chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient with high blood pressure and high cholesterol, no drug reaction/allergies. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot # J007211, exp. date: 20-SEP-2014), subcutaneous in the arm. No concomitant medication and no drug reaction were reported. On 13-JAN-2014, within a day of the administration, thea patient experienced an injection site reaction. The patient called the pharmacist. The pharmacist viewed a picture of the reaction and described it as being hot and bright pink at the injection site (1 inch wide by 3 inches long) and surrounding this the patient's skin is duller pink and swollen. The pharmacist noted the total injection site reaction is about 6 inches by 8 inches); from patient's deltoid (site of injection) down to patient's elbow and wrapped around her arm. Pharmacist recommended that patient draw a circle around the site with a black marker to see if the reaction gets any bigger. The treatment was not given for AE. Lab was not performed. The outcome of events was not recovered. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had drug reaction/allergy for penicillin. Pertinent medical history not reported. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot # J011338, exp. date: 19-DEC-2014, single dose, subcutaneous injection in the right arm) for vaccination. No concomitant therapies reported> on 15-JAN-2014 the patient developed redness, warmth, swelling, and itching at the injection site on the right arm. The patient also developed right arm pain and tingling of the fingers. The patient sought medical attention via pharmacy visit. No treatment was given. The outcome of events was not recovered. The relatedness between ZOSTAVAX and events was not reported. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 year old female patient. The patient had drug reaction/allergy for penicillin. Pertinent medical history not reported. On 13-JAN-2014 the patient was vaccinated with ZOSTAVAX (lot # J011338, exp. date: 19-DEC-2014, single dose, subcutaneous injection in the right arm) for vaccination. No concomitant therapies reported> on 15-JAN-2014 the patient developed redness, warmth, swelling, and itching at the injection site on the right arm. The patient also developed right arm pain and tingling of the fingers. The patient sought medical attention via pharmacy visit. No treatment was given. The outcome of events was not recovered. The relatedness between ZOSTAVAX and events was not reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site reaction
Clinical narrative: This spontaneous report as received from a nurse practitioner, via a company representative, refers to several (also reported as multiple) patients of unknown age. Recently (dates unspecified) the patients were vaccinated with ZOSTAVAX, by intramuscular route instead of by subcutaneous route. Dosing information and lot numbers were not provided. On unknown dates the patients experienced a higher than normal level of significant injection site reactions (unspecified). The patients had received the vaccine at the same pharmacy. The outcome of the injection site reactions and causality assessment were not provided. Additional information has been requested.
Age: 1.88
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 23 months old female patient. The patient's medical history included contact dermatitis. Patient had no drug reactions/allergies. On 14-JAN-2014 the patient was vaccinated with VARIVAX (Merck) dose 1, subcutaneous injection for routine immunization. Dosing information and lot number were not provided. No concomitant medication was used. On 22-JAN-2014, the patient experienced vesicular rash. Patient visited the office for medical attention. The event was treated with nystatin cream for diaper area. No lab diagnostics studies were performed. The outcome of vesicular rash was reported as not recovered/not resolved. Causality assessment was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received from a nurse, via a company representative, refers to a female patient of unknown age. In 2013 (reported as "sometime last year") the patient was vaccinated with ZOSTAVAX, subcutaneous for prevention of herpes zoster. Dosing information and lot number were not provided. On an unknown date the patient was seen in the office and had a very red and swollen arm but there were no pustules or rash. The outcome of the event and the causality assessment were not provided. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Immediate post-injection reaction, Pain in extremity, Tinnitus
Clinical narrative: Pt complained of leg pain and ringing in her head. Started immediately after vaccines and lasted 1 week. Symptoms have completely resolved.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Patient states varying degrees of edema and redness at site since injection. Currently minimal swelling with very faint redness appx 70mm in diameter.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pain at injection site. Unable to raise arm or bring arm behind back due to pain at injection site. Pain persists despite several months from injection.
Age: 3.0
Sex: M
Vaccine: HEPA
Symptoms: Fall, Musculoskeletal stiffness, Opisthotonus
Clinical narrative: Approximately 2 min after receiving Hep A vaccine and fingerstick for hemoglobin pt was sitting in the chair and fell from the chair onto the floor pt. began arching and stiffening for only seconds. Pt was assessed by in house pediatrician and sent to local emergency room for assessment.
Age: 78.0
Sex: F
Vaccine: UNK
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Patient called 2 days after receiving immunization and complained of a red itchy rash the size of a tomatoe.
