chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site vesicles, Injection site warmth
Clinical narrative: Swelling, redness, blistering with some weeping, warm to touch, some pain and itching at injection site where Tdap and Menveo were given. on 9/16/2015, area measured 1inch by 1inch and was red and warm to touch. On 9/17/2015, area measured 6inches long by 5inches wide with blistering and weeping at injection site. Area was cleaned and dressed with TAO, 2x2 gauze and wrapped loosely because of weeping from area. Physician prescribed oral steroids for patient. Follow up call made on 9/18/2015 and mother reported that area was improving. Another follow up call made on 9/21/2015 to parent and mother reported that area was completely healed now. Noted in patient chart that reaction took place and advised caution with next dose of vaccines.
Age: 43.0
Sex: F
Vaccine: FLUX, HEP, HEPA
Symptoms: Visual field defect, Visual impairment
Clinical narrative: Visual disturbance: kaleidescope vision outside area of focus, strobe effect in peripheral vision.
Age: 1.03
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Excessive eye blinking, Insomnia, Irritability
Clinical narrative: Hard Blinking throughout the day. Increased irritability. Trouble Sleeping.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and slight swelling on upper arm, generally just below the injection site.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Rash to left arm (vaccine site, red, raised, patchy, very itchy).
Age: 25.0
Sex: F
Vaccine: FLU4, VARCEL
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site swelling
Clinical narrative: This nurse consulted with overseeing MD at MC. Dr. said it is okay to still give the vaccine and patient advised to keep rash covered if it develops and to report any reaction. Symptoms noted by patient were redness, raised area at vaccine admin site and slight itching (less than previous vaccine reaction.) Symptoms lasted approx. 1 week.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Gingival swelling, Lip swelling, Sneezing, Swelling face
Clinical narrative: Sneezing, coughing, wheezing, swelling of face, tongue, gums and lips. Took Advil at 3:45 P.M. and one Claritin at 8:45 PM.  Took second Claritin after ER visit.
Age: 54.0
Sex: M
Vaccine: FLU3
Symptoms: Swollen tongue, Wheezing
Clinical narrative: Sneezing, coughing, wheezing, swelling of face, tongue, gums and lips. Took Advil at 3:45 P.M. and one Claritin at 8:45 PM.  Took second Claritin after ER visit.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Injection site hypoaesthesia, Pain, Paraesthesia
Clinical narrative: At injection site, my arm became numb. The numbness spread to the whole right side of my body withing an hour, including my neck, ear, and cheek, as well as my side, breast, leg and foot. During the remainder of the day, the numbness would come in waves, followed by sharp pains on the right side of my body. The numbness would spread further during each wave and eventually made my tongue and throat numb.
Age: 27.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal hypoaesthesia
Clinical narrative: At injection site, my arm became numb. The numbness spread to the whole right side of my body withing an hour, including my neck, ear, and cheek, as well as my side, breast, leg and foot. During the remainder of the day, the numbness would come in waves, followed by sharp pains on the right side of my body. The numbness would spread further during each wave and eventually made my tongue and throat numb.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Blister, Injection site nodule, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Woke up with pin-head size blisters on arm, (localized), raised, hot. Inj site has remained heat sensitive for 3 days already. If out in sun, more blisters developed. Localized burning at injection site. Feels like a knot, deep, localized muscle ache (like feeling when get a tetanus shot, low grade fever.
Age: 48.0
Sex: F
Vaccine: FLUC3
Symptoms: Photosensitivity reaction, Pyrexia, Skin warm
Clinical narrative: Woke up with pin-head size blisters on arm, (localized), raised, hot. Inj site has remained heat sensitive for 3 days already. If out in sun, more blisters developed. Localized burning at injection site. Feels like a knot, deep, localized muscle ache (like feeling when get a tetanus shot, low grade fever.
Age: 38.0
Sex: F
Vaccine: HEP
Symptoms: Facial paresis, Hypoaesthesia, Immediate post-injection reaction, Muscular weakness, Paraesthesia
Clinical narrative: This is a historical event per patient. Pt states she recieved Hep B vaccine (Manufacturer: Glaxosmithkline, Lot: 4T4GJ) in R Deltoid and numbness, paresthesia, and weakness occured immediately in R side of face and RUE. Traveled to L side of face only within 2 minutes. Pt states she informed primary care of event as it was happening and it resolved within 45 minutes.
