chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This solicited report was received from a physician referring to a 60 years old male patient enrolled in a marketing research program. The patient's concurrent conditions, medical history and concomitant therapy were not reported. On an unknown date in 2016, the patient was vaccinated with 1 dose of ZOSTAVAX, one time injection (route of administration, lot# and expiry date were not reported). On an unknown date in 2016, the patient went down with a "self contained" injection site reaction that lasted approximately 3 days (shingles) after receiving the ZOSTAVAX. The patient recovered with sequelae from the event on an unknown date, 3 days after the onset of shingles in 2016. Causality assessment was not provided. Additional information is not expected, as there was no consent for follow up.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Nurse Practitioner and refers to a 17 year old (currently an 18 year old) male patient. The patient did not suffer from any illnesses at the time of the vaccination and did not have any preexisting allergies, birth defects or medical conditions. On 18-MAR-2016, the patient was vaccinated with the first dose of GARDASIL 9 lot # L013429, expiration date 21-JUL-2017, intramuscularly in the left arm (dose not reported). The vaccine administered to the patient was improperly stored as it underwent temperature excursion for an unspecified cumulative period of time since January 2016 at 0.5 degrees Celsius. There had been no previous temperature excursion and the aforementioned one was identified due to a data logger. No adverse symptoms or reactions occurred. This is one of several reports received from the same source. Additional information is not expected as all scheduled correspondence has been received.
Sex: U
Vaccine: MENB
Symptoms: Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of nausea in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving BEXSERO, the patient experienced nausea, influenza-like symptoms, vomiting and fever. On an unknown date, the outcome of the nausea,  influenza-like symptoms, vomiting and fever were recovering/resolving. The reporter considered the nausea, influenza-like symptoms, vomiting and fever to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient was administered BEXSERO and experienced nausea, fever and flu-like symptoms. The reporter was not certain about vomiting experience. The reporter felt the symptoms that were experienced by the patient were excessive. The reporter was contacted again but no information was obtained.
Sex: F
Vaccine: PPV
Symptoms: Bacterial infection, Culture, Erythema, Localised infection, Pyrexia
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 52 year old female patient. The patient's concurrent condition included pre-leukemia and was under the care of a hematologist. The patient had drug reactions/allergies to several antibodies. On 06-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L035687 expiry date: 16-FEB-2016) (dose and route were not reported). Information on concomitant medication was not known by reporter. On 06-SEP-2016, the patient developed infection in her vaccinated arm, she experienced high fever, redness on the arm and developed a bacterial infection which could be from possibly a contaminated vial. The physician reported that the patient went testing at the emergency room (ER). The physician reported that he had never seen anything like this in his years of practice and stated that the patients white blood cell count elevated from normal 10800 to 30000 (units not provided) which indicated that it was a very serious infection. The physician requested to have the vaccine lot checked further. The patient sought medical attention and was hospitalized at an unspecified hospital on an unspecified date. The patient received unspecified treatment for the adverse events. Lab diagnostic test included blood count and culture test (result not reported). It was reported that the patient was discharged from the hospital on an unspecified date and was doing okay (outcome considered as recovering). The causality assessment was not reported. No further information provided. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: White blood cell count increased
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 52 year old female patient. The patient's concurrent condition included pre-leukemia and was under the care of a hematologist. The patient had drug reactions/allergies to several antibodies. On 06-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (lot # L035687 expiry date: 16-FEB-2016) (dose and route were not reported). Information on concomitant medication was not known by reporter. On 06-SEP-2016, the patient developed infection in her vaccinated arm, she experienced high fever, redness on the arm and developed a bacterial infection which could be from possibly a contaminated vial. The physician reported that the patient went testing at the emergency room (ER). The physician reported that he had never seen anything like this in his years of practice and stated that the patients white blood cell count elevated from normal 10800 to 30000 (units not provided) which indicated that it was a very serious infection. The physician requested to have the vaccine lot checked further. The patient sought medical attention and was hospitalized at an unspecified hospital on an unspecified date. The patient received unspecified treatment for the adverse events. Lab diagnostic test included blood count and culture test (result not reported). It was reported that the patient was discharged from the hospital on an unspecified date and was doing okay (outcome considered as recovering). The causality assessment was not reported. No further information provided. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Erythema, Hot flush
Clinical narrative: Flushing (face felt very hot, turned bright red). Lightheadedness.
