chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: FLU(H1N1), FLU(H1N1)
Symptoms: Activities of daily living impaired, Blood test, Insomnia, Sleep study, Somnolence
Clinical narrative: Case number PHHY2013US032587 is an initial spontaneous report from consumer via Vaccine Adverse Event Reporting System (VAERS reference number: 483236) on 04 Apr 2013, with a follow-up received on 06 May 2013. This report refers to a 32-year-old female patient. The patient's preexisting conditions included asthma, migraines and seasonal allergies (not at the time of vaccination). Concomitant medications included SINGULAIR, LEXAPRO, TOPAMAX, VENTOLIN and imipramine. The patient received pandemic H1N1 vaccine (batch number: unknown) on 05 Nov 2009. On 08 Nov 2009, four days after receiving the H1N1 vaccination, she just could not get enough sleep. But later, "she began sleeping through her alarm at 5:00 am" and was unable to get out of bed until 12:00 or 1:00pm. She would nod off while driving to work, even though it was only a 30 minute drive and she had only been awake less than 2.5 hours. She actually drove her car off the side of the road once, when she woke up, she was just sitting in her car. She would fall asleep at the light at the exit ramp of the freeway to work. She would be so overcome with the need to sleep; she would shut her office door and sleep on the floor at 9am. She would sleep in her car instead of eating lunch. She came home from work and took 3-4 hour naps. On the weekends, she would sleep 15-19 hours a day. She tried to drink caffeine (she usually don't) but it did help her to stay awake. In mid-Dec, she went to see her gynecologist, thinking maybe she was anemic. Gynecologist woke her up (she fell asleep in the exam chair) and told her that there was no way the extreme sleepiness was caused by her cycle. She ordered a multiple sleep latency test and blood work. She averaged 5 minutes to fall asleep for each nap. Since then she had been to doctor's offices, trying a variety of pills, lifestyle changes, anything to get her life back. Since Nov 2009, she was not able to function daily. Events were assessed as life threatening and disability. Outcome of the events was reported as condition unchanged. Causality of the events were not reported. No further information was available. Follow-up was received on 06 May 2013: The patient was vaccinated with monovalent influenza vaccine of other manufacturer (batch number: 500751P). As no Novartis vaccine was involved, this case will be deactivated.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13, VARCEL, DTAPIPV, MMRV, PNC13, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Child with high fever, vomiting, body aches- directed to hospital ER by doctor.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV, PNC13, VARCEL, DTAPIPV, MMRV, PNC13, VARCEL
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: Child with high fever, vomiting, body aches- directed to hospital ER by doctor.
Age: 0.34
Sex: F
Vaccine: DTAP
Symptoms: Crying, Irritability, Pyrexia, Rash erythematous, Rash generalised
Clinical narrative: She ran a low grade fever after the shot and into the evening. That afternoon and evening she was fussy and wouldn't nap. When she woke up the next morning she was extremely fussy and cried all day non stop. She wouldn't nap still. When we went to give her a bath at 7:30 we noticed a spotty red rash with tiny bumps covering her body. The rash is different than her eczema. I will call the doctor in the morning.
Age: 27.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Local swelling
Clinical narrative: Swelling and redness at injections site. Nausea, low-grade fever (99.9 orally), chills, generalized body aches. These symptoms lasted for 24 hours. Localized redness and swelling has continued.
Age: 27.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Swelling and redness at injections site. Nausea, low-grade fever (99.9 orally), chills, generalized body aches. These symptoms lasted for 24 hours. Localized redness and swelling has continued.
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Local swelling, Lymphadenopathy, Neck pain
Clinical narrative: Pt woke up to a sore and swollen neck. No change to diet or activities. No trauma. No previous reaction to last 3 doses of Anthrax.
Age: 42.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Influenza like illness, Myalgia, Pain
Clinical narrative: Flu-like symptoms: body aches, joint and muscle pain, chills, and fever (101 degrees).
Age: 42.0
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Flu-like symptoms: body aches, joint and muscle pain, chills, and fever (101 degrees).
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Has a 2 1/2 x 2 1/2 inch red area around injection site. Area is warm to the touch. Started on KEFLEX 500 mg p.o. QID x 10 days.
