chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information was received from a 81 years old female consumer stated that she received ZOSTAVAX subcutaneously (dosage unknown) for the treatment as part of a clinical study in 2005. She stated that she did get the shingles on her right side in the lower back spine, and buttocks region on 22-NOV-2011. She was treated with VALTREX. Unspecific medical attention was sought. At the time of the report, the outcome of AE was not reported. Action taken with the study therapy due to the event was not applicable. The relationship between study therapy and AE was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to 7 unspecified patients. On an unknown date in 2013 the patients were administered expired PNEUMOVAX23 (lot # 671038/0811AA, expiration 15-MAR-2013), injection, 0.5 ml, intramuscularly. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a nurse (Licensed Vocational Nurse) refers to a patient of unknown age and gender reported as child. On an unknown date the patient was inadvertently, instead of VARIVAX (Merck) vaccinated with PROQUAD (Merck), injection (dose, route and lot number not provided). This resulted receiving a 3rd dose of MMR II. No adverse effect was reported. The outcome of events was not reported. This is one of 2 reports from the same source. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Activities of daily living impaired, Autonomic nervous system imbalance, Chronic fatigue syndrome, Computerised tomogram thorax abnormal, Laboratory test normal
Clinical narrative: Developed chronic fatigue syndrome and dysautonomia symptoms temporally associated with receipt of Anthrax #4 and also had prolonged URI. Symptoms waxed and waned over the next years and now reports continuous symptoms with a great impact on daily functioning.
Age: 25.0
Sex: F
Vaccine: ANTH
Symptoms: Pulmonary mass, Upper respiratory tract infection
Clinical narrative: Developed chronic fatigue syndrome and dysautonomia symptoms temporally associated with receipt of Anthrax #4 and also had prolonged URI. Symptoms waxed and waned over the next years and now reports continuous symptoms with a great impact on daily functioning.
Sex: U
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. In July 2013 (reported as about month ago) the patient was vaccinated with GARDASIL (intramuscular, lot #, dose, strength, site of administration not reported). In July 2013, immediately after being administered the GARDASIL, the patient passed out. The outcome of the patient passed out was reported as recovered/resolved (date not reported).  Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Rash erythematous, Skin warm
Clinical narrative: 2" red raised rash, warm to touch, painful.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Developed redness, warmth, no drainage at the site of injection.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: 6-8" x 2"-3" rash left arm warm hot rash itch.
Age: 4.0
Sex: M
Vaccine: DTAP, HEPA, IPV, MMRV
Symptoms: Acne, Erythema, Pyrexia, Scab
Clinical narrative: Mom called on 8/28/13 and reported client had little red pimples about 20 of them that have burst open and now dried- reports also had fever of 101 degrees up until last night - reported these symptoms started 3 days post vaccines.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Insomnia, Pain in extremity
Clinical narrative: Pt stated vaccine given too high in deltoid which resulted in arm pain for multiple days and difficulty sleeping.
Age: 20.0
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B antibody negative
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 20 year old patient, gender unknown. On an unknown date, in the past when the patient was younger, the patient was vaccinated with 3 doses of RECOMBIVAX HB, injection (lot number, exp.date not provided). The reporter stated that the patient was found to have a negative titer for Hepatitis B approximately on an unknown date in 2013 (reported as after a recent titer test) and sought medical attention. The nurse gave a dose of RECOMBIVAX HB (lot#, expiration date and route not reported), 10 microgram on 07-AUG-2013. The outcome of event was unknown. Causality was not reported. Additional informaiton has been requeted.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Had a syncope reaction. Lost consciousness for 30 seconds to 1 minute.
Age: 0.15
Sex: U
Vaccine: RV5
Symptoms: Clostridium test negative, Diarrhoea, Haematochezia
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse, refers to a 1 month old patient of unknown age. On 13-AUG-2013 the patient was vaccinated with oral ROTATEQ (dose, and lot number were not provided), oral solution, for prevention of rotavirus gastroenteritis. Concomitant medications were not reported. Licensed Practical Nurse reported that on 19-AUG-2013, that the patient experienced diarrhea and blood in stool after being vaccinated with oral ROTATEQ. A Clostridium difficile test (reported as "C Diff test") was performed, on an unspecified date in August 2013, and it came back negative. The outcome of diarrhoea and blood in stool was reported as not recovered/not resolved. The relationship between the oral ROTATEQ and the events was not reported. Patient had an office visit on an unspecified date. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Erythema, Local swelling, Vomiting
Clinical narrative: Patient indicates arm red and swollen from elbow to shoulder and stomach upset and had been vomiting.
