chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PNC
Symptoms: Injection site pain
Clinical narrative: New information was received regarding use of Ethyl Chloride. Information regarding PREVNAR was received from a physician regarding a patient who experienced very painful injection. The patient received a dose on an unspecified date. Relevant medical history was not provided. Indication for PREVNAR was immunization. Product was administered on an unspecified date. Dose regimen was 1 dose 1 time per day. Concomitant therapy included Ethyl Chloride. The patient experienced very painful injection on an unknown date. Outcome is unknown. Ethyl chloride is used as skin refrigerant or anesthesia to prevent pain at injection site. No additional information was available at the time of this report.
Age: 0.2
Sex: F
Vaccine: PNC
Symptoms: Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of the mother of the patient (mother does not wish to be further contacted). A 2-month-old female patient received 4 vaccinations at the same time during a routine well visit in Mar2009. Vaccines were unspecified however PREVENAR 7 was suspected (on routine childhood immunization schedule) but not verified. Relevant medical history, concomitant medications and past product history were not reported. Three days after vaccination, in Mar2009, the patient experienced fever (peaked over 102 degrees Fahrenheit), the child began to vomit and the vaccination site became extremely swollen. The patient was taken to the Emergency Room and was treated with TYLENOL and released. The patient was closely monitored for 4 days. The fever and other symptoms slowly subsided and the child is healthy today with no apparent permanent effects.
Age: 0.2
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report from a doctor via a Pfizer Sales Representative with follow-up from the contactable physician. A 2-month-old female patient was administered a dose of PREVNAR intramuscularly and a dose of PENTACEL (not SYNTHASIL as previously reported) intramuscularly, on 02May2011. No relevant past medical history, nor other illnesses were reported. Concomitant medications of the patient were non-applicable. On an unknown date, after the vaccinations, the patient experienced hives all over the body and the patient had an unspecified reaction. The relevant laboratory data was unknown. Status of both the therapies was unknown at the time of report. Therapeutic measures taken, if any, were unknown. Clinical outcome of the reported event was unknown at the time of report. Follow-up (14Jun2011): New information received from a contactable physician included: patient demographics, date of administration of PREVNAR and PENTACEL on 02May2011, route of administration, indication, description of event as hives all over body, concomitant medications are non-applicable, no other illness/relevant history were reported.
Sex: F
Vaccine: PNC
Symptoms: Induration
Clinical narrative: This is a spontaneous report from a contactable consumer (mother) via a Pfizer sales representative. A female patient (age unknown) received a dose of PREVNAR 7 on an unknown date. It was reported that, it was unknown if patient received PREVNAR 7 or PREVNAR 13. Relevant medical history and concomitant medications were not provided. On an unknown date, after receiving the vaccination, the patient experienced a hard lump (site not specified). Therapeutic measures taken as a result of the event were unknown. The patient recovered from the event on an unknown date. Follow-Up (08DEC2011) Follow-up attempts completed. No further information expected.
Age: 1.01
Sex: F
Vaccine: PNC
Symptoms: Antibody test abnormal, Incorrect route of drug administration
Clinical narrative: This is a spontaneous report from a contactable nurse. A 12-month-old female patient received the fourth dose of PREVNAR 7 intravenously on an unspecified site of administration 05Sep2007. The patient previously received the first, second and third doses of PREVNAR 7 on 28Nov2006, 27Mar2007 and 01Jun2007. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Past vaccine history included DTaP and HIB on 02Feb2007. On an unspecified date, at the age of 5 years, the patient was diagnosed with no immunity to Streptococcus pneumonia. The patient underwent an immunoglobin G (IgG) test for Streptococcus pneumonia on an unknown date which revealed no immunity to Streptococcus pneumonia. The event did not require an emergency room or doctor visit. At the time of the report, the outcome of the event was unknown. Follow-up (21Oct2011): Follow-up attempts completed. No further information expected.
Age: 0.17
Sex: F
Vaccine: PNC
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer. A 7-year old female received a dose of PREVNAR 7 intramuscularly for immunization on 10Mar2014. It was reported that the patient had completed therapy with PREVNAR. Relevant medical history was none. Relevant concomitant medications were unknown. In Feb2011 after the patient completed therapy with PREVNAR 7 vaccine, her blood work results revealed low titers. At the time of the report, outcome was unknown. Follow-up (30-AUG-2011): Follow-up attempts completed. No further information expected.
Age: 0.26
Sex: M
Vaccine: PNC
Symptoms: Cough
Clinical narrative: This is a spontaneous report from a contactable nurse. A 3-month-old male patient (race unknown) received a dose of PREVNAR in the thigh via intramuscular route of administration on 11Apr2011. Past vaccine history included ROTARIX. Relevant medical history and concomitant medications were not provided. On 11Apr2011, the patient continuously coughed for 2 hours after PREVNAR was administered. The patients dad reported that he felt the cough was a cold symptom instead of a reaction to PREVNAR. Therapeutic measures taken in response to the event were unknown. The clinical outcome of the event at the time of the report was unknown. Follow-up attempts completed. No further information expected. Follow-up (10MAY2011): New information reported from a contactable nurse includes: patient age; patient gender; dose details for suspect product; and past vaccine history.