Age: 65.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site was red, warm, swollen, tender to touch.  Patient went to urgent care on 9/19/2015 who instructed her to take Benadryl.  Spoke with patient today and symptoms are improving.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: Pt. had Hep A and Menactra vaccine. Left with mother and father. Fainted in elevator, brought back into exam room by parents. Laid down on floor, vss, became alert, verbal, responsive, EMS transported pt. to ER per parents request, 911 had been called.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: At site of injection, red, hot, hard, swollen. Patient went to MD. MD treated with CLARITIN. MD told patient to monitor, and call MD if redness spreads or feels fever/chills/nausea.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Computerised tomogram, Fall, Fatigue, Gait disturbance
Clinical narrative: weeks after receiving I began to feel very weak & fatigued. This dragged on about 2 months until started having trouble walking, leg weakness & falling. Several more months until leg paralysis.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Lumbar puncture, Monoplegia, Muscular weakness, Myelitis transverse
Clinical narrative: weeks after receiving I began to feel very weak & fatigued. This dragged on about 2 months until started having trouble walking, leg weakness & falling. Several more months until leg paralysis.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, X-ray
Clinical narrative: weeks after receiving I began to feel very weak & fatigued. This dragged on about 2 months until started having trouble walking, leg weakness & falling. Several more months until leg paralysis.
Age: 25.0
Sex: F
Vaccine: YF
Symptoms: Arrhythmia, Injection site pruritus, Injection site warmth, Vaccination site oedema
Clinical narrative: Areas around the vaccination administration site began to itch followed by edema and arrhythmia. Site is warm to touch. Located on posterior L arm.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site mass, Injection site pain, Injection site reaction
Clinical narrative: Burning pain near injection site for a few minutes. Next day, kept burning, bruise and slight lump appeared. On 9/17/2015 a large scab (size of a quarter, colored yellowish brown) appeared. Patient saw MD Sept 18. He reportedly said it is a strange reaction. Patient called me 9/21/2015 to verify which arm was injected. Now reporting peeling, black around edges, large lump with occasional pain.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site scab, Pain, Skin exfoliation
Clinical narrative: Burning pain near injection site for a few minutes. Next day, kept burning, bruise and slight lump appeared. On 9/17/2015 a large scab (size of a quarter, colored yellowish brown) appeared. Patient saw MD Sept 18. He reportedly said it is a strange reaction. Patient called me 9/21/2015 to verify which arm was injected. Now reporting peeling, black around edges, large lump with occasional pain.
Age: 89.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Skin warm, Swelling
Clinical narrative: Patient complained for Redness, swelling, warm to touch and sore arm.
Age: 66.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that her right arm at site of injection turned red, was warm to touch, and the area was itching and swollen.  Had put cold compresses on thea area, which helped aleviate the itching.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Swelling
Clinical narrative: Blister fluid filled down length of arm, redness and swelling.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Dizziness, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: First symptom in evening was sore, stiff arm.  In early next morning, I woke up with terrible dizziness causing nausea, headache and terrible fatigue.  Site of injection very sore and swollen.  Spent the day in bed, slept a lot.  24 hours after the injection, I started to gradually feel better.  To my knowledge I had not been exposed to any type of virus/illness prior to the vaccine.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Musculoskeletal stiffness, Nausea, Pain in extremity, Somnolence
Clinical narrative: First symptom in evening was sore, stiff arm.  In early next morning, I woke up with terrible dizziness causing nausea, headache and terrible fatigue.  Site of injection very sore and swollen.  Spent the day in bed, slept a lot.  24 hours after the injection, I started to gradually feel better.  To my knowledge I had not been exposed to any type of virus/illness prior to the vaccine.
Age: 54.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Bronchitis
Clinical narrative: BRONCHITIS.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Abdominal discomfort, Anxiety, Chest pain, Crying, Emotional distress
Clinical narrative: Case number PHEH2015US017711, is an initial spontaneous report from a consumer (patient's parent) received on 09 Sep 2015. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of meningitis vaccine (manufacturer and batch number unknown) in 2004 and her last vaccination of any kind was in 2010. She was vaccinated with MENVEO (batch number: A14089, expiry date: 30 Nov 2015) at a dose of 0.5 ml into left arm on 14 Jul 2015. In Jul 2015 the patient was nervous, crying, felt sick to her stomach and was almost suicidal. Further the patient also had anxiety, irritability, chest pain and was upset. The patient was taken to the emergency room (ER) for treatment on 19 Jul 2015 and released. Blood test indicated low platelet levels which were fine previously. The patient now sees a doctor 3 or 4 times per week and an intravenous immunoglobulin (IVIG) was being considered. Outcome of crying, nervous, stomach discomfort and almost suicidal was reported as not recovered. Outcome of the other events were not reported. Seriousness and causality of the events were not reported. Seriousness assessment of "almost suicidal" was upgraded based on the NVS-IMS list.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Immunoglobulin therapy, Irritability, Nervousness, Platelet count decreased, Suicidal ideation
Clinical narrative: Case number PHEH2015US017711, is an initial spontaneous report from a consumer (patient's parent) received on 09 Sep 2015. This report refers to a 16 years old female patient. Medical history and concomitant medications were not reported. Her vaccination history included administration of meningitis vaccine (manufacturer and batch number unknown) in 2004 and her last vaccination of any kind was in 2010. She was vaccinated with MENVEO (batch number: A14089, expiry date: 30 Nov 2015) at a dose of 0.5 ml into left arm on 14 Jul 2015. In Jul 2015 the patient was nervous, crying, felt sick to her stomach and was almost suicidal. Further the patient also had anxiety, irritability, chest pain and was upset. The patient was taken to the emergency room (ER) for treatment on 19 Jul 2015 and released. Blood test indicated low platelet levels which were fine previously. The patient now sees a doctor 3 or 4 times per week and an intravenous immunoglobulin (IVIG) was being considered. Outcome of crying, nervous, stomach discomfort and almost suicidal was reported as not recovered. Outcome of the other events were not reported. Seriousness and causality of the events were not reported. Seriousness assessment of "almost suicidal" was upgraded based on the NVS-IMS list.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Peripheral swelling
Clinical narrative: Patient's arm swelled up and patient experienced trouble breathing.