Sex: F
Vaccine: HPV4
Symptoms: Anogenital warts
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL dose 1 (route, site and lot number not provided). On an unknown date the patient developed genital warts, after receiving the first dose of GARDASIL. The outcome of the event was unknown. The casual relationship was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Skin warm, Urticaria
Clinical narrative: 3" welt on pts arm where vaccine was given. Warm to touch.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a physician refers to a 65 year old female patient. On 15-AUG-2013, the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneously. On an unknown date in August 2013, the patient developed a, not major but noticeable, rash on both arms, after receiving ZOSTAVAX. The patient sought medical attention: office visit on an unspecified date. The outcome of noticeable rash on both arms was reported as recovering. Additional information has been requested.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 87 year old female patient with rheumatoid arthritis. The patient had no pertinent drug reactions/allergies. On 17-JUN-2013 the patient was vaccinated with ZOSTAVAX (lot # J000434, exp. date, 10-APR-2013) 0.65 ml subcutaneous in the left arm. Concomitant therapies included methotrexate (manufacturer unknown). The pharmacist noted that the patient, experienced an injection site reaction after receiving ZOSTAVAX. On 18-JUN-2013, the patient noted that her left arm where she had the injection of ZOSTAVAX was red, swollen, warm to touch and painful. The patient was seen by her unspecified physician on an unspecified date for evaluation. The patient returned on 23-AUG-2013 to see the pharmacist and inform her that the injection site from the ZOSTAVAX was still red and "about the size of a silver dollar", but no longer was swollen, warm to touch or painful. No treatment was given for the adverse events. The relationship between ZOSTAVAX and the events was not reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient c/o itchy raised red rash 24 hours after receiving varicella vaccine.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Pain in extremity, Swelling
Clinical narrative: Swelling and sore arm - treated in walk-in care on 8/22/13. Treated w/ Medrol and Cephalexin - diagnosed w/ cellulitis.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Pt began pain in forearm that progressed to numbing in fingers and hands. Spoke w/ pt again 8/24/13 and symptoms subsided.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Furuncle, Rash
Clinical narrative: 61 year old male presents with chief complaint rash on his face and neck. States about 2 weeks after he had the shingles vaccine he started having boil type lesions on his face and in his nose and in his ear. He states if the lesions drained they then spread to other parts of his face or neck. (PGN dated 6/5/2013-NP Office).
Age: 64.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Right deltoid and large, red, raised, painful area on deltoid and fever. PREDNISONE 20 MG QWEEK, CETIRIZINE 10 MG QWEEK.
Age: 8.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Eye swelling, Swelling face
Clinical narrative: Face swelled and eyes swelled - child was given standard peds dose of diphenhydramine and stayed home from school. By later that day - around 6:00 pm child was back to normal.
Age: 43.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Pt presents to show RN and PCP his pneumonia vaccine injection site. Site is red, swollen, tender....Area is outlined and pt is instructed to RTC on Monday to evaluate for progress. PGN - Nurse (Clinic). Symptoms: Rash.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Local swelling, Pruritus
Clinical narrative: Arm had immense itching, swole area 3 times size, area moving towards shoulder.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On the injection site left posterolateral part of upper arm, erythema, swelling and warmth, tenderness.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Feeling hot, Injection site reaction, Swelling, Tenderness
Clinical narrative: On the injection site left posterolateral part of upper arm, erythema, swelling and warmth, tenderness.
