chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.4
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: This is a spontaneous report from a contactable unspecified healthcare professional. This 4-month-old male patient of unknown ethnicity received PREVNAR 13 (Lot# 32487, Exp. Date: Dec2014) at 0.5 ml single dose in the left thigh at 12:10 hr on 17May2013. The relevant medical history was none. The relevant concomitant medication included HIB vaccine (Mfg by Sanofi, lot # UH770AA) Intramuscular in the right thigh, at an unknown dose and frequency on unknown date in 2013 for an unknown indication, the second dose of which (Sanofi, lot # UH770AA) was given on 17May2013 in the right thigh. On 17May2013 the consumer experienced redness around the injection site and on an unknown date in May2013 the patient experienced a rash at the injection site which covered upper part of the leg, after he was given his 4 month dose of PREVNAR 13. The relevant laboratory data was none. The last action taken with PREVNAR 13 therapy was unknown. Therapeutic measures taken in response to the reported events were none. The consumer had not recovered from the reported events at the time of report. This child had on an unspecified date an injection site reaction with PEDIARIX and HIB vaccine. Outcome of the event was unknown. Follow Up (20May2013): New information reported from a contactable medical assistant calling from a physician office, who reported for a consumer, includes: patient ethnicity: PREVNAR 13 data; medical history none; concomitant medication; new event; laboratory data was none; events outcome; birth weight. Follow-up (28-JUN-2013) Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Dizziness, Feeling drunk
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A adult male patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on 20Feb2014 at 0.5 ml, single dose. The patient medical history and concomitant medications were not reported. The patient felt like he was drunk or dizzy on an unspecified date with outcome of unknown. The pharmacist asked if syncope and dizziness were reported.
Age: 1.0
Sex: U
Vaccine: HEPA, PNC13
Symptoms: Agitation, Psychomotor hyperactivity
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 12 month old patient of an unknown gender. On an unknown date, the patient was vaccinated with a dose of VAQTA lot # K005958 (dose and route were not reported). Concomitant therapies included PREVNAR13 and an unspecified HIV vaccine. Shortly after administration, the patient experienced agitation becoming very excitable and psychomotor  hyperactivity described as "hyperactive". At the time of the report the outcome of agitation and psychomotor hyperactivity was unknown.  Additional information is not expected because the reporter did not provide any contact details.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date in November 2013, the patient was vaccinated with GARDASIL dose 1, standard dose, intramuscularly. On 30-JAN-2015, the patient was vaccinated with GARDASIL dose 2. No adverse effect was reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is an initial spontaneous report from Pfizer Medical Information for a contactable pharmacy technician who reported for an unknown consumer. This consumer (age, race and gender unknown) might have started receiving PREVNAR 13 since an unknown date at an unknown dose and frequency for an unknown indication. Relevant medical history and concomitant medication was unknown. Since an unknown date, the consumer was ill after administering with PREVNAR 13 [elaborated that the consumer was possibly on a series of PREVNAR 13 and missed dose of PREVNAR 13 on an unknown date [elaborated that the consumer was possibly on a series on PREVNAR 13 and this might be second or third dose in the series, which could not be given as the consumer was ill]. Relevant laboratory data was unknown. Last action taken with PREVNAR 13 was unknown at the time of report. Therapeutic measures taken in response to the reported events were not provided. Clinical outcome of the reported events was unknown at the time of report.
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Local swelling, Lymphadenopathy
Clinical narrative: Initial report was received on 07 September 2013 from a consumer who is also the patient. A male patient (date of birth not reported) had received ACAM2000 (lot number, route, site and date of administration not reported) and an unspecified amount of time later, reported the area was red and swollen, he had enlarged lymphnodes and he had two red, raised lines going to his underarm. No further information was available at the time of the report. The patient's outcome was not reported. Documents held by sender: None.