Age: 20.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Cellulitis, Injection site erythema, Lymph node pain, Pain, Vaccination site induration
Clinical narrative: After patient took off his vaccination site bandage, surrounding skin also removed, and patient noted tenderness, redness and swelling. Over 24 hour period, significant increase in redness and swelling of RUE surrounding vaccination site. Also, tenderness in right axilla. No systemic symptoms. ON EXAM on 21 SEP 2015: +2 CM right axillary lymph node appreciated Right arm: tender to palpation, vaccination site red, warm, indurated area about 5 cm in diameter across Pain rated as 8/10 Dx: cellulitis Treated with doxycycline 100 mg twice daily x 14 days
Age: 20.0
Sex: M
Vaccine: JEV1, SMALL
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: After patient took off his vaccination site bandage, surrounding skin also removed, and patient noted tenderness, redness and swelling. Over 24 hour period, significant increase in redness and swelling of RUE surrounding vaccination site. Also, tenderness in right axilla. No systemic symptoms. ON EXAM on 21 SEP 2015: +2 CM right axillary lymph node appreciated Right arm: tender to palpation, vaccination site red, warm, indurated area about 5 cm in diameter across Pain rated as 8/10 Dx: cellulitis Treated with doxycycline 100 mg twice daily x 14 days
Age: 1.08
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash vesicular
Clinical narrative: Vesicular rash and fever 11 days after varicella vaccine; pt got better, no major complications.
Age: 91.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: 10 cm rash with itching and warm to the touch.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dysphagia, Feeling cold, Immediate post-injection reaction
Clinical narrative: IMMEDIATELY AFTER IMZ SHE FELT NAUSEOUS BUT IT RESOLVED.  AT 7 PM SHE FELT NAUSEOUS AND BEGAN VOMITING AS WELL AS DIARRHEA.  SHE FELT VERY COLD AND UNABLE TO WARM UP.  SHE HAD DIFFICULTY SWALLOWING AND FELT AS IF HER "ADAMS APPLE WAS CLOSED".  PATIENT NOTIFIED THE PHARMACY THE NEXT DAY AT 9AM. THE NAUSEA/VOMITING/DIARRHEA/DIFFICULTY SWALLOWING HAD ALL RESOLVED.  SHE WAS STILL FEELING CHILLED AND A LITTLE WEAK BUT MUCH BETTER THAN THE DAY OF THE IMMUNIZATION. SHE DID NOT GO TO THE HOSPITAL.
Age: 84.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Vomiting
Clinical narrative: IMMEDIATELY AFTER IMZ SHE FELT NAUSEOUS BUT IT RESOLVED.  AT 7 PM SHE FELT NAUSEOUS AND BEGAN VOMITING AS WELL AS DIARRHEA.  SHE FELT VERY COLD AND UNABLE TO WARM UP.  SHE HAD DIFFICULTY SWALLOWING AND FELT AS IF HER "ADAMS APPLE WAS CLOSED".  PATIENT NOTIFIED THE PHARMACY THE NEXT DAY AT 9AM. THE NAUSEA/VOMITING/DIARRHEA/DIFFICULTY SWALLOWING HAD ALL RESOLVED.  SHE WAS STILL FEELING CHILLED AND A LITTLE WEAK BUT MUCH BETTER THAN THE DAY OF THE IMMUNIZATION. SHE DID NOT GO TO THE HOSPITAL.
