration date was unspecified), dose and frequency were unspecified. Concomitant medication was unspecified. The patient had transported the ZOSTAVAX from the pharmacy to the unspecified physician's office were it was administered. The patient stated that the ZOSTAVAX was at room temperature, approximately 70 Fahrenheit (F), for 1 and a half hours. On an unknown date in 2009, the patient was administered the improperly stored dose of ZOSTAVAX. No product quality complaint was involved. No further information was provided. Additional information has been requested.
Age: 1.02
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Blood culture, Pyrexia, Rash, Urticaria
Clinical narrative: Fever 101 + on 10-12-2013 to 10-15-2013. Rashes on 10-14-2013. Urticarial type rashes noted 10-17-2013.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site reaction, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 18-MAR-2014 the patient was vaccinated with ZOSTAVAX. On 20-MAR-2014 the patient experienced injection site reaction. The pharmacist described the reaction as: red, warm with a little hardening around the injection site appearing to be about 6 inches by 4 inches in diameter. HCP adamant about not receiving and HCP stated this was an injection site reaction rather than a rash. The outcome of injection site reaction was not recovered. This is one of two reports from the same patient MARRS: 1403USA014293. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: 3/21/14 Mom and child report soreness, redness, and itching to right arm. Mom reports seen in ER and told normal reaction. PHN observed arm and it (3/21/14) was red and warm. RN instructed Mom to follow up with PMD if continues. PHN observed no swelling.
Age: 1.04
Sex: F
Vaccine: HEPA, HIBV, MMR, VARCEL
Symptoms: Erythema, Feeling hot, Induration, Pyrexia, Swelling
Clinical narrative: Symptoms (redness, swelling, induration, heat) started soon after shots given on 3/10/14. Apply warm compress, give TYLENOL for fever every 4-6 hr. Cortisone cream 1% twice a day 1 week.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Blood test, Chills, Hypoaesthesia, Injection site swelling
Clinical narrative: Pt given TDAP vaccine 3/18/14. Reports 3/19/2014 while at work had chills, swelling to (L) deltoid and numbness to LE. Sent to ER. Reports blood work done. IV fluids given.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a nurse via company representative refers to a female patient of unknown age. It was reported that the patient received each of three doses of GARDASIL "almost a year apart" (dates of vaccinations, doses lot/batch numbers, expiration dates not reported). On an unknown date, the patient got result of a positive HPV test after receiving GARDASIL. The outcome of events was unknown. The relatedness between the events and the GARDASIL was not reported. Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Paraesthesia, Rash macular
Clinical narrative: An area above injection site broke out in a red splotch and was having some pain at that location. Patient also said she was having some nerve tingling in an area where she had previously broken out with shingles.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Immediate post-injection reaction, Rash, Rash erythematous
Clinical narrative: Immediately after vaccines listed below were administered, pt developed pinpoint erythematous rash starting on scalp - spread to face, upper trunk, no breathing difficulties. BENADRYL recommended order sent to pharmacy. Pt monitored for 20-30 min after administration.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Blister, Injection site erythema, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: Mother returned with child on 3/20/14 - (L) upper arm red, warm to touch and swollen, blisters noted just above elbow - swelling noted from deltoid to elbow and around arm. Mother took child to urgent care - states she was told it was a local reaction and to use cool, wet compress.
Age: 21.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash
Clinical narrative: Employee came in and stated she had a rash on the upper left part of her back and in both her left and right armpits. It had started on 3/22/14 which is when she noticed her rash. 2nd vaccine was given 3/10/14.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Erythema, Injection site erythema
Clinical narrative: Child received 12 MO vaccines and within 2-3 min became red on thighs BIL around injection site and on (R) upper arm and face. Gave 1 dose BENADRYL and almost completely cleared within 10-15 min.
