chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple patients (demographics unknown). The patients pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of ROTATEQ (Lot # L035510, expiration date: 13-MAU-2017) oral. The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34.2 F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via company representative refers to a patient of unknown age and gender. The patient pertinent medical history and drug allergies/reactions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength 19400 PFU) (dosing details, anatomical location, lot# and expiry date unknown). On an unknown date approximately in 2014 (reported as about 2 years ago) the patient developed shingles after receiving the vaccination. The outcome of the event was unknown. The reporter did not provide the relatedness of the event with ZOSTAVAX. No VZVID pack was sent as the administering healthcare provider was unknown. No product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Human papilloma virus test positive, Papilloma viral infection, Smear cervix abnormal
Clinical narrative: This literature marketed report was received from the authors of a published literature article, concerning 22 female patients who had a positive high-risk human papillomavirus (HR HPV) result after vaccination with GARDASIL injection (dates of vaccination, dose, route of administration, lot# and expiry date were not reported). Data was collected on a series of 297 consecutive women with HPV immunization. The following parameters were gathered: age, date(s) of immunization(s), type(s) of vaccine, cytology results, and surgical biopsy results, if available. The presence of pre-vaccination HPV infection was also noted wherever possible. Specimens with abnormal cytologic results (as defined by an abnormal Papanicolaou smear result, including atypical cells of undetermined significance (ASCUS) with a positive reflex high-risk HPV) subsequently underwent molecular screening of high-risk HPV (HR HPV). All samples were then reflexed to the line probe assay for specific genotyping. Of the 297 women, 27 patients (9.1%) had an abnormal cytological result. Two specimens had insufficient material remaining for molecular testing, and one specimen failed to run due to excessive clotting. Of the remaining 24 specimens, 21 (87.5%) showed a positive HR HPV result on initial screening. Twenty-three samples were then successfully genotyped. The frequencies for the genotypes covered by HPV vaccination (HPV types 16, 18, 6 and 11) were 17.4%, 4.3%, 4.3% and 0%, respectively. Of note, one patient with HPV 18 infection had received an incomplete vaccination series, and one of the patients with HPV 16 had definite pre-existing cervical dysplasia before immunization. The most common HR HPV genotypes were HPV 39, 59 and 66 (17.4% each). The average number of HPV strains per patient was 2.6. The authors concluded that immunized women were not exempt from HR HPV infection and although their data supported the efficacy GARDASIL against HPV 16 and 18 infection, the current vaccination scheme offered only limited protection against cervical cancer. The outcome of the event was not reported. The authors considered the event of HPV infection in HPV-vaccinated women to be related to the vaccination with GARDASIL. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza, Vaccination failure
Clinical narrative: Initial unsolicited report received from a consumer on 25 March 2016. This case is linked with case 2016SA064185. This case involves a male patient who was vaccinated with a dose of INFLUENZA VACCINE (Flu vaccine) (batch number, expiry date, dose, dose number, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unspecified date, following vaccination, the patient experienced flu. It was also the case for vaccination failure. Lab data and corrective treatments were not reported. The outcome of flu was not reported. It was unknown at the time of vaccination whether the patient developed any adverse event or not. List of documents held by sender: none. Sender's Comments: This is a very poorly documented case of Flu. The date of administration of the Influenza vaccine and start date and stop date of the event Flu was not reported. Additional information regarding the medical confirmation of the case, concomitant medication, concurrent conditions, if any, relevant medical history and investigation results, if any are needed for complete assessment of the case. Due to the limited information provided the temporal association cannot be established and causality for suspected vaccine failure cannot be assessed for now.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and unknown gender. No pertinent medical history and drug reactions/allergies were reported. On 25-MAR-2016, the patient was inadvertently vaccinated with an expired dose of ZOSTAVAX (strength, dose and frequency were not reported) (lot # L029480, expiry date: 16-MAR-2016). No adverse effects reported. No product quality complaint (PQC) was involved. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 23 year old female patient. On an unknown date in 2009, the patient was vaccinated with her first dose of GARDASIL. On 21-MAR-2016 (reported as today), the patient will get her second dose of GARDASIL 9. No adverse effects were reported. No product quality complaints (PQC) was involved. Additional information is not expected as the reporter did not wish further contact.
