chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.6
Sex: M
Vaccine: PNC13, HEPA, PNC13
Symptoms: Blood test, Hypersensitivity, Urticaria
Clinical narrative: This is an initial spontaneous report by a contactable consumer. This female consumer reported for her currently 19 month old son who received PREVNAR 13 intramuscular injection on an unknown site on an unknown date. Relevant medical history was none. Relevant concomitant medications were none. Vaccines given on the same day were unknown. Vaccines taken within the last four weeks were unknown. In 2011 after PREVNAR 13 vaccine the patient had an allergic reaction and hives all over the body. Relevant lab data was unknown. At the time of the report he had recovered from the events on an unknown date. Follow-up (18MAY2012) Follow-up attempts completed. No further information expected.
Age: 1.6
Sex: M
Vaccine: PNC13, HEPA, PNC13
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: This is an initial spontaneous report from a contactable consumer. The reporter is the patient's mother. A 19-month-old, male patient received PREVNAR 13 via the intramuscular route on an unspecified date and hepatitis a vaccine via an unspecified route of administration on an unspecified date. Medical history included an allergic reaction in 2011 and hives all over the body in 2011. There were no concomitant medications. On 23Mar2012 at 1500 hours, while on the PREVNAR 13, the patient experienced an allergic reaction and hives all over the body. Relevant laboratory data included blood work on 28Mar2012 with unknown results. Therapeutic measures were taken as a result of the events and included administration of BENADRYL. The outcomes of the events allergic reaction and hives all over the body were recovered on 27Mar2012. Follow-up (18MAY2012) Follow-up attempts completed. No further information expected.
Age: 1.6
Sex: M
Vaccine: PNC13, HEPA, PNC13
Symptoms: Blood test, Hypersensitivity, Urticaria
Clinical narrative: This is an initial spontaneous report from a contactable consumer. The reporter is the patient's mother. A 19-month-old, male patient received PREVNAR 13 via the intramuscular route on an unspecified date and hepatitis a vaccine via an unspecified route of administration on an unspecified date. Medical history included an allergic reaction in 2011 and hives all over the body in 2011. There were no concomitant medications. On 23Mar2012 at 1500 hours, while on the PREVNAR 13, the patient experienced an allergic reaction and hives all over the body. Relevant laboratory data included blood work on 28Mar2012 with unknown results. Therapeutic measures were taken as a result of the events and included administration of BENADRYL. The outcomes of the events allergic reaction and hives all over the body were recovered on 27Mar2012. Follow-up (18MAY2012) Follow-up attempts completed. No further information expected.
Age: 1.25
Sex: M
Vaccine: PNC13
Symptoms: Poor quality drug administered, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting on behalf of his son. A 16-month-old, male patient received PREVNAR 13, via an unspecified route of administration on an unknown date in Mar2012 at 1 single dose on an unknown anatomical site for an unspecified indication. The patient medical history was not reported. Sibling information for this three elder brothers was unknown. There were no concomitant medications. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were none. On an unknown date in Mar2012, it was reported that the patient was administered a bad lot of the vaccine and he experienced a mild fever. Relevant lab data was none. Therapeutic measures were taken as a result of the mild fever and included treatment with TYLENOL. The clinical outcome of the event, mild fever, was recovered on an unknown date in Mar2012. The clinical outcome of the event, the patient was administered a bad lot of the vaccine, was unknown. Follow-up (18MAY2012) Follow-up attempts completed. No further information expected.
Age: 3.0
Sex: M
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer. A 3-year-old male patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration on 18Apr2012. The patient medical history was not reported. The patient's concomitant medications were not reported. On 18Apr2012, the patient was not able to lift his arm after vaccination. Relevant laboratory tests were unknown. Therapeutic measures taken as a result of the event were unknown. The outcome was reported as not recovered at the time of the report.
Age: 58.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: This is an initial spontaneous report from a contactable Pfizer internal colleague. A 58-year-old female patient received PREVNAR 13 via an unspecified route of administration on her forearm on 10May2012 at 15:00. Medical history included ongoing high blood pressure. Concomitant medication included lisinopril for high blood pressure (unspecified date-present). On 10May2012, at an unknown time after the administration of PREVNAR 13, the patient experienced redness at the site of injection. On 16May2012, the patient mentioned that the site of injection was swollen, hard to touch, and sore. The outcomes of the events were not recovered at the time of the report.
Age: 0.2
Sex: M
Vaccine: PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: This is an initial spontaneous report from a contactable reporter. This mother reported that her 3-month-old, son who received PREVNAR 13 on 13Apr2012 (dose and frequency unknown) as a vaccination. The consumer did not have any relevant medical history and was not taking any concomitant medications. The consumer developed fever and irritability on receiving PREVNAR 13 on 13Apr2012. The relevant laboratory data was none. Last action taken with PREVNAR 13 was unknown in response to the events. The consumer was given TYLENOL (dose and frequency was unknown) for fever on an unknown date in Apr2012. The consumer was still suffering from the reported events at the time of report.