Sex: F
Vaccine: PNC13
Symptoms: Decreased appetite, Injection site erythema, Injection site mass, Pyrexia
Clinical narrative: This is a spontaneous report by a contactable consumer (patient mother) through a Pfizer Sales Representative, and then from a contactable physician. A 15 months old female patient received the fourth dose of PREVNAR 13 single dose on 31Jan2014 as a part of the immunization. Vaccines given on the same day included unspecified vaccines on arm on 31Jan2014. The patient was previously administered with PREVNAR 13, single dose intramuscular injection on arm on an unknown date when she was 2 months old. Vaccines given within the last four weeks were none. On 02Feb2014 she experienced low grade fever, decreased appetite and had "red lump at the site of injection". She did not visit emergency room or was hospitalized because of the above mentioned events and she also did not report this events to her physician. Relevant therapeutic measures included TYLENOL for low grade fever. Relevant sibling information was none. Relevant lab data was none. The patient recovered from the above mentioned events in Feb2014. The reporting physician did not confirm the occurrence of the events reported by the patient. Follow-up (19Feb2014): New information received from a contactable physician includes: the reporting physician did not confirm the occurrence of the events reported by the patient. Follow-up attempts completed. No further information expected.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Blood test, Chills, Hypersensitivity, Hypertension
Clinical narrative: This is a spontaneous report from a contactable consumer. This 78-year-old female consumer received a dose of PREVNAR12 on 21 JAN 2014 at 11:45 single dose in the right arm. Relevant medical history included hip replacement surgery done on an unknown date. Relevant concomitant medication was unknown. The consumer reported that on 21 JAN 2014 at 15:00, she had an allergic reaction to it. Joints of her left hand swelled up and inflamed, her knee welled up, her ankle and calf sw3elled up, she couldn't mover her legs and feet, she was in severe pain, she had chills, her blood pressure went sky high, she couldn't move her fingers, couldn't move her joints, she had pain in the wrist and she had red streaks at the site of injection. The consumer also reported that on an unknown date several years ago she had an allergic reaction with unspecified tuberculosis vaccine. Relevant laboratory data included blood work and x-ray, both done on 22 JAN 2014, the results were unknown at the time of reporting. Therapeutic measures taken in response to the reported events were unknown. The consumer had not recovered from the event "had red streaks at the site of injection" while she had recovered from all other events on an unknown date in JAN 2014.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Hypoaesthesia, Inflammation, Injection site erythema, Joint swelling, Movement disorder
Clinical narrative: This is a spontaneous report from a contactable consumer. This 78-year-old female consumer received a dose of PREVNAR12 on 21 JAN 2014 at 11:45 single dose in the right arm. Relevant medical history included hip replacement surgery done on an unknown date. Relevant concomitant medication was unknown. The consumer reported that on 21 JAN 2014 at 15:00, she had an allergic reaction to it. Joints of her left hand swelled up and inflamed, her knee welled up, her ankle and calf sw3elled up, she couldn't mover her legs and feet, she was in severe pain, she had chills, her blood pressure went sky high, she couldn't move her fingers, couldn't move her joints, she had pain in the wrist and she had red streaks at the site of injection. The consumer also reported that on an unknown date several years ago she had an allergic reaction with unspecified tuberculosis vaccine. Relevant laboratory data included blood work and x-ray, both done on 22 JAN 2014, the results were unknown at the time of reporting. Therapeutic measures taken in response to the reported events were unknown. The consumer had not recovered from the event "had red streaks at the site of injection" while she had recovered from all other events on an unknown date in JAN 2014.
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Peripheral swelling, X-ray
Clinical narrative: This is a spontaneous report from a contactable consumer. This 78-year-old female consumer received a dose of PREVNAR12 on 21 JAN 2014 at 11:45 single dose in the right arm. Relevant medical history included hip replacement surgery done on an unknown date. Relevant concomitant medication was unknown. The consumer reported that on 21 JAN 2014 at 15:00, she had an allergic reaction to it. Joints of her left hand swelled up and inflamed, her knee welled up, her ankle and calf sw3elled up, she couldn't mover her legs and feet, she was in severe pain, she had chills, her blood pressure went sky high, she couldn't move her fingers, couldn't move her joints, she had pain in the wrist and she had red streaks at the site of injection. The consumer also reported that on an unknown date several years ago she had an allergic reaction with unspecified tuberculosis vaccine. Relevant laboratory data included blood work and x-ray, both done on 22 JAN 2014, the results were unknown at the time of reporting. Therapeutic measures taken in response to the reported events were unknown. The consumer had not recovered from the event "had red streaks at the site of injection" while she had recovered from all other events on an unknown date in JAN 2014.
