chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Chronic inflammatory demyelinating polyradiculoneuropathy, Dysphagia, Dysstasia
Clinical narrative: Symptoms began with loss of grip in hands then loss of muscle strength in arms. Progressed to muscle weakness in legs such that if I could not stand up without assistance from a crouching position. Diagnosed with Guillain-Barre on 1/12/15 then treated with 5 days of IVIG. Symptoms improved then began regressing 2/16/15. Retreated with 5 days of IVIG with minimal improvement. Relapsed further and diagnosis was changed to Chronic Inflammatory Demyelinating Polyneuropathy on 3/12/15. Started on high dose steroids. Symptoms continued to relapse until I could no longer move my arms or walk. Last walked on 3/20/15. Admitted for hypertension urgency on 3/24/16 for 2 days. Had a syncopal episode on 3/29/15 requiring a visit to the ED. By 4/3/15, I had lost 20 pounds due to swallowing difficulty and was no longer moving anything but my head. Admitted for 5 days of plasmapheresis. Discharged on 4/10/15 able to move my arms and walk. Treatment to prevent relapses continue with IVIG every 3 weeks and methotrexate weekly.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Electromyogram abnormal, Grip strength decreased, Guillain-Barre syndrome, Hypertensive crisis, Immunoglobulin therapy
Clinical narrative: Symptoms began with loss of grip in hands then loss of muscle strength in arms. Progressed to muscle weakness in legs such that if I could not stand up without assistance from a crouching position. Diagnosed with Guillain-Barre on 1/12/15 then treated with 5 days of IVIG. Symptoms improved then began regressing 2/16/15. Retreated with 5 days of IVIG with minimal improvement. Relapsed further and diagnosis was changed to Chronic Inflammatory Demyelinating Polyneuropathy on 3/12/15. Started on high dose steroids. Symptoms continued to relapse until I could no longer move my arms or walk. Last walked on 3/20/15. Admitted for hypertension urgency on 3/24/16 for 2 days. Had a syncopal episode on 3/29/15 requiring a visit to the ED. By 4/3/15, I had lost 20 pounds due to swallowing difficulty and was no longer moving anything but my head. Admitted for 5 days of plasmapheresis. Discharged on 4/10/15 able to move my arms and walk. Treatment to prevent relapses continue with IVIG every 3 weeks and methotrexate weekly.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Lumbar puncture abnormal, Mobility decreased, Muscular weakness, Nervous system disorder, Plasmapheresis
Clinical narrative: Symptoms began with loss of grip in hands then loss of muscle strength in arms. Progressed to muscle weakness in legs such that if I could not stand up without assistance from a crouching position. Diagnosed with Guillain-Barre on 1/12/15 then treated with 5 days of IVIG. Symptoms improved then began regressing 2/16/15. Retreated with 5 days of IVIG with minimal improvement. Relapsed further and diagnosis was changed to Chronic Inflammatory Demyelinating Polyneuropathy on 3/12/15. Started on high dose steroids. Symptoms continued to relapse until I could no longer move my arms or walk. Last walked on 3/20/15. Admitted for hypertension urgency on 3/24/16 for 2 days. Had a syncopal episode on 3/29/15 requiring a visit to the ED. By 4/3/15, I had lost 20 pounds due to swallowing difficulty and was no longer moving anything but my head. Admitted for 5 days of plasmapheresis. Discharged on 4/10/15 able to move my arms and walk. Treatment to prevent relapses continue with IVIG every 3 weeks and methotrexate weekly.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Syncope, Weight decreased
Clinical narrative: Symptoms began with loss of grip in hands then loss of muscle strength in arms. Progressed to muscle weakness in legs such that if I could not stand up without assistance from a crouching position. Diagnosed with Guillain-Barre on 1/12/15 then treated with 5 days of IVIG. Symptoms improved then began regressing 2/16/15. Retreated with 5 days of IVIG with minimal improvement. Relapsed further and diagnosis was changed to Chronic Inflammatory Demyelinating Polyneuropathy on 3/12/15. Started on high dose steroids. Symptoms continued to relapse until I could no longer move my arms or walk. Last walked on 3/20/15. Admitted for hypertension urgency on 3/24/16 for 2 days. Had a syncopal episode on 3/29/15 requiring a visit to the ED. By 4/3/15, I had lost 20 pounds due to swallowing difficulty and was no longer moving anything but my head. Admitted for 5 days of plasmapheresis. Discharged on 4/10/15 able to move my arms and walk. Treatment to prevent relapses continue with IVIG every 3 weeks and methotrexate weekly.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Fatigue
Clinical narrative: She reported dizziness and fatigue, described as severe.  She reports spending much of the time since her visit in bed.  She has not been seen since the date that the vaccine was administered.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Fall, Gait disturbance, Guillain-Barre syndrome, Immunoglobulin therapy
Clinical narrative: On August 8, 2015, general malaise. August 15, altered gait and visited prompt care. August 17, saw PCP. Aug 19, went to ER due to falling and sent home. Aug 21, weak, falling, return to ER and hospitalized, put in ICU and diagnosed by neurologist for Guillain-Barre Syndrome and immediately treated with immunoglobulin (6 treatments). Went to rehab at same hospital for 6 weeks and then transferred to another rehab center and was released December 28 and currently doing outpatient therapy.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Intensive care, Malaise, Nerve conduction studies abnormal
