chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Pain
Clinical narrative: This spontaneous report was received from a registered pharmacist refers to a patient of unknown age and gender. On 09-OCT-2013 the patient was inadvertently vaccinated with ZOSTAVAX (lot # J002777, expiration date 07-JUN-2014) intramuscularly. No adverse effects reported. Additional information has been requested. Follow up information has been received from registered pharmacist concerning to a 69 year old female patient. None medical conditions, none current conditions or drug allergies and no illness at the time of vaccination. The patient had an historical drug of pneumonia vaccination. On 09-OCT-2013 AM, the patient was vaccinated with a first dose (also reported as previous doses 1) of ZOSTAVAX 0.65ml in the right deltoid area at 5/8 subcutaneous, lot # J002777, expiration date 07-JUN-2014. Diluent (unspecified) 0.7ml, lot#J004088 expiration date 31-AUG-2015 (also reported as 15-AUG-2013). Concomitant therapies included FLUVIRIN. In 2013, the patient experienced soreness. The pharmacist reported that the patient felt that the shot was given inappropriately; she said it should have been given under arm area, subcutaneous. The pharmacist said that she or he give it subcutaneous in the deltoid are with 5/8". The pharmacist massaged area well at referred to massaging deep in the muscle. She inferred this to get intramuscular shot, the patient said to the pharmacist that she or he gave her IM but the pharmacist did not. The pharmacist referred to massage as deep to help with soreness. The patient did not seek medical attention. The outcome of soreness was unknown. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age. Patient's concurrent or historical conditions were not reported. On 10-DEC-2013 (reported as yesterday by the physician) the patient was vaccinated with ROTATEQ lot # 0210AE, expiration date 29-SEP-2013. Co-suspect or concomitant therapies were not reported. The physician reports that the patient was vaccinated yesterday with ROTATEQ expiration 29-SEP-2013, lot 0210AE. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy, Mumps, Smear buccal, Viral test
Clinical narrative: This spontaneous report, as received from a company representative, refers to a female patient of less than twenty years old (not further specified). Her medical history was unknown. On an unspecified date, the patient was allegedly vaccinated with M-M-R II. She then (about a month ago, in November 2013) developed mumps and symptoms of extremely swollen glands in the lymph node area under the ears. The patient sought medical attention because of the adverse events, by going to the health department. A buccal test and blood test for mumps were performed on an unknown date. The results of the tests were unknown. The outcome of mumps and symptoms of extremely swollen glands in the lymph node area under the ears was unknown. A causality assessment was not provided. This report is linked with report 1312USA006048, 1312USA006053 and 1312USA008378, received from the same reporter, regarding the additional patients, who also allegedly underwent vaccination with M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report, as received from a company representative, refers to a female patient of less than twenty years old (not further specified). Her medical history was unknown. On an unspecified date, the patient was allegedly vaccinated with M-M-R II. She then (about a month ago, in November 2013) developed mumps and symptoms of extremely swollen glands in the lymph node area under the ears. The patient sought medical attention because of the adverse events, by going to the health department. A buccal test and blood test for mumps were performed on an unknown date. The results of the tests were unknown. The outcome of mumps and symptoms of extremely swollen glands in the lymph node area under the ears was unknown. A causality assessment was not provided. This report is linked with report 1312USA006048, 1312USA006053 and 1312USA008378, received from the same reporter, regarding the additional patients, who also allegedly underwent vaccination with M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Lymphadenopathy, Mumps, Smear buccal, Viral test
Clinical narrative: This spontaneous report, as received from a company representative, refers to three female patients of unknown age. No medical history was reported. On an unspecified date, the patients were allegedly vaccinated with M-M-R II. They then developed mumps. The outcome of mumps was unknown and a causality assessment were not provided. This report is linked with report 1312USA006048, 1312USA006053 and 1312USA006064, received from the same reporter, regarding five additional patients, who also allegedly received M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.
Sex: F
Vaccine: MMR, MMR
Symptoms: Mumps
Clinical narrative: This spontaneous report, as received from a company representative, refers to three female patients of unknown age. No medical history was reported. On an unspecified date, the patients were allegedly vaccinated with M-M-R II. They then developed mumps. The outcome of mumps was unknown and a causality assessment were not provided. This report is linked with report 1312USA006048, 1312USA006053 and 1312USA006064, received from the same reporter, regarding five additional patients, who also allegedly received M-M-R II, and then developed mumps. It was stated that all patients in the linked reports were in close contact to one another by being related or working together. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Dizziness, Fatigue, Headache, Injection site erythema
Clinical narrative: Hard, red bump around injection site, 12/17/13 around 7:00 pm. Swelling, soreness, throbbing. 12/18/13 10am same as above plus headache, tired, weak, woozy.