Age: 0.7
Sex: F
Vaccine: PNC13
Symptoms: Bronchitis, Ear infection
Clinical narrative: This is a spontaneous report from Non-Clinical-Study-Program Prevnar 13 Public Moms and Sandwich Generation Market Research from a contactable consumer (patients mother). A currently 7-months-old female started to received PREVNAR 13 via an unspecified route of administration on an unspecified date. The patient medical history and concomitant medications were not reported. Since turning 4 months old the patient had 3 ear infections and bronchitis twice on an unspecified date. Therapeutic measures were taken in response to the events were not reported. The patient recovered at the time of the report.   Follow-up (18FEB2014): Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Local reaction
Clinical narrative: This is an initial spontaneous report from a Pfizer Sales representative reporting on behalf of the contactable Physician for a patient. This 56 year old female patient receivd PREVNAR 13 since an unknown date at an unknown dose and frequency. Relevant medical history and relevant concomitant medication was unkonwn. Since an unknown date the patient experienced localized reaction after three days of injection  while on PREVNAR 13. Relevant laboratory data was unknown. Last action taken with PREVNAR 13 therapy was unknown. Therapeutic measures taken in response to the event were unknown. Clinical outcome of the event was unknown at the time of report. Follow-up (30Jan2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Ill-defined disorder
Clinical narrative: This is a spontaneous report by a non-contactable consumer: This female consumer received PREVNAR 13 single dose on an unknown date. Relevant medical history was and concomitant medications were none. Vaccines given on the same day and within the last four weeks were unknown. In 2013, shortly after she was administered with PREVNAR 13, she mentioned that she got a collapse like a really bronchitis and cold which had been dragging on to about two or three months now. Relevant sibling information lab was unknown. Relevant data was none. At the time of the report she had not recovered from the above mentioned events. No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 40 (unit not provided) female patient received PREVNAR 13 on unspecified date, at single dose. On an unspecified date after vaccination the patient experienced erythema in her arm. Outcome of the reported event was unknown.   Follow-up (07-FEB-2014): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Peripheral swelling, Pyrexia, Rash, Skin ulcer
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. This consumer reported similar adverse event for three different patients. This is the second of three reports.  A male patient received PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were unknown. ON an unspecified date, in NOV 2013, while on PREVNAR 13 the patient experienced rash on arm, swelling on arm, inflammation on arm, fever and sores. Relevant laboratory data was unknown. Therapeutic measures taken in response to the events were unknown. At the time of this report, the patient recovered from the event, sores (lasted for two days) while clinical outcome of the events was unknown.   Follow-up (16JAN2014): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Inflammation, Peripheral swelling, Pyrexia, Rash, Skin ulcer
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. This consumer reported similar adverse event for three difference patients. This is the first of three reports. A male patient received PREVNAR 13 single dose on an unspecified date. Relevant medical history and concomitant medications were unknown. ON an unspecified date in NOV2013, while on PREVNAR 13, the patient experienced rash on arm, swelling on arm, inflammation on arm, fever and sores. Relevant laboratory data was unknown. Therapeutic measures taken in response to the events were unknown. At time of this report, clinical outcome of the events was unknown.   Follow-up (16JAN2014): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Hyperhidrosis, Hypotension, Nausea
Clinical narrative: This is a spontaneous report from a contactable nurse who reported for a patient. A 69-year-old female patient received PREVNAR 13 (lot # G98134, expiration date: FEB2015) intramuscularly on 08NOV2013 DTP on an unknown date.  Relevant medical history included reflux disease, hyperlipidemia and anxiety, all  since an unknown date. Relevant concomitant medication included ATIVAN, CRESTOR, nortriptyline, and NEXIUM; all at an unknown dose and frequency since an unknown date for an unknown indication. It was reported that the patient had extreme diaphoresis, hypotension, and nausea; all since an unknown date in NOV2013. Relevant laboratory data was none. Therapeutic measures taken in response to the events were unknown. Patient was recovered from the reported events on an unknown date in NOV2013.  