Age: 81.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a physician via a field representative referring to an 81 year old male patient. There was no medical history or drug reaction/allergies reported. A month ago, in February 2016, the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml, subcutaneous, lot # and expired date were unknown). No concomitant therapy was reported. After administration, on an unknown date in 2016, the patient developed shingles. The patient visited the physician for medical attention. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Age: 0.41
Sex: M
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Vomited for 10 days. No diarrhea. No fever. No other problems. Pedialyte given.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling
Clinical narrative: 2 days after vaccination of TRUMENBA, teen told someone his arm was red and slightly swollen. It improved with ice and ZYRTEC. 48 hrs later swelling resolved.
Age: 1.29
Sex: F
Vaccine: DTAP, HEP, HIBV, PNC13
Symptoms: Febrile convulsion
Clinical narrative: 3/23/16: Per parent - child was seen at E.R. following "febrile seizure".
Age: 72.0
Sex: U
Vaccine: PNC13
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Awoke night of vaccination with severe trembling for 1-2 minutes. Next I had body aches all over. Severe pain at site of shot - unable to sleep well. Tiredness, chills, headache.
Age: 72.0
Sex: U
Vaccine: PNC13
Symptoms: Poor quality sleep, Tremor
Clinical narrative: Awoke night of vaccination with severe trembling for 1-2 minutes. Next I had body aches all over. Severe pain at site of shot - unable to sleep well. Tiredness, chills, headache.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: Cellulitis of left upper extremity.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Dyspnoea
Clinical narrative: Severe issue of breathing. Using asthma medications seems to help.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Cardiac arrest
Clinical narrative: Cardiac arrest.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Bronchoscopy normal, Computerised tomogram normal, Crying, Dyspnoea, Endoscopy normal
Clinical narrative: My son rather than cry he whimpered and his body went limp after receiving the rotavirus, PREVNAR and DTaP. When is was putting on his clothes he was still limp and was having trouble breathing. When I sat him up to get the doctor he vomited streaky blood in the vomit and stopped breathing. The doctor bagged him once and he started breathing again. The pressure from the bag caused him to have a pneumothorax and he received two chest tubes because they did not put the first chest tube in far enough. He was hospitalized for a week for more testing. They did an endoscopy and bronchoscopy which were negative. After being released he went to the allergy clinic to receive his vaccines to rule out what may have caused the reaction. They gave each vaccine individually without giving him the pertussis which is what they think is why he had the reaction.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Haematemesis, Hypotonia, Pneumothorax, Respiratory arrest, Thoracostomy
Clinical narrative: My son rather than cry he whimpered and his body went limp after receiving the rotavirus, PREVNAR and DTaP. When is was putting on his clothes he was still limp and was having trouble breathing. When I sat him up to get the doctor he vomited streaky blood in the vomit and stopped breathing. The doctor bagged him once and he started breathing again. The pressure from the bag caused him to have a pneumothorax and he received two chest tubes because they did not put the first chest tube in far enough. He was hospitalized for a week for more testing. They did an endoscopy and bronchoscopy which were negative. After being released he went to the allergy clinic to receive his vaccines to rule out what may have caused the reaction. They gave each vaccine individually without giving him the pertussis which is what they think is why he had the reaction.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: X-ray normal
Clinical narrative: My son rather than cry he whimpered and his body went limp after receiving the rotavirus, PREVNAR and DTaP. When is was putting on his clothes he was still limp and was having trouble breathing. When I sat him up to get the doctor he vomited streaky blood in the vomit and stopped breathing. The doctor bagged him once and he started breathing again. The pressure from the bag caused him to have a pneumothorax and he received two chest tubes because they did not put the first chest tube in far enough. He was hospitalized for a week for more testing. They did an endoscopy and bronchoscopy which were negative. After being released he went to the allergy clinic to receive his vaccines to rule out what may have caused the reaction. They gave each vaccine individually without giving him the pertussis which is what they think is why he had the reaction.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Depressed mood, Rash, Urticaria, Viral infection
Clinical narrative: Rash started on tops of hands and feet and one cheek, no fever, unhappy.  Patient given Tylenol. Mom sent picture of "rash" at 4:29 PM, rash looks likes hives.  Dr. spoke with mom.  Patient was sent to ED, they felt like it was not from the vaccines and was a viral rash.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Patient say since received FLUZONE HD vaccine on 11/9/15 she is having problem with sore arm. States loss of strength in arm that has increased in last 2 months.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Peripheral swelling
Clinical narrative: Pt called 6 days after administration complaining of swelling in arm. Golf ball size swelling at injection site.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Injection site pain, Musculoskeletal pain, Pain in extremity, X-ray
Clinical narrative: From initial injection very painful. Persisted ever since. Spread to entire arm and into shoulder and back. Impaired movement of arm to reduced ability to adjust clothing and put on coat.