Age: 26.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 26 years old patient. On 02-MAY-2013 the patient was vaccinated with an expired first dose of M-M-R II (lot number 670080/0402AA, expiry date 16-MAR-2013). No adverse symptoms reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 0.48
Sex: M
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea
Clinical narrative: This spontaneous report as received from a physician via Company Representative refers to a 21 month old male patient. The patient was vaccinated with 3 doses of 2 ml ROTATEQ (Dose 1 lot number 17242 was an invalid lot number for ROTATEQ; Dose 2 batch# 670237, lot# 670237/0919AA, expired on 12-DEC-2012; Dose 3 lot# 1539AA) on 12-SEP-2011, 15-NOV-2011 and 08-JAN-2012, respectively. On 22-APR-2013 the patient experienced diarrhea and dehydration. Patient tested positive for Rotavirus with unspecified lab test. Patient presented to urgent care clinic on 25-APR-2013 and was given fluids and unspecified medications. The outcome of dehydration and diarrhea was reported as recovered/resolved. The relatedness for the events was unknown for ROTATEQ. Additional information has been requested.
Age: 84.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Feeling abnormal
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 84 year old female patient. On 30-APR-2013 the patient was vaccinated with a single dose of PNEUMOVAX23 lot # H017759 Exp 04-JUL-2014, 0.5 ml, intramuscular. On 30-APR-2013, the patient experienced extreme fatigue and not feeling good several hours after administration of PNEUMOVAX23. The patient called the office for medical attention but no treatment was prescribed. No lab test was performed. The nurse stated she contacted the patient "today", 01-MAY-2013, and the symptoms were improving. The relationship between the events and PNEUMOVAX23 was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Inflammation and redness to site.
Sex: F
Vaccine: MNQ
Symptoms: Meningitis aseptic, Meningococcal sepsis
Clinical narrative: Case number PHHY2013US042539 is an initial literature report received on 26 Apr 2013: The author in this article investigated the use of eculizumab a therapeutic monoclonal IgG that neutralizes the complement protein C5 in neuromyelitis optica spectrum disorders. An open label pilot study was conducted to investigate the same and the patients who were AQP4-IgG-seropositive, aged at least 18 years, had a neuromyelitis optica spectrum disorder and had at least two attacks in the preceding 6 months or three in the previous 12 months were recruited into the study. The patients received meningococcal vaccine at a screening visit and 2 weeks later began eculizumab treatment. This report refers to an adult female patient. The patient received MENVEO (batch number: not reported) on an unknown date. Despite tetravalent meningococcal vaccination two weeks before the first eculizumab infusion, this patient developed meningococcal septicaemia and sterile meningitis, but responded readily to antibiotic treatment (unspecified). The authors concluded that she was unprotected to the specific serotype, because it could not be classified into a group and the vaccine protects against only serotypes A, C, W-135, and Y. The seriousness and outcome of the events were not reported.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC, VARCEL
Symptoms: Rash generalised
Clinical narrative: Rash on body and face. No fever.
Sex: U
Vaccine: DTAP
Symptoms: Chest discomfort, Immediate post-injection reaction, Livedo reticularis, Muscle disorder, Pain in extremity
Clinical narrative: Immediately pain and constriction of heart and leg pain - almost dropped to my knees. Continued muscular impairment. Mottled skin. Pain down arms and legs. Still happening 5/8/13 with less intensity.
Age: 34.0
Sex: F
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, Off label use, Therapeutic response unexpected
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient. The pharmacist reports that the patient received a dose of 0.5 ml ZOSTAVAX injection subcutaneously "four years ago" in 2009 when the patient was 34 years old. The patient states that she took the ZOSTAVAX to treat a chronic dermatologic type disorder (name of disorder unspecified). The patient stated that the ZOSTAVAX improved the symptoms of that condition. Patient had sought medical attention by office visit. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, PNC, VARCEL
Symptoms: Diarrhoea, Pyrexia, Rash
Clinical narrative: Fever, rash and diarrhea.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker (certified medical assistant) concerning a patient of unknown age and gender. On 03-MAY-2013, the patient was vaccinated with an expired of M-M-R II (lot number and expiry date reported as 669467/0005AA and 18-DEC-2012 respectively, dose and route unspecified) by an another healthcare worker (certified medical assistant). No concomitant medications were reported. No adverse effect was reported. This is one of the two reports from the same source. Additional information has been requested.