Age: 0.59
Sex: M
Vaccine: DTAP, FLU3, HBHEPB, IPV, PNC13, RV5
Symptoms: Body temperature increased, Irritability
Clinical narrative: The baby received the DTaP, Hib, IPV, PREVNAR, rotavirus, FLUZONE in the am. By night, he developed at a temp of 104.8 degrees and was fussy. He was seen at local ER.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to other patients including a pharmacy staff member of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot#, dose, route, frequency and indication not provided). On an unknown date, after vaccination, the patients developed less severe injection site reaction. At the time of the report, the patients' outcome was unknown. This is one of two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (CMA), refers to a patient of unknown age and gender. On 22-AUG-2013 the patient was vaccinated with the third dose of GARDASIL (lot # H012973, exp date 05-MAR-2015) (0.5 ml, intramuscular) that was unsupported due to lack of in house stability data. Concomitant therapy was not reported. The reporter noted that his was the third and final dose in the vaccine series for the patient. This medical assistant was uncertain of the date for the start of the GARDASIL series. No adverse effect reported. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Patient was given 8/27/13 and called and talked with patient on the phone 8/30/13 states injection site red and hard. Advised warm compress to site TID. If not improved, call for appoint.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, HIBV, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: 8-16-13 Received vaccine. 8-19-13 started running low grade fever (101 degrees) 8-26-13 rash on face, neck, chest, and back and continue low grade fever. 8/30/13 rash "pretty much gone."
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Dizziness, Immediate post-injection reaction, Presyncope
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 19 year old male patient who on 14-AUG-2013, was vaccinated with GARDASIL lot # H015555 dose 1, 0.5ml, intramuscular. Pharmacist reported that patient experienced sudden dizziness and almost fainted. According to the pharmacist the patient "had to be held up by his grandmother" immediately after receiving the GARDASIL injection. The patient was given some food and something to drink and observed for an additional half hour at which point patient was considered well enough to leave the unspecified physician's office. No further information available. Therapy was not discontinued. The outcome of sudden dizziness was reported as recovered/resolved on 14-AUG-2013. The relatedness between adverse event and GARDASIL was unknown.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 67 year old female patient. On 20-AUG-2013 the patient was vaccinated with ZOSTAVAX (lot number reported as J003359, exp. date 21-JUN-2014) (dose and route were not provided). Concomitant medications were not reported. The pharmacist reported that in August 2013, a patient developed an injection site reaction following vaccination with ZOSTAVAX. The injection site reaction was described as an area that was swollen, red (no rash), warm and itchy at the ZOSTAVAX injection site. Patient contacted with the pharmacy. The outcome of swollen, itchy, warm and red at the ZOSTAVAX injection site, was reported as not recovered/not resolved. The relationship between ZOSTAVAX and the events was not reported. Additional information is not expected.
Age: 0.78
Sex: F
Vaccine: HIBV
Symptoms: Abdominal X-ray, Full blood count, Laboratory test, Vomiting
Clinical narrative: Repeated vomiting of formula and baby foods, onset 4-6 ours after receipt of vaccine, duration 48 hrs. No fever or other illness symptoms immediately prior to vaccine.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Symptoms: SkinRash. Treatment: Fluocinonide every day.
Age: 16.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Patient received DTAP/IPV on left arm. 48 Hs c/o develop swollen and redness on site in small blisters, on site of injection. Today the arm is swollen, mild redness. He had no fever or breathing difficulties.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse, refers to a patient of unknown age and gender. On 23-AUG-2011, the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose and route not reported). A second dose of GARDASIL (Lot # not reported) (dose and route not reported) was administered to the patient on 22-AUG-2012 and the patient was currently at the physician's office and a third dose of GARDASIL (Lot # not reported) (dose and route not reported) will be administered that day on 27-AUG-2013. Concomitant therapy was not reported. No adverse symptoms reported.  Additional information has been requested.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Pain in her arm, red and swollen. Advised ice compress and Advil as needed for pain.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Low grade fever, redness and tenderness at injection site and swelling (Anterior side of injection). Limited arm mobility for one day.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Asthenia, Dizziness, Pain, Urticaria
Clinical narrative: Pt broke out in hives 1 hr after injection and later in the day had dizzy, weakness, body aches.