Follow-up (09JAN2014): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Blood pressure increased, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: This is a spontaneous report by a contactable physician. This Pfizer Sales Representative reported on behalf on a male physician for a female patient who received a dose of PREVNAR 13 intramuscularly in arm on 04Nov2013 at 9 AM. Relevant medical history was unknown. Relevant concomitant medication was unknown. Vaccines given on the same day were reported as none. Vaccines taken within the last four weeks included unspecified Flu vaccine. On 04Nov013 at an unknown time in the morning she experienced redness, tenderness, rash and pain at the site of administration and her blood pressure went up. Therapeutic measure taken in response to redness, tenderness, rash and pain at the site of administration included CELESTONE. At the time of the report the clinical outcome of the above mentioned events was unknown. Follow-up (26Dec2013): Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This is a spontaneous report from a contactable nurse. A 26 years old female patient started to receive PREVNAR 13 (lot #657035, Expiration date Oct2015) intramuscularly on 04NOV2013. Relevant medical history included high blood pressure, and hyperlipidemia; both since an unknown date. Relevant concomitant medications included LIVALO at a dose of 2mg daily for hyperlipidemia and LISINOPRIL/HYDROCHLOROTHIAZIDE tablet orally at 20/25 mg daily (two tablets of 10/12.5 mg each) for high blood pressure. It was reported that on 04NOV2013, the patient experienced a local reaction in left deltoid when the shot was administered and later on it became the systemic reaction on the same day. Relevant laboratory data was unknown. Therapeutic measures taken in response to the event included ice at an unknown dose and frequency and CELESTONE intramuscularly at a dose of 6 mg (unknown frequency). Clinical outcome of the event was unknown at the time of report. The nurse confirmed that the event was due to PREVNAR 13.   Follow-up (26DEC2013): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Erythema, Headache, Pain, Peripheral swelling, Pruritus
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 69 year old male patient (race unknown) received intramuscular PREVNAR 13 at 0.5 ml single dose. On 14Oct2013. Relevant medical history and concomitant medications were unknown. It was reported that the patient received PREVNAR 13 (in his right arm) and an unspecified flu injection (on his left arm) on 14Oct2013 after which since 15Oct2013 he had severe headache, fever, pain, swelling, itching and redness in right arm. Relevant laboratory data was unknown. Therapeutic measures taken, if any, were unknown. The patient recovered from severe headache, fever, pain, swelling since 17Oct2013 however did not recover from the other reported events at the time if report. Follow-up (13DEC2013): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A 69 year old male patient (race unknown) received intramuscular PREVNAR 13 at 0.5 ml single dose. On 14Oct2013. Relevant medical history and concomitant medications were unknown. It was reported that the patient received PREVNAR 13 (in his right arm) and an unspecified flu injection (on his left arm) on 14Oct2013 after which since 15Oct2013 he had severe headache, fever, pain, swelling, itching and redness in right arm. Relevant laboratory data was unknown. Therapeutic measures taken, if any, were unknown. The patient recovered from severe headache, fever, pain, swelling since 17Oct2013 however did not recover from the other reported events at the time if report. Follow-up (13DEC2013): Follow-up attempts completed. No further information expected.
Age: 0.09
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: This is a spontaneous report from a contactable nurse calling from physician's office who reported for a patient. This is second of the two reports from the same reporter. This 4-weeks old female patient received PREVNAR 13 (Lot# G75073) on 17Oct2013 in left thigh, at 0.5ml single. The patient had no relevant medical history. Relevant concomitant medication included HIB on 15Oct2013 at single dose on left thigh, DTAP vaccine on 15Oct2013 at single dose on right thigh, Polio on 15Oct2013 at single dose on left arm and rotavirus vaccine on 15Oct2013 at single dose orally. It was reported that on 17Oct2013 while on PREVNAR 13 the patients leg was red, tender and swollen. Relevant laboratory data was unknown. Therapeutic measures taken in response to the reported events were unknown. Clinical outcome of the reported events was unknown at the time of report. Follow-up (10Dec2013): New information received from a contactable nurse includes: addition of the event inappropriate age at vaccine administration. Follow-up attempts completed. No further information expected.
Age: 0.17
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This is an initial spontaneous report from a contactable nurse calling from physician's office who reported for a patient. This is first of the two reports from the same reporter. This 2 month old male patient received PREVNAR 13 (Lot# G75073) on 15OCT2013 at 0.5ml single dose. The patient had no relevant medical history. Relevant concomitant medication included HIB on 15Oct2013 at an unknown dose on left thigh; DTaP on 15Oct2013 at an unknown dose on right thigh, polio on 15Oct2013 at an unknown dose on left arm; rotavirus vaccine on 15Oct2013 at an unknown dose orally. It was reported that on 15Oct2013 the patients leg was red and hard. Therapeutic measures taken in response to the reported events and outcome were unknown at the time of report. Follow-up (11Dec2013): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Genital swelling, Peripheral swelling
Clinical narrative: This is an initial spontaneous report from a Pfizer sales representative on behalf of a contactable nurse who reported for a patient. This male patient (age and race unknown) received PREVNAR 13 and other unspecified vaccines on an unknown date at an  unknown dose. Relevant medical history, laboratory data, and relevant concomitant medications were unknown. It was reported that on an unknown date the patient experienced swelling in his lower extremities (from hip to toes) and in his genitals. Therapeutic measures taken in response to the reported events were unknown. Clinical outcome of the reported events was unknown at the time of report.   Follow-up (11DEC2013): Follow-up attempts completed. No further information expected.