Age: 19.0
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Incomplete course of vaccination, Live birth, No adverse event
Clinical narrative: This spontaneous retrospective pregnancy report as received from an approximately 19 year old female patient with no drug reactions or pertinent medical history. The patient was vaccinated with the first dose of GARDASIL (Lot # and route not reported) in the upper left arm in August or September 2012. There was no concomitant medication. The patient found out she was pregnancy after the administration of the vaccine. The patient did not receive the 2nd and 3rd dose of GARDASIL. The patient did not suffer any adverse effects, and was reporting the event only at the time of reference point upon advisement from her current pediatrician. The patient had a successful pregnancy and delivered on 25-MAR-2013. The patient's LMP was approximately on 18-JUN-2012. The patient didn't seek medical attention. No treatment was given. No lab diagnostics studies were performed. At the time of reporting, the patient felt fine. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Body aches, lack of energy, nausea, headaches, chills.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a 60 year old female patient. The patient reported that she had no previous injection-site reactions, including when she received unspecified "flu" nad "TD" vaccines. The only reaction to prescription medications that the consumer reported was having felt "sick to [her] stomach" after taking certain painkillers including VICODIN, NORCO, and DARVOCET-N (reported as "DARVOCET"). On 30-APR-2013 the patient was vaccinated with a dose of ZOSTAVAX (0.65 ml/one shot, injection, strength, formulation, lot#, route and duration were unspecified). Concomitant therapies included KLONOPIN, omeprazole (manufacturer unspecified) and unspecified vitamins. Patient reported that almost exactly 24 hours later on 01-MAY-2013, she noticed an injection-site reaction including and "inch and a half circle" at the injection site which was red and swollen as a hard lump that felt hot to the touch. Another 24 hours later on 02-MAY-2013 (48 hours after receiving ZOSTAVAX), the circle at the injection site had grown "twice a big" and was still red, hot, and a hard lump. The injection-site reaction did not include any itching or rash. The consumer did not want to specify whether the physician in the "Physician Name" field could be contacted because the consumer has not yet contacted her physician about this reaction. The consumer stated that she might soon be contacting a different, unspecified doctor instead about the reaction. The patient received the ZOSTAVAX from an unspecified pharmacist. The reaction has not diminished. Patient did not seek medical attention. No lab diagnostics studies were performed and no treatment was given for the events. The outcome of the events were reported as not recovered. Causality were not provided. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cheilitis, Impetigo, Rash, Rash generalised, Varicella post vaccine
Clinical narrative: Patient went to ER on 4/29/13 rash around lips and nares. Dx impetigo Rx BACTRIM. Shot administered on 4/25/13 MMR/VZV. 5/8/13 patient came to office with rash all over body. Dx varicella rash secondary VZV shot 4/25/13.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a female patient of unknown age concerning herself. On an unknown date in January 2013 the patient was vaccinated with ZOSTAVAX (lot number, dose, route and injection site were not reported) for the prevention of shingles. Sometime in April 2013 the patient got a case of the shingles. The outcome of shingles was unknown. The action taken and causality were not reported. It was unspecified if the patient sought any medical attention. Additional information is not expected.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age (gender unspecified). On 03-MAY-2013 the patient was vaccinated with an expired ZOSTAVAX (lot # 0170AE, exp. 06-MAR-2013. Administration route and dose information was unspecified. No adverse effect reported. Additional information has been requested.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 75 year old female patient. On 29-APR-2013 the patient was vaccinated with ZOSTAVAX lot # J000494, 0.65 ml, subcutaneous. On an unknown date in 2013 the patient experienced painful swelling about the size of a half dollar at the injection site. The patient sought medical attention by calling her pharmacist. The pharmacist reported that the patient has been putting ice on it, and he will go visit the patient at her home today. The outcome of painful swelling about the size of a half dollar at the injection site was reported as not recovered. The relatedness of the event was not reported for ZOSTAVAX. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 12 year old female patient. The patient was vaccinated with the first dose of GARDASIL in November 2012, the second dose of GARDASIL in March 2013, and the third dose of GARDASIL on 01-MAY-2013. No adverse effects reported. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site vesicles
Clinical narrative: 4/13/13 following vaccination had redness and firmness of upper arm where shot given. Developed several small blisters at the injeciton site over the next 24 hours through 4/14/13. Was seen on Monday 4/15/13 and found to have reddened firm area on entire upper arm (R) with blisters at site, used cortoid cream and cool compesses overnight. On 4/16 had 3" reddened area at site and no blisters. Symptoms continued to subside over the next 2-3 days and was back to normal.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Enema administration, Haematochezia, Intussusception, Irritability, Ultrasound abdomen abnormal
Clinical narrative: This patient presented with fussiness and blood in the stool 24 hrs after administration of ROTATEQ vaccine. Intermittent fussiness persisted with vomiting and then another bloody stool this one described as currant jelly stool. The baby was sent to the ER where an intussusception was diagnosed by ultrasound and then reduced by air enema. The baby was hospitalized for 24 hrs of observation with no recurrence and then discharged the following day.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: This patient presented with fussiness and blood in the stool 24 hrs after administration of ROTATEQ vaccine. Intermittent fussiness persisted with vomiting and then another bloody stool this one described as currant jelly stool. The baby was sent to the ER where an intussusception was diagnosed by ultrasound and then reduced by air enema. The baby was hospitalized for 24 hrs of observation with no recurrence and then discharged the following day.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash, upper chest, arm, face and hair line.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site vesicles, Injection site warmth
Clinical narrative: Approximately 3 inch round red area around injection site, heat at redness, a little tender, small clear fluid filled bump at apparent injection site.