Age: 18.0
Sex: F
Vaccine: IPV, TDAP
Symptoms: Erythema, Rash macular, Swelling face
Clinical narrative: Pt. received IPV and TDAP vaccines on 3/28/16 at 1:30 pm. Pt. states at approx 2:30 pm her face became red, blotchy and swollen. She denied any diff. swallowing or breathing. She states she did not seek medical care because she had classes. She states all symptoms were gone within 24 hrs.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On 09-FEB-2016, the patient was vaccinated with improperly stored ROTATEQ (lot # L008966, expiry date: 01-DEC-2016). The vaccine underwent a temperature excursion of 28 degrees Fahrenheit for a duration of 2 hours. No adverse effect was reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Oropharyngeal pain, Swelling, Upper-airway cough syndrome
Clinical narrative: Redness, swelling, sore throat, postnasal drip, diarrhea.
Age: 10.0
Sex: M
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Axillary pain, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Left arm (over deltoid) mild swelling, erythema (12 cm) and itching with mild warmth. Also has left axillary pain/tenderness.
Age: 10.0
Sex: M
Vaccine: HEPA, IPV, MMRV, TDAP
Symptoms: Tenderness
Clinical narrative: Left arm (over deltoid) mild swelling, erythema (12 cm) and itching with mild warmth. Also has left axillary pain/tenderness.
Age: 1.94
Sex: M
Vaccine: MMR
Symptoms: Arthralgia, Malaise, Pyrexia
Clinical narrative: Fevers, malaise and persistent joint pain in hands, knees and ankles.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant concerning multiple unspecified patients (demographics). The patient's pertinent medical history and concurrent conditions were not provided. On multiple unspecified dates, the patients were administered improperly stored doses of VAQTA (Lot # L023232; expiration date: 25-FEB-2017) (route not provided). The patients' concomitant medications were not provided. No adverse effects were reported. It was reported the following temperature excursion for the administered vaccines: 34.2 degrees F for 9 days (216 hours). No previous temperature excursion was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 25.0
Sex: F
Vaccine: FLU3, TDAP, VARCEL
Symptoms: Peripheral swelling
Clinical narrative: Pt states after getting the VARIVAX #2 and BOOSTRIX her LEFT arm had severe swelling. Pt states the swelling has decreased and has not effected her way of life.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ, RV1
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No known adverse reaction.
Age: 19.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pt received Trumenba vaccine on Saturday - that night noted redness to the area. Today co increased erythema, pruritis, and tenderness. No increase in size. No fevers, pain, cough, sob, vomiting. Good appetite.  Feeding well with good urine output.  Active, happy, sleeping well.
Age: 54.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Pyrexia, Rash, Rash morbilliform
Clinical narrative: Fever developed and peaked after 36 hours. Arthralgias presented on day 2 with peak fever of 104 by history. Rash developed on Day 3. Fever resolved by day four, rash persisted on day 4- morbiliform chest, back, sparing neck, face, extremities.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Irritability, Screaming
Clinical narrative: Fussiness/screaming in the evenings.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Computerised tomogram head, Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Patient fainted seconds after administration of Tdap, MCV4, and HPV vaccine. Patient fell and hit right side of head on floor. She lost consciousness for about 30 seconds and also lost bladder control. There was no vomiting. Checked vitals of patient which were normal. Observed patient in clinic for 45 minutes then she was sent to ER for further monitoring.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urinary incontinence
Clinical narrative: Patient fainted seconds after administration of Tdap, MCV4, and HPV vaccine. Patient fell and hit right side of head on floor. She lost consciousness for about 30 seconds and also lost bladder control. There was no vomiting. Checked vitals of patient which were normal. Observed patient in clinic for 45 minutes then she was sent to ER for further monitoring.