Age: 61.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Erythema, Local swelling, Pain in extremity, Skin warm
Clinical narrative: (L) arm swollen, red, hot to touch, shooting pain (L) arm down to fingers x several wks.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Bright red large area around injection site, itchy and warm. Spread more after approximately 3 days.
Sex: M
Vaccine: FLU3
Symptoms: Autism, Maternal exposure timing unspecified, Neonatal disorder
Clinical narrative: This retrospective pregnancy case was reported by a healthcare professional and described the occurrence of autism in a neonate male subject exposed to FLULAVAL (GlaxoSmithKline) transplacentally when his mother was vaccinated. On 17 September 2010, the 33-year-old mother of the subject received a dose of FLULAVAL via intramuscular injection. Her last menstrual period and estimated date of deliver were unknown. The neonate was exposed to FLULAVAL at an unspecified gestation age during the 3rd trimester. On 21 September 2010, at unknown weeks gestation, the neonate was born; method of delivery, weight and Apgar were unknown. At the time of this report, no birth defects were reported. At an unspecified time after vaccination with FLULAVAL, the neonate developed autism. The reporter was inquiring about thimerosol in the multi-dose vial for FLULAVAL and mentioned that a mother was inquiring because her son was diagnosed with Autism. At the time of the report no other information was provided. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the autism was unresolved.
Age: 23.0
Sex: F
Vaccine: FLU3, HPV4, PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: Client reports when she woke up the day after shots were given, she was unable to move her (L) arm. Client came to our office, Dr. evaluated her, prescribed Tramadol, 50mg, 1 PO, Q 6 hrs PRN. Advised her to contact us as needed.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site swelling, Local swelling
Clinical narrative: Patient reported significant swelling in entire (L) arm where vaccine was admin.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling
Clinical narrative: This spontaneous report as received form a nurse via a company representative refers to a female patient of unknown age. On an unknown date in December 2013 the patient was vaccinated with ZOSTAVAX, dose and route were not provided. The patient was seen in the office on an unspecified date with a swollen and red arm. It was reported that there was no rash, and the nurse had mentioned something about giving TYLENOL as treatment. The outcome of swollen arm is unknown. Additional information has been requested.
Age: 0.53
Sex: M
Vaccine: DTAP, FLU3, HIBV, PNC13
Symptoms: Rash generalised, Urticaria
Clinical narrative: Urticaria. Rash entire body appeared the next day of vaccination. Treatment: Cetirizine 5 mg/5 mL oral sol. 2.5 mL for 7 days.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Pt reports redness and itchiness near vaccination site which started night of vaccination; which is slowly getting better, but still present today (8 days later). Pt reports icing site and taking oral BENADRYL to aid with itchiness and redness.
Age: 13.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Asthenia, Pallor, Syncope, Tremor
Clinical narrative: Shot administered IM, Left arm. She sat for 10 minutes then walked and shopped in store. At checkout she fainted - came back to Pharmacy sat for 40 mins. Had shaking tremors (very slight) white as a ghost, very weak, but did not faint again. Gave her water then she left to get something to eat with her mother and brothers.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Pain, Pruritus, Urticaria
Clinical narrative: Began to develop rash a few hours after flu vacc. (hives-type)... took BENADRYL to help with itching aches and headaches developed for 3 days - no BENADRYL taken 01-14-14 - Hives returning and to occ. health.
Age: 5.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 1/15 vaccines swollen. 1/16 red swollen and painful.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Headache, Injection site erythema, Injection site swelling, Myalgia, Pain in extremity
Clinical narrative: Fever, headache, myalgias and arm pain about 12 hrs post injection, prescribed TAMIFLU. Worsening left arm pain with redness and swelling at injection site, within about 48hrs, given cephalexin.
Age: 32.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: Fever, headache, myalgias and arm pain about 12 hrs post injection, prescribed TAMIFLU. Worsening left arm pain with redness and swelling at injection site, within about 48hrs, given cephalexin.
Age: 34.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site joint pain, Injection site pain
Clinical narrative: Pt. is experiencing joint pain in left shoulder, arm (severe pain) - also numbness in arm and wrist.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Pain in extremity, Pyrexia
Clinical narrative: Seen initially 15 hrs after injection administered with complaints of soreness and redness at the injection site. No fluctuance. Return to ED several hours later due to low-grade fever and "shakiness". ED doc had concern for cellulitis and started KEFLEX and BACTRIM. Mom called with update. States arm still painful today but able to extend it out (but not fully without further pain). Out of bed today; came downstairs to eat. Taking fluids well and urinating fine. Breathing easy. Denies facial swelling. On one ABX BID and another QID. Confirms taking as prescribed. Dosed with Ibuprofen x 1 today. States area of redness unchanged from ED visit. Red rash no better no worse. Denies any increase in red streaking. Advised to keep office updated and should see improvement after it has been 48-72 hours since ABX started.