Age: 0.8
Sex: M
Vaccine: FLU3
Symptoms: Wrong drug administered
Clinical narrative: Got flu #3 rather than Hep B #3 in error. Was off schedule due to moving and mother serious medical problems postpartum.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: ZOSTAVAX injection, next day start swelling, redness, and itchy at injection site. Patient used aspirin, BENADRYL and ice to help alleviate symptoms.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Injection site cellulitis, Rash erythematous
Clinical narrative: Patient came to pharmacy on 3/31/14 and stated that she got the shingles vaccine on 3/28 and then spent the majority of the day at the ER on 3/29 and the doctor diagnosed her with cellulitis at site of injection.  She was prescribed Bactrim DS which she got at another pharmacy and is currently taking.  Site was raised, blistered, and rashy with a bright red tint.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Injection site swelling
Clinical narrative: Patient states he had swelling at the injection site and some lower abdominal pain. Abdominal pain started the next evening.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 37.0
Sex: M
Vaccine: ANTH, HEPA
Symptoms: Expired drug administered
Clinical narrative: Hep A Vaccine administered to patient on 31 March 2014 was from a lot that expired on 09 March 2014.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Allergy to vaccine, Rash generalised
Clinical narrative: Patient had an allergic reaction to the Zostavax. She had a rash all over her body.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ear swelling, Eyelid oedema, Urticaria
Clinical narrative: Patient had an allergic reaction to the Zostavax. She had a rash all over her body.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Paraesthesia oral
Clinical narrative: Redness and swelling at injection site.  Tingling in hands and mouth. Swelling increased as the day progressed. Emergency room treatment, area iced Benadryl for swelling and Tylenol 600 administered for pain.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Dizziness, Eyelid oedema, Headache, Laboratory test normal, Local swelling
Clinical narrative: Swelling of upper and lower eyelids, headache, dizziness, blurry vision, white spots in vision, arm that was injected became swollen.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Vision blurred, Visual impairment
Clinical narrative: Swelling of upper and lower eyelids, headache, dizziness, blurry vision, white spots in vision, arm that was injected became swollen.
Age: 2.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: NONE KNOWN.
Age: 11.0
Sex: M
Vaccine: HEP, HPV4, MMR, MNQ, TD
Symptoms: Fall, Feeling abnormal, Staring
Clinical narrative: Eleven year old was assessed by the check-in staff and Nurse to need TD, Hep B, Polio, MMR, Meningococcal, and his first HPV.  History taken given via questionnaire provided by father.  After nurse administered each vaccine, the client was asked to sit in the chair outside the administration room for observation as procedure and wait 15 minutes. Before the 15 minutes of time elapsed (approx 11:40am), client was observed by Nurse as she came down the hall toward him to slouch over toward the floor from the chair.  Client landed on side and rolled over supine.  Hitting of head not observed but a sound as he hit the floor was heard.  Client seemed to contract both arms upward with eyes open looking straight ahead. Seemed dazed momentarily (10 sec), and then sat up with assistance.  Nurse assisted him to cot as other nurse proceded to take vital signs.  First set of vital signs 100/60; p-76 ; r-18 at 11:45am.  Client was oriented to name and day of week when asked by nurse. No swelling, redness or knots palpated on head. He stated to interpreter that his head did not hurt.  EMS activated by RN at that time.  Second set of vital signs 100/70  p-68;  r-18. Paramedics arrived at approx 11:50am. Staff member assisted with interpretation the whole time.   Father gave no contraindicated history for administration of vaccines.  Client was assessed by paramedics and determined to need precautionary evaluation at hospital. Client was walked from clinic by paramedics accompanied by father and siblings.
Age: 20.0
Sex: F
Vaccine: FLU3, HEP
Symptoms: Alopecia, Back pain, Injection site rash, Liver function test, Rash
Clinical narrative: There have been many effects but the main ones include persistent back pain and my hair started falling out after my hepatitis B shot.  I have a bald spot and my hair has thinned out severely.  There have been many articles linking the hepatitis b vaccine to alopecia areata.  Additionally, I had rashes that developed on 2 places in my body, one near the injection site and one on my knee.