Age: 0.11
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Administration site swelling, Administration site warmth, Discomfort, Injection site erythema
Clinical narrative: This is a spontaneous report by a contactable physician. This physician reported that a 6-week-old female baby received the first dose of PREVNAR 13 (Batch/Lot # G75073) at 0.5 ml single dose intramuscularly in the left thigh, and HIB in the left thigh, both on 17Oct2013. Relevant medical history and concomitant were reported as none. On 17Oct2013 the baby experienced lots of discomfort, and reaction at the administratoin site such as skin got swollen, redness and warmth. Therapeutic measures taken in response to above mentioned events included ice and TYLENOL. The baby fully recovered on 18Oct02013. Follow-up attempts completed. No further information expected. Follow-up (05Nov2013): New information from a contactable physician includes: vaccination date and Batch/Lot, concomitant vaccine, patient's demographics, outcome. Follow-up (26Nov2013): New information from the same contactable physician includes: details on administered vaccines, and, details on medical history and concomitant medications.
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Feeling hot, Pain, Swelling, Tenderness
Clinical narrative: This is an initial spontaneous report by a contactable physician. This Pfizer sales representative on behalf of a physician for one of his 55 year old male consumer who was administered with PREVNAR 13 unknown dose frequency intramuscular injection at an unknown time in deltoid muscle on 07OCT2013. Relevant medical history was unknown. Relevant concomitant medication was unknown. Vaccines given on the same day were unknown. Vaccines taken with the last four weeks were unknown. In OCT2013 after 12 hours of administration of PREVNAR 13 the patient experienced warmth, pain, swelling, redness and tenderness. Therapeutic measures taken in response to pain included ADVIL. Relevant sibling information was unknown. Relevant lab data was unknown. At time of report it was unknown if he was administering PREVNAR 13. At the time of the report he was not recovered from pain and swelling. At the time of report clinical outcome of other events was unknown.   Follow-up (06DEC2013): Follow-up attempts completed. No further information expected.
Age: 0.39
Sex: M
Vaccine: PNC13
Symptoms: Inappropriate schedule of drug administration, Speech disorder developmental, Toxicity to various agents
Clinical narrative: This is a spontaneous report by a non-contactable consumer. The female consumer reported that her 4-year-oldson received the third dose of PREVNAR 13 injection on 08Sep2009 at the age of 4-months. First dose was administered on 30Jun2009 and second dose on 24Aug2009. Relevant medical history and concomitant medications and vaccines were unknown. On 08Sep2009 she mentioned that her son was accidentally administered third dose of PREVNAR 13 too early. On an unkown date the reporter suspect PREVNAR 13 poisoning due to accidental dose as her son experienced language delayed. Relevant lab data and outcome were unknown. No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable physician, through a Pfizer Sales Representative. A male patient was administered with PREVNAR 13 single dose unknown route on an unknown site at an unknown time on an unknown date. Anatomical location of the administration of the vaccine was unknown. Relevant medical history was unknown. Relevant concomitant medications were unknown. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. An unknown date at an unknown time the patient had sore throat. It was unknown if the patient had any siblings. Relevant lab data was unknown. At the time of report it was unknown if the patient was taking pneumococcal 13-val conj vac. At the time of report the clinical outcome of the above mentioned event was unknown. The patient did provide information to the reporter regarding the reported adverse event with the use of the product. The reporter could confirm the occurrence of the events reported by the patient and was not willing to be contacted again by Pfizer for follow-up information on the reported adverse event. Follow-up attempts completed. No further information expected. Follow-up (04Ot2013): New information reported from a contactable physician includes: reporter informed by patient about the event; reporter confirmed the events reported by the patient; reporter not confirmed further contactability.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia, Upper extremity mass
Clinical narrative: This is an initial spontaneous report from a Pfizer sales representative for a contactable physician who reported for a patient. This 68 year old female patient received PREVNAR 13 (Lot# G98134, Exp. date: Dec2014) on an unknown date in Sep2013 for pneumonitis prevention. The relevant medical history and concomitant medication were unknown. At night of 09Sep2013 when the PREVNAR 13 was administered the patient experienced fever and swollen lump on her left arm. The relevant laboratory data were unknown. The therapeutic measure included cephalexin (manufacturer unknown) since an unknown date in Sep2013 at an unknown dose and frequency to red swollen lump on her left arm. It was also reported that the cephalexin did not work for the patient because the patient was still experiencing the red swollen lump on her left arm. The patient had not recovered from the event red swollen lump on her left arm, the clinical outcome of fever was unknown at the time of report. Follow-up (08Nov2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report from a contactable physician through a Pfizer Sales Representative. A patient of unknown gender and age received PREVNAR-13 single dose, unknown route for immunization on unknown date. Relevant medical history and relevant concomitant medications were unknown. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were unknown. On 06Sep2013 the patient experienced swelling on the arm and pain in the arm. Relevant lab data was unknown. At the time of the report clinical outcome of above mentioned events was unknown. Follow-up (01NOV2013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. An adult female patient received PREVNAR 13 intramuscularly on the left upper arm on an unspecified date. Relevant medical history was unknown. Relevant concomitant medications were unknown. On an unspecified date, the patient experienced swelling at the site of injection and swelling on the left upper arm was more than normal. The outcome of the events, swelling at the site of injection and swelling on the left upper arm was more than normal, were unknown. The physician considered that there was a reasonable possibility that the event was related to PREVNAR 13. Follow-up (11Oct2013): Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site reaction, Pain, Peripheral swelling, Tenderness
Clinical narrative: This spontaneous report as received from a nurse practitioner and male physician of 72 year old who is also the patient. Patient medical history and current condition was not reported. Approximately on an unknown date in 2008 (reported as 7 years ago) he received first dose of PNEUMOVAX 23. On 28-JAN-2015 the patient was vaccinated with the second dose of PNEUMOVAX 23 (Lot # K005957 and expiry date 08-MAR-2015) (strength, dose and frequency not provided). It was reported that he received a second dose of PNEUMOVAX 23 because he works in healthcare. Other co-suspects and concomitant medication was not reported. On 28-JAN-2015 the patient experienced redness, swollenness, and tenderness throughout his whole arm. Also reported that the patient was in a lot of pain. He states that he would rate his injection site reaction with PNEUMOVAX 23 as severe, but he denies any systemic symptoms. The patient received treatment with ADVIL and ice. Cancer and overdose was not reported. The outcome of the events was unknown. This is one of two reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Menstruation delayed
Clinical narrative: This spontaneous report as received from a mother reporting on her daughter of unknown age. On 26-JAN-2015 the patient was vaccinated with a second dose of GARDASIL (dose, route and lot # was not provided). The reporter stated that after first dose of GARDASIL (date unspecified) her daughter did not experienced adverse effects. However after second dose, patient's menstrual period which was normally on time had not yet started. By the time of the report (reported as "yet") the event was not resolved. Relatedness between the event and GARDASIL was not specified. Additional information is not expected as the reporter did not wish to provide specific information.
Age: 1.02
Sex: M
Vaccine: DTAP
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a nurse and described the occurrence of drug dose administration interval too short in a 12-month-old male patient who received INFANRIX (batch number N5339, expiry date 25th March 2016). On 25th November 2014, the patient received the 4th dose of INFANRIX. On 25th November 2014, an unknown time after receiving INFANRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information: a 12 month old child was given their 4th dose early on 25 November 2014 inadvertently when they were actually due for it on 9 December 2014.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a female patient who received ENGERIX B (batch number AHBVC103AA, expiry date 30th May 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unkown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: HCP stated that 7 doses of expired ENGERIX-B were administered to patients. She said that her office does not pay attention to expiration dates very well. All patients received a dose from the same lot number and expiration date.
Age: 61.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Hot flush, Pain, Unevaluable event, Vaccination complication
Clinical narrative: This is a spontaneous report from a contactable consumer. This 61-year-old male consumer started to receive PREVNAR 13 on 16Jul2013 at 10:00 AM. Relevant medical history included high cholesterol since an unknown duration. Relevant concomitant medication included CRESTOR since an unknown duration at a dose of 10mg daily for high cholesterol and aspirin since an unknown duration at a dose of 81mg daily. The consumer reported that on 16Jul2013 he took PREVNAR 13 without prescription on his left arm and had chills, hot flashes, body ache and a bad reaction. No relevant laboratory data was reported. Therapeutic measures taken in response to the reported events was that the consumer visited his physician on 17Jul2013 and was prescribed ibuprofen at an unknown dose and frequency. The clinical outcome of the event took medication without prescription was unknown however the consumer was recovered from the other reported events since an unknown date in Jul2013. Follow-up (23Oct2013): Follow-up attempts completed. No further information expected.