Age: 0.17
Sex: F
Vaccine: PNC
Symptoms: Irritability, Pneumonia streptococcal, Pyrexia, Streptococcus test positive
Clinical narrative: Follow up information provided QA Results. Information regarding PREVNAR was received from a healthcare professional regarding a 3 month old female patient who was fussy and had a blood work that was positive for Streptococcus pneumoniae. The patient received the first dose on 12 Feb 2010. The patient's concurrent illnesses include dermatitis diaper and gastrooesophageal reflux disease (possible). Concomitant medications were not reported. On 28 Mar 2010 in the early hours, the patient was seen in the Emergency Room because of a fever and was unusually fussy. The patient was not admitted. During the night of 28 Mar 2010, the patient returned to the Emergency Room with the same symptoms. In the early morning hours of 29 Mar 2010, blood work was done which later confirmed that the patient had a Streptococcus pneumoniae infection. On 30 Mar 2010, the patient was admitted to the hospital due to the infection. The patient recovered. QA results were within specifications for Lot number E25197. Physical examination (results: head circumference of 13 3/4 inches and height of 20 inches) was done on 08 Dec 2009. Physical examination (results: developmental milestones within normal range) was done in Mar 2010. Blood test (results: positive for Streptococcus pneumoniae) was done on 29 Mar 2010. No additional information was available at the time of this report.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Abnormal behaviour, Contusion, Erythema, Oral mucosal eruption, Pyrexia
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding her son, a 3-year-old male, who experienced possible incorrect vaccine given, change of behaviour, fever, arm and shoulder became pink, red and very warm to touch, slight rash around mouth and what looked like a chemical reaction and shoulder looked like it was bruised. The patient received a dose on 12-Aug-2010. The patient experienced possible incorrect vaccine given. The consumer read the product description, which describes the vaccine as looking light blue, but it looked to her "more like a clear pink or orange" color. The mother observed a changed of behaviour of the child and fever on 12-Aug-2010, arm and shoulder became pink, red and very warm to touch and slight rash around mouth on 13-Aug-2010. The patient was taken to the doctor's office, and the patient was started on amoxicillin/clavulanic acid. Because symptoms continued, the patient was taken to the Emergency Room on 14-Aug-2010, where the physician ruled out cellulitis and said that it looked like a chemical reaction on 14-Aug-2010. No treatment was given. The patient was feeling better by 15-Aug-2010. The shoulder looked like it was bruised on 17-Aug-2010. The patient's behavioral change has not resolved. The outcome of the other events is unknown. No additional information was available at the time of this report. Follow-up (29Nov2010): Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Skin warm
Clinical narrative: Information regarding PREVNAR 13 was received from a consumer regarding her son, a 3-year-old male, who experienced possible incorrect vaccine given, change of behaviour, fever, arm and shoulder became pink, red and very warm to touch, slight rash around mouth and what looked like a chemical reaction and shoulder looked like it was bruised. The patient received a dose on 12-Aug-2010. The patient experienced possible incorrect vaccine given. The consumer read the product description, which describes the vaccine as looking light blue, but it looked to her "more like a clear pink or orange" color. The mother observed a changed of behaviour of the child and fever on 12-Aug-2010, arm and shoulder became pink, red and very warm to touch and slight rash around mouth on 13-Aug-2010. The patient was taken to the doctor's office, and the patient was started on amoxicillin/clavulanic acid. Because symptoms continued, the patient was taken to the Emergency Room on 14-Aug-2010, where the physician ruled out cellulitis and said that it looked like a chemical reaction on 14-Aug-2010. No treatment was given. The patient was feeling better by 15-Aug-2010. The shoulder looked like it was bruised on 17-Aug-2010. The patient's behavioral change has not resolved. The outcome of the other events is unknown. No additional information was available at the time of this report. Follow-up (29Nov2010): Follow-up attempts completed. No further information expected.
Age: 4.0
Sex: M
Vaccine: DTAP, PNC13
Symptoms: Rash, Urticaria
Clinical narrative: Information regarding PREVNAR 13 was received from a nurse regarding a 4 year old male patient who experienced rash and hives. The patient received a dose on 09 Sep 2010. The patient also received a dose of DAPTACEL (Aventis Pasteur) on 09 Sep 2010. Relevant medical history was not provided. Concomitant medications were not reported. The patient experienced rash and hives on 09 Sep 2010. Both events resolved on an unknown date in Sep 2010. No additional information was available at the time of this report.