Age: 37.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site induration, Injection site swelling, Pain, Swelling
Clinical narrative: Hard, red bump around injection site, 12/17/13 around 7:00 pm. Swelling, soreness, throbbing. 12/18/13 10am same as above plus headache, tired, weak, woozy.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Joint swelling, Oropharyngeal pain, Osteoarthritis
Clinical narrative: Swelling and pain in (R) knee (L) elbow. Increased osteoarthritic pain in all joints. Slight sore throat, continuing on 12/18/13.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Information has been received from a 25 year old female with no drug reactions/allergies and no pertinent medical history, for HPV, a Pregnancy Registry product, concerning herself who on 28-NOV-2011 was vaccinated with her first dose of HPV vaccine (lot# not reported). There was no concomitant medication. The patient reported she received her first dose of HPV vaccine on 28-NOV-2011, found out she was pregnant in December 2011, and estimates she conceived between November 16th through the19th. No adverse effect reported. The patient sought unspecified medical attention. No lab diagnostic study was performed. Therapy with HPV vaccine was discontinued. The patient's LMP was approximately 16-NOV-2011 (also reported as "10 weeks"). The estimated delivery date was 22-AUG-2012. Follow up information has been received from the physician via a nurse who stated that the patient had a normal delivery and a healthy baby in August 2012. Additional information is not expected.
Age: 42.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Immediate swelling left deltoid then redness. BENADRYL 50mg IM given - redness and swelling resolved 15 minutes. Monitored additional 30 minutes with no reaction. Driver provided by family.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Diagnosed Guillain Barre post influenza vaccine.
Age: 69.0
Sex: U
Vaccine: FLU3
Symptoms: Ear pain, Malaise, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat, ear pain, runny nose. Sick about week and half after shot.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Influenza, Influenza A virus test positive
Clinical narrative: Positive for Influenza type A after Flu vaccine on 09/28/2013.
Age: 38.0
Sex: M
Vaccine: SMALL
Symptoms: Unevaluable event
Clinical narrative: Pt should have permanent exemption for the vaccination due to contraindication of eczema.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Blindness, Dry mouth, Eye irritation, Lacrimation increased, Muscle spasms
Clinical narrative: Xerostomia and epiphora 12 hours post vaccination; left eye irritation and muscle spasm of neck 24 hours post vaccination; loss of vision to left eye 7 days post vaccination; post ER physician presciption education to patient Bell's Palsy - acetaminophen-codeine, acyclovir, codeine phosphate oral tablet, medrol dose pack.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Xerostomia and epiphora 12 hours post vaccination; left eye irritation and muscle spasm of neck 24 hours post vaccination; loss of vision to left eye 7 days post vaccination; post ER physician presciption education to patient Bell's Palsy - acetaminophen-codeine, acyclovir, codeine phosphate oral tablet, medrol dose pack.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Livedo reticularis, Lymphadenopathy, Rash erythematous, Vaccination site discolouration, Vaccination site exfoliation
Clinical narrative: Swollen lymphnode in left armpit 48 hours after vaccination. Developed red mottled rash. 7 days post vaccination, skin around vaccination site became grey & flaked off. Resolution 3 to 4 weeks post injection. No treatment provided.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: DEVELOPED BODY RASH TO BREAST BACK ABDOMEN, ARMS AND LOWER EXTREMITIES.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity, Thrombosis, Ultrasound Doppler normal
Clinical narrative: Pt had soreness in arm and possible leg pain 2 weeks after vaccination of Fluzone high dose that doctor thought could be blood clot.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Angioedema, Myalgia, Penile swelling, Rash, Swelling
Clinical narrative: Hives all over, swollen tender penis.  Rash and swelling come and go as does the angioedema which has also occurred on lips, face, eyes.  As of 12/18 has not yet resolved.  Also with some myalgias.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Tenderness, Urticaria
Clinical narrative: Hives all over, swollen tender penis.  Rash and swelling come and go as does the angioedema which has also occurred on lips, face, eyes.  As of 12/18 has not yet resolved.  Also with some myalgias.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Vomiting
Clinical narrative: I vomited within 30 minutes and then again later in the day.  I hadn't eaten breakfast, they didn't ask or mention that it was required.
Age: 61.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Varicella
Clinical narrative: Chicken pox appearing on trunk and, later, limbs, with itching but no fever.
Age: 18.0
Sex: M
Vaccine: FLU3, HEP, HEPA, HPV4, MMR, MNQ, TDAP
Symptoms: Dizziness
Clinical narrative: Patient felt dizzy after vaccines were administered.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Influenza virus test negative, Nausea, Neck pain
Clinical narrative: Fever, chills, headache, neck pain, nausea.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, chills, headache, neck pain, nausea.