Age: 14.0
Sex: M
Vaccine: PPV
Symptoms: Rash erythematous, Tremor
Clinical narrative: Seen initially 15 hrs after injection administered with complaints of soreness and redness at the injection site. No fluctuance. Return to ED several hours later due to low-grade fever and "shakiness". ED doc had concern for cellulitis and started KEFLEX and BACTRIM. Mom called with update. States arm still painful today but able to extend it out (but not fully without further pain). Out of bed today; came downstairs to eat. Taking fluids well and urinating fine. Breathing easy. Denies facial swelling. On one ABX BID and another QID. Confirms taking as prescribed. Dosed with Ibuprofen x 1 today. States area of redness unchanged from ED visit. Red rash no better no worse. Denies any increase in red streaking. Advised to keep office updated and should see improvement after it has been 48-72 hours since ABX started.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial pain, Headache, Injection site erythema, Nasal congestion, Pain in jaw
Clinical narrative: Large red spot at site of injection, headache, severe pain in the right side of face and jaw, stuffy nose.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Body temperature increased, Culture urine negative, Loss of consciousness, Pallor, Urine analysis normal
Clinical narrative: Approximately 3 - 4 hrs after vaccine administration, patient was in stroller noted to have pallor, vomiting with loss of consciousness. No jerking or tremors noted. Lasted 1 - 2 min. EMT's called and taken to ER - noted temp 103. In ER, noted normal UA and negative urine culture. Patient recovered, followed up the next day and was well.
Age: 0.6
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Vomiting
Clinical narrative: Approximately 3 - 4 hrs after vaccine administration, patient was in stroller noted to have pallor, vomiting with loss of consciousness. No jerking or tremors noted. Lasted 1 - 2 min. EMT's called and taken to ER - noted temp 103. In ER, noted normal UA and negative urine culture. Patient recovered, followed up the next day and was well.
Age: 19.0
Sex: F
Vaccine: FLUN4, HEPA
Symptoms: Fall, Syncope
Clinical narrative: After injection given, pt. fainted and fell forward from her chair.
Age: 82.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Local swelling, Pain in extremity
Clinical narrative: Swelling and redness upper arm - pain 12/26/13. Swelling increased redness now extended below elbow traveling to wrist - pain ER visit #2 12-28-13.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Palpitations, Throat tightness, Vomiting
Clinical narrative: Palpitations, difficulty breathing, vomiting, felt throat was tight, lightheaded.
Age: 45.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: After pt left our center pt called to c/o nausea, vomiting, and headache starting 15-20 mins after receiving MMR and varicella vaccines at our center. Pt instructed to f/u PCP or ER with worsening sxs. Pt told to f/u with us with any questions.
Age: 1.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS, MMR, VARZOS
Symptoms: Wrong drug administered
Clinical narrative: Zostavax was inadvertantly administered instead of varicella vaccine. Patient has not reported any adverse signs or symptoms.
Age: 1.0
Sex: M
Vaccine: MMR, VARZOS, VARZOS, MMR, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Zostavax was inadvertantly administered instead of varicella vaccine. Patient has not reported any adverse signs or symptoms.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: The morning after the high dose flu vaccine was given in left arm, patient awoke to extreme left arm soreness and could not lift left arm. As of 1/27/14 client still cannot lift left arm and is scheduled to see physician on 1/28/14.
Age: 0.43
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Autism, Childhood disintegrative disorder, Developmental delay
Clinical narrative: Development began to delay, milestones were no longer met on time if at all, displaying signs of autism, began homeopathic treatment January 10th, 2014.
Age: 0.83
Sex: M
Vaccine: PNC13
Symptoms: Developmental delay, Diet refusal, Hypotonia, Somnolence, Underweight
Clinical narrative: After vaccine slept all day.  Woke up refused to eat.  Started eating became extremely picky.  Over the next 10 days he became floppy and lost weight.  Stopped meeting milestones. Diagnosed with low muscle tone, underweight and developmental delay.  As a baby he was strong and healthy.