Age: 2.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This is an initial spontaneous report by a contactable nurse. This nurse reported that a 2-year-old male patient who received PREVNAR 13 unknown dose injection intramuscular on an afternoon in the right thigh on 29Nov2010. Relevant medical history was none. Relevant concomitant medications were none. Concomitant vaccine given on the same day was FLUMIST. Vaccines taken within the last four weeks were none. On 01Dec2010 after receiving PREVNAR 13 protein the patient had red localized swelling and itching at the entire site. On an unknown date, the patient was prescribed BENADRYL for the treatment of red localized swelling and itching. Relevant lab data was none. At the time of the report he had recovered from red localized swelling and itching at the entire site on 03Dec2010.
Age: 0.66
Sex: M
Vaccine: PNC13
Symptoms: Crying, Irritability
Clinical narrative: This is a spontaneous report from a contractable nurse. An 8-month old male patient received a dose of PREVNAR13, on 16MAY2011. Relevant medical history was not reported. Concomitant medications included hepatitis B with an unknown date of administration. Past product history was not reported. On 20MAY2011, following administration of the vaccination, the patient developed irritability and inconsolable crying. At the time of this report, the outcome of the events was unknown.  Follow-up (06JUN2011): New information reported from the same contactable nurse includes: clarification that the nurse had actually only reported on one patient; not six as originally reported.
Age: 63.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report by a contactable nurse, a Pfizer internal colleague. A 63-year-old female patient received a dose of PREVNAR 13 intramuscularly at 1200 hrs in left arm on 12Mar2012. Relevant medical history includes breast cancer. Relevant concomitant medications included unspecified medications. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 12Mar2012 the patient experienced soreness at the site of the injection. Relevant lab data was none. At the time of the report she had not recovered from the above mentioned event. The patient additionally stated she did not have any further information to share and she did not wish to received any follow-up letters. Follow-up (21Mar2012): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse who is an internal colleague. A 54-year-old female patient received a dose of PREVNAR13, intramuscularly, at 12:00 PM in left arm on 12MAR2012. Relevant medical history was unknown and it was unknown if she had any siblings. Relevant concomitant medications were none. Vaccines given on the same day or administered within the last four weeks were none. On 12MAR2012 post-vaccination, the patient experienced chills, headache, weakness and soreness at the site of the injection. The events did not require an emergency room visit. Therapeutic measure taken in response to the headache included ADVIL. Relevant laboratory data was none. She had recovered from chills on 12MAR2012. At the time of the report she was recovering from headache and weakness and she had not recovered from the soreness at the site of the injection. The reported additionally noted she had received follow-up letters from your office requesting any additional information on these events but indicated that who did not have any additional information to provide. Follow-up (03APR2012) #2: New information received from the contactable nurse who reported on behalf of Nurse, whom the HCP letter was sent included: additional information regarding follow-up. Follow-up attempts completed. No further information expected. Follow-up (09APR2012): Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable nurse (internal colleague). A 58-year-old male patient received a dose of PREVNAR 13 intramuscularly in the left arm, at 0900 on 12Mar2012. Relevant medical history and concomitant medications were unknown. The patient experienced soreness at the injection site on 12Mar2012. The patient had not yet recovered. Follow-up (21Mar2012): Follow-up attempts completed. No further information expected.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Asthenia, Chills, Headache, Injection site pain, Injection site swelling
Clinical narrative: This is a spontaneous report by a contactable nurse who is a colleague. A 57-year old female patient received a dose of PREVNAR13, intramuscularly, in the left arm at 0730 hours on 12MAR2012. Relevant medical history included high blood pressure, high cholesterol, hypothyroidism and sinusitis. Relevant concomitant medications includes COREG and lisinopril for high blood pressure, LIPITOR for high cholesterol, SYNTHROID for hypothyroidism, and NASONEX for sinusitis. On 12MAR2012 at 0730 hours, the patient experienced soreness at the site of injection, weakness, chills, headache, and little bit of swelling at the site of injection. Therapeutic measures taken as a result of the event included treatment with ADVIL. The patient recovered from the events on 14MAR2012. Follow-up (03APR2012): Case closed. No further information expected.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: This is an initial spontaneous report by a contactable nurse. The nurse reported on 3 patients. This is the third of three reports. A 60-year-old female patient received a dose of PREVNAR13 intramuscularly on the left arm on 12MAR2012 at 15:45. Relevant medical history included high blood pressure and high cholesterol. Relevant drug history was unknown. Relevant concomitant medications included losartan for high blood pressure and TRICOR for high cholesterol. On 12MAR2012 at 15:45 the patient experienced soreness at the site of injection and bruising at the site of injection. At the time of the report she was recovering from the events. Follow-up (03APR2012): Case closed. No further information expected.