Age: 0.24
Sex: M
Vaccine: PNC13
Symptoms: Culture stool positive, Diarrhoea, Frequent bowel movements, Haematochezia, Occult blood positive
Clinical narrative: This is a spontaneous report from a contactable nurse and a contactable pharmacist reported on behalf of physician. A 3-month-old male patient received the first dose of PREVNAR 13 injection in the right thigh, at 0.5ml (Lot # G73024, Expiration Date 01Oct2014) on 28Mar2013 at 10:24 am. The relevant medical history included acid reflux since an unknown date and on 12Feb2013 switch to Nutramigen due to spitting and frequent stools (4-6x/day) that tested heme positive- after changing to Nutramigen stool decrease to 2x/day and stools were heme neg- until had PREVNAR-13. The patient received previous vaccines first dose of PENTACEL (Sanofi manufacturer) injection in the left thigh, Batch/lot # expiration date: C4372AA, Exp: 13Apr2014 on 28Feb2013. The relevant concomitant medications included ZANTAC syrup at a dose of 0.5ml as needed on 13Feb2013, it was off for few weeks- resumed on 18Apr2013 for acid reflux (GER). On 29Mar2013, the patient developed watery stools, watery, frequent stools with blood at times. Seriousness criteria: very concerning due infants age and nutrition and possible dehydration. The patient has not had solid stool since vaccine. Relevant lab tests included stool test for cold blood on an unknown date in 2013 for the watery stools for which the report was negative, however, results were unknown. On 02Apr2013 stool HEME Test: +positive; on 09Apr2013 stool HEME Test: +positive; on 10Apr2013 stool culture, Fecal FAT, Fecal reducing substance OVA + Parasite, Giardia, IAMBIIA AG, EIA: Trace Fecal reducing substance. On 22Apr2013 stool HEME Test: negative. Therapeutic measures was required. Stool studies, formula changed, Gastroenterologist consult and follow-up, weight checks. Patient had not recovered from the reported event at the time of report. Follow-up (29Apr2013): New information obtained from a contactable pharmacist reported on behalf of physician includes: patient's age updated (3-month-old not 2-month-old); expiration date of PREVNAR 13; anatomical location of the administration; additional medical history; previous vaccines administered (PENTACEL); details of concomitant medication; additional lab data; treatment; event details including new events (blood in stool and dehydration), onset and outcome of the events. Follow-up attempts completed. No further information expected.