Age: 33.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Musculoskeletal pain
Clinical narrative: Severe left shoulder pain that is debilitating at times when arm is brought above shoulder height or goes across the body or is lifting even minor weighted objects (i.e., gallon of milk).  Noticed more pain than usual flu shot at time of vaccine, and pain has gradually increased since the vaccine was administered. Started noticing more pain in shoulder around 10 days post vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Rash macular
Clinical narrative: Shot straight to end of my finger. Slowly developed headache. Had to go to bed. Slept 3 hours. Three days later arm has red splotches, very sore.
Age: 12.0
Sex: M
Vaccine: HPV4, IPV, MNQ, TDAP
Symptoms: Dizziness, Hyperhidrosis, Pallor
Clinical narrative: 9:55 AM after vaccines patient became dizzy- pale color, skin moist. 9:58 AM Ammonium Inhalants 1/1 administered intranasal- and wet, cool, paper towel applied to face and forehead. 10:02 AM B/P 110/60-70-18. 10:15 AM Patient stated he felt better. Instructed if he has any other problems take to M.D. 10:30 AM Patient denies pain and no noted blisters left other ambulatory.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain in same spot as shingles pain one year ago. No lesions but same pain and location as one year ago. Dr. treating as last year with anti viral med and pain med.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Diplopia, Dizziness
Clinical narrative: Client reports feeling slightly dizzy and some double vision when first stands up; both symptoms clear shortly.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Injection site pain, Paraesthesia, Poor quality sleep
Clinical narrative: Felt pain, cold, tingling in L arm with injection. Experienced pain for a week, then gone for 2 weeks, then returned with constant pain, achiness in L arm for 4 weeks after vaccination.  Pain during night would wake her up. Pain subsided early December. Does not currently have pain.
Age: 64.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea, Pain, Pyrexia
Clinical narrative: Head aches, body aches, fever, nausea.
Age: 55.0
Sex: M
Vaccine: PPV
Symptoms: Fatigue, Injection site bruising, Injection site pain, Neck pain
Clinical narrative: Severe pain in L deltoid and up L neck and very tired. Some mild bruising in area of shot. No sign of hematoma.
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Diastolic hypertension, Dizziness, Hearing impaired, Visual impairment
Clinical narrative: Within a few minutes of receiving the shot, I felt incredibly dizzy. Ever since then, I've his visual and auditory disturbances, diastolic hypertension, severe dizzy spells requiring hospitalization. These did not begin until after I got the flu shot.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Antinuclear antibody negative, Arthralgia, Blood immunoglobulin G normal, Bursitis
Clinical narrative: Red, itchy rash on face, arms, trunk 18 hours after injection which resolved by evening after taking oral antihistamines. Developed knee pain on 10/17/13, then ankle pain on 10/21/13, then knee pain again on 10/23/13, then bursitis in R hip on on 10/31/13.   This worsens until unable to walk on 11-3-13 due to pain.   Started on prednisone burst.  R wrist starts to swell and is extremely painful 11-6-13 and spreads to L wrist.  See physician on 11-14-13 and diagnosed with Migrating Polyarthritis secondary to flu shot.  Tested for Rheumatoid Factor, SSA (RO) Antibody, IgG, ENA SSB (LA) Ab, and ANA and all were negative.  Still having symptoms of pain in wrists and occasionally in other joints (12-17-13) and malaise.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Joint swelling, Malaise, Polyarthritis, Rash erythematous, Rash pruritic
Clinical narrative: Red, itchy rash on face, arms, trunk 18 hours after injection which resolved by evening after taking oral antihistamines. Developed knee pain on 10/17/13, then ankle pain on 10/21/13, then knee pain again on 10/23/13, then bursitis in R hip on on 10/31/13.   This worsens until unable to walk on 11-3-13 due to pain.   Started on prednisone burst.  R wrist starts to swell and is extremely painful 11-6-13 and spreads to L wrist.  See physician on 11-14-13 and diagnosed with Migrating Polyarthritis secondary to flu shot.  Tested for Rheumatoid Factor, SSA (RO) Antibody, IgG, ENA SSB (LA) Ab, and ANA and all were negative.  Still having symptoms of pain in wrists and occasionally in other joints (12-17-13) and malaise.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Rheumatoid factor negative
Clinical narrative: Red, itchy rash on face, arms, trunk 18 hours after injection which resolved by evening after taking oral antihistamines. Developed knee pain on 10/17/13, then ankle pain on 10/21/13, then knee pain again on 10/23/13, then bursitis in R hip on on 10/31/13.   This worsens until unable to walk on 11-3-13 due to pain.   Started on prednisone burst.  R wrist starts to swell and is extremely painful 11-6-13 and spreads to L wrist.  See physician on 11-14-13 and diagnosed with Migrating Polyarthritis secondary to flu shot.  Tested for Rheumatoid Factor, SSA (RO) Antibody, IgG, ENA SSB (LA) Ab, and ANA and all were negative.  Still having symptoms of pain in wrists and occasionally in other joints (12-17-13) and malaise.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Back pain, Impaired driving ability, Injection site erythema, Injection site pain