Age: 0.83
Sex: M
Vaccine: PNC13
Symptoms: Weight decreased
Clinical narrative: After vaccine slept all day.  Woke up refused to eat.  Started eating became extremely picky.  Over the next 10 days he became floppy and lost weight.  Stopped meeting milestones. Diagnosed with low muscle tone, underweight and developmental delay.  As a baby he was strong and healthy.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Vertigo
Clinical narrative: Vertigo upon awakening each morning after vaccination, which lasts approximately 5-15 seconds; has progressively worsened so that vertigo also occurs when tilting head up or down.
Age: 2.0
Sex: M
Vaccine: FLU3
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Patient became fussy a few minutes after receiving vaccines on 1-24-14.  Patient's mom undressed him around noontime later that day, and she noticed that patient had redness and swelling on both legs, starting at the injection sites on both legs and travelling distally to his toes, the right leg being worse than the left. Area of redness seemed tender to touch.  Patient was brought by his mother to ED, where patient was given an oral dose of Benadryl.  Pt's mom reports that 20-25 minutes after the administration of Benadryl to patient, patient's symptoms resolved.  Symptoms have not come back.  Patient also had a heart rate of 170-200 bpm while at the ED, heart rate was normal when patient seen at pediatrician on 1-27-14 for recheck appointment.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Eye swelling, Headache, Nausea, Visual impairment
Clinical narrative: Ongoing headaches, dizzy, nausea, swelling behind eyes, vision problems.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Pt stated by evening she had developed fever, achy joints, tenderness at the site. Light headedness, tired. Patient was offered an appt, refused at the time. Advised if symptoms continue or worsen, go to ER.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site induration, Injection site swelling
Clinical narrative: Swelling, induration around injection site.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Convulsion
Clinical narrative: Mom reports child had "mild" seizure upon waking up from nap at school.
Age: 10.0
Sex: M
Vaccine: MMRV
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Red and warm to touch, measuring 7 inches width and 6 inches length. Erythema and swelling on left shoulder, improved with ice pack. Instructed mother to return if spreading.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory arrest, Unresponsive to stimuli
Clinical narrative: Patient was sitting in chair not breathing and unresponsive. His wife and myself lowered him to the floor. He was still unresponsive, I told my tech to call 911. I started to do CPR but with slight pressure on the chest he opened his eyes. I stopped and asked him if he could breathe, he replied yes he could. I continued asking him questions until EMT arrived. They took him to the hospital.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Asthenia, Flushing, Injection site pain, Laboratory test normal
Clinical narrative: 1/26/14 - Mom called pharmacy to inquire as to which vaccine patient provided. Said over 9 days patient had extreme leg/arm pain, loss of strength in legs. Flushing and irregular pain at injection site with no visible signs of reaction 1/26/14 unable to walk; taken to MC.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 1/26/14 - Mom called pharmacy to inquire as to which vaccine patient provided. Said over 9 days patient had extreme leg/arm pain, loss of strength in legs. Flushing and irregular pain at injection site with no visible signs of reaction 1/26/14 unable to walk; taken to MC.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Patient is complaining of a raised, half dollar sized, red, pruritic injection site. Referred pt to primary care physician for further assessment.
Age: 0.34
Sex: F
Vaccine: DTAPHEPBIP, RV1
Symptoms: Convulsion, Hypotonia, Immediate post-injection reaction, Staring, Unresponsive to stimuli
Clinical narrative: Started with short staring spell once a day for 4 days on the 5th day she rolled to the right went limp and unresponsive for 30 sec, this began happening every hour on the hour once we were in ER and admitted to the hospital for weeks which turned into months of in and out of the hospital.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Herpes simplex, Simplex virus test positive
Clinical narrative: Onset of herpes simplex 1 (on genitals) never had a breakout before.
Age: 4.0
Sex: M
Vaccine: YF
Symptoms: Ocular hyperaemia, Pruritus generalised, Urticaria, Wheezing
Clinical narrative: Patient was given Yellow Fever vaccine. Ten minutes later, he began to have generalized itching, red eyes, and eventually hives and wheezing. He was then given IM epinephrine twice, oral BENADRYL, oral prednisone 20mg, and 2 puffs of albuterol inhaler. He was observed in office for 90 mins before discharge and given Rx for prednisolone to continue at home.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Flushing, Rash macular
Clinical narrative: Today pt feel face flash and red/blotchy skin.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chest pain, Decreased appetite, Dysgeusia, Hypersomnia, Pain
Clinical narrative: Chest pain and hurting in both arms. Congestion and hurting all over body. Sleeping all the time. Loss of apetite and bad taste in mouth.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Respiratory tract congestion
Clinical narrative: Chest pain and hurting in both arms. Congestion and hurting all over body. Sleeping all the time. Loss of apetite and bad taste in mouth.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient had sore arm since immediately after injection, developed area of redness and swelling approx 1 1/2 inches across and hard, swollen upper arm area. Taking naproxen and BENADRYL currently, will consult MD if gets worse.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Middle insomnia, Nuclear magnetic resonance imaging normal
Clinical narrative: Per patient onset of headache at approx 7 pm. She went to bed early and awoke at 1:30 am. She then asked her partner to call for help at hospital she received an MRI - negative. Treated with Morphine which helped.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Muscle pain at site of injection. 4 months ongoing. Patient needs therapy.