Age: 0.35
Sex: F
Vaccine: PNC13
Symptoms: Culture negative, Injection site discharge, Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable nurse. A 4-month-old female patient received the second dose of PREVNAR 13 (Lot# 917242) via the intramuscular route in her left thigh on 20Mar2012. The patient medical history was not reported. Concomitant medications included PEDIARIX, HIB, and ROTATEQ all administered on unspecified dates. The patient was previously immunized with PREVNAR 13 on her right thigh and experienced a large red bump with yellow greenish drainage. On an unspecified date in 2012, the patient experienced a large red bump in her left thigh, injection site swelling, and redness. Relevant lab data included culture and sensitivity on 19Apr2012 and 23Apr2012 showing no growth. Therapeutic measures were taken as a result of the events and included treatment with antibiotic ointment. The outcome of the event large red bump was unknown at the time of the report. The outcomes of the events injection site swelling and redness were recovering. Follow up (15May2012): New information reported by the contactable nurse included product lot numbers, dosage regimens, concomitant vaccinations, relevant lab data, outcome information, and treatment details. Follow-up (31MAY2012) Follow-up attempts completed. No further information expected.
Age: 0.4
Sex: U
Vaccine: PNC13
Symptoms: Body temperature increased, Inflammation
Clinical narrative: This is a spontaneous report from a contactable physician communicated to field force sales representative. A 5 month old infant received PREVNAR 13 1 DF intramuscular on an unknown date for immunization. The patient received a total of 7 vaccines. On an unknown date the patient developed a temperature of 38.2C and "inflammation in the fontella". Follow-up (11JUL2012) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Peripheral swelling, Rash
Clinical narrative: This is a spontaneous report from a contactable nurse. This nurse reported for a patient of unknown age, gender and race who received a single dose of PREVNAR 13 on unknown date. The patient experience allergic reaction with rash and significant swelling of leg on unknown date. It was also reported that it blanches with pressure. There was no clear indication that the reported events occurred after 4th or 5th administration of PREVNAR 13. The outcome of the events was unknown at the time of this report. Follow-up (05SEP2012) Follow-up attempts completed. No further information expected.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Bronchitis, Gastrointestinal pain
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. This 53 year old, male patient received single dose, on 15May2012 as a pneumonia preventive vaccine. Relevant medical history and concomitant medications were none. The patient experienced gastrointestinal cramping since 24May2012 (which was king of severe stomach cramping) and bronchitis like symptoms since 27May2012. Relevant laboratory data was none. The therapeutic measures included ADVIL (dose and frequency was unknown) for bronchitis like symptoms since an unknown date in May2012 and the patient also mentioned that he had taken unspecified OTC (dose and frequency was unknown) for gastrointestinal cramping on an unknown date in May2012. The patient had recovered from the events on an unknown date in 2012. Follow-up (03AUG2012) Follow-up attempts completed. No further information expected.
Age: 67.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Blood pressure increased, Injection site pain, Insomnia, Pyrexia
Clinical narrative: This is an initial spontaneous report from a contactable consumer. This 67 year old male consumer was administered PREVNAR 13 unknown dose intramuscular injection in the right upper arm on 11Jun2012 at 09:30. Relevant medical history included high blood pressure and infection in tooth which were still ongoing. Relevant concomitant medications included amoxicillin for infection in tooth which he was still taking it. Vaccines given on the same day were none. Vaccines taken within the last four weeks were none. On 11Jun2012 while on PRENAR 13 unknown dose at an unknown time he experienced muscle soreness at the site of injection, joint soreness, slight fever, minor sleeplessness and blood pressure was elevated. Relevant lab data was none. At the time of the report it was unknown he was on PREVNAR 13. At the time of the report clinical outcome of blood pressure was elevated was unknown. At the time of report he had not recovered from the other above mentioned events. Follow-up (07AUG2012) Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Headache, Infection