Clinical narrative: On August 8, 2015, general malaise. August 15, altered gait and visited prompt care. August 17, saw PCP. Aug 19, went to ER due to falling and sent home. Aug 21, weak, falling, return to ER and hospitalized, put in ICU and diagnosed by neurologist for Guillain-Barre Syndrome and immediately treated with immunoglobulin (6 treatments). Went to rehab at same hospital for 6 weeks and then transferred to another rehab center and was released December 28 and currently doing outpatient therapy.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Blood electrolytes decreased, Epistaxis, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: On August 8, 2015, general malaise. August 15, altered gait and visited prompt care. August 17, saw PCP. Aug 19, went to ER due to falling and sent home. Aug 21, weak, falling, return to ER and hospitalized, put in ICU and diagnosed by neurologist for Guillain-Barre Syndrome and immediately treated with immunoglobulin (6 treatments). Went to rehab at same hospital for 6 weeks and then transferred to another rehab center and was released December 28 and currently doing outpatient therapy.
Age: 64.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Hypotonia, Intensive care, Malaise, Sinusitis
Clinical narrative: On August 8, 2015, general malaise. August 15, altered gait and visited prompt care. August 17, saw PCP. Aug 19, went to ER due to falling and sent home. Aug 21, weak, falling, return to ER and hospitalized, put in ICU and diagnosed by neurologist for Guillain-Barre Syndrome and immediately treated with immunoglobulin (6 treatments). Went to rehab at same hospital for 6 weeks and then transferred to another rehab center and was released December 28 and currently doing outpatient therapy.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Acute disseminated encephalomyelitis, Headache, Seizure, Vomiting
Clinical narrative: An hour after getting the shot he got a headache and then started throwing up. The headache and throwing up last on and off for almost a month he then had a seizure and was diagnosed with ADEM on 1/14/16.
Age: 83.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Loss of consciousness
Clinical narrative: Pt. reported severe joint pain and black-out 3 days after injection. Unsure if related.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PEDVAXHIB, lot # K025006 with expiration date 22-JUL-2017, (dose and route of administration were not provided). Concomitant medications was not reported. No adverse effects reported. Third excursion for PEDVAXHIB: Temperature/time: 34.7F for 15 minutes. Previous excursion: 34.4F for 30 minutes plus 48F for 8 hours. This is one of several reports received from the same source. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia
Clinical narrative: This spontaneous report was received from a physician, via a company representative, referring to a 23 year old female patient. The patient's medical history and concurrent condition were not reported. On an unknown date, when the patient was a teenager, she was vaccinated with a dose of GARDASIL, 0.2 (units not provided) intramuscular. Concomitant medication was not reported. On an unknown date, the patient experienced cervical intraepithelial neoplasia II, after receiving the GARDASIL. The patient sought medical attention. The outcome and causality of cervical intraepithelial neoplasia II were unknown. Additional information is not expected as the reporter did not wish further contact.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On an unknown date, the patients were vaccinated with improperly stored dose of oral, ROTATEQ, lot # K004432 with expiration date 27-JAN-2016, (dose was not provided). Concomitant medication was not reported. No adverse effects reported. Second excursion for oral, ROTATEQ: Temperature/time: 34.7F for 15 minutes. Previous excursion: 34.4F for 30 minutes. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: TDAP
Symptoms: Seizure
Clinical narrative: This case was reported by a consumer and described the occurrence of seizure in a female patient who received BOOSTRIX (batch number 2E9JG, expiry date 8th October 2017). On 5th December 2015, the patient received BOOSTRIX. In December 2015, 3 days after receiving BOOSTRIX, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown. It was unknown if the reporter considered the seizure to be related to BOOSTRIX. Additional details were received as follows: This case was reported by a pharmacy via a pharmacy claims management company. In December 2015, 3 days after receiving BOOSTRIX, the patient experienced 2 known seizures.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Joint dislocation, Neck pain
Clinical narrative: The day after the injection, pt reports intense neck, head, and hip pain on the opposite side of his body from the injection site. Pt states pain did not respond to pain killers and that he felt his hip was popping out of socket. Soreness next day.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse referring to multiple unspecified patients of unknown demographics. Information about the patient's pertinent medical history, concurrent conditions and drug reactions/allergies were not reported. On an unknown date, the patients were inadvertently vaccinated with improperly stored doses of ZOSTAVAX, lot # L012475 with expiration date 10-JUL-2016 and lot # L012476 with expiration date 10-JUL-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects reported. Temperature: 6F; time frame: 15 hours. There is reported a previous temperature excursion, the highest temperature reached was 12F for a cumulative time out of range of 51 hours and 32 minutes. This is one of two reports received from the same source. Additional information is not expected since no consent was given to reach follow up.