Age: 0.24
Sex: M
Vaccine: PNC13
Symptoms: Parasite stool test positive
Clinical narrative: This is a spontaneous report from a contactable nurse and a contactable pharmacist reported on behalf of physician. A 3-month-old male patient received the first dose of PREVNAR 13 injection in the right thigh, at 0.5ml (Lot # G73024, Expiration Date 01Oct2014) on 28Mar2013 at 10:24 am. The relevant medical history included acid reflux since an unknown date and on 12Feb2013 switch to Nutramigen due to spitting and frequent stools (4-6x/day) that tested heme positive- after changing to Nutramigen stool decrease to 2x/day and stools were heme neg- until had PREVNAR-13. The patient received previous vaccines first dose of PENTACEL (Sanofi manufacturer) injection in the left thigh, Batch/lot # expiration date: C4372AA, Exp: 13Apr2014 on 28Feb2013. The relevant concomitant medications included ZANTAC syrup at a dose of 0.5ml as needed on 13Feb2013, it was off for few weeks- resumed on 18Apr2013 for acid reflux (GER). On 29Mar2013, the patient developed watery stools, watery, frequent stools with blood at times. Seriousness criteria: very concerning due infants age and nutrition and possible dehydration. The patient has not had solid stool since vaccine. Relevant lab tests included stool test for cold blood on an unknown date in 2013 for the watery stools for which the report was negative, however, results were unknown. On 02Apr2013 stool HEME Test: +positive; on 09Apr2013 stool HEME Test: +positive; on 10Apr2013 stool culture, Fecal FAT, Fecal reducing substance OVA + Parasite, Giardia, IAMBIIA AG, EIA: Trace Fecal reducing substance. On 22Apr2013 stool HEME Test: negative. Therapeutic measures was required. Stool studies, formula changed, Gastroenterologist consult and follow-up, weight checks. Patient had not recovered from the reported event at the time of report. Follow-up (29Apr2013): New information obtained from a contactable pharmacist reported on behalf of physician includes: patient's age updated (3-month-old not 2-month-old); expiration date of PREVNAR 13; anatomical location of the administration; additional medical history; previous vaccines administered (PENTACEL); details of concomitant medication; additional lab data; treatment; event details including new events (blood in stool and dehydration), onset and outcome of the events. Follow-up attempts completed. No further information expected.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Areflexia, Asthenia, Back pain, CSF oligoclonal band present, CSF test
Clinical narrative: 1st seen Jan c/o back/spinal pain full length (x 2-3 mo) tingling between shoulder blades. 2 wks later (2/4) tingling hands & feet, weakness, wt loss, loss of DTR's, decreased grips. 3/5/13 trouble walking, diffuse weakness. NCS/EMG 4/2/13 severe demyelination. CSF fluid oligoclonal c/w GBS Guillain Barre Syndrome.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Demyelination, Electromyogram, Gait disturbance, Grip strength decreased, Guillain-Barre syndrome
Clinical narrative: 1st seen Jan c/o back/spinal pain full length (x 2-3 mo) tingling between shoulder blades. 2 wks later (2/4) tingling hands & feet, weakness, wt loss, loss of DTR's, decreased grips. 3/5/13 trouble walking, diffuse weakness. NCS/EMG 4/2/13 severe demyelination. CSF fluid oligoclonal c/w GBS Guillain Barre Syndrome.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Immunoglobulin therapy, Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal, Paraesthesia
Clinical narrative: 1st seen Jan c/o back/spinal pain full length (x 2-3 mo) tingling between shoulder blades. 2 wks later (2/4) tingling hands & feet, weakness, wt loss, loss of DTR's, decreased grips. 3/5/13 trouble walking, diffuse weakness. NCS/EMG 4/2/13 severe demyelination. CSF fluid oligoclonal c/w GBS Guillain Barre Syndrome.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Spinal pain, Weight decreased
Clinical narrative: 1st seen Jan c/o back/spinal pain full length (x 2-3 mo) tingling between shoulder blades. 2 wks later (2/4) tingling hands & feet, weakness, wt loss, loss of DTR's, decreased grips. 3/5/13 trouble walking, diffuse weakness. NCS/EMG 4/2/13 severe demyelination. CSF fluid oligoclonal c/w GBS Guillain Barre Syndrome.
Age: 51.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Flushing, Headache, Insomnia
Clinical narrative: Inside of mouth felt like sore when have bit/chewed on inner jaws, cheeks red and flushed, H/A, unable to sleep started approximately 11pm. Took BENADRYL x 2 and s/s resolved without cheeks still a little red. No MD eval. Cannot r/t any other thing that came in contact with on 5/7.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: 3 cm oval area over injection site that was warm, erythematous, minimally indurated. c/o burning pain at injection site. Tx: ibuprofen. Symptoms lasted 5 days.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Rash generalised, Varicella post vaccine
Clinical narrative: Rash developed on upper body and arms 5/4/13 at 6:00 pm went to ER 5-4-13 at 11:30 pm. - Misdiagnosed. Went to ER 5-8-13 at 09:00 am - Diagnosed with varicella (rash only present on both thighs - 1 or 2 spots - on lower body/extremities) rash progressed to face and back. Severe case as noted by Dr.
Age: 15.0
Sex: M
Vaccine: HEPA, TDAP, VARCEL, VARCEL
Symptoms: Biopsy, Infection, Varicella post vaccine
Clinical narrative: Rash developed on upper body and arms 5/4/13 at 6:00 pm went to ER 5-4-13 at 11:30 pm. - Misdiagnosed. Went to ER 5-8-13 at 09:00 am - Diagnosed with varicella (rash only present on both thighs - 1 or 2 spots - on lower body/extremities) rash progressed to face and back. Severe case as noted by Dr.