Age: 1.58
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Streptococcus test negative
Clinical narrative: Low grade fever throughout day around 101. Went up to 103 overnight on 2nd night.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Eyelid oedema, Foreign body sensation in eyes, Photophobia
Clinical narrative: Patient started to have grittiness in her eyes and her eyelids swelled up slightly starting the evening of 9/5. She used Visine eye drops several times during the night and her eyes were extremely sensitive to light on 9/6 and 9/7. By 9/8, her eyes were completely back to normal. The patient did not experience an injection site reaction.
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Localized swelling at injection site.
Age: 47.0
Sex: F
Vaccine: HEP
Symptoms: Rash
Clinical narrative: Patient admitted that she had a rash due to the vaccine.
Age: 11.0
Sex: F
Vaccine: HEP, IPV, MMRV, TDAP, VARCEL
Symptoms: Medication error
Clinical narrative: No adverse event occurred. Noted 9/8/16 that client inadvertently received Proquad and Varicella vaccine in seperate arms instead of MMR and Varicella seperately.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Rash erythematous
Clinical narrative: Round, red, rash with soreness.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site irritation, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Localized irritation to the left thigh, presenting redness, swelling and warm to touch, non tender. For a past 48hrs, recommended treatments with ice packs, Tylenol and/ or Motrin for pain.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Blood culture, C-reactive protein, Chest X-ray, Culture urine, Fontanelle bulging
Clinical narrative: Fever, bulging fontanel occurred within 24 hours post vaccine administration, baby was admitted to the Hospital.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Full blood count, Pyrexia, Ultrasound skull
Clinical narrative: Fever, bulging fontanel occurred within 24 hours post vaccine administration, baby was admitted to the Hospital.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Fear, Hallucinations, mixed, Insomnia, Panic attack, Visual impairment
Clinical narrative: Panic attack, vomiting for 10 hours, vision disturbance, auditory and visual hallucinations, fearfulness, insomnia.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Panic attack, vomiting for 10 hours, vision disturbance, auditory and visual hallucinations, fearfulness, insomnia.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Insomnia
Clinical narrative: Insomnia.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Aphasia, Dizziness, Dysphagia, Immediate post-injection reaction, Speech disorder
Clinical narrative: Patient was light headed/dizzy, then after going home began having what she described as "mini-strokes", but after speaking with her we determined it may have been dysphagia/aphasia.  She has had trouble talking at times and difficulty finding words periodically.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Transient ischaemic attack
Clinical narrative: Patient was light headed/dizzy, then after going home began having what she described as "mini-strokes", but after speaking with her we determined it may have been dysphagia/aphasia.  She has had trouble talking at times and difficulty finding words periodically.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site inflammation
Clinical narrative: Inflammation, turning into cellulitis.  The reaction tracked below the site of injection.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PT REPORTED BURNING AT TIME OF INJECTION, LATER BRUISED AROUND INJECTION SITE WHICH TURNED INTO LEFT UPPER ARM REDNESS AND SWELLING WHICH SHE SAID WAS HOT AND TENDER TO THE TOUCH-TREATMENT WITH ICE PACKS AND CLARITIN.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site warmth
Clinical narrative: PT REPORTED BURNING AT TIME OF INJECTION, LATER BRUISED AROUND INJECTION SITE WHICH TURNED INTO LEFT UPPER ARM REDNESS AND SWELLING WHICH SHE SAID WAS HOT AND TENDER TO THE TOUCH-TREATMENT WITH ICE PACKS AND CLARITIN.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Eye pain, Hypersensitivity, Rhinorrhoea, Sinus disorder
Clinical narrative: "Allergy attack," Runny nose, Sore eyes, "Heated sinus."