Age: 64.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm red and swollen at injection site. Pain worsened to shoulder area. Prescribed Methapred injection and prednisone by mouth.
Age: 21.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: Fever, body aches, was not able to move arm - advised cold compress and TYLENOL or ADVIL.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Condition aggravated, Loss of consciousness, Muscle twitching, Opisthotonus, Syncope
Clinical narrative: After pt was vaccinated, he was still sitting in a chair when suddenly he arched his back into a plank position, twitched and lost consciousness. After a few seconds he came to with no other effects. Mother recognized this as him fainting.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Mother states that client developed a pinpoint red raised red rash on his trunk and back within one hour after vaccination. No other sx, mother gave him BENADRYL for itchiness. PHN advised her to contact clients PMP to discuss this.
Age: 1.08
Sex: F
Vaccine: DTAP, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised, Rash papular
Clinical narrative: Parent reported to physician at 16 mo well, states child had fever 102-103.4 (started 8 days post MMR given) with small papillar rash on cheeks, stomach, back and thigh, no swollen glands, no dyspnea, no other sx noted. Call MD on call, lasted 3 days.
Age: 4.0
Sex: U
Vaccine: DTAP, IPV, MMR
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Headache, Throat irritation, Tic
Clinical narrative: Developed a tic-within-24 hours of vaccine. Juts chin out/clears throat - worse at night. Bad headache after 2 days of vaccination.
Age: 17.0
Sex: M
Vaccine: TDAP, VARCEL
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Hyperhidrosis
Clinical narrative: About 2 minutes after shots were given; client felt dizzy, weak, light headed. Stated he felt faint. BP dropped, he became diaphoretic. He did not lose consciousness. We gave him a cool cloth for his forehead offered apple juice and had him stay at clinic until symptoms subsided.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Induration, Nodule, Pain
Clinical narrative: Hard red know on upper arm, sore and red to touch. Patient taking benadryl and ibuprofen and will followup with MD.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: Swelling and itching to left deltoid 8/29/13 worse 8/30/13.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness
Clinical narrative: Pt. became lightheaded and dizzy after receiving vaccine. Patient's legs were propped. Meclizine administered. Breathing continued steady and ambulance was called. All within about a 20 minute window.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm and erythema, and swelling, and warmth firm to palpation and itchiness. Full ROM with no pain, numbness, nor fever. Advised to use TYLENOL/Ibuprofen as needed, BENADRYL, ice call with worse symptoms.
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Burning sensation, Hypoaesthesia, Paraesthesia
Clinical narrative: About 2 days after vaccine, right arm was numb, tingling, and burning for 1-2 hours. About 2 days later, left wrist and part of hand was numb for a couple of hours. Symptoms went away without treatment.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation, Injection site rash, Injection site vesicles
Clinical narrative: Pt rec. Zostavax on 8/23/13 approx 2PM. Pt states 4 days later she developed a rash on her left shoulder (rear part) with small fluid filled blisters. It covered an arm of about 3-4 inches long. It was not itchy or painful but it gets irritated when her blouse rubs on it.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Hypersensitivity, Pruritus, Rash, Urticaria
Clinical narrative: Allergy reaction rash, itching, hives body, chest, hands. Medical treatment with prednisone tablet 8/22/13.