Age: 17.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Syncope
Clinical narrative: After administration of the vaccine (about 5 min) pt experienced an episode of syncope. Pt regained consciousness after a few seconds w/out further complaints.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Excoriation, Pruritus, Rash, Rash erythematous
Clinical narrative: Pt. states she began mild itching over Friday night and woke up Sat. with patches of red rash on (L) side of face - Provider describes "diffusely spread patches of erythema with excoriations on neck, left cheek and chin with erythematous patches and scaling. Mild swelling over chin" on 1-14-14.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Skin exfoliation, Swelling face
Clinical narrative: Pt. states she began mild itching over Friday night and woke up Sat. with patches of red rash on (L) side of face - Provider describes "diffusely spread patches of erythema with excoriations on neck, left cheek and chin with erythematous patches and scaling. Mild swelling over chin" on 1-14-14.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Pain in extremity, Tremor
Clinical narrative: Mother called to report pt began the following s/s at 9pm same day as vaccine. Arm hurt significantly ice applied 3a significant body shakes, chills, sweating temp 98 degrees F - 100.8 F taken throughout night. 3:30 a ADVIL taken arm hurt more. Approx 4:30 am s/s subsided and pt fell asleep no s/s since.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Inflammation
Clinical narrative: Received the flu shot 11/9 - a few wks after have undiagnosed inflammation all over body.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Induration, Pyrexia, Skin warm
Clinical narrative: Cellulitis left arm, warm, "hard", fever. ER visit the following day or two. CEFTIN 500mg and CIPRO 500mg.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Injected limb mobility decreased, Local swelling, Pain in extremity, Pyrexia
Clinical narrative: Left arm received immun. 1/9/14; on 1/10/14 pt experienced soreness, redness, swelling, and fever in the arm left arm by 1/11/14 pt could barely move arm and had a fever; symptoms improved by 1/13/14; received MEDROL DOSEPAK 1/14/14.
Age: 65.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Asthenia, Headache, Hyperhidrosis, Malaise
Clinical narrative: Patient was severely sick 24 hours after receiving FLUVIRIN and PNEUMOVAX. Symptoms included excessive sweating, weakness, headache, pt almost required a hospital visit, it resolved 3 days later.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash pruritic, Urticaria
Clinical narrative: On 1/27/14 patient woke up with a rash on his left leg that is slightly itchy, but not burning or painful. He described the rash as large hives.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Local swelling, Pruritus
Clinical narrative: Redness, itchiness, and swelling of the left arm. Necessitating ER visit 1 day after Tdap, MENACTRA, and HPV vaccination.
Age: 54.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site rash, Injection site swelling, Injection site vesicles
Clinical narrative: Rash, swelling and blistering skin at and around injection site on right arm - started Friday, 01/24/2014.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Hypersensitivity, Local swelling, Pain in extremity
Clinical narrative: Patient called the health dept 1/27/14. Stated she had an "allergic reaction" to Tdap vaccine given on 1/24/14. Reaction began on 1/25/14. Seen in emergency dept on 1/26/14. Left arm was red, swollen and painful. SOLUMEDROL 125mg IM given in emergency room. BENADRYL 50mg qid PRN. Ice to affected area PRN. Patient stated her arm was less swollen and red on 1/27/14 when calling to report adverse reaction.
Age: 37.0
Sex: M
Vaccine: HEPA, TDAP, YF
Symptoms: Pain, Paraesthesia
Clinical narrative: Client developed pins/needles type pain, around waist that traveled to behind knees by PM on 1/25/14. Eased since then with use of Ibuprofen. Was told by friend he had YE-ALD and should go to the ED if developed weakness. Has appt tomorrow with his PCP. Has tingling around ankles now only.