Age: 23.0
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Lip swelling, Pruritus generalised, Wheezing
Clinical narrative: Patient noted on rounds to be in subjective distress. RN had given varicella vaccine (Varivax) @ 12:25. Shortly therafter patient c/o generalized itching, swelling of lips, and difficulty breathing. Assessed to be having anaphylactic response, patient was placed on continuous pulse oximetry, AFVSS with SpO2 >90%. Noted diffuse wheezing on exam, otherwise without abnormality. Patient was given Benadryl 25mg IMx1, Prednisone 40mg POx1, and albuterol neb treatment x1. Patient remained AFVSS, had prompt response to treatment and was continuously monitored without event. On reassessment 2 hrs later patient was well appearing and asymptomatic.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Inflammation, Influenza like illness, Pain in jaw, Pyrexia, Temporomandibular joint syndrome
Clinical narrative: Severe jaw pain and inflammation (TMJ), fever, flu like symptoms.
Age: 68.0
Sex: M
Vaccine: HEPAB
Symptoms: Back pain, Hypoaesthesia, Injection site erythema, Injection site pain, Neck pain
Clinical narrative: Significant pain with some degree of redness in right shoulder blade area began approximately 24-28 hours after vaccine.  Pt said he did change vehicle brakes 24 hours after vaccine and may have strained muscle in affected area while doing so.  Pain peaked Thursday 3/27 and Friday 3/28 (8 or 9 out of 10 scale).  Pain worsened with ice, improved with heat.  By Sunday 3/30 pain had moved to neck and upper back of shoulder with some numbness in right wrist but consiedered 3 or 4 of 10 scale.  Started using OTC NSAID Aleve Sunday evening and noted improvement.
Age: 42.0
Sex: F
Vaccine: DTAP, FLUX
Symptoms: Dyspnoea, Rash, Urticaria
Clinical narrative: Rash, hives, difficulty breathing. Face, arms, neck legs, abdomen, back.
Age: 5.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site discolouration, Injection site induration, Injection site oedema
Clinical narrative: Mother reported noticing redness-purplish color, edema and induration around injection site morning of 3/12/2014. No fever. Able to move arm without difficulty. Referred pt to pediatrician for recommendations. No d/c from site.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 59 year old female patient who on 05-DEC-2013 the patient, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that on 18-MAR-2014, the patient came into the pharmacy with a prescription for acyclovir for treatment of shingles. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional infomration has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Activities of daily living impaired, Gait disturbance, Headache, Herpes zoster, Local swelling
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 59 year old female patient who on 05-DEC-2013 the patient, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that on 18-MAR-2014, the patient came into the pharmacy with a prescription for acyclovir for treatment of shingles. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional infomration has been requested.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neuralgia, Pain in extremity, Rash, Skin lesion
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 59 year old female patient who on 05-DEC-2013 the patient, was vaccinated with a dose of ZOSTAVAX (dose, route and lot number not reported). It was reported that on 18-MAR-2014, the patient came into the pharmacy with a prescription for acyclovir for treatment of shingles. At the time of the report, the patient's outcome was unknown. The relatedness for shingles and ZOSTAVAX was unknown. Additional infomration has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV. The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. PAP with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report was received from a nurse via a company representative concerning a 59 year old male patient with diabetes. On 17-FEB-2014 the patient was vaccinated with PNEUMOVAX 23 lot # H014196, expiration date 19-MAR-2014 dose 1, intramuscular in the arm. The nurse reported that the patient developed an injection site reaction described as a cellulitis from the top of the arm to the elbow within 12 hours of vaccination, on approximately 17-FEB-2014, with the first dose of PNEUMOVAX 23. The patient was treated with KEFLEX and the patient was currently recovered. The nurse requested a lot check. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with VARIVAX (dose, route and lot number were not reported) that in January of 2014 were exposed to 69.5F for 72 hours. No adverse effects reported. This case is linked to cases 1403USA014486, 1403USA014487, 1403USA014488 and 1403USA014486 via same reporter link. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose normal, Headache, Immediate post-injection reaction, Injection site pain, Syncope
Clinical narrative: Pt immediately developed arm pain at site of inj and then a HA, then she fainted. Was still on exam table. VSS +/0. Kept for 30 min. BS = 81.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain lower, Adnexa uteri cyst, Computerised tomogram abdomen abnormal, Haemorrhagic ovarian cyst, Lymphadenitis
Clinical narrative: C/O rt lower abd pain 3-4 wks after GARDASIL vaccine given - CT scan done 6-14-13 - showed mesenteric lymphadenitis - continued to have pain off and on RLQ - ultrasound done 6-30-13 1.7 cm rt adnexal cyst revealed - Feb 19, 2014 ultrasound RLQ showed large complex hemorrhagic cyst in rt ovary.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Ultrasound abdomen abnormal
Clinical narrative: C/O rt lower abd pain 3-4 wks after GARDASIL vaccine given - CT scan done 6-14-13 - showed mesenteric lymphadenitis - continued to have pain off and on RLQ - ultrasound done 6-30-13 1.7 cm rt adnexal cyst revealed - Feb 19, 2014 ultrasound RLQ showed large complex hemorrhagic cyst in rt ovary.