Age: 40.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: PNEUMOVAX administered, patient states after couple hours site became painful, hot, swollen.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Mom noticed the reaction yesterday 8/29/13 around 6:00 PM red, warm and swelling. Pt. got PROQUAD on the left arm on 8/27/13. Reaction's measurements 20 x 30 mm.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: -5 min after admin pt feels dizzy. Rested w/husband in waiting area. - 10 min after admin pt said "very dizzy and lightheaded" wanted EMT called. I called 911 pt. responsive and talking until ambulance arrived. EMT did not need further info from me. EMT took pt with them. Per patient, she was given "steroids and an IV" in the E. R.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea
Clinical narrative: Pt claimed that 3 hrs after receiving the flu vaccine, she had a hard time breathing.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: Red, swollen area with fever.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Gastrointestinal disorder
Clinical narrative: GI tract issues including diarrhea. I took IMODIUM AD and MAALOX ADVANCED.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Feeling hot, Flushing, Induration, Nodule, Pain in extremity
Clinical narrative: Whole arm hurts, hot, face flushed (cheeks), hard lump.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash pruritic
Clinical narrative: This spontaneous report as received from a licensed practical nurse (L.P.N) concerning to a 5 year old male patient with none drug reactions/allergies and none pertinent medical history. On 20-AUG-2013, the patient was vaccinated with VARIVAX (Merck) (dose, frequency, concentration and route of administration were not provided), lot number J002317, subcutaneous. There were no concomitant medications. On 20-AUG-2013, 12 hours later after vaccination; the patient experienced rash pruritic that appeared on the inner thigh and then spread from there to unspecified locations of the body. No laboratory studies were reported. On an unknown date the patient was given acetaminophen (manufacturer unknown) and hydrocortisone (manufacturer unknown ) as treatment for the event. No further information was available. At the time of this report the outcome of rash pruritic was unknown. The causality between the adverse event and the vaccine was unknown. Additional information has been requested.
Age: 1.52
Sex: M
Vaccine: MMR
Symptoms: Crying, Pyrexia
Clinical narrative: Patient began have crying spells the day after immunization. He would start crying for no apparent reason and nothing would console him. This continued till 08/29/2013. On 08/30/2013 he presented with a fever of 102.5.
Age: 1.02
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Low grade fewer and rash all over body.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Confusional state, Convulsion, Dysphemia, Electroencephalogram abnormal, Epilepsy
Clinical narrative: Had immunizations on 7/29/13 developed headaches wed. 7/31-8/1 and 8/2/13 and awoke 8/3/13 in AM repeating words, stuttering and brief periods of confusion.  Diagnosis Seizures, Epilepsy. Abnormal EEG, Normal MRI, Now taking seizure medication Keppra.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Headache, Nuclear magnetic resonance imaging brain normal, Speech disorder
Clinical narrative: Had immunizations on 7/29/13 developed headaches wed. 7/31-8/1 and 8/2/13 and awoke 8/3/13 in AM repeating words, stuttering and brief periods of confusion.  Diagnosis Seizures, Epilepsy. Abnormal EEG, Normal MRI, Now taking seizure medication Keppra.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site cellulitis
Clinical narrative: Cellulitis of right deltoid area, advised Tylenol/Motrin, Benadryl, and prescribed oral antibiotic.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Injection site erythema, Injection site pruritus, Injection site swelling, Oropharyngeal pain
Clinical narrative: Injection point became itchy.  Removed Band-Aid to check area.  No viewable reaction.  Continued itching and fatigue for the rest of the day.  Woke up at 6:00 AM on 8/30 with a slight sore throat.  Injection site was red/swollen and "bubbly".  Didn't feel sick, but "down" all day. Gargled with salt water several times in afternoon/evening after returning home from work.  Too fatigued to do anything but watch tv for remainder of evening.  Body aches. Asleep by 11 PM. Woke up at 8 AM 8/31, feeling unrested.  Sore throat persists (slightly less pain).  Injection site still swollen, but less coloration and "bubbles".  Is now 10:15 AM.  Gargled with saltwater once.  Fatigue and soreness (body & injection sight), as well as slight sore throat persists.  Injection sight is no longer itchy, but slightly sore.  Still swollen.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Injection point became itchy.  Removed Band-Aid to check area.  No viewable reaction.  Continued itching and fatigue for the rest of the day.  Woke up at 6:00 AM on 8/30 with a slight sore throat.  Injection site was red/swollen and "bubbly".  Didn't feel sick, but "down" all day. Gargled with salt water several times in afternoon/evening after returning home from work.  Too fatigued to do anything but watch tv for remainder of evening.  Body aches. Asleep by 11 PM. Woke up at 8 AM 8/31, feeling unrested.  Sore throat persists (slightly less pain).  Injection site still swollen, but less coloration and "bubbles".  Is now 10:15 AM.  Gargled with saltwater once.  Fatigue and soreness (body & injection sight), as well as slight sore throat persists.  Injection sight is no longer itchy, but slightly sore.  Still swollen.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Eye discharge, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Difficulty breathing, sore throat and difficulty swallowing, red eyes emitting a sticky substance.