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for herself. This female consumer reported that on 10May2012 she received 1 dose of PREVNAR 13. On 15May2012 she felt very tired. On 17May2012 and on 18May2012, she experienced mild intestinal upset early morning. From the evening of 18May2012 to 20May2012, she was still very tired and lethargic. On 21May2012 at noon she experienced headache and slight nausea so, she decided to go to the physician who diagnosed an unspecified infection. Treatment provided was an antibiotic. She is still not recovered: on 23May2012 she felt sick, on 25May2012 she had swollen glands and sore throat. She felt fine but she was still on antibiotics and taking ADVIL COLD AND SINUS each day. She has not a lot of appetite. No follow up attempts possible. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Lethargy, Lymphadenopathy, Nausea, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer who reported for herself. This female consumer reported that on 10May2012 she received 1 dose of PREVNAR 13. On 15May2012 she felt very tired. On 17May2012 and on 18May2012, she experienced mild intestinal upset early morning. From the evening of 18May2012 to 20May2012, she was still very tired and lethargic. On 21May2012 at noon she experienced headache and slight nausea so, she decided to go to the physician who diagnosed an unspecified infection. Treatment provided was an antibiotic. She is still not recovered: on 23May2012 she felt sick, on 25May2012 she had swollen glands and sore throat. She felt fine but she was still on antibiotics and taking ADVIL COLD AND SINUS each day. She has not a lot of appetite. No follow up attempts possible. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Chills, Decreased appetite, Headache, Lethargy, Pain
Clinical narrative: This is an initial spontaneous report by a contactable consumer. This male consumer (age unknown) was administered with PREVNAR 13 unknown dose intramuscular vaccine unknown frequency on arm on 18Jul2012. Relevant medical history included high blood pressure and it was unknown if he had recovered from it. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were unknown. Relevant concomitant medications included unspecified medication for high blood pressure and it was unknown if he was still taking this medication. On 18JUL2012 while on PREVNAR 13 unknown dose unknown frequency he experienced soreness in arm. On 19JUL2012 while on PREVNAR 13 unknown dose unknown frequency he experienced headache, chills, overall soreness, was lethargic and had no appetite. Relevant lab data was unknown. At the time of report it was unknown that he was administering PREVNAR 13. At the time of report he had not recovered from the above mentioned events.
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: This is an initial spontaneous report by a contactable consumer. This male consumer (age unknown) was administered with PREVNAR 13 unknown dose intramuscular vaccine unknown frequency on arm on 18Jul2012. Relevant medical history included high blood pressure and it was unknown if he had recovered from it. Vaccines given on the same day was unknown. Vaccines taken within the last four weeks were unknown. Relevant concomitant medications included unspecified medication for high blood pressure and it was unknown if he was still taking this medication. On 18JUL2012 while on PREVNAR 13 unknown dose unknown frequency he experienced soreness in arm. On 19JUL2012 while on PREVNAR 13 unknown dose unknown frequency he experienced headache, chills, overall soreness, was lethargic and had no appetite. Relevant lab data was unknown. At the time of report it was unknown that he was administering PREVNAR 13. At the time of report he had not recovered from the above mentioned events.
Age: 55.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Myalgia
Clinical narrative: This is a spontaneous report obtained from a contactable consumer. This 55 year old female consumer received intramuscular PREVNAR 13 at 09:00 am on right arm on 21Jun2012. Relevant medical history, concomitant medication and vaccines given on the same day were none. Vaccine taken within the last four weeks was none. On 21Jun2012, at 09:30 pm while on PREVNAR 13, she had sore muscle and mild pain at the site of injection. At the time of the report, the patient had not recovered from the events.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Body temperature increased, Malaise, Peripheral swelling
Clinical narrative: This is a spontaneous report by a contactable physician through a Pfizer Sales Representative. A 79 year old female patient received PREVNAR 13 unknown dose, at unknown anatomical site, at an unknown time on an unknown date. Relevant medical history and relevant concomitant medications were unknown. Vaccines given on the same day and vaccines taken within the last four weeks were unknown. On 20Aug2012 she experienced severe swelling in the arms, was severely sick and temperature was up to 102 degree F. It was unknown if she had any siblings. Relevant lab data was unknown. At the time of the report clinical outcome of the above mentioned events was unknown.