Clinical narrative: I got the shot by the pharmacist and immediately it hurt as she gave it. More than normal (I've gotten the flu shot for ten years).  I immediately had soreness and it worsened over the evening. I could barely raise my arm without pain. By the next day it was so bad I couldn't shower, dress, drive or move it without extreme shooting pains down my arm. It radiated into my neck and back. I took Ibuprofen and used heat on it with no relief. Red sore bump at injection site and the top of my shoulder. She clearly didn't give the shot where she was supposed to. By Tuesday (2 days after) it was even worse. Called pharmacist, she said this was rare, and to take pain meds and go to my doctor if it didn't stop. Just went to my family doctor and they prescribed physical therapy and prescription anti-inflammatory drugs. It is still very painful and I am very limited in the use of my arm.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Musculoskeletal disorder, Neck pain, Pain, Pain in extremity
Clinical narrative: I got the shot by the pharmacist and immediately it hurt as she gave it. More than normal (I've gotten the flu shot for ten years).  I immediately had soreness and it worsened over the evening. I could barely raise my arm without pain. By the next day it was so bad I couldn't shower, dress, drive or move it without extreme shooting pains down my arm. It radiated into my neck and back. I took Ibuprofen and used heat on it with no relief. Red sore bump at injection site and the top of my shoulder. She clearly didn't give the shot where she was supposed to. By Tuesday (2 days after) it was even worse. Called pharmacist, she said this was rare, and to take pain meds and go to my doctor if it didn't stop. Just went to my family doctor and they prescribed physical therapy and prescription anti-inflammatory drugs. It is still very painful and I am very limited in the use of my arm.
Age: 19.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Burning sensation, Injection site pain, Injection site rash, Paraesthesia, Rash
Clinical narrative: Burning feeling at site of injection at right deltoid, going down arm to hand, with tingling of hand. Rash noted 8 hours later from site of injection down to mid forearm; it looked like hives.
Age: 19.0
Sex: M
Vaccine: FLU4, MNQ
Symptoms: Urticaria
Clinical narrative: Burning feeling at site of injection at right deltoid, going down arm to hand, with tingling of hand. Rash noted 8 hours later from site of injection down to mid forearm; it looked like hives.
Sex: F
Vaccine: PPV
Symptoms: Vaccination complication
Clinical narrative: Information has been received from a third party claims administrator on behalf of a pharmacy, concerning a female customer (age not reported) who on an unspecified date was vaccinated with PNEUMOVAX23. (It was reported that the PNEUMOVAX, manufactured by Merck, was involved in the incident.) The facts of the incident are the customer sustained a severe reaction after receiving the PNEUMOVAX vaccine. The "date of loss" was reported as 22NOV2013. The lot # reported for the PNEUMOVAX23 was reported to be J009827 with an expiration date of 10AUG2014. Treatment and outcome of the adverse experience was unknown. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Anaemia, Condition aggravated, Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse, concerning an 18 year old female. Patient's past drug history was unknown. On 08-SEP-2012, the patient was vaccinated with the first dose of GARDASIL, a second dose of GARDASIL 12-APR-2012 (also reported on 12-APR-2011) and a third dose of GARDASIL on 29-MAY-2012 (three doses: lot # 671006/1291AA, expired on 12-APR-2014; dose and route not reported). Concomitant medications were unknown. As of 29-MAY-2012, the patient was 6 months pregnant. Relevant laboratory data was unknown. As of 2-MAY-2012, the patient remained six months pregnant. Follow-up information has been received which reported the patient with no concurrent medical conditions and no previous pregnancies was vaccinated with a first dose of GARDASIL (lot #, dose and route not provided) on 02-SEP-2008, a second dose GARDASIL (lot #, dose and route not provided) on 12-APR-2011 and a GARDASIL on 29-MAY-2012 (lot # 671006/1291AA) (dose and route not provided). Concomitant therapies included prenatal vitamins daily (manufacturer unknown), iron and calcium. The patient became pregnant with EDD of 18-JUL-2012. The date of last menstrual period was 10-OCT-2011. On 01-MAR-2012 an ultrasound was performed to confirm gestation which showed viable intrauterine gestation, transverse lie. On an unknown date, the patient experienced anemia. At the time of reporting, the patient's pregnancy outcome was unknown. At the time of the report, the outcome of anemia was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Additional information is not expected.