Age: 43.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness in a circular pattern at injection site approximately 3.5 inches in diameter, soreness from left shoulder to elbow.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Lymphadenopathy, Rash pustular, Thyroid mass
Clinical narrative: Pustule on left side of back and swollen lymph nodes. Irritated thyroid nodule. Reported to primary care physician.
Age: 77.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Laboratory test, Local swelling
Clinical narrative: Red mark on right arm roughly 3 inches by 2 inches slightly raised.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Around where shot was given on my left shoulder; skin was raised and a dark red, warm, circle formed. It was about three inches in diameter. Continued to be swollen for entire day and night. I took a CLARITIN in the morning and then another one at bedtime. The circle remained for another day, so two days in total. My arm is still sore to the touch as well, especially where circle was at.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Erythema, Inflammation
Clinical narrative: Inflammation and redness.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV, FLUX, PPV
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: Inflammation and redness.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Loss of consciousness, Unresponsive to stimuli, Vision blurred
Clinical narrative: We were explaining the yellow immunization card to her when I noticed that she was not responding.  Her eyes her not focused so I held her shoulder and asked "are you ok?"  Since we were across the counter, I asked a coworker to help run around to corner to support her to a chair.  That was when she passed out.  We got her to the chair and attempted to call 911 when patient came to and said "no, don't call 911, I am ok".  She continued to be in and out of focus for a few more times and recovered.  We asked if this happen before and she said that she get like that with shots and blood draw.  We asked if she had someone to come and pick her up but she said she will be ok and will go home after.  She sat for 30 minutes.  Once, she seemed to return to normal, she left.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Cough, Oxygen saturation decreased, Swelling face, Urticaria, Vomiting
Clinical narrative: Pt received vaccine around 1020 am by 1030 am- he had profuse vomiting, cough, wheezing and low O2 Sat. Pt was given BENADRYL and Albuterol w/O2. He developed facial swelling and hives around the eyes. Pt was sent to ER for further management.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Wheezing
Clinical narrative: Pt received vaccine around 1020 am by 1030 am- he had profuse vomiting, cough, wheezing and low O2 Sat. Pt was given BENADRYL and Albuterol w/O2. He developed facial swelling and hives around the eyes. Pt was sent to ER for further management.
Sex: F
Vaccine: VARZOS
Symptoms: Hypotension, Laboratory test, Muscular weakness, Pyrexia, Vaccination complication
Clinical narrative: Information has been received from an investigator and refers to a 62 year old female subject enrolled in a study. The subject's concurrent conditions included aphasia, anxiety, libido decreased, depression, cough, seasonal allergies, and urinary urgency. The subject's medical history included thyroid biopsy and colloidal cyst. Concomitant therapies included montelukast and IOPHEN C NR. On 28-AUG-2015, the subject was randomized into one of the three treatment plans with MK-8931, 12 mg, or 40 mg, or placebo tablet taken orally once a day. On the same day at 11:40, the subject started therapy with double blinded MK-8931 for Alzheimer's disease. The subject was in the main cohort of the study. ^^Other suspect therapy included Zoster Vaccine Live (manufacturer unknown) administered on 16-AUG-2016, single dose, intramuscularly.^^ The subject was given the varicella vaccination (also reported as on 15-AUG-2106). The following morning she developed a high fever, low blood pressure and muscle weakness and was brought into the hospital (information was also captured in MARRS # 1608USA015723). On 16-AUG-2016, the subject experienced shingles vaccine adverse reaction (severe) and was hospitalized on the same day. The subject was treated for fever, hypotension and generalized muscle weakness. She was tested for tick born infections and was given intravenous (IV) fluids overnight. The subject felt at baseline following one overnight in the hospital. Her vital signs were stable. On 17-AUG-2016, the subject recovered from shingles vaccine adverse reaction (severe) and was discharged on the same day with a diagnosis of fever and hypotension. She was instructed to follow up with her primary care physician (PCP) within one week of discharge. The action taken with the study therapy was reported as ^^not applicable. The last reported dose of the study therapy was administered on 24-AUG-2016. The action taken with Zoster Vaccine Live (manufacturer unknown) was reported as not applicable^^. The investigator considered shingles vaccine adverse reaction (severe) to be not related to the study therapy and not related to the study procedure. The investigator considered shingles vaccine adverse reaction (severe) to be related to ^^the Zoster Vaccine Live (manufacturer unknown)^^. Updated information received on 07-SEP-2016 from the investigator has been captured in between double caret (^^).