Age: 34.0
Sex: F
Vaccine: TD
Symptoms: Dizziness, Hyperventilation, Hypoaesthesia, Nausea, Paraesthesia
Clinical narrative: DIZZINESS, NAUSEA, TINGLING/NUMBNESS IN EXTREMITIES, BEGAN HYPERVENTILATING.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Shot given too high and pain in arm so bad she cannot move it.  Received shot after night shift.  After sleeping, awoke in pain. Employee health recommended f/u with urgent care. Ice, ibuprofen and ROM exercises prescribed for over the weekend.  Symptoms improved and have now completely resolved.
Age: 56.0
Sex: F
Vaccine: FLUC3
Symptoms: Gait disturbance, Headache, Pain in extremity
Clinical narrative: Severe pain in sides and backs of both legs. Difficult to walk. I will be calling my doctor in the morning as pain is worsening. Headache severe at times.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Oropharyngeal pain
Clinical narrative: Chest tightness start at 1:00pm, difficulty breathing 1:30pm, sore throat, restricted breathing/airways 1:45pm, dizziness and weakness throughout.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Injection site pain
Clinical narrative: Pt reported arm pain at injection site starting ~ 1 hour after receipt, also general fatigue.  Pt had dental appointment day after vaccine administration and reported needing more novocaine than typical.
Age: 1.42
Sex: M
Vaccine: HIBV
Symptoms: Injection site irritation, Pyrexia, Rash generalised
Clinical narrative: Injection site irritation, high fever of 103.6 degrees that lasted 4 days, a Rash has been forming since the fever stopped. The rash is still getting worse as of this time.
Age: 32.0
Sex: F
Vaccine: VARCEL
Symptoms: Blister, Erythema, Laboratory test
Clinical narrative: Red blisters noted on breast, face and torso.
Age: 35.0
Sex: F
Vaccine: FLUX
Symptoms: Impaired driving ability, Injection site pain, Injection site swelling, Injection site warmth, Swelling
Clinical narrative: Severe swelling after nurse injected flu shot through my tattoo. I asked of that was okay to do and she said yes. It's very hot and sore and very swollen at site and in a pretty wide area around. It's sore in my shoulder and down to elbow making it hard to drive today. Saw nurse at work and was instructed to ice the area and take Tylenol for the pain.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Fatigue, Influenza like illness, Malaise, Pain
Clinical narrative: Temperature 100.5, body aches, malaise, fatigue; states took Tylenol for increased temp; "felt like I had the flu".
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Nausea
Clinical narrative: Fever, chills, nausea. Red swollen warm area on arm where shot was given.
Age: 61.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: Fever, chills, nausea. Red swollen warm area on arm where shot was given.
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot
Clinical narrative: Pt came back saying she felt lightheaded and faint and hot. I inspected the injection site, there was no visible reaction. I gave her some water, she requested a coke, she requested to lie down on the bench; after about 30 minutes her husband came and picked her up.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Joint swelling
Clinical narrative: R ankle swelling/pain 4 hours after injection of both Zostavax and flu vaccine given at a local store. pt has had flu shots in past without problems.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Eye irritation, Hyperaesthesia, Peripheral swelling, Photophobia, Rash macular
Clinical narrative: Left arm, swollen, hot, red blotches, sensitive to touch. Used ice and took ibuprofen. Did not help, went to hospitals occupational health office next morning. The following day both my eyes became irritated red, burning sensation, light sensitivity went to eye doctor and currently being treated with antibiotic and steroid eye drops. Eye doctor thinks this also may be related to flu shot.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Left arm, swollen, hot, red blotches, sensitive to touch. Used ice and took ibuprofen. Did not help, went to hospitals occupational health office next morning. The following day both my eyes became irritated red, burning sensation, light sensitivity went to eye doctor and currently being treated with antibiotic and steroid eye drops. Eye doctor thinks this also may be related to flu shot.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea
Clinical narrative: Pt had shortness of breathe, said can't breathe, mom drove to urgent care for help..they gave an epinephrine and Benadryl injection.
Age: 26.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Cough, Headache, Oropharyngeal pain, Pain
Clinical narrative: Cough, sore throat, achey, no energy, headache.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site pain, Pain, Pain in extremity
Clinical narrative: Light headed/dizzy.  Body aches all over. Severe arm pain at site radiating down arm.
Sex: M
Vaccine: PNC13
Symptoms: Seizure
Clinical narrative: This is a spontaneous report from a contactable health care professional (at the vaccine provider's office), through a Pfizer sales representative. The reporter's son (age and race unknown) received PREVNAR 13 on an unknown date at an unknown dose and frequency. The relevant medical history and concomitant medications were unknown. It was reported that the patient after the third dose of PREVNAR 13, experienced seizure on an unknown date. Relevant laboratory data were unknown. Therapeutic measures against the reported event were unknown. The clinical outcome of the reported event was unknown at the time of the report. Follow-up (27Apr2011): Follow-up attempts completed. No further information expected.