Age: 48.0
Sex: M
Vaccine: FLU4
Symptoms: Alopecia
Clinical narrative: Patient reported that he started experience alopecia after his flu shot.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site necrosis
Clinical narrative: About 2 wks after getting IM flu injection noticed a dark purplish indentation at injection site about 1 1/2" in diameter and 1/4" deep. Saw primary care doctor who said it was a fat necrosis (on Nov. 4th). Site still looks the same - has seen no improvement - denies pain.
Age: 92.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Erythema, Feeling abnormal, Pain
Clinical narrative: Redness, pain, likely bruising left arm all the way to wrist.  Felt poorly.
Age: 66.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Local swelling, Pruritus, Skin warm
Clinical narrative: Arm hot to the touch. It was itchy and swollen. Patient went to clinic to seek treatment. She received Steroid shot and dose pack and a antibiotic.
Age: 8.0
Sex: F
Vaccine: FLUN4
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 43.0
Sex: F
Vaccine: DTAP
Symptoms: Asthenia, Fatigue, Joint swelling, Local swelling, Pain
Clinical narrative: PAIN, SORENESS, SWELLING IN ARM AND SHOULDER, BODY ACHES, TIREDNESS, WEAKNESS.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Fever and chills, redness and swelling left upper arm down to elbow.
Age: 1.45
Sex: F
Vaccine: DTAP
Symptoms: Nodule, Pain
Clinical narrative: My daughter is now 22 months. I noticed a knot the day after her immunizations in her leg. It eventually went down some. It's approx. 4 months later and there is a marble sized knot on her upper thigh. She says it hurts when we apply pressure to it.
Age: 69.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Lacrimation increased, Tremor
Clinical narrative: Extreme chills, headache, runny eyes.  Uncontrollable shaking for 4 hours (until 2 am 12/18/13).  Had an electric blanket turned on to 9 for 4 hours.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Postural orthostatic tachycardia syndrome
Clinical narrative: POTS SYNDROME- POSTURAL TACHYCARDIA 3 HRS AFTER THE VACCINE. EMPLOYEE HAD TO GO TO THE ER.
Age: 13.0
Sex: M
Vaccine: FLUN4, HPV4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient receieved Gardasil and FluMist vaccines in offices.  Patient fainted approx. 15 mins. afterwards. Regained consciousness within a few seconds.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Constipation, Hypoaesthesia, Musculoskeletal pain, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient had a sharp pain and tightness across her shoulder and arm that was the opposite arm of her flu shot.  She also had complete paralysis from the waist down for approximately 3 hours.  She also had numbness that resonated from her waist down that still comes and goes.  She was constipated and could not urinate for about 24 hours even though she felt she needed to. She consulted her accupuncturist because she thought it could be gall stones and she has had them in the past.  That doctor told her to go see us and have us report the event.  She is going to see a neurologist in the end of January because that is the earliest she could get seen.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Paraplegia, Urine output decreased
Clinical narrative: Patient had a sharp pain and tightness across her shoulder and arm that was the opposite arm of her flu shot.  She also had complete paralysis from the waist down for approximately 3 hours.  She also had numbness that resonated from her waist down that still comes and goes.  She was constipated and could not urinate for about 24 hours even though she felt she needed to. She consulted her accupuncturist because she thought it could be gall stones and she has had them in the past.  That doctor told her to go see us and have us report the event.  She is going to see a neurologist in the end of January because that is the earliest she could get seen.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Arthralgia, Blood test, Chest pain, Disturbance in attention
Clinical narrative: Migraine, insomnia, chronic fatigue, muscle pain, dizziness, nausea, chest pain, heart palpitation, shortness of breath, joint pain, tingling, fainting, cycle changes, low blood pressure, vomiting, lack of concentration. Have been to GP, neurologists, cardiologists. Hasn't been to school in 3 months now.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Dyspnoea, Echocardiogram, Electrocardiogram, Electroencephalogram
Clinical narrative: Migraine, insomnia, chronic fatigue, muscle pain, dizziness, nausea, chest pain, heart palpitation, shortness of breath, joint pain, tingling, fainting, cycle changes, low blood pressure, vomiting, lack of concentration. Have been to GP, neurologists, cardiologists. Hasn't been to school in 3 months now.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Hypotension, Insomnia, Menstrual disorder, Migraine
Clinical narrative: Migraine, insomnia, chronic fatigue, muscle pain, dizziness, nausea, chest pain, heart palpitation, shortness of breath, joint pain, tingling, fainting, cycle changes, low blood pressure, vomiting, lack of concentration. Have been to GP, neurologists, cardiologists. Hasn't been to school in 3 months now.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Myalgia, Nausea, Palpitations, Paraesthesia, Syncope
Clinical narrative: Migraine, insomnia, chronic fatigue, muscle pain, dizziness, nausea, chest pain, heart palpitation, shortness of breath, joint pain, tingling, fainting, cycle changes, low blood pressure, vomiting, lack of concentration. Have been to GP, neurologists, cardiologists. Hasn't been to school in 3 months now.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Migraine, insomnia, chronic fatigue, muscle pain, dizziness, nausea, chest pain, heart palpitation, shortness of breath, joint pain, tingling, fainting, cycle changes, low blood pressure, vomiting, lack of concentration. Have been to GP, neurologists, cardiologists. Hasn't been to school in 3 months now.