Age: 64.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Pain in extremity, Periarthritis
Clinical narrative: Pain (severe) at injection site; saw PCP. Pt was referred to orthopedist. Pain and numbness in (L) fingers continued. Pt saw orthopedist specialist in shoulders who diagnosed adhesive capsulitis. Dr said mist likely secondary to flu vaccine (saw this dr 1/24/14).
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Large red and swelling at injection site. About 1 inch diameter around injection has blisters and outside this area (about 2 inch diameter) is red and swelling. No fever.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Injection site abscess, Injection site pain
Clinical narrative: Large red and swelling at injection site. About 1 inch diameter around injection has blisters and outside this area (about 2 inch diameter) is red and swelling. No fever.
Age: 2.0
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Eczema, Injection site reaction
Clinical narrative: Patient has a rash on left leg eczematous in nature.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Neck pain, Pain, Paraesthesia
Clinical narrative: Patient complaining of pain in the upper arm, through shoulder and neck at left arm where FLUZONE ID was administered. (Pain described as tingling/burning). Patient complaining of pain since 1/22 - until today ratio of pain "1 - 10" is "7" Her arm hurts every time she move it.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Pain in extremity, Tenderness
Clinical narrative: Sore arm, that goes through her chest causing pain, hard to lay on at night.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a registered nurse regarding an unknown age and gender patient. On 16-OCT-2012, the patient was administered an incorrectly stored dose of ZOSTAVAX, lot# 0468AE, expiration date: 04-APR-2013 (dose and route were not reported). No adverse experience had been reported. This is one of 182 reports from the same source. Additional information has been requested.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Pt c/o pain (L) shoulder at site of vaccine pain with motion, decreased ROM, pain down (L) arm at times.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Mobility decreased, Pain in extremity, Skin warm, Swelling
Clinical narrative: PNEUMOVAX given 1-21-14 1630 Pneumo vaccine given rt arm. At 1900 pt c/o pain in arm, no redness, difficulty lifting arm took ibuprofen 800mg and BEN GAY. Woke us decreased soreness took VICODIN and ibuprofen. At 1420 1-22-14 c/o pain warm to touch, red, difficulty raising ar. Dr notified. Tx - ice, ibuprofen, elevate arm, re check tomorrow 1-23-14 0800 Arm is better. Able to lift decreased swelling. Still warm.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Herpes zoster, Rash, Rash erythematous, Skin warm
Clinical narrative: Patient called on 1/24/14 describing a red, warm rash on shoulder and chest that developed 1-2 days after getting a flu shot. I encouraged him to see a doctor to have the rash evaluated. Prescriptions filled on 1/26/14 indicate the rash is shingles. I tried to call the patient for follow up on 1/27/14 but there was no answer.
Age: 0.48
Sex: M
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from registered nurses refers to a 5 month old male infant. On 22-JAN-2014, the patient was seen in office for a "nurse visit" for vaccines and was vaccinated with his first dose of ROTATEQ (lot #H016249, expire date 27-MAR-2014), 2.0 ml once, oral. NO adverse effects reported. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Cellulitis, Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Pyrexia
Clinical narrative: Case number PHHY2013US084005 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491901) web site on 06 Aug 2013 and a follow-up information was received from Quality Assurance Department (reference number: 245526) on 08 Aug 2013 and another follow up was received from QA department on 20 Jan 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11073) and GARDASIL (other manufacturer, batch number: H020901); both vaccines administered intramuscularly in to right arm on 15 May 2013. His mother stated that on 15 May 2013, after vaccination immediately he developed redness at vaccination site which progressively became worse. He also developed pain and itching at vaccination site and fever. He went to emergency room and was seen by local urgent care and primary care physician. As per his mother, he developed cellulitis. He was prescribed steroid dose pack, Cephalexin 500 mg twice a day for 7 days and BENADRYL. The outcome of the event was reported as complete recovery as of 17 May 2013. The seriousness and causality were not reported. Batch review report (reference number: 245526) received from quality assurance department on 20 Jan 2014. Based on the batch review performed, it was concluded that MENVEO (batch number: M11073, expiry date: Dec 2013) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 245526) on 08 Aug 2013: Updated QA reference number only. Significant follow up received from Quality Assurance Department on 20 Jan 2014: Updated Batch review report.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Vaccination site pain