Age: 1.02
Sex: F
Vaccine: HIBV, MMRV, PNC13
Symptoms: Blood electrolytes normal, Blood glucose normal, Computerised tomogram head normal, Febrile convulsion, Generalised tonic-clonic seizure
Clinical narrative: Complex febrile seizure (generalized tonic-clonic seizure lasting 15 mins); required treatment VERSED, ATIVAN for resumption on seizure activity. Head CT normal, glucose, electrolytes nml.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 22-JUN-2016 the patient received an improperly stored (Oka/Merck)VARIVAX (lot # L031066, expiry date: 13-JAN-2017 (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 66.0
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 66 year old patient of unknown gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 16-MAR-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # L012521 and expiration date 01-FEB-2017 (dose and route of administration were not reported). The vaccine underwent temperature excursion of 1 degree Celsius for 158 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Productive cough
Clinical narrative: Patient received vaccination 8/20/16. On 8/22/16 productive cough. Went to walk in clinic 8/30/16. (Azithromycin Z-PAK, TESSALON prescribed). Fully recovered.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site erythema, Injection site pain
Clinical narrative: Patient claims having redness and a burning sensation at injection site. Patient called 9/8/16 for suggestion on management of discomfort.
Age: 82.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Injection site reaction-itchy, painful grapefruit-sized red spot.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of GARDASIL. No adverse effect reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperaesthesia, Rash erythematous, Swelling
Clinical narrative: Patient had raised rash, sensitive, slightly red and elevated. Advised patient to active to apply 1 CC to area to reduce swelling, take OTC pain relievers. OTC BENADRYL.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of ROTATEQ lot#: L038534 orally. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered.  This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram normal, Electroencephalogram normal, Laboratory test normal, Mental status changes, Neurological examination normal
Clinical narrative: Neurological symptoms present 96 hrs after receiving GARDASIL #1 injection. Altered mental status - w/o known etiology.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Neurological symptom
Clinical narrative: Neurological symptoms present 96 hrs after receiving GARDASIL #1 injection. Altered mental status - w/o known etiology.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of M-M-R II lot #: L039551. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Eye swelling, Fatigue, Feeling abnormal, Paraesthesia
Clinical narrative: Patient says she was tired, spacey next day. Pin prick sensation on 8/30, awakened 8/31 at 0330 with eyes swollen, chest heaviness. 8/31 0800 she went to urgent care. From there she saw PCP.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of VARIVAX. No adverse effect reported. The temperature excursion details included exposure to temperature of 6 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of VAQTA. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Fatigue, Laboratory test normal, Pain, Swelling
Clinical narrative: Pt. was seen soon after vaccine was administered at an urgent care facility for redness, swelling and pain. Since then he has complained of worsening chronic fatigue.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reports as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of RECOMBIVAX HB. No adverse effect reported. The temperature excursion details included exposure to temperature of 47 Fahrenheit for 8 hours. No previous temperature excursions reported. No additional doses have been administered. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. On an unknown date (also reported as since 11-MAY-2016) the patient was vaccinated with improperly stored dose of (Oka-Merck) PROQUAD. No adverse effect reported. The temperature excursion details included exposure to temperature of 6 Fahrenheit for 8 hours. No previous temperature excursion reported. No additional doses have been administered. This is one of several reports received form the same source. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Area of redness and warm to touch approx 3"x5" Left deltoid. Ice/TYLENOL
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Joint stiffness, Myalgia, Pain
Clinical narrative: Swollen, red, warm to touch, pain, tightness. Symptoms: Myalgia, rash and injection site reaction.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Swollen, red, warm to touch, pain, tightness. Symptoms: Myalgia, rash and injection site reaction.