Age: 0.34
Sex: M
Vaccine: PNC13
Symptoms: Ear infection bacterial, Ear tube insertion, Otorrhoea, Pneumococcal infection, Purulent discharge
Clinical narrative: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 4-month-old male patient was administered the second dose of PREVNAR 13 intramuscularly on 11Feb2011. The first dose of PREVNAR 13 was administered on 03Dec2010. Relevant concomitant medications were nystatin and albuterol. On 21Mar2011, at the age of 5 months, the patient had pressure equalizing tube placement. At this point, the patient had purulent ear discharge. On 15Apr2011, the patient was seen for purulent ear discharge. Culture test (15Apr2011) confirmed pneumococcal ear infection. On this day, the patient was administered the third dose of PREVNAR 13 along with the DTaP-Hib-IPV and rotavirus vaccine. On 21Apr2011, culture of the ear discharge above the PET was positive for scant growth streptococcal pneumoniae. Therapeutic measures taken in response to pneumococcal ear infection included treatment with CIPRODEX, then oral unspecified antibiotics. Outcome was unknown. The patient has not returned to the office. There are no etiological factors. Follow-up attempts completed. No further information expected. Follow-up (01Jun2011): New information reported from a contactable physician includes: updated medical history, concomitant medications, clinical course, treatment and causality assessment.
Age: 0.34
Sex: M
Vaccine: PNC13
Symptoms: Streptococcus test positive
Clinical narrative: This is a spontaneous report from a contactable pediatrician via a Pfizer sales representative. A 4-month-old male patient was administered the second dose of PREVNAR 13 intramuscularly on 11Feb2011. The first dose of PREVNAR 13 was administered on 03Dec2010. Relevant concomitant medications were nystatin and albuterol. On 21Mar2011, at the age of 5 months, the patient had pressure equalizing tube placement. At this point, the patient had purulent ear discharge. On 15Apr2011, the patient was seen for purulent ear discharge. Culture test (15Apr2011) confirmed pneumococcal ear infection. On this day, the patient was administered the third dose of PREVNAR 13 along with the DTaP-Hib-IPV and rotavirus vaccine. On 21Apr2011, culture of the ear discharge above the PET was positive for scant growth streptococcal pneumoniae. Therapeutic measures taken in response to pneumococcal ear infection included treatment with CIPRODEX, then oral unspecified antibiotics. Outcome was unknown. The patient has not returned to the office. There are no etiological factors. Follow-up attempts completed. No further information expected. Follow-up (01Jun2011): New information reported from a contactable physician includes: updated medical history, concomitant medications, clinical course, treatment and causality assessment.
Age: 1.26
Sex: M
Vaccine: PNC13
Symptoms: Blood test, Febrile convulsion, Irritability, Pyrexia
Clinical narrative: This is an initial spontaneous report from a contactable nurse practitioner. This is the first of two reports by the same reporter. A 15-month-old, male patient received PREVNAR 13 on 08Apr2011. The relevant medical history and concomitant medications of the consumer were unknown. On 08Apr2011, night after receiving PREVNAR 13 the patient experienced high fever, extreme irritability and febrile seizures and was taken to emergency room. The relevant laboratory data included unspecified blood work on an unknown date in Apr2011 and th results were unknown. The status of the PREVNAR 13 therapy was unknown at the time of the report. Treatment included unspecified medications int he emergency room as therapeutic measures. The patient had recovered from the high fever and febrile seizures on an unknown date in Apr2011 however the clinical outcome of the other event was unknown at the time of the report. Follow-up (07Jun2011): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Meningitis pneumococcal, Therapy change
Clinical narrative: This is a spontaneous report from a contactable nurse via a Pfizer representative. A currently 3-year-old male received three dose of PREVNAR 7 and one dose of PREVNAR 13 on unknown dates. The relevant medical history was therapy regimen changed from PREVNAR 7 to PREVNAR 13. Concomitant medications of the patient were unknown. It was reported that the patient was still having pneumococcal meningitis on an unknown date and was hospitalized on an unknown date. The reporter also mentioned that there might be product failure in this case, however serotype was not provided. The relevant lab data were unknown. Therapeutic measures taken in response to the reported event were unknown. The clinical outcome of the reported event was unknown at the time of the report.