Clinical narrative: Case number PHHY2013US084005 is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 491901) web site on 06 Aug 2013 and a follow-up information was received from Quality Assurance Department (reference number: 245526) on 08 Aug 2013 and another follow up was received from QA department on 20 Jan 2014. This report refers to an 11-year-old male patient. His medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M11073) and GARDASIL (other manufacturer, batch number: H020901); both vaccines administered intramuscularly in to right arm on 15 May 2013. His mother stated that on 15 May 2013, after vaccination immediately he developed redness at vaccination site which progressively became worse. He also developed pain and itching at vaccination site and fever. He went to emergency room and was seen by local urgent care and primary care physician. As per his mother, he developed cellulitis. He was prescribed steroid dose pack, Cephalexin 500 mg twice a day for 7 days and BENADRYL. The outcome of the event was reported as complete recovery as of 17 May 2013. The seriousness and causality were not reported. Batch review report (reference number: 245526) received from quality assurance department on 20 Jan 2014. Based on the batch review performed, it was concluded that MENVEO (batch number: M11073, expiry date: Dec 2013) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 245526) on 08 Aug 2013: Updated QA reference number only. Significant follow up received from Quality Assurance Department on 20 Jan 2014: Updated Batch review report.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Immediate post-injection reaction, Nausea, Pallor, Rash
Clinical narrative: Case number PHHY2013US084026, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493666) website on 06 Aug 2013 and a follow-up information was received from Quality Assurance Department (reference number: 245995) on 12 Aug 2013 another follow up was received from QA department on 27 Jan 2014. This report refers to 14-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12027, expiry date: Dec 2014) intramuscularly in the left arm on an unknown date. Right after vaccination he felt nauseous and appeared pale. He also complained of feeling dizzy and itchy rash on hands. He did not lose consciousness, had no drooling or wheezing. He received one Epipen injection on his left thigh. The outcome of the events was reported as recovered. The case was reported as serious (life-threatening). The causality of the events was not reported. Batch review report (reference number: 245995) received from quality assurance department on 27 Jan 2014. Based on the batch review performed, it was concluded that MENVEO (batch number: M12027, expiry date: Dec 2014) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 245995) on 12 Aug 2013: Updated QA reference number only. Follow up received from Quality Assurance Department on 27 Jan 2014: Updated Batch review report.
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Rash pruritic
Clinical narrative: Case number PHHY2013US084026, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 493666) website on 06 Aug 2013 and a follow-up information was received from Quality Assurance Department (reference number: 245995) on 12 Aug 2013 another follow up was received from QA department on 27 Jan 2014. This report refers to 14-year-old male patient. His medical history and concomitant medication were not reported. He was vaccinated with MENVEO (batch number: M12027, expiry date: Dec 2014) intramuscularly in the left arm on an unknown date. Right after vaccination he felt nauseous and appeared pale. He also complained of feeling dizzy and itchy rash on hands. He did not lose consciousness, had no drooling or wheezing. He received one Epipen injection on his left thigh. The outcome of the events was reported as recovered. The case was reported as serious (life-threatening). The causality of the events was not reported. Batch review report (reference number: 245995) received from quality assurance department on 27 Jan 2014. Based on the batch review performed, it was concluded that MENVEO (batch number: M12027, expiry date: Dec 2014) was manufactured in accordance with approved internal procedures and it is in compliance with the current good manufacturing practices (cGMP) requirements. Non-significant follow-up received from Quality Assurance Department (reference number: 245995) on 12 Aug 2013: Updated QA reference number only. Follow up received from Quality Assurance Department on 27 Jan 2014: Updated Batch review report.