Age: 65.0
Sex: F
Vaccine: TD
Symptoms: Pain, Pyrexia, Rash pruritic
Clinical narrative: Systemic rash - pruritic. Body aches. Fever greater than 102.
Age: 1.25
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Wrong drug administered
Clinical narrative: PEDIARIX given by mistake. Extra Hep B/IPV too soon.
Age: 17.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: She needed Hepatitis B number 4; titers showed she was not immuned.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: 1 day after vaccination, redness, tenderness, heat around injection site and down the arm about 6 inches.
Sex: U
Vaccine: PPV, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. Medical history and concurrent conditions were not provided. On an unknown dates, the patients were vaccinated with an improperly stored doses of PNEUMOVAX 23 lot# reported as L048462, the expiration date: 02-DEC-2017 (dose was not reported) or VARIVAX lot# L048462, the expiration date: 02-FEB-2017 (dose was not reported). There was no concomitant medications provided. No adverse effect reported. Additional information has been requested.
Age: 39.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Antinuclear antibody, Arthralgia, HIV infection, Rheumatoid factor
Clinical narrative: Develop severe joint pains of hands and feet.
Age: 1.1
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site reaction
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 13 month old female patient. The patient had no pertinent medical history, nor concomitant medications and no drug reactions/allergies. The patients concurrent conditions were not reported. On 22-AUG-2016, the patient was vaccinated with a dose of VARIVAX injection, (which had a lot number reported as M022103 with an expiration date on 04-MAY-2018) dose 1, subcutaneously (dose, concentration and frequency were not reported). On 26-AUG-2016, 5 days after onset of therapy the patient experienced injection site erythema and injection site reaction. The patient sought medical attention as she went to the physicians office on an unspecified date and did not receive treatment for the above mentioned adverse events. There was no product quality complain involved (PQC). No laboratory diagnostic studies were performed. Furthermore, it was reported that there was no intervention to prevent serious criteria, the patient was not hospitalized, there was no significant disability or incapacity and the patient did not died. At the time of reporting, the outcome of injection site erythema and injection site reaction was reported as recovering. The primary reporter did not provide the causal relationship between VARIVAX and the events. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Head injury, Laceration, Syncope
Clinical narrative: Syncope - fainted shortly after leaving our office in the hall way of our building. He hit his head - laceration - we cleared and he was able to go home.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 20-JUL-2016 the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: In LA w/ZOSTAVAX pt had baseball sized, warm welt, that decreased next day to size of golf ball.
Age: 25.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Local swelling
Clinical narrative: Two raised red lines emanating from deltoid area of injections laterally around front of arm to underarm. Patient said they did not itch but were painful. Recommended emergency room.