Age: 33.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Immediate post-injection reaction, Injection site haemorrhage, Injection site swelling
Clinical narrative: Immediate swelling at injection site with blood coming out as needle was drawn out. Starting feeling a little dizzy immediately. Rested for 10-15 minutes. No change in dizziness. BP 155/101. Rested for another 15-20 minutes. Started to feel better. BP 132/80. Patient was able to get up and felt fine to leave pharmacy.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Asthenia, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Shortness of breath, general weakness and tiredness and fast heart beat.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site inflammation, Injection site pruritus, Injection site warmth
Clinical narrative: Injection Site reaction (hardness, redness, warmth, itching). Inflammation has gone down after 2 days but still itching and red mark the size of a fist around injection site.
Age: 4.0
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Body temperature increased, Crying, Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Felt warm to touch (temp not taken immediately), crying that his arm was extremely sore. Visibly red, swollen and enlarged injection site. Injection site very hot to the touch. Later on, temperature was taken - reading 101.5. Complaints of arm pain continued - redness increased (deepened in color) and he began crying that his lips hurt and started pulling on them because they felt tight.
Age: 4.0
Sex: M
Vaccine: FLUX, MMR, VARCEL
Symptoms: Lip dry, Lip pain, Skin warm
Clinical narrative: Felt warm to touch (temp not taken immediately), crying that his arm was extremely sore. Visibly red, swollen and enlarged injection site. Injection site very hot to the touch. Later on, temperature was taken - reading 101.5. Complaints of arm pain continued - redness increased (deepened in color) and he began crying that his lips hurt and started pulling on them because they felt tight.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Hypersensitivity, Injection site inflammation, Pyrexia, White blood cell count increased
Clinical narrative: The patient alleges three hours after receiving the vaccine began to feel fever and inflammation that spread across the top of the arm where the shot was given. She visited dr who began treatment as an allergic reaction and order labs.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: Erythema, Local swelling, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: The patient alleges three hours after receiving the vaccine began to feel fever and inflammation that spread across the top of the arm where the shot was given. She visited dr who began treatment as an allergic reaction and order labs.
Age: 72.0
Sex: F
Vaccine: FLU3, PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: The patient alleges three hours after receiving the vaccine began to feel fever and inflammation that spread across the top of the arm where the shot was given. She visited dr who began treatment as an allergic reaction and order labs.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Vaccination site warmth
Clinical narrative: Pt. was vac. 8/29/13 approximately 11:40 AM - pt noticed redness and warmth around vac. site at approx noon on 8/30. Area widened in redness and sore to touch. Pt has been using ice on the area. Approx. 2 PM on 8/31/13 pt came into pharmacy with redness and swelling approx 5" x 3". Pt was advised to continue ice and use HC 1% cream and BENADRYL 25 mg.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Headache, Influenza like illness, Myalgia, Vomiting
Clinical narrative: Fatigue, headache, muscle aches, vomiting. Vaccination at 11:44 AM. Patient presents with flu like symptoms around 10 PM until 2 AM - vomiting also.
Age: 9.0
Sex: F
Vaccine: FLU3
Symptoms: Convulsion, Fall, Head injury, Loss of consciousness, Wound haemorrhage
Clinical narrative: Approximately 3-5 minutes after vaccine was given pt lost consciousness and hit her head (occipital lobe) as she fell. Pt appear to seize for about 2-4 minutes then came around. Bled at wound, pressure applied.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Diffuse swelling of leg from upper thigh to knee. No redness. Painful with lump.