Age: 59.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site pain, Pain
Clinical narrative: This is a spontaneous report by a contactable nurse who is a colleague. This nurse reported on 3 patients. This is the second of three reports. A 59-year-old male colleague received a dose of PREVNAR13, intramuscularly at on the right arm on 12MAR2012 at 0645 hours. Relevant medical history and concomitant medication was none. On 12MAR2012 at 0645 hours the patient experienced soreness at the site of injection, fatigue, chills and boy ache. On 12MAR2012 he recovered from all the above mentioned events. Relevant lab data was none. Follow-up (03APR2012): Case closed. No further information expected.
Age: 54.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea, Pyrexia, Rash macular, Vomiting projectile
Clinical narrative: This is a spontaneous report from a contactable nurse who is Pfizer internal colleague. A 54-year-old female patient received PREVNAR 13 via the intramuscular route at 1400 hours on 12May2012. Medical history included ongoing hypothyroidism, ongoing celiac sprue, and possible renal illness. Concomitant medication included ongoing SYNTHROID for hypothyroidism. On 12Mar2012, patient experienced a red macular rash on her neck, anterior and posterior trunk, and bilateral upper side. In addition, on 12Mar2012, the patient experienced nausea and projectile vomiting. On 13Mar2012, the patient experienced a low grade fever. The patient did not receive treatment for her rash, nausea, or projectile vomiting. Therapeutic measures taken as a result of he low grade fever were not specified. The outcomes of the events nausea, projectile vomiting, and low grade fever were reported as recovered on 14Mar2012. The event rash was reported as recovered on an unspecified date. Follow-up (05Apr2012): New information reported by a contactable nurse included lot number, expiration date, route and administration, updated event onset, relevant history, and outcome information. No follow-up attempts needed. No further information expected. Follow-up (26APR02012) Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: This is a spontaneous report from a contactable physician communicated to an internal colleague. A 53-year-old male patient received a dose of PREVNAR13, intramuscularly in the left arm on 12MAR2012 at 1530 hours. Medical history included ongoing concurrent conditions of high blood pressure, high cholesterol, gout, acid reflux and psoriasis. Concomitant medications included MICARDIS, ASPIRIN, TOPROL XL, ZOCOR, NEURONTIN, and FISH OIL. On 17MAR2012, at 1300 hours, the patient developed nausea, headache, dizziness, and fatigue. At the time of the report, the patient was recovering from the events. The reporter additionally noted that she received follow-up letters requesting any additional information on these events but indicated she did not have any additional information to provide. Follow-up (03APR2012): New information reported from a contactable physician though an internal colleague includes: medical confirmation. Follow-up attempts completed. No further information expected. Follow-up (03APR2011): New information reported from a contactable nurse on behalf of the physician includes: information that the reporter received follow-up letters requesting additional information on these events but indicated she did not have any additional information to provide.
Sex: M
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner. A male patient (age unknown) received a dose of PREVNAR 13 intramuscular in the left upper deltoid as a prophylactic measure on 27Mar2012. Relevant medical history included seasonal allergy and allergy to cats and horses. Relevant concomitant medications were unknown. On 28Mar2012, the patient experienced arm pain when raising his arm. At the time of the report, the patient had not recovered. Follow-up (25MAY2012) Follow-up attempts completed. No further information expected.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report by a contactable nurse. A 58-year-old female patient received a dose of PREVNAR 13 at 1000 hrs intramuscularly in right deltoid on 03Apr2012. Relevant medical history included high cholesterol from an unknown date and ongoing. Relevant concomitant medications included LIPITOR for high cholesterol. On 03Apr2012 at 1700 hrs the patient experienced soreness at the site of vaccination. On 04Apr2012 at 0300 hrs she developed swelling at the site of vaccination, fatigue and chills. Therapeutic measure taken in response to soreness at the site of injection and swelling at the site of injection included treatment with ADVIL two tablets of 200mg two times a day. Relevant lab data was none. At the time of the report she was recovering from the swelling at the site of injection. At the time of the report she had recovered from the other mentioned events on 04Apr2012. No follow-up attempts possible. No further information expected.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Blood test, Crying, Irritability, Pyrexia, Swelling
Clinical narrative: This is a spontaneous report from a contactable nurse and from contactable physician. This is second of the four reports from the same reporter. A 2 month-old female patient received PREVNAR 13 (Lot: F24141, Expiration Date: 31Mar2013) 0.5 ml single dose, intramuscularly, on 26Mar2012; ROTATEQ (Lot: 1240AA, Expiration Date: 29May2013) daily dose regimen 2 ml, on 26Mar2012 and PENTACEL (Lot: C3928AA, Expiration Date: 05Jul2013) intramuscularly, daily dose regimen: 0.5 ml, on 26Mar2012 at 04:23 pm. Concomitant medications were unknown. Relevant medical history included drug allergies. Family's medical history included: asthma for father / half sister, blood pressure increased and diabetes mellitus for father. The nurse reported that the patient experienced extra puffiness and was crying excessively on 26Mar2012 after receiving the first dose of PREVNAR 13, ROTATEQ and PENTACEL. After the vaccine therapies, on 26Mar2012, the patient experienced also fever and her temperature was 100.4 degrees rectally and on 27Mar2012 her temperature was found between 100.5 to 101 degrees rectally due to which she was hospitalized on 27Mar2012. On an unknown date, the patient developed increase fussiness. Relevant laboratory data included blood work on an unknown date in Mar2012 while the patient was in hospital however the results of the tests were unknown. Fever was treated with antipyretic drug: TYLENOL with good clinical response. As of 29Mar2012, the patient was not discharged from the hospital. The patient had recovered from the events. Follow up (30Apr2012): Follow-up attempts completed. No further information expected. Follow-up (08May2012): New information reported from the contactable physician includes: patient history, suspect drug details; and reaction data. Follow-up (24May2012): Follow-up attempts completed. No further information expected.