Age: 1.0
Sex: M
Vaccine: HEP, HEPA, HIBV, MMRV, PNC13
Symptoms: Rash, Streptococcus test negative
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 12 months old male patient. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2016, the patient was vaccinated with PROQUAD (injection, 5ml, lot #L046506, expiration date 15-MAY-2015, by subcutaneous route), PEDVAXHIB (injection), ENGERIX-B, PREVNAR and HAVRIX. There were no concomitant medications reported. The primary reporter stated that on 02-SEP-2016, the patient developed a rash on his face and chest. The pharmacist stated that a rapid strep test was performed on 02-SEP-2016, which the result was negative. The outcome of the event was not recovered and no product quality complain was involved. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Fatigue, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelling, hot to touch, fatigue, weakness.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions and historical conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (concentration, dose, anatomical place of vaccination and route were not reported) which had a lot # reported as "M013067" and an expiration date of 01-APR-2017, a lot # of L019835 with an expiration date of 23-MAR-2017 and a lot # of L040053 with an expiration date of 10-MAY-2017. Information regarding concomitant therapies was not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Burning sensation, Dyspnoea
Clinical narrative: Pt stated difficulty breathing for about 4 hrs at the same day of vaccination, and burning sensation all over the body for about 8 hrs on the same day of vaccination.
Sex: U
Vaccine: MMR
Symptoms: Measles, Measles antibody negative
Clinical narrative: This literature report was received from the authors of a published literature article concerning a 49 year old patient of unknown gender who was classified to be a Reinfected Case (RIC). On an unknown date, the patient was vaccinated with the third dose of M-M-R II (route and lot # not reported). Despite the continued importations of measles virus into the article country, the elimination of indigenous measles had been maintained for over 15 years because of sustained high coverage with two doses of M-M-R II. Many countries have eliminated measles or have made significant progress toward achieving goals for measles elimination. However, measles remained endemic in many parts of the world and both sporadic cases and large outbreaks have occurred in this country following importations of the virus. Although most measles cases in the country have occurred among unvaccinated individuals, some confirmed cases have occurred among vaccinated and presumptively immune individuals. A suspected measles case in a previously vaccinated individual could be classified as a primary vaccine failure (PVF) by measurement of low-avidity measles IgG antibody. Individuals with confirmed measles and a prior immunologic response to measles virus (reinfection) from either vaccination or natural disease that occurred at least 4 months before symptom onset can be identified by the presence of high-avidity measles IgG antibody. A measles virus reinfection that occurs in an individual who had measurable specific antibodies after documented vaccination constitutes a secondary vaccine failure (SVF). However, the vaccination history of some persons with confirmed reinfections could be unknown, and among those with higher or equal to 1 documented doses of vaccine, evidence of a protective titer of antibody to measles following vaccination is rarely available. Therefore, the term reinfection case (RIC) can be universally applied to a confirmed measles case in a person with high-avidity measles IgG antibody. In this study, persons suspected of having measles with high avidity measles IgG antibody in serum were tested by standard laboratory methods and were classified as having either a RIC or a rash illness not attributable to measles (noncase). On an unknown date, the patient was reported to have had no detectable IgG despite the receipt of three doses of M-M-R II vaccine. It was reported that the IgG concentrations in this reinfected case increased rapidly after rash onset and reached peak titers before 10 days after rash onset. Between 1 and 2 months after rash onset, the elevated concentrations had fallen below 40,000 mIU/mL. In conclusion, although high coverage with two doses of M-M-R II vaccine has eliminated measles, vaccination may fail to stimulate a protective level of antibody in some individuals, even after two doses of M-M-R II. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Eating disorder, Oropharyngeal pain, Swollen tongue