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Blood test, Exposure during pregnancy, Pregnancy test positive, Ultrasound scan, Vaginal haemorrhage
Clinical narrative: Since 10/14/2013 to 11/20/13 I had stopped taking NuvaRing due to the symptoms, and everything was not adding up. 11/16/2013 I decided to take a at home pregnancy test and results took less than a min, Positive. I was worried! I still had been bleeding all this time. Reason why I stopped NuvRing and if on 10/14/2013 they took a test and it was negative, then how was I pregnant. Made a doctors apt 11/20/13.11/20/2013 @ approx 11AM that I found out I was 9 weeks pregnant. Why was I a
Age: 24.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Since 10/14/2013 to 11/20/13 I had stopped taking NuvaRing due to the symptoms, and everything was not adding up. 11/16/2013 I decided to take a at home pregnancy test and results took less than a min, Positive. I was worried! I still had been bleeding all this time. Reason why I stopped NuvRing and if on 10/14/2013 they took a test and it was negative, then how was I pregnant. Made a doctors apt 11/20/13.11/20/2013 @ approx 11AM that I found out I was 9 weeks pregnant. Why was I a
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Redness and swelling of upper arm around injection site and nausea and felt light headed.
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Activities of daily living impaired, Diarrhoea, Fatigue, Headache, Lumbar puncture abnormal
Clinical narrative: Day # 5 of illness that started immediately on return from a trip, where he collected air samples for his grad program. Initially he had diarrhea and fever of 101, started Cipro and on day 3 diarrhea improved but he had fever to 102. Yesterday, day 4 he stopped the diarrhea but this AM was so exhausted he couldn't get out of bed, had a fever or 101 and a severe 8/10 headache and a stiff neck. He was sent to ER on the same day of 11/22/2013 and admitted to hospital and discharged on  11/24/2013. Rx of Aspec meningitis, LP sample sent to CDC and compatible.  He has been completely recovered.
Age: 26.0
Sex: M
Vaccine: YF
Symptoms: Meningitis aseptic, Musculoskeletal stiffness, Pyrexia
Clinical narrative: Day # 5 of illness that started immediately on return from a trip, where he collected air samples for his grad program. Initially he had diarrhea and fever of 101, started Cipro and on day 3 diarrhea improved but he had fever to 102. Yesterday, day 4 he stopped the diarrhea but this AM was so exhausted he couldn't get out of bed, had a fever or 101 and a severe 8/10 headache and a stiff neck. He was sent to ER on the same day of 11/22/2013 and admitted to hospital and discharged on  11/24/2013. Rx of Aspec meningitis, LP sample sent to CDC and compatible.  He has been completely recovered.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Cardiac monitoring normal, Cardiac stress test normal, Computerised tomogram normal, Convulsion, Electrocardiogram normal
Clinical narrative: Syncope, muscle pain, daily seizures, paralysis, muscle twitching. Tests normal (video EEG, MRI, CT scan, X-rays, tilt table test, heart monitors, EKG, stress test, pulmonary function test).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Electroencephalogram normal, Muscle twitching, Myalgia, Nuclear magnetic resonance imaging normal, Paralysis
Clinical narrative: Syncope, muscle pain, daily seizures, paralysis, muscle twitching. Tests normal (video EEG, MRI, CT scan, X-rays, tilt table test, heart monitors, EKG, stress test, pulmonary function test).
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pulmonary function test normal, Syncope, Tilt table test normal, X-ray normal
Clinical narrative: Syncope, muscle pain, daily seizures, paralysis, muscle twitching. Tests normal (video EEG, MRI, CT scan, X-rays, tilt table test, heart monitors, EKG, stress test, pulmonary function test).
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discomfort, Injection site movement impairment, Injection site pain
Clinical narrative: Complains of right shoulder pain with ongoing discomfort and difficulty with range of motion since receiving flu vaccine.
Age: 14.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Local reaction, Skin lesion
Clinical narrative: Local reaction inj. site - raised erythematous lesion 10 x 11 cm.