Age: 0.33
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Incorrect route of drug administration, Vomiting
Clinical narrative: This is a spontaneous report obtained from a contactable nurse. This nurse reported on behalf of a 4 month old female patient who received, at 10 weeks, PREVNAR 13 intramuscularly on 21Mar2012. Vaccine given on the same day included PENTACEL. Vaccines taken within the last four weeks were none. Relevant medical history, drug history and concomitant medications were none. On 08May2012, she was accidentally administered PREVNAR 13 by oral route instead of intramuscular route and experienced two episodes of diarrhea and one episode of vomiting. The patient had two siblings who did not experienced and side effects. Relevant laboratory data was none. At the time of the report she had recovered from diarrhea and vomiting on 09May2012.
Age: 4.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer employee. This physician reported a 4 year old, female patient administered with PREVNAR 13 on 19Jul2012 as a single dose as a booster vaccination. There was no relevant medical history and concomitant medications. It was reported that the patient had rashes since 19Jul2012 and a slight headache and fever since 20Jul2012 after being administered with the medication on 19Jul2012. There was no relevant laboratory data. The status of PREVNAR 13 vaccine therapy was not applicable. The therapeutic measures were unknown. The patient was still experiencing the events at the time of the report. Follow-up (16AUG2012) Follow-up attempts completed. No further information expected.
Age: 0.5
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline. Manufacturer report No. A0993889A. A contactable other health care professional (Certified Medical Assistant) reported on behalf of the physician about a 6 months-old male patient that received a dose of pneumococcal 13-Val Conj Vaccine at 0.5 single dose, a dose of haemophilus influenzae type b vaccine at 1 DF single dose, a dose of ENGERIX B at 1 DF single dose, and the second dose of KINRIX (lot # AC20B178CB) at 1 DF single dose on 10Sep2012. He had no relevant medical history and was taken no concomitant medications. No adverse events were reported with previous vaccinations. On 10Sep2012, after vaccination, the patient experienced fever and dyspnoea. On 16Sep2012, the patient was hospitalized due to shortness of breath. The healthcare professional stated that the fever had improved but at the time of the report the subject's status was unknown. At the time of reporting the outcome of fever and shortness of breath were unknown. The healthcare professional reported that the vaccines were administered to a patient of inappropriate age. The healthcare professional reported also that the patient received vaccines underdose. Company Clinical Evaluation comment Based on the information provided in the case, this individual report would not seem to modify the benefit/risk profile of PREVENAR 13. Follow-up (21Nov2012): Follow-up attempts completed. No further information expected.
Age: 1.29
Sex: F
Vaccine: PNC13
Symptoms: Clostridium test negative, Diarrhoea, Escherichia test negative, Helicobacter test negative, Laboratory test normal
Clinical narrative: This is spontaneous report from a contactable consumer received via the non-clinical study program. A 15-month old female received the second dose of PREVNAR13; lot number F11149, Expiration Date 28AUG2014) 0.5 ml single dose administered intramuscularly into the left thigh on 08JAN2013 at 1600 hours. Relevant medical history and concomitant medications were not reported. Relevant family history included 5 siblings; autism in siblings (as reported, not specified). Past vaccine history included first dose of PREVNAR13 on 30APR2012, HIB on 24JUN2012 and polio vaccine on 26JUN2012 (according to the reporting physician, the patient's mother delayed vaccines because of autism concerns in sibling). Drug allergies were none. On 09JAN2013, the patient experienced vomiting and diarrhea and on 11JAN2013, the patient was diagnosed with rotavirus (confirmed by lab results on 18JAN2013). Relevant lab data included the following tests conduction on 11JAN2013 with results reported on 18JAN2013: rota stool test with positive results (rotavirus antigen enzyme immune assay (EIA) positive); salmonella/shingella screen with results no salmonella/shingella recovered; campylobacter culture with results no campylobacter species isolated; Ecoli shiga toxini with results EIA negative; and C difficile crytoxin B with negative results (not cytotoxin detected). Therapeutic measures included Pedialyte oral solution to treat vomiting and diarrhea. The patient recovered from vomiting on 13JAN2013, recovered from diarrhea on an unknown date in JAN2013, and the outcome of rotavirus was unknown. The physician assessed causality as reasonably possible, but did not specify for which events. The physician reported seriousness of events vomiting and diarrhea as "mild to moderate" and did not report seriousness criteria. The physician commented as follows: "I feel that syndrome of vomiting following PCV shot were likely related to rotavirus infection that was found by stool studies 3 days after immunization". Follow-up (12FEB2013): New information reported from a contactable physician includes: drug data (dosage, lot number and expiration date, and route of administration), family history (autism), reaction data (added event diarrhea with onset of 09JAN2013 and added event rotavirus with onset date of 11JAN2013), lab data, therapeutic measures (Pedialyte oral solution), outcome (vomiting: recovered on 13JAN2013; diarrhea; recovered on an unknown date in JAN2013; rotavirus; unknown), causality (related); seriousness (no seriousness criteria specified). Follow-up attempts completed. No further information expected.