Age: 11.0
Sex: F
Vaccine: FLU3, HPV4, MNQ, TDAP
Symptoms: Convulsion, Fall, Musculoskeletal stiffness
Clinical narrative: Case number PHHY2013US127743, is an initial report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 502915) website on 11 Nov 2013 and a follow-up received from Quality Assurance Department (QA, reference number: 263369) on 23 Jan 2014. This report refers to a 11-years-old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1307901) intramuscularly in the right arm and GARDASIL (other manufacturer, batch number: J006850) intramuscularly in the right arm on 16 Sep 2013. She was also vaccinated with MENACTRA (other manufacturer, batch number: U4597AB) intramuscularly in the left arm and ADACEL (other manufacturer, batch number: U4586AA) intramuscularly in the left arm on 16 Sep 2013. On the same day after vaccination, she fell to the ground and had a brief seizure with stiffening lasting for 30-60 seconds. The outcome of the events was reported as completely recovered as of 17 Sep 2012. The seriousness and causality of the events was not reported. Based on the investigation performed, the QA department stated that, the FLUVIRIN (batch number: 1307901) was manufactured in accordance with the approved internal procedures and it is was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (QA, reference number: 263369) on 23 Jan 2014: Updated batch review report.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: Balance disorder, Blepharospasm, Dizziness, Eye movement disorder, Gait disturbance
Clinical narrative: Case number PHHY2013US147774, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508472) website on 16 Dec 2013 with a follow up report received from the quality assurance department (QA reference number: 272153) on 24 Jan 2014. This report refers to a 20-year-old female patient. She was vaccinated with MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly in the left arm on 21 Aug 2013. On 08 Sep 2013 in the morning, she felt dizzy and complained of eyes spinning around in her head. Later she was lurching to the left, left eye was twitching and pupil was small with the right pupil large. She was taken to the emergency department and they evaluated her eyes. It was hard for her to open her eyes because it felt like things were moving. An MRI was done and did not show anything. The discharge diagnosis was reported as right ocular motor nerve palsy. She taking prednisone 80 mg and the first day all signs had gone away by evening but returned again on the next day. She saw the ophthalmologist and both eyes were tracking. When they saw the neurologist and right eye was not moving past midline. Her symptoms gone away and patient was seeing fine and had no further symptoms. The seriousness and causality of the events were not reported. Based on the batch review performed, it was concluded that this MENVEO batch (M11081) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up report was received from the quality assurance department: The batch review summary (QA reference number: 272153) and expiry date were updated.
Age: 20.0
Sex: F
Vaccine: MNQ
Symptoms: IIIrd nerve paralysis, Nuclear magnetic resonance imaging normal, Pupils unequal, Vertigo
Clinical narrative: Case number PHHY2013US147774, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 508472) website on 16 Dec 2013 with a follow up report received from the quality assurance department (QA reference number: 272153) on 24 Jan 2014. This report refers to a 20-year-old female patient. She was vaccinated with MENVEO (batch number: M11081, expiry date: Apr 2014) intramuscularly in the left arm on 21 Aug 2013. On 08 Sep 2013 in the morning, she felt dizzy and complained of eyes spinning around in her head. Later she was lurching to the left, left eye was twitching and pupil was small with the right pupil large. She was taken to the emergency department and they evaluated her eyes. It was hard for her to open her eyes because it felt like things were moving. An MRI was done and did not show anything. The discharge diagnosis was reported as right ocular motor nerve palsy. She taking prednisone 80 mg and the first day all signs had gone away by evening but returned again on the next day. She saw the ophthalmologist and both eyes were tracking. When they saw the neurologist and right eye was not moving past midline. Her symptoms gone away and patient was seeing fine and had no further symptoms. The seriousness and causality of the events were not reported. Based on the batch review performed, it was concluded that this MENVEO batch (M11081) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow up report was received from the quality assurance department: The batch review summary (QA reference number: 272153) and expiry date were updated.
Age: 23.0
Sex: M
Vaccine: FLUN4, SMALL, FLUN4, SMALL
Symptoms: Blood creatine phosphokinase increased, Computerised tomogram thorax abnormal, Cough, Dyspnoea, Echocardiogram normal
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 23 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 12 days after the subject had received the following vaccines on 24 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Influenza, live, intranasal quadrivalent vaccine (manufacturer and lot number not reported). On 06 October 2013, Troponin I result was abnormal with highest record value of 20.00ng/mL with a normal echocardiogram and normal MRI of heart. ECG result was not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.
Age: 23.0
Sex: M
Vaccine: FLUN4, SMALL, FLUN4, SMALL
Symptoms: Ejection fraction decreased, Electrocardiogram abnormal, Feeling abnormal, Hepatitis B antibody positive, Hepatitis C antibody positive
Clinical narrative: Note: Any requests for follow-up information on this case should be sent directly to the sponsor of this study, Sanofi Pasteur. This study case was received from the investigator in a trial on 14 January 2014. A 23 year-old male subject with no significant past medical history was found to have unspecified disease of pericardium 12 days after the subject had received the following vaccines on 24 September 2013: an injection of ACAM2000 (lot number, route and site of administration not reported) and Influenza, live, intranasal quadrivalent vaccine (manufacturer and lot number not reported). On 06 October 2013, Troponin I result was abnormal with highest record value of 20.00ng/mL with a normal echocardiogram and normal MRI of heart. ECG result was not available. Lumbar puncture and MRI of the brain and spinal cord were not performed. Treatments were not reported. The subject's outcome was not reported. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. Documents held by sender: none.