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Rash, Rash pruritic
Clinical narrative: Report of pain at injection site as well as swelling. Also developed a rash from the elbow to the shoulder. The rash was itchy last night, but is no longer itchy.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site rash, Injection site swelling, Rash, Rash erythematous
Clinical narrative: This spontaneous report as received  from a Nurse Practitioner refers to a 58 year old female patient with high cholesterol, type II diabetes and allergy to morphine and aspirin. On 05-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # were unknown). Concomitant therapies included ZOLOFT, NOVOLOG, and omeprazole (manufacturer unknown). On 09-AUG-2013, the patient presented in office with shingles-like symptoms. The patient had a red, blotchy and itchy rash on both sides of her face; however the rash was not "shingles-like" in appearance. The patient also was experiencing general malaise, headache, fever and nausea. All these symptoms began on 07-AUG-2013 ("Wednesday"). The nurse practitioner planning on treating these symptoms with BENADRYL and KENALOG. The outcome of events was unknown. Additional information has been  requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Herpes zoster, Malaise, Nausea, Pyrexia
Clinical narrative: This spontaneous report as received  from a Nurse Practitioner refers to a 58 year old female patient with high cholesterol, type II diabetes and allergy to morphine and aspirin. On 05-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # were unknown). Concomitant therapies included ZOLOFT, NOVOLOG, and omeprazole (manufacturer unknown). On 09-AUG-2013, the patient presented in office with shingles-like symptoms. The patient had a red, blotchy and itchy rash on both sides of her face; however the rash was not "shingles-like" in appearance. The patient also was experiencing general malaise, headache, fever and nausea. All these symptoms began on 07-AUG-2013 ("Wednesday"). The nurse practitioner planning on treating these symptoms with BENADRYL and KENALOG. The outcome of events was unknown. Additional information has been  requested.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: This spontaneous report as received  from a Nurse Practitioner refers to a 58 year old female patient with high cholesterol, type II diabetes and allergy to morphine and aspirin. On 05-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (route, dose and lot # were unknown). Concomitant therapies included ZOLOFT, NOVOLOG, and omeprazole (manufacturer unknown). On 09-AUG-2013, the patient presented in office with shingles-like symptoms. The patient had a red, blotchy and itchy rash on both sides of her face; however the rash was not "shingles-like" in appearance. The patient also was experiencing general malaise, headache, fever and nausea. All these symptoms began on 07-AUG-2013 ("Wednesday"). The nurse practitioner planning on treating these symptoms with BENADRYL and KENALOG. The outcome of events was unknown. Additional information has been  requested.
Age: 63.0
Sex: M
Vaccine: DTP
Symptoms: Balance disorder, Gait disturbance
Clinical narrative: Walking difficulties and balance issues.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Headache, Hyperhidrosis
Clinical narrative: High fever, chills, pain all over body, tired, headache, cough, producing mucous, sweating, cold sensation inside chest area which suggests lung infection.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Lower respiratory tract infection, Lung infection, Pain, Pyrexia, Respiratory tract congestion
Clinical narrative: High fever, chills, pain all over body, tired, headache, cough, producing mucous, sweating, cold sensation inside chest area which suggests lung infection.
Sex: M
Vaccine: VARCEL
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. On an unknown date in approximately August 2003 (reported as on an unspecified date 10 years) the patient was vaccinated with the first dose of VARIVAX (Merck). The patient would not like to receive his second dose. No adverse symptoms was reported. It was unknown if the patient sought medical attention or not. At the time of report, the status of patient was unknown. Additional information has been requested.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report as received from a consumer refers to a 60 year old male patient with medical history of "toe nail fungus" and with no drug reactions/allergies. The patient stated about a year ago (about August 2012) he was diagnosed with the shingles. His doctor recommended he got a ZOSTAVAX vaccine after the shingles went away 6-7 weeks ago (about in June 2013) he got the ZOSTAVAX shot (1 injection, under the skin of the right arm, lot #, dose were unspecified) . There was no concomitant therapy. And then a few weeks after (on 08-AUG-2013), he broke out with the shingles and still had some of the rash present. He went to the doctor and started taking Acyclovir and "a cream of some kind" on 09-AUG-2013. No lab diagnostics studies was performed. The outcome of shingles was reported as recovering/resolving. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 22-AUG-2013 the patient was vaccinated with one dose of ZOSTAVAX rather than VARIVAX (Merck) for the second dose of VARIVAX (Merck) (first dose of VARIVAX (Merck) was administered on 17-MAR-2013) (dose, route and lot # not provided). No product confusion discovered, just a medication error. No adverse event reported. Additional information is not expected.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest discomfort, Dyspnoea, Heart rate increased