Age: 1.29
Sex: F
Vaccine: PNC13
Symptoms: Rotavirus infection, Rotavirus test positive, Vomiting
Clinical narrative: This is spontaneous report from a contactable consumer received via the non-clinical study program. A 15-month old female received the second dose of PREVNAR13; lot number F11149, Expiration Date 28AUG2014) 0.5 ml single dose administered intramuscularly into the left thigh on 08JAN2013 at 1600 hours. Relevant medical history and concomitant medications were not reported. Relevant family history included 5 siblings; autism in siblings (as reported, not specified). Past vaccine history included first dose of PREVNAR13 on 30APR2012, HIB on 24JUN2012 and polio vaccine on 26JUN2012 (according to the reporting physician, the patient's mother delayed vaccines because of autism concerns in sibling). Drug allergies were none. On 09JAN2013, the patient experienced vomiting and diarrhea and on 11JAN2013, the patient was diagnosed with rotavirus (confirmed by lab results on 18JAN2013). Relevant lab data included the following tests conduction on 11JAN2013 with results reported on 18JAN2013: rota stool test with positive results (rotavirus antigen enzyme immune assay (EIA) positive); salmonella/shingella screen with results no salmonella/shingella recovered; campylobacter culture with results no campylobacter species isolated; Ecoli shiga toxini with results EIA negative; and C difficile crytoxin B with negative results (not cytotoxin detected). Therapeutic measures included Pedialyte oral solution to treat vomiting and diarrhea. The patient recovered from vomiting on 13JAN2013, recovered from diarrhea on an unknown date in JAN2013, and the outcome of rotavirus was unknown. The physician assessed causality as reasonably possible, but did not specify for which events. The physician reported seriousness of events vomiting and diarrhea as "mild to moderate" and did not report seriousness criteria. The physician commented as follows: "I feel that syndrome of vomiting following PCV shot were likely related to rotavirus infection that was found by stool studies 3 days after immunization". Follow-up (12FEB2013): New information reported from a contactable physician includes: drug data (dosage, lot number and expiration date, and route of administration), family history (autism), reaction data (added event diarrhea with onset of 09JAN2013 and added event rotavirus with onset date of 11JAN2013), lab data, therapeutic measures (Pedialyte oral solution), outcome (vomiting: recovered on 13JAN2013; diarrhea; recovered on an unknown date in JAN2013; rotavirus; unknown), causality (related); seriousness (no seriousness criteria specified). Follow-up attempts completed. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Erythema multiforme, Rash
Clinical narrative: This is a spontaneous report from two contactable physicians received via a Pfizer sales representative. A 2-month-old male patient of unspecified ethnicity, received the first single dose of 0.5 ml PREVNAR (Lot G47423 and expiration date: 31Jul2014) intramuscularly, in the right thigh, on 15Aug2013. Concomitant medications included vaccines administered on 15Aug2013: first single dose of PEDIARIX (GSK; Lot 749 CT) in the left thigh, first single dose of Hib vaccine (Sanofi; Lot UH770AA) in the right thigh and first single dose of oral ROTATEQ (Merck; Lot J003952). The patient was 27 weeks premature infant. No relevant drug history or drug allergies were reported. There was no illness at time of vaccination; no antipyretics were administered prior to vaccination. Two days after vaccination, on 17Aug2013, the patient experienced erythema multiforme and rash, for which patient was hospitalized for three days. The diagnosis was erythema multiforme. Patient was allergic to PREVNAR (previously reported as allergic to PREVNAR 13); onset date 17Aug2013. The events erythema multiforme and allergy were considered life threatening by the reporter. On 20Aug2013, the patient recovered from erythema multiforme, rash and allergic to PREVNAR. The reporter considered that there was a reasonable possibility that the events were related to PREVNAR. Follow-up (26Mar2014): New information reported from a contactable physician includes: patient data (history), suspect product data (dose, route, batch/lot, dose number, vaccine changed from PREVNAR 13 to PREVNAR), concomitant medications, outcome and causality. Follow-up (08Apr2014): Follow-up attempts completed. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from two contactable physicians received via a Pfizer sales representative. A 2-month-old male patient of unspecified ethnicity, received the first single dose of 0.5 ml PREVNAR (Lot G47423 and expiration date: 31Jul2014) intramuscularly, in the right thigh, on 15Aug2013. Concomitant medications included vaccines administered on 15Aug2013: first single dose of PEDIARIX (GSK; Lot 749 CT) in the left thigh, first single dose of Hib vaccine (Sanofi; Lot UH770AA) in the right thigh and first single dose of oral ROTATEQ (Merck; Lot J003952). The patient was 27 weeks premature infant. No relevant drug history or drug allergies were reported. There was no illness at time of vaccination; no antipyretics were administered prior to vaccination. Two days after vaccination, on 17Aug2013, the patient experienced erythema multiforme and rash, for which patient was hospitalized for three days. The diagnosis was erythema multiforme. Patient was allergic to PREVNAR (previously reported as allergic to PREVNAR 13); onset date 17Aug2013. The events erythema multiforme and allergy were considered life threatening by the reporter. On 20Aug2013, the patient recovered from erythema multiforme, rash and allergic to PREVNAR. The reporter considered that there was a reasonable possibility that the events were related to PREVNAR. Follow-up (26Mar2014): New information reported from a contactable physician includes: patient data (history), suspect product data (dose, route, batch/lot, dose number, vaccine changed from PREVNAR 13 to PREVNAR), concomitant medications, outcome and causality. Follow-up (08Apr2014): Follow-up attempts completed. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Allergy to vaccine, Erythema multiforme, Rash
Clinical narrative: This is a spontaneous report from two contactable physicians received via a Pfizer sales representative. A 2-month-old male patient of unspecified ethnicity, received the first single dose of 0.5 ml PREVNAR (Lot G47423 and expiration date: 31Jul2014) intramuscularly, in the right thigh, on 15Aug2013. Concomitant medications included vaccines administered on 15Aug2013: first single dose of PEDIARIX (GSK; Lot 749 CT) in the left thigh, first single dose of Hib vaccine (Sanofi; Lot UH770AA) in the right thigh and first single dose of oral ROTATEQ (Merck; Lot J003952). The patient was 27 weeks premature infant. No relevant drug history or drug allergies were reported. There was no illness at time of vaccination; no antipyretics were administered prior to vaccination. Two days after vaccination, on 17Aug2013, the patient experienced erythema multiforme and rash, for which patient was hospitalized for three days. The diagnosis was erythema multiforme. Patient was allergic to PREVNAR (previously reported as allergic to PREVNAR 13); onset date 17Aug2013. The events erythema multiforme and allergy were considered life threatening by the reporter. On 20Aug2013, the patient recovered from erythema multiforme, rash and allergic to PREVNAR. The reporter considered that there was a reasonable possibility that the events were related to PREVNAR. Follow-up (26Mar2014): New information reported from a contactable physician includes: patient data (history), suspect product data (dose, route, batch/lot, dose number, vaccine changed from PREVNAR 13 to PREVNAR), concomitant medications, outcome and causality. Follow-up (08Apr2014): Follow-up attempts completed. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dermatitis allergic, Erythema multiforme, Rash
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline. Reference number: A1063242A, by a contactable physician. A 2-month-old male patient of an unspecified ethnicity received on 15Aug2013 unspecified dose of PREVNAR 13 via an unspecified route of administration, 1st dose of PEDIARIX (Lot number: 749CT) via an unspecified route of administration at 0.5 ml in the left arm, unspecified dose of ACTHIB via an unspecified route of administration and unspecified dose of ROTATEQ via an unspecified route of administration. Medical history included premature birth, the patient was born at 31 weeks gestation. Concomitant medication included vitamin and CHILDRENS TYLENOL. On 17Aug2013, the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and sent home on prednisone. On 18Aug2013, the rash worsened and the patient was taken to a hospital with a pediatric ward. Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing to determine which vaccine may have caused the reaction before they go forward with administering any vaccines to thiw child. The patient was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the events were resolved. Follow-up (15May2014): Follow-up attempts completed. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Anaphylactic reaction, Pharyngeal oedema, Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline. Reference number: A1063242A, by a contactable physician. A 2-month-old male patient of an unspecified ethnicity received on 15Aug2013 unspecified dose of PREVNAR 13 via an unspecified route of administration, 1st dose of PEDIARIX (Lot number: 749CT) via an unspecified route of administration at 0.5 ml in the left arm, unspecified dose of ACTHIB via an unspecified route of administration and unspecified dose of ROTATEQ via an unspecified route of administration. Medical history included premature birth, the patient was born at 31 weeks gestation. Concomitant medication included vitamin and CHILDRENS TYLENOL. On 17Aug2013, the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and sent home on prednisone. On 18Aug2013, the rash worsened and the patient was taken to a hospital with a pediatric ward. Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing to determine which vaccine may have caused the reaction before they go forward with administering any vaccines to thiw child. The patient was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the events were resolved. Follow-up (15May2014): Follow-up attempts completed. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, PNC, RVX, DTAPHEPBIP, HIBV, PNC, RV5, DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Allergy to vaccine, Erythema multiforme, Rash