Age: 1.16
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Rash erythematous, Skin warm
Clinical narrative: First noted 2 small red bumps 3/29/14. Developed into red round patch which became hard and warm to touch, over next 24 hours. Seen in office 3-30-14. No treatment needed.
Age: 1.01
Sex: F
Vaccine: MMR, PNC13, VARCEL
Symptoms: Irritability, Pyrexia
Clinical narrative: Fever, irritability 7 days after vaccination.
Age: 9.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Moderate erythema of skin surrounding injection site. Patient c/o itching without pain in same area. Started about 24 hrs after injection given.
Age: 75.0
Sex: U
Vaccine: FLUX
Symptoms: Skin cancer, Vaccination site reaction
Clinical narrative: I developed skin cancer at the site of vaccination. It was twice removed by a dermatologist, but, as of this date is still there. A flu shot it was given at store.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: No adverse event
Clinical narrative: Pt states he has no adverse symptoms.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Convulsion
Clinical narrative: Seizure 3/28/2014. Went to Emergency Room.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Blood glucose, Concussion, Dizziness, Electrocardiogram, Excoriation
Clinical narrative: Patient syncopal after administration of vaccine. No incontinence. No tremors. After rising continues to feel dizzy with poor recall of event - sent by EMS to ED for eval concussion. Abrasion -> chin.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Memory impairment, Syncope
Clinical narrative: Patient syncopal after administration of vaccine. No incontinence. No tremors. After rising continues to feel dizzy with poor recall of event - sent by EMS to ED for eval concussion. Abrasion -> chin.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Erythema, Oedema, Pain, Skin warm
Clinical narrative: Pain, edema, redness. Hot area.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Slight dizziness after receiving shot lasting 5 minutes. Gave patient water to drink and a sucker. She felt better after 2-3 minutes. No dizziness on standing.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Blood pressure abnormal, Bradycardia, Heart rate abnormal, Hypotension
Clinical narrative: Hypotension and bradycardia - responded to p.o. fluid, but persisting unstable B.P. and H.R. response upon ambulation after an hour of monitoring - transferred to local E.D.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at site of injection 2 in x 4 1/2" M.D. called in Rx of Cephalexin 500mg 3/21/2014.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Eye pain, Myelopathy, Neck pain, Neuromyelitis optica, Nuclear magnetic resonance imaging brain
Clinical narrative: Neck pain Dx Myelopathy Eye pain change vision Dx. Optic Neuritis Devic's disease.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Nuclear magnetic resonance imaging spinal, Optic neuritis, Visual impairment
Clinical narrative: Neck pain Dx Myelopathy Eye pain change vision Dx. Optic Neuritis Devic's disease.