Age: 10.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth
Clinical narrative: Pt checking out of office notified staff had rash at injection site and was itchy. Rash slightly warm to touch, flat lacey pattern noted. Dr notified and assessed. VSS, no difficulty breathing. Rash fading at time leaving.
Age: 62.0
Sex: F
Vaccine: FLUC3
Symptoms: Arthralgia, Joint stiffness, Musculoskeletal pain, Musculoskeletal stiffness, Polymyalgia rheumatica
Clinical narrative: About 2 to 3 weeks after taking the flu shot I start having pain in my left hip but at the time I didn't think it had anything to do with the flu shot. I would take 2 ALEVE and it would stop the pain but then I started to have pain and stiffness in my left shoulder, my right shoulder and knee. I told Dr. about the pain and stiffness he suggested over the counter Ibuprofen and Arthritis pain pills. When I went back to the doctor on Jan. 25 of this year with joint pain and stiffness still in my left shoulder, right shoulder, right knee and both of my hands Dr. diagnosed me with polymyalgia rheumatica. He never said the flu shot was the cause because I didn't get the vaccine at his office. But I noticed that I did not have these symptoms until after the vaccines. This condition is causing me to toss and turn all night because of the shoulder pain.
Age: 53.0
Sex: U
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: 11-21-15 she put the needle in my shoulder joint, I told her it hurt and she said it would for a couple days. I called her two weeks later and told her I cannot left my arm over my head or out in front of me. She told me to go to the doctor.
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Heart rate increased, Hypoaesthesia, Myalgia, Pyrexia
Clinical narrative: Fever 102, fast heart rate, muscle pain, pain L elbow, numbness L little and ring fingers.  All symptoms were resolved when she got up Sat. morning 4/2/16.
Age: 10.0
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Bruxism, Confusional state, Eye movement disorder, Hypotonia, Loss of consciousness
Clinical narrative: After administration patient said arm was hurting and at that point eyes rolled up and clenched his mandible, then he lost tone of his body. Patient was unconscious for about 2 minutes then confusion for about 10 minutes.
Age: 10.0
Sex: M
Vaccine: HEPA, IPV, VARCEL
Symptoms: Pain in extremity
Clinical narrative: After administration patient said arm was hurting and at that point eyes rolled up and clenched his mandible, then he lost tone of his body. Patient was unconscious for about 2 minutes then confusion for about 10 minutes.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Sleep disorder
Clinical narrative: Vaccine area turned red and swelling occurred. Painful to touch and painful when lifting arm - could not sleep on the arm. Red area spread from shoulder, down and around bicep area. As of today, 4/04/16 2:30 pm area still red.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Vaccine area turned red and swelling occurred. Painful to touch and painful when lifting arm - could not sleep on the arm. Red area spread from shoulder, down and around bicep area. As of today, 4/04/16 2:30 pm area still red.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain, Sleep disorder
Clinical narrative: Pain, redness, itching.
Age: 66.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Pain, Pruritus
Clinical narrative: Pain, redness, itching.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity, Peripheral swelling, Upper extremity mass
Clinical narrative: Patient had first Gardasil, and arm still has a persistent swelling/lump, and is still sore.  Does not look like an infection.
Age: 1.01
Sex: M
Vaccine: MMR, PNC13, VARCEL
Symptoms: Injection site urticaria
Clinical narrative: Hive at injection site on right upper thigh with Varivax. Gave 3/4 teaspoon of 12.5 Diphenhydramine at 2:45 PM.