Age: 1.09
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Induration, Injection site erythema, Local swelling, Vaccination site induration
Clinical narrative: This is a spontaneous report from Pfizer Medical Information for a contactable reporter who reported for her son. This 13 month old, male consumer received PREVNAR 13 (expiration date: 696157) on 01Jul2013 single dose on his right upper thigh as a preventative vaccine. There was no relevant medical history as well as relevant concomitant medications. The patient developed red lump (red, firm, and raised area) on 01Jul2013 evening and a red firm on the vaccination site, which did not required treatment and had pain since 7:00am on 02Jul2013. There was no relevant laboratory data. The therapeutic measures included MOTRIN since 02Jul2013 at an unknown dose every 8 hours for pain. The consumer was still experiencing the events at the time of the report. The physician stated the mother called and reported the red spot on the leg, but the physician never saw the patient for the problem. The reporter could confirm the occurrence of the events. The reporter and was willing to be contacted again by Pfizer for follow-up information on the reported adverse event. Follow-up (23Jul2013): New information received from a contactable physician includes: expiration date; onset date; reporter informed about the event; reporter confirmed the events; reported confirmed further contactability. Follow-up (09-AUG-2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test negative
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer Colleague. An infant patient of an unspecified gender received three doses of PREVNAR 13, all on an unspecified date at single dose. The patient medical history and concomitant medications were not reported. Although the patient received 3 doses of vaccine, there was no response as titers were 0. The outcome of the event was unknown. The physician asked about process for revaccinating. Follow-up (19Jul2013): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker (Certified Medical Assistant (CMA)) refers to a patient of unknown age, gender and ethnicity. On 26-JAN-2015, the patient was inadvertently administered an expired dose of PNEUMOVAX 23 lot # J009833, expiration date 25-JAN-2015 (dose, route of administration and indication were not provided). No adverse effect was reported. Additional information is not expected. The reporter did not wish to participate in adverse event (AE) report.
Age: 0.56
Sex: F
Vaccine: DTP, HIBV, PNC13
Symptoms: Injection site discolouration, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable reporter who reported for her daughter. A 6 months old, female patient received on 06Apr2010 the following vaccines for immunization: PREVNAR 13 (Lot # E44519; Expiration Date May2011) at single dose on the right thigh, polio vaccine, HIB vaccine on the left thigh and DPT vaccine on the left thigh. Relevant medical history was none. On 06Apr2010 the patient developed a red spot at the site of injection on the top of her right thigh. This spot further darkened over the time (3 to 5 days after of the vaccination) in Apr2010. Relevant laboratory data was none. Therapeutic measures taken in response to the event were unknown. The clinical outcome of the event was not recovered at the time of report. Follow-up (21Jun2013): This is a spontaneous report from a contactable physician. This physician reported that the patient is not one of his/her patients. Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Axillary pain, Chest pain, Feeling abnormal, Headache, Musculoskeletal chest pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. This 53 year-old male patient received PREVNAR 13 single dose, on 31May2013. Relevant medical history and concomitant medication were none. The patient had pain in left arm and arm pit since 31May2013. Then, on 01Jun2013, he experienced low grade fever, pain in rib cage, nausea, headache, some congestion and some collapse. Subsequently the patient reported he still felt bad and was having chest pains. Therapeutic measures taken in response to the adverse events were none. Clinical outcome of the events was unknown at the time of report. Follow-up (01Jun2013): New information reported from agency and was forwarded to Pfizer's agency includes: new events felt bad and chest pains. Follow-up - (26-JULY-2013) Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Nausea, Pain in extremity, Pyrexia, Respiratory tract congestion, Syncope
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. This 53 year-old male patient received PREVNAR 13 single dose, on 31May2013. Relevant medical history and concomitant medication were none. The patient had pain in left arm and arm pit since 31May2013. Then, on 01Jun2013, he experienced low grade fever, pain in rib cage, nausea, headache, some congestion and some collapse. Subsequently the patient reported he still felt bad and was having chest pains. Therapeutic measures taken in response to the adverse events were none. Clinical outcome of the events was unknown at the time of report. Follow-up (01Jun2013): New information reported from agency and was forwarded to Pfizer's agency includes: new events felt bad and chest pains. Follow-up - (26-JULY-2013) Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Drug ineffective
Clinical narrative: This is a spontaneous report obtained from a non-contactable consumer. This adult female consumer reported for her currently 2-year-old son. The baby, that was born premature, received intramuscular PREVNAR 13, (Lot not provided) single dose, on an unspecified date. The mother stated that PREVNAR 13 was not effective on her son. She went on to explain that since he was born premature they needed to undergo tests to determine efficacy of all childhood vaccinations received. No follow up attempts possible. No further information expected.