Age: 1.0
Sex: M
Vaccine: PNC13, UNK
Symptoms: Administration site induration, Injection site erythema
Clinical narrative: This is a spontaneous report from a contactable consumer. This male consumer reported on behalf of his 12 month old son who received PREVNAR13 0.5 ml single dose intramuscular injection at 17:30 on right arm on 04Jun2012. Relevant medical history was none. Relevant concomitant medication was none. Vaccine given on the same day included two other unspecified vaccine on left arm. Vaccines taken within the last four weeks were none. Illness at the time of vaccination was none. On 05Jun2012, he experienced red spot at the site of administration which was hard to touch. Relevant lab data was none. At the time of the report he had not recovered from the event. The contactable physician stated that the patient provided information regarding reported adverse event. The contactable physician also stated that cannot confirm the occurrence of the events reported by the patient. Follow-up (25Jun2012): New information received from a contactable physician includes: the physician did not confirm the occurrence of the events. Follow-up (02Jul2012): This follow-up report is being submitted to amend previously reported information. The case was not medically confirmed. Follow-up (12JUL2012) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A patient (age, race and gender unknown) received PREVNAR 13 since an unknown duration at an unknown dose and frequency. The relevant medical history and the relevant concomitant medications of the patient were unknown. It was reported that the patient developed swelling while being on PREVNAR 13 on an unknown date. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event and the clinical outcome of the event were unknown at the time of report.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a Pfizer Vaccine Representative for a contactable reporter. The physician reported that a 65 year old, female patient (race unknown) received PREVNAR 13 injection on 13Jun2012 single dose on left arm. The relevant medical history was unknown. The relevant concomitant medications included isosorbide mononitrate at 60 mg daily, guanidine hydrochloride at 0.3 mg three times a day, simvastatin 40 mg daily, aspirin at 81 mg daily, metoprolol tartrate at 100 mg three times a day, benazepril hydrochloride 40 mg daily, hydralazine 100 mg three times a day, all since an unknown duration for an unknown indication. The past drug history included pneumococcal vaccine in Nov2007 however she did not experience any pain at that time. On 13Jun2012, few hours after PREVNAR 13 injection was administered, she started experiencing severe pain in her left arm at the site of injection due to which she visited emergency room however she was not admitted and was relieved on the same day on 13Jun2012. The relevant laboratory tests were unknown. Therapeutic measures taken for the reported event was unknown. Clinical outcome of the reported event was unknown at the time of the report. Follow-up (20JUL2012 Follow-up attempts completed. No further information expected.
Age: 0.96
Sex: M
Vaccine: PNC13
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient's mother. An 11-month-old male patient received a dose of either PRENAR or PREVNAR 13, via an unspecified route of administration on 27Jul2012 at 3:30 pm at a single dose for vaccination. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccine 4 weeks prior to receiving either PREVNAR or PREVNAR 13; but he was administered two unspecified vaccines 5 weeks ago in 2012. On 27Jul2012 at 4:30 pm, one hour after receiving the vaccine, the patient had a fever. On 30Jul2012, the patient developed cold symptoms. Therapeutic measures were taken as a result of the fever and cold symptoms and included treatment with MOTRIN and TYLENOL, both at 1.875 ml alternating every four hours. the patient had recovered from the fever on 29Jul2012 and had recovered from the cold symptoms on 03Aug2012.
Sex: F
Vaccine: PNC13
Symptoms: Chills, Lethargy, Night sweats, Pyrexia, Upper extremity mass
Clinical narrative: This is a spontaneous report from a contactable physician reporting on his wife. An adult female patient of an unspecified age and ethnicity received PREVNAR 13 on an unspecified date. Relevant medical history and concomitant medications were not provided. The patient previously received two pneumococcal vaccines (unspecified trade names). The reported believes that the patient received the first pneumococcal vaccine when the patient was 59-years old and the second pneumococcal vaccine approximately two years ago on an unspecified date in 2010 and the patient did not have any problems after receiving the vaccines. After the patient received the PREVNAR 13, she experienced night sweats, chills, fever, intense lethargy and a lump in the left deltoid. Therapeutic measures taken in response to the night sweats, chills, fever, lethargy and lump were unknown. The clinical outcome of the events night sweats, chills, fever, lethargy and lump in deltoid were unknown.
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Erythema
Clinical narrative: This is a spontaneous report from a contactable consumer (medical assistant). This medical assistant reported on behalf of a female patient of unknown age and race who received the second dose of PREVNAR 13 at 0.5 ml single, intramuscular, on 15Jun2012 at 15:18. On the same day she received DTaP, HIB, ROTATEQ and Polio vaccine. Vaccines taken within the last four weeks were unknown. Previously the patient had received the first dose of PREVNAR 13, at 0.5 ml single, intramuscularly, on 13Apr2012 at 15:18. Relevant medical history was none. On 15Jun2012 the patient turned red. Illness at the time of the vaccination was none. Relevant lab data was none. The event did not require an emergency room or doctor visit. At the time of the report the clinical outcome of the event was unknown.