Age: 76.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Abdominal discomfort, Choking, Cough, Cyanosis, Wheezing
Clinical narrative: Received phone call from patient's daughter on 10/01/13 around 3:30 pm (day after injections). Stated patient had same side effects that started shortly after injections. She was choking, wheezing, cough, upset stomach, fingernails turned blue. These lasted well into the night but was beginning to feel better. I asked her if she needed medical care (emergency room or her personal physician). She indicated that patient didn't think she needed medical attn. I called Dr, her personal physician and reported the incident.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Pt seen in ED 10/24/13 x 2 day after vaccine received. Tenderness, redness, warmth and swelling noted surrounding vaccine site. Flu like symptoms. Treated with antibiotics, antihistamine, analgesic
Age: 65.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Headache, Pain of skin, Pyrexia, Tremor
Clinical narrative: Fever >103 degrees F, shaking, severe headache, skin hurting. Approximately 1 hr after receiving vaccine. Pt took acetaminophen to reduce fever.
Age: 50.0
Sex: F
Vaccine: TYP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: Client given oral Typhoid 12/3/13 4 caps. Client took the last capsule 12/10/13 looked at the box which stated exp date Nov 2013. Brought back the box and CDC was called and Dr. recommending to give 2nd dose. No adverse reactions noted by client. No GI upset N/V or diarrhea noted. F/U call 12/12/13 and pt stated she was fine. To take last oral capsule 12/18/13.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Local reaction, Pruritus, Skin warm
Clinical narrative: Pt called states she had a localized reaction, whole upper arm turned bright red and skin was hot. Lasted a few days. Itching. Pt fine now.
Age: 0.31
Sex: U
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Wheezing, Wrong drug administered
Clinical narrative: Wheezing. FLUMIST given instead of injectable Flu vaccine.
Age: 16.0
Sex: U
Vaccine: MMRV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered nurse refers to a 16 year old patient of unknown gender. On 23-SEp-2013 the patient was vaccinated with a first dose of PROQUAD (route, lot number and expiration date not reported) for vaccination and then received a second dose of PROQUAD (Merck) (route, lot number and expiration date not reported) for vaccination. There was no concomitant medication reported. It was reported that there was not product confusion, just a medication error. No Adverse event reported. Additional information is not expected.
Age: 44.0
Sex: F
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a 44 year old female patient, reporting on herself. On unknown dates the patient received doses 1 and 2 of GARDASIL (route, dosage and lot number unknown). On 20-DEC-2013 the patient was scheduled to receive her third dose of GARDASIL (route, dosage and lot number unknown). Her age is other than indicated in the prescribing information for this vaccine. No side effects have been reported. Additional information is not expected.
Age: 0.51
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: Approximately 2 minutes after receiving vaccinations, pt began with swelling and darkening of bilateral legs. Father was holding the pt at the time, pt was calm, no crying, and in no acute distress. Upon noticing the reaction, the Band-Aids were removed and the pt's diaper was taken off. Warm pads were applied to the area and color began to return to normal on the legs. Bilateral inguinal and brachial pulses were strong and equal. Pt was observed for 15 minutes and remained stable, with vital signs normal and return of normal color and no further swelling of the legs. Pt was sent home with instructions to observe the area.
Sex: M
Vaccine: DTAPIPV, FLU3
Symptoms: Amniocentesis normal, Exposure during pregnancy, Foetal disorder, Ultrasound antenatal screen normal
Clinical narrative: This case was reported by a consumer (subject's mother) and described the occurrence of increased fetal movement in a foetus subject of unspecified gender who was exposed to KINRIX (GlaxoSmithKline), FLUARIX. A physician or other health care professional has not verified this report. On 22 November 2013 the 29-year-old mother of the patient received a dose of KINRIX (transplacentary), a dose of influenza (transplacentary). The mother's last menstrual period was not reported. The estimated date of delivery was reported as 26 January 2014. The neonate was exposed to KINRIX and influenza approximately 30 weeks (calculated) during the 3rd trimester. Prenatal diagnostic tests included amniocentesis with normal results. Prenatal diagnostic tests also included ultrasound examinations on 28 June 2013, 16 August 2013, and 4 September 2013 with no evidence of defect from prenatal testing. On 22 November 2013, less than one day after vaccination with influenza and KINRIX, the neonate experienced increased fetal movement, drug exposure in utero. At the time of reporting, the outcome of the event was resolved per the mother.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Asthenia, Back pain, Blood product transfusion, Blood test
Clinical narrative: Case number PHHY2013US116560 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 498562) website on 15 Oct 2013 with a follow-up received on 16 Dec 2013. This report refers to a 52-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN  (batch number: 1206401) intramuscularly on 17 Jan 2013. On 15 Feb 2013, he experienced paralysis in legs and face, prolonged numbness in hands, weakness, soreness in back and hips and legs. He had plasma replacement and underwent some physical therapy. He underwent nerve conduction test, blood test and lumbar puncture (results not disclosed). He was hospitalized for 11 days following these events. Outcome of the events was reported as not recovered as of 01 Jul 2013. No causality assessment was reported for the events. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498562) website on 16 Dec 2013: Updated information about trade name of suspect influenza vaccine as FLUVIRIN along with route of administration and updated information about seriousness assessment by the reporter as hospitalization.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Diplegia, Hypoaesthesia, Lumbar puncture, Nerve conduction studies, Pain in extremity
Clinical narrative: Case number PHHY2013US116560 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 498562) website on 15 Oct 2013 with a follow-up received on 16 Dec 2013. This report refers to a 52-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN  (batch number: 1206401) intramuscularly on 17 Jan 2013. On 15 Feb 2013, he experienced paralysis in legs and face, prolonged numbness in hands, weakness, soreness in back and hips and legs. He had plasma replacement and underwent some physical therapy. He underwent nerve conduction test, blood test and lumbar puncture (results not disclosed). He was hospitalized for 11 days following these events. Outcome of the events was reported as not recovered as of 01 Jul 2013. No causality assessment was reported for the events. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498562) website on 16 Dec 2013: Updated information about trade name of suspect influenza vaccine as FLUVIRIN along with route of administration and updated information about seriousness assessment by the reporter as hospitalization.