Age: 62.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Myalgia
Clinical narrative: Left arm muscle very sore. Application of heat and deep muscle massage provide temporary relief, but still painful to this day.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Guillain-Barre syndrome
Clinical narrative: Patient said diagnosed with Guillain-Barre Syndrome 12/28/15 at hospital.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Arthritis, Central nervous system inflammation, Ear infection, Influenza like illness, Periarthritis
Clinical narrative: Flu like symptoms for four days followed by sinus and ear infection for two weeks followed by frozen right shoulder and joint/ spinal inflammation in whole body till now January 19th.
Age: 37.0
Sex: M
Vaccine: FLUX
Symptoms: Sinusitis
Clinical narrative: Flu like symptoms for four days followed by sinus and ear infection for two weeks followed by frozen right shoulder and joint/ spinal inflammation in whole body till now January 19th.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Local swelling, Pruritus, Rash pustular
Clinical narrative: Developed "zoster" rash to back, size of "silver dollar" with raised, itchy pustules. States called her PMD, was not prescribed medication at this time.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: PATIENT STATED ARM WAS RED, SWOLLEN AND ITCHY.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site paraesthesia
Clinical narrative: Pain, tingling L quadricept (same site as injection).
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Back pain, Blood test normal, Chest X-ray normal, Diarrhoea, Electrocardiogram normal
Clinical narrative: Arm at sight and shoulder sore, pain in left side of upper back.  Not feeling well.  Slight temp., cold, nausea, threw up, diarrhea, right eye watery, slight runny nose.  7:30 PM B/P 187/91.  Went to ER. Testing neg.  Took 5 days before feeling somewhat better.  15 days later still not feeling like I did before vaccine.  B/P still not at previous numbers. Eye remains water and nose runny.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Lacrimation increased, Malaise, Nasopharyngitis, Nausea
Clinical narrative: Arm at sight and shoulder sore, pain in left side of upper back.  Not feeling well.  Slight temp., cold, nausea, threw up, diarrhea, right eye watery, slight runny nose.  7:30 PM B/P 187/91.  Went to ER. Testing neg.  Took 5 days before feeling somewhat better.  15 days later still not feeling like I did before vaccine.  B/P still not at previous numbers. Eye remains water and nose runny.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Rhinorrhoea, Vomiting
Clinical narrative: Arm at sight and shoulder sore, pain in left side of upper back.  Not feeling well.  Slight temp., cold, nausea, threw up, diarrhea, right eye watery, slight runny nose.  7:30 PM B/P 187/91.  Went to ER. Testing neg.  Took 5 days before feeling somewhat better.  15 days later still not feeling like I did before vaccine.  B/P still not at previous numbers. Eye remains water and nose runny.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient. The patient's concurrent conditions included allergy to codeine. On 29-DEC-2015, the patient was vaccinated with ZOSTAVAX (Lot # L002422, expiration date 23-APR-2016) 0.65 ml once, subcutaneous in the right arm. No concomitant medications were reported. On 30-DEC-2015, the patient experienced redness, swelling and a rash at the injection site, the pharmacist also reported injection site warmth and injection site induration (also reported as the injection site was warm and hard to the touch). The patient visited the pharmacist, no treatment was given. At the time of the report, the outcome of the adverse events was reported as not recovered/not resolved. Additional information has been requested.