Age: 0.52
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Diarrhoea, Gastric disorder
Clinical narrative: This is the first of two reports from the same reporter. This is a spontaneous report from a contactable medical assistant. A 6-month-old male patient received a third single dose of PREVNAR 13, intramuscular, on 29Apr2011 along with a dose of PEDIARIX, intramuscular, on 29Apr 2011. The patient had previously received two doses of PREVNAR 13 and two previous doses of PEDIARIX. Information on adverse events following the previous doses was not provided. Vaccines taken within the last four weeks were unknown. Relevant medical history was unknown. Relevant concomitant medications were unknown. On an unknown date, after administration of PREVNAR 13, the patient experienced a gastric problem. On 30Apr2011, the patient experienced diarrhea for 5 days. Diarrhea was considered medically significant. No treatment for diarrhea was administered. Relevant laboratory data was unknown. At the time of the report the outcome of the gastric disorder was unknown. The outcome of the event of diarrhea was recovered with sequelae (not further specified). Follow-up (23May2011): New information was received and includes: patient details including birthdate and age, updated event details with event onset date and recovery status for the event of diarrhea, product details including date of administration and number of previous doses, and additional suspect vaccine.
Age: 3.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable nurse, who reported on behalf of her 3-year-old daughter. A 3-year-old female patient was administered a dose of PREVNAR 13 by unspecified injection in the left thigh on 16May2011. Relevant medical history was none. Relevant concomitant medications were none. On 16May2011, at 22:30, the patient experienced fever and chills. On 17May2011, she experienced vomiting and fever which she mentioned to be 101.1 degrees. Therapeutic measures taken in response to fever and chills included treatment with TYLENOL and MOTRIN. Relevant lab data included body temperature of 101.1 degrees (unspecified) on 17May2011. At the time of this report she had not recovered from the events.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable Pfizer Sales Representative who reported on behalf of a physician. A 3-year-old male patient received the first dose of PREVNAR 13 on 25Apr2011. Past product vaccine history includes the first dose of PREVENAR 7 on 10Jun2008, the second dose on 14Aug2008, the third dose on 10Oct2008, and fourth dose on 22Oct2009. Relevant medical history included therapy regimen changed. Concomitant medications were unknown. On 25Apr2011, the patient experienced mild pain and soreness at the site of injection. It was elaborated that the patient refused to walk for 2 hrs. No laboratory tests were provided. Therapeutic measures taken for the reported events included ice application at the site of injection and acetaminophen as needed for pain. The patient recovered after two days. The physician believes it is unknown if there is a reasonable possibility that the event is related to suspect product. Follow-up attempts completed. No further information expected. Follow-up (08Jun2011): New information reported from a contactable physician includes past vaccine history, treatment, outcome causality assessment.
Age: 0.25
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable reporter who called on behalf of her friend's daughter. A 3-month-old, female patient received a dose of PREVNAR 13 on 05Mar2011. Relevant past medical history and concomitant medications were none. The patient experienced fever and diarrhea 9 hours after the injection was given on 05Mar2011. Relevant laboratory tests were unknown. Therapeutic measures taken were unknown. The patient recovered on an unknown date in Mar2011. Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: M
Vaccine: FLU4, HIBV, MMR
Symptoms: Irritability, Pyrexia
Clinical narrative: Fussiness and fever day after vaccines, irritability x 6 days.
Age: 68.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Localized redness, swelling, warm to touch, mild itching of left deltoid.
Age: 72.0
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Small rash on elbow.
Age: 92.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling cold, Tremor
Clinical narrative: Pt developed chills, shaking. Brought to ER by daughter.
Age: 92.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Feeling abnormal, Feeling cold, Tremor
Clinical narrative: Pt developed chills, shaking. Brought to ER by daughter.
Age: 62.0
Sex: M
Vaccine: FLU3
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Patient requested trivalent flu vaccine. We gave him this. He later came back and said he had already received vaccine this season.
Age: 57.0
Sex: M
Vaccine: FLU3, PPV, TDAP
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Upper arm became red, swollen, painful approximately 12 hours after admin. of flu vaccine. Improved with BENADRYL PO. Also given PNEUMOVXA in the same arm.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Swollen tongue
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. An elderly female patient received PREVNAR 13, intramuscularly (site of administration unknown) on 17Dec2014, as a single dose in combination with the Flu vaccine. The patient medical history and concomitant medications were not reported. The patient experienced swollen tongue on 17Dec2014. Clinical course was as follows: PREVNAR 13 was given in combination with the Flu vaccine. The male elderly patient experienced swelling of tongue within 8 hours of receiving the vaccines. She went home and then returned to the emergency room. The physician does not think that the patient was admitted. The outcome of swelling of tongue was unknown. The physician did not believe that they are related. Follow-up (12Feb2015): Follow-up attempts completed. No further information expected.