Clinical narrative: Patient was immunized at 10:30 AM and per pt about 60 min. later she felt tightness in chest, difficulty catching her breath and rapid HR. She called at 7:18 PM told me the SOB had resolved but had a HR 127 and BP 127/85. I called her back at 9:00 PM, she was asleep. Called at 2:45 all symptoms resolved. On 09/01/2013 she was monitoring her BP. Pt is ok and knows she is not allergic to shots. RPh again followup at 9:10 PM (9/1/2013). Per pt is feeling better and HR = 84, BP 132/78 mmHg.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Local swelling, Pain in extremity
Clinical narrative: Swelling of arm, pain, pt said could not raise arm, right arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: 8/30 - Pt showed a red, raised area at injection site about 3 inches in diameter - not painful or itchy, but said she had a headache and wheezy stomach. 8/31 - Became 8 inches, skin leathery, woke up w/sore joints.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin disorder
Clinical narrative: 8/30 - Pt showed a red, raised area at injection site about 3 inches in diameter - not painful or itchy, but said she had a headache and wheezy stomach. 8/31 - Became 8 inches, skin leathery, woke up w/sore joints.
Age: 14.0
Sex: M
Vaccine: HPV4, PNC13, HPV4
Symptoms: Emotional distress, Fall
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On 13-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021861, expiration date 09-OCT-2015)(0.5ml, intramuscular in the right arm). Concomitant therapies included one dose of PREVNAR13 (route, dose indication not reported) in the right arm. On 13-JUN-2013, the patient experienced dizziness, trouble with coordination and was emotional for up to 24 hours after the vaccination. There was no treatment given for the events. No lab diagnostics  studies performed. The patient did not seek the medical attention. On 14-JUN-2013, the patient was recovered from the events.  Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HPV4, PNC13, HPV4
Symptoms: Coordination abnormal, Dizziness, Emotional distress
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 14 year old male patient. The patient had no pertinent medical history or drug reactions/allergies. On 13-JUN-2013 the patient was vaccinated with the first dose of GARDASIL (lot # H021861, expiration date 09-OCT-2015)(0.5ml, intramuscular in the right arm). Concomitant therapies included one dose of PREVNAR13 (route, dose indication not reported) in the right arm. On 13-JUN-2013, the patient experienced dizziness, trouble with coordination and was emotional for up to 24 hours after the vaccination. There was no treatment given for the events. No lab diagnostics  studies performed. The patient did not seek the medical attention. On 14-JUN-2013, the patient was recovered from the events.  Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Chest X-ray, Computerised tomogram, Cough, Dizziness, Increased upper airway secretion
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Laboratory test, Pulmonary function test, Respiration abnormal, Respiratory distress, Retching
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Tinnitus, Vision blurred, Vomiting
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Activities of daily living impaired, Cough, Dizziness, Dyspnoea, Increased upper airway secretion
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV, PPV, PPV
Symptoms: Retching, Vision blurred, Vomiting, Wheezing
Clinical narrative: This spontaneous report as received from a consumer refers to a 66 year old female patient with tobacco allergy. Prior, patient's sister experienced illness with respiratory distress on 16-Jan-2013, one day after vaccination with PNEUMOVAX23 (linked case 1308USA014836). On 15-AUG-2013 the patient was vaccinated with PNEUMOVAX23 lot # J002646. Dosing information and route of administration were not provided. On 16-AUG-2013 (reported as the following day) the patient experienced severe coughing episodes, dry heaves, vomiting, wheezing and excessive mucus production. Additional symptoms included difficulty in breathing, blurred vision and dizziness. Treatment was sought through patient's physician in the form of "PREGNAZONE" (Watson labs brand), at an unspecified dosage and frequency and an unspecified "Z-PACK" antibiotic course. The adverse symptoms had not improved and patient had been forced to cancel her vacation and seek additional help of a pulmonologist. It was reported that an X-ray and computed tomography (CT) scan were performed on 26-AUG-2013. Causality assessment was not provided. Additional information has been requested.