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline. Reference number: A1063242A, by a contactable physician. A 2-month-old male patient of an unspecified ethnicity received on 15Aug2013 unspecified dose of PREVNAR 13 via an unspecified route of administration, 1st dose of PEDIARIX (Lot number: 749CT) via an unspecified route of administration at 0.5 ml in the left arm, unspecified dose of ACTHIB via an unspecified route of administration and unspecified dose of ROTATEQ via an unspecified route of administration. Medical history included premature birth, the patient was born at 31 weeks gestation. Concomitant medication included vitamin and CHILDRENS TYLENOL. On 17Aug2013, the patient experienced rash and was taken to the emergency room. The patient was diagnosed with allergic rash and sent home on prednisone. On 18Aug2013, the rash worsened and the patient was taken to a hospital with a pediatric ward. Per the physician, the patient was hospitalized due to a life threatening condition. The patient was tested along with several consultations to different doctors. The patient was discharged with a diagnosis of erythema multiforme. The patient was referred to an allergist to do allergy testing to determine which vaccine may have caused the reaction before they go forward with administering any vaccines to thiw child. The patient was hospitalized and the physician considered the events were life threatening. The patient was treated with prednisone. At the time of reporting the events were resolved. Follow-up (15May2014): Follow-up attempts completed. No further information expected.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site pain, Injection site reaction, Somnolence
Clinical narrative: This is a spontaneous report by a contactable physician. This male physician reported on behalf of a 66-year-old female patient who was administered, on 03Feb2014 at around 1:00-1:30 pm, with PREVNAR 13 at 0.5ml single, intramuscular injection on left deltoid arm for prevention of pneumonitis. Relevant medical history included hypothyroidism since 1982 and migraine since childhood both ongoing during the onset of events. Relevant concomitant medications included FIORICET, alprazolam, INDERAL, LEVOXYL for hypothyroidism, IMITREX and PAXIL and she was taking them during the events onset. Vaccines given on the same day and vaccines taken within the last four weeks were none. In Feb2014 after administering PREVNAR 13, she had a reaction at the site of injection, localized pain in muscle where injection was performed, excess fatigue and excess drowsiness. Relevant lab data was none. At the time of the report she had not recovered from the above mentioned events. The physician suspected that the events were due to PREVNAR 13 vaccine. Follow-up (30May2014): Follow-up attempts completed. No further information expected.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Crying, Full blood count, Irritability, Opisthotonus, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable healthcare professional (business manager reporting on behalf of a physician) and from contactable physician. A 6-month-old male patient received, on 11Jun2014 at 15:30, PREVNAR 13 (lot number H47689) 0.5 ml, single dose, intramuscular on left thigh, and PEDIARIX (lot number KN2FL) 1 DF, single dose, intramuscular on right thigh; both for immunization. Relevant medical history included gastrooesophageal reflux disease (GERD). After previous unspecified vaccinations, the patient experienced fussiness and fever. Concomitant medication included ZANTAC. On 11Jun2014, the patient experienced unconsolable crying and on the same day, in the evening, he experienced fever, which on the following morning (12Jun2014) increased to 104.1 degrees Fahrenheit. The patient received a OTC treatment in order to reduce fever. On 12Jun2014, the patient was also irritable with an arching back. It was further reported that the patient ended up in emergency room on 12Jun2014 due to the events however the reporter was not sure if the patient was admitted or not. The reporter mentioned that the physician believes that the reported events were either caused by PREVNAR 13 vaccine or DTAP, HIB vaccine, poliomyelitis vaccine inactivated. On an unknown date in Jun2014, the patient underwent laboratory test which included a complete blood count (CBC) of which the result were unknown. The patient recovered from fever and unconsolable crying on an unspecified date, which clinical outcome of the events irritable, and arching back was unknown. Follow-up (18Jul2014): New information reported the contactable physician includes: patient clinical course and reaction data (unconsolable crying added as additional adverse event). Follow-up (12Sep2014): Follow-up attempts completed. No further information expected.