Age: 40.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 40-year-old female subject was enrolled in a study. The subject received BOOSTRIX (intramuscular) .5 ml on 22nd October 2014. The subject's last menstrual period was on 24th March 2014 and estimated date of delivery was 29th December 2014. The subject received BOOSTRIX at week 30 of the pregnancy. On an unknown date, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Sex: M
Vaccine: PNC13
Symptoms: Anxiety, Injected limb mobility decreased, Pain in extremity
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer posted on one of the parenting listserve. A consumer reported that her husband (age and gender unknown), with a medical history of chronic lung problems, was immunized with PREVNAR 13 on 06May2013. On the same day, after vaccination, he started having extreme pain in the arm he was injected in. He can't move it and was really in agony. He told his doctor and she simply gave him the following answer: "it's normal to have pain and swelling but 1% have extreme pain" line. The consumer wanted to know how long the extreme pain could last. The patient was really worried. At the time of reporting, the outcome of the events was unknown. No follow-up attempts possible. No further information expected.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test, Epistaxis
Clinical narrative: This is a spontaneous report from a contactable consumer. A 71-year-old female patient received PREVNAR 13, intramuscular on 12Feb2013 at 15:30 at a single dose in the left shoulder. Medical history unspecified mycobacterium infection, unknown if ongoing; and triple bypass surgery done on an unknown date. Concomitant medications included PLAVIX, BABY ASPIRIN, LIPITOR, DIOVAN; all ongoing since unknown dates. There were no other vaccines given on the same day or within the prior four weeks. On 14Feb2013, the patient experienced terrific nose bleeding at 3:00 am due to which she went to emergency room. Therapeutic measures were taken in response to the event, terrific nose bleeding, that included treatment with cocaine. Relevant labs included unspecified blood work done on 14Feb2013, the results of which were unknown. The clinical outcome of the event, terrific nose bleeding, was recovered on an unknown date in Feb2013. As of 17Apr2013, follow-up was received from a contactable nurse reporting on behalf of the patient's physician. The nurse reported that after the administration of PREVNAR 13, the physician had not evaluated the patient. Follow-up (17Apr2013): New information from contactable nurse on behalf of a physician in response to a healthcare professional follow-up letter includes: physician had not evaluated patient after administration of PREVNAR 13. Follow-up (10-MAY-2013)): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of an unknown gender and age. Medical history and current conditions were not reported. On an unknown date, the patient's were vaccinated with a dose of (Oka/Merck) PROQUAD (dose, dose number and route were not reported) with lot number reported as K012929 expiration dates 28-FEB-2016, that was improperly stored. No adverse effects were reported. Additional information has been requested. This is one (1) of two (2) reports from the same source.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to incorrect product storage due to on 02-FEB-2015 unkonwn number of patients of unknown ages and genders were vaccinated with improperly stored doses of GARDASIL (does, lot #, expiration dates and route were not reported). No adverse effects reported. It was unknown if the patients sought medical attention. This one of several reports from the same source. Additional information is not expected because we cannot contact the physician.
Sex: U
Vaccine: FLUX, PNC13
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a contactable physician communicated through a Pfizer sales representative. This physician reported that he referred a patient to the infectologist. The patient was co-administered Flu and Pneumococcal shots. After vaccinations, the patient reported that had Herpes Zoster. The reporter considered the event related to pneumococcal vaccine. At the time of reporting, it was unknown if the patient had received PREVNAR 13 or PPSV 23. Follow-up (20-MAR-2013): Follow-up attempts completed. No further information expected.
Age: 1.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This case was reported by a nurse and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received 4th dose of KINRIX (batch number 9AB77, expiry date 19th October 2015). On an unknown date, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information: a 12 month old was inadvertently given KINRIX as the 4th dose of DTaP series.
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a other health professional and described the occurrence of expired vaccine used in a male patient who received ENGERIX B (batch number AHBVC103AA, expiry date 30th May 2014). On an unknown date, the patient received ENGERIX B. On an unknown date, an unknown time after receiving ENGERIX B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. Additional information: HCP stated that 7 doses of expired ENGERIX-B were administered to patients. She said that her office does not pay attention to expiration dates very well. All patients received a dose from the same lot number and expiration date.