Age: 28.0
Sex: F
Vaccine: FLU3, MENB
Symptoms: Blindness, Blood test, Multiple sclerosis, Nuclear magnetic resonance imaging
Clinical narrative: I woke up blind in both eyes. My sight slowly came back over the next few weeks. I went to an ophthalmologist, who sent me to a neuro ophthalmologist, who sent me for MRI scans and was then send to a neurologist. I went to a second neurologist who after many, many tests diagnosed me with MS.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Cognitive disorder, Dizziness, Ear discomfort, Electroencephalogram normal
Clinical narrative: Flu like symptoms for 24 hours after vaccine, within weeks following frequent headaches, dizzy spells, ear pressure, tinnitus. Referral to ENT appointment in Dec. Second vaccine dose in November of 2014. Flu like symptoms again following vaccine. Frequency of headaches, dizzy spells ear complaints increased. See ENT in Dec. Diagnosis of Meneire's Disease bilateral. Refered to a Neurologist specializing in balance and vestibular conditions. Diagnosed with vestibular migraines. [February 2015]. New symptoms continue to pop up extreme exhaustion, muscle aches and weakness and joint pain. Diet changes do not help initial symptoms. Amitriptyline is prescribed for migraines. In May removed from amitriptoline because of possible absent seizure activity. EEG is normal but Topamax prescribed. Dose is increased in July to 50mg at bedtime. Cognitive issues ensue and all symptoms are still present. Dose is dropped to 37.5 all symptoms still present.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Fatigue, Headache, Influenza like illness, Meniere's disease, Migraine
Clinical narrative: Flu like symptoms for 24 hours after vaccine, within weeks following frequent headaches, dizzy spells, ear pressure, tinnitus. Referral to ENT appointment in Dec. Second vaccine dose in November of 2014. Flu like symptoms again following vaccine. Frequency of headaches, dizzy spells ear complaints increased. See ENT in Dec. Diagnosis of Meneire's Disease bilateral. Refered to a Neurologist specializing in balance and vestibular conditions. Diagnosed with vestibular migraines. [February 2015]. New symptoms continue to pop up extreme exhaustion, muscle aches and weakness and joint pain. Diet changes do not help initial symptoms. Amitriptyline is prescribed for migraines. In May removed from amitriptoline because of possible absent seizure activity. EEG is normal but Topamax prescribed. Dose is increased in July to 50mg at bedtime. Cognitive issues ensue and all symptoms are still present. Dose is dropped to 37.5 all symptoms still present.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness, Myalgia, Tinnitus
Clinical narrative: Flu like symptoms for 24 hours after vaccine, within weeks following frequent headaches, dizzy spells, ear pressure, tinnitus. Referral to ENT appointment in Dec. Second vaccine dose in November of 2014. Flu like symptoms again following vaccine. Frequency of headaches, dizzy spells ear complaints increased. See ENT in Dec. Diagnosis of Meneire's Disease bilateral. Refered to a Neurologist specializing in balance and vestibular conditions. Diagnosed with vestibular migraines. [February 2015]. New symptoms continue to pop up extreme exhaustion, muscle aches and weakness and joint pain. Diet changes do not help initial symptoms. Amitriptyline is prescribed for migraines. In May removed from amitriptoline because of possible absent seizure activity. EEG is normal but Topamax prescribed. Dose is increased in July to 50mg at bedtime. Cognitive issues ensue and all symptoms are still present. Dose is dropped to 37.5 all symptoms still present.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: SMALL AMOUNT OF HEAT FELT ON RIGHT DELTOID INJECTION SITE. COLD COMPRESS PLACED. 2 MIN LATER NOTICED REDNESS AND HEAT AT THE LEFT DELTOID FRONT INJECTION SITE. COLD COMPRESS PLACED.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: IMMUNIZATION GIVEN AT 6PM ON 3/29, PT WAS WARNED OF POSSIBLE RASH. PT NOTICED RASH ON 3/30/16 AND STATES THAT IT PROGRESSED THROUGHOUT THE DAY. NEW RX CALLED IN FOR ACYCLOVIR ON 4/4/16 AND PICKED UP IN THE EVENING OF 4/4/16.
Age: 13.0
Sex: M
Vaccine: HEPA, HPV9
Symptoms: Injection site erythema, Injection site mass, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: On rt arm pt. received GARDASIL 9 on Wed. 3-30-16. On Thurs. 3-31-16 his rt arm began to turn red and swollen at injection site. Then developed a lump. Was also itchy and painful when lifting. On Fri 4-1-16 was no longer red and swelling was decreased.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On 30-MAR-2016 the patient was vaccinated with a dose of expired RECOMBIVAX HB (dose, unit and route not reported, lot # K019502 with EXP. date 04-FEB-2016, also reported as 04-FEB-2015). No adverse effect was reported. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Injection site swollen to elbow, redness, warm to the touch and hardened tissue under skin.