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Anxiety, Nausea
Clinical narrative: PT reported extreme nausea approximately 2 hours after administration of FLUZONE HD.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Epicondylitis, Pain in extremity
Clinical narrative: Patient is experiencing symptoms of tennis elbow. Patient has pain radiating from elbow to wrist.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Grip strength decreased, Injection site pain
Clinical narrative: Patient is experiencing symptoms of tennis elbow. Patient has pain radiating from elbow to wrist.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Activities of daily living impaired, Chills, Dyspnoea, Fatigue, Malaise
Clinical narrative: Fever, runny nose, cramps, coughing up Green And Black phlegm  (nose) difficulty breathing, fatigue and chills. Missed three consecutively days of work plus 1 trip to ER and still not feeling well.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Muscle spasms, Productive cough, Pyrexia, Rhinorrhoea, Sputum discoloured
Clinical narrative: Fever, runny nose, cramps, coughing up Green And Black phlegm  (nose) difficulty breathing, fatigue and chills. Missed three consecutively days of work plus 1 trip to ER and still not feeling well.
Age: 1.11
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Injection site reaction, Rash generalised, Rash pruritic
Clinical narrative: Itchy rash started on the left thigh. Rash later spread all over body.
Age: 52.0
Sex: M
Vaccine: TD, TDAP
Symptoms: Expired product administered
Clinical narrative: Went to give patient TD vaccination (as instructed by Dr.). Hand-written expiration on box said 09/2016, did not check vial. Actual expiration date was 01/10/2016.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Rash
Clinical narrative: Patient had rash over chest, abdomen.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Prevnar 13 injection administered by the pharmacist was extremely painful. Two and a half months later I have ongoing pain in my arm when I extend or lift it. Nothing my doctor has suggested has helped. This injection has worsened my health which was fine before this!
Age: 46.0
Sex: F
Vaccine: HEP, TYP, YF
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Swelling, erythema and induration around injection site (5cm in diameter). Benadryl and topical Triamcinolone cream.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Pain
Clinical narrative: Typical soreness after the shot after a few days. Three to four days later I could not lift my arm at all. Excruciating pain with movement along with muscular pain around the shot area.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Diarrhoea, Irritability, Swelling, Vomiting
Clinical narrative: Swollen, fussy, vomiting, diarrhea.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Chills, fatigue, headache.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Vaccination site induration
Clinical narrative: Redness and induration at vaccine site, 4.5x4.5cm.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Aphonia, Asthenia, Chills, Cough, Dyspnoea
Clinical narrative: Started with arm pain. Saturday 1/9/2016, started coughing, sweats, chills weakness loss of voice shortness of breathe. Symptoms persistent to the present.
Age: 60.0
Sex: M
Vaccine: PNC13
Symptoms: Hyperhidrosis, Pain in extremity
Clinical narrative: Started with arm pain. Saturday 1/9/2016, started coughing, sweats, chills weakness loss of voice shortness of breathe. Symptoms persistent to the present.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: (L) arm pain and weakness x 3 months symptoms started after getting flu shot.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Conjunctivitis, Eye swelling, Face oedema
Clinical narrative: Rec. vaccination 12-29. On 12-31  had peri-orbital swelling, facial edema and conjunctivitis lasted 4 to 5 days.
Age: 82.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Pain in extremity, Skin warm
Clinical narrative: Lt arm heavy, warm and sore. Alternate heat/ice, TYLENOL #3 for pain.
Age: 0.57
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV
Symptoms: Crying, Dyspnoea, Injection site erythema, Injection site swelling
Clinical narrative: Incessant crying, difficulty breathing (may be related to the crying), redness and swelling around injection site.
Age: 60.0
Sex: U
Vaccine: FLU3
Symptoms: Injection site induration, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Pt reported stiff arm and swelling/"hard skin" at site of injection.