Age: 75.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site bruising, Injection site pruritus, Injection site reaction, Urticaria
Clinical narrative: This is a spontaneous report from a non-clinical study program, from a contactable pharmacist. A 75-year-old female patient received the first dose of PREVNAR 13 (lot J23867, expiration date Jan2016, NDC 00005197102) intramuscular in the right arm 03Nov2014 at 0.5 ml single for pneumonia prevention. The patient medical history was not reported. Concomitant medication included the first dose of influenza vaccine administered for immunization intramuscularly in the left arm at 1 dosage form single on the same day. On 03Nov2014 the patient experienced bruising at injection site that then went away on an unspecified date, there was also a welt and it still itched at the injection site and these conditions had been persisting for 2 months after the injection. Follow up (26Jan2015): New information from the same contactable pharmacist includes: events duration detail.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the sixth of six reports. A child (age and gender unknown) received a dose of PREVENAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date approximately five to six days after vaccination, the patient had large, raised, dark red swelling about 4 inches in diameter at the vaccination site and fever. Outcome was unknown. Follow-up (03Aug2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the fifth of six reports. A child (age and gender unknown) received a dose of PREVENAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date approximately five to six days after vaccination, the patient had large, raised, dark red swelling about 4 inches in diameter at the vaccination site and fever. Outcome was unknown. Follow-up (04Aug2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the fourth of six reports. The child (age and gender not specified) received a dose of PREVNAR 13 on an unspecified date. On an unspecified date, the child developed large, raised, dark red, swelling, about 4 inches diameter in size and a fever. The child came back to the office after five to six days after the vaccination. The outcome was unknown. Follow-up (03Aug2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported the same events for six patients. This is the second of six reports. A child (age, race and gender unknown) received a dose of PREVENAR 13 on an unspecified date. Relevant medical history and concomitant medications were not provided. The patient experienced a large, raised, dark red, and swollen area about 4 inch diameter in size. The patient also had a fever. The patient came back to the office after five to six days after they were vaccinated. Outcome was unknown. Follow-up (04Aug2011): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the first of six reports. A child (age and gender unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date approximately five to six days after vaccination, the patient had large, raised, dark red swelling about 4 inches in diameter at the vaccination site and fever. Outcome was unknown. Follow-up (04Aug2011): Follow-up attempts completed. No further information expected.
Age: 1.4
Sex: M
Vaccine: PNC13
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner, with follow-up from the same contactable nurse, who reported about a few patients. This is the second of two reports from the same reporter. A 17-month-old male patient was administered a dose of PREVNAR 13 (lot 914516, expiration date 29Feb2012) by intramuscular route of administration on 08Apr2011. The relevant medical history and the concomitant medications were unknown. On 08Apr2011, the patient experienced high fever and had a febrile seizure at home. The patient was taken to a hospital Emergency Room on 08Apr2011, and was treated for fever. The febrile seizure and high fever resolved on an unknown date. Relevant laboratory data of the patients was unknown. Therapeutic measures taken in response to events were unknown. Follow-up (11Jul2011): This follow-up from a contactable nurse included: product details, patient details, onset dates and outcomes.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Pyrexia, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician reported via a Pfizer sales representative. This physician reported similar events for six patients. This is the third of six reports. A child (age and gender unknown) received a dose of PREVNAR 13 on an unknown date. Relevant medical history and concomitant medications were not provided. On an unspecified date, approximately five to six days after vaccination, the patient had large, raised, dark red swelling about 4 inches in diameter at the vaccination site and fever. Outcome was unknown.
Age: 0.9
Sex: U
Vaccine: PNC13
Symptoms: Antibody test positive, Pneumococcal infection
Clinical narrative: This is a spontaneous report from a contactable physician. A 13 month old patient completed 3 doses of PREVNAR at 3, 5, 9 months. Relevant history and concomitant medications were not provided. On an unspecified date, the patient developed invasive pneumococcal disease, despite good titer levels (healthy, non-immunogenicity situation). The outcome of the event is unknown.