Clinical narrative: Pt given FLUZONE HD on 9/7/16-pt fine at time of shot, but later that day had sore throat and left side of tongue swelling up to cause difficulty swallowing and eating. Pt states no fever or other symptoms. Symptoms lessen with gargle of hydrogen peroxide.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concurrent conditions and medical history were not reported. On an unspecified date in December 2015, the patient was vaccinated with the second dose of GARDASIL 9 (Lot number, expiration date and route were not provided). Concomitant medications were not reported. The reporter stated that "today" on 08-SEP-2016, the patient would be administered the third dose of the GARDASIL 9 series, which was longer than the recommended time frame. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 11-JUL-2016 the patient received an improperly stored dose of VARIVAX (lot # L031066, expiry date: 13-JAN-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 29-JUN-2016 the patient received an improperly stored dose of VARIVAX (lot # L031066, expiry date: 13-JAN-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several 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 as received from a registered nurse refers to a patient of unknown age and gender. On 20-JUL-2016, the patient received an improperly stored dose of PROQUAD (lot # L040412, expiry date: 13-APR-2017) (incorrect product storage). No adverse effect reported. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions and historical conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (concentration, dose, anatomical place of vaccination and route were not reported) which had a lot # of L003192 with an expiration date of 22-OCT-2016, and a lot # of M000442 with an expiration date of 31-MAR-2018. Information regarding concomitant therapies was not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to an unknown number of patients of unknown age and gender. The patients' concurrent conditions and historical conditions were not reported. On an unknown date, the patients were vaccinated with improperly stored doses of  M-M-R II (concentration, dose, anatomical place of vaccination and route were not reported) which had a lot # of L024264 with an expiration date of 01-JUN-2017. Information regarding concomitant therapies was not reported. No adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAP, FLU4, MMRV, PNC
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left leg is red, swollen, warm to touch.
Age: 40.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Conjunctival haemorrhage, Eye swelling, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: 9-18-16AM Rt eye swollen below eye, at eye with conjunctival hemorrhage, that spread through the day. 9-9-16 - LD - hard, red, hot were it was given, felt feverish - 9-8-16  9-9-16 TYLENOL was taken.
Age: 40.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Pyrexia, Tuberculin test
Clinical narrative: 9-18-16AM Rt eye swollen below eye, at eye with conjunctival hemorrhage, that spread through the day. 9-9-16 - LD - hard, red, hot were it was given, felt feverish - 9-8-16  9-9-16 TYLENOL was taken.
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Incoherent, Lethargy
Clinical narrative: 7 hours after administration, pt started sweating, became incoherent, and was lethargic for 24 hours. Pt reports eating food to relieved symptoms, but didn't help. Resolved after 24 hours.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Syncope
Clinical narrative: Pt had syncopal episode a few minutes after receiving vaccine. Episode occurred while getting blood work. Recovered quickly, no treatment needed.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic reaction. EPIPEN, BENADRYL IM, and SOLU-MEDROL IM.
Age: 16.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 16 year old patient of unknown gender. On 05-APR-2016, the patient was vaccinated with improperly stored dose of GARDASIL 9 (dose, anatomical location and route of administration were not provided, lot # L026602 with expiration date 19-OCT-2017). The vaccine underwent temperature excursion of either +1 or -1 degree Celsius for 255.5 total cumulative hours, which was detected by a data logger. There was no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Hand-foot-and-mouth disease, Pyrexia, Rash pustular, Stomatitis
Clinical narrative: Patient had blistery welts or poxlike sores appear all over hands, including palms. The pox did not ooze. Doctor diagnosed it erroneously as hand foot and mouth despite the fact that there were no other rashes nor fever. Patient contracted actual hand foot and mouth on 9/5/2016, developing a fever, sores in mouth, on bottoms of feet, and on the palms of his hands.
Age: 6.0
Sex: M
Vaccine: VARCEL
Symptoms: Urticaria
Clinical narrative: Patient had blistery welts or poxlike sores appear all over hands, including palms. The pox did not ooze. Doctor diagnosed it erroneously as hand foot and mouth despite the fact that there were no other rashes nor fever. Patient contracted actual hand foot and mouth on 9/5/2016, developing a fever, sores in mouth, on bottoms of feet, and on the palms of his hands.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Dysphonia, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Scratchy sore throat, cough with wheezing on expiration, chest tightness, throat swelling, hoarseness.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Throat irritation, Wheezing
Clinical narrative: Scratchy sore throat, cough with wheezing on expiration, chest tightness, throat swelling, hoarseness.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Chest pain, Dizziness, Impaired work ability, Muscular weakness, Pain
Clinical narrative: Patient started with a very sore arm that spread to rest of body. Patient's legs became wobbly and patient became dizzy and got blurry vision. Patient also got chest pains and went to ER but was found no issues with heart. Patient hasn't been able to work and symptoms still continuing as of this report 9/10/16.