Age: 47.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Burning sensation, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Back of the left arm on the tricep swelled up with a burning aching pain. Patient states it felt hot to the touch. Occurred about 12 hours after the shot, and it lasted for about 24 hours. Patient took TYLENOL for the swelling, which seemed to help some. Patient was vaccinated 31 days before at previous facility with both FLUVIRIN and PNEUMOVAX.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This spontaneous report was received from a nurse practitioner, via company representative, concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions or allergies were unspecified by reporter. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (strength, dose number, route, anatomical location, lot number and expiration date were unspecified). On an unknown date the patient developed hives, in an unspecified location, following the administration of ZOSTAVAX. The outcome of hives was unknown. The relatedness between hives and ZOSTAVAX was not reported. Additional information has been requested.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site discomfort, Pain in extremity
Clinical narrative: This spontaneous report was received from an anonymous reporter referring to a 71 year old male patient as part of a market research. The patient's concurrent conditions included chronic obstructive pulmonary disease and his medical history was unknown. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX, intravenous route (Lot number, dosage and dose number were unknown). Concomitant therapies were not provided. On an unknown date the patient experienced injection site discomfort and pain in extremity. The outcome of injection site discomfort and arm soreness was reported as recovered within 24 hours. The reporter considered injection site discomfort and pain in extremity to be related to ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history was not reported. The patient received an improperly stored dose of VARIVAX (Merck) (route not reported, lot # L0030158 and Exp. date 11-AUG-2017) on 07-JAN-2016. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse concerning a patient of unknown age and gender. Patient's pertinent medical history was not reported. The patient received an improperly stored dose of PROQUAD (route not reported, lot # L031603 and Exp. date 18-FEB-2017) on 07-JAN-2016. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been expected.
Age: 1.11
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 13 month old female patient. No concurrent conditions were reported. Patient had no medical history or allergy/drug reactions. On 12-JAN-2016 the patient was inadvertently vaccinated with PROQUAD lot#L041626 expiry date: 20-APR-2017 and VARIVAX lot# L021211 with expiry date: 10-JUNE-2017, during the same office visit. Concomitant therapies included albuterol. On the same day shorter after the vaccination while still in the physician's office, the patient developed an unspecified reaction at the injection site. No treatment was provided for the event. Lab diagnostics studies were not performed. There were no product quality complaints (PQC) involved. The reporter did not provide the causality between the reaction at the injection site and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. On 03-DEC-2015 the patient was vaccinated with a dose of ZOSTAVAX (lot # L031273, expiration date 19-NOV-2016, dose and route unknown). On 12-JAN-2016, the same patient inadvertently received another dose of ZOSTAVAX (lot # L031273, expiration date 19-NOV-2016, dose and route unknown) (extra dose administered). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple unspecified patients of unknown ages and genders. There was no pertinent medical history, concurrent conditions, concomitant medications or drug allergies/drug reactions described. On 21-OCT-2015, 22-OCT-2015, 09-NOV-2015, 23-NOV-2015 and 30-NOV-2015, multiple unspecified patients received improperly stored product PEDVAXHIB lot # I002866 with expiration date of 10-NOV-2017 (strength, dose, frequency and route were not reported). On 08-DEC-2015, 15-DEC-2015 and 17-DEC-2015, multiple unspecified patients received improperly stored product PEDVAXHIB lot # L012838 with expiration date of 10-MAR-2018 (strength, dose, frequency and route were not reported). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site oedema, Injection site pain
Clinical narrative: Patient developed large red area where PREVNAR injection was given. The area had edema and slight pain to touch.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Rash
Clinical narrative: Information has been received from the physician assistant and refers to a 73 years-old female subject enrolled Study, approximately 12 years ago. The subject medical history and concurrent conditions were not reported. Concomitant therapy included unspecified cholesterol medication and hormone replacement (unspecified). On unspecified date (approximately 12 years ago), the subject was vaccinated with ZOSTAVAX (dose, frequency, route of administration unspecified by the reporter). On 08-APR-2014, the subject experienced a significant rash, with grouped vesicles, on the left flank to midline (also reported as presented with shingles). The subject was seen in the office on 11-APR-2014 (also reported as 11-APR-201). There was no laboratory diagnostic studies performed. The outcome of the event was not reported. The action taken with the study therapy was reported as not applicable. The dechallenge and rechallenge was reported as not applicable. The causality between the event significant rash, with grouped vesicles, on the left flank to midline (also reported as presented with shingles) and ZOSTAVAX was not reported. No further information was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Polymerase chain reaction positive, Post herpetic neuralgia, Rash vesicular
Clinical narrative: Information has been received from the physician assistant and refers to a 73 years-old female subject enrolled Study, approximately 12 years ago. The subject medical history and concurrent conditions were not reported. Concomitant therapy included unspecified cholesterol medication and hormone replacement (unspecified). On unspecified date (approximately 12 years ago), the subject was vaccinated with ZOSTAVAX (dose, frequency, route of administration unspecified by the reporter). On 08-APR-2014, the subject experienced a significant rash, with grouped vesicles, on the left flank to midline (also reported as presented with shingles). The subject was seen in the office on 11-APR-2014 (also reported as 11-APR-201). There was no laboratory diagnostic studies performed. The outcome of the event was not reported. The action taken with the study therapy was reported as not applicable. The dechallenge and rechallenge was reported as not applicable. The causality between the event significant rash, with grouped vesicles, on the left flank to midline (also reported as presented with shingles) and ZOSTAVAX was not reported. No further information was provided.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from the physician assistant and refers to a 73 years-old female subject enrolled Study, approximately 12 years ago. The subject medical history and concurrent conditions were not reported. Concomitant therapy included unspecified cholesterol medication and hormone replacement (unspecified). On unspecified date (approximately 12 years ago), the subject was vaccinated with ZOSTAVAX (dose, frequency, route of administration unspecified by the reporter). On 08-APR-2014, the subject experienced a significant rash, with grouped vesicles, on the left flank to midline (also reported as presented with shingles). The subject was seen in the office on 11-APR-2014 (also reported as 11-APR-201). There was no laboratory diagnostic studies performed. The outcome of the event was not reported. The action taken with the study therapy was reported as not applicable. The dechallenge and rechallenge was reported as not applicable. The causality between the event significant rash, with grouped vesicles, on the left flank to midline (also reported as presented with shingles) and ZOSTAVAX was not reported. No further information was provided.