Age: 1.99
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse. The nurse reported that a 23-months-old, female patient received the fourth dose of PREVNAR 13 (Lot n. F45130, expiration date 01Feb2014) at 0.5 ml single, intramuscularly, on 09Jul2012 for immunization. The relevant medical history included allergy to egg and milk since an unknown date. There were no relevant drug history, drug allergies and family history. The relevant concomitant medications were unknown. Previously the patient received the first dose of PREVNAR 13 (Lot n. E87534), at 0.5 ml single, at the age of 2 months, intramuscularly in the left thigh on 05Oct2010 for immunization; the second dose of PREVNAR 13 (Lot n. E88939) at 0.5 ml single, at the age of 5 months, intramuscularly in the left thigh on 03Jan2011 for immunization and the third dose of PREVNAR 13 (Lot n. E89951) at 0.5 ml single, at the age of 7 months, intramuscularly in the left thigh on 25Feb2011 for immunization. The patient had swelling and hives at the injection site on 10Jul2012. The nurse elaborated that the patient had redness at the site of injection so they made a circle at the site of injection and the redness spread beyond the circle within 12 hours. The relevant laboratory data was unknown. The events resulted in a doctor visit. Therapeutic measures taken for the reported events included BENADRYL and ibuprofen for 72 hrs. The patient recovered from the events on 16Jul2012. Follow-up (30Jul2012): New information reported from the same contactable nurse includes: PREVNAR 13 treatment details, adverse event information updated, therapeutic measures, medical history, outcome of the events, previous vaccinations information. Follow-up (31AUG2012): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer. A Pfizer employee reported on behalf of his colleague's daughter. A female patient of unspecified age received PREVNAR 13 on 30Jul2012 in the late afternoon between 4-5 PM for routine immunization. The relevant medical history of the patient was unknown. Relevant concomitant medications included unspecified vaccines administered on 30Jul2012 for an unknown indication. After the patient received the PREVNAR 13 on 30Jul2012, she experienced pain at the site of injection. No relevant laboratory data was reported. Therapeutic measures taken in response to the injection site pain were unknown. The clinical outcome of the injection site pain was unknown. Follow-up (31AUG2012): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: PNC13
Symptoms: Laboratory test normal, Urticaria
Clinical narrative: This is a spontaneous report from Pfizer Medical information department for a contactable nurse. This nurse reported for a 9 year old male consumer who received PREVNAR 13 on 11Jun2012 at an unknown dose and frequency for immunization. The relevant medical history included asthma and autoimmune deficiency since an unknown date. The relevant concomitant medications included QVAR, both since an unknown date at an unknown dose two puffs two times a day for asthma and multivitamins daily (duration, dose and indication unknown). On 11Jun2012 after two hours of receiving PREVNAR 13 vaccine he experienced hives. The laboratory data included unspecified test on an unknown date in 2012 done after thirty days of receiving PREVNAR 13 vaccine to check how the consumer responded to the medication and the result was good. Therapeutic measures taken in response to the event included BENADRYL (duration, dose and frequency unknown). At the time of the report he was recovering from the reported event. Follow-up (05SEP2012): Follow-up attempts completed. No further information expected.
Age: 0.5
Sex: U
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales representative. A 6-months old patient of unknown gender and race received the third dose of PREVNAR 13 on an unknown date for immunization. The patient had previously received the first dose of PREVNAR 13 on unknown date at the age of two months and the second dose of PREVNAR 13 on unknown date at the age of five months. Relevant medical history and concomitant medications were unknown. After the third dose of PREVNAR 13 the patient developed fever of 106 degrees Fahrenheit on unknown date. Therapeutic measures taken for the event included acetaminophen (dose and frequency unknown). The outcome of the reported event was unknown at the time of the report. Follow-up (05SEP2012): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report from a non contactable consumer. This adult female consumer reported to Pfizer Internal Colleague that she received a dose of PREVNAR 13 in her arm on an unknown date. On an unknown date, after vaccination, she experienced soreness in her arm at the site of injection. At the time of the report the clinical outcome of the above mentioned event was unknown.
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain
Clinical narrative: This is a spontaneous report obtained from a non contactable consumer through a Pfizer sales representative. A male patient received PREVNAR 13 on an unknown date. Vaccine was administered in the arm. Relevant medical history and concomitant medications were unknown. Vaccines given on the same day and taken within the last four weeks were unknown. On an unknown date, the patient experienced soreness in his arm at the site of injection. Relevant laboratory data was unknown. At time of this report, the clinical outcome of the event was unknown.
Age: 0.2
Sex: F
Vaccine: PNC13
Symptoms: Crying, Incorrect dose administered, Injection site haemorrhage, Needle issue
Clinical narrative: This is a spontaneous report by a contactable consumer. This male consumer reported on behalf of his two month old daughter who received PREVNAR 13 single dose on thigh of the right leg on 12Sep2012. Relevant medical history was unknown. While administration the needle of the vaccine broke due to which only some of the vaccine was injected and the broken needle remained in her right thigh and her right leg was bleeding. The doctor wanted her to get a second dose, so a second dose was given. The nurse was rushing because my daughter was crying. As the needle was being put in the thigh, the nurse hit the needle with the pinky of her hand and broke off the needle. The needle was stuck in her leg. It was not an issue with they syringe. The reporter does not have the pack of PREVNAR 13 handy as the product was received in hospital, hence LOT #, expiration date, NDC # and other product complaint information was unknown. Outcome was unknown. Follow-up (08NOV212) Follow-up attempts completed. No further information expected.