Age: 1.39
Sex: F
Vaccine: DTAP, FLU3
Symptoms: Erythema, Papule, Pyrexia, Skin warm, Vaccination complication
Clinical narrative: Vaccine reaction. Right arm with erythematous papule and warmth which developed after flu vaccine administration. Fever 103.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Fall, Head injury, Presyncope
Clinical narrative: Patient became dizzy with near syncope after TDAP (approximately 5 minutes after shot). Fell to carpeted floor. Hit (L) forehead against wall.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Joint stiffness, Muscle tightness, Nausea, Pain
Clinical narrative: 2/19/14 Nausea about 8:30 pm chills, muscle tightness, pain, hand and arm tightness, fever about 102 9pm - 10pm took Ibuprofen 400mg at 10:30 pm and 12 pm. 2/20/14 Chills, fever subsided, soreness slowly subsided took Ibuprofen 400mg and BENADRYL 25mg about 12:00 noon took additional 25mg BENADRYL at bed time.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia
Clinical narrative: 2/19/14 Nausea about 8:30 pm chills, muscle tightness, pain, hand and arm tightness, fever about 102 9pm - 10pm took Ibuprofen 400mg at 10:30 pm and 12 pm. 2/20/14 Chills, fever subsided, soreness slowly subsided took Ibuprofen 400mg and BENADRYL 25mg about 12:00 noon took additional 25mg BENADRYL at bed time.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Chills, Muscle tightness, Nausea, Pain, Pyrexia
Clinical narrative: 2/19/14 Nausea about 8:30 pm chills, muscle tightness, pain, hand and arm tightness, fever about 102 9pm - 10pm took Ibuprofen 400mg at 10:30 pm and 12 pm. 2/20/14 Chills, fever subsided, soreness slowly subsided took Ibuprofen 400mg and BENADRYL 25mg about 12:00 noon took additional 25mg BENADRYL at bed time.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date, patients were vaccinated with M-M-R II (dose, route, albumin status and lot number were not reported) that in January 2014 were exposed to 69.5F for 72 hours. No adverse effects reported. This case is linked to cases 1403USA014177, 1403USA014487, 1403USA014488 and 1403USA014486 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014, patients were vaccinated with LIQUID PEDVAXHIB (dose, route and lot number were not reported) that in January of 2014 were exposed to 69.5F for 72 hours. No adverse effects reported. This case is linked to cases 1403USA014177, 1403USA014486, 1403USA014488 and 1403USA014486 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014, patients were vaccinated with GARDASIL (dose, route and lot number were not reported) that in January of 2014 were exposed to 69.5F for 72 hours. No adverse effects reported. This case is linked to cases 1403USA014177, 1403USA014486, 1403USA014487 and 1403USA014488 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from an other healthcare worker refers to an unspecified number of patients of unknown age and gender. On an unknown date in 2014, patients were vaccinated with oral ROTATEQ (dose, route and lot number were not reported) that in January 2014 were exposed to 69.5F to 72 hours. No adverse effects reported. This case is linked to cases 1403USA014177, 1403USA014486, 1403USA014487 and 1403USA014486 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients (unknown age and gender). The nurse reported that improperly stored GARDASIL might have been administered to an unknown number of patients on unspecified dates. Lot# and administration information were not provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV (human papilloma virus). The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. Pap with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV (human papilloma virus). The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. Pap with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV (human papilloma virus). The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. Pap with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4, HPV4, HPV4, HPV4, HPV4, HPV4
Symptoms: Human papilloma virus test positive, Smear cervix abnormal
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a female patient now in her 20's. The patient's current conditions or medical history were not reported. On an unspecified date, in the last year, the patient was vaccinated as adolescent with all 3 doses of GARDASIL (dose, route, lot number and expiration date were not reported). On an unspecified date, the patient was diagnosed with high risk HPV (human papilloma virus). The patient cleared the HPV without requiring treatment. The high risk HPV serotype was not determined. The patient went to the doctor's office for medical attention. Pap with HPV DNA testing were performed on an unspecified date, HPV serotype was not determined. This one of several reports from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients (unknown age and gender). The nurse reported that improperly stored oral ROTATEQ might have been administered to an unknown number of patients on unspecified dates. Lot # and administration information were not provided. No adverse effects reported. This is one of two reports received from the same reporter. Additional information is not expected.