Age: 63.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Vision blurred
Clinical narrative: Patient started with a very sore arm that spread to rest of body. Patient's legs became wobbly and patient became dizzy and got blurry vision. Patient also got chest pains and went to ER but was found no issues with heart. Patient hasn't been able to work and symptoms still continuing as of this report 9/10/16.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Widespread itching - mostly to upper body, chest and arms. No hives.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: Patient described her upper arm becoming very red, warm, and sore. Noticed it before going to bed a few hours after vaccine administered. Symptoms had mostly faded by time I saw her on Fri. 9-9-16.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, erythema and warmth at the side of injection, about 11x8 cm.
Age: 25.0
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Diarrhoea, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Hardness, pain, swelling at injection site, persistent diarrhea.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain, Pyrexia
Clinical narrative: Patient experience fever, sharp abdominal pain.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: CSF lymphocyte count abnormal, CSF monocyte count decreased, CSF neutrophil count increased, CSF white blood cell count increased, Computerised tomogram head abnormal
Clinical narrative: Home: Pale, limp, listless, not responding to stimuli. ED: intermittent periods of tonic activity of upper and lower extremities with clonus noted in the left lower extremity.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cytogenetic analysis, Electroencephalogram abnormal, Endotracheal intubation, Enterovirus test negative, Epilepsy
Clinical narrative: Home: Pale, limp, listless, not responding to stimuli. ED: intermittent periods of tonic activity of upper and lower extremities with clonus noted in the left lower extremity.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Herpes simplex test negative, Hypotonia, Listless, Mechanical ventilation, Nuclear magnetic resonance imaging brain abnormal
Clinical narrative: Home: Pale, limp, listless, not responding to stimuli. ED: intermittent periods of tonic activity of upper and lower extremities with clonus noted in the left lower extremity.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pallor, Pleocytosis, Polymerase chain reaction, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Home: Pale, limp, listless, not responding to stimuli. ED: intermittent periods of tonic activity of upper and lower extremities with clonus noted in the left lower extremity.
Age: 1.25
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Rash generalised
Clinical narrative: Quickly developing bad rash all over body. Arms, legs, stomach, diaper region, face. Got worse over the course of 3 days.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Pain
Clinical narrative: Immediate ache at vaccination site.  By 6:15, upper arm around injection site to three inch diameter was red and swollen.  On 9/9 redness had moved downward toward elbow; by evening on 9/9 redness extended into chest wall.  On 9/10 injection site has less redness but redness continues toward elbow and into chest wall.  No itching.  Pain occurs when elbow is raised to shoulder height.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Vaccination site pain
Clinical narrative: Immediate ache at vaccination site.  By 6:15, upper arm around injection site to three inch diameter was red and swollen.  On 9/9 redness had moved downward toward elbow; by evening on 9/9 redness extended into chest wall.  On 9/10 injection site has less redness but redness continues toward elbow and into chest wall.  No itching.  Pain occurs when elbow is raised to shoulder height.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Gait disturbance, Injection site pain, Injection site reaction, Lethargy, Movement disorder
Clinical narrative: Could have begun previous night, we noticed when he woke 2 hours early 9/10/16.  He is experiencing lethargy and "green" look to skin tone.  Biggest issue is that site (leg) appears to be very stiff and sore.  He is limping and seems unable to bend the leg.  More stiff than sore.  Better word for limping probably, because it is that he is keeping the stiff leg completely straight while walking.  Administered ibuprofen. Still experiencing symptoms so appropriate event outcomes can't be checked at this time.