Age: 5.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Following the integration of the legacy safety adverse event reporting databases, this case has been migrated from the legacy company database into the current safety database for processing follow-up information. As a consequence of this migration, the follow-up report may indicate in the appropriate field that is an initial report. Information regarding PREVNAR 13 (syringe pre-filled) was received from a healthcare professional regarding a 4-year-old female patient who experienced swelling in thigh, pain in thigh and redness in thigh. The patient received a dose in Sep-2010. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered in Sep-2010. Dose regimen was 1 dose 1 time per day (subcutaneous). Unspecified flu vaccine on the same day as the PREVNAR vaccine (opposite thigh). CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced swelling in thigh, pain in thigh and redness in thigh in Sep-2010. Treatment included cold compresses to help relieve the pain from the reaction. Three days later, the events resolved. No additional information was available at the time of this report. Follow-up (17Nov2010): New information received from a contactable nurse. A 5-year-old female patient received PREVNAR 13 on 07Sep2010 in the right thigh. No pertinent medical history was reported. Relevant drug history included 4 doses of PREVNAR 7. Adverse event onset was 08Sep2010. Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: F
Vaccine: PNC13
Symptoms: Anaphylactic shock, Dyspnoea, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer sales representative. This physician had reported for a 12-months-old female patient who received the fourth dose of PREVNAR 13 on an unknown date at 0.5 ml single. There was no relevant medical history and concomitant medications of the patient. The patient had previously received three doses of PREVNAR 13 on unknown dates. It was reported by the physician that on an unknown date after receiving the vaccine,  the patient had an anaphylactic shock, a reaction like rash, hives and had trouble breathing for which the patient had visited the physician. Relevant laboratory tests were unknown. The therapeutic measures if any taken were unknown. The clinical outcome of the reported events was unknown at the time of report. Follow-up (05Oct2012): New information reported from the same contactable physician includes: vaccine history, reaction data (added "rash"). Follow-up (19NOV2012): Follow-up attempts completed. No further information expected.
Age: 0.7
Sex: M
Vaccine: 6VAX-F, FLU3, HIBV, PNC13
Symptoms: Expired product administered, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported for a 7-months-old, male consumer who received PREVNAR 13 on unknown date. The relevant medical history included viral illness and sore throat since an unknown date. The relevant concomitant medications included PEDIARIX at 0.5 cc, HIB at 0.5 cc and FLUZONE at 0.25 cc, all medications on unknown date for immunization. On 30Oct2012, the patient was administered with the expired PREVNAR 13 and after that on unknown date in 2012 he experienced fever. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported events were unknown. The clinical outcome of reported events was unknown. Follow-up (09DEC2012): Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report by a contactable pharmacist through a Pfizer sales Representative. A 74 year old male patient was administered with PREVNAR 13 intramuscular injection as a single dose on arm for prevention of pneumonia on 26Oct2013. Relevant medical history was unknown. On the same day the patient received an influenza vaccine. Vaccines given within the last four weeks were unknown. On 26Oct2013 the patient mentioned that his arm was sore and had trouble lifting his arm. On 26Oct2013 he stopped PREVNAR 13 as he took just one single dose. Relevant lab data was unknown. At the time of the report the patient had not recovered from the above mentioned events. Follow-up (06DEC2013): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC13, PNC13, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced developed a red area about the size of a pancake on leg and leg swelled. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced developed a red area about the size of a pancake on leg and leg swelled on an unknown date in 2010. The outcome of the events was unknown. No additional information was available at the time of this report. Follow-up (17NOV2010): This is a spontaneous follow-up from the contactable physician. The physician reported that the patient took also Connaught FLUZONE via an unspecified route of administration on an unspecified date. The developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were all within normal range. At the time of this report, the patient recovered. Patient's data and lot number updated. Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC13, PNC13, PPV
Symptoms: Peripheral swelling, Rash erythematous
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3-year-old female patient who experienced developed a red area about the size of a pancake on leg and leg swelled. The patient received a dose on an unspecified date. MEDICAL HISTORY: Relevant medical history was not provided. PRODUCT DETAILS: Indication for PREVNAR 13 was immunisation. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. CONCOMITANT THERAPY: Concomitant medications were not reported. EVENT DETAILS: The patient experienced developed a red area about the size of a pancake on leg and leg swelled on an unknown date in 2010. The outcome of the events was unknown. No additional information was available at the time of this report. Follow-up (17NOV2010): This is a spontaneous follow-up from the contactable physician. The physician reported that the patient took also Connaught FLUZONE via an unspecified route of administration on an unspecified date. The developmental milestones (language/speech; emotional/social; fine/gross motor skills; and cognitive thinking) were all within normal range. At the time of this report, the patient recovered. Patient's data and lot number updated. Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC13, PNC13, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Information regarding PREVNAR 13 was received from a healthcare professional regarding a 3 year old female patient who experienced pancake size red spot on leg and swollen leg. At 3 years of age, the patient received a dose on 22 Oct 2010. The patient also received a dose of PNEUMOVAX (Merck Sharp & Dome) on 22 Oct 2010. Relevant medical history was not provided. Indication for PREVNAR 13 was immunisation. Product was administered on 22 Oct 2010. Dose regimen was 1 dose 1 time per day. Concomitant medications were not reported. The patient experienced pancake size red spot on leg and swollen leg during the weekend following vaccination in Oct 2010. Outcome for swollen leg was recovered as of 25 Oct 2010. Outcome for pancake size red spot on leg was not recovered. No additional information was available at the time of this report. See related case (s): US WYE H1841116010 (adverse event, non expedited).