Age: 20.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Cellulitis, Erythema, Induration, Injection site erythema, Lymph node pain
Clinical narrative: This unsolicited case was received on 06 January 2016 via a third party query tool search on the VAERS database, under reference number 596869. This case involves a 20-years old male patient who received the following vaccinations on 09 September 2015: a first dose of ACAM2000, lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co. in the right arm via an unknown route and a dose of IXIARO, lot number: JEV14D66E, manufacturer: Intercell in the left arm via intramuscular route. The patient did not take any concomitant medications. She did not have any current illnesses and medical history included allergy to penicillin (PCN), sulfa drugs, Acetylsalicylic Acid (ASA), Primaquine and G6PD Deficiency. The prior vaccination details were not provided. On 20 September 2015, 11 days post vaccination; the patient had tenderness, redness and swelling. It was reported that over a period of 24 hours i.e. on examination on 21 September 2015, there was a significant increase in redness and swelling of vaccination site (surrounding) and he had tenderness in right axilla/+2 CM right axillary lymph node appreciated right arm was tender to palpation; was red and warm, indurated area was about 5 cm in diameter across, pain was rated 8/10 and was diagnosed with cellulitis. The patient required emergency visit. There were no laboratory investigations done. The patient was treated with doxycycline 100 mg twice daily for 14 days. The outcome of the event was reported as unknown. Upon internal review, this case was considered serious due to important medical event: cellulitis. List of documents held by sender: none.
Age: 20.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Pain, Skin warm, Swelling, Tenderness, Vaccination site swelling
Clinical narrative: This unsolicited case was received on 06 January 2016 via a third party query tool search on the VAERS database, under reference number 596869. This case involves a 20-years old male patient who received the following vaccinations on 09 September 2015: a first dose of ACAM2000, lot number: VV04003A, manufacturer: Sanofi Pasteur Biologics Co. in the right arm via an unknown route and a dose of IXIARO, lot number: JEV14D66E, manufacturer: Intercell in the left arm via intramuscular route. The patient did not take any concomitant medications. She did not have any current illnesses and medical history included allergy to penicillin (PCN), sulfa drugs, Acetylsalicylic Acid (ASA), Primaquine and G6PD Deficiency. The prior vaccination details were not provided. On 20 September 2015, 11 days post vaccination; the patient had tenderness, redness and swelling. It was reported that over a period of 24 hours i.e. on examination on 21 September 2015, there was a significant increase in redness and swelling of vaccination site (surrounding) and he had tenderness in right axilla/+2 CM right axillary lymph node appreciated right arm was tender to palpation; was red and warm, indurated area was about 5 cm in diameter across, pain was rated 8/10 and was diagnosed with cellulitis. The patient required emergency visit. There were no laboratory investigations done. The patient was treated with doxycycline 100 mg twice daily for 14 days. The outcome of the event was reported as unknown. Upon internal review, this case was considered serious due to important medical event: cellulitis. List of documents held by sender: none.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Arthritis, Computerised tomogram, Injected limb mobility decreased, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Severe pain and stiffness in Rt shoulder (she gave the injection too high) inability to move arm full range of motion.  4mm tear rotator cuff involving 20% thickness of tendon, 14mm of bursa, tendinosis, and inflammation all in the shoulder 3 different types of oral anti-inflammatories, two rounds of steroids, tram and LORTAB for pain, cortisone injection into shoulder and pt up until Jan 14th was stopped due to worsening progression.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Rotator cuff syndrome, Tendon disorder
Clinical narrative: Severe pain and stiffness in Rt shoulder (she gave the injection too high) inability to move arm full range of motion.  4mm tear rotator cuff involving 20% thickness of tendon, 14mm of bursa, tendinosis, and inflammation all in the shoulder 3 different types of oral anti-inflammatories, two rounds of steroids, tram and LORTAB for pain, cortisone injection into shoulder and pt up until Jan 14th was stopped due to worsening progression.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and refers to a 278 patients of unknown age and gender who reported the events via Vaccine Adverse Event Reporting System. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced unspecified adverse events that required an extended hospital stay (start and stop dates and duration of hospitalization were not reported). The outcome of adverse events was unknown. the relatedness between the events and quadrivalent HPV (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Age: 14.0