Age: 1.0
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash erythematous
Clinical narrative: Child received vaccines on Wed mar 23, 2016 in the afternoon. Developed a rash on his back around March 31, 2016. Rash (not blisters) salmon in color. Rash became darker on Saturday 4, 2016 and child developed a low grade fever. Mother tool child to the ER. All family members are current on immunizations. Patient is the youngest child. Mother staying with him for 12 days.
Age: 51.0
Sex: M
Vaccine: TDAP
Symptoms: Rash generalised
Clinical narrative: Rash on most of body within hours of administration.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Swelling
Clinical narrative: Received 4/1/16 at 11:30 am, then mid afternoon area felt painful and increased redness from (L) deltoid to elbow, inner aspect of arm. This lasted x 48 hours and now redness and swelling resolving in the last 24 hours.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions/allergies or concurrent conditions were reported. On 29-MAR-2016, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) (which had a lot # L031065 and an expiration date of 18-AUG-2017; however dose, dosage number, anatomical location and route of administration were not reported). The temperature excursion involved was 0 degree C for a time frame of 7 hours. However, no adverse effects were reported. Additionally, it was stated that a previous temperature excursion of 4.5 degree C had occurred for a time frame of 14 hours. Also, no product quality complaint was involved. Additional information is not expected since consent to be contracted for follow up was denied.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent and historical conditions were not reported. On 01-APR-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB (Lot # J008505, expiration date 07-FEB-2016) intramuscular, anatomical location and dose were not reported. There was not concomitant medication reported. No product quality complaint was involved. No adverse effects were reported. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Fall, Syncope, Urinary incontinence
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of syncopal attack in a 17-year-old female patient who received BEXSERO. In January 2016, the patient received the 1st dose of BEXSERO .5 ml. In January 2016, 1 day after receiving BEXSERO, the patient experienced syncopal attack and fall. On an unknown date, the outcome of the syncopal attack and fall were unknown. It was unknown if the reporter considered the syncopal attack and fall to be related to BEXSERO. Additional details were provided as follows: The next day after vaccination, the patient experienced syncopal episodes, even falling in the bathroom and urinating on herself. The exact date of occurrence of the event was unknown, but possibly sometime in January 2016. Little information was known about prescribing physician. The patient's initials, date of birth, vaccine batch number and expiration date were unknown. The patient called their doctor, but their doctor said it was something else. The patient did not visited the doctor or hospital.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Disorientation, Food allergy, Headache, Hypothyroidism
Clinical narrative: While taking a shower she got extremely nauseous and disoriented. Eventually her face went completely gray and she passed out. After coming too she has been extremely ill. Has constant headaches (24/7) that peak into migraines. Has become hypothyroid. Has muscle and joint pain. Has no stamina, and always has an ill feeling. Has developed severe food allergies that never existed prior to the vaccination.
Age: 11.0
Sex: F
Vaccine: HPV4
Symptoms: Loss of consciousness, Malaise, Migraine, Myalgia, Nausea
Clinical narrative: While taking a shower she got extremely nauseous and disoriented. Eventually her face went completely gray and she passed out. After coming too she has been extremely ill. Has constant headaches (24/7) that peak into migraines. Has become hypothyroid. Has muscle and joint pain. Has no stamina, and always has an ill feeling. Has developed severe food allergies that never existed prior to the vaccination.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Chest pain, Feeling abnormal, Limb discomfort, Oral pruritus, Swollen tongue
Clinical narrative: Developed mouth pruritus, tongue swelling, diffuse itching. Transported by EMS to ED, given prednisone and Benadryl.
Age: 12.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Oral pruritus, Pruritus, Swollen tongue
Clinical narrative: Developed mouth pruritus, tongue swelling, diffuse itching. Transported by EMS to ED, given prednisone and Benadryl.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Movement disorder, Paraesthesia, X-ray
Clinical narrative: Pain in left arm from site of injection down the arm. A little range of motion.