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: 15 year old client was unable to obtain Hep B dose 3 at PCP.  Not eligible for VFC. Gave her private, which was adult dose of Hep B vaccine.  No adverse symptoms that day or 3 days later per mother.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK, DTAPHEPBIP, HIBV, RVX
Symptoms: Convulsion
Clinical narrative: Prolonged Seizure.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK, DTAPHEPBIP, HIBV, RVX
Symptoms: Convulsion, Electroencephalogram, Endotracheal intubation, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Prolonged Seizure.
Age: 0.35
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RVX, UNK, DTAPHEPBIP, HIBV, RVX
Symptoms: Respiratory disorder
Clinical narrative: Prolonged Seizure.
Age: 0.14
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Crying
Clinical narrative: Mother reports that after patients 2 months vaccines given at previous pediatrician's office the patient cried 3.5 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia
Clinical narrative: Patient states has had numbness in her arm since she received the vaccination.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Abdominal pain upper, Asthenia, Chest pain, Dyspnoea, Ear pain
Clinical narrative: Severe itching, rash, hives, earache, sore throat, shortness of breath, stomach pain, fever, welts, chest pain, white dots in throat, weakness.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Hypersensitivity, Oropharyngeal pain, Pharyngeal disorder, Pruritus, Pyrexia
Clinical narrative: Severe itching, rash, hives, earache, sore throat, shortness of breath, stomach pain, fever, welts, chest pain, white dots in throat, weakness.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Rash, Urticaria, Vaccination complication
Clinical narrative: Severe itching, rash, hives, earache, sore throat, shortness of breath, stomach pain, fever, welts, chest pain, white dots in throat, weakness.
Age: 1.25
Sex: M
Vaccine: MMRV
Symptoms: Injection site urticaria
Clinical narrative: Hives at injection site within minutes, Benadryl given and hives went away within two hours.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 30.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Allergy test negative, Computerised tomogram abnormal, Increased upper airway secretion, Injection site inflammation, Nasal inflammation
Clinical narrative: Started as sore throat.  Turned into a bad cold and then a severe sinus infection that lasted 6 weeks.  Again on April 4, 2013, the same symptoms occurred. Finally was given Augmentin which got rid of dark mucus, but I still have non-allergic rhinitis and cannot get rid of it.  I never had a sinus infection before 12/26/12.  Reflecting upon this, I strongly believe it is related to the flu vaccine administered on December 21, 2012. Please note that there was localized inflammation at the site of the injection.  This lasted about a week.
Age: 63.0
Sex: F
Vaccine: FLUX
Symptoms: Nasopharyngitis, Oropharyngeal pain, Rhinitis allergic, Sinusitis, Skin test negative
Clinical narrative: Started as sore throat.  Turned into a bad cold and then a severe sinus infection that lasted 6 weeks.  Again on April 4, 2013, the same symptoms occurred. Finally was given Augmentin which got rid of dark mucus, but I still have non-allergic rhinitis and cannot get rid of it.  I never had a sinus infection before 12/26/12.  Reflecting upon this, I strongly believe it is related to the flu vaccine administered on December 21, 2012. Please note that there was localized inflammation at the site of the injection.  This lasted about a week.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: Severe arm pain, has been getting worse every day, it is now 5/8/13.  At night it hurts so bad it wakes her up.
Age: 1.29
Sex: F
Vaccine: HIBV, MMR, VARCEL
Symptoms: Crying, Injection site pain, Injection site swelling
Clinical narrative: Noticed at 3pm on 5/09/13 there was a bump on right arm where injection was. Went to go touch it and my daughter cried, this is quite a solid bump, and very painful. I attempted to apply a warm compress but she was not going to let me due to the pain. She has never had a reaction before.
Age: 1.23
Sex: F
Vaccine: MMR
Symptoms: Erythema, Swelling
Clinical narrative: After the 2nd of 5 shots (MMR broken up into 5 shots by allergist) skin developed large bump and redness that started spreading. Given Zyrtec.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Chills, Fatigue, Headache, Malaise
Clinical narrative: Chills, headache, malaise, fever 100.3, prostration. Started about nine hours after shingles vaccine was administered.  Still have headache 24 hours later and had fever of 100.3 all day.  BP also elevated.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Chills, headache, malaise, fever 100.3, prostration. Started about nine hours after shingles vaccine was administered.  Still have headache 24 hours later and had fever of 100.3 all day.  BP also elevated.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Burning sensation, Dysphagia, Headache, Hypersensitivity, Pruritus
Clinical narrative: Shingles shot in pharmacy. Soreness around shot area. Swelling, rash hot, itchy, extreme headache. April 17 Saw Dr allergic reaction to shot. (Ice and BENADRYL) rash and raised bumps were getting larger, burning through my head. Apr. 27, 013 went to clinic, give DECADRON 7 in long 2 in wide rash difficult to swallow.