Sex: M
Vaccine: HPV4
Symptoms: Chest X-ray normal, Chest pain, Costochondritis
Clinical narrative: Patient developed sharp midsternal pain in the center of chest. He was diagnosed with Costochondritis. Clear Chest Xray. No hx of fever.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site joint pain, Injection site pain, Myalgia
Clinical narrative: Joint and muscle pain in right arm, right shoulder and upper right back. It has been 6 weeks and 1 day since the vaccination was administered and the pain is still present. Personal doctor said symptoms are 'normal', but 6+ weeks of pain does not seem normal to me.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and refers to a 4131 patients of unknown age and gender. The events were reported via Vaccine Adverse Event Reporting System. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not reported). On unknown dates, the patients experienced unspecified adverse events and were hospitalized on unknown dates. The outcome of adverse events was unknown. The relatedness between the events and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Sex: F
Vaccine: HPV4
Symptoms: Bordetella test positive, Burning sensation, Dizziness, Epstein-Barr virus test positive, Pain
Clinical narrative: This spontaneous report derives from an internet website, where the patient's mother reported on her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient used to be a competitive horse rider and a cheerleader. On an unknown date in August 2013, the patient was vaccinated with a dose of GARDASIL (exact dose, route of administration, lot # and expiration date were not reported). In October 2013, the patient experienced pain, constant state of dizziness and her fingers tingled and burnt. Since an unknown date, the patient walked with a cane (reported as "now"). She had positive Epstein Barr and Pertussis blood tests (date unspecified). In 2014, she was hospitalized five times. The mother stated, that they tried her on everything. They were going to see immunologist in March 2015. Outcome of the events was not recovered. Causality assessment was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Paraesthesia, Walking aid user
Clinical narrative: This spontaneous report derives from an internet website, where the patient's mother reported on her daughter of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The patient used to be a competitive horse rider and a cheerleader. On an unknown date in August 2013, the patient was vaccinated with a dose of GARDASIL (exact dose, route of administration, lot # and expiration date were not reported). In October 2013, the patient experienced pain, constant state of dizziness and her fingers tingled and burnt. Since an unknown date, the patient walked with a cane (reported as "now"). She had positive Epstein Barr and Pertussis blood tests (date unspecified). In 2014, she was hospitalized five times. The mother stated, that they tried her on everything. They were going to see immunologist in March 2015. Outcome of the events was not recovered. Causality assessment was not provided. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPVX
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to a 1394 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration date not reported). On unknown dates, the patients experienced a disabling adverse event. The outcome of adverse event was unknown. The relatedness between the event and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Additional information is not expected as no contact details were provided.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swelling and redness to injection site.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Bedridden, Computerised tomogram normal, Diabetes mellitus, Diplopia
Clinical narrative: Suffered from weakness, fatigue, mild fever gradually getting worse leading to body aches, nausea and severe vomiting. Bedridden x 5 days, double vision and dizziness with left eye paralyzed. Hospitalized x 3 days, CT, MRI test were normal, ruled out stroke, labs drawn CBC, CMP, UA, Hemo A1C, results within normal limits, Vision consult and neuro eval, diagnosed with 3rd Ocular Nerve Palsy, Diabetes controlled. Presently recovering, continued double and blurred vision. Remain under Physician care.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fatigue, Full blood count normal, Glycosylated haemoglobin normal, IIIrd nerve paralysis
Clinical narrative: Suffered from weakness, fatigue, mild fever gradually getting worse leading to body aches, nausea and severe vomiting. Bedridden x 5 days, double vision and dizziness with left eye paralyzed. Hospitalized x 3 days, CT, MRI test were normal, ruled out stroke, labs drawn CBC, CMP, UA, Hemo A1C, results within normal limits, Vision consult and neuro eval, diagnosed with 3rd Ocular Nerve Palsy, Diabetes controlled. Presently recovering, continued double and blurred vision. Remain under Physician care.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Laboratory test normal, Metabolic function test normal, Nausea, Neurological examination abnormal, Nuclear magnetic resonance imaging normal