Age: 72.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Ultrasound scan, X-ray
Clinical narrative: Pain in left arm from site of injection down the arm. A little range of motion.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Anger, Asthenia, Confusional state, Constipation, Dizziness
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Dizziness postural, Feeling abnormal, Malaise, Vertigo
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Balance disorder, Dizziness, Nausea
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Confusional state, Constipation, Dizziness, Injection site pain
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Malaise, Nausea, Vertigo
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Asthenia, Balance disorder, Blood chloride increased, Blood creatinine normal, Blood glucose normal
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Blood potassium normal, Blood sodium normal, Blood urea normal, Carbon dioxide decreased, Dizziness
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Haematocrit normal, Haemoglobin normal, Lymphadenopathy, Nausea, Neurological examination abnormal
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: PPV, PPV, PPV, PPV
Symptoms: Nystagmus, Vertigo
Clinical narrative: This spontaneous report was received from a male patient of unknown age. Information on his concurrent conditions, medical history and drug allergies were not reported. On 16-MAR-2016, the patient was vaccinated with PNEUMOVAX 23 (lot, expiry date, dose number and units were not specified), intramuscular or subcutaneously. Concomitant medication were not reported. On 16-MAR-2016 (later that evening), the patient felt lightheaded, weak, dizziness, nauseous, and off balance. The patient stated that although, he felt a little better, the systems kept reappearing, and each time got a little worse. The patient had not been able to reach his primary provider for care. The patient would attempt contact with emergency room in his area. Patient had sought medical attention for events by an attempt to call physician. The outcome of balance disorder, asthenia, nausea and dizziness were reported as not recovered/not resolved at the time of reporting. There was no Product Quality Concern (PQC) involved. Relatedness of the events with PNEUMOVAX 23 were not reported. Additional information has been requested.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Electrocardiogram, Heart rate increased, Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Pt received his 8th anthrax vaccine; day after receiving it developed erythematous rash around injection site and swelling with taught skin. Pt reports this is typically how he reacts to vaccine - sought medical care at request of co-worker.
Age: 28.0
Sex: M
Vaccine: ANTH
Symptoms: Skin tightness, Vaccine positive rechallenge
Clinical narrative: Pt received his 8th anthrax vaccine; day after receiving it developed erythematous rash around injection site and swelling with taught skin. Pt reports this is typically how he reacts to vaccine - sought medical care at request of co-worker.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Pyrexia
Clinical narrative: Fever of 105 starting at 10:30. Two doses of Tylenol given and a cool bath. Temp down to 100 by morning.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: (L) arm swelling, redness, hot to touch x 2 days, no fever. Relieved by BENADRYL and ice.
Age: 12.0
Sex: M
Vaccine: VARCEL
Symptoms: Arthralgia, Herpes zoster, Laboratory test, Polymerase chain reaction positive, Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 12 year old male patient with attention deficit/hyperactivity disorder (ADHD). The patient had no drug reactions or allergies. On an unknown date (at the age of 1 year old), the patient was vaccinated with the first dose of VARIVAX (Merck) (dose, route of administration, lot number and expiration date were not reported). On an unknown date (at the age of 5 year old), the patient received a second dose of VARIVAX (Merck) (dose, route of administration, lot number and expiration date were not reported). It was stated that the patient had no exposure to anyone else. Concomitant therapy included unspecified ADHD medications. On an unknown date, the patient presented to unspecified urgent care/emergency room with knee and hip pain with difficulty weight bearing. The physician stated that there were some diagnostic tests (unspecified) completed (results were not provided) and the patient was treated with gabapentin for severe pain. Later, on an unknown date, the patient developed a rash and shingles on left lower leg and back. The patient was placed on valacyclovir hydrochloride and was doing better a couple of days later and lesions started to crust. The polymerase chain reaction (PCR) testing was completed and showed positive for varicella zoster virus (VZV). The sample was sent to another doctor for genotyping but it leaked in transit so a second attempt was being made. The outcome of weight bearing difficulty, knee and hip pain and severe pain was unknown. The outcome of varicella zoster virus infection was recovering/resolving. The relatedness between the events and VARIVAX (Merck) was not reported. Additional information has been requested.