Age: 61.0
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash generalised, Skin warm, Swelling
Clinical narrative: Shingles shot in pharmacy. Soreness around shot area. Swelling, rash hot, itchy, extreme headache. April 17 Saw Dr allergic reaction to shot. (Ice and BENADRYL) rash and raised bumps were getting larger, burning through my head. Apr. 27, 013 went to clinic, give DECADRON 7 in long 2 in wide rash difficult to swallow.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Meningococcal and GARDASIL HPV vaccines were given on 5/6/13 both in right arm. Went to Urgent Care next day with red swollen 1/2 right upper arm and warm to touch. Received at UC clindamycin. Came into office today 5-8-13. Still red, warm, and swollen.
Age: 1.53
Sex: F
Vaccine: DTAP, HIBV, MMR
Symptoms: Malaise, Pyrexia, Rash
Clinical narrative: Pt did not feel well after shots on 4/25/13 fever. Rash was present on 5/6/13.
Age: 48.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Limb discomfort, Pain
Clinical narrative: Weakness and discomfort (L) arm since. She received vaccine, first visit to provider since vaccine administered unable to do resistance traveling with out pain and weakness.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Skin induration
Clinical narrative: Skin induration.
Age: 24.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Hypersensitivity, Rash erythematous, Skin warm, Swelling, Tenderness
Clinical narrative: Allergic reaction to VZV given 5-6-13 red rash, swelling 4mmx4.5 min, hot to touch, painful to touch.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR, VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Serum sickness
Clinical narrative: Instructed to apply ice for 20 min every D 2 hrs, return to clinic if condition doesn't improve or gets worse. (Red rash swelling to thigh).
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Blood thyroid stimulating hormone decreased, Cough, Pyrexia, Rash, Speech disorder
Clinical narrative: Deterioration of speech and development noted on 8-8-12 exam. was normal on 5-30-12 exam, received MMR, VARIVAX and PENTACEL on 5-30-12. Developed fever and rash on 6-14-12.
Age: 1.34
Sex: F
Vaccine: DTAPIPVHIB, MMR, VARCEL
Symptoms: Thyroxine free normal
Clinical narrative: Deterioration of speech and development noted on 8-8-12 exam. was normal on 5-30-12 exam, received MMR, VARIVAX and PENTACEL on 5-30-12. Developed fever and rash on 6-14-12.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Confusional state, Fatigue, Myalgia
Clinical narrative: Marked myalgias lower extremities fatigue and mild confusion onset within 24 hours of #3 HPV. Improved on 5/8/2013. Used ibuprofen.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site reaction- redness, itching pain, swelling in about a 1 1/2 inch round area around site on Rt ARM will apply hydrocortisone.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Antineutrophil cytoplasmic antibody negative, Antinuclear antibody negative, Blood folate normal, Blood glucose normal, Blood test normal
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 47-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to case 1 in the literature article. Concurrent medical conditions included mild strabismic amblyopia in her right eye. In October 1994, the subject received an unspecified dose of Influenza vaccine (unknown) (administration site and route unspecified, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced decreased vision with transient eye pain. 5 days later, she developed blurriness in her left eye and optic disc atrophy. This case was assessed as medically serious by GSK. On examination, her visual acuity was 20/20 in both eyes, but Goldman perimetry showed a superior arcuate defect in right eye and an inferior altitudinal defect in left eye. There was no relative afferent pupillary defect. Both optic discs were moderately edematous with splinter hemorrhages and cotton-wool spots. The serum protein electrophoresis with immunofixation showed a nonspecific polyclonal hypergammaglobulinemia. The subject was treated with methylprednisolone and prednisone. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for abnormal serum markers (elevated sedimentation rate and polyclonal hypergammaglobulinemia). The visual field defects in either eye didn't improve and eventually, segmental disc atrophy appeared. At the time of reporting, the events were unresolved. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subjects recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: CSF test normal, Cardiolipin antibody negative, Cryoglobulins absent, DNA antibody negative, Electrophoresis protein abnormal