Age: 52.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: VIIth nerve paralysis
Clinical narrative: Case number PHHY2013US116560 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 498562) website on 15 Oct 2013 with a follow-up received on 16 Dec 2013. This report refers to a 52-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN  (batch number: 1206401) intramuscularly on 17 Jan 2013. On 15 Feb 2013, he experienced paralysis in legs and face, prolonged numbness in hands, weakness, soreness in back and hips and legs. He had plasma replacement and underwent some physical therapy. He underwent nerve conduction test, blood test and lumbar puncture (results not disclosed). He was hospitalized for 11 days following these events. Outcome of the events was reported as not recovered as of 01 Jul 2013. No causality assessment was reported for the events. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 498562) website on 16 Dec 2013: Updated information about trade name of suspect influenza vaccine as FLUVIRIN along with route of administration and updated information about seriousness assessment by the reporter as hospitalization.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Balance disorder, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy, Neck pain
Clinical narrative: Case number PHHY2013US135476 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 53-year-old male patient. The medical history of the patient included Penicillin allergy and concomitant medication included fenofibrate and diazepam. The patient was vaccinated with FLUVIRIN (batch number: 1203301) intramuscularly in to the left arm on 18 Dec 2012. On 04 Mar 2013, the patient was diagnosed with Guillain-Barre Syndrome, and paralysis. The patient went to emergency room and received immunoglobulin treatment for these events. Stamina was recovered in about two months with this therapy, but lower neck pain and balance disorder was still unrecovered. Patient had constant pain in feet, could not walk as well and had balance off. Outcome of the events was reported as not recovered. Reporter assessed the case as serious (life threatening and permanent disability). No causality was reported for the events. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 16 Dec 2013: Updated patient demographics and trade name of suspect influenza vaccine as FLUVIRIN along with site and route of administration.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Paralysis, X-ray
Clinical narrative: Case number PHHY2013US135476 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 53-year-old male patient. The medical history of the patient included Penicillin allergy and concomitant medication included fenofibrate and diazepam. The patient was vaccinated with FLUVIRIN (batch number: 1203301) intramuscularly in to the left arm on 18 Dec 2012. On 04 Mar 2013, the patient was diagnosed with Guillain-Barre Syndrome, and paralysis. The patient went to emergency room and received immunoglobulin treatment for these events. Stamina was recovered in about two months with this therapy, but lower neck pain and balance disorder was still unrecovered. Patient had constant pain in feet, could not walk as well and had balance off. Outcome of the events was reported as not recovered. Reporter assessed the case as serious (life threatening and permanent disability). No causality was reported for the events. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 16 Dec 2013: Updated patient demographics and trade name of suspect influenza vaccine as FLUVIRIN along with site and route of administration.
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity, Paralysis
Clinical narrative: Case number PHHY2013US135476 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 25 Nov 2013 with a follow-up received on 16 Dec 2013. This report refers to a 53-year-old male patient. The medical history of the patient included Penicillin allergy and concomitant medication included fenofibrate and diazepam. The patient was vaccinated with FLUVIRIN (batch number: 1203301) intramuscularly in to the left arm on 18 Dec 2012. On 04 Mar 2013, the patient was diagnosed with Guillain-Barre Syndrome, and paralysis. The patient went to emergency room and received immunoglobulin treatment for these events. Stamina was recovered in about two months with this therapy, but lower neck pain and balance disorder was still unrecovered. Patient had constant pain in feet, could not walk as well and had balance off. Outcome of the events was reported as not recovered. Reporter assessed the case as serious (life threatening and permanent disability). No causality was reported for the events. Follow-up received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502015) website on 16 Dec 2013: Updated patient demographics and trade name of suspect influenza vaccine as FLUVIRIN along with site and route of administration.