Clinical narrative: Suffered from weakness, fatigue, mild fever gradually getting worse leading to body aches, nausea and severe vomiting. Bedridden x 5 days, double vision and dizziness with left eye paralyzed. Hospitalized x 3 days, CT, MRI test were normal, ruled out stroke, labs drawn CBC, CMP, UA, Hemo A1C, results within normal limits, Vision consult and neuro eval, diagnosed with 3rd Ocular Nerve Palsy, Diabetes controlled. Presently recovering, continued double and blurred vision. Remain under Physician care.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Ophthalmoplegia, Pain, Pyrexia, Urine analysis normal, Vision blurred
Clinical narrative: Suffered from weakness, fatigue, mild fever gradually getting worse leading to body aches, nausea and severe vomiting. Bedridden x 5 days, double vision and dizziness with left eye paralyzed. Hospitalized x 3 days, CT, MRI test were normal, ruled out stroke, labs drawn CBC, CMP, UA, Hemo A1C, results within normal limits, Vision consult and neuro eval, diagnosed with 3rd Ocular Nerve Palsy, Diabetes controlled. Presently recovering, continued double and blurred vision. Remain under Physician care.
Age: 57.0
Sex: M
Vaccine: FLU4
Symptoms: Visual acuity tests abnormal, Vomiting
Clinical narrative: Suffered from weakness, fatigue, mild fever gradually getting worse leading to body aches, nausea and severe vomiting. Bedridden x 5 days, double vision and dizziness with left eye paralyzed. Hospitalized x 3 days, CT, MRI test were normal, ruled out stroke, labs drawn CBC, CMP, UA, Hemo A1C, results within normal limits, Vision consult and neuro eval, diagnosed with 3rd Ocular Nerve Palsy, Diabetes controlled. Presently recovering, continued double and blurred vision. Remain under Physician care.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site swelling, Pharyngitis
Clinical narrative: (Adverse event onset time is estimated, not known) Redness, swelling, tenderness at injection site. Temp. 99.1, pharyngitis. Patient was given Rx for Augmentin. Advised Benadryl prn, ibuprofen prn, warm or cold compresses prn.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: PREVNAR vaccination right deltoid 1-7-16. Redness and swelling at site, required systemic steroids (prednisone 20mg daily for 5 days).
Age: 1.82
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Rash
Clinical narrative: Patients mother states rash that comes and goes, started after receiving vaccination on 1/12/16. The mother took him to the Emergency Room on 1/13/16 and 1/14/16. Was treated with PRELORE and BENADRYL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: CSF protein increased, Guillain-Barre syndrome, Hordeolum, Nuclear magnetic resonance imaging spinal
Clinical narrative: Pt had 5 yr check up 2/23/15. Seen in ofc 3/6/15 for stye. Guillain-Barre diagnosed 3/11 - 3/12/15.
Sex: U
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a consumer who saw a segment of a broadcast refers to an unspecified number of female patients. The patient's medical history was not reported. On an unknown dates, the patients were vaccinated with the doses of GARDASIL. On an unknown dates, the patients were losing their lives because of those. The reporter considered deaths to be related to GARDASIL. Additional information is not expected. This is one of several reports from the same reporter.
Sex: U
Vaccine: HPVX
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report was received from an unspecified reporter via an online article published and Vaccine Adverse Event Reporting System and refers to a 104 patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of quadrivalent HPV vaccine (manufacturer unknown) (route, dose, lot # and expiration dates not reported). On unknown dates, the patients experienced a cervical cancer. The outcome of cervical cancer was unknown. The relatedness between the cervical cancer and quadrivalent HPV vaccine (manufacturer unknown) was not reported. This is one of several reports received from the same reporter. Upon internal review the event of cervical cancer was considered to be medically significant. Additional information is not expected as no contact details were provided.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown demographics. Information about the patients' pertinent medical history, concurrent conditions and drug reactions/allergies was not reported. On unspecified dates, since 03-AUG-2015, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB lot # L007558 with expiration date 10-NOV-2016, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. The RECOMBIVAX HB was also exposed to 68F for 19 hours. Additional information has been requested.