Age: 0.18
Sex: F
Vaccine: HEP, PNC13, RV1
Symptoms: Incorrect dose administered, Injection site haemorrhage, Needle issue
Clinical narrative: This is a spontaneous report by a contactable consumer and then from a contactable physician. This male consumer reported on behalf of his two month old daughter who received PREVNAR 13 single dose on thigh of the right leg on 12Sep2012 at 11:35. Relevant medical history was unknown. Vaccine given on the same day included ROTARIX oral vaccine and Hepatitis B vaccine given on left thigh. Vaccines taken within the last four weeks were none. On 12Sep2012 at 11:35 while administration the needle of the vaccine broke due to which only some of the vaccine was injected and the broken needle remained in her right thigh and her right leg was bleeding. The patient did not have any sibling. Relevant lab data was none. The physician clarified that this was not a malfunction of the vaccine. The needle separated from the pre-loaded syringe when the nurse was giving me vaccine. However we put the needle in the syringe so it was not a manufacturer error. At the time of the report the outcome was unknown. Follow-up (15Oct2012): New information received from a contactable physician includes: confirmation of the events and reaction details. Follow-up attempts completed. No further information expected. Follow-up (08NOV2012) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician via a sales representative. A patient of unspecified age ethnicity and gender received PREVNAR 13 on unknown date. The patient did not have antibodies after vaccine. The outcome was unknown. Follow-up (21NOV2012) Follow-up attempts completed. No further information expected. Follow-up (06Dec2012): This follow-up report is being submitted to amend previously reported information: PREVNAR 13 recoded to add the correct formulation to the appropriate database field for proper submission. Follow-up (10Dec2012): This follow-up report is being submitted to amend previously reported information: PREVNAR 13 to the appropriate database field for proper submission.
Sex: U
Vaccine: PNC13
Symptoms: Hypersensitivity, Injection site rash
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sale representative. A patient (age and gender unknown) received the first dose of intramuscular PREVNAR 13 0.5 ml, single on an unspecified date. The patient experienced an allergic reaction to PREVNAR 13, local skin reaction at injection site, described as severe rash, which resolved upon giving BENADRYL and steroid shot. Lasted for about a week.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales representative. This physician reported similar event for two patients. This is first of two reports. An adult patient received PREVNAR 13 on arm, unknown date for immunization. Relevant medical history, drug history and concomitant medications were unknown. On unknown date, the patient experienced injection site reaction. Therapeutic measures taken in response to above mentioned event included treatment with unspecified steroid for one week. Sibling information was unknown. Relevant lab data was unknown. At the time of the report the patient was recovered from above mentioned event on an unknown date. Follow-up (25NOV2012): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction
Clinical narrative: This is an initial spontaneous report from a contactable physician via a Pfizer Sales representative. This physician reported similar event for two patients. This is second of the two reports. An adult patient received PREVNAR 13 unknown dose unknown route unknown dosage form unknown frequency on an unknown time on arm for an unknown indication on an unknown date. Relevant medical history was unknown. Relevant drug history was unknown. Relevant concomitant medications were unknown. Vaccine given on the same day was unknown. Vaccine taken within the last four weeks was unknown. On an unknown date at an unknown time while on PREVNAR 13 unknown dose unknown frequency patient experienced injection site reaction. Sibling information was unknown. Relevant lab data was unknown. At the time of the report it was unknown if patient was taking PREVNAR 13. At the time of the report the patient had recovered from above mentioned event on an unknown date. Follow-up (25NOV2012): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Swelling
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. A female patient (age unknown) received PREVNAR 13 on an unknown date. On an unknown date, an extreme amount of swelling occurred. Patient went to the Emergency Department (ED) and followed up with her medical doctor. Follow-up (06DEC2012) Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Pruritus, Skin reaction
Clinical narrative: This is a spontaneous report from a contactable nurse practitioner through Pfizer Sales Representative. This nurse practitioner reported for a patient (age, race and gender unknown) who received a dose of PREVNAR 13 on an unknown date for immunization. The relevant medical history included cellulitis. Relevant concomitant medications were unknown. It was reported that on an unknown date after the patient received PREVNAR 13, developed itch on her/his arm and her/his arm was dark red which was elaborated as it was about 5 inch in length and 4 inches in diameter. At the time of this report therapeutic measures taken to treat the reported events, if any, were unknown. At the time of the report clinical outcome of the reported events was unknown.