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 47-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to case 1 in the literature article. Concurrent medical conditions included mild strabismic amblyopia in her right eye. In October 1994, the subject received an unspecified dose of Influenza vaccine (unknown) (administration site and route unspecified, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced decreased vision with transient eye pain. 5 days later, she developed blurriness in her left eye and optic disc atrophy. This case was assessed as medically serious by GSK. On examination, her visual acuity was 20/20 in both eyes, but Goldman perimetry showed a superior arcuate defect in right eye and an inferior altitudinal defect in left eye. There was no relative afferent pupillary defect. Both optic discs were moderately edematous with splinter hemorrhages and cotton-wool spots. The serum protein electrophoresis with immunofixation showed a nonspecific polyclonal hypergammaglobulinemia. The subject was treated with methylprednisolone and prednisone. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for abnormal serum markers (elevated sedimentation rate and polyclonal hypergammaglobulinemia). The visual field defects in either eye didn't improve and eventually, segmental disc atrophy appeared. At the time of reporting, the events were unresolved. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subjects recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Eye pain, Hypergammaglobulinaemia, Lumbar puncture normal, Nuclear magnetic resonance imaging normal, Optic atrophy
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 47-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to case 1 in the literature article. Concurrent medical conditions included mild strabismic amblyopia in her right eye. In October 1994, the subject received an unspecified dose of Influenza vaccine (unknown) (administration site and route unspecified, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced decreased vision with transient eye pain. 5 days later, she developed blurriness in her left eye and optic disc atrophy. This case was assessed as medically serious by GSK. On examination, her visual acuity was 20/20 in both eyes, but Goldman perimetry showed a superior arcuate defect in right eye and an inferior altitudinal defect in left eye. There was no relative afferent pupillary defect. Both optic discs were moderately edematous with splinter hemorrhages and cotton-wool spots. The serum protein electrophoresis with immunofixation showed a nonspecific polyclonal hypergammaglobulinemia. The subject was treated with methylprednisolone and prednisone. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for abnormal serum markers (elevated sedimentation rate and polyclonal hypergammaglobulinemia). The visual field defects in either eye didn't improve and eventually, segmental disc atrophy appeared. At the time of reporting, the events were unresolved. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subjects recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Optic disc haemorrhage, Optic ischaemic neuropathy, Papilloedema, Red blood cell sedimentation rate increased, Retinal exudates
Clinical narrative: This case was reported in a literature article and described the occurrence of ischemic optic neuropathy in a 47-year-old female subject who was vaccinated with Influenza vaccine ((unspecified), manufacturer unspecified). This case corresponds to case 1 in the literature article. Concurrent medical conditions included mild strabismic amblyopia in her right eye. In October 1994, the subject received an unspecified dose of Influenza vaccine (unknown) (administration site and route unspecified, batch number not provided). 1 week after vaccination with Influenza vaccine (unspecified), the subject experienced decreased vision with transient eye pain. 5 days later, she developed blurriness in her left eye and optic disc atrophy. This case was assessed as medically serious by GSK. On examination, her visual acuity was 20/20 in both eyes, but Goldman perimetry showed a superior arcuate defect in right eye and an inferior altitudinal defect in left eye. There was no relative afferent pupillary defect. Both optic discs were moderately edematous with splinter hemorrhages and cotton-wool spots. The serum protein electrophoresis with immunofixation showed a nonspecific polyclonal hypergammaglobulinemia. The subject was treated with methylprednisolone and prednisone. The final diagnosis was bilateral anterior ischemic optic neuropathy rather than demyelinative optic neuritis due to the close temporal relationship to influenza vaccination and the bilateral involvement. According the authors, it might be an immune complex -mediated vasculopathy. This presumptive mechanism might also account for abnormal serum markers (elevated sedimentation rate and polyclonal hypergammaglobulinemia). The visual field defects in either eye didn't improve and eventually, segmental disc atrophy appeared. At the time of reporting, the events were unresolved. Summary of the literature article: Optic neuritis is an occasional complication of vaccination. Visual loss can be unilateral or bilateral and most subjects recover substantially without treatment. The presumptive mechanism is an immune-mediated demyelinating injury of the optic nerve. The authors report 2 subjects who had permanent visual loss following influenza vaccination. Their pattern of visual loss, segmental optic disc changes and failure of visual recovery were atypical for demyelinating optic neuritis and reminiscent of a primary ischemic injury to the optic nerve. The authors speculate that an immune complex-mediated vasculopathy following vaccination can cause anterior ischemic optic neuropathy. Clinicians should be aware of this entity because of the less favorable prognosis for visual recovery in these cases.