Sex: U
Vaccine: PNC13
Symptoms: Injection site reaction, Local reaction
Clinical narrative: This is a spontaneous report from a contactable physician communicated through a Pfizer sales representative. This physician reported for an adult patient (more than 50-year-old), race and sex unknown, who received PREVNAR 13 at 0.5 ml single dose on an unspecified date. Relevant medical history and relevant concomitant medications of the patient were unknown. It was reported that on an unknown date the patient had a local site reaction. Relevant laboratory tests were unknown. Therapeutic measures were unknown. Clinical outcome of the reported event was unknown at the time of the report.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Skin exfoliation
Clinical narrative: This is a spontaneous report from a contactable physician through a Pfizer Sales Representative. A 85 year old, female patient of an unknown race, received PREVNAR 13 on an unknown date in 2012, single dose. The relevant medical history of the patient included asthma and allergic to penicillins since unknown durations. The relevant concomitant medications of the patient were unknown. The relevant past product history of the consumer included PNEUMOVAX since an unknown date in 2003 at an unknown dose and frequency for an unknown indication. It was reported that on an unknown date in 2012, the patient experienced redness in her arm and skin of the arm peeled off. The relevant laboratory data were unknown. Therapeutic measures taken if any, in response to the reported events was unknown. The consumer had recovered from the reported evens on an unknown date in 2012 at the time of report.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is a spontaneous report by a contactable nurse through a Pfizer Sales Representative. This female nurse reported similar events for three different patients. This is the first of three reports. A patient received PREVNAR 13 injection unknown dose as a single shot at unknown time on an unknown anatomical site on an unknown date. Relevant medical history, relevant drug history and relevant concomitant medications were unknown. Vaccine given on the same day was unknown. Vaccines taken within the last four weeks were unknown. In Sep2012 after taking the single shot of PREVNAR 13 the area around the site of injection was warm to touch and had redness and swelling around the site of injection. Relevant lab data was unknown. At the time of the report clinical outcome of the above mentioned events were unknown. Follow-up (19OCT2012): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This is an initial spontaneous report from a contactable nurse. This female nurse reported similar events for three different patients. This female Pfizer Sales Representative reported on behalf of a nurse for the second patient who was administered PREVNAR 13 injection unknown dose as a single shot at unknown time on an unknown anatomical site on an unknown date. Relevant medical history was unknown. Relevant drug history was unknown. Relevant concomitant medications were unknown. Vaccine given on the same day was unknown. Vaccines taken within the last four weeks were unknown. In Sep2012 after taking the single shot of PREVNAR 13 the area around the site of injection was warm to touch and had redness and swelling around the site of injection. The patient was administered PREVNAR 13 as a single dose. Relevant lab data was unknown. At the time of the report patient was not on PREVNAR 13 as it was given as single dose. At the time of the report clinical outcome of the above mentioned events were unknown. Follow-up (19OCT2012): Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC13
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This is a spontaneous report by a contactable pharmacist via a Pfizer Sales Representative reported on behalf of a female pharmacist in regards to PREVNAR 13. This pharmacist mentioned that on 29Oct2012 "10 doses of PREVNAR 13 were stored in freezer instead of refrigerator". At the time of report PREVNAR 13 was not used by the patient, hence no patient involved. Follow Up (19Nov2012): This is a follow up spontaneous report from a contactable reporter who was calling on behalf of the Pharmacist. This follow up report is a result of a letter received by the Pharmacist from Pfizer. New information: No new adverse event was reported. The reporter wanted to know why they have received this letter from Pfizer. Follow Up (26Nov2012): New information received from a contactable other HCP on behalf of the Pharmacist included: product never left the store. Never used never dispensed. The PREVNAR 13 was received into the store and by accident was placed in the Freezer. The product was never used/never dispensed. Lot # F45119 Exp: Feb2014. Follow-up attempts completed. No further information expected.
Age: 0.8
Sex: M
Vaccine: PNC13
Symptoms: Ear swelling, Eye swelling, Injection site mass, Mouth swelling, Swelling face
Clinical narrative: This is a spontaneous report from a contactable reporter who reported for her son. This 9-months-old, male patient was administered with PREVNAR 13 single dose on 26Sep2012. The relevant medical history included cold and running nose both since an unknown duration. The relevant concomitant medication was none. The reporter mentioned that on 28Sep2012 morning the patient experienced hives and swelling all over face for which it was elaborated that his mouth, ears and eyes were swelled up after receiving PREVNAR 13. The reporter further stated that swelling got worse throughout the day and by the evening he was rushed to the emergency room. The reporter also mentioned that since an unknown date the patient had a very hard lump on his thigh at the site of vaccine administration. The relevant laboratory tests were none. Therapeutic measure taken for the reported events hives and swelling all over face included prednisone at a dose of 3 ml daily, BENADRYL at a dose of 2ml every 6 hours and ibuprofen at a dose of 1.8 ml every 6 hours and an unspecified antihistamine at an unknown dose and frequency all since an unknown date. The patient recovered from hives and swelling all over face on an unknown date however the clinical outcome of the other reported event was unknown at the time of report. Follow-up (07NOV20120: Follow-up attempts completed. No further information expected.
Age: 0.8
Sex: M
Vaccine: PNC13
Symptoms: Urticaria, Vaccination site induration
Clinical narrative: This is a spontaneous report from a contactable reporter who reported for her son. This 9-months-old, male patient was administered with PREVNAR 13 single dose on 26Sep2012. The relevant medical history included cold and running nose both since an unknown duration. The relevant concomitant medication was none. The reporter mentioned that on 28Sep2012 morning the patient experienced hives and swelling all over face for which it was elaborated that his mouth, ears and eyes were swelled up after receiving PREVNAR 13. The reporter further stated that swelling got worse throughout the day and by the evening he was rushed to the emergency room. The reporter also mentioned that since an unknown date the patient had a very hard lump on his thigh at the site of vaccine administration. The relevant laboratory tests were none. Therapeutic measure taken for the reported events hives and swelling all over face included prednisone at a dose of 3 ml daily, BENADRYL at a dose of 2ml every 6 hours and ibuprofen at a dose of 1.8 ml every 6 hours and an unspecified antihistamine at an unknown dose and frequency all since an unknown date. The patient recovered from hives and swelling all over face on an unknown date however the clinical outcome of the other reported event was unknown at the time of report. Follow-up (07NOV20120: Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer via a sales representative. This consumer reported on behalf of her 4 year old daughter who received a single dose of PREVNAR13 on an unknown date. Relevant medical history and concomitant medications were unknown. The reported mentioned that only PREVNAR13 was administered to the patient. On an unknown date, at an unknown time, the patient experienced 102 degree F fever for 8 days. Relevant lab data was unknown . Emergency room or doctor visit were not required. At the time of the report the clinical outcome of above mentioned event was unknown. Follow-up (06DEC2012): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a sales representative. A female patient of an unspecified age and ethnicity received PREVNAR13 on arm at 0.5 ml single dose. The patient medical history and concomitant medications were not reported. The patient experienced redness and swelling in arm where vaccine was given occurring 3 days post injection. The outcome of the events was unknown. Follow-up (09NOV2010) Follow-up attempts completed. No further information expected.
Age: 0.39
Sex: M
Vaccine: PNC13
Symptoms: Amphetamines positive, Hair metal test abnormal
Clinical narrative: This is a spontaneous report from a contactable nurse reporting on her son. An 8-month-old male patient received PREVNAR13, via an unspecified route of administration on 09AUG2012 (Lot Number: F72493) and 12NOV2012 at single doses. The patient medical history was not reported. There were no concomitant medications. On 20NOV2012, the patient had a 5 panel hair drug test revealed t hat his amphetamine and methamphetamine levels were high at 3068pg/mg. The nurse also reported that 5 panel hair drug test also revealed that there were high levels of aluminum phosphate in the patient's body. Therapeutic measures taken in response to the events, amphetamine and methamphetamine levels were high and high levels of aluminum phosphate, were unknown; however the nurse reported that the patient was under physician care. The clinical outcome of the events, amphetamine and methamphetamine levels were high and high levels of aluminum phosphate, was unknown at the time of report. The nurse mentioned that the high levels of amphetamine and methamphetamine were due to aluminum phosphate base present in PREVNAR13. Follow-up (21-FEB-2013): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Antibody test abnormal
Clinical narrative: This is a spontaneous report from a contactable physician. This physician reported on behalf of a 67 year old female consumer who received a single dose of PREVNAR13 on an unknown date. Relevant medical history included leukemia from which she had recovered on an unknown date. Relevant drug history was unknown. Relevant concomitant medications were unknown. Vaccine given on the same day was unknown. Vaccines taken with in the last four weeks were unknown. On an unknown date, patient's unspecified titer levels were low. Relevant lab data included an unspecified test carried out on an unknown date which revealed that unspecified titer levels were low. At the time of report clinical outcome of the above mentioned event was unknown. Follow-up (07FEB2013) Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Rash
Clinical narrative: This is a spontaneous report from a contactable physician via a colleague. This physician reported that a female patient received PREVNAR13, 0.5 ml, single dose on an unknown date and developed a painful rash and erythema 3 x 3 of diameter on left deltoid. The patient reported the event 48 hours after the administration. The outcome of the events was unknown.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Eye swelling, Swelling face
Clinical narrative: This is a spontaneous report from a contactable physician received via a sales representative. A female patient of unknown age and ethnicity received a single dose of PREVNAR13 on 08JAN2013. Relevant medical history, concomitant medications, and past drug history were not reported. No other vaccines were administered on the same day and vaccines administered within the last four weeks were unknown. On 08JAN2013, the patient experienced swollen eyes, facial swelling, and the patient's "face got real red". Therapeutic measures received included use of BENADRYL. The patient recovered from the events swollen eyes, facial swelling and "face got real red" on an unspecified date in  JAN2013. Follow-up